Amgen Inc. v. F. Hoffmann-LaRoche LTD et al
Filing
1347
Objection to #1318 Proposed Jury Instructions by F. Hoffmann-LaRoche LTD, Roche Diagnostics GmbH, Hoffmann LaRoche Inc. (Roche's Preliminary Objections to Amgen's [Proposed] Revised Final Jury Instructions). (Rizzo, Nicole)
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; ROCHE DIAGNOSTICS GmbH; and HOFFMANN-LA ROCHE INC., Defendants. ) ) ) ) ) ) ) ) ) ) ) ) )
CIVIL ACTION No.: 05-CV-12237WGY
ROCHE'S PRELIMINARY OBJECTIONS TO AMGEN'S [PROPOSED] REVISED FINAL JURY INSTRUCTIONS
Leora Ben-Ami (pro hac vice) Mark S. Popofsky (pro hac vice) Patricia A. Carson (pro hac vice) Thomas F. Fleming (pro hac vice) Howard S. Suh (pro hac vice) Peter Fratangelo (BBO# 639775) Vladimir Drozdoff (pro hac vice) David L. Cousineau (pro hac vice) KAYE SCHOLER LLP 425 Park Avenue New York, New York 10022 Tel. (212) 836-8000 Lee Carl Bromberg (BBO# 058480) Timothy M. Murphy (BBO # 551926) Erik Paul Belt (BBO # 558620) Julia Huston (BBO# 562160) Nicole A. Rizzo (BBO# 663853) BROMBERG & SUNSTEIN LLP 125 Summer Street Boston, MA 02110 Tel. (617) 443-9292 Attorneys for Defendants
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TABLE OF CONTENTS ROCHE'S GENERAL OBJECTIONS...........................................................................................1 OBJECTIONS TO AMGEN'S INTRODUCTORY INSTRUCTIONS (Section X of Amgen's Instructions) ............................................................................................. 2 X. POST-TRIAL FINAL INSTRUCTIONS NTRODUCTION .......................... 2 A. Role of the Jury [Modified] ................................................................. 3 B. Evidence............................................................................................... 4 1. Expert Witnesses.......................................................................... 5 2. Testimony by Deposition............................................................. 6 3. Exhibits ........................................................................................ 6 4. Stipulations .................................................................................. 6 C. Deliberations................................................................................ 7
OBJECTIONS TO AMGEN'S INSTRUCTION ON BURDEN OF PROOF (Section XI of Amgen's Instructions)............................................................................................ 9 XI. BURDEN OF PROOF [Modified]................................................................... 9 OBJECTIONS TO AMGEN'S INSTRUCTIONS ON THE CLAIMS OF THE PATENTS-IN-SUIT (Section XII of Amgen's Instructions) ...................................................... 11 XII. THE CLAIMS OF THE PATENTS-IN-SUIT .............................................. 11 A. Construction of the Claims ................................................................ 12 B. Independent and Dependent Claims .................................................. 12 C. Process and Source Limitations in Product Claims ........................... 13 D. "Comprising" Claims......................................................................... 15 E. Limitations of the Claims at Issue ..................................................... 16
OBJECTIONS TO AMGEN'S INFRINGEMENT INSTRUCTIONS (Section XIII of Amgen's Instructions) ....................................................................................... 17 XIII. INFRINGEMENT [Modified] ....................................................................... 17 A. Patent Infringement Generally [Modified] ........................................ 17 1. Proposed Instruction for Infringement of `933 Claims 3, 7-9, 11 and 12 ............................................................ 19 2. Proposed Instruction for Infringement of `868 Claims 1-2, `698 Claims 6-9, and `349 Claim 7........................ 21 3. Proposed Instruction for Infringement of `933 Claims 11 and 14 ....................................................................... 24 B. Doctrine of Equivalents [Modified]................................................... 25 C. Infringement of Open Ended or "Comprising" Claims ..................... 27 D. Infringement of Dependent Claims.................................................... 27 E. Infringement of Process Claims Under 35 U.S.C. 271(G) ................ 27 F. Infringement and Improvements to Patented Invention..................... 27 i
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G. H.
Determination of Infringement .......................................................... 29 Inducing Infringement ....................................................................... 29
OBJECTIONS TO AMGEN'S INSTRUCTIONS ON VALIDITY (Section XIV of Amgen's Instructions)....................................................................................... 30 XIV. VALIDITY .................................................................................................... 30 A. Presumption of Validity ..................................................................... 30 B. Patent Validity Generally ................................................................ 32 C. Prior Art: Definition [Modified] ........................................................ 33 D. Conception and Reduction to Practice [Modified] ............................ 37 E. Prior Art Prior Invention [Modified]............................................... 39 F. Prior Art: Printed Publication............................................................. 41 G. Prior Art: Prior Knowledge or Use by Another in the United States .................................................................................................. 42 H. Anticipation [Modified] ..................................................................... 43 I. Anticipation Effect of Process or Source Limitations [Modified] .......................................................................................... 45 J. Anticipation Purified Compounds .................................................. 48 K. Obviousness [Modified]..................................................................... 48 L. Obviousness: Scope and Content of the Prior Art [Withdrawn] ........ 53 M. Obviousness: Differences Between the Inventions of the Claims and the Prior Art [Withdrawn]............................................... 53 N. Obviousness: Level of Ordinary Skill [Withdrawn] .......................... 53 O. Obviousness: Motivation to Combine [Withdrawn].......................... 53 P. Obviousness: Objective Indications Concerning Obviousness [Withdrawn] ....................................................................................... 53 Q. Obviousness: Summary [Withdrawn] ................................................ 53 R. [Provisional Instruction] Obviousness-Type Double Patenting [Withdrawn] ....................................................................................... 53 S. Written Description [Modified] ......................................................... 54 T. Enablement ........................................................................................ 55 U. Definiteness [Modified] ..................................................................... 57
OBJECTIONS TO AMGEN'S PROVISIONAL INSTRUCTIONS ON INEQUITABLE CONDUCT (Section XV of Amgen's Instructions) ........................................ 58 XV. INEQUITABLE CONDUCT [Modified] ...................................................... 58 A. Materiality.......................................................................................... 62 B. Intent .................................................................................................. 63 C. Balancing of Materiality and Intent ................................................... 64
