MDY V'S ROCHE COURT CASE Case IS DISMISSED. 2/02/2006

I. INTRODUCTION.

Defendants Apex Biotechnology Corp. and Hypoguard USA, Inc. (collectively "Apex") respectfully submit this Memorandum in Support of Their Motion to Compel Production of Documents Relating to Testing of Accused Products for Infringement of U.S. Patent No. Re.
36,268 ("the 268 patent"). Despite Apexs repeated requests, Plaintiffs Roche Diagnostics Corporation, Roche Diagnostics Operations, Inc., and Corange International Ltd. (collectively, "Roche") have failed to provide answers or produce documents responsive to Apexs various interrogatories and requests for production related to testing of the products accused of infringing Roches now unenforceable 268 patent. Roche has also refused to produce a witness or witnesses to testify on Roches behalf on each of the subjects identified in Defendants July 26, 2005 Notice of Rule 30(b)(6) Videotaped Deposition ("Apexs Rule 30(b)(6) Notice"). Roche claims that the requested documents and testimony topics are subject to blanket attorney-client privileges and/or the work product exception to the discovery requirements. For one thing, Roche has taken no steps to meet its burden of demonstrating that either of these exceptions
apply. Moreover, the work product exception is not applicable where, as here, Apex has exhausted all means of trying to obtain the withheld information, the patent at issue is invalid and unenforceable, the plaintiffs attorneys conduct is at issue, and the need for the items identified as work product is compelling. Furthermore, even assuming that Roche properly performed pre-suit testing of Apexs products, it is inconceivable that all of the testing results would be subject to the well-defined attorney-client privilege.
Notably, the facts of the current dispute follow those in Loctite Corp. v. Fel-Pro, Inc., 667 F.2d 577 (7th Cir. 1981), in which the Seventh Circuit affirmed the district courts dismissal of the patentees action and award of attorneys fees to the defendants where the patentee refused to disclose the test results of defendants products upon which patentee based its complaint. Importantly, in Loctite, as here, the technology at issue mandated that an infringement determination could not be alleged reasonably, and certainly could not be assessed, without extensive testing. This is especially noteworthy as the key technical terms in the asserted 268 patent claims had already been construed by the Court in the Roche v. Bayer litigation, two years before Roche filed suit against Apex.
Loctite is exemplary. Substantial evidence adduced in the litigation history of the 268 patent, including the Roche v. Bayer trial and the present Roche v. Apex matter, well establish that not all electrochemical blood glucose monitor kits employ the so-called "Cottrell current" "substantial completion" and "open circuit" claim limitations recited in the 268 patent claims. Thus, as in Loctite and in Roche v. Bayer, absent extensive testing there is simply no way to know whether the key technical claim limitations exist in the Apex accused products. Indeed, as evidenced by expert testimony from both sides in the recent inequitable conduct trial of May 31 through June 2, 2005, most electrochemical blood glucose monitoring devices do not employ the "Cottrell current" or "substantial completion" limitations. And, as the jury found in Roche v. Bayer, not every electrochemical blood glucose monitoring device employs an "open circuit."
While Apexs discovery requests pertain to both of Roches patents-in-suit, Apex has offered to compromise, for now, by limiting its immediate requests to information related to the defunct 268 patent. Still, Roche refuses discovery and responds with only blanket, wholesale refusals to respond meaningfully to Apexs discovery requests. To date, Roche has provided Apex with no more than conclusory statements parroting the Courts claim constructions in Roche v. Bayer to allege infringement in its discovery responses and infringement contentions served pursuant to the Courts Case Management Plan. Absent relief from the Court, Apex has no way of determining how, or if, Roche allegedly determined, before filing suit, that Apexs products supposedly meet complex claim limitations in the 268 patent, claims such as "Cottrell current", "substantial completion" and "open circuit."
At a minimum, Roche has not complied with the Courts Case Management Plan. It has made no more than blanket infringement assertions. Whether Apexs products meet the key Court-construed limitations of the 268 patent cannot be determined by looking at the product sitting on the shelf, or even by operation of the product. Moreover, there are no documents that would show that the Apex products meet any of these 268 patent claim limitations. Yet, Roche refuses to provide evidence to show how it allegedly determined that Apexs products meet the precise, complex, experimentally determinable limitations of the 268 patent claims, including "Cottrell current", "substantial completion" and "open circuit".
When the Court found Roches 268 patent to be unenforceable in June 2005, as a matter of law this became an "exceptional" case." Thus, at least with respect to the 268 patent, Roche should be required to provide all of the answers and to produce all of the documents requested in the various interrogatories and requests for production outlined below, and Roche should produce one or more knowledgeable witnesses to testify on the matters identified in Apexs July 26, 2005 Rule 30(b)(6) Notice. Should Roche continue to shelter any evidence of pre-suit testing, pursuant to Loctite it should be required to pay all of Apexs attorneys fees and costs, as
the court ordered in Loctite. In any event, given Roches shell game conduct on discovery, it should be required to pay Apexs attorneys fees and costs for filing this motion.


II. FACTUAL BACKGROUND.
A. "Cottrell Current" and "Substantial Completion" Have Been Central to the
268 Patents Prosecution and Litigation Histories.

A quick review of the facts set forth in the recent inequitable conduct trial regarding the
long 268 patent prosecution history at the U.S. Patent and Trademark Office ("USPTO") and its
related ten-year litigation history reminds us that the claim terms "Cottrell current" and
"substantial completion" have been central to the 268 patent from day one. The following facts
are undisputed:

1. The original patent application owned by Tall Oaks that led to the subject 268 patent
contained broad claims directed to methods for measuring materials in body fluids consisting of
(1) placing the sample fluid in an electrochemical cell (e.g., a test strip having two electrodes)
containing a chemical that reacts with a substance in the sample, thereby creating an electrical
current, and (2) measuring the current when a potential (i.e., voltage) is applied to the cell.
These and similar claims were rejected by the USPTO over certain prior art.

2. To distinguish the cited prior art, the Tall Oak inventors amended the claims to
require, among other things, that (1) a reaction had to "proceed substantially to completion," and
(2) the current being measured be a special kind of current called a "Cottrell current." The Tall
Oak inventors argued that their amendments rendered the claims patentable because the prior art
failed to teach or suggest measuring the "Cottrell current" after the reaction in the first step had
gone to "completion." The PTO Examiner then allowed the claims, accepting Tall Oaks
representations that the prior art failed to teach, among other things, using a "Cottrell current" to
perform measurements in a biosensor after the "reaction proceeds to completion." The
application issued as U.S. Patent No. 5,128,015 ("the 015 patent") on July 7, 1992.

3. A separate but related patent application (called a divisional application) contained
claims that were similarly amended to add the same "substantial completion" and "Cottrell
current" limitations. Again, the PTO Examiner relied on the Tall Oak applicants


representations, the same as those that were made in the 015 application. The divisional
application issued as U.S. Patent No. 5,108,564 ("the 564 patent") on April 28, 1992.

4. Roche purchased the Tall Oak 015 and 564 patents and filed an application for
reissue of the 564 patent on December 20, 1993. U.S. Patent No. Re 36,268 ("the 268 Patent")
issued as a reissue of the 564 patent on August 17, 1999. In August 2000, Roche filed suit
against Bayer for infringement of the 268 patent.1 Roche Diagnostics Corp. v. Inverness Med.
Tech., Ct. No. IP 00-1103-C-M/F ("Roche v. Bayer litigation").

5. The Roche v. Bayer case settled, but only after the jury found that two of three Bayer
products infringed the claims of the 268 patent. Central to the liability portion of the Roche v.
Bayer case were: (i) whether the Bayer products included "Cottrell current" responses; (ii)
whether the Bayer products allowed the blood sample to proceed to "substantial completion"
before the meter measured the blood glucose level in the sample; and (iii) whether the Bayer
products operated with an "open circuit."

B. Roche Initiated This Action Against Apex Knowing That "Cottrell Current"
and "Substantial Completion" Would Be Central Issues Again.


On February 20, 2004, Barnes & Thornburg LLP initiated this action on behalf of Roche
by filing a Complaint alleging infringement of the 268 Patent and U.S. Patent No. 5,366,609
("the 609 Patent") by Apex and several other Defendants. See Exh. 1, U.S. Patent No.
5,366,609; Exh. 2, U.S. Patent No. Re 36,268. Donald E. Knebel executed the Complaint on
behalf of Barnes & Thornburg in its capacity as counsel for Roche. Exh. 3, Complaint for Patent
Infringement (Feb. 20, 2004). Roche filed an Amended Complaint on April 23, 2004, signed by
Helen K. Geib. Exh. 4, Amended Complaint for Patent Infringement (Apr. 23, 2004).

By executing the Complaint and Amended Complaint, Mr. Knebel and Ms. Geib certified
that Barnes & Thornburg had complied with the prefiling requirements imposed by Rule 11 of

1 Roche initially asserted the 268 patent against both Bayer and Inverness Medical Technology,
Inc. Roche and Inverness settled the lawsuit before trial.


the Federal Rules of Civil Procedure. In the specific context of a patent infringement action,
their signatures were also a certification that Barnes & Thornburg had obtained a sample of each
accused device in order to determine its actual design and function and had used the results of its
investigation to conduct an independent comparison of the construed claims to each accused
device. They were certifying that Barnes & Thornburg had used all of this information to reach
an objectively reasonable conclusion that Apex infringed the 609 and 268 patents.

On June 20, 2005, the Court ruled that the 268 patent and its predecessor, U.S. Patent
No. 5,108,564, were unenforceable as a result of inequitable conduct before the U.S. Patent and
Trademark Office during prosecution of U.S. Patent No. 5,108,564. Memorandum and Opinion
on Defendants Inequitable Conduct Counterclaim, Roche Diagnostics Corp. v. Apex
Biotechnology Corp., Case No. 1:04-cv-00358 (June 20, 2005). As a result, the Court dismissed
with prejudice the patent infringement claims against Apex arising from the 268 patent.

In light of the Courts ruling on the unenforceability of the 268 patent, that patent is now
defunct and this case is "an exceptional case." See 35 U.S.C. 285; Cambridge Prods. Ltd. v.
Penn Nutrients Inc., 962 F.2d 1048, 1050-51 (Fed. Cir. 1992). Apex is seeking discovery to
determine whether Roche and Barnes & Thornburg in fact conducted the pre-filing testing
implied by Mr. Knebels signature on the Complaint. To date, none of the materials produced in
discovery or pursuant to the Courts Case Management Plan have shown that adequate testing, if
any, was performed.

Moreover, Apexs understanding of its products leads it to the inescapable conclusion
that Roche could not have concluded in good faith, either prior to or after filing the lawsuit, that
any of the Apex products meet the Court-construed limitations of the now unenforceable 268
patent. Barnes & Thornburg has alleged to Apex that such testing did take place, but has refused
to provide any details, even the dates of testing or the identities of those involved, on the grounds
that all such information is protected by the attorney-client privilege and/or the work product
exception. Additionally, Barnes & Thornburg has refused to provide a deposition witness or
witnesses on 22 of 27 topics set forth in Apexs Rule 30(b)(6) Notice. See Exh. 5, Apex Defs.


Rule 30(b)(6) Notice of Videotaped Deposition of Plaintiffs (July 26, 2005). Apex has filed this
Motion to Compel to request that the Court order Roche to respond to Apexs various requests
for production and interrogatories and to produce the witness or witnesses requested in Apexs
Rule 30(b)(6) Notice with respect to any and all testing issues related to the 268 patent.

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C. Roches Conclusory Infringement Allegations Do Not Suggest Any Prefiling Testing That Would Reasonably Support Its Infringement Claims.
Roches Complaint does not describe any investigation that Roche or its counsel performed to determine whether any of the Defendants products infringe Roches patents or whether an infringement suit would be frivolous. Exh. 3. It contains only blanket assertions that
the 609 and 268 patents were infringed. Similarly, Roches Amended Complaint provides comparable unsupported assertions. Exh. 4.
Roches subsequent filings have done nothing to further clarify whether any pre- or post-filing testing has occurred. Notably, Plaintiffs Disclosure of Asserted Claims and Preliminary Infringement Contentions ("Infringement Contentions"), served on Apex pursuant to the Case Management Plan, provided no descriptions and cited no evidence to support an objectively reasonable conclusion that any of Apexs products infringe any claim of either of Roches patents. See Exh. 6, Pls. Discl. of Asserted Claims & Prelim. Infringement Contentions (July 21, 2004). Instead, for each of Apexs products, Roches Infringement Contentions recited no more than the claim language with corresponding conclusory descriptions of how the products allegedly meet the respective listed limitations. Id. The key conclusions, however, are completely unsupported by any citation to extrinsic evidence.2

2 For example, Roche simply declared that the Apex Assure product follows the Court-construed definition of the claim term "Cottrell current". See Exh. 6 attach. B at 2 ("The Assure meter measures current which decays substantially in accordance with 1/t1/2, and correlates current measurement to the concentration of the selected compound (glucose) in the sample."). Similarly, Roche made the blanket statement for all of the Apex products that "[t]he reaction is allowed to proceed with an open circuit between the test strip electrodes[,]" but it did not describe how it determined that this was so. E.g., id. Finally, Roche recited that "The Assure
3 meter has an integrated circuit chip and other circuitry that includes a sense means[,]" but did not cite the document, test procedure, or individual on which it relied in substantiating the validity of this claim. Id. attach. B at 14. These are just examples the pattern continued throughout Roches Disclosure of Asserted Claims.
Even where Roches Infringement Contentions did cite to scant extrinsic evidence, frequently the evidence cited was unrelated to the statement that it followed. For example, the first page of Tab B of the Infringement Contentions contained the unsupported statement, "The reaction is allowed to proceed substantially to completion." The corresponding evidence cited by Roche is the Assure meter users guide at page 34, which states that "test time is 35 seconds[.]" Id. attach. B at 1. Test time, however, says nothing about whether a reaction has proceeded to completion.
Moreover, the litigation history of the 268 patent the Tall Oak v. Roche arbitration, the Roche v. Bayer litigation, and now the current litigation proves that not every electrochemical blood glucose monitoring device employs the so-called "Cottrell current" and/or "substantial completion" requirements of the 268 patent claims.3 See, e.g., Exh. 7, Roche v. Apex, Day 3 Inequitable Conduct H. Tr. Excerpts (June 2, 2005).4 Simply put, the long litigation and 3 Even Roche cannot make up its mind as to whether certain prior art devices use a "Cottrell current." The following facts are not disputed: in arbitration between Roche and Tall Oak, conducted while the reissue patent application that led to the 268 patent was pending in the USPTO, Michael Young, patent attorney for Roche, testified under oath concerning Youngs and Roches belief in the invalidity of the Tall Oak patent because the Matsushita reference, at a
minimum, "implied" a "Cottrell current." See, e.g., Tall Oak Arb. Trx. 8/22/96 Tr. at 2922:15-2932:11, 2945:1-11, 2963:3-2966:18.
In August 2000, in the Roche v. Bayer litigation Mr. Young was forced to address numerous documents from the 1989 time period expressing Roches concerns that the Tall Oak application was invalid in view of Matsushita reference because it disclosed using the "Cottrell current." See, e.g., Bayer 2/10/03 Tr. at 1909:21-1910:21, 1913:2-24, 1920:10-15, 1922:4-10, 1935:7-14.
When asked to explain his statement in his USPTO Office Action response that the "Cottrell current" is "not recited" by the Matsushita reference, Mr. Young departed from his original view and from his sworn response to the arbitrators questioning. When asked whether he ever told the PTO examiner that Matsushita did not disclose Cottrell current, he replied, "No. I didnt think that it did because it doesnt recite those words, and it is not very clear what the disclosure really does teach." Bayer 1/30/03 Tr. at 427:3-13 (emphasis added).

4 See pages 579:3-19; 610:12-613:24; 662:7-663:22; 693:16-694:4 and 702:13-710:24; 715:9-11 (testimony by Apexs expert, Professor Turner, and Roches expert, Professor Weber, as to whether the Matsushita prior art device and Professor Turners Medisense prior art device prosecution histories of the 268 patent inescapably demonstrate that it would be unreasonable for Roche to have assumed that any of Apexs products yield a "Cottrell current" or go to "substantial completion" as required by each of the 268 patent claims. In short, there is simply no way of knowing, absent testing, whether any Apex product employs these highly technical limitations, which are not observable by the naked eye. employed "Cottrell current" and/or went to "substantial completion" prior to measuring a blood
glucose level in a blood sample).
No evidence exists that Roche ever tested the Apex products for "Cottrell current" or "substantial completion" before filing suit. Nevertheless, Roches Complaints and Infringement Contentions alleged that Apexs products infringe the 268 patent.

