Amgen Inc. v. F. Hoffmann-LaRoche LTD et al

Filing 807

PRETRIAL MEMORANDUM by F. Hoffmann-LaRoche LTD, Amgen Inc.. (Attachments: #1 Exhibit A (Amgen's Contested Issues of Fact)#2 Exhibit B (Roche's Statement of Contested Issues of Fact)#3 Exhibit C (Amgen's Legal Standards and Burden of Proof)#4 Exhibit D (Roche's Statement of Legal Standards and Burdens of Proof)#5 Exhibit E (Amgen's List of Witnsses for Trial)#6 Exhibit F (Roche's List of Potential Witnesses))(Gottfried, Michael)

Amgen Inc. v. F. Hoffmann-LaRoche LTD et al

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UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS ) AMGEN INC., ) ) Plaintiff, ) ) v. ) ) ) F. HOFFMANN-LA ROCHE ) LTD., a Swiss Company, ROCHE ) DIAGNOSTICS GmbH, a German ) Company and HOFFMANN LA ROCHE ) INC., a New Jersey Corporation, ) ) Defendants. ) __________________________________________)

Civil Action No.: 05-12237 WGY

JOINT PRETRIAL MEMORANDUM Amgen, Inc. ("Amgen") and F. Hoffmann-La Roche Ltd., Roche Diagnostics GmbH, and Hoffmann La Roche Inc., (collectively, "Roche") offer the following Joint Pretrial Memorandum.

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TABLE OF CONTENTS Page No. I. PARTIES' SUMMARY OF EVIDENCE TO BE OFFERED............................... 1 A. B. II. III. Summary of Evidence to be Offered by Amgen.......................................... 1 Summary of Evidence to be Offered by Roche ........................................... 3

STATEMENT OF FACTS ESTABLISHED BY PLEADINGS, STIPULATIONS, OR ADMISSIONS ..................................................................... 5 CONTESTED ISSUES OF FACT ........................................................................... 5 A. B. Amgen's Contested Issues of Fact ................................................................ 5 Roche's Contested Issues of Fact.................................................................. 5

IV.

JURISDICTIONAL QUESTIONS .......................................................................... 5 A. B. Amgen's Position ........................................................................................... 5 Roche's Position ............................................................................................. 6

V.

QUESTIONS RAISED BY PENDING MOTIONS................................................ 7 A. B. Amgen's Position ........................................................................................... 7 Roche's Position ............................................................................................. 8

VI.

ISSUES OF LAW, INCLUDING EVIDENTIARY QUESTIONS, TOGETHER WITH SUPPORTING AUTHORITY ........................................... 12 A. Amgen's Position ......................................................................................... 12 1. 2. B. Legal Standards and Burden of Proof ........................................... 12 Evidentiary disputes ........................................................................ 12

Roche's Position ........................................................................................... 22 1. 2. Legal Standards and Burden of Proof ........................................... 22 Evidentiary disputes ........................................................................ 22

VII.

REQUESTED AMENDMENTS TO THE PLEADINGS.................................... 35 A. Amgen's Position ......................................................................................... 35

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B. VIII.

Roche's Position ........................................................................................... 35

ANY ADDITIONAL MATTERS TO AID IN THE DISPOSITION OF THE ACTION ................................................................................................... 36 A. Amgen's Position ......................................................................................... 36 1. 2. B. Exchanges during trial .................................................................... 36 Prior Findings and Alleged Admissions......................................... 38

Roche's Position ........................................................................................... 38 1. 2. 3. Exchanges During Trial and Other Logistical Issues Raised by Amgen ............................................................................. 38 Prior Findings .................................................................................. 40 Admissions in Amgen's Patents...................................................... 62

IX.

PROBABLE LENGTH OF TRIAL;...................................................................... 66 A. B. Length of trial............................................................................................... 66 Amgen's Position ......................................................................................... 66 1. 2. 3. C. Amgen's request for a bench trial .................................................. 66 Inequitable conduct should be tried to the bench......................... 66 Obviousness-type double patenting should be tried to the bench........................................................................................... 68

Roche's Position ........................................................................................... 69 1. 2. 3. The Court Correctly Held All Patent and Antitrust Issues in This Case Will be Tried to a Jury................................... 69 The Court Correctly Ruled That The Patent Jury Should Hear and Decide Inequitable Conduct ............................. 70 The Court Correctly Ruled That Roche's Claim of Invalidity Based on Obviousness-Type DoublePatenting Will Be Tried To The Jury ............................................ 73

X.

NAMES, ADDRESSES AND TELEPHONE NUMBERS OF POTENTIAL WITNESSES (INCLUDING EXPERTS) ..................................... 75 A. Amgen's List of Potential Witnesses .......................................................... 75

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B. XI.

Roche's List of Potential Witnesses............................................................ 75

LIST OF PROPOSED EXHIBITS......................................................................... 76

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I.

PARTIES' SUMMARY OF EVIDENCE TO BE OFFERED A. Summary of Evidence to be Offered by Amgen

Amgen will present evidence demonstrating that the manufacture, use, sale, offer to sell, or importation into the United States of glycosylated recombinant human erythropoietin containing products, including "MIRCERA®," "CERA," "RO0503821," "Ro 0503821,""R744," "Continuous Erythropoiesis Receptor Activator," "pegserepoetin alfa," "methoxy polyethylene glycol-epoetin beta," (collectively "peg-EPO") by defendants F. Hoffmann-La Roche LTD., Roche Diagnostics GmbH and Hoffmann La Roche (collectively "Roche") has and will infringe, either literally or under the Doctrine of Equivalents, the following claims of the patents-in-suit: · · · · · U.S. Patent No. 5,441,868, claims 1 and 2; U.S. Patent No. 5,618,698, claims 6-9;1 U.S. Patent No. 5,756,349, claim 7; U.S. Patent No. 5,547,933, claims 3, 7-9, 11, 12, and 14; and U.S. Patent No. 5,955,422, claim 1. Amgen's evidence regarding infringement will consist of Roche's own documents (including Roche's regulatory filings with the Food and Drug Administration describing its product and manufacturing process), the deposition admissions of Roche employees or contractors, and the testimony of Amgen's experts regarding infringement. Amgen will submit evidence of infringement based on the claim construction adopted to date by the Court as law of the case. It is Amgen's understanding that the Court does not wish

1

Per the 8/2/07 letter from Day to Ben-Ami, Amgen has advised Roche that it will not assert `698 claims 4 and 5 at trial.