OBJECTIONS TO AMGEN'S SUPPLEMENTAL PROPOSED JURY INSTRUCTIONS (D.N. 1074-2) ................................................................................................. 66 XII.C. XIV. I. Process and Source Limitations in Product Claims ....................................... 66 Anticipation -- Effect of Process or Source Limitations................................ 66 ii
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ROCHE'S PRELIMINARY OBJECTIONS TO AMGEN'S PROPOSED POST-TRIAL JURY INSTRUCTIONS Defendants F. Hoffman-La Roche Ltd, Roche Diagnostics GmbH, and Hoffmann-La Roche Inc. (collectively, "Roche"), object as follows to Amgen's proposed post-trial jury instructions (as set forth in D.N. 918). Roche has proposed its own jury instructions for the Court's consideration (D.N. 917 and D.N. 1030) and requests that the Court give these instructions instead. Because Amgen filed its revised instructions only late last night, Roche has not yet had the opportunity to review and object to the revised instructions (which Amgen has substantially modified from its previous version) as thoroughly as it would like and thus reserves the right to modify and supplement these objections before the final jury charge or the final charge conference at the close of all the evidence. ROCHE'S GENERAL OBJECTIONS 1. Roche objects to Amgen's proposed post-trial jury instructions because they are
worded in a manner that favors Amgen's position, rather than in a neutral manner, and are thus argumentative and prejudicial. 2. Roche objects to Amgen's proposed post-trial jury instructions to the extent that
they are repetitive, misleading, confusing, or vague. See Grajales-Romero v. American Airlines, Inc., 194 F.3d 288, 299 (1st Cir. 1999) (jury instruction must "show no tendency to confuse or mislead the jury with respect to the applicable principles of law"); Sweeney v. Westvaco Co., 926 F.2d 29, 35 (1st Cir. 1991) ("Parties have no right to an instruction that would confuse the jury"). 3. Roche objects to Amgen's proposed post-trial jury instructions to the extent that
they fail to state the correct burdens, presumptions, or standards or otherwise to state the law correctly. Id; see also, e.g., Hathaway v. Coughlin, 99 F.3d 550, 552-53 (2d Cir. 1996); ("A jury
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charge is erroneous if it misleads the jury as to the correct legal standard, or if it does not adequately inform the jury of the law"). 4. Roche objects to Amgen's proposed post-trial instructions to the extent that they See, e.g., Prentiss & Carlisle Co. v.
are not supported by the evidence admitted at trial.
Koehring-Waterous Div. of Timberjack, Inc., 972 F.2d 6, 10 (1st Cir. 1992) (affirming district court's refusal to give requested instruction, stating that "[a] jury instruction should not be given if there is not sufficient evidence to support it"). 5. below. Note: For the Court's convenience, each of Amgen's proposed instructions is reprinted below (single spaced, block indented), immediately followed by Roche's objection to that instruction. The instructions are numbered and labeled as in Amgen's original proposal. Roche incorporates each of its general objections into the specific objections
OBJECTIONS TO AMGEN'S INTRODUCTORY INSTRUCTIONS (Section X of Amgen's Instructions)
X. POST-TRIAL FINAL INSTRUCTIONS INTRODUCTION I am going to explain to you in detail the law which you must follow in this case. When I'm done explaining the law we'll take a break. Then the lawyers will get a chance to give their closing arguments to talk about the evidence and urge you to certain conclusions within the legal framework as I describe it. So we start this morning with my explanation as to the law which must govern in this particular case. You must listen carefully now because you are required to apply and follow my instructions on the law. You can ask questions, but please keep your questions until you go back into your deliberation room and talk among yourselves so that collectively you form a question. When deliberating, if you don't understand any aspect of the law, write out your question and there will be a court security officer outside the door here. Give the question to the court security officer, and if I believe I can clarify the question, we'll have you back in the courtroom and I will explain it better. Do not hesitate
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to do that. If justice is to be done here you must understand and apply the law in the case, and it is my job to teach and explain the applicable law to you. I start my charges by a brief explanation of what our separate roles are, the nature of the evidence that has been presented, the tools you have to work with, and what the law is that governs this case. In addition to the General Objections, and without waiving any, Roche specifically objects to the phrase "If justice is to be done here" because that phrase suggests that there is an injustice that needs to be rectified and it is slanted towards a plaintiff's perspective in the courtroom. As such, the instruction unfairly prejudices Roche. A. ROLE OF THE JURY [MODIFIED]
You are the judges of the facts. Though I will necessarily have to make mention of evidence and mention of particular witnesses, that's only to remind you of testimony or evidence that may bear on certain aspects of the case. You are the judges of the evidence. I have nothing to say about the facts of the case. Now, you're going to judge the evidence as I said at the beginning of the case fairly and impartially without any bias or prejudice, without any sympathy for anyone, without any desire that anyone be punished or have revenge. Carefully and coolly sift through this evidence to see that justice may be done. Your verdict must be unanimous. We're going to ask you certain questions that can be answered yes or no. So you must be unanimous as to a yes, and you must be unanimous as to a no. Unanimous means that you all come genuinely to agree. And you'll deliberate. Not that seven of you think this and the other couple go along with it. It must be a genuinely unanimous verdict. And your verdict must be concentrated entirely on the evidence. You can listen to the lawyers to better understand the evidence. You may look at the demonstrative aids to better understand the evidence. But the evidence is what governs and you, and you alone, decide what you believe about the evidence. Now, I am the judge of the law. I simply mean to point out to you that in this courtroom I am the one who has the responsibility of teaching you the law. We make a careful record of what I've said. And that's the fair way. You cannot quarrel with the law as I explain it to you. I am going to tell you who has to prove what in this case. I am going to tell you the burden of proof that each side bears. But you can't add to the parties' burden. Likewise, you can't subtract from their burden. When I say they've got to prove something, then they have to prove that. You can't say, well, forget about that because this or that, something else is proved. I'll tell you what has to be proved, what the burden of proof is, and what the standard of proof is to meet that burden. Listen to my whole charge start to finish. Don't seize on one part of it and say "Aha, the case turns on this or that." Listen to the whole charge and consider all aspects of the charge together.