D. Apex Has Repeatedly Asked Roche to Provide Evidence of Any Prefiling Investigation.
Apex has repeatedly asked Roche to supply information regarding any examination, product testing, or other analysis conducted to determine whether any product infringes any of the patents-in-suit. In each instance, Roche has played a shell game, refusing to provide the information requested by Apex, and merely pointing to each of its previous conclusory, nonresponsive answers to the Infringement Contentions mandated by the Courts Case Management Plan and to Apexs Interrogatories, Document Requests, queries regarding Roches Privilege Log, and Requests for a Rule 30(b)(6) Deposition.
1. Apexs Interrogatories
Apex served its first set of interrogatories pursuant to Fed. R. Civ. P. 33 in August 2004. Exh. 8, Def. Apexs 1st Set of Interrogs. to Pl. Roche Diagnostics Corp. (Aug. 4, 2004). On September 13, 2004, Roche served a response that failed to provide any useful information about any testing that may have occurred, either before or after Roche filed suit. See Exh. 9, Pls. Resp. to 1st Set of Interrogs. from Defs. (Sept. 13, 2004).
Apexs Interrogatory No. 1 requested that Roche "identify each person with knowledge of facts relevant to [its] claims in this case, and provide a brief description of the facts known to each person." Exh. 8 at 5. Roches response incorporated by reference its Supplemental Rule 26(a) Disclosures of June 21, 2004. Exh. 9 at 4. In that document, the list of "individuals likely to have discoverable information" did not identify any person with knowledge of analysis or product testing conducted to substantiate Roches claims regarding the Defendants products. Exh. 10, Pls. Supp. R. 26(a) Disclosures (June 21, 2004).
Apexs Interrogatory No. 3 asked Roche to "[d]escribe [its] construction of the meaning of each element of each claim of the 268 patent that [it] contend[s] has been infringed" and to identify, among other things, "any extrinsic evidence that [it] contend[s] support[s] [its]
construction." Exh. 8 at 5. In response, Roche objected to these questions as "premature" and referred to its July 21, 2004 Infringement Contentions. Exh. 9 at 5. As discussed above, Roches Infringement Contentions do not cite any evidence that would support an objectively reasonable conclusion that any of Apexs products infringe Roches patents. See Exh. 6.
Apex served a second set of interrogatories in December 2004. Exh. 11, Def. Apexs 2nd Set of Interrogs. to Pl. Roche Diagnostics Corp. (Dec. 2, 2004). Apex Interrogatory No. 17 asked Roche to identify "all entities and persons you have communicated with or contacted . . . regarding the sales, marketing or other business practices, product lines, technology, accused product development, accused product operation, or market presence of any of the Apex Defendants[.]" Id. at 5-6. In each instance, the Interrogatory asked Roche to provide the date of the communication; the subject, including the Apex Defendant and product line involved; the identity and geographic location of each entity or person; and all documents and things related to these contacts. Id. In response, Roche answered that it had produced all non-privileged documents relating to communications regarding the accused products in response to the First
Set of Interrogatories and First Set of Requests for Production. Exh. 12, Pls. Resp. to 2nd Set of Interrogs. from Defs. (Jan. 11, 2005). Roche failed to provide any of the additional details requested in the Interrogatories. Likewise, Apex Interrogatory No. 18 asked Roche to identify: all entities or persons who have conducted or been involved in any reverse engineering study or analysis of . . . any product or product line designed, manufactured and/or sold by any of the Apex Defendants . . . , and for each such entity or person describe in detail:
(a) their title and position;
(b) who contacted or approached the entity or persons to be involved in the reverse engineering study or analysis;
(c) where, when, why and how the reverse engineering study or analysis was initiated, performed, or completed;
(d) whether the reverse engineering study or analysis is ongoing;
(e) the product or product line being reverse engineered;
(f) the compensation received by such person or entity for the reverse engineering study or analysis;
(g) and all documents and things, identified by Bates number range, that refer or relate to the reverse engineering study, analysis, meetings, discussions, or conferences, including but not limited to any reverse engineering reports.
Exh. 11 at 6-7. In response, Roche answered that it "has already produced all non-privileged documents relating to studies or analyses regarding the accused products in response to defendants First Set of Interrogatories and First Set of Requests for Production[,]" citing its responses to Requests for Production Nos. 28, 29, 31, and 33. Exh. 12 at 6. Roche provided none of the details requested in Apex Interrogatory No. 18. It also failed to provide any explanation of the reasons why it believed that any withheld information was privileged.
2. Apex Defendants Requests for Production
Roches responses to Apex Defendants requests for production under Fed. R. Civ. P. 34 have been equally devoid of details regarding any prefiling testing of any accused product. The Apex Defendants served their first set of requests for production in August 2004.5 Exh. 13, Defs. 1st Set of Requests for Production from Roche Diagnostics Corp. (Aug. 4, 2004). These production requests included the following: Request No. 18: All documents and things that support . . . Roches allegations and contentions . . . including, without limitation, any documents supporting Roches allegations that Defendants have infringed or are infringing any of the
Patents-in-Suit and any pre-litigation opinion letters concerning the same.

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5 Apex served a Second Set of Requests for Production from Pl. Roche Diagnostics Corp. on August 23, 2005. The Second Set of Requests for Production was directed to an unrelated issue.
Request No. 22: All documents and things referring or relating to any testing, experimentation, research, and/or development of any of the subject matter described and/or claimed in any of the Patents-in-Suit.
Request No. 28: All documents and things referring or relating to any analysis, determination, assertion, notification, conclusion, or charge that a product of any of the Defendants and/or any third party infringes any of the Patents-in-Suit.
Request No. 29: All documents and things referring or relating to any contention by Roche that Defendants activities, products, or devices have infringed or currently infringe any of the Patents-in-Suit.
Id. at 9-11. In response to these requests, Roche merely referred to public documents such as the patents themselves, their file histories, the Courts previous orders and litigation files from the Bayer litigation. Exh. 14, Pls. Resp. to Defs. 1st Set of Requests for Production at 15, 21 (Sept. 13, 2004). Roche stated that it had produced documents relating to the research and development of Roches own products. Id. at 17. And, in multiple locations, it stated, "Roche will produce non-privileged documents relating to the accused products." Id. at 21.
Yet, the documents that Roche has produced to date are not fully responsive to the production requests above. With just one exception, Apex has not located any documents pertaining to "testing performed by or on behalf of Plaintiff to determine whether any of
Defendants products or methods infringe any claim(s) of any of the Patents-in-Suit." The one exception is a document entitled Competitive Product Analysis: Hypoguard Assure 3, Bates Nos. RDC1237274-1237311.6 Exh. 15, Theron, Inc., Competitive Product Analysis: Hypoguard Assure 3 v.1b (June 2003) ("Theron documents"). If product testing occurred, no documents other than the Theron documents have been produced to demonstrate it. By failing to provide either additional documents or further detail about any documents withheld, Roche not only has failed to respond fully to Apexs Requests for Production, but it also has failed to respond to
Apexs Second Set of Interrogatories, which Roche claims were answered by the documents produced in response to Requests for Production Nos. 28, 29, 31, and 33. See Exh. 14.
6 Duplicate copies appear at Bates Nos. RDC1237236-1237273 and RDC1237312-1237349, and an apparently earlier version appears at Bates Nos. RDC1237207-1237235.

3. Roche Privilege Log
On July 26, 2005, Apex served its Rule 30(b)(6) Notice on Roche, providing 27 topics related to Roches testing of Apexs accused products. Exh. 5. In a telephone conversation of August 10, 2005 concerning Roches objections over the Notice, Helen Geib of Barnes & Thornburg LLP indicated that additional testing-related documents existed, but that they had been withheld as privileged documents. See Exh. 16, Letter from Robert W. Busby, Jr. to Helen K. Geib at 1 (Aug. 12, 2005) (describing telephone conference). Ms. Geib refused to provide any additional information regarding the withheld documents, instead referring Apexs counsel to the Roche privilege log. That log contains references to numerous testing-related documents, but the entries referring to product testing do not contain sufficient explanation to establish either the nature of the documents or the basis for Roches failure to produce them. See id.
Apex outlined its concerns in a letter to Ms. Geib, providing a detailed list of each of the documents on the Roche privilege log that appeared to be related to product testing and requesting a fuller description of each. Id. Roche responded on August 23, 2005, providing a revised privilege log for some documents. Exh. 17, Letter from Helen K. Geib to Robert W. Busby, Jr. (Aug. 23, 2005). Roches explanations, however, still do not provide the information that Apex has requested. For example, Roche still fails to identify which of the accused products were tested; the individuals or entities involved in any reverse engineering study or analysis; where, when, why or how the reverse engineering or analysis was performed; whether the analysis is ongoing; or even which patent claims were compared to the accused products characteristics. Neither does Roche explain the basis for claiming both the attorney-client privilege and a work product exception for every document listed on the revised pages of its privilege log. See id. attach 1.
Roche explained that "Roches privilege logs include many entries for documents withheld from files that have no connection to the accused products in this case[.]" Id. at 1. According to Roche, the only documents appearing on Roches privilege log that are relevant to
product testing of the accused products are those falling within the production range RDC1229796-1229935. Id. at 2. "Listed log entries outside this production range are from files that do not relate to the Apex defendants accused products." Id. Through its responses to the
numerous discovery requests outlined above, Roche has repeatedly represented that no other documents related to testing of the accused products exist. The adequacy of Roches testing procedures, therefore, can only be determined by examining the documents falling within the identified production range and by questioning one or more witnesses who are knowledgeable about the contents of those documents and the circumstances in which they were created.