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Amgen to present evidence of infringement based on alternative claim constructions which the Court has already rejected. If the Court were to change any of its claim construction rulings, Amgen would request leave to offer additional evidence to address infringement under the changed claim construction. Amgen seeks a permanent injunction restraining defendants and their officers, subsidiaries, successors, affiliates, contractors, agents and all persons acting in concert with them from making, having made, importing, using, selling, or offering to sell in the United States or any of its territories peg-EPO, or any of the inventions claimed in the claims of the patents-insuit identified above. Amgen requests leave to present evidence immediately following trial that it is entitled to an injunction under the relevant legal standard. Per the Court's request, Amgen has not included injunction issues in this pretrial memorandum. Amgen will not seek actual or enhanced damages for defendants' actual or threatened infringement of the claims-in-suit occurring prior to the commencement of trial, but reserves the right to seek damages for any activities of Roche subsequent to the commencement of trial of this matter. Accordingly, Amgen will not present evidence at trial regarding damages it may have suffered to date. If necessary, Amgen will respond to invalidity or unenforceability arguments properly presented by Roche as well as properly presented arguments related to non-infringement. Amgen expects to rebut such arguments with the testimony of various fact and expert witnesses, including the testimony of the inventor of the patents-in-suit Dr. Fu-Kuen Lin, documents relating to Dr. Lin's inventions, the prosecution history of the patents-in-suit, the state of the relevant art at the time of Lin's inventions, the long-felt but unmet need for Lin's inventions, and other objective evidence demonstrating the non-obviousness of Lin's inventions.

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B.

Summary of Evidence to be Offered by Roche

This Court has determined that the issues of validity, infringement and unenforceability of the asserted claims of the patents-in-suit will be tried to the jury starting September 4, 2007. Roche will present evidence showing that Amgen's asserted claims2 are invalid for obviousness type double patenting over two prior Amgen patents that are now expired. Roche expects also to prove that prior to the effective filing date of the asserted claims, November 30, 1984, which is the critical date for determining prior art given that Amgen cannot prove an earlier invention date, the subject matter of the claims was already in possession of the public by virtue of what was publicly known or used, invented by others, or taught in patents or printed publications. Roche expects to prove through documents and the testimony of fact witnesses and expert witnesses that the asserted claims cover subject matter that was obvious to a person of skill in the art as early as October 1983. Roche also expects to offer evidence that will prove that Dr. Lin derived enough of the subject matter of the patents-in-suit from others to render the asserted claims obvious. Roche's evidence will show that, in fact, a number of the product claims read on chemical structures that existed long before Dr. Lin completed his inventions and thus those claims are anticipated, the epitome of obviousness. Further Roche expects to prove that Amgen's asserted claims do not satisfy the enablement, written description, and definiteness requirement of 35 U.S.C. § 112. The specification filed by Amgen fails to describe the claimed subject matter in such full, clear, concise, and exact terms as to enable any person skilled in the art to make and use it, or to recognize that Dr. Lin had possession of the full scope of the claim at the time of filing. The

As used herein, Amgen's "asserted claims" includes all the claims that are the subject of Roche's pleaded declaratory counterclaims of invalidity, including claims 4 and 5 of the `698 patent, and Roche continues to include said claims.

2

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evidence will show that the asserted claims do not particularly point out and distinctly claim the subject matter which Dr. Lin regarded as his invention. Roche will present evidence showing Amgen's patents-in-suit are unenforceable as a result of Amgen's inequitable conduct during prosecution of the applications that led to the patents in suit. Specifically the evidence will show that Amgen, and those owing a duty of candor to the PTO, intentionally misled the PTO by omitting, misrepresenting and burying information that would have been important to a reasonable examiner. Roche will also present evidence at trial rebutting Amgen's contention that Roche infringes the claims of U.S. Patent No. 5,411,868, ("the `868 patent"); U.S. Patent No. 5,547,933, ("the `933 patent"); U.S. Patent No. 5,618,698, ("the `698 patent"); U.S. Patent No. 5,756,349, ("the `349 patent"); and U.S. Patent No. 5,955,422 ("the `422 patent"). The evidence will show that Roche's product MIRCERATM, is formulated with a new, unique chemical molecule, and that the process for making MIRCERATM in Europe, and the methods of using MIRCERATM, if approved by the FDA will not infringe Amgen's asserted claims, either literally or, if not otherwise dismissed from the case, under the doctrine of equivalents. In addition the evidence will show that MIRCERATM is a product that has been materially changed by subsequent processes as compared to the product of the processes patented in the asserted claims. The evidence will also show that Roche's product is so far changed in principle from the patented product that it is no longer the same invention as what Amgen claims in the asserted patents. Roche will also show that it has not engaged and will not engage in any culpable conduct directed to encouraging others to infringe any of Amgen's asserted patent claims. A complete explanation of Roche's theories was set forth in its interrogatory responses and expert reports served in this action.

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II.

STATEMENT OF FACTS ESTABLISHED BY PLEADINGS, STIPULATIONS, OR ADMISSIONS The parties agree that the following facts have been established by the pleadings,

stipulation, or summary adjudication: 1. 2. 3. 4. 5. 6. United States Patent No. 5,441,868 (the `868 patent) issued on August 15, 1995. United States Patent No. 5,547,933 (the `933 patent) issued on August 20, 1996. United States Patent No. 5,618,698 (the `698 patent) issued on April 8, 1997. United States Patent No. 5,756,349 (the `349 patent) issued on May 26, 1998. United States Patent No. 5,955,422 (the `422 patent) issued on September 21, 1999. U.S. Patent Application No. 06/747,119 ("the Lai/Strickland `119 application") was filed on June 20, 1985 and issued as U.S. Patent No. 4,667,016 ("the Lai/Strickland `016 patent") on May 19, 1987.

III.

CONTESTED ISSUES OF FACT A. Amgen's Contested Issues of Fact

Amgen's position is attached as Exhibit A. B. Roche's Contested Issues of Fact

Roche's position is attached as Exhibit B. IV. JURISDICTIONAL QUESTIONS A. Amgen's Position

Amgen contends this Court has jurisdiction to hear Amgen's claims for declaratory judgment of infringement of the patents-in-suit. Amgen also contends this Court has jurisdiction to hear Amgen's claims for infringement of the patents-in-suit and to enter a permanent injunction against Roche if Amgen prevails in the patent case. This Court has previously held that it has jurisdiction to hear Amgen's claims. See October 20, 2006 Memorandum and Order (D.I. 121) (holding "the Court will not decline jurisdiction over this case at this time."). Amgen

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does not contest jurisdiction to hear Roche's counterclaims given the Court's ruling granting jurisdiction for Amgen's claims. B. Roche's Position

Roche contends that the Court has jurisdiction over its counterclaims for declaratory judgment, antitrust and other claims. Amgen had previously commenced an action against Roche in the International Trade Commission based on the same asserted claims of the patents-in-suit here and the same alleged conduct that is the subject of this action. After a thorough investigation, including extensive discovery from Roche, the Commission determined that there was no conduct by Roche that constituted an act of infringement for which an investigation commenced by Amgen could proceed, including a finding that Roche's challenged conduct was exempt from infringement under 35 U.S.C. § 271(e)(1). As the initiator of that action, Amgen is bound by that Commission determination. Before this Court, Roche has pled and maintains the affirmative defense of lack of subject matter jurisdiction for Amgen's action in that all MIRCERATM imported into the United States is within the safe harbor of 35 U.S.C. § 271(e)(1) and thus cannot infringe, and at the time the complaint was filed in this action, FDA approval of MIRCERATM was not imminent. Roche reserves its right to appeal the Court's denial of Roche's motion to dismiss on this issue, and Roche maintains that the evidence at trial will be insufficient to maintain this suit regardless of the denial of the motion to dismiss.