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Likewise, don't think that because I charge you as to all aspects of the case that I think anything is proved or not proved. I have nothing to say about that. I simply am trying to build for you a complete mental framework so that you will understand the law which you have to follow. That's my role. Finally, as I told you during this trial, my role is also to decide what remedy will be available, if any. You should not speculate about any remedy in this case, or what effect any remedy might have in this case. You should not consider issues of whether patients will or will not have access to MIRCERA, or whether patients should or should not have a choice between Amgen's products and Roche's product (such considerations should not enter your deliberations on any issue in this case). I alone will make that determination. That's my role. Now, I emphasize that you must confine your analysis to the evidence. So let's take a moment and go over the evidence in this case, not witness by witness, but rather type by type, so that you know what tools you have. Roche repeats its General Objections and does not specifically object to this instruction other than to note that it omits concepts concerning the deliberation process that the jury should hear. Roche requests that the Court instead give Roche's proposed instructions 8.1-8.4 [D.N. 917 at pp. 84-87] concerning deliberation and verdict. B. EVIDENCE
The first category of evidence for you to consider is the testimony of the witnesses. You have the power to believe everything that any witness said to you here from the witness stand. Equally, you have the power to disbelieve and disregard everything a witness said as though that witness never testified. Between those two extremes you have the power to believe some things a witness says but to disbelieve other things the witness says. You are not prevented from reaching a verdict because one witness has testified to one version of an event and another witness has testified to another version of the same event. You believe one or believe the other. You can decide where the truth lies. How do you do it? You use your common sense as reasonable men and women. You may use everything you know about the witness. What was the opportunity of the witness to observe, to comprehend, to understand, to recall those matters about which the witness testified? Is the testimony of the witness backed up, or corroborated, by other evidence in the case? It is backed up by exhibits or depositions or any other evidence in the case? Or, does the other evidence in the case undercut, or take away from the testimony of the witness who was before you? How did the witness impress you testifying on the witness stand? How did the witness respond to question both on direct and on crossexamination?
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In short, you can sum up a witness' testimony and as reasonable men and women you can decide what you believe. In addition to the General Objections, and without waiving any, Roche specifically objects to this instruction because it fails to instruct the jury that the number of witnesses who testified is irrelevant and that the jury's decision should be based on the credibility of each witness and the amount of weight each witness's testimony deserves. Roche requests that the Court give Roche's proposed instruction No. 1.7 [D.N. 917 at p. 7]. The jury should also be instructed as to the effect of mistakes in testimony. See Roche's proposed instruction No. 1.6 [D.N. 917 at p. 6]. Roche further objects to this section because it fails to instruct the jury on the difference between direct and circumstantial evidence. The jury should be instructed that it should consider both direct and circumstantial evidence and that it should not make a distinction between the weight given to either one. Amgen's failure to instruct the jury in this manner is prejudicial to Roche and will mislead the jury. instruction No. 1.4 [D.N. 917 at p. 4]. 1. EXPERT WITNESSES Roche requests that the Court give Roche's proposed
Some witnesses have been allowed to give their opinion about certain things. The law provides that when a witness has background, experience, and training that the judges and juries don't have, we'll let that witness render his or her opinion to the jury to aid the jury in doing their function. Like any other witness, your powers with respect to opinions given by these witnesses are no different. That is, if I've allowed you to hear an opinion you may believe it; but equally you may disregard it. You may decide that's just not believable, that's not credible. Or you could believe part of what a witness says and disbelieve other parts of an opinion given by a witness. It's left to your good judgment. I suggest to you that in evaluating any opinion given by any expert witness you want to look at what underlies their opinion. What was the witness relying on? How did the witness come to that opinion? Both by their experience, generally having nothing to do with this case, but also what do they know about
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things having to do with this case upon which their opinion rests. You're the judge of that. So with respect to opinions you may believe them, but you may disbelieve them or believe them in part. Other than its General Objections, which Roche maintains, Roche does not specifically object to this instruction. 2. TESTIMONY BY DEPOSITION
Now, not all the witnesses in this case testified live here in court. Some witnesses, because of the geographical distance from here, or for whatever other reasons, testified by way of videotaped deposition or lawyers reading portions of a deposition. The fact that a witness testifies by way of deposition does not make that witness any more believable or less believable than a witness testifying in court. Like any other testimony in the case, you may believe it, disbelieve it, believe parts of it. Now, with respect to witnesses who testified by way of deposition, you listened very carefully to their testimony, and you should compare that testimony with the testimony of other witnesses, including testimony in other depositions. It's evidence in the case. You may believe it, disbelieve it, or believe part of it. Other than its General Objections, which Roche maintains, Roche does not specifically object to this instruction. 3. EXHIBITS
In this case there are a large number of exhibits. And shortly after we send you out, once the arguments are over, when we send you out to begin your deliberations, those exhibits will be brought into the jury room. Exhibits are like the testimony of witnesses and your powers are exactly the same. That is, you may read, look at or view an exhibit. If it persuades you of some aspect of the case, that's perfectly appropriate because it's evidence. But equally, if you don't find an exhibit believable, either because you think it's not genuine, or if you believe that even though this may be genuine, it is either inaccurate or it doesn't help you, disregard it. That's your power. You are the judges of the facts. And as with any other evidence in the case you can take part of an exhibit and say, well, this is persuasive, but another part is not persuasive. In addition to the General Objections, and without waiving any, Roche objects to the last paragraph of this instruction to the extent it is repetitive and unnecessary. Roche requests that the Court instead give Roche's proposed instruction No. 1.9 [D.N. 917 at p. 9].
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4.
STIPULATIONS
Withdrawn. Although Amgen has now withdrawn this proposed instruction (which had provided that stipulations could not be disregarded or contradicted), Roche requests that the Court instruct the jury that any admission that Amgen made in response to Rule 36 requests is evidence and cannot be disregarded or contradicted. See Trial Transcript, Vol. 10, at 1377-79 (reading into evidence admission by Amgen in response to a Rule 36 request).
C.