4. Apexs Rule 30(b)(6) Notice
Apex attempted to question Roche representatives about the nature and extent of any prefiling product testing of Apex accused products. This too was met by obstruction and interference, and has been without success. Apexs Rule 30(b)(6) Notice requested a deposition
of one or more plaintiffs representatives, beginning on August 29, 2005. Exh. 5. Apex identified 27 matters that it intended to examine at the deposition, generally related to:
(1) the existence, extent, and duration of any prefiling testing of Apexs accused products and the products selected for testing;
(2) the identities of those involved with any such testing, with the preparation of Roches Disclosure of Asserted Claims, and/or the preparation of responses to Apexs discovery requests;
(3) the June 2003 Competitive Product Analysis created by Theron, Inc.; and
(4) any analysis, reverse engineering, evaluation or testing of any accused product conducted to determine whether the products characteristics corresponded to various terms used in the 268 and 609 patents.
Id. All of these matters are closely related to the issue of whether Roche complied with the requirements of Rule 11 by conducting an objectively reasonable claim construction analysis before suing Apex for infringing the 268 patent. Apex has a compelling need to obtain this information in order to determine whether Roches unethical actions extended beyond the inequitable conduct that the Court has already found to invalidate the 268 patent.
Roche has wholesale refused to provide any witnesses to answer even the most basic of questions, except with regard to topic Nos. 13-14 and 17-19, and then only to the extent that the questions seek non-privileged information relating to the June 2003 Theron report described above. Exh. 18, Pls. Resp. & Objections to Notice of R. 30(b)(6) Videotaped Dep. of Pls. (Aug. 22, 2005).7 As was pointed out to Roches counsel by phone on August 10 and again by email on August 26, 2005, Roche could have provided a witness, answered as many questions as possible, and had the witness refuse to answer any question that Roche believed was asking for privileged information. See Exh. 19, E-mail from Robert W. Busby, Jr. to Helen K. Geib (Aug. 26, 2005). Instead, Roche has refused to provide any witnesses to testify on 22 of the 27 matters listed in the Rule 30(b)(6) Notice, claiming privilege before a question is even asked. Exh. 18.
In light of this refusal, Apex attempted one last time to obtain even minimal information regarding Roches prefiling product testing. On August 26, 2005, Apex contacted counsel for Roche by e-mail and requested that Roche at least provide copies of withheld documents that relate to any testing of the unenforceable 268 patent, including the documents originally contained in the produced file folder labeled "RDPC 03041 Evaluation of Hypoguard ASSURE 1,2,3 & Medline EvenCare System 1 of 2." Exh. 19. These documents fall within the production range RDC1229796-1229935 and identified by Roche as being relevant to the product testing issue. Exh. 17 at 1. On August 30, 2005, counsel for Roche responded that
(1) with the exception of the Theron report, Roches pre-filing testing "is protected from disclosure by the attorney-client privilege and work product exception[;]"
(2) topics in Apexs 30(b)(6) notice relating to Roches post-filing testing and post-filing litigation conduct are irrelevant, privileged and work product; and
(3) "Roche does not agree to waive attorney-client privilege or work product protection with respect to the contents of these documents or other information relating to privileged pre-filing testing. We do not agree with your position that the case law requires that Roche do so."
7 On August 23, 2005, counsel for Roche notified Apex that the witness intended to respond to questions about the Theron report also would not be available on the scheduled deposition date.
Exh. 20, E-mail from Helen K. Geib to Robert W. Busby, Jr. (Aug. 30, 2005). Accordingly, having exhausted all discovery means, Apex is forced to resort to this Motion to Compel in an attempt to obtain the discovery materials necessary to determine whether to challenge Roche on its compliance with its Rule 11 responsibilities before filing suit against Apex.
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III. ARGUMENT.
A. Rule 11 Requires That Plaintiffs Counsel Conduct an Independent Prefiling Investigation of Claim Construction and Infringement.
Rule 11 of the Federal Rules of Civil Procedure requires that all pleadings be signed by at least one attorney of record certifying that counsel has "conducted a reasonable inquiry and determined that any papers filed with the court are well grounded in fact [and] legally tenable." Cooter & Gell v. Hartmax Corp., 496 U.S. 384, 405 (1990). In connection with an action for patent infringement, compliance with Rule 11 requires that a number of specific issues be addressed before the Complaint can be filed. In particular, compliance with Rule 11 requires that counsel conduct an independent investigation, including an objectively reasonable analysis of claim construction and infringement, before filing suit. See, e.g., Q-Pharma, Inc. v. Andrew Jergens Co., 360 F.3d 1295, 1300-01 (Fed. Cir. 2004).
Where a court finds that an attorney or law firm has failed to comply with these requirements, Rule 11(c) authorizes an "appropriate sanction upon the attorneys, law firms, or parties" that are responsible for the violation, including monetary sanctions and dismissal of the asserted claim. Fed. R. Civ. P. 11, adv. comm. note. See also, Jimenez v. Madison Area Tech. College, 321 F.3d 652, 657 (7th Cir. 2003) (affirming dismissal of complaint as sanction for violation of Rule 11). Rule 11(c)(2)(A) also provides that the Court may award reasonable attorneys fees incurred in presenting the motion.8
8 Issues not unique to patent law are determined under the law of the regional circuit in which the district court sits. See, e.g., Midwest Indus., Inc. v. Karavan Trailers, Inc., 175 F.3d 1356, 1359
(Fed. Cir. 1999). Accordingly, in this case Seventh Circuit law applies to the question of sanctions under Rule 11. See Q-Pharma v. The Andrew Jergens Co., 360 F.3d 1295, 1299 (Fed. Cir. 2004). The issue of attorney fees in patent infringement cases is a matter of Federal Circuit law. Id.; Special Devices, Inc. v. OEA, Inc., 269 F.3d 1340, 1343 (Fed. Cir. 2001).
1. Before filing suit, counsel must first conduct an independent and "objectively reasonable" claim construction analysis.
Because claim interpretation is a matter of law, counsels proposed claim construction is subject to Rule 11(b)(2), which requires that the proposed construction be "warranted by existing law or by a non-frivolous argument for the extension, modification, or reversal of existing law or the establishment of a new law." In the Seventh Circuit, the viability of an attorneys legal argument is determined using a standard of objective reasonableness. See, e.g., Gottlieb v. Westin Hotel Co., 990 F.2d 323, 327 (7th Cir. 1993) (holding that an attorneys failure to make objectively reasonable investigation of facts underlying a claim or applicable law justifies sanctions). Accordingly, counsel will be subject to sanctions if a reasonable attorney would recognize the proposed claim construction as unsupportable or frivolous. Id.
To conduct a reasonable inquiry into infringement, in the context of patent litigation, Rule 11 requires that counsel first interpret the claims of the patent. "Rule 11 requires an attorney who files a patent infringement action to compare the accused device with the construed patent claims." Antonious v. Spalding & Evenflo Cos., 275 F.3d 1066, 1073 (Fed. Cir. 2002) (citing View Engg, Inc. v. Robotic Vision Sys., 208 F.3d 981, 986 (Fed. Cir. 2000)); see also Q-Pharma, 360 F.3d at 1300-01 ("In the context of patent infringement actions, we have interpreted Rule 11 to require, at a minimum, that an attorney interpret the asserted patent claims
and compare the accused device with those claims before filing a claim alleging infringement."). In assessing claim interpretation, counsel may not rely solely on the clients proposed interpretation, but instead must perform an "independent claim analysis." Antonious, 275 F.3d at 1073 (citing Judin v. United States, 110 F.3d 780, 784 (Fed. Cir. 1997); S. Bravo Sys. v. Containment Techs. Corp., 96 F.3d 1372, 1375 (Fed. Cir. 1996)).
Thus, by signing the Complaints in this action, Barnes & Thornburg, Mr. Knebel, and Ms. Geib were certifying that they had conducted an independent analysis of claim construction consistent with current law and had developed a claim construction that was objectively
reasonable. This is not the typical case where the claims have never been adjudicated Roche had knowledge of how this Court construed the claims in the 268 patent in the Bayer litigation. See Exh. 21, Roche v. Bayer, Ct. No. IP 00-1103-C-M/F, Excerpts from Claims Construction Order. By signing Complaints alleging that Apexs products infringed the 268 patent, Roches attorneys were certifying that in light of their independent investigation and analysis of this prior litigation, a reasonable attorney would not consider the infringement allegations frivolous. Apex is requesting discovery to confirm that this independent analysis was in fact performed.
2. Rule 11 requires that counsel obtain a sample of each accused device and compare its actual design and function to the construed claims.
It is not enough for an attorney to conclude independently that a proposed claim of infringement is "legally tenable"; that attorney also must determine that "any papers filed with the court are well grounded in fact[.]" Cooter & Gell, 496 U.S. at 405. Patent infringement is a question of fact. E.g., Embrex, Inc. v. Service Engg Corp., 216 F.3d 1343, 1348-49 (Fed. Cir. 2000). Thus, assuming that the certifying attorneys conclusions concerning the construction of each and every claim term are objectively reasonable, Rule 11(b)(3) then requires an attorney filing a patent infringement action to determine that all allegations of infringement have evidentiary support. "[A]n attorney violates Rule 11(b)(3) when an objectively reasonable attorney would not believe, based on some actual evidence uncovered during the prefiling investigation, that each claim limitation reads on the accused device either literally or under the doctrine of equivalents." Antonious, 275 F.3d at 1074. Thus, for example, counsel may not rely solely on the clients opinion that the accused device infringes the patent. Id. at 1074. Instead, counsel must independently apply each of the claims to the accused device and make a
reasonable effort to determine whether the accused device satisfies each of the claim limitations. Id. (citing Judin, 110 F.3d at 784); see also View Engg, 208 F.3d at 986.
Moreover, an attorney must develop reasonable evidentiary support for a patent infringement claim before filing suit, not later during discovery. See, e.g., Judin, 110 F.3d at 782 (Rule 11 "requires that the inquiry be undertaken before the suit is filed, not after.") As the
Seventh Circuit has noted, Rule 11 imposes an affirmative duty to investigate the facts that support a pleading before filing to "think first and file later, on pain of personal liability." Stewart v. RCA Corp., 790 F.2d 624, 633 (7th Cir. 1986) (citing Thornton v. Wahl, 787 F.2d 1151 (7th Cir. 1986)). While Rule 11 permits filings based on a belief that factual claims are likely to have evidentiary support after a reasonable opportunity for further investigation or discovery, see Apostol v. Landau, No. 86 C 5070, 1994 U.S. Dist. LEXIS 3772, at *4-*6 (N.D. Ill. Mar. 25, 1994),9 "[i]t is not permissible to file suit and use discovery as the sole means of finding out whether you have a case. Discovery fills in the details, but you must have the outline of a claim at the beginning. Rule 11 requires independent inquiry." Szabo Food Serv. v. Canteen Corp., 823 F.2d 1073, 1083 (7th Cir. 1987) (citations omitted); Brown v. Federation of State Medical Bds., 830 F.2d 1429, 1435 n.4 (7th Cir. 1987); see also Federal Deposit Ins. Corp. v. Elefant, 790 F.2d 661, 667 (7th Cir. 1986).
Accordingly, by filing a Complaint, counsel certifies that even if discovery may later provide additional relevant details, at the time of filing the Complaint the claims are supported by an objectively reasonable amount of "actual evidence uncovered during the prefiling
investigation[.]" Antonious, 275 F.3d at 1074. In a patent case, under ordinary conditions this requires that counsel obtain, examine and reverse engineer a sample of the accused device "so that its actual design and functioning could be compared with the claims of the patent." Judin, 110 F.3d at 784-85 (citing Refac Intl v. Hitachi, Ltd., 141 F.R.D. 281, 286-88 (C.D. Cal. 1991) (imposing Rule 11 sanctions on patent infringement plaintiff that failed to reverse engineer or examine accused products prior to filing the complaint).
The Seventh Circuit has explained that to determine whether a prefiling investigation was objectively reasonable, a district court should consider 9 Factual allegations filed without evidentiary support on the premise that such support will become available during discovery must, however, be clearly identified as such in the pleadings. Fed. R. Civ. P. 11(b)(3); Apostol, 1994 U.S. Dist. LEXIS 3772, at *4-*6. In its complaint, Barnes & Thornburg did not identify any infringement claim as currently being without evidentiary support but likely to have such support after further discovery. whether the signer of the documents had sufficient time for investigation; the extent to which the attorney had to rely on his or her client for the factual foundation underlying the pleading, motion, or other paper; whether the case was accepted from another attorney; the complexity of the facts and the attorneys ability to do a sufficient pre-filing investigation; and whether discovery would have been beneficial to the development of the underlying facts.
Brown, 830 F.2d at 1435. Here, Roche had plenty of time for investigation. Roche knew what it was up against. It had a dry run two years previously on the same patent against Bayer Corporation. There, Roche was able to prove infringement on only two of three products. Exh. 22, Bayer, Ct. No. IP 00-1103-C-M/F, Jury Verdict Form. Thus, Roche knew that proving infringement of Apexs products, manufactured in Taiwan, was no easy task. Moreover, Roche knew the scope of the 268 patent claims, as the same Court and same Judge had construed them. See Exh. 21. It knew what it had to do to prove "Cottrell current", "substantial completion" and
"open circuit" in the Apex products.
While "[o]nly a reasonable inquiry is necessary" under Rule 11, Szabo, 823 F.2d at 1083, in a case such as this where Roche was under no time pressure, where the accused products were readily available commercially at reasonable cost, where one of the asserted
patents had been construed and tried once already, and where none of the facts necessary to establish support for an infringement claim were in the exclusive control of the Defendants, any definition of a reasonable inquiry would include a prefiling analysis of all of the accused products and a comparison of those products to terms such as "Cottrell current." Roche was in a position where it could readily obtain information to verify or corroborate its clients infringement allegations by obtaining a sample of each accused device prior to filing the Complaint and comparing the actual design and function to the construed claims.10
10 It knew, moreover, that only testing of Apexs Taiwanese-manufactured products would yield information as to whether those products exhibited the known, required, characteristics for infringement, e.g., Cottrell current and substantial completion. Roche had an absolute obligation under Rule 11 to conduct testing of Apexs products for Cottrell current, open circuit and substantial completion before filing suit. See Apostol, 1994 U.S. Dist. LEXIS 3772, at *5-6. There are no Apex documents for Apexs products that would even suggest its products meet these limitations. Roche is challenged to produce any for the Court.
3. The burden is on Roches counsel to demonstrate that it complied with the prefiling requirements of Rule 11.
In determining whether there has been a violation of Rule 11, the burden is on Plaintiffs counsel to demonstrate compliance with each of the many prefiling requirements:
A patent suit can be an expensive proposition . . . . Performing a pre-filing assessment of the basis of each infringement claim is, therefore, extremely important. In bringing a claim of infringement, the patent holder, if challenged, must be prepared to demonstrate to both the court and the alleged infringer exactly why it believed before filing the claim that it had a reasonable chance of proving infringement."
View Engg, 208 F.3d at 686. Under Rule 11, sanctions may be imposed for any invalid legal or factual theory advanced in the Complaint, even if others are found to be valid, since even a single unsupported theory may require the expenditure of "hundreds or thousands of hours, as opposing counsel try to verify or refute the allegations and theories." Antonious, 275 F.3d at
1075 (citing Fed. R. Civ. P. 11(c)(1)(A)).
Apex is seeking discovery to determine the extent of Barnes & Thornburgs prefiling investigation and whether it constituted a "reasonable" inquiry into whether Apexs accused products infringed the 268 patent. It is not sufficient for Barnes & Thornburg simply to state that "there was product testing," as Ms. Geib represented in her August 10, 2005 telephone conversation with Apex counsel. See Exh. 16. This does not tell the Court how much testing took place, or on which products, or whether it resulted in evidentiary support for every infringement allegation. The question is not limited to whether testing occurred, but includes whether the extent of Roches prefiling investigation was objectively reasonable under the circumstances and whether it resulted in evidentiary support for each infringement allegation against each of the Apex accused products. Apex and the Court cannot determine this unless Roche produces the discovery materials that Apex has requested.
B. Roche Cannot Avoid Its Burden of Proving That It Conducted the Prefiling Investigation Required Under Rule 11 by Hiding Behind Claims of Privilege.
As described above, Roche has informed Apex that testing-related documents exist, but has refused to provide either the documents or a witness knowledgeable about their contents on the grounds that any information about Roches testing procedures, other than that listed in the Roche privilege log, is subject to both attorney-client privilege and the work product exception. On August 23, 2005, Roche did provide revised privilege log pages for documents in the range of RDC1229796 to RDC1229935, which, according to Roche, are the only documents that relate to the Apex defendants accused products. Exh. 17. Each document listed on the revised pages was labeled as both work product and privileged. Id. attach. 1. Roches August 23 response also indicated that documents to or from "Consulting Expert 2" "generally concerned" the 268 patent. The revised privilege log pages show thirty-seven privileged documents within the range indicated. Id. Ten of those documents involve "Consulting Expert 2" and therefore presumably refer to the 268 patent. Id. An additional thirteen documents do not indicate which consulting expert was involved, and thus may or may not relate to the 268 patent. (The remainder seem to involve the 609 patent.) Of the ten documents involving "Consulting Expert 2," four are identified in the privilege log as copies of Consulting Expert 2s test report: RDC1229837-1229839, RDC1229840-1229841, RDC1229854-1229854, and RDC1229909-1229912.
Apexs requests for information about Roches prefiling investigation of the Apex accused products in light of the 268 patent claims are both limited and reasonable. With regard to the 268 patent, Roche can respond to the numerous interrogatories and requests for
production outlined above by producing a minimum of four, and a maximum of twenty-three, documents, plus a witness to testify concerning the circumstances in which the documents were created. Producing these documents will not jeopardize the "zone of privacy" needed for Roche to prepare for litigation. See Hickman v. Taylor, 329 U.S. 495, 510-11 (1947). Apex is not asking Roche to reveal its legal strategies after all, it is no secret that under Rule 11 Roche was required to perform a prefiling investigation. Apex is merely asking for a limited quantity of factual information that cannot be obtained in any other way and that is necessary for determining whether Roche has complied with Rule 11s prefiling requirements. Roche should not be permitted to use either attorney-client privilege or the work product exception as an excuse to refuse Apexs reasonable and necessary discovery request.

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1. Roches application of the attorney-client privilege is over-broad.
As a preliminary matter, Apex does not concede that all of the documents listed in production range RDC1229796 to RDC1229935 are privileged. Roche has the burden of proving that these documents are privileged or subject to the work product exception. "The party
claiming privilege has the burden of establishing that the privilege applies." See In re Grand Jury Proceedings, 220 F.3d 568, 571 (7th Cir. 2000); Ocean Atl. Dev. Corp. v. Willow Tree Farm, No. 01 C 5014, 2002 U.S. Dist. LEXIS 15841 (N.D. Ill. Aug. 22, 2002).
For general issues of privilege that are not unique to patent law, the law of the regional circuit applies.11 Smithkline Beecham Corp. v. Pentech Pharms., Inc., No. 00 C 2855, 2001 U.S. Dist. LEXIS 18281, at *3 (N.D. Ill. Nov. 5, 2001); see also McCook Metals L.L.C. v. Alcoa, Inc., 192 F.R.D. 242, 251 (N.D. Ill. 2000) (quoting In re Spalding Sports Worldwide, Inc., 203 F.3d 800 (Fed. Cir. 2000)). In the Seventh Circuit, communications from client to attorney are privileged where: (1) legal advice of any kind is sought (2) from a professional legal advisor in his capacity as such, (3) the communications relating to that purpose, (4) made in confidence (5)
by the client, (6) are at his instance permanently protected from disclosure by himself or by the legal advisor, (7) except that the protection may be waived. United States v. Evans, 113 F.3d 1457, 1461 (7th Cir. 1997). Communications from attorney to client are privileged only if (1) "it is shown that the client had a reasonable expectation in the confidentiality of the statement; or, put another way, if the statement reflects a client communication that was necessary to obtain informed legal advice (and) which might not have been made absent the privilege[,]" Ohio-Sealy Mattress Mfg. Co. v. Kaplan, 90 F.R.D. 21, 28 (N.D. Ill. 1980) (quoting In re Walsh, 623
F.2d 489, 494 (7th Cir. 1980)); or (2) if the communications "tend to directly or indirectly reveal 11 Federal Circuit law applies to privilege issues unique to patent law, such as the privileged nature of invention control reports. McCook, 192 F.R.D. at 254. a client confidence." IBJ Whitehall Bank & Trust Co. v. Cory & Assocs., No. 97 C 5827, 1999 U.S. Dist. LEXIS 12440, at *7-*8 (N.D. Ill. Aug. 10, 1999).
The privilege is narrowly construed in the Seventh Circuit. Smithkline Beecham Corp. v. Apotex Corp., 193 F.R.D. 530, 534 (N.D. Ill. 2000). The mere fact that an attorney has requested or received documents does not, by itself, mean that the documents are privileged. Pentech, 2001 U.S. Dist. LEXIS 18281, at *4; Blanchard v. EdgeMark Fin. Corp., 192 F.R.D. 233, 238 (N.D. Ill. 2000); IBJ Whitehall, 1999 U.S. Dist. LEXIS 12440, at *7-*8. For example, communication of business or technical information not involving legal advice is not privileged. McCook, 192 F.R.D. at 252. The primary question is whether "the document in question reveal[s], directly or indirectly, the substance of a confidential attorney-client communication." Apotex, 193 F.R.D. at 534. If not, then the document is not privileged and must be produced if subject to a discovery request.
In McCook Metals, v. Alcoa, Inc., where the plaintiff disputed the privileged nature of several documents drafted in relation to the patent application process, the court provided a detailed analysis of the types of documents that were and were not privileged under Seventh Circuit law. It found that a number of document categories were not privileged and therefore were subject to discovery, including the following:
5. Interoffice Memoranda Containing Business or Technical Information With No Request for Legal Advice: Not Privileged. [The documents] contain no request for legal advice, nor is any legal advice given, and therefore, they fall outside the scope of the privilege. Many are to or from an attorney, or contain an attorney on the circulation list, although business persons are also included. To the extent that the memo contains an opinion of an attorney, that phrase or sentence is privileged and must be redacted. . . .
8. Cover Sheets to Faxes and Other Interoffice Memoranda: Not Privileged. These documents, while from or to attorneys, contain no legal advice, and simply identify the parties to the correspondence, address, and phone and fax numbers. They bear insufficient relation to the securing of legal advice to be accorded attorney-client privilege. . . .
11. Letter From Third Party as Attachment to Requests for Legal Advice: Not Privileged. This document is a letter from a third party competitor of Alcoa that is attached to a request for legal and business advice. Because it is from an outside party, it cannot be confidential, and is therefore not privileged. . . .
14. Technical Drawings, Sketches, Tables, Test Results: Not Privileged. These documents are technical drawings and sketches, tables and test results produced from the inventors and engineering departments and sent to the patent department. Some are attachments to letters to in-house patent attorneys in response to a request for information., while others are freestanding. The documents themselves
contain no request for legal advice, nor is any given, and thus fall outside the ambit of the privilege.
McCook, 192 F.R.D. at 253-55 (citing Amsted Indus., Inc. v. National Castings, Inc., No. 88 C 0924, 1990 U.S. Dist. LEXIS 8699, at *4 (N.D. Ill. July 13, 1990).
There are ten documents listed in Roches revised privilege log that are both within the production range related to testing of the Apexs accused products and marked as being to or from "Consulting Expert 2" (and therefore associated with the 268 patent). Based on the
descriptions provided in Roches revised privilege log, under the McCook analysis, none of these ten documents are privileged:
(1) Three documents, RDC1229801-1229801, RDC1229807-1229807, and RDC1229917-1229917, are described as letters from in-house counsel Brent Harris to "Consulting Expert 2" that forwarded product samples for testing. They are communications from an attorney to a third party conveying physical specimens and possibly containing some technical data in the cover letter. "The
documents themselves contain no request for legal advice, nor is any given, and thus fall outside the ambit of the privilege." McCook, 192 F.R.D. at 255.
(2) Four documents, RDC1229837-1229839, RDC1229840-1229841, RDC1229854-l229854, and RDC1229909-RDC1229912, are described as e-mails from "Consulting Expert 2" to in-house counsel Brent Harris (and in three cases, in-house counsel Michael Young), each containing an attached copy of the consultants test report. Absent an attorney-client relationship between the attorneys and "Consulting Expert 2", these communications fail on their face to qualify for the privilege. Moreover, they are technical test results, not offers of or requests for legal advice, and as such they fall squarely into the "non-privileged" category of documents described in McCook. Id.
(3) The remaining three documents, RDC1229913-1229914, RDC1229915-1229915, and RDC1229916-1229916, are e-mails from Brent Harris to "Consulting Expert 2", copied to in-house counsel Michael Young and Donald Knebel of Barnes & Thornburg. They are summarized as "analysis of competitor meter (discussing tests)." As communications with a third party, discussing technical data rather than legal analysis, these documents too do not qualify for the attorney-client privilege.12
Under Seventh Circuit law these ten documents are not privileged, and therefore must be produced unless the work product doctrine applies.
2. The work product exception is not applicable where, as here, the attorneys conduct is at issue and the need for the discovery
materials is compelling.
Roche labeled all of the documents listed in its revised privilege log as both privileged and subject to the work product doctrine. As discussed above, none of the ten most relevant documents listed in the revised log pages are actually privileged. They are also not protected by the work product doctrine, for the reasons given below.
The work product doctrine is distinct from, and broader than, the attorney-client privilege. Blanchard, 192 F.R.D. at 237; Allendale Mut. Ins. Co. v. Bull Data Sys., 145 F.R.D. 84, 86 (N.D. Ill. 1992). It protects "documents and tangible things . . . prepared in anticipation of litigation or for trial by or for another party or by or for that other partys representative (including the other partys attorney, consultant, surety, indemnitor, insurer, or agent)." Fed. R. Civ. P. 26(b)(3). A document is considered work product only if it is primarily concerned with legal assistance. Loctite Corp. v. Fel-Pro, Inc., 667 F.2d 577, 582 (7th Cir. 1981); North Shore Gas Co. v. Elgin, J. & E. Ry., 164 F.R.D. 59, 64 (N.D. Ill. 1995). Documents prepared for other reasons cannot be withheld as work product. See Pentech, 2001 U.S. Dist. LEXIS 18281, at *8; Allendale, 145 F.R.D. at 87. The general test is "whether, in light of the nature of the document and the factual situation in the particular case, the document can fairly be said to have been prepared or obtained because of the prospect of litigation." Binks Mfg. Co. v. National Presto
12 It is true that an exception to the general third-party waiver rule may exist where the disclosure to the third party is for the purpose of assisting the attorney in rendering legal advice. Blanchard, 192 F.R.D. at 236-37. Here, however, the key is not merely that a third party was involved, but that the communication was strictly concerned with technical analysis and data, not with formulating legal advice. Presumably "Consulting Expert 2" was not consulted as an expert in the principles of patent infringement law. His or her role was presumably technical, and thus outside the realm of attorney-client privilege.
Indus., Inc., 709 F.2d 1109, 1119 (7th Cir. 1983)); accord North Shore, 164 F.R.D. at 61; Allendale, 145 F.R.D. at 86.
Work product is commonly divided into two categories: opinion work product, meaning the "mental impressions, conclusions, opinions, or legal theories of an attorney or other representative of a party concerning the litigation[,]" Fed. R. Civ. P. 26(b)(3), and ordinary work
product, referring to any other document or thing prepared for litigation purposes. Opinion work product receives a higher level of protection from discovery. Id.
It is far from certain that any of the documents that Roche has identified as related to product testing and the 268 patent are genuine work product at all. The Seventh Circuit analyzed this issue when faced with a similar situation in Loctite Corp. v. Fel-Pro, Inc. and
found that the work product doctrine did not apply. Loctite, 667 F.2d 577. In that case, Loctite filed a patent infringement suit alleging that the defendants were infringing three chemical patents. The patent claims each specified a series of ingredients and the quantities of those ingredients that had to be present for a product to fall within the scope of the patents. Loctites complaint failed to identify either the ingredients or the quantities present in the accused products. During discovery, Loctite "refused to disclose the test results of
defendants products upon which Loctite based its complaint, stating that they were irrelevant and that they were protected by the attorney-client or work-product privileges, or both." Loctite, 667 F.2d at 579. When Loctite continued its refusal despite court orders to produce the test results, the trial court dismissed the action and awarded attorneys fees to the defendants.
The Seventh Circuit affirmed, expressly rejecting Loctites argument that test results are protected by attorney-client privilege or the work product doctrine. In Loctite, the court held:
Loctite instituted and fought to maintain this patent infringement action. It was Loctites duty to identify the basis for the suit. . . . In a chemical patent, there is no way to show that these elements [identified in the claims] exist in the accused product without utilizing highly technical tests performed by experts. In order to establish that a justiciable controversy existed, Loctite had to have test results
showing the existence of infringing ingredients in specific amounts in Fel-Pros products. Thus, the production of the test results was not only relevant, but essential to the case.