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V.

QUESTIONS RAISED BY PENDING MOTIONS A. Amgen's Position

Amgen's pending summary judgment motions, if granted, will significantly narrow the issues for trial in this phase of the case.3 Amgen respectfully relies on the papers submitted in opposition to Roche's motions identified below, as well as oral argument on July 17, 2007, and continues its opposition to Roche's motions. 1. Amgen's Motion for Summary Judgment of No Obviousness-Type Double Patenting (D.I. 499)

Because obviousness type double patenting ("ODP") is a question of law for resolution by the Court, Amgen has moved for summary judgment on Roche's defense. The Court can and should delimit the issues for trial by deciding, as a matter of law, that the safe harbor provision of 35 U.S.C. § 121 immunizes the asserted claims of the `933, `349, and `422 patents from ODP over the claims of the `008 patent. Similarly, the Court should decide the appropriate legal testthe "one-way" or "two-way" test ­ and that under either test, the claims of the patents-in-suit are patentably distinct over Claim 10 of the Lai/Strickland patent. Alternatively, as noted herein in Section IX, Amgen respectfully requests that the Court, rather than a jury, act as fact-finder to resolve this issue. 2. Amgen's Motion for Summary Judgment of Infringement of `422 Claim 1, `933 Claim 3, and `698 Claim 6 (D.I. 510)

Amgen seeks summary judgment that Roche's importation, use or sale of peg-EPO in the U.S. will literally infringe claim 1 of the `422 patent, claim 3 of the `933 patent, and claim 6 of the `698 patent. The relevant inquiry is whether each of the claim limitations is present in Roche's accused product. There is and can be no genuine issue of material fact regarding the
3

Amgen's Motion for Summary Judgment Dismissing Roche's Antitrust Counterclaims is not discussed herein, but would serve to remove the need for an additional trial following the patent

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composition and identity of Roche's accused product or the process by which peg-EPO is produced in Germany. The only dispute is purely a legal dispute over the Court's construction of the relevant claim terms and the statutory test for infringement under 35 U.S.C. § 271(g) for imported products made by a process patented in the United States. 3. Amgen's Motion for Summary Judgment that Lin's `933, `422 and `349 Claims are Definite, Adequately Described and Enabled (D.I. 532)

Amgen and Roche have both moved for summary judgment on, and thus agree that there are no genuine issues of material fact regarding, the issue of whether Lin's asserted `933, `422 and `349 claims are definite, and that the issue of definiteness under 35 U.S.C. § 112 presents a question of law for the Court's decision. B. Roche's Position

Roche respectfully relies on the papers submitted in opposition to Amgen's motions listed above, as well as the oral argument before the Court on July 17, 2007 and continues its opposition to Amgen's motions. The following is a brief summary of pending motions filed by Roche. 1. Docket Item 539 - Roche's Motion for Summary Judgment That Claim 7 of

U.S. Patent No. 5,756,349 Is Invalid Under 35 U.S.C. § 112 and Is Not Infringed. Since the test specified in the claim cannot measure EPO, as required by the claim, one of skill in the art cannot identify the boundaries of claim 7, or practice the claim without undue experimentation, and the claim therefore is indefinite, lacks written description and is not enabled. Amgen also cannot prove infringement of this claim as Amgen's testing expert did not grow the cells under "suitable nutrient conditions" as required by claim 7, nor is there any evidence that the material measured by the expert was "EPO." case to be tried in September 2007.

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2.

Docket Item 614 - Roche's Motion for Summary Judgment that Claim 1 of

U.S. Patent No. 5,995,422 Is Invalid For Indefiniteness and Lack of Written Description. This Court has previously held that claims which expressly distinguished the claimed EPO from prior art human urinary EPO based on glycosylation differences were invalid for indefiniteness and lack of written description, finding the glycosylation of naturally occurring EPO to be a "standardless standard." This Court's previous decision, affirmed by the Federal Circuit, mandates that claim 1 of the `422 patent is invalid for indefiniteness and lack of written description and Amgen should be precluded from arguing otherwise. At oral argument on this motion Roche emphasized the fact that if the claim language of the `422 patent "purified from mammalian cells grown in culture" is to limit the structures of human EPO included in the claimed product, the claim is invalid because a person of skill in the art in 1984 has no way to determine what the structure of the human EPO is. (July 17, 2007 Hearing Tr. pp. 21-24). The Court asked counsel for Amgen, more than once, to provide an answer to the question "what is the structure of human erythropoietin?" (Id p. 75). Amgen's counsel, however, failed to provide a meaningful response: THE COURT: I really want to hear the structure of human EPO. MR. DAY: Okay, I understand that. So let me, let me just get to that. I want to be sure to give you that examiner's -- because it shows how you have to check the record. Not everything said in this courtroom is consistent with the record. With respect to the, with respect to the definiteness of human EPO, Roche makes a straw man argument. The claim '422 claim 1 is to human erythropoietin purified from mammalian cells grown in culture. The Court construes the claim human erythropoietin to mean a polypeptide having amino acid sequence of naturally-occurring human EPO. Roche then says that means it must be 1 to 165 and Roche then uses its interpretation of the Court's construction to say that, and we must find that in the specification. So we've had an abstraction of an abstraction of an abstraction. What Lin must describe is what he invented, human erythropoietin. Column 27 and column 28 describe the product of Example 10 as human erythropoietin. Lin describes and points out very specifically the product that he possessed. That meets the written description requirement. Is it sufficiently definite that one of ordinary skill in the art would be able to 9