DELIBERATIONS
Now, that's the body of evidence that you have in this case. A few words about what you do with it, how you analyze it. You use your common sense. You don't check your common sense at the door to the jury room. Rather I charge you to apply your common sense to the evidence in this case to the end that justice may be done. At the same time, you don't go in there and guess or speculate You can use your common sense as reasonable men and women and draw what are called reasonable inferences. Now, a reasonable inference is a logical deduction. It's common sense. And I'm going to give you an example that has nothing to do with this case to illustrate what a reasonable inference is and also to illustrate how far you can take it. Let's say we have a witness and she testifies that she's walking along a road and she looks out and there's a field of tall grass. She sees that the grass is knocked down in an irregular course through the field. And suppose you believe that testimony. From that alone you could infer something went through the field. I mean, it just doesn't happen that grass falls down along a path unless something knocks it down. It isn't all fallen down in a windstorm, it's fallen down in a course through the field. So it's a reasonable inference that something went through the field. We don't have a witness who saw that something go through the field, but there's a reasonable inference something went through that field. Now, that's a reasonable inference. But unless you had other evidence from some other source in the case you wouldn't know what went through the field. A child. An adult. A big animal. A small animal. You just wouldn't know. That would be guessing. The reasonable inference, if you believe the witness I gave you as an example, is something went through the field. But you can't guess about it unless there's other evidence. Guessing about what went through the field would be speculation--not a reasonable inference. Okay, we've talked about our roles and the tools that you have to resolve
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this case. I want to say just a very few words about what's not evidence in the case, not to emphasize it but just point out to you what's not evidence in the case. You're not going to judge this case in any way, shape or form based upon how you react to the lawyers as human beings, or how you judge them as speakers or presenters of witnesses. They've done their job, and they will later on this morning keep doing it for their respective clients. You've got to focus on the evidence. The lawyers are not sources of the evidence. And your reaction to them plays no role. Equally important. If you somehow think that I think something about this case based upon the manner in which I have presided over it, I most earnestly instruct you to disregard it, I don't. And I tell you candidly I have no idea how this case will come out. This, however, I tell you and this I believe passionately. I believe in the jury system. I believe that you will do justice in this case. But I, clear as I am about constantly saying I am the judge of the law, I have nothing to say about the facts in this case. I believe that you will justly and impartially decide the facts in this case. Now let's get to it. Other than the General Objections, which Roche maintains, Roche does not specifically object to this instruction.
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OBJECTIONS TO AMGEN'S INSTRUCTION ON BURDEN OF PROOF
(Section XI of Amgen's Instructions) XI. BURDEN OF PROOF [MODIFIED] In this case, as with all other cases, facts must be proved by a required standard of evidence, known as the "burden of proof." It's not a question of how much evidence there is on one side or the other, it's a question of what you believe the evidence proves and whether evidence that convinces you unanimously that the party that has the burden of proof on an issue has met that burden. In a patent infringement case such as this, there are two different burdens of proof that are used, which I mentioned at the beginning of the trial. The first burden of proof standard, called the "clear and convincing evidence" standard, applies to Roche's claim that the patents are invalid. Clear and convincing evidence is evidence which produces in your mind an abiding conviction that the truth of the factual contentions is highly probable. As I have said repeatedly, this standard applies to the defendant Roche's invalidity defenses. As I instructed you at the start of the case, Roche has to make things clear to you. If it is not clear to you, then you cannot declare the patents invalid. Roche also has got to present convincing evidence that the claims are invalid. Convincing evidence leaves you with the abiding conviction that the truth of the factual contentions is highly probable. The second burden of proof standard, called "fair preponderance of the evidence" standard, applies to Amgen's claims that Roche infringes Amgen's patent claims. A "fair preponderance of the evidence" means that you must be persuaded that it is more likely to be true than something else. In other words, if evidence regarding infringement by Amgen was placed on a scale, you must find that the scale tips in favor of Amgen by just the slightest bit in order for Amgen to meet its burden on its infringement case. You may have heard of a burden of proof that is used in criminal cases called "beyond a reasonable doubt." That requirement is the highest burden of proof. It applies to criminal cases, and not to civil cases like this patent infringement case. Therefore, put "beyond a reasonable doubt" out of your mind. In addition to the General Objections, and without waiving any, Roche specifically objects to Amgen's definition of "clear and convincing evidence." In the 2007 AIPLA Model Instructions, at page 9, this burden is defined as evidence that shows that it is "highly probably" that the claims are invalid or that the fact has been established. Roche also objects to the framing of the preponderance of the evidence standard and, in particular, the words "fair" (which prejudicially suggests some fairness rationale should be applied) and "by just the slightest bit,"
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which prejudicially suggests that the burden of proof is easier than the law actually requires. The instructions should also make clear that the jury must find for Roche if it finds either that Amgen has not sustained its burden or that Roche has sustained its burden on invalidity. Roche requests that the Court give Roche's proposed instruction on this issue, which accurately explains each party's burden of proof. See Roche's proposed instruction No. 3 [DN 917 at p. 17]. Roche also objects to the instruction regarding preponderance of the evidence in that it fails to include the instruction that, in the event that the jury believes the evidence is split evenly, then the party with the burden has failed to prove its case. See Yamaha Int'l Corp. v. Hoshino Gakki Co., 840 F.2d 1572, 1580, n. 11 (Fed Cir. 1988); see also Director, Office of Workers' Compensation Programs v. Greenwich Collieries, 512 U.S. 267, 281 (1994).
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OBJECTIONS TO AMGEN'S INSTRUCTIONS ON THE CLAIMS OF THE PATENTS-IN-SUIT
(Section XII of Amgen's Instructions) XII. THE CLAIMS OF THE PATENTS-IN-SUIT As I told you at the beginning of the trial, the claims of a patent are the numbered sentences at the end of the patent. The claims describe the inventions made by the inventor and describe what the patent owner owns and what the patent owner may prevent others from doing. Claims may describe products, such as machines or chemical compounds, or processes for making or using a product. Claims are usually divided into parts or steps, called elements or "limitations." For example, a claim that covers the invention of a table may recite the tabletop, four legs and the glue that secures the legs to the tabletop. The tabletop, legs and glue are each a separate element of the claim. In addition to the General Objections, and without waiving any, Roche specifically objects to the term "describe.". A claim does not describe but rather "defines" an invention. Markman v. Westview Instruments, Inc., 517 U.S. 370, 373 (1996). This distinction is important and is not merely semantic. Amgen's term improperly suggest that a patent claim functions as a teaching tool (which is the role of the patent's specification) rather than as a boundary marker. As such, Amgen's term improperly suggest that a claim can be broadened at the whim of the jury when, in many cases, a claim should be read narrowly. Athletic Alternatives, Inc. v. Prince Mfg., Inc., 73 F.3d 1573, 1581 (Fed. Cir. 1996) ("Where there is an equal choice between a broader and a narrower meaning of a claim, . . . we consider the notice function of the claim to be best served by adopting the narrower meaning").
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A.