Loctites attempts to shelter them under the attorney-client and/or work-product privileges cannot stand. Only where the document is primarily concerned with legal assistance does it come within these privileges; technical information is otherwise discoverable. Burlington Industries v. Exxon Corp., 65 F.R.D. 26 (D. Md. 1974). Furthermore, the privileges are not absolute. Where the benefit to the resolution of the suit outweighs the potential injury to the party from whom discovery is sought, as is clearly true in the case before us, disclosure is required. See Hickman v. Taylor, 329 U.S. 495 (1946); Maginnis v. Westinghouse Electric Corp., 207 F. Supp. 739, 743 (E.D. La. 1962).

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Loctite, 667 F.2d at 582 (emphasis added).13

The Loctite analysis applies here as well. Roche accused Apex of infringing the 268 patent, and it is Roches responsibility to identify the basis for the suit. The 268 patent contained requirements such as "allowing such reaction to proceed substantially to completion"
and the presence of "Cottrell current" that cannot be established merely on sight. There is no way to show that these elements exist in an accused product without conducting highly technical tests. There are no documents (in either English or Chinese) that would tell one that the Apex products meet these limitations. If Roche did not conduct such tests on each of the accused products before filing suit, or if its tests did not uncover the presence of each element required by the 268 patent, then Roche did not establish that a "justiciable controversy" existed before filing suit and violated Rule 11. Thus, production of the test results is not only relevant, but essential
to the case. Roche cannot refuse to produce them on either privilege or work product grounds the test results are technical data, not legal assistance, and therefore neither doctrine applies.
Even if the documents that Roche has identified as related to product testing and the 268 patent were work product, disclosure would still be required, as "the benefit to the resolution of the suit outweighs the potential injury to the party from whom discovery is sought[.]" Loctite, 667 F.2d at 582. The work product doctrine is an exception to the general duty of disclosure
13 Cf. Vardon Golf Co. v. BBMG Golf Ltd., 156 F.R.D. 641 (N.D. Ill. 1994) (plaintiffs discovery request for defendants post-filing test reports denied where tests against mechanical patent were not "highly technical" as in Loctite and were attorney-initiated in preparation for infringement defense rather than determining whether to file suit). under Rule 26, and it is not an absolute bar to discovery. Under Rule 26(b)(3), ordinary work product is discoverable "upon a showing that the party seeking discovery has substantial need of
the materials in the preparation of the partys case and that the party is unable without undue hardship to obtain the substantial equivalent of the materials by other means." Fed. R. Civ. P. 26(b)(3); accord Logan v. Commercial Union Ins. Co., 96 F.3d 971, 976 (7th Cir. 1996).
Here, Apex is seeking discovery of the results of Roches investigation into whether the Apex accused products infringed the 268 patent. As the question is whether adequate prefiling investigation and product testing occurred, there is an obvious substantial need for the materials that show what testing took place. Moreover, Apex is unable to obtain the substantial equivalent of Roches testing materials by any other means. Only Roches documents can establish that Roche had a valid basis for filing suit accusing Apex of violating the 268 patent.
Neither can Roche hide behind a claim that either the test reports or any analysis of those reports are protected as opinion work product. Opinion work product enjoys a higher level of protection, Fed. R. Civ. P. 26(b)(3), but it is not completely immune from discovery "when the activities of counsel are directly at issue in a lawsuit." Lexecon Inc. v. Milberg Weiss Bershad Specthrie & Lerach, No. 92 C 7768, 1993 U.S. Dist. LEXIS 6898, at *15 (N.D. Ill. May 21, 1993); AM Intl, Inc. v. Eastman Kodak Co., No. 80 C 4016, 1982 U.S. Dist. LEXIS 17378 (N.D. Ill. Oct. 25, 1982). Apex is questioning whether Roches counsel filed a lawsuit based in part on an unenforceable patent without determining that each of the accused products contained each of the required elements in that patent, in violation of Rule 11. This issue necessarily turns on the activities and mindset of Roches counsel. Under such circumstances, courts have held that discovery of opinion work product is appropriate, as "the work product doctrine permits discovery when mental impressions are the pivotal issue in the current litigation and the need for the material is compelling." Lexecon, 1993 U.S. Dist. LEXIS 6898, at *17 (quoting Holmgren v. State Farm Mut. Auto. Ins. Co., 976 F.2d 573, 577 (9th Cir. 1992)); AM Intl, 1982 U.S. Dist.
LEXIS 17378, at *10 ("[I]n exceptional cases . . . , the need for discovery outweighs the right of an attorney to retain the benefits of his own work.").
For example, in AM International, Inc., the court permitted discovery of pre-suit product tests in a patent infringement action despite the plaintiffs work product claim. AM Intl, 1982 U.S. Dist. LEXIS 17378. In that case, the defendant raised various affirmative defenses,
including invalidity and unenforceability based on, among other things, failure to inform the Patent Office of relevant prior art. The defendant also filed an unfair competition counterclaim, alleging that the infringement suit was groundless and was filed to achieve objectives unrelated to the patents in issue. During discovery, the plaintiff withheld certain material on work product grounds, and the defendant filed a motion to compel production of all material withheld on that basis, "including pre-suit product tests." Id. at *2. The court ordered the materials produced, holding that the work product exception should not apply under the circumstances:
One of Kodaks major allegations in its counterclaim is that AMI knowingly filed suit based on invalid patents in order to unfairly compete with Kodak. Kodaks success thus depends upon a showing that AMI pursued this suit knowing it would be unsuccessful on the merits. Directly at issue, then, are the opinions of AMIs attorneys as to the merits of the action and the validity of the underlying
patents Kodak has a particularized and compelling need for the production of the relevant work product of these attorneys.
Id. at *4. The court concluded that "[a]n attorneys work product is discoverable where such information is directly at issue and the need for production is compelling." Id. at *7.14 Accordingly, citing Loctite v. Fel-Pro, the court ordered plaintiff to produce all documents
identified as referring to the four patents-in-suit, including pre-suit product test information.15
14 Citing Panter v. Marshall Field & Co., 80 F.R.D. 718, 726 (N.D. Ill. 1978) (discovery of counsels advice permitted in shareholders derivative suit); Handgards, Inc. v. Johnson & Johnson, 413 F. Supp. 926 (N.D. Cal. 1976) (work product discovery permitted in antitrust action alleging that patent infringement suits were filed in effort to monopolize); Bird v. Penn Cent. Co., 61 F.R.D. 43 (E.D. Pa. 1973) (work product discoverable where legal theories of attorneys were key element of laches defense); Kearney & Trecker Corp. v. Giddings & Lewis, Inc., 296 F. Supp. 979, 982 (E.D. Wis. 1969) (discovery of opinion work product ordered in patent infringement suit where defendant alleged plaintiff obtained patent through improper means, as "the alleged improprieties involved the activities of the very lawyer whose work product was sought.").
15 The court later ordered plaintiff to produce post-litigation test reports also. AM Intl, Inc. v. Eastman Kodak Co., No. 80 C 4016, 1984 U.S. Dist. LEXIS 20337 (N.D. Ill. Jan. 17, 1984).
The court concluded that "if a test has been made concerning a product which plaintiff claims is relevant to the patents at issue, it is part of discovery and defendants are entitled to access to the reports of that test." AM Intl, 1982 U.S. Dist. LEXIS 17378, at *9 (emphasis added).
"Post-litigation knowledge as to the validity of the allegation of infringement . . . is relevant" because defendant alleged that plaintiff continued to prosecute the suit "in bad faith." Id. at *6.
C. In This Exceptional Case, Where Inequitable Conduct Has Already Been Established, Apex Is Being Thwarted in Its Justified Efforts to Investigate Whether Roche Conducted an Adequate Prefiling Investigation.
As demonstrated above, none of the key documents that Apex is asking the Court to compel Roche to produce are privileged or subject to the work product doctrine. They are technical data rather than legal advice, and as such they are discoverable. In addition to the
clearly discoverable test reports identified in Roches revised privilege log, Apex is also asking for production of all documents related to testing the Apex accused products against the 268 patent, regardless of whether or not they are work product, on the grounds that they are the sole source of evidence as to whether Roche complied with Rule 11 when filing its Complaint.
1. The Courts ruling that the 268 patent is unenforceable for inequitable conduct is prima facie evidence of bad faith justifying
further inquiry.
Apex recognizes that "a naked claim of bad faith cannot, without more, authorize a fishing expedition into privileged communications." Logan, 96 F.3d at 977. The Seventh Circuit has explained that "a mere allegation of bad faith is insufficient to overcome the work
product privilege. The plaintiff must demonstrate some likelihood or probability that the documents sought may contain evidence of bad faith." Id. Even so, where there are credible reasons to suspect that bad faith may have occurred, as, for example, when a court has already found that a plaintiff engaged in bad faith practices in the past, then a defendant should be permitted to investigate its claim by obtaining materials that might otherwise qualify as work product. As the Seventh Circuit has also explained, "Of course, this required showing is not a high hurdle because the [opposing party], without seeing the documents, can only speculate as to their likely contents. He need only show the possibility, not the certainty, that the claim documents contain evidence of bad faith." Id.
This Court already has evidence that Roche has a history of acting in bad faith with regard to the 268 patent. On June 20, 2005, the Court ruled that the 268 patent and its predecessor, U.S. Patent No. 5,108,564, were unenforceable as a result of inequitable conduct on
the part of one of the inventors, Dr. Pottgen, who intentionally withheld material prior art from the patent examiner during prosecution of the predecessor patent. This alone is prima facie evidence of fraud sufficient to defeat any claimed privilege for materials related to any ongoing enforcement of the 268 patent. "It is well settled that the attorney-client privilege has no application where the communication involves advice in furtherance of a criminal or fraudulent transaction. This extends to frauds perpetrated upon the Patent Office, as well as other illegal activities."16 Natta v. Zletz, 418 F.2d 633, 636 (7th Cir. 1969) (citing Ziegler v. Natta, 157 U.S.P.Q. 400 (S.D.N.Y. 1968); 8 Wigmore on Evidence, 2298-99 (rev. ed. 1961)); Creative Indus., Inc. v. Mobil Chem. Corp., No. 86 C 1370, 1989 U.S. Dist. LEXIS 16631, at *5 (N.D. Ill. Oct. 23, 1989).
Given this history, it is reasonable for Apex to raise the question of whether Roche and its counsel filed a lawsuit based in part on a now-invalidated patent without adequately meeting the prefiling investigation requirements of Rule 11. Apex has made the threshold showing that there is a reasonable likelihood the discovery materials it seeks may contain evidence of bad faith conduct. Accordingly, Apex is requesting the Court to compel discovery regardless of Roches privilege and work product claims.
16 "The elements of common law fraud are (1) a knowing, willful, and intentional act of misrepresentation or omission before the Patent Office; (2) materiality of the misrepresentation or omission; and (3) actual reliance by the Patent Office upon the misrepresentation or
omission." Creative Indus., Inc, 1989 U.S. Dist. LEXIS 16631, at *5. All are present here.
2. Although the 268 patent is unenforceable, Apex needs continued discovery to establish the extent of the remedies to which it is
entitled.
The Courts June 20, 2005 Order rendered the 268 patent unenforceable. Even so, there is a need for limited continued discovery related to that patent in order to determine the extent of the remedies to which Apex is entitled as the result of being subjected to a meritless lawsuit. The extent of the total sanctions merited will depend on the extent of Roches unethical conduct, which is why discovery related to the 268 patent continues to be important even though the patent itself is unenforceable.
Apex is already eligible for attorneys fees under 35 U.S.C. 285 as a result of the Courts Order, because inequitable conduct is an identified "exceptional circumstance." See, e.g., Cambridge Prods. Ltd., 962 F.2d at 1050-51; Standard Oil Co. v. American Cyanamid Co., 774 F.2d 448, 455 (Fed. Cir. 1985); Lampi Corp. v. Am. Power Prods., Inc., No. 93 C 1225, 2004 U.S. Dist. LEXIS 14049, at *21-*22 (N.D. Ill. July 20, 2004) ("Circumstances that support a finding of an exceptional case include inequitable conduct in the procurement of a patent[.]").
In addition, if in fact Roche failed to conduct an adequate prefiling investigation of each Apex accused product then it is subject to a range of sanctions, ranging from payment of Apexs attorneys fees, Fed. R. Civ. P. 11(c)(2)(A), to outright dismissal of the entire cause of action, see, e.g., Jimenez, 321 F.3d 652; Loctite, 667 F.2d 577. It would be particularly egregious in this case if Roche failed to adequately determine whether its 268 infringement contentions had merit, as the 268 patent claims had already been construed by this Court in previous litigation against Bayer Corporation. See Exh. 21. As a result of the Bayer litigation, Roche was well aware of the meaning of each term found in the claims, as well as the product characteristics necessary to show infringement. Thus, any failure to confirm that each Apex accused product fell within each element of the patent claim should be considered deliberate, and not the result of mere negligence. As such, any inadequacy in Roches prefiling investigation should be met with equally serious sanctions, including at a minimum payment of any Apex attorneys fees and costs not already awarded under 35 U.S.C. 285.
Finally, if the Court grants Apexs Motion to Compel, Apex should also be entitled under Fed. R. Civ. P. 37(a)(4)(A) to the fees and costs associated with bringing this Motion. Apex has been asking Roche to produce discovery materials related to prefiling product testing since August 2004, without success. It has taken every possible measure to obtain the information needed without resorting to a motion to compel, but has met with resistance from Roche at every turn. Roche has refused to provide even the most obviously nonprivileged details, such as the identity of "Consulting Expert 2", the products tested, the dates of testing, or the identities of the
Roche personnel involved. And, as shown above, Roche improperly relied on an overbroad interpretation of privilege when denying access to these results. Given Roches dilatory tactics over the last twelve months and its express refusal to provide even the most basic factual non-privileged information requested, the Court should award Apex its full attorneys fees and costs associated with bringing this motion.