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figure out what that is? Well, as we pointed out in our opposition to Roche's motion, yes, their own expert Bertozzi testified that it was, that she would understand right away that human erythropoietin would be that polypeptide that's produced by cells which contain a DNA that encodes EPO. And it has the essential or the characteristic amino acid sequence that's encoded by that gene however produced by the cell. Let me get to the '422 claim 1 which says purified by mammalian cells grown in culture. The Federal Circuit has said that's a source limitation. Going back as far as 1896 when the Commissioner of Patents issued the In re Painter decision, the Patent Office and the Courts have recognized that source or process limitations may be used to describe a novel product where the product, because of the process by which it's produced, the full features or the full structure of the product cannot be captured in words. That's why you resort to product, by process or product by source limitations, to encompass the array or panoply of structures that are obtained by following the process. There need not be, it's a false premise that there need be in the patent words that set out a formula by which you discern the structure where the claimed invention is claimed as the product of a source or a process. The last point. THE COURT: It's three o'clock. I'm sticking to the time schedule rigorously because we need to meet informally. MR. DAY: Regents of University of New Mexico. THE COURT: Thank you. (Id p. 81 - 83). Having done nothing more than point generally to Example 10 of the `422 patent without raising an a genuine issue of material fact of how one of skill in the art would determine the structure of human EPO beyond an amino acid sequence the Court should grant Roche's motion as a matter of law. 3. Docket Item 620 - Roche's Motion for Summary Judgment That Amgen is

Estopped From Asserting Infringement Under the Doctrine of Equivalents of the Asserted Claims of the '933 and '422 Patents. Amgen is estopped because of prosecution history estoppel from asserting that certain terms in the asserted claims of U.S. Patent Nos. 5,547,933 and 5,955,422 encompass erythropoietin fragments, analogs or synthetic polypeptides, that the product of the claims can be anything other than human EPO, that the claims cover any

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molecules that do not have the structure and function of the direct product of the expression of an exogenous DNA sequence, or any product that is not produced in vitro by mammalian cells in culture. 4. Docket Item 624 - Roche's Motion for Summary Judgment That Amgen is

Estopped From Asserting Infringement Under the Doctrine of Equivalents of the Asserted Claims of the '698 and '868 Patents. Amgen is estopped because of prosecution history estoppel from asserting that the term "mature erythropoietin amino acid sequence of FIG. 6" in claims 4-9 of U.S. Patent No. 5,618,698 patent and the term "an isolated DNA sequence encoding human erythropoietin" in claims 1 and 2 of U.S. Patent No. 5,441,868 could cover by equivalents a DNA sequence coding for a 165 amino acid sequence. 5. Docket Item 724 - Defendants' Motion To Preclude Testimony From

Amgen's Belatedly Disclosed Fact Witnesses. Testimony from proposed Amgen witnesses Arnold Berk, Joseph Eschbach, Stuart Orkin, Axel Ullrich, Dennis Fenton, Eli Friedman, and Nancy Spaeth should be precluded at trial because though Amgen has known the identity of these witnesses for long before fact discovery ended, Amgen first disclosed these individuals on FRCP 26(a) statements served well after the close of fact discovery. 6. Docket Item 331 - Roche's Motion to Compel Production of Documents, and

Deposition Testimony Under Rule 30(b)(6), Relating to Pegylation and Aranesp®. Amgen placed its second-generation product Aranesp® and pegylation of Aranesp® at issue by contending that Aranesp® is an "EPO product" covered by the patents-in-suit, and should therefore be required to provide a complete copy of Amgen's BLA for Aranesp®, documents, including documents of Thomas Boone, related to pegylation of Aranesp® or other compounds Amgen claims are "EPO products" covered by the patents-in-suit, a knowledgeable 30(b)(6) witness on this topic, and any other documents related to Amgen work on "Peg-EPO."

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7.

Docket Item 652 - Roche's Motion Pursuant to Fed. R. Civ. P. 56(f) for Relief

from Amgen Inc.'s Motion for Summary Judgment that Dr. Lin's Asserted Claims are Definite, Adequately Described and Enabled. Roche should be permitted to supplement its opposition to Amgen's motion for summary judgment to add numerous relevant, material statements made by Amgen expert Dr. Harvey Lodish at his deposition conducted just two days prior to the date when Roche's opposition was due in that the transcript of the deposition was not available at the time of the opposition. 8. Docket Item 741 - Motion to Strike, In the Alternative, Untimely Expert

Testimony of Ralph A. Bradshaw Regarding Amgen's Motion for Summary Judgment of No Obviousness-Type Double Patenting. If the Court grants Amgen's Motion to Strike the Expert Testimony of Roche experts Drs. Lowe and Harlow (Docket Item 504), the Court should strike certain testimony of Amgen expert Dr. Bradshaw contained in a declaration submitted in support of Amgen's Motion for Summary Judgment of No Obviousness-Type Double Patenting (Docket Item 498) as Drs. Harlow and Lowe were responding to never previously disclosed testimony of Dr. Bradshaw. VI. ISSUES OF LAW, INCLUDING EVIDENTIARY QUESTIONS, TOGETHER WITH SUPPORTING AUTHORITY A. Amgen's Position 1. Legal Standards and Burden of Proof

Amgen's position is attached as Exhibit C. 2. Evidentiary disputes

Exhibit lists. Roche has indicated that they believe they can introduce new exhibits at any time up to and during trial, which are not listed on the exhibit lists exchanged on July 28, 2007. Amgen believes it will be prejudiced by the late introduction of new exhibits, and intends to object to their use at trial. Amgen also objects to Roche's unilateral supplementation of its

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exhibit list on August 3, 2007 and August 9, 2007, well after the parties' agreed-upon exchange date of July 28. Roche's practice of continuously adding to its pretrial disclosures after the agreed-upon exchange dates unfairly prejudices Amgen and makes it impossible for Amgen to prepare for trial in an orderly and predictable manner.4 Objections to live witnesses. Roche has indicated in its pretrial filings that it intends to call 11 expert witnesses at trial. Amgen does not agree and has never agreed that Roche is entitled to call 11 expert witnesses. The parties' stipulation and the Court's order on this issue, as reflected in the Clerk's Notes of the proceeding on June 6, 2007, clearly states "[t]he parties agree to 10 trial experts." Amgen objects to Roche's listing of 11 trial experts. Furthermore, Amgen believes that it is entitled to immediate notice of the identity of the 10 particular trial experts Roche is limited to.5 Amgen reserves its objection to Roche's use as live witnesses at trial individuals not identified in any of Roche's 26(a) disclosures. Amgen reserves the right to object to Roche's supplementation of its list of live trial witnesses on August 9, 2007. On August 9, 2007, Roche indicated that it will call seven (7) of Amgen's fact witnesses to testify in Roche's case-in-chief. This will unnecessarily disrupt the lives and schedules of Amgen's witnesses, and will preclude Amgen from presenting its own case effectively and in an orderly fashion. Amgen objects to Roche calling anyone beyond Dr. Lin in its case-in-chief as unfairly prejudicial to Amgen and unworkable.
4

Roche has continued to insist that the parties "agreed" to ongoing supplementation of the exhibit list. The parties have no such agreement. See 7/30/07 letter from Brown to Fleming and 8/3/07 letter from Brown to Fleming. Amgen has not supplemented its exhibit list. Roche has already done so twice, and continues to insist it may do so unilaterally through trial.