CONSTRUCTION OF THE CLAIMS
I will instruct you now about the meaning of some of the claim language. In deciding whether or not an accused process or product infringes a patent, the first step is to understand the meaning of the words used in the patent claims. It is my job as Judge to determine what the patent claims mean and to instruct you about that meaning. You must accept the meanings I give you and use them when you decide whether or not the patent is infringed, and whether or not it is invalid. At the start of the trial, I instructed you about the meaning of the words of the claims and the different types of claims that are at issue in this case. I will now review those instructions with you again. It may be helpful to refer to the copy of the `933 patent that you have been given as I discuss the claims at issue here. The claims are at the end of the `933 patent, starting in column 38. The claims of the `933 patent, the `868 patent, the `698 patent, the `349 patent and the `422 patent that are at issue in this case are shown on the verdict form. [Read constructions from juror notebook glossary]
Other than its General Objections, which Roche maintains, Roche does not specifically object to this instruction. Roche, however, requests that the Court give Roche's proposed posttrial instruction on this issue. See Roche's Proposed Jury Instructions No 5.1 [DN 917 at p. 44]. B. INDEPENDENT AND DEPENDENT CLAIMS
Patent claims may exist in two forms, referred to as independent claims and dependent claims. An independent claim does not refer to any other claim of the patent. Thus it is not necessary to look at any other claim to determine what an independent claim covers. Claim 3 of the `933 patent, for example, is an independent claim. A dependent claim refers to at least one other claim in the patent. A dependent claim includes each of the elements of the other claim or claims to which it refers, as well as the additional elements recited in the dependent claim i t s e l f . Therefore, to determine what a dependent claim covers, it is necessary to look at both the dependent claim and the other claim or claims to which it refers. For example, claims 7, 8 and 9 of the `933 patent are dependent claims because they each refer to previous claims in the patent. To determine what dependent claim 7 covers, for example, the words of either claims 3, 4 5, or 6 must be read together along with the words of claim 7. Here, Amgen is only asserting claim 7 as it depends from claim 3. So you must read the words of claim 7 together with the words of claim 3. You need not consider claim 7 as it depends from claim 4, 5, or 6.
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In addition to the General Objections, and without waiving any, Roche specifically objects to this instruction because it fails to state the requirement of 35 U.S.C. § 112 that the jury must not imply the limitations of a narrower dependent claim into a broader independent claim if that broader claim does not include the same limitations. See Fromson v. Advance Offset Plate, Inc., 720 F.2d 1565, 1570 (Fed. Cir. 1983). Roche requests that the Court give Roche's proposed post-trial instruction on this issue. See Roche's proposed instruction No 5.2 [DN 917 at p. 45]. C. PROCESS AND SOURCE LIMITATIONS IN PRODUCT CLAIMS
Sometimes a product may best be described by the process by which it is made, or by the source from which it is derived, instead of by describing its structure or chemical characteristics. Claims which describe a product by describing the process by which it is made are called "product-by-process" claims. Claims 3, 7-9, 11, 12 and 14 of the `933 patent are product-by-process claims or depend from product-by-process claims. Claims which describe a product by reference to the source from which the product is obtained are called "source" claims. Claim 1 of the `422 patent is not, however, a product-by-process claim; it is a product claim with a source element. (The "purified from mammalian cells grown in culture" element of `422 Claim 1 "only speaks to the source of the EPO and does not limit the process by which the EPO is expressed.") In addition to the General Objections, and without waiving any, Roche specifically objects to Amgen's instruction because, as written, it does not make clear the difference between product-by-process claims of the `933 patent versus the product claim reciting a source limitation of the `422 patent. The instruction should make clear that a product-by-process claim simply claims a product and "that a claimed product shown to be present in the prior art cannot be rendered patentable solely by the addition of source or process limitations." Amgen Inc. v. Hoechst Marion Roussel, 314 F.3d 13131, 1354 fn. 20 (Fed. Cir. 2003). The instruction should further make clear that `422 claim 1 is simply a product claim that recites a source limitation and "source limitations cannot impart novelty to old compositions." Id. at 1356. Because Amgen
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chose to draft its claims in these formats, Amgen bears the burden of proving that source or process limitations impart a structural distinction over the prior art. Roche further objects to the proposed instruction because it does not make clear that any purported distinction of the claimed product over the prior art must be based on technology for generating the experimental data that was available as of the earliest effective filing date of the patents-in-suit, i.e., before November 30, 1984. Roche further objects to the sentence describing Claim 1 of the `422 patent as a product claim with a "source element." The sentence is misleading or confusing because Amgen does not provide a written description or any definition of "human erythropoietin" or how one of skill in the art would determine its structure if it is limited by a source limitation. Roche further objects because Amgen did not apply the "source element" in its motion for summary judgment of infringement of `422 claim 1 and should not be permitted to now invoke the "source element" to distinguish prior art. A claim must be construed in the same manner for infringement and validity.1 Roche requests that the Court give Roche's proposed instruction on this issue. See Defendants' Proposed Jury Instructions [D.N. 917 and D.N. 1030].
Although this Court has previously ruled on infringement of Claim 1 of the `422 patent, the portion relating to `422 Claim 1 is still relevant. First, the claim construction is still relevant to the validity inquiry because the claim should be construed the same way for both infringement and validity. Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1330 (Fed. Cir. 2003)( "It is axiomatic that claims are construed the same way for both invalidity and infringement"). Second, Roche contends that it still has defenses to infringement, including under the Reverse Doctrine of Equivalents and the safe harbor of 35 U.S.C. § 271(e).
1
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D.
"Comprising" Claims
The beginning portion, or preamble, of a patent claim may use the words "comprising," "comprising the steps of" or "comprises." "Comprising" means "including" or "containing." A claim that uses the word "comprising" or "comprises" is not limited to products or processes having only the elements or steps that are recited in the claim, but also covers products or processes that have additional elements or steps beyond those stated in the claim. Let's take the example of the claim to a table. If the claim recites a table "comprising" a tabletop, four legs and glue, the claim will cover structures that contain other structures, such as a fifth leg or wheels on the legs. In addition to the General Objections, and without waiving any, Roche specifically objects to Amgen's proposed instruction because it appears to allow the jury to interpret the claims-in-suit, which task is solely for this Court. Markman v. Westview Instruments, Inc., 517 U.S. 370, 390-91 (1996). Roche also objects because the instruction fails to account for the "material change" doctrine under 35 U.S.C. § 271(g) and the Reverse Doctrine of Equivalents. Under these inquiries, an accused product or process may not infringe--even though the claim uses the terms "comprises" or "comprising" and even though the accused product or process includes additional components or steps--because the additions so far change the product or process that it cannot be deemed an infringement. See, e.g., Eli Lilly & Co. v. American Cyanamid Co., 66 F. Supp. 2d 924, 931-32 (S.D. Ind. 1999) (Barker, C.J.) (discussing the "material change" inquiry under § 271(f)); Amgen, Inc. v. Hoechst Marion Roussel, Inc., 339 F. Supp. 2d. 202, 287 (D. Mass. 2004) (Young, C.J.) (discussing Reverse Doctrine of Equivalents), aff'd in part, rev'd in part, vacated in part on other grounds, 457 F.3d 1293 (Fed. Cir. 2006).