179-1g
IV. CONCLUSION.
The fact discovery period will close within a few months following the Courts pending decision in the claim construction phase of the suit. If Apex is to obtain discovery of Roches prefiling conduct, it must obtain that discovery now. Apex has agreed to compromise by
limiting its discovery on this issue, for now, to the 268 patent, but Roche has refused to cooperate. Accordingly, Apex respectfully requests the Court to compel Roche to produce any and all documents responsive to the discovery requests outlined in Part II above, and to produce a witness or witnesses to testify on the matters outlined in Defendants July 26, 2005 Rule 30(b)(6) Notice. Apex asks the Court to require, as an absolute minimum acceptable response, that Roche (1) provide the identity of "Consulting Expert 2;" (2) produce the following documents withheld from production:
Bates Nos. RDC1229837-1229839, RDC1229840-1229841, RDC1229854-1229854, RDC1229909-1229912, RDC1229801-1229801, RDC1229807-1229807, RDC1229913-1229914, RDC1229915-1229915, RDC1229916-1229916, and RDC1229917-1229917;
and (3) produce a witness or witnesses knowledgeable about the prefiling investigation that Roche conducted, if any.
DATED: September 13, 2005
APEX BIOTECHNOLOGY CORP. and HYPOGUARD USA, INC.


Medisys PLC

('Medisys' or 'the Company')

Roche Complaint for Patent Infringement

Court Makes Favourable Finding on 609 Patent Claim Construction


Medisys announces that the US District Court (Southern District of Indiana
Indianapolis Division) has issued an Order on Claim Construction (the 'Order')
for US Patent Number 5,366,609 (the '609 Patent') in Roche's Complaint for
Patent Infringement filed in February 2004 against Hypoguard (along with certain
other defendants) in respect of the Assure products.

The 609 Patent is the remaining patent in issue following the Courts prior
ruling in June of this year that the other patent that Roche claimed was being
infringed was unenforceable as a result of inequitable conduct before the US
Patent and Trademark Office during the prosecution of that patent.

The Order sets out how the Court has determined that the terms used in the 609
Patent shall be construed in an infringement trial to determine whether the
product in issue (being Assure 3 in the case of Hypoguard) actually infringes
the 609 Patent. Under the Court's timetable, such an infringement trial is
currently scheduled to take place in the latter part of 2006. However, based
upon the Order, Hypoguard now plans to file a motion to ask the Court to dismiss
Roche's Complaint on the basis that by applying the Court's claim construction,
no reasonable jury could find that the Assure 3 product infringes the 609
Patent.

The Board is pleased with the Court's findings in relation to the construction
of the 609 Patent claims and remains confident of a successful outcome to this
litigation, without cost to Medisys. To date, all costs associated with
Hypoguard's defence of the claims have been paid by Apex (the manufacturer of
the Assure, Assure II and Assure 3 products) under the terms of an indemnity
given by Apex.



- Ends -

Enquiries:

Medisys PLC 01394 446 717
Michael Barry, Chief Financial Officer

Weber Shandwick Square Mile 020 7067 0700
Kevin Smith/John Moriarty


6/10/2005

286
ON DEFENDANTS MOTION FOR LEAVE TO FILE SUPPLEMENTAL MEMORANDUM IN SUPPORT OF THEIR MOTION TO COMPEL PRODUCTION OF DOCUMENTS RELATING TO TESTING OF ACCUSED PRODUCTS FOR INFRINGEMENT OF U.S. PATENT NO. RE. 36,268

The Court, having received Defendants Motion For Leave To File Supplemental Memorandum In Support Of Their Motion To Compel Production Of Documents Relating To Testing Of Accused Products For Infringement Of U.S. Patent No. Re. 36, 268, and being duly and fully advised in the premises:
IT SHALL BE AND IS HEREBY ORDERED THAT:
Defendants above-described motion is granted and the supplemental memorandum tendered therewith shall be accepted and filed as of the date of this Order. Plaintiffs response to Apexs Motion to Compel, including the supplemental memorandum, shall be filed on or before 15 days from the date of this Order.
ENTERED: __________________
_____________________________
United States District Court Southern District of Indiana
Distribution list attached.
_______________________________ V. Sue Shields, Magistrate Judge
10/04/2005

287
BARNES & THORNBURG
Lynn C. Tyler

Via E-Mail and First Class Mail

Robert W. Busby, Esq. Baker & McKenzie LLP 815 Connecticut Ave., N.W. Washington, D.C. 20006

Re: Roche Diagnostics Corporation, et al. v. Apex Biotechnology Corp., et al.; Home Diagnostics, Inc. Our File No. 5727-77, 79

Dear Bob:
I am writing with regard to recently filed motion to compel. Frankly, I am surprised that you have elected to take this issue up with the Court.
As you should be aware, in all relevant respects this precise issue was already addressed by Judge McKinney in the prior Roche v. Bayer case. There, Inverness sought a motion to compel responses to interrogatories that sought the basis for Roche's allegations against defendant Inverness. Specifically, the interrogatories at issue sought information regarding the testing data of its product and the underlying data reports. The testing was performed by a person whom Roche had not identified as a testifying expert. Invoking Rule 11 and in reliance on Loctite Corp. v. Pel-Pro, Inc., 94 F.R.D. 1 (N.D. Ill 1980), aff'd, 667 F.2d 577 (7th Cir. 1981), Inverness argued that it was entitled to discover the factual basis for Roche's allegations against it and that it could only do so by discovery of the testing data: "Inverness cannot determine whether Roche even had a good faith basis for alleging that the [Inverness' products] induce infringement of the '268 patent in the absence of that information." See RDC 1001633.
In opposition, Roche set forth the important reasons why these tests and test results were immune from discovery under Fed. R. Civ. P. 26(b)(4)(B). Roche also explained why the Loctite decision was inapplicable, including that the tests and reports in Loctite were not protectable in that case to begin with because they were made by the employees in the course of their standard business practice (and thus were not work product), they were not undertaken at the direction of counsel, and they were used by Loctite as its only proof of infringement. See RDC 1002176-77. (Indeed, Roche disclosed to you a report compiled by Theron, which, as in Loctite, was created in the course of Roche's standard business practices.)

Robert W. Busby, Esq. September 21,2005 Page 2

Magistrate Judge Foster's decision to allow this discovery was reversed on Roche's objection by Judge McKinney, who concluded: "The Court finds that the document at issue are protected from discovery pursuant to Federal Rules of Civil Procedure 26(b)(3) and 26(b)(4)(B) because they were done for Roche's in-house counsel by an expert who (1) was retained by Roche in anticipation of filing suit against Inverness for infringement of [the '268 patent], and (2) is not expected to testify at trial."
The briefing on this issue, which is voluminous, along with the orders from the Court, are found at RDC 1001624-34; RDC 1002167-88; RDC 1001973-81; RDC 1027180-98; RDC 1005803-20; RDC 1006812-61; RDC 1006501-34; RDC 1008939-40.
Review of your motion would lead me to believe that you have not reviewed these briefs and orders, which are part of the production in this case. As you know, prior to filing your motion you never disclosed to us the authority on which you planned to rely. If you had, we could have pointed out that Judge McKinney has already considered that same authority in this context and rejected the argument you are making. In view of the fact that the identical issue you present to the Court was already raised in a prior case and resolved contrary to your position, we respectfully request that you withdraw your motion to compel. If you do not withdraw this motion, then we reserve the right to request costs and attorney's fees associated with the defense of this motion.
Please let me know your decision as soon as is practicable so that we may cease working on our response to your motion.

Lynn C. Tyler



*************************************************************




ENTRY ON APEX'S MOTION FOR SUMMARY JUDGMENT OF NONINFRINGEMENT OF CLAIM 1

The Court, having received "Apex's Motion for Summary Judgment of Noninfringement of Claim 1" ("Apex's Motion for Summary Judgment"), and all responses and replies to Apex's Motion, being duly and fully advised in the premises and finding that such motion should be granted:
IT SHALL BE AND IS HEREBY ORDERED THAT:
Plaintiffs' remaining claims of infringement against Apex's Assure 3, Apex Defendants' only remaining product in the litigation, are hereby dismissed, with prejudice. No claims remain against any Apex Defendant. This Court shall retain jurisdiction over this matter to consider any motions for sanctions that Apex Defendants may seek by separate motion. ENTERED:
Judge, United States District Court Southern District of Indiana


LATEST ON MDY V'S ROCHE COURT CASE 11/10/2005

It apeares that the cc is still on going and is not yet won or lost

Two documents were filed on Pacer under the same reference (289) which meant they weren't linked to each other. The first was a motion from Apex, the second was a draft judgement document produced by Apex that they wanted the judge to issue

Instead of those being filed as master and slave documents, clearly showing they were both produced by Apex, it looked as though one was from Apex and the other was issued by the judge. Pacer now shows the correct relationships between the documents.


LATEST ON MDY V'S ROCHE COURT CASE 18/10/2005

APEXS MOTION TO SUBSTITUTE SUMMARY JUDGMENT APPENDIX ITEM (WITH CONSENT OF PLAINTIFFS)
Apex Biotechnology Corporation and Hypoguard USA, Inc. (collectively Apex), by their attorneys, move for entry of an Order substituting the attached Declaration of Anthony P.F. Turner with Corrected Paragraph No. 30 (Substitute Declaration) (attached as Exh. 1) for the Declaration of Anthony P.F. Turner that was attached as Appendix item number 2 to Apexs Motion for Summary Judgment of Noninfringement of Claim 1, (Summary Judgment Motion), which was filed October 6, 2005. In support of this motion, Apex states:

1. During the editing and completion of Dr. Anthony P.F. Turners declaration, a word was inadvertently omitted from paragraph 30 on page 6. (See Exh. 2, Affidavit of Anthony P.F. Turner Regarding Typographical Error in Paragraph No. 30, at para. 2.) Namely, paragraph 30 should have read, consistent with the surrounding paragraphs of Dr. Turners declaration, In consideration of the Courts Order on Claim Construction and my understanding of U.S. Patent No. 5,366,609, after operating the Assure 3 it is my opinion that the Assure 3 meter does not meet the requirements of claim 1 of the patent. The not was inadvertently omitted from the original filing. The attached Substitute Declaration includes the omitted word with no further text ual revisions. Exh. 1, at 6.

2. On October 18, 2005, Shannon D. Landreth, counsel for Apex, contacted Helen
K. Geib, counsel for Plaintiffs, regarding the typographical error. Plaintiffs consented to the filing of the Substitute Declaration. No party will be prejudiced by this substitution of the omitted language. Apex has served all parties with this motion and the attached Substitute Declaration.
WHEREFORE, Apex prays that this Court enter an Order in the form submitted
herewith, granting the motion to substitute the attached Declaration of Anthony P.F. Turner with Corrected Paragraph No. 30, and direct the clerk to detach the attached Substitute Declaration and substitute it for Append ix item number 2 in support of Apexs Summary Judgment Motion, filed on October 6, 2005.

DATED: October 18, 2005
APEX BIOTECHNOLOGY CORP. and HYPOGUARD USA, INC.

REPLY TO PLAINTIFFS RESPONSE IN OPPOSITION TO DEFENDANTS MOTION TO COMPEL PRODUCTION OF DOCUMENTS RELATING TO TESTING OF ACCUSED PRODUCTS FOR INFRINGEMENT OF U.S. PATENT NO. RE. 36,268

Defendants Apex Biotechnology Corp. and Hypoguard USA, Inc. (collectively Apex) respectfully submit this Reply to Plaintiffs Response in Opposition to Defendants Motion to Compel Production of Documents Relating to Testing of Accused Products for Infringement of U.S. Patent No. Re. 36,268 (Roche Opp.). Apex seeks to determine whether Roches pre-suit
investigation was adequate.
I. INTRODUCTION

II. ROCHE HAS NOT ESTABLISHED A VALID REASON FOR REFUSING TO PRODUCE THE MATERIALS REQUESTED.

III. THE EVIDENCE OF PRE-FILING TESTING ON THE RECORD IS INSUFFICIENT TO JUSTIFY ROCHES DECISION TO FILE SUIT.

IV. CONCLUSION
Apex has agreed to compromise by limiting its discovery on this issue, for now, to the 268 patent, but Roche has refused to cooperate. None of the reasons that Roche has provided, either in its correspondence with Apex or in its Response filed with the Court, justify its refusal to cooperate in discovery. Accordingly, Apex respectfully requests the Court to compel Roche
to produce a witness and any and all documents responsive to the discovery requests outlined in Apexs September 13, 2005 Memorandum in Support of Defendants Motion to Compel. In addition, Apex requests that the Court compel Roche to produce the nine documents added to Roches privilege log for the first time on October 14, 2005.

DATED: October 18, 2005
APEX BIOTECHNOLOGY CORP. and HYPOGUARD USA, INC.

=============================

NEW

296 (highlights)

REPLY TO PLAINTIFFS RESPONSE IN OPPOSITION TO DEFENDANTS MOTION TO COMPEL PRODUCTION OF DOCUMENTS RELATING TO TESTING OF ACCUSED PRODUCTS FOR INFRINGEMENT OF U.S. PATENT NO. RE. 36,268

Defendants Apex Biotechnology Corp. and Hypoguard USA, Inc. (collectively Apex) respectfully submit this Reply to Plaintiffs Response in Opposition to Defendants Motion to Compel Production of Documents Relating to Testing of Accused Products for Infringement of U.S. Patent No. Re. 36,268 (Roche Opp.). Apex seeks to determine whether Roches pre-suit
investigation was adequate.
I. INTRODUCTION

II. ROCHE HAS NOT ESTABLISHED A VALID REASON FOR REFUSING TO PRODUCE THE MATERIALS REQUESTED.

III. THE EVIDENCE OF PRE-FILING TESTING ON THE RECORD IS INSUFFICIENT TO JUSTIFY ROCHES DECISION TO FILE SUIT.

IV. CONCLUSION
Apex has agreed to compromise by limiting its discovery on this issue, for now, to the 268 patent, but Roche has refused to cooperate. None of the reasons that Roche has provided, either in its correspondence with Apex or in its Response filed with the Court, justify its refusal to cooperate in discovery. Accordingly, Apex respectfully requests the Court to compel Roche
to produce a witness and any and all documents responsive to the discovery requests outlined in Apexs September 13, 2005 Memorandum in Support of Defendants Motion to Compel. In addition, Apex requests that the Court compel Roche to produce the nine documents added to Roches privilege log for the first time on October 14, 2005.

DATED: October 18, 2005
APEX BIOTECHNOLOGY CORP. and HYPOGUARD USA, INC.