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Trial witnesses not disclosed Amgen reserves its objections to Roche's use as live witnesses at trial individuals not identified in any of Roche's 26(a) disclosures. Roche's objection to seven fact witnesses not named in Amgen's original initial disclosure ignores the fact that Roche had notice of and took discovery on all but three of these witnesses during the fact discovery period. Roche's motion ignores that the three additional witnesses were added to replace two witnesses -- Joseph Eschbach and George Rathmann -- who are each too ill to testify at trial. Amgen incorporates and rests on its Opposition to Roche's Motion to more fully and accurately account why Amgen had substantial justification for adding each of these witnesses to its Rule 26 disclosures and why Roche will not be prejudiced by this addition. (D.I. 781) Regarding Ms. Spaeth, Roche claims that her testimony goes beyond the scope of Dr. Eschbach's testimony, that it is duplicative of other testimony Amgen intends to offer from Drs. Friedman and Brugnara, and that Roche would be prejudiced by Ms. Spaeth's testimony in a trial in this matter. But Roche's argument fundamentally distorts Dr. Eschbach's prior testimony and ignores the fact that Ms. Spaeth's testimony is admissible and highly relevant to rebutting Roche's argument that Dr. Lin's man-made EPO was obvious. Roche misrepresents both the scope and the breadth of Dr. Eschbach's prior testimony. Dr. Eschbach testified in several capacities on several occasions. For example, he testified as a nephrologist (a kidney doctor) and provided relevant testimony from a scientific and medical perspective on the inadequacy of prior art treatments for the anemia of chronic kidney failure and the dramatic change in the care of anemic chronic kidney patients as a result of the advent of Dr.
5

In addition, Roche has listed 11 additional experts as "possible other experts" in its witness list. Amgen similarly objects that this list of additional experts is improper in light of the Court's

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Lin's man-made EPO. Dr. Eschbach also testified as an experimentalist with a good deal of knowledge and experience regarding hematology, ferrokinetics, and experimental design. In particular, he testified as to the deficiencies of the Goldwasser three-patient urinary EPO experiment and other purported prior art references. But that was not all. Dr. Eschbach, among other things, also testified as a fact witness regarding specific patient anecdotes concerning what it was like for them from their perspective in the world before Dr. Lin's rEPO was available. The Court will recall that Dr. Eschbach specifically related the experience of a patient who so much wanted to share a skiing trip with her son, but the plasma infusion she had received did nothing for her and she had to stay in the ski lodge all day. But when she received rEPO she was able to ski all day with her son. Plainly, the topic of the world before and after rEPO from the perspective of a patient and not a medical doctor or scientist was addressed as a result of Eschbach the fact witness. Roche has known about this scope literally for years. Dr. Eschbach's trial testimony has been available since 2000. His testimony on remand presented the same topics and has been available since 2003. All of Dr. Eschbach's prior testimony was produced to Roche at the outset of this case in June of 2006 in the related ITC proceeding. Given his breadth of experience, knowledge, and expertise, Amgen was not able to replicate and replace it in a single witness. Instead, it identified Dr. Friedman, who is a nephrologist, to address from the medical perspective of a nephrologist various topics, including the inadequacy of the prior art treatments for the anemia of chronic kidney failure and the enormous breakthrough Dr. Lin's man-made EPO has been. Given his position and experience, Dr. Friedman will address what was known to doctors and scientists in the prior art. Dr. Brugnara is a practicing pathologist and the director of the Hematology Laboratory at Boston's order on this issue.

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Children's Hospital. From that perspective, Dr. Brugnara will analyze the experimental design of and specific data from the various putative prior art references, including the Goldwasser urinary EPO experiment. Ms. Spaeth is the only individual identified on Amgen's Rule 26(a) list who is able to testify with direct personal experience as to living with the anemia of chronic renal failure before the advent of rEPO and the change in her life as a result of the advent of rEPO. Again, it should be pointed out that in asserting that Dr. Lin has made no invention and that rEPO was obvious in light of the prior art, it is Roche who has made highly probative and directly relevant Ms. Spaeth's testimony. The jury should be permitted to consider Ms. Spaeth's factual experience in the world before and after rEPO in order to evaluate what Roche has placed at issue. As noted above, Roche has known for quite some time that Dr. Eschbach's testimony related specific instances directly from the point of view of a patient. Ms. Spaeth is also properly included on Amgen's supplemental Rule 26 disclosures because Amgen did not learn of her until after the close of fact discovery while searching for a replacement for Dr. Eschbach. Amgen promptly supplemented its Rule 26(a) disclosures as per rule 26(e) and provided notice of Ms. Spaeth to Roche. Furthermore, neither Dr. Friedman's testimony nor Dr. Brugnara's will be redundant of one another or of Ms. Spaeth's testimony; they will testify as to their observations as doctors and scientists within the framework of their specific areas of expertise and knowledge. Finally, Roche claims that Ms. Spaeth's testimony also should be precluded because it is prejudicial. This is simply another way of saying that her testimony is highly probative and persuasive -- hardly a ground for excluding it. If Roche is so concerned about Ms. Spaeth's testimony, it can drop the defenses that make it relevant. Moreover, Roche has known of Amgen's intent to call Ms. Spaeth for over a month. Roche's purported prejudice -- if any -- is simply the result of its refusal to take her deposition

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Eschbach documents From the outset of this litigation, Roche has known of Dr. Eschbach's testimony as a fact witness. Roche served a subpoena on Dr. Eschbach, and his responsive documents have all been produced and in Roche's possession for over two months. In addition, Dr. Eschbach's prior testimony was produced to Roche in June of 2006 and to the extent it was made public, Roche has been aware of his prior testimony for more than three years now. Dr. Eschbach's deposition, like those of all expert witnesses who were to be deposed on factual knowledge, was postponed per the parties' mutual agreement on this matter. Shortly after expert reports were served, Dr Eschbach became gravely ill. As soon as Amgen learned of it, Amgen informed Roche that Dr. Eschbach's grave condition prevented his participation in the litigation. For a more fulsome description of the events relating to Dr. Eschbach's availability as a fact witness, please see D.I. 781. Plainly these are circumstances well beyond Amgen's control and circumstances for which it should not be blamed. On July 26, Roche wrote to Amgen asking for a stipulation on admissibility of documents produced from Dr. Eschbach's files as well as certain Amgen documents. In the spirit of compromise, Amgen agreed to waive foundation objections (authenticity and hearsay) with respect to the Eschbach documents. Roche's only complaint is that Amgen has not waived its objections as to relevance, an issue that even Dr. Eschbach's deposition would not have accomplished. To date, Roche has not provided any explanation for the relevance of these documents, nor has it made a motion to the Court for relief regarding these documents. Moreover, Roche's assertions regarding the timing of Dr. Eschbach's production of documents are at odds with its own conduct. Roche's request that Amgen be precluded from offering Dr. Eschbach's prior testimony ignores both the fact that Amgen complied with its production obligations and that Dr. Eschbach