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E.
Limitations of the Claims at Issue
I have now instructed you as to the types of claims at issue in this case. I have already provided you with a glossary defining the meaning of the words used in the patent claims at issue. You must use the definitions I provided to you in your consideration of infringement and invalidity issues. The construction of certain claim terms is supplied in your juror notebooks. Roche does not specifically object to this instruction per se but does reserve its right to object to and/or appeal the Court's various claim constructions.
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OBJECTIONS TO AMGEN'S INFRINGEMENT INSTRUCTIONS
(Section XIII of Amgen's Instructions) XIII. INFRINGEMENT [MODIFIED] A. PATENT INFRINGEMENT GENERALLY [MODIFIED]
This is the test for infringement: does the alleged infringing product contain every element of the patent claim? If only one element of the claim is missing from the accused product or process, there is no infringement, even if all the other elements of the claim are present. If the accused product contains other things beyond the elements of the claim, or if the accused process includes other steps beyond those stated in the claim, it still infringes so long as the accused product or process has every element or step of the claim. If the accused product or process is improved, made better or more sophisticated, it still infringes so long as it has every element or step of the claim. Miss an element and there is no infringement. But add to the elements or make the elements better, and there is still infringement so long as Roche's MIRCERA has every element of an Amgen patent claim. To prove infringement, it is Amgen's burden to prove by a fair preponderance of the existence that MIRCERA or the process by which MIRCERA is made includes every element of an Amgen product or process claim. Amgen's burden is not clear and convincing proof. Rather, it is by a fair preponderance of the evidence. On all the evidence you believe does the evidence tend to prove that it is more likely than not that Roche's MIRCERA product infringes every element of the claim? That's infringement. When you get to the dependent claims, you must consider both the referenced claim and the dependent claim together. If you find that that referenced claim is infringed, you still must separately determine whether the claim which depends from it will also be infringed. You have to go back to the referenced claim, and consider every element of the referenced claim plus the dependent claim. In addition to the General Objections, and without waiving any, Roche specifically objects because this instruction is slanted in favor of the plaintiff rather than presenting a neutral recitation of the law. For example, in the fourth paragraph, the instruction emphasizes what is infringement without also instructing the jury how it can find that Roche does not infringe (e.g., "That's infringement"). The instruction should include a statement that if Amgen fails to show that each and every limitation of a claim is found in MIRCERA, then there is no infringement.
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Roche further objects to the second paragraph (concerning additional elements and improvements) to the extent it unfairly suggests to the jury that it should not consider how MIRCERA is different from the product of the claimed processes. For example, MIRCERA has a longer "half life," enabling it to be administered much less frequently. That and similar comparisons help to highlight how MIRCERA has different molecular structures, functions, and properties from the EPO products of the asserted claims. In turn, this information is relevant to Roche's defenses that MIRCERA (a) is "materially changed" and thus does not infringe under 35 U.S.C. § 271(g); (b) does not infringe under the Doctrine of Equivalents; and (c) does not infringe under the Reverse Doctrine of Equivalents. See, e.g., Eli Lilly & Co. v. American Cyanamid Co., 66 F. Supp. 2d 924, 931-32 (S.D. Ind. 1999) (increased efficacy of new compound over patented compound helped to show that product was materially changed); Genentech, Inc. v. The Wellcome Foundation Ltd., 29 F.3d 1555, 1569 (Fed. Cir. 1994) (accused protein, formed through recombinent DNA technology, did not infringe under doctrine of equivalents because, inter alia, it had a far longer "half-life" and other clinical advantages, thus showing that it achieved a different result); Amgen, Inc. v. Hoechst Marion Roussel, Inc., 339 F. Supp. 2d. 202, 287 (D. Mass. 2004) (Young, C.J.) (recognizing that the reverse doctrine of equivalents supports innovation--especially in the area of biotechnology where blocking patents are common--because it offers some chance of protection to those that make substantial changes or radical improvements to inventions"), aff'd in part, rev'd in part, vacated in part on other grounds, 457 F.3d 1293 (Fed. Cir. 2006). Roche further objects to the characterization of Amgen's burden of proof. First, the burden should not be described as a "fair" preponderance of the evidence, which prejudicially suggests that the jury should apply a fairness standard to infringement. Furthermore, it fails to
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mention that Amgen bears the burden of proving whether or not the imported product has been "materially changed." In other words, in its assertion of various process claims, Amgen must prove that any imported product resulting from those process claims was not materially changed. Finally, Roche objects because the instruction fails to state that if the jury finds that an independent claim is not infringed, then it must also find that any claim dependent there from is not infringed. Wolverine World Wide v. Nike Inc., 38 F.3d 1192, 1199 (Fed. Cir. 1994). 1. Proposed Instruction for Infringement of '933 Claims 3, 7-9, 11 and 12
`933 claims 3, 7-9, 11 and 12 are product-by-process claims or depend from product-by-process claims. A product-by-process claim describes a product by reference to the process by which the product is made, not by reference to the particular structure or function of the claimed product. In order for MIRCERA to infringe a product-by-process claim, you must find that Amgen has proved by a fair preponderance of the evidence that MIRCERA contains the claimed product made by the same process described in the claim. The fact that MIRCERA may contain additional elements, including elements not made by the process recited in the claims, does not mean that MIRCERA does not infringe the claim. Like a product claim, a product-by-process claim is still infringed by a product that meets every element of claim, even if the accused product also contains elements beyond those stated in the claim. In addition to the General Objections, and without waiving any, Roche specifically objects to Amgen's instruction because it fails to instruct the jury that, to infringe a product-byprocess claim, Amgen must prove that Roche's product has the same material structure and functional characteristics as the claimed product-by-process and is made by a process employing each and every one of the steps recited in the claims. See Scripps Clinic & Research Found. v. Genentech, Inc., 927 F.2d 1565, 1580 (Fed. Cir. 1991); Atlantic Thermoplastics Co. v. Fate Corp., 970 F.2d 834, 846-47 (Fed. Cir. 1992). Amgen, however, has failed to identify those
structures or characteristics, let alone where in the patent they are required. See SmithKline v. Geneva Parma, Inc. 2002 U.S. Dist. LEXIS 25275 at *20 (E.D. Pa. 2002) ("[W]e decline to
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recognize
product
properties
that
are
not
required
by
the
patent
claims
or
specification.")(emphasis added). Moreover, in stating that a product-by-process claim is written in terms of "the process by which the product is made, not by reference to the particular structure or function of the claimed product," Amgen misleadingly and incorrectly converts a product claim into a pure process claim. A product-by-process claim, however, is still a product claim. SmithKline Beecham Corp. v. Apotex Corp., 439 F.3d 1312, 1317 (Fed. Cir. 2006) ("Regardless of how broadly or narrowly one construes a product-by-process claim, it is clear that such claims are always to a product, not a process"). Roche further objects to the instruction regarding "additional elements" as improperly suggesting that the jury should not consider the differences in MIRCERA, which are relevant to defenses such as "material change" and the reverse doctrine of equivalents. objection to XENIA above. In addition, the use of the words "describes" and "described. " A claim does not describe but rather "defines" an invention. Markman v. Westview Instruments, Inc., 517 U.S. 370, 373 (1996). Amgen's term improperly suggest that a patent claim functions as a teaching tool (which is the role of the patent's specification) rather than as a boundary marker. As such, Amgen's term improperly suggest that a claim can be broadened at the whim of the jury when, in many cases, a claim should be read narrowly. Athletic Alternatives, Inc. v. Prince Mfg., Inc., 73 F.3d 1573, 1581 (Fed. Cir. 1996) ("Where there is an equal choice between a broader and a narrower meaning of a claim, . . . we consider the notice function of the claim to be best served by adopting the narrower meaning"). See Roche's
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2.