297

ORDER GRANTING APEXS MOTION TO SUBSTITUTE APPENDIX ITEM
This Court, having received Apexs Motion to Substitute Summary Judgment
Appendix Item (With Consent of Plaintiffs); being duly and fully advised in the premises; and finding that said motion should be granted;
IT SHALL BE AND IS HEREBY ORDERED THAT:
The clerk shall detach the Declaration of Anthony P.F. Turner with Corrected
Paragraph No. 30 from Apexs Motion and shall substitute that declaration for Appendix item number 2 in support of Apexs Motion for Summary Judgment of Noninfringement of Claim 1, filed October 6, 2005.
ORDERED: _______________________
____________________________________
Larry J. McKinney, Judge
United States District Court
Southern District of Indiana
Distribution list attached.
___________________________________
LARRY J. McKINNEY, CHIEF JUDGE
United States District Court
Southern District of Indiana
10/19/2005

New Stuff
26/10/2005

300
PLAINTIFFS MOTION FOR EXTENSION OF CERTAIN PRETRIAL DEADLINES

Plaintiffs, Roche Diagnostics Corporation, Roche Diagnostics Operations, Inc., and Corange International, Ltd. (collectively, Roche), respectfully move the Court for extension of certain pretrial deadlines. In support of this motion, Roche respectfully shows the Court:

1. The Case Management Plan in this case currently provides that Roche shall file its final infringement contentions 45 days after the Courts Markman ruling or on or before November 10, 2005, which time has not expired.

2. The Case Management Plan also provides that all parties shall file and serve their final witness and exhibit lists 45 days after the Courts Markman ruling or on or before November 10, 2005, which time has not expired.

3. Roche seeks an extension of the deadline to file its final infringement contentions until January 6, 2006 and to file its witness and exhibits lists until January 13, 2006 for the reasons that follow.

4. As explained in detail in Roches Motion for an Extension of Time to Respond to Defendants Motion for Summary Judgment Pursuant to Rule 56(f), which is being filed contemporaneously, Roche has scheduled depositions of Apex, the manufacturer of all the defendants accused products, and two of its employees for the week of December 12, 2005. Roche reasonably waited until fairly recently to schedule these depositions. First, Roche was awaiting the completion of the defendants document production and the translation of many Chinese documents produced by Apex that appeared to be relevant to the issues in this case before scheduling the depositions. Second, Roche waited because the defendants made known early that any depositions of Apex and its employees would have to take place in Taiwan, where Apex is located. Given the time and expense involved in conducting depositions in Taiwan, Roche wanted to conduct all depositions of Apex in one trip. Third, Roche reasonably waited to pursue depositions of Apex on infringement until after the Court had issued its Markman ruling, which the Court issued on September 26, 2005. On September 29, 2005, Roche contacted Apexs counsel about scheduling the depositions and asked to take them in late October or early November so it could complete its final infringement contentions in a timely manner. Apexs counsel advised that the week of December 12 was the only week convenient for both it and Apex, so Roche agreed to schedule the depositions during that week.

5. Because the precise details of the operation of the defendants meters, in particular the interaction between the processor and the code key as governed by the software programmed into the processor, are known only to Apex, Roche should be able to depose Apex and its employees on these subjects prior to submitting its final infringement contentions and final witness and exhibits lists.

6. To allow time for receipt of the deposition transcripts and in light of the intervening holidays, Roche seeks an extension of time to and including January 6, 2006 to file its final infringement contentions and until January 13, 2006 to file its final witness and exhibit lists.
7. Trial in this case is not set until the middle of 2007. Therefore the requested extensions will not delay resolution of this case.
WHEREFORE, Roche respectfully moves the Court for an extension of certain pretrial deadlines as set forth above, and for all other just and proper relief.
Respectfully submitted,
s/Lynn C. Tyler Donald E. Knebel




301

PLAINTIFFS MOTION FOR AN EXTENSION OF TIME TO RESPOND TO DEFENDANTS MOTION FOR SUMMARY JUDGMENT PURSUANT TO RULE 56(f)

Plaintiffs, Roche Diagnostics Corporation, Roche Diagnostics Operations, Inc., and Corange International Ltd. (collectively, Roche), pursuant to Fed. R. Civ. P. 56(f), respectfully move the Court for an extension of time to and including January 6, 2006, to respond to defendants Motion for Summary Judgment of Non-Infringement of Claim 1 of Roches 609 Patent. In support of this motion, Roche respectfully shows the Court:

1. On October 6, 2005, the defendants filed a Motion for Summary Judgment of Non-Infringement of Claim 1 of the 609 patent (defendants Motion).

2. Roches response to defendants Motion is due at the earliest on or before November 7, 2005, which time has not expired.

3. In brief, Roche requests an extension of time to and including January 6, 2006, to file its response to the defendants Motion. On September 29, 2005, a week before defendants filed their Motion, Roche contacted the defendants about scheduling depositions of Apex Biotechnology Corporation (Apex), the manufacturer of all the accused products. Roche later asked to depose certain individual employees of Apex during the same trip. Although Roche had requested to take the depositions in late October or early November, 2005, the earliest mutually convenient date for all witnesses and counsel was the week of December 12, 2005. The depositions are now scheduled for December 13 and 14 in Taipei, Taiwan. To allow time to obtain the transcripts and complete the briefing, in light of the intervening holidays, Roche believes an extension until January 6, 2006 is reasonable and necessary. Given that the trial in the case is not set until mid-2007, the requested extension will not delay the ultimate resolution of the case.

4. Roche will depose Apex on the design and operation of the meters and on damages. Roche also seeks to depose two individuals, Alphe Hsu and Shane Chu.1 According to Apexs interrogatory answers, Mr. Hsu was the meter development leader and was responsible for meter engineering. Mr. Chu is an electronic engineer responsible for design and integration of the meter. Thus, both individual deponents appear knowledgeable about the meters. Roche reasonably expects the depositions to provide evidence of facts creating a genuine issue of material fact that will defeat the defendants Motion. To understand why, it is necessary to review the basis for the defendants Motion.

5. The sole basis defendants Motion is that the Assure 3 meter allegedly does not satisfy the coupled to limitation of claim 1 of the 609 patent. See Defendants Memorandum in Support of Their Motion for Summary Judgment of Non-Infringement of Claim 1 (filed October 6, 2005, Docket No. 290; Defendants Memorandum, at 1-2). More specifically, the defendants assert that [a]nyone operating the Assure 3 can see that it calculates glucose levels
1 Roche is continuing to review Apexs documents and may identify additional individual deponents.
2
Case 1:04-cv-00358-LJM-VSS Document 301 Filed 10/26/2005 Page 2 of 8

without the code key inserted. Id. at 4 (emphasis added). Defendants even submitted two declarations from experts stating that they ran tests using the Assure 3 meter without the code key inserted and it appeared to work properly. Id. at 4-5 and 9 (describing experts declarations); see also id. at 7-8 (noting that after initial use of code key to calibrate meter for a particular batch of strips, the code key can be discarded and is not required until a new batch of strips is used, at which point a new code key is needed).

6. In other words, Defendants Motion is premised on how their meters operate when the code key is not inserted. This is not even the proper test. The proper test is how the meters operate when the code key is inserted. The Defendants meters are sold with an instruction manual that instructs the user to insert the key into the meter and does not instruct the user to ever remove the key. See, e.g., Apex App. 1 at 19. Rather, it affirmatively instructs the user to Store the code chip in the meter, or with the test strip bottle and to not discard the code chip until you have used all of the test strips. Id. (emphasis added). The Defendants Memorandum is noticeably silent on how their meters works when the key is inserted. The Court could deny the defendants Motion on this basis alone. Nonetheless, because the Defendants Motion is potentially dispositive of Roches remaining claim in this case, Roche wishes to complete the proposed depositions so it can present the Court with a full record of how the defendants meters operate when the key is inserted.

7. Based on documents produced by one or more of the defendants in this case, some of which were in Chinese and have been translated, Roche reasonably expects the depositions to confirm that, contrary to the assertions of Defendants Memorandum, the Assure 3s processor does . . . with . . . the key inserted . . . respond to data on the key during performance of the algorithm. Defendants Memorandum at 2 (footnote omitted; underscore in original). Among other reasons, Roche needs these depositions to confirm the authenticity of these documents, to confirm the accuracy of its translations and its understanding of their meaning, and to confirm their applicability to one or more of the different generations of the defendants meters.

8. Further, Roche reasonably expects that the depositions will provide evidence that, even if the defendants meters do not literally infringe claim 1 of the 609 patent, they infringe under the Doctrine of Equivalents. In other words, Roche expects the deposition to show that the difference, if any, between the operation of the defendants meter and claim 1 of the 609 patent is insubstantial. Roche expects the depositions to show that the defendants meters perform substantially the same function, in substantially the same way, to achieve substantially the same result as the meter of claim 1.

9. The details of the interaction between the code key and processor in the defendants meters, as controlled by the software programming the processor, is only available from the defendants. Prior to filing suit, Roche confirmed that the timing of the test run by the defendants meter was affected by the values in the defendants code key, strongly supporting Roches position that the Assure 3s processor does respond to data on the code key during the performance of the algorithm, contrary to defendants assertions. Roche was not able to reverse engineer the entire algorithm performed by the defendants meters because they use an integrated circuit, the operations of which were not visible to the outside. Thus, this information is only available from the defendants through the proposed depositions. Roche expects this information to confirm that, when inserted as instructed, the code key is connected to and influences the microprocessor (and sense means) in the defendants meters.

10. It was reasonable for Roche to wait until this point in the case to seek the proposed depositions. Prior to deposing Apexs witnesses, Roche first wanted to obtain and review the defendants relevant documents. Roche served its initial document requests in April, 2004. The Apex Defendants began producing documents in mid-September, 2004. Defendant Apex did not complete its production until July 8, 2005. Apex produced in total approximately 29,000 pages. Many of the Apex documents are written entirely or partly in Chinese, including about 20 handwritten lab notebooks and extensive design histories for the accused products, among other documents. Roche obtained summary translations of many of the Chinese documents and, following a relevance evaluation of the summary translations, full translations of a number of Apex's Chinese documents. Hypoguard's initial production in late September, 2004 included approximately 75,000 pages. Following some supplemental productions in January and February, 2005, Hypoguard more than doubled its production in late June, 2005 (from approximately 92,000 to 189,000 documents). Hypoguard made two more productions in July, 2005, culminating with a final production on July 27, 2005 of nearly 75,000 additional pages. In short, Roche reasonably waited to take any depositions until the production was complete, which was not until the very end of July. Although Apex's total production was relatively small, there were many documents in Chinese, and Hypoguard's production was fairly large (265,000 pages) and Roche received about two thirds of it between June 20 and July 27.

11. Further, the defendants made known fairly early that any depositions of Apex and its employees would have to be taken in Taiwan, where Apex is located. Given the time and expense involved in conducting depositions in Taiwan, Roche wanted to combine all the depositions of Apex and its employees into a single trip. This is another reason Roche needed to wait until it had obtained and translated all relevant documents.

12. Moreover, the Court held the Markman hearing in this case on August 1, 2005, and it was reasonable for Roche to wait until the Court had issued its ruling on claim construction before incurring the time and expense to travel to Taiwan to depose Apex and its employees on issues of infringement. The Court issued its claim construction ruling on September 26, 2005. On September 29, before the defendants filed their Motion, Roche contacted Apexs counsel about scheduling the Apex deposition. As noted above, Roche had originally requested to take the depositions in late October or early November, which would have allowed Roche to respond to the defendants Motion within the time allowed by the rules or a relatively brief extension. Apexs counsel took the position, however, that the week of December 12 was the only remaining week during 2005 that was convenient for both Apexs counsel and its witnesses, so Roche agreed to schedule the depositions during that week.

13. Finally, it was reasonable for Roche to wait until now to seek the depositions because the Case Management Plan provides four months after the issuance of the Markman ruling to conduct fact discovery. Roche has scheduled the Apex depositions in this time period allowed by the Plan. The Case Management Plan further contemplates that summary judgment motions will be filed after the close of fact discovery. The defendants should not be allowed to deprive Roche of discovery needed to present a full record to oppose defendants Motion simply by filing the Motion earlier than the Plan contemplates.
14. Plaintiffs have sought the defendants consent to this motion, but the defendants would not consent to the relief sought.

15. This motion is supported by the accompanying Affidavits of Donald E. Knebel and Helen K. Geib.

WHEREFORE, Roche respectfully moves the Court for an extension of time to and including January 6, 2006, to file its response to defendants Motion for Summary Judgment of Non-Infringement of Claim 1 of the 609 Patent, and for all other just and proper relief.
Respectfully submitted,
s/Lynn C. Tyler Donald E. Knebel


31/10/2005
Judge has granted the extension to Roche

UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF INDIANA
INDIANAPOLIS DIVISION
ROCHE DIAGNOSTICS CORPORATION,
ROCHE DIAGNOSTICS OPERATIONS,
INC., and CORANGE INTERNATIONAL,
LTD.,
Plaintiffs,
vs.
APEX BIOTECHNOLOGY CORP.,
HYPOGUARD USA, INC., and MEDLINE
INDUSTRIES, INC.,
Defendants.
))))))))
1:04-cv-358-LJM-VSS
))))))
ORDER
This matter comes before the Court on Plaintiffs Roche Diagnostics Corporation, Roche
Diagnostics Operations, Inc., and Corange International, Ltd. (collectively, Roche) Corrected
Motion for Extension of Certain Pretrial Deadlines. The Court, having reviewed the Motion and
being otherwise duly informed in the premises, hereby
ORDERS that Plaintiffs Motion is GRANTED. Plaintiffs shall have to and including
January 6, 2006, to file their final infringement contentions, and to and including January 13,
2006 to file their final witness and exhibit lists.
SO ORDERED.
Date:
Judge, U.S. District Court
Case 1:04-cv-00358-LJM-VSS Document 303-2 Filed 10/27/2005 Page 1 of 2

10/31/05
___________________________________
United States District Court
Southern District of Indiana
Case 1:04-cv-00358-LJM-VSS Document 306 Filed 10/31/2005 Page 1 of 2

================================

6/11/2005

309 4-11-2005

APEX DEFENDANTS MOTION FOR PROTECTIVE ORDER AS TO DISCOVERY ON PRODUCTS OTHER THAN ASSURE 3
Defendants Apex Biotechnology Corp. and Hypoguard USA, Inc. (Apex defendants),
by their attorneys, respectfully move the Court, pursuant to Federal Rule of Civil Procedure 26(c), for entry of a Protective Order that limits Plaintiffs discovery of Apex and Apex and Hypoguard employees to the Assure 3 the only product remaining at issue in the litigation.
Apex Defendants submit herewith, and incorporate herein, the accompanying
Memorandum in Support of Apex Defendants Motion for Protective Order as to Discovery on Products Other Than Assure 3, and the exhibits referenced therein. As the memorandum and exhibits show, Roche has alleged and argued that only the Assure 3 infringes U.S. Patent No.5,366,609 (the 609 Patent). Plaintiffs time to amend their complaint pursuant to the parties
Case Management Plan expired over four months ago, on June 24, 2005. Because only one product (the Assure 3) remains at issue in this litigation, Apex Defendants would be unfairly prejudiced if required to incur costs for discovery that yields inadmissible material or information relating to any other Apex products. Moreover, Apex should not be forced to unnecessarily risk disclosing its trade secrets to Roche and co-defendant Hypoguard, through
discovery related to products no longer at issue in the litigation and never accused of infringing the remaining patent, even in view of an existing protective order.
WHEREFORE, Apex Defendants respectfully request that this Court enter a Protective Order precluding plaintiffs from seeking any documents, eliciting any testimony or conducting other discovery of any Apex or Hypoguard employees, or any deponent, witness or party in this case on any product other than the accused Assure 3, and granting Apex Defendants all other appropriate relief.
APEX BIOTECHNOLOGY CORP. and HYPOGUARD USA, INC.
Respectfully submitted,


------------------------------------------------

11/11/2005

311-1

APEXS MOTION FOR ENLARGEMENT OF TIME TO AND INCLUDING JANUARY 13, 2006 TO FILE FINAL WITNESS AND EXHIBIT LISTS (WITH CONSENT OF PLAINTIFFS)Apex Biotechnology Corp. and Hypoguard USA, Inc. (collectively Apex), by counsel, requests entry of an order enlarging the time for Apex to prepare, file and serve their final witness and exhibit lists to and including January 13, 2006 (the same date on which plaintiffs final witness and exhibit lists are due). In support hereof, Apex states:
1. Pursuant to the parties Case Management Plan, final witness and exhibit lists are to be prepared, file and served on or before 45 days after the Court issues its Markman Order. (CMP, R.)