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became unavailable through no fault of Amgen. Roche's request that Amgen's documents (as well as Dr. Eschbach's documents) be deemed admissible for any purpose ignores the fact that Dr. Eschbach, even had he been available for deposition, could not have established the relevance of the documents for any potential argument Roche would make at trial (nor could he have even authenticated most of them). Roche's request should be denied. Expert Reports Adopting the adage that the best defense is a good offense, Roche inaccurately suggests that Amgen's experts are relying on and seeking to introduce evidence withheld by Amgen during the discovery period. The only late produced discovery cited by Amgen's experts is third party discovery that was properly sought during the fact discovery period but produced thereafter by third parties and publicly available documents that were not in Amgen's possession, custody or control during the fact discovery period. By contrast, Roche has served expert reports that rely on and seek to introduce into evidence Roche's own documents that it stalwartly refused to produce during the fact discovery period. Amgen will be serving motions in limine as described herein that seek to preclude Roche's attempt to back-door through its expert reports documents that it purposefully withheld during the discovery period. Objections to witnesses testifying by designation. Roche has designated testimony from numerous witnesses that relates only to the antitrust and injunction issues in this case, which is irrelevant and should not be allowed in the patent portion of this trial. Amgen objects to Roche's designated testimony from Leslie Mirani, Maureen Michael, Anthony Messana, Tracey Mooney, Helen Torley , Kevin Sharer, Robert McGorty of Fresenius and Dennis Kogod of DaVita on these grounds. Furthermore, because Mr. McGorty resides within the subpoena power of the District of Massachusetts, Amgen objects to Roche's designation of Mr. McGorty's deposition transcript. Amgen has provided counterdesignations for this testimony to Roche per

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the parties' agreement, but maintains its position that the testimony should be precluded and reserves the right to make additional objections to Roche's designated testimony at trial. Amgen objects to Roche's overbroad designations for multiple witnesses. Roche has designated virtually entire transcripts of certain witness's testimony. Such overbroad designations do not provide Amgen with the requisite notice of the testimony Roche intends to introduce at trial, prevents Amgen from making meaningful counterdesignations, and encompass entirely irrelevant testimony. Amgen further objects that Roche has failed to provide counterdesignations for many of Amgen's designations, with no explanation or justification being offered. Amgen reserves the right to object should Roche attempt to belatedly introduce additional counterdesignations. Motions in limine that require resolution prior to the start of trial. 6 Amgen offers the following preliminary list of motions in limine that Amgen intends to file that bear on the opening statement and proceedings and on issues surrounding alleged invalidity. Amgen will file these motions shortly. 1. Motion in Limine to exclude argument, testimony or other evidence relating to

Roche's attempt to relitigate the obviousness or anticipation of Lin's expired `008 patent, as well as inequitable conduct in the prosecution of the patent applications, or issues raised in relation to any of these. 2. Motion in Limine to exclude argument, testimony or other evidence relating to

tPA clinical data, because such data cannot constitute prior art to any asserted claim. 3. Motion in Limine to exclude argument, testimony or other evidence relating to

ODP based on the specification of the previously-issued Lai `016 patent and the Lin `008
6

Amgen reserves the right to file additional motions in limine at any time, and further reserves the right not to file any motion in limine on this list.

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patent; and to exclude any testimony by Roche's expert Blobel testimony regarding ODP, because his opinions improperly rely upon a comparison of the `008 specification to the specification of the claims-in-suit. 4. Motion in Limine to exclude Roche expert Harlow from offering testimony

regarding ODP based on the `008 claims, because his opinions are not based upon a claim-by-claim analysis. 5. Motion in Limine to exclude Roche's experts Kadesch and Lowe from offering

testimony on peptide or protein sequencing because neither has the requisite qualifications. 6. Motion in Limine to exclude Roche expert Spinowitz from offering testimony

relating to whether it would have been obvious to administer increased amounts of urinary EPO to patients to achieve therapeutic effect, because his opinions are based solely on clinical trials conducted with recombinant EPO made available by Dr. Lin's inventions. 7. Motion in Limine in exclude argument, testimony or other evidence relating to the

1986 Lai publication, because that publication cannot constitute prior art to any asserted claim and is not representative of the art of protein sequencing in 1983-1984. 8. Motion in Limine to exclude argument, testimony or other evidence regarding Dr.

Eschbach's single-patient study of the administration of human EPO, because the study cannot constitute prior art to any asserted claim. 9. Motion in Limine to exclude argument, testimony or other evidence relating to the

invalidity of the `080 claims, which have been dismissed with prejudice. 10. Motion in Limine to exclude argument, testimony or other evidence suggesting

that Amgen's conduct that complied with the rules of the PTO was somehow improper.

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11.

Motion in Limine to exclude argument, testimony, or other evidence such as

statistical analysis tending to suggest that PTO procedures or capabilities are deficient and accompanying inference that the patents-in-suit were not well examined. 12. Motion in Limine to exclude argument, testimony or other evidence relating to

Amgen's request for injunctive relief in this case and whether the grant of such an injunction would negatively impact the public if peg-EPO therapy is unavailable. 13. Motion for standing order precluding introduction of opinions or supporting

evidence not previously identified in any expert report. 14. Motion in Limine to exclude testimony regarding opinions presented in

supplemental expert reports that incorporated literally or by reference opinions of experts who had already been deposed. 15. 16. Motion in Limine to exclude references to patents as "monopolies." Motion in Limine to preclude argument, testimony or other evidence relating to

allegations made against Dennis Fenton in unrelated litigation. 17. Motion in Limine to preclude argument, testimony or other evidence relating to

Amgen's revenues derived from sales of EPOGEN. 18. Motion in Limine to preclude argument, testimony or other evidence relating to

whether Dr. Goldwasser violated any duty as a recipient of public research funding by his collaboration with Amgen. 19. Motion in Limine to preclude argument, testimony or other evidence relating to

claims in the patents-in-suit that have previously been found invalid. 20. Motion in Limine to limit each opening statement to the subject matter of that

phase of the trial.