Proposed Instruction for Infringement of '868 Claims 1-2, '698 Claims 6-9, and '349 Claim 7
`868 claims 1 and 2, '698 claims 6-9, and '349 claim 7 are process claims. Amgen contends that Roche will infringe the asserted process claims by practicing these patented processes for making EPO in Germany, and then importing the EPO product produced by those processes into the United States. To determine infringement of the asserted process claims, you must first determine whether Roche's process for making EPO in Germany satisfies all of the elements of the asserted process claims. The fact that MIRCERA may contain elements beyond those contained in the product of Amgen's claimed process, or that Roche uses steps beyond those recited in a patented process claim to produce MIRCERA, does not mean that Roche's process does not satisfy all of the elements of an asserted process claim. An accused process that uses every step of the claimed process infringes the claim regardless of whether other steps are used as well, or the imported product contains additional elements or features beyond those produced by the claimed process. If you find that Roche's process for making EPO satisfies every element of an asserted process claim, you must then determine whether the EPO product of the claimed process is materially changed by Roche prior to its importation of MIRCERA into the United States. If you find, for example, that the EPO product contained in MIRCERA is materially changed by the attachment of polyethylene glycol, then Roche will not infringe the asserted process claim. A material change is a significant change to the structure and properties of the EPO product, which changes the basic utility of the EPO product. The attachment of additional structure to the EPO product of the claimed process is not a material change to the product of the process unless it changes the structure and properties of the EPO product in a way that alters the basic utility of the EPO product. Even a significant change to the structure and properties of the EPO product will not be a "material change" if it would not be possible or commercially viable to make MIRCERA but for the use of Amgen's patented process. You must also determine whether the EPO contained in MIRCERA is a trivial and nonessential component of MIRCERA. If you find that it is, then Roche will not infringe the asserted process claim. Therefore, in order to find that Roche will infringe an asserted process claim, you must find that (1) Roche's process for making MIRCERA in Germany includes every element of an asserted process claim, (2) the EPO product of the claimed process is not materially changed by Roche, and (3) the EPO product in MIRCERA is not a trivial and non-essential component of MIRCERA. In addition to the General Objections, and without waiving any, Roche specifically objects to Amgen's proposed instruction because it fails to state that Amgen has the burden to show that the accused product is not materially changed and, instead, implies that Roche has the
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burden to show that the product has been materially changed. See Genentech, Inc. v. Bushranger Mannheim GmbH, 47 F. Supp. 2d 91, 108 (D. Mass. 1999) (Saris, J.) (patentee bears burden of proof on "material changed" issue). Roche further objects to the instruction to the extent it prevents the jury from considering how MIRCERA is different from the product of the claimed processes. For example, MIRCERA has a longer "half life," enabling it to be administered much less frequently. That and similar comparisons help to highlight how MIRCERA has different molecular structures, functions, and properties from the claimed products. In turn, this information is relevant to Roche's defenses that MIRCERA (a) is "materially changed" and thus does not infringe under 35 U.S.C. § 271(g); (b) does not infringe under the Doctrine of Equivalents; and (c) does not infringe under the Reverse Doctrine of Equivalents. See, e.g., Eli Lilly & Co. v. American Cyanamid Co., 66 F. Supp. 2d 924, 931-32 (S.D. Ind. 1999) (increased efficacy of new compound over patented compound helped to show that product was materially changed); Genentech, Inc. v. The Wellcome Foundation Ltd., 29 F.3d 1555, 1569 (Fed. Cir. 1994) (accused protein, formed through recombinent DNA technology, did not infringe under doctrine of equivalents because, inter alia, it had a far longer "half-life" and other clinical advantages, thus showing that it achieved a different result); Amgen, Inc. v. Hoechst Marion Roussel, Inc., 339 F. Supp. 2d. 202, 287 (D. Mass. 2004) (Young, C.J.) (recognizing that the reverse doctrine of equivalents supports innovation--especially in the area of biotechnology where blocking patents are common--because it offers some chance of protection to those that make substantial changes or radical improvements to inventions"), aff'd in part, rev'd in part, vacated in part on other grounds, 457 F.3d 1293 (Fed. Cir. 2006).
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Amgen's instruction also improperly refers to the accused product as "EPO" and "EPO product" rather than as "MIRCERA." That description is scientifically inaccurate. Indeed,
MIRCERA is not "EPO" or an "EPO product" at all. Rather, it is an erythropoietin stimulating agent ("ESA"). MIRCERA is a new and different compound and is not created simply by the "attachment of polyethylene glycol," as Amgen asserts. Rather, MIRCERA results from
chemical reactions in which bonds are broken, atoms are removed and others substituted, and new bonds are formed to create new molecules. Roche's process includes more than simply attaching polyethylene glycol. Other
processing steps also help materially change the accused product. Thus, the jury should not be told, in essence, to ignore the other processes. Roche likewise objects to the similar implication is Amgen's proposed instruction that the "attachment of peg" is somehow the only subsequent processing step used by Roche. Finally, Roche objects because Amgen's proposed instruction suggests that there can be a significant change only if the change in structure or properties "changes the basic utility of the EPO product" While change in the utility of a compound is one measure of "material change," other changes can also show "material change." For example, if the subsequent processes confer significant structural differences to the product, such as the addition or removal of certain chemical groups, that alone can show material change, regardless of whether the basic utility has been affected. See Eli Lilly & Co. v. American Cyanamid Co., 82 F.3d 1568, 1572-73 (Fed. Cir. 1996). Roche requests that the Court instead instruct the jury per Roche's proposed instructions on material change and on these claims. See D.N. 917.