2. The Court issued its Markman Order on September 26, 2005. Thus, final witness
and exhibit lists are due on November 10, 2005, which time has not expired.

3. Discovery remains ongoing.

4. On October 31, 2005, the Court granted Plaintiffs an extension to and including January 13, 2006, to prepare, file and serve their final witness and exhibit lists.

5. Consequently, to remain consistent with the Case Management Plan (which
provided for simultaneous schedules for filing final witness and exhibit lists) and to reduce the need to amend the lists later, Apex requests an extension to and including January 13, 2006, to prepare and file its final witness and exhibit lists.

6. Pursuant to L.R. 37.1 Shannon Landreth, counsel for Apex, contacted Lynn Tyler, counsel for Plaintiffs, by telephone on November 10, 2005, and discussed this proposed enlargement of time. Mr. Tyler consented to the requested enlargement.

WHEREFORE, Apex respectfully requests entry of an Order enlarging to and including January 13, 2006, Apexs time to prepare and file its final witness and exhibit lists, and for all other appropriate relief for Apex.

APEX BIOTECHNOLOGY CORP. and HYPOGUARD USA, INC.
Respectfully submitted,




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==============================
16/11/2005

UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF INDIANA
INDIANAPOLIS DIVISION
ROCHE DIAGNOSTICS CORPORATION,
Plaintiff,
vs.
APEX BIOTECHNOLOGY CORP, et. al.,
Defendants.
)))
) 1:04-cv-0358- LJM/VSS
)))
ENTRY FOR NOVEMBER 15, 2005
MAGISTRATE JUDGE V. SUE SHIELDS
This cause is set for a settlement conference on November 22, 2005 at 9:30 A.M. in
Room 256, United States Courthouse, 46 E. Ohio Street, Indianapolis, Indiana, before the
Honorable V. Sue Shields.
Unless excused by order of the court, clients or client representatives with complete
authority to negotiate and consummate a settlement shall attend the settlement conference along
with their counsel. This requires the presence of each party, or the authorized representative of
each corporate, governmental, or other organizational entity. For a defendant, such
representative must have final settlement authority to commit the organization to pay, in the
representatives own discretion, a settlement amount up to the plaintiffs prayer, or up to the
plaintiffs last demand, whichever is lower. For a plaintiff, such representative must have final
authority, in the representatives own discretion, to authorize dismissal of the case with
prejudice, or to accept a settlement in the amount of the defendants last offer. Any insurance
company that is a part, or is contractually required to defend or indemnify any party, in whole or
in part, must have a fully authorized settlement representative present at the conference. Such
representative must have final settlement authority to commit the company to pay, in the
Case 1:04-cv-00358-LJM-VSS Document 312 Filed 11/15/2005 Page 1 of 3

representatives own discretion, an amount within the policy limits, or up to the plaintiffs last
demand, whichever is lower. If trial counsel has been fully authorized to commit the client to
pay or to accept in settlement the amount last proposed by the opponent, in counsels sole
discretion, the client, client representative, or insurance company, as applicable, need not attend.
Counsel are responsible for timely advising any involved non-party insurance company of the
requirements of this order. The purpose of this requirement is to have in attendance a
representative who has both the authority to exercise his or her own discretion, and the
realistic freedom to exercise such discretion without negative consequences, in order to
settle the case during the settlement conference without consulting someone else who is not
present.
Each party shall submit (not file) a confidential settlement statement directly to the
magistrate judge no later than two business days prior to the conference, setting forth the
relevant positions of the party concerning factual issues, issues of law, damages, and the
settlement negotiation history of the case, including a recitation of any specific demands and
offers that have been conveyed.
Copies to:

Case 1:04-cv-00358-LJM-VSS Document 312 Filed 11/15/2005 Page 2 of 3

List of names.....

--------------------------------------------

22/11/2005
a new entry

UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF INDIANA
INDIANAPOLIS DIVISION
ROCHE DIAGNOSTICS CORPORATION, )
ROCHE DIAGNOSTICS OPERATIONS, INC., )
and CORANGE INTERNATIONAL LTD., )
)
Plaintiffs, )
)
vs. ) Civil Action No. 1:04-CV-00358-LJM-VSS
)
APEX BIOTECHNOLOGY CORP., )
HYPOGUARD USA, INC., )
)
Defendants. )
NOTICE OF MANUAL FILING
Please take notice that the Plaintiffs, Roche Diagnostics Corporation, Roche Diagnostics
Operations, Inc., and Corange International Ltd., are manually filing Plaintiffs Response to
Apex Defendants Motion for a Protective Order as to Discovery on Products Other Than the
Assure 3.
This document has not been filed electronically because it contains confidential
information and is being filed under seal pursuant to Court order.

--------------------------------------------------------------------

29/11/2005

317-1

REPLY TO PLAINTIFFS RESPONSE IN OPPOSITION TO APEX DEFENDANTS MOTION FOR A PROTECTIVE ORDER AS TO DISCOVERY ON PRODUCTS OTHER THAN ASSURE 3

Defendants Apex Biotechnology Corp. and Hypoguard USA, Inc. (collectively Apex)respectfully submit this Reply to Plaintiffs Response in Opposition to Defendants Motion for a Protective Order as to Discovery on products other than the Assure 3. Apex filed its motion for a protective order on November 4, 2005. Roche filed its response on November 21, 2005. Pls.
Resp. to Apex Defs. Mot. for a Protective Order as to Discovery on Products Other than the Assure 3 (Pls. Resp.).
I. ARGUMENT
Apex seeks a protective order to limit future discovery the depositions of Shane Chu, Alphe Hsu, and Apex Biotechnology Corp. to the subject matter of this litigation: the Assure 3
meter and its relation to the 609 patent. Roche complains that [b]y this Motion, Apex
apparently seeks to preclude Plaintiffs (Roche) from asking even a single question that
includes a reference to their prior Assure and Assure II products at depositions of Apex and
two of its employees that have been scheduled for mid-December, 2005. Pls. Resp. at 1. Roches characterization of Apexs motion is correct Apex is asking the Court to prohibit
Roche from asking even a single question about irrelevant topics such as products that are no
longer involved in this case. This is hardly an unreasonable discovery limitation. Apexs
request is squarely in accordance with the Courts Order of November 1, 2005, which
unambiguously warned that [t]o the extent that Roche intends to use the two depositions of
Apex personnel as fishing expeditions about products that the parties agreed were no longer at
issue, the Court cannot agree that Roches motion is proper. Order on Pls. Mot. for Time
Pursuant to Rule 56(f) (Nov. 1, 2005).
Roches Opposition provides still further evidence that it plans to try to circumvent the
Courts Order and obtain testimony on the Assure and Assure II, even though Roche reassures
the Court that based on the documents produced by Apex to date, Roche has concluded that it
will not accuse the Assure and Assure II of infringement of the 609 patent. Pls. Resp. at 4..
See Pls. Resp. at 4. Apex has good cause to request a protective order in that (1) the Court has
stated that questions about products no longer at issue in this case would be improper; (2) Roche
has, in its deposition notices and again in its opposition to Apexs motion, announced its
intention to ask such questions;1 and (3) the only purpose that these irrelevant questions can
serve is to burden Apex rather than to lead to evidence admissible at trial.
A. Legal Standard
The Federal Rules of Civil Procedure provide that [p]arties may obtain discovery
regarding any matter, not privileged, that is relevant to the claim or defense of any party[.] Fed.
R. Civ. P. 26(b)(l) (emphasis added). The information sought need not be admissible at trial, but
1 Even in its amended deposition notice regarding Apex Biotechnology Corp., which Roche
claims does not include an overbroad definition of Accused Products, Pls. Resp. at 2 n.2,
Roche continues to define the term to mean the Assure 3 blood glucose meters and test strips
and all identical meters and strips marketed under any other name. Amended Notice of
Deposition of Apex Biotechnology Corp. Pursuant to Fed. R. Civ. P. 30(b)(6), Schedule A at 1
(Nov. 3, 2005). This is still broader than the only acceptable definition at this stage of the
litigation: the Assure 3 blood glucose meters. it must be relevant. Id. The converse is equally true. Matters that are not relevant to any
existing claim or defense are not discoverable. Thus, matters relevant only to claims already
conclusively laid to rest by the Court are not suitable topics for further discovery. Moreover, the
scope of discovery is limited by Rule 26(b)(2), which allows the court to limit discovery where
the burden or expense of the proposed discovery outweighs its likely benefit or where the
discovery sought is unreasonably cumulative or duplicative[.] Fed. R. Civ. P. 26(b)(2).
Although the Federal Rules generally support a policy of liberal discovery, when a party
attempts to conduct discovery of irrelevant matters, courts will circumscribe discovery by means
of a protective order. Upon motion and for good cause shown, the Court may make any order
which justice requires to protect a party or person from annoyance, embarrassment, oppression,
or undue burden or expense[.] Fed. R. Civ. P. 26(c). Such orders include orders that certain
matters not be inquired into, or that the scope of the disclosure or discovery be limited to certain
matters[.] Fed. R. Civ. P. 26(c)(4). [A] showing of irrelevancy of proposed discovery can
satisfy the good cause requirement for a protective order. 6 James W. Moore, Moores
Federal Practice 26.105[5] (3d ed. 2005). See also Smith v. City of Chicago, 2005 U.S. Dist.
LEXIS 26454, at *3 (N.D. Ill. 2005) (The relevancy of the information to the litigation should
be considered in making the good cause determination.); Balistrieri v. Holtzman, 52 F.R.D. 23,
24-25 (D. Wis. 1971) (protective order prohibiting certain depositions maintained where
interrogation by the defendants would harass the plaintiff and the proposed witnesses rather
than lead the defendants to relevant evidence and [t]he good cause contemplated in 26(c)
appeared by reason of the magnitude of the proposed discovery and the courts past experience
with the proceedings of the instant case.).
B. Roches Objections
Roche opposes Apexs motion for a protective order on the grounds that questions about
the Assure and Assure II products are relevant to how Apexs accused Assure 3 product
works, to Roches claim that Apexs manufacture and sale of the Assure 3 device willfully
Case 1:04-cv-00358-LJM-VSS Document 317-1 Filed 11/28/2005 Page 3 of 11

4
infringes Roches U.S. Patent No. 5,366,609 (the 609 patent), and to damages issues. Pls.
Resp. at 1. Incredibly, Roche also interprets the Courts November 1st Order prohibiting
fishing expeditions to apply only to the two proposed depositions of individuals, and not to the
proposed Rule 30(b)(6) deposition of Apex itself.
Contrary to Roches claims, nothing about the Assure and Assure II products is
relevant to these issues. Roche admits that the Assure and Assure II do not infringe the 609
patent. Pls. Resp. at 4 ([B]ased on the documents produced by Apex to date, Roche has
concluded that it will not accuse the Assure and Assure II of infringement of the 609 patent.).
Yet at the same time, it alleges that Apex must provide evidence confirming that . . . the
Assure and Assure II do not infringe the 609 patent for a particular reason (unrelated to the
coupled to limitation)[.] Pls. Resp. at 4-5. In short, Roche is trying to make the Assure and
Assure II appear relevant by claiming that it may force Apex to demonstrate that they do not
infringe. This it may not do. As in every other patent litigation, Plaintiffs may not seek
discovery on products not relevant to the suit. See Fed. R. Civ. P. 26(b)(l). Moreover, even if
information about the Assure and Assure II products were relevant, which it is not, the
additional discovery would be unreasonably cumulative or duplicative[,] and the additional
burden and expense to Apex would outweigh its likely benefit[.] Fed. R. Civ. P. 26(b)(2).
Roche can obtain any information it needs to establish the infringement that it has alleged by
asking questions about the Assure 3 itself.
1. Apex does not have to prove that the Assure and Assure II do not
infringe the 609 patent
Roches first argument is that questions about products not accused of infringing the 609
patent are relevant to the issue of whether the Assure 3 infringes that patent. If this were true,
then every product owned by every defendant in a patent infringement case would always be at
issue. Roche states that how the Assure II works is indisputably relevant to how the Assure 3
works. . . . Given that the Assure II and Assure 3 use the same algorithm, the relevance of
questions about the Assure II is apparent. Pls. Resp. at 3. It is not apparent. In fact, how the
Case 1:04-cv-00358-LJM-VSS Document 317-1 Filed 11/28/2005 Page 4 of 11

5
Assure II works has nothing to do with the relevant questions of how the Assure 3 works and
whether its operation infringes the 609 patent. Assume for the moment that Roche could
establish that the operation of the Assure II is similar even identical to the operation of the
Assure 3. What relevant information would Roche learn from this? The Assure II is not
accused of infringing the 609 patent and the deadline for Roche to amend its complaint has
passed, so Roche could not use the information to resurrect its infringement allegations against
the Assure II.2 Neither would it learn anything about the operation of the Assure 3 that it
could not learn more directly by asking Apex about the operation of the Assure 3 product. If
Roche has questions about the operation of the Assure 3 that were not answered by its pre-filing
testing procedures, which appear to be limited, then it can simply ask Apex about the operation
of the Assure 3 without reference to the Assure II. According to Roche itself, the Assure
and Assure II products are not at issue; therefore, their operation is irrelevant.
2. Willfulness
Roches second argument is that questions about the Assure II are relevant to Apexs
willful infringement. Pls. Resp. at 4. Roches theory is that
evidence confirming that (1) the Assure and Assure II did not infringe the 609
patent for a particular reason (unrelated to the coupled to limitation), (2) the
Assure III was changed from the Assure and Assure II in the particular respect
that made the prior devices non-infringing, and (3) as a result of the change the
Assure 3 infringes goes directly to Roches claim of willful infringement[.]
Id. at 4-5. Note that this argument that Roche needs information regarding the Assure and
Assure II products to support its infringement theory (that in some relevant respects the
Assure II and Assure 3 are the same) is inconsistent with its willfulness theory (that the
2 The Assure and Assure II (as well as the EvenCare, Sensorex, Sensorex II, Sensorex 3, and
Glucosure product lines, and defendant Medline) were removed from this case when the Court
held that the 268 patent was unenforceable. See Order on Defendants Motion to Separate &
Stay, at 3-4 (Dec. 2, 2004).
Case 1:04-cv-00358-LJM-VSS Document 317-1 Filed 11/28/2005 Page 5 of 11

6
introduction of the Assure 3 constituted willful infringement because the Assure and
Assure II do not infringe). Cf. Pls. Resp. at 3-4 with id. at 4-5.3
Again, the theory that Apex willfully infringed the 609 patent when it developed the
Assure 3 can be tested without engaging in a fishing expedition regarding other Apex
products. Roche claims that it already has evidence that the Assure 3 was introduced in 2003
and that no later than June 23, 2003 Apex was aware of the 609 patent. Id. at 4 & exh. 3. If
so, then if Roche can show that (1) Apex deliberately introduced an infringing design in 2003
while aware of the 609 patent, and (2) that in doing so Apex was not acting in good faith, i.e.,
acting in a commercially reasonable manner under the circumstances, then Roche may allege
willful infringement. There is no need to engage in an irrelevant investigation of whether or not
prior unaccused products infringe the 609 patent. In depositions, Roche can ask questions
regarding the development of the Assure 3 to determine the reasons for developing the product
and whether or not it infringes the 609 patent. Roche can do this without asking a single
question about products other than the Assure 3. Whether or not the Assure and Assure II
products infringe the 609 patent is irrelevant, and allowing Roche to depose Apex or its
employees on the subject would be unduly burdensome and contrary to the Federal Rules of
Civil Procedure.
3. Damages
Finally, Roche argues that questions as to how the Assure and Assure II work and why
Apex changed from their design to the design of the Assure 3 are relevant to damages issues
such as whether there are acceptable, non-infringing alternatives to the patented invention and
the utility and advantages of the patented invention over old modes or devices. Pls. Resp. at 5.
Non-infringing substitutes relate only to a theory of damages known as lost profits. See,
e.g., Panduit Corp. v. Stahlin Bros. Fibre Works, Inc., 575 F.2d 1152, 1156 (6th Cir. 1978).
3 If Roche seeks an admission regarding the non-infringement of the Assure and Assure II
products, Apex is willing to stipulate that they do not infringe the 609 patent. The Assure 3
does not infringe, either.
Case 1:04-cv-00358-LJM-VSS Document 317-1 Filed 11/28/2005 Page 6 of 11