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Objections to claim construction Amgen agrees with the Court's claim constructions. Amgen reserves the right to present evidence should the Court change its claim construction. To the extent that Roche is seeking to re-litigate claim construction arguments in the guise of validity or infringement arguments at trial, Amgen objects. B. Roche's Position 1. Legal Standards and Burden of Proof

Roche's position is attached as Exhibit D. 2. Exhibits The parties agreed that the lists exchanged on July 28, and thereafter were "preliminary" and could be supplemented and amended up to and including the submission of the Final Pretrial Memorandum ("PTM").7 Roche and Amgen have also agreed to extend the time for interposing objections to each others' lists, to meet and confer about the admitted/numbered exhibits and to submit the final Exhibit Lists to the Court after the date of the submission of the Final Pretrial Memorandum. Amgen also submitted a revised Exhibit List on August 6, 2007. Amgen cannot complain and has no legitimate prejudice. Amgen's statements of supplementation are inaccurate. The parties agreed to exchange "preliminary" pretrial documents (witness list, exhibit lists, statements of contested facts, etc. well before the preparation of the Final PTM, which the parties did) with the understanding that they could be supplemented or amended through the creation of this Final Pretrial Memorandum. Roche has continually confirmed that the parties "agreed" that the pretrial exchanges were "preliminary" and that the lists could be supplemented at least to the point of the submission of this Pretrial Memorandum. The parties had a clear agreement. See 7/23/07 letter from Fleming to Brown, 7/24/07 email Brown to Fleming (confirming), 8/2/07 and 8/3/07 letters from Fleming to Brown.
7

Evidentiary disputes

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Roche has followed the parties' agreement. Amgen has no complaint. Roche believes that all exhibits the parties intend to use at trial should be included on the exhibit lists, but that the parties should not be precluded from adding exhibits to the lists they exchanged to deal with documents and other evidence based on the evidence, including, for example, exhibits and documents that may become available or that either party may discover in preparing for trial or based on evidence adduced during trial. Amgen's initial list, unlike Roche's more focused list, contained well over 7,500 entries. Since this Pretrial Memorandum is restricted to the jury trial issues of validity, infringement and unenforceability, Roche submits Amgen's list was unfairly excessively large and not meant to be a meaningful representation of the evidence to be presented to the jury. Roche also objects to many of the items on Amgen's current proposed exhibit list which contains over 4,800 entries, as this list contains materials not previously produced in this action or available to Roche, not identified during discovery as relevant by Amgen or set forth in timely served interrogatory responses, and are otherwise improper. Amgen and Roche had seemed to agree to the following provision which now does not appear in Amgen's portion of the order, Roche respectfully submits that the Court should have this provision apply in the case: "With respect to documents produced in this action from the files of a party that were prepared, created or authored by that party, such exhibits are stipulated to be authentic pursuant to Rule 901 of the Federal Rules of Evidence. The certified copies of the patents-in-suit are presumed to be authentic. This stipulation of authenticity should not be construed to include any marking or writing on any such document." Roche believes that each party should follow a reasonable and practical method of exchanging the identity of witnesses and provide copies of demonstrative charts and other trial disclosures. Roche was the first to suggest such a process, and proposed a reasonable schedule. Amgen then expanded the dates in Roche's proposal to unreasonable limits making it impossible

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given the fluidity of a jury trial. For example, Roche proposed to exchange demonstratives for openings with Amgen, and to identify witnesses and exhibits by 5pm the day before they are to testify. Amgen wants to exchange opening demonstratives five days in advance, where the Court has not even had the chance to rule on motions in limine or other matters, and this is completely impractical. Roche's suggestion is far more reasonable and given that the openings are only 15 minutes, not burdensome at all to the parties. This has been employed with success in many Courts and reduces the need for the Court to micromanage the trial as Amgen suggests. Roche respectfully asks that if the Court is inclined to even address this issue without a motion, which is the proper method, the Court should follow Roche's proposal as set forth in section VIII (B)(1) herein. Amgen's Abuse as to Documents and Evidence Relating to Dr. Eschbach. During the discovery period, Roche subpoenaed Dr. Eschbach as a fact witness for documents and his deposition. Amgen responded that he was to be an Amgen expert and that Roche would have the full opportunity to depose him when he was deposed as an expert. Later, during the expert discovery phase, as Roche repeatedly demanded the Eschbach documents responsive to the subpoena, Amgen was silent. Then at the last minute announced that Dr. Eschbach was too ill to participate in the trial and had to be replaced. This denied Roche the ability to depose Dr. Eschbach as a fact witness. Then, again after the end of fact discovery, Amgen finally produced personal documents from Dr. Eschbach that were the subject of Roche's subpoena. These documents are extremely relevant to Roche's invalidity arguments. By Amgen's delaying tactics, Roche was denied the opportunity to seek meaningful discovery from Dr. Eschbach on his documents and related testimony. Roche then asked Amgen to have the Eschbach documents be admitted in evidence. For example, Dr. Eschbach conducted studies with prior art EPO pharmaceutical compositions, tested in animals and administered to humans,

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for which he applied for and received federal grants. Amgen led Roche to believe that they would agree to have the Eschbach documents be admitted and given numbers on the exhibit list. By letter delivered late last night, Amgen has now refused this request. Amgen should be precluded from offering any evidence that Dr. Eschbach as a fact witness would have offered, and further, all of his documents, including Amgen documents relating to Dr. Eschbach be deemed admissible for Roche in this action. Objections to Live Witnesses During the pretrial conference, the Court stated that an adverse party can call as a live witness in its case any witness identified to be called live by the other party. The Court acknowledged the practice of calling an adverse, hostile witness in such circumstances. Following that instruction, Roche waited to see Amgen's list of witnesses it would call live, and from that list identified witnesses that Roche would call as live in its case. FRE 611. Dr. Lin will be such a witness who will be called by Roche; Roche believes that there may be others. Amgen cannot complain about this process, as it was expressly ordered by the Court. Roche was entitled to identify Amgen witnesses on its preliminary trial witness to be called live and crossexamined (FRE 611 permits a party to call hostile or adverse witnesses in their case and to also cross-examine them by use of leading questions.) Amgen was aware of this and has no reason to complain. Roche acknowledged that there might be some witnesses of the other party who need not be called live (even though listed as a live witness by the other party) and offered a compromise to Amgen. Roche offered to Amgen to have some witnesses testify by deposition to avoid inconvenience to those witnesses; and asked Amgen to agree. Amgen refused to agree. It appears now that Amgen has changed its mind without informing Roche. Roche continues to hope that Amgen will agree to Roche's proposal, and given the Court's prior ruling, Amgen's proposed restriction is improper.