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3. Proposed Instruction for Infringement of '933 Claims 11 and 14 The act of encouraging or inducing others to infringe a patent is called "inducing infringement." In this case, Amgen asserts that Roche will induce others to infringe the methods of treatment claimed in claims 11 and 14 of the '933 patent as soon as it receives regulatory approval to sell MIRCERA in the United States. There can be no inducement of infringement unless someone will directly infringe the patent. Thus, in order to prove that Roche will induce another person to infringe '933 claims 11 and 14, Amgen must prove by a fair preponderance of the evidence that another person will directly infringe claims 11 or 14 and that Roche will induce that infringement. A person induces patent infringement if he or she purposefully causes, urges or encourages another to perform an act that infringes a patent claim and knows or should have known that his or her actions would induce actual infringement. Inducing infringement cannot occur unintentionally. Amgen asserts that Roche will induce infringement of '933 claims 11 and 14. Amgen must prove by a fair preponderance of the evidence that: Roche has or will encourage or instruct another person to use the method described in `933 claim 11 or 14. Roche knows of the '933 patent. Roche knows or should know that its encouragement or instructions will induce others to use MIRCERA in a manner that will infringe `933 claim 11 or 14. The other person will use MIRCERA to perform the method described in '933 claim 11 or 14. In addition to the General Objections, and without waiving any, Roche specifically objects to Amgen's proposed instruction because it includes several materially incorrect statements of law. First, the instruction improperly refers to hypothetical future direct
infringement. For example: "In this case, Amgen asserts that Roche will induce others to infringe the methods of treatment . . . " and "There can be no inducement of infringement unless someone will directly infringe the patent." There can be no liability for hypothetical future infringement. See Benitec Australia, Ltd. v. Nucleonics, Inc., 495 F.3d 1340, 1346-47 (Fed. Cir. 2007) (affirming dismissal of declaratory judgment action because accused infringer had not yet started making, using, or selling a product other than for purposes of testing the product under the safe harbor of 35 U.S.C. § 271(e)(1) and thus there could be no case or controversy). And 24
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there can be no indirect infringement unless there has first been a direct infringement. Water Techs. Corp. v. Calco, Ltd., 850 F.2d 660, 668 n. 7 (Fed. Cir. 1988) ("Direct infringement is a prerequisite to finding induced infringement"). Second, the instruction fails to instruct that if Roche had a good faith basis for believing that it does infringe, that good faith basis could negate the required showing of a specific intent to cause an infringement. DSU Med. Corp. v. JMS Co., 471 F.3d 1293, 1307 (Fed. Cir. 2006) (en banc) ("To the contrary, the record contains evidence that ITL did not believe its [accused product] infringed. Therefore, it had no intent to infringe"). B. DOCTRINE OF EQUIVALENTS [MODIFIED] The law says this: A copier who changes the invention a bit may still be guilty of infringement. And that's known as infringement by the doctrine of equivalents. If you build what's really the equivalent of the patented invention, the law will hold that to be an infringement. What must you do? You must look at the claim again. We always start with the claim. And then ask yourselves this. If there is a particular element in the claim that is literally missing in Roche's MIRCERA, there may still be infringement under the doctrine of equivalents. Ask yourself with respect to each claim element, considered separately, whether Roche's MIRCERA product contains the claimed element or an equivalent thereto that performs substantially the same function, in substantially the same way, to achieve substantially the same result, as the claimed element. If Amgen persuades you by a fair preponderance of the evidence that MIRCERA does, then MIRCERA infringes by the doctrine of equivalents. In addition to the General Objections, and without waiving any, Roche specifically objects because Amgen is not entitled to invoke the doctrine of equivalents for the asserted claims because it has not overcome prosecution history estoppel. Based on the file histories of the patents-in-suit, which have been entered into evidence, each of the asserted claims was the result of amendments that narrowed its scope. As a result, there is a presumption that there are no equivalents of these claims. See Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., Ltd.,
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525 U.S. 722, 740 (2002). Amgen has submitted no evidence rebutting this presumption, such as proof that the alleged equivalent would have been unforeseeable at the time of the narrowing amendment. Id. Furthermore, Amgen now concedes that infringement under the doctrine of equivalents must be considered on a limitation by limitation basis, rather than based on the claim as a whole. See Terlep v. Brinkmann Corp., 418 F.3d 1379, 1384-85 (Fed. Cir. 2005). Amgen's previously proposed instruction did not make this distinction. But Amgen has failed to submit evidence of equivalents on a limitation by limitation basis and thus is not entitled to an instruction on the doctrine of equivalents. See, e.g., Prentiss & Carlisle Co. v. Koehring-Waterous Div. of
Timberjack, Inc., 972 F.2d 6, 10 (1st Cir. 1992) (affirming district court's refusal to give requested instruction, stating that "[a] jury instruction should not be given if there is not sufficient evidence to support it"). Roche also objects because the instruction oversimplifies and misstates application of the doctrine of equivalents. "The doctrine of equivalents comes into play only when actual literal infringement is not present." Hughes Aircraft Co. v. United States, 717 F.2d 1351, 1361 (Fed. Cir. 1983); see also, e.g., ZMI Corp. v. Cardiac Resuscitator Corp., 844 F.2d 1576, 1581 (Fed. Cir. 1988) ("When literal infringement is not found, the equitable doctrine of equivalents comes into play"). Thus, the jury should first be instructed that it should not apply the doctrine of equivalents unless it has first found that Roche has not literally infringed the given claim. Roche requests that the Court instead give Roche's proposed instruction on the doctrine of equivalents. See Roche's proposed instructions Nos. 6.7 - 6.12 [D.N. 917 at pp. 55-61]. Roche further objections because the instruction fails to include limitations on application of the doctrine of equivalents, as recited in Roche's Proposed Instruction Nos. 6.7 - 6.12
26
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