7
Thus, the damages issues that Roche cites are relevant only to a lost profits theory of recovery, a
theory that Roche has not alleged. In its interrogatory responses, Roche has stated that it seeks
only a reasonable royalty as damages for any infringement found. Exh. 1 (Pls. Resp. to 1st Set
of Interrogatories from Defs. Apex Biotechnology Corp., Hypoguard USA, Inc. & Medline
Indus., Inc., at 12 (Sept. 13, 2004)). Accordingly, lost profits analysis is not relevant to this
litigation, especially as Roche has repeatedly admitted that the parties operate in different
markets.
A lost profits approach to recovery calculates damages based on the profits on sales the
plaintiff would have made absent the infringement, and requires a patent owner to prove: (1)
demand for the patented product, (2) absence of acceptable noninfringing substitutes, (3) his
manufacturing and marketing capability to exploit the demand, and (4) the amount of the profit
he would have made. Panduit, 575 F.2d at 1156; see also Georgia-Pacific Corp. v. United
States Plywood Corp., 318 F. Supp. 1116, 1127 (S.D.N.Y.), modified and affd sub nom.,
Georgia-Pacific Corp. v. United States Plywood Champion Papers, Inc., 446 F.2d 295 (2d Cir.
1970).
Alternatively, under a reasonable royalty theory of damages, a party may show the
value by proving what would have been a reasonable royalty, considering the nature of the
invention, its utility and advantages, and the extent of the use involved. Georgia-Pacific, 318 F.
Supp. at 1121 (quoting Dowagiac Mfg. Co. v. Minnesota Moline Plow Co., 235 U.S. 641, 648
(1915)). The relevant question is the size of the licensing fee that theoretically would have been
negotiated between the parties had a license been sought before any infringing activity took
place. See id. at 1120. The presence of alternative non-infringing products is immaterial under
this theory of recovery, the theory that Roche has adopted.
Roche has not alleged a lost profits theory of recovery. In its first set of interrogatories,
Apex asked Roche to describe in detail each of Roche's theories of monetary relief. In response,
Roche stated that
Case 1:04-cv-00358-LJM-VSS Document 317-1 Filed 11/28/2005 Page 7 of 11

8
Roche expects to seek relief based on a reasonable royalty measure of damages. A
reasonable royalty for the defendants sales is the subject of expert testimony.
Roche has produced non-privileged litigation files relating to the prior litigation
between RDC and Bayer, which include documents relating to a reasonable
royalty measure in connection with Bayer. If Roche seeks relief based on a lost
profits measure of damages, then Roche will produce summary financial
documents establishing its revenue, expenses, and profits in connection with
products for which it is asserting it lost sales as a result of sales of the accused
products for the time period for which it asserts lost sales.
Exh. 1. Roche has not notified Apex of any change in its theory of recovery and has not
produced the summary financial documents that it promised to provide in the event that it
changed to a lost profits theory of recovery. Roches response is unambiguous Roche is
pursuing a reasonable royalty theory of recovery only. It follows, therefore, that lost profits
information, such as that relating to the presence of alternative non-infringing products like the
Assure and Assure II products, is irrelevant to the question of damages.
4. Judge McKinneys November 1, 2005, Order
In its last argument, Roche attempts to erode the Courts November 1st Order by limiting
its effect to the proposed depositions of Apex personnel, and not to the proposed Rule 30(b)(6)
deposition of Apex itself. Roche states the following:
Finally, upon closer examination, it is far from clear that the Courts Order on
Roches Rule 56(f) Motion is as broad as Apex would like to think . . . . [T]he
Court wrote: To the extent that Roche intends to use the two depositions of Apex
personnel as fishing expeditions about products that the parties agreed were no
longer at issue, the Court cannot agree that Roches motion is proper (emphasis
added). In other words, the Courts Order is expressly limited to the two
depositions of Apex personnel and not to the deposition of Apex itself.
Pls. Resp. at 5. Roches argument, that the Courts Order is limited to the depositions of Shane
Chu and Alphe Hsu, and not to the deposition of Apex Corp., does not merit serious discussion.
It does not matter which deponent is subjected to an improper fishing expedition. Roches
attempt to diminish the plain meaning of the Courts Order should not be permitted.
II. CONCLUSION
Roche has failed to identify a single persuasive reason why it should be permitted to ask
questions about products that it has decided not to accuse of infringing the sole patent remaining
Case 1:04-cv-00358-LJM-VSS Document 317-1 Filed 11/28/2005 Page 8 of 11

9
in this case. Despite Roches interpretation of the Courts Order, the Court has already warned
Roche that it may not engage in fishing expeditions about products that the parties agreed were
no longer at issue. Order on Pls. Mot. for Time Pursuant to Rule 56(f) (Nov. 1, 2005). As
demonstrated above, inquiries regarding any product other than the Assure 3 are irrelevant, and
therefore improper, at this point in this litigation. Accordingly, Apex respectfully requests the
Court to grant Apexs motion for a protective order with regard to the depositions of Shane Chu,
Alphe Hsu, and Apex Biotechnology Corporation: (1) denying Plaintiffs discovery of any
documents relating to any product other than the Assure 3, and (2) precluding inquiry by the
Plaintiffs of Mr. Chu, Mr. Hsu, or Apex Biotechnology Corp. on any product other than the
Assure 3.


=================================================

It looks like its finely over. this case be dismissed.

2/02/2006 21hrs
STIPULATION OF DISMISSAL WITH PREJUDICE
A settlement having been reached, the above-identified parties, through their
undersigned attorneys, hereby stipulate and agree pursuant to Fed. Rule Civ. P. 41 that the Plaintiffs Amended Complaint and the Defendants Amended Counterclaims in this case be dismissed with prejudice. The parties further stipulate that the Court shall retain jurisdiction over any disputes arising out of or related to the parties Confidential Settlement Agreement. Each of these parties will bear its own costs and attorneys fees.
Respectfully submitted,
s/Lynn C. Tyler
Donald E. Knebel
Larry A. Mackey
Lynn C. Tyler
Paul B. Hunt
Helen K. Geib
BARNES & THORNBURG LLP
11 South Meridian Street
Indianapolis, Indiana 46204
s/Robert W. Busby
Robert W. Busby
W. Jackson Matney, Jr.
Baker & McKenzie LLP
815 Connecticut Avenue, N.W.
Washington, DC 20006




325
This matter came before the Court upon the Stipulation of Dismissal of the plaintiffs,
Roche Diagnostics Corporation, Roche Diagnostics Operations, Inc., and Corange International,
Ltd. and the defendants, Apex Biotechnology Corporation, Hypoguard USA, Inc., and Medline
Industries, Inc. The Court, being duly advised, it is hereby
ORDERED that the Plaintiffs Amended Complaint and the Defendants Amended
Counterclaims are DISMISSED WITH PREJUDICE, with each party to bear its own costs and
attorneys fees.
IT IS FURTHER ORDERED THAT the Court shall retain jurisdiction over any
disputes arising out of or related to the parties Confidential Settlement Agreement.
SO ORDERED.

===========================================

It looks like its finely over. case be dismissed

2/02/2006 21hrs
STIPULATION OF DISMISSAL WITH PREJUDICE
A settlement having been reached, the above-identified parties, through their
undersigned attorneys, hereby stipulate and agree pursuant to Fed. Rule Civ. P. 41 that the Plaintiffs Amended Complaint and the Defendants Amended Counterclaims in this case be dismissed with prejudice. The parties further stipulate that the Court shall retain jurisdiction over any disputes arising out of or related to the parties Confidential Settlement Agreement. Each of these parties will bear its own costs and attorneys fees.
Respectfully submitted,
s/Lynn C. Tyler
Donald E. Knebel
Larry A. Mackey
Lynn C. Tyler
Paul B. Hunt
Helen K. Geib
BARNES & THORNBURG LLP
11 South Meridian Street
Indianapolis, Indiana 46204
s/Robert W. Busby
Robert W. Busby
W. Jackson Matney, Jr.
Baker & McKenzie LLP
815 Connecticut Avenue, N.W.
Washington, DC 20006




325
This matter came before the Court upon the Stipulation of Dismissal of the plaintiffs,
Roche Diagnostics Corporation, Roche Diagnostics Operations, Inc., and Corange International,
Ltd. and the defendants, Apex Biotechnology Corporation, Hypoguard USA, Inc., and Medline
Industries, Inc. The Court, being duly advised, it is hereby
ORDERED that the Plaintiffs Amended Complaint and the Defendants Amended
Counterclaims are DISMISSED WITH PREJUDICE, with each party to bear its own costs and
attorneys fees.
IT IS FURTHER ORDERED THAT the Court shall retain jurisdiction over any
disputes arising out of or related to the parties Confidential Settlement Agreement.
SO ORDERED.

-------------------------------------------------------------------------
It looks like its finely over. case be dismissed.

2/02/2006 21hrs
324 STIPULATION OF DISMISSAL WITH PREJUDICE
A settlement having been reached, the above-identified parties, through their
undersigned attorneys, hereby stipulate and agree pursuant to Fed. Rule Civ. P. 41 that the Plaintiffs Amended Complaint and the Defendants Amended Counterclaims in this case be dismissed with prejudice. The parties further stipulate that the Court shall retain jurisdiction over any disputes arising out of or related to the parties Confidential Settlement Agreement. Each of these parties will bear its own costs and attorneys fees.
Respectfully submitted,
s/Lynn C. Tyler
Donald E. Knebel
Larry A. Mackey
Lynn C. Tyler
Paul B. Hunt
Helen K. Geib
BARNES & THORNBURG LLP
11 South Meridian Street
Indianapolis, Indiana 46204
s/Robert W. Busby
Robert W. Busby
W. Jackson Matney, Jr.
Baker & McKenzie LLP
815 Connecticut Avenue, N.W.
Washington, DC 20006

325
This matter came before the Court upon the Stipulation of Dismissal of the plaintiffs,
Roche Diagnostics Corporation, Roche Diagnostics Operations, Inc., and Corange International,
Ltd. and the defendants, Apex Biotechnology Corporation, Hypoguard USA, Inc., and Medline
Industries, Inc. The Court, being duly advised, it is hereby
ORDERED that the Plaintiffs Amended Complaint and the Defendants Amended
Counterclaims are DISMISSED WITH PREJUDICE, with each party to bear its own costs and
attorneys fees.
IT IS FURTHER ORDERED THAT the Court shall retain jurisdiction over any
disputes arising out of or related to the parties Confidential Settlement Agreement.
SO ORDERED.

Can anyone give a summary in words of one sylable please !!

UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF INDIANA
INDIANAPOLIS DIVISION
ROCHE DIAGNOSTICS CORPORATION, )
ROCHE DIAGNOSTICS OPERATIONS, INC., )
and CORANGE INTERNATIONAL LTD., )
)
Plaintiffs, )
)
vs. ) Civil Action No. 1:04-CV-00358-LJM-VSS
)
APEX BIOTECHNOLOGY CORP., )
HYPOGUARD USA, INC., and MEDLINE )
INDUSTRIES, INC., )
)
Defendants. )
MOTION FOR EXTENSION OF PRETRIAL DEADLINE AND ROCHES RESPONSE
TO MOTION FOR SUMMARY JUDGMENT
Plaintiffs Roche Diagnostics Corp., Roche Diagnostics Operations, Inc., and Corange
International, Ltd. (collectively, Roche) respectfully move the Court for a two week extension
of time to respond to Defendants Apex Biotechnology Corp. and Hypoguard USA, Inc.s
(defendants) Motion for Summary Judgment and to file final infringement contentions as to
defendants. In support of this motion, Roche would show the Court:
1. On October 6, 2005, the defendants filed a Motion for Summary Judgment of
Non-Infringement of Claim 1 of the 609 patent. Roche moved for an extension of time pursuant
to Rule 57(f) to respond to the summary judgment motion. The Court granted Roches motion
for extension of time to allow Roche to depose Apex personnel regarding the operation of the
defendants accused product. (docket no. 308) Roches response to the Defendants Motion for
Summary Judgment is currently due January 6, 2006, which time has not expired.
2. Similarly, Roche moved for an extension of time to certain pre-trial deadlines as
to the defendants. Specifically, Roche moved for an extension of the deadline to file its final
Case 1:04-cv-00358-LJM-VSS Document 320 Filed 01/06/2006 Page 1 of 4

2
infringement contentions. The Court granted Roches motion, also extending the deadline to file
final infringement contentions to January 6, 2006. (docket no. 306)
3. Subsequently, Roche and the Apex defendants engaged in settlement discussions
and have reached a settlement in principle. The parties have exchanged multiple draft settlement
agreements and are currently attempting to finalize the settlement.
4. In light of the advanced status of the parties ongoing settlement discussions,
Roche requests a two week extension of time to January 20, 2006 for the deadlines for Roche to
respond to defendants Motion for Summary Judgment and to file final infringement contentions
as to defendants. In the unexpected event that the settlement is not completed, Roche would then
expect to seek defendants agreement to and/or the Courts approval for a new schedule
affording Roche time to complete the necessary depositions, briefing, and contentions.
5. Counsel for Roche contacted defendants counsel to request defendants consent
to this motion. At the time of filing this motion, Roche had not received a response to the
request. Additionally, Roche informed defendants counsel that Roches American counsel will
recommend approval of defendants most recent draft settlement agreement.
Wherefore, Roche respectfully requests a two week extension of time to January 20 to
file its response to Defendants Motion for Summary Judgment and Roches final infringement
contentions as to the Apex defendants.

mp
Thanks for posting the lattest cc stuff its looking good for MDY
Roche and the Apex defendants engaged in settlement discussions.

20/01/2005Roche has ask for another two week extension.

UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF INDIANA
INDIANAPOLIS DIVISION
ROCHE DIAGNOSTICS CORPORATION, )
ROCHE DIAGNOSTICS OPERATIONS, INC., )
and CORANGE INTERNATIONAL LTD., )
)
Plaintiffs, )
)
vs. ) Civil Action No. 1:04-CV-00358-LJM-VSS
)
APEX BIOTECHNOLOGY CORP., )
HYPOGUARD USA, INC., and MEDLINE )
INDUSTRIES, INC., )
)
Defendants. )
AGREED MOTION FOR EXTENSION OF PRETRIAL DEADLINE AND ROCHES
RESPONSE TO MOTION FOR SUMMARY JUDGMENT
Plaintiffs Roche Diagnostics Corp., Roche Diagnostics Operations, Inc., and Corange
International, Ltd. (collectively, Roche) respectfully move the Court for a two week extension
of time to respond to Defendants Apex Biotechnology Corp. and Hypoguard USA, Inc.s
(defendants) Motion for Summary Judgment and to file final infringement contentions as to
defendants. In support of this motion, Roche would show the Court:
1. Roches response to defendants Motion for Summary Judgment of Non-
Infringement of Claim 1 of the 609 patent is currently due January 20, 2005, which time has not
expired. Roches deadline to file final infringement contentions is also currently due January 20.
See Order granting extension (docket no. 321).
2. Roche has accepted defendants draft settlement agreement, and the parties
anticipate the agreement will be executed shortly.
3. Accordingly, Roche moves the Court for a two week extension of time for these
deadlines to February 3 to permit the parties to execute the settlement agreement.
Case 1:04-cv-00358-LJM-VSS Document 322 Filed 01/20/2006 Page 1 of 3

2
4. Defendants agree to this Motion.
Wherefore, Roche respectfully requests a two week extension of time to February 3, 2006
to file its response to defendants Motion for Summary Judgment and Roches final infringement
contentions as to the Apex defendants.
Respectfully submitted,

It looks like its finely over. case be dismissed.

2/02/2006 21hrs
324
STIPULATION OF DISMISSAL WITH PREJUDICE
A settlement having been reached, the above-identified parties, through their
undersigned attorneys, hereby stipulate and agree pursuant to Fed. Rule Civ. P. 41 that the Plaintiffs Amended Complaint and the Defendants Amended Counterclaims in this case be dismissed with prejudice. The parties further stipulate that the Court shall retain jurisdiction over any disputes arising out of or related to the parties Confidential Settlement Agreement. Each of these parties will bear its own costs and attorneys fees.
Respectfully submitted,
s/Lynn C. Tyler
Donald E. Knebel
Larry A. Mackey
Lynn C. Tyler
Paul B. Hunt
Helen K. Geib
BARNES & THORNBURG LLP
11 South Meridian Street
Indianapolis, Indiana 46204
s/Robert W. Busby
Robert W. Busby
W. Jackson Matney, Jr.
Baker & McKenzie LLP
815 Connecticut Avenue, N.W.
Washington, DC 20006

325
This matter came before the Court upon the Stipulation of Dismissal of the plaintiffs,
Roche Diagnostics Corporation, Roche Diagnostics Operations, Inc., and Corange International,
Ltd. and the defendants, Apex Biotechnology Corporation, Hypoguard USA, Inc., and Medline
Industries, Inc. The Court, being duly advised, it is hereby
ORDERED that the Plaintiffs Amended Complaint and the Defendants Amended
Counterclaims are DISMISSED WITH PREJUDICE, with each party to bear its own costs and
attorneys fees.
IT IS FURTHER ORDERED THAT the Court shall retain jurisdiction over any
disputes arising out of or related to the parties Confidential Settlement Agreement.
SO ORDERED.