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It was also proper for Roche to add the Amgen witnesses to its preliminary witness list once it learned whom Amgen intended to call live. Roche's witnesses were properly identified in its initial disclosure, because as acknowledged by Amgen, Roche's initial disclosure states that it also identified witnesses identified in Amgen's initial disclosures. Of the few witnesses of which Amgen complains, Amgen either deposed them, or had the opportunity during discovery to depose them.8 Expert Reports Roche has objected to Amgen's attempts to have its experts rely on and introduce evidence that was denied to Roche during discovery in this action, and also to improperly rely on materials and information in violation of FRE 702 and 703. In response to one of Roche's motions, this Court has ruled that "No Witness May Rely On Evidence Withheld From Discovery." (5/16/07 Order). Roche continues its objections to such opinions and testimony and will interpose those objections should Amgen offer such experts at trial. Also Roche objects to Amgen offering documentary evidence and/or opinion testimony that is contrary to findings in prior litigations including those made by this Court (see Roche MIL No. 1 and section VIII (B)(2), infra) that form the basis for issue preclusion. For example, under that doctrine Amgen is precluded from arguing that differences in glycosylation provide a definite limitation sufficient to distinguish product claims of the '422 patent and the '933 patent from prior art erythropoietin. At least Amgen's expert, Dr. Varki has submitted expert reports that would indicate he intends to offer such contrary opinions. As this Court clearly held: "Dr. Lin's disclosure [in the patents-insuit] fails adequately to describe an EPO glycoprotein whose glycosylation differs from that of human urinary erythropoietin." ... "[T]he glycosylation of human urinary erythropoietin is a

As to only one witness who Amgen appears to object, who was not deposed, his testimony was explained to Amgen in detail as it relates to a very limited issue.

8

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standardless standard"... [because] (1) the glycosylation of urinary erythropoietin has `enormous heterogeneity....'" Amgen, Inc. v. Hoechst Marion Roussel, Inc., 126 F. Supp. 2d 69, 155 (D. Mass. 2001). Trial Witnesses Not Disclosed on Amgen's Initial Disclosures Roche objects to Amgen's attempt to identify and list as fact witnesses on Amgen's witness list, witnesses who were not properly disclosed on Amgen's Rule 26 Initial Disclosure during the discovery period. Roche has been prejudiced in not having the appropriate opportunity for full and coordinated discovery of Amgen and these witnesses, and therefore they should not be allowed to testify. Included among these witnesses are those set forth in Roche's pending motion (D.I. 724). In addition, Amgen claims that they need a nurse, anemia patient, and motivational speaker, Ms. Spaeth, to substitute for Dr. Eschbach. However, the subject matter Amgen has identified for which Ms. Spaeth may testify (a purported long-felt need for therapeutically effective treatment for the anemia of chronic renal failure) is duplicative of the testimony Amgen intends to offer from the other two experts it has identified to replace Dr. Eschbach, Dr. Brugnara and Dr. Friedman. The testimony Amgen intends to offer from Ms. Spaeth is also unduly prejudicial and far beyond the subject matter of Dr. Eschbach's original expert report. Given that, and the late disclosure and duplicative nature of Ms. Spaeth's testimony she should not be allowed to testify. Amgen never identified any witness nor disclosed one who was an anemia patient certainly not Dr. Eschbach. Objections to witnesses testifying by designation Amgen is simply incorrect that the witnesses identified by Roche do not have relevant testimony in this portion of the jury trial. Amgen's conclusory statements ignores the issues that Amgen itself raised in the contested issues of fact and law that have prompted the need for select testimony from witnesses such as Leslie Mirani, Maureen Michael, Anthony Messana, Tracey

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Mooney, Helen Torley, Kevin Sharer, Robert McGorty of Fresenius and Dennis Kogod of DaVita . For Amgen to ask this Court to exclude at this juncture such testimony is improper, the Court need not anticipate what evidence may be offered by Amgen and then by Roche in response at this early juncture. Amgen has asked the Court to limit the number of experts for each side that will testify before the jury. Amgen then has in its deposition designations, identified testimony of nontestifying experts. There is no evidentiary basis for proffering a non-testifying expert's deposition, and when Roche asked Amgen to explain, Amgen refused. Amgen's designations of such non-testifying experts is improper and inadmissible, and Roche should not be made to offer counterdesignations. The overbreadth of Amgen's own purported contested issues of fact have compelled the deposition designations proffered by both sides. There is no doubt that as the case progresses both sides will pare down what is actually presented to the jury. Roche also believes that the parties should be free to modify their designations and counterdesignations as necessary based on the evidenced adduced at trial. Fact Witnesses in the Courtroom During Trial Pursuant to FRE 615, Roche respectfully requests that any witness who may testify as a fact witness should be excluded from the courtroom or access to trial evidence when they are not testifying, other than corporate representatives. Motions in Limine to Be Decided Prior to Start of Trial Roche identifies the following preliminary list of motions in limine ("MIL"), relating to the parties' opening or the first two days of evidence in the invalidity portion of the case, that Roche may submit and evidentiary issues that may arise during trial9:

The parties have agreed that the listed motions need only relate to those concerning the openings on validity and the evidence for the first two days of trial. Roche reserves the right to
9

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1. Roche MIL No. 1, that Amgen should be judicially estopped from offering argument, evidence or expert testimony that contradicts positions Amgen successfully advocated during prosecution of the patents-in-suit and in related interference and foreign proceedings. 2. Roche MIL No. 2, Amgen should be precluded from offering argument, evidence or expert testimony that contradicts findings of fact and holdings on issues in prior cases to which Amgen was a party. 3. Roche MIL No. 3, Amgen should be precluded from offering argument, evidence or expert testimony that the product license between Amgen and J&J (Ortho) which was entered before the issuance of any of the Lin patents is a recognition of the validity of the patents in suit. 4. Roche MIL No. 4, Amgen should be precluded from offering argument, evidence or expert testimony that contradicts its admissions regarding the prior art in the specification to the patents-in-suit. 5. Roche MIL No. 5, pursuant to FRE 703, Amgen's experts should be precluded from relying on inadmissible evidence which is of a type not typically reasonably relied upon by experts in their field of expertise, such as testimony from other judicial proceedings. 6. Roche MIL No. 6, Amgen should be precluded from arguing, maintaining or presenting any evidence to the jury to the effect that statements or actions by other corporations such as Chugai, Genentech, Genetics Institute, or Boehringer Mannheim are admissions by Roche or binding on Roche for any issues regarding non-infringement, invalidity or unenforceability.

submit such other and further motions in limine or to make such other evidentiary applications to the Court based on the evidence adduced or proposed to be adduced at trial. Roche also reserves the right to file additional motions in limine at any time, and further reserves the right not to file any motion in limine on this list or to separate out certain motions into other motions.

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7. Roche MIL No. 7, Amgen and its experts and other witnesses should be precluded from mentioning to the jury the existence or outcomes of prior litigations relating to Amgen or the patents-in-suit, as Roche was not a party in these litigations and thus these actions in no way