Amgen Inc. v. F. Hoffmann-LaRoche LTD et al
Filing
917
Proposed Jury Instructions by F. Hoffmann-LaRoche LTD, Roche Diagnostics GmbH, Hoffmann LaRoche Inc.. (Huston, Julia)
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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 ) ) ) ) ) )
DEFENDANTS' PROPOSED JURY INSTRUCTIONS Defendants, F. Hoffman-La Roche Ltd., Roche Diagnostics GmbH, and Hoffmann-La Roche Inc., respectfully request that the Court read the attached jury instructions to the jury at the conclusion of trial. Dated: August 31, 2007 Boston, Massachusetts Respectfully submitted, F. HOFFMANN-LA ROCHE LTD, ROCHE DIAGNOSTICS GMBH, and HOFFMANN-LA ROCHE INC. By their attorneys, /s/ Julia Huston Lee Carl Bromberg (BBO# 058480) Timothy M. Murphy (BBO# 551926) Julia Huston (BBO# 562160) Keith E. Toms (BBO# 663369) Nicole A. Rizzo (BBO# 663853) Kimberly J. Seluga (BBO# 667655) BROMBERG & SUNSTEIN LLP 125 Summer Street Boston, MA 02110 Tel. (617) 443-9292 jhuston@bromsun.com
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Leora Ben-Ami (pro hac vice) Patricia A. Carson (pro hac vice) Thomas F. Fleming (pro hac vice) Howard S. Suh (pro hac vice) Christopher T. Jagoe (pro hac vice) KAYE SCHOLER LLP 425 Park Avenue New York, New York 10022 Tel. (212) 836-8000
CERTIFICATE OF SERVICE I hereby certify that this document filed through the ECF system will be sent electronically to the registered participants as identified on the Notice of Electronic Filing (NEF) and paper copies will be sent to those indicated as non registered participants on the above date. /s/ Julia Huston Julia Huston
03099/00501 725187.4
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DEFENDANTS' PROPOSED JURY INSTRUCTIONS TABLE OF CONTENTS
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GENERAL INSTRUCTIONS .................................................................................................................... 1
1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9
2
INTRODUCTION.............................................................................................................1 JURORS' DUTIES ........................................................................................................... 2 EVIDENCE DEFINED ...................................................................................................... 3 DIRECT AND CIRCUMSTANTIAL EVIDENCE ..................................................................... 4 CONSIDERATION OF EVIDENCE ...................................................................................... 5 CREDIBILITY OF WITNESSES .......................................................................................... 6
NUMBER OF WITNESSES.................................................................................................7 EXPERT WITNESSES ....................................................................................................... 8 DOCUMENTS ................................................................................................................. 9
THE PARTIES AND THEIR CONTENTIONS ...................................................................................... 10 2.1 THE PARTIES .................................................................................................................................. 10 2.2 SUMMARY OF PLAINTIFF'S CONTENTIONS .............................................................................. 11 2.3 SUMMARY OF DEFENDANTS' CONTENTIONS........................................................................... 12 2.4 SUMMARY OF PARTIES' ISSUES .................................................................................................. 13 2.5 ISSUES ESTABLISHED BY PRIOR LITIGATIONS......................................................................... 15 3 BURDEN OF PROOF............................................................................................................................... 17 4 VALIDITY DEFENSES............................................................................................................................ 18
4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10 4.11 4.12 4.13 4.14 4.15 4.16 4.17 4.18 4.19 4.20
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PRIOR ART DEFINED...................................................................................................19 ANTICIPATION............................................................................................................20 EFFECTIVE FILING DATE AND DATE OF INVENTION ..................................................... 23 PRIOR PUBLIC USE ...................................................................................................... 24 PRIOR INVENTION ....................................................................................................... 25 PRIOR PUBLIC KNOWLEDGE........................................................................................26 PRINTED PUBLICATION ............................................................................................... 27 PRIOR PATENT............................................................................................................28 OBVIOUSNESS ............................................................................................................. 29 OBVIOUSNESS DECISION .............................................................................................. 31 SCOPE AND CONTENT OF THE PRIOR ART ...................................................................... 32 OBJECTIVE FACTORS................................................................................................... 33 LEVEL OF ORDINARY SKILL IN THE ART ....................................................................... 34 FACTORS INDICATING OBVIOUSNESS............................................................................ 35 DERIVATION OF INVENTION ........................................................................................ 36 ENABLEMENT ............................................................................................................. 37 WRITTEN DESCRIPTION................................................................................................ 39 INDEFINITENESS ......................................................................................................... 41 INVALIDITY FOR DOUBLE PATENTING .......................................................................... 42 BIOTECHNOLOGICAL PROCESS ELECTION ..................................................................... 43
CONSTRUCTION OF CLAIMS.............................................................................................................. 44 5.1 GENERAL PRINCIPLES .................................................................................................................. 44 5.2 DEPENDENT AND INDEPENDENT CLAIMS................................................................................. 45 5.3 MARKUSH GROUPS ....................................................................................................................... 46 6 INFRINGEMENT..................................................................................................................................... 47 6.1 GENERAL PRINCIPLES .................................................................................................................. 47
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DIRECT INFRINGEMENT - KNOWLEDGE OF PATENT OR INTENT TO INFRINGE IS IMMATERIAL.................................................................................................................................. 48 6.3 INDUCING PATENT INFRINGEMENT........................................................................................... 49 6.4 LITERAL INFRINGEMENT ............................................................................................................. 51 6.5 INFRINGEMENT OF DEPENDENT CLAIMS.................................................................................. 52 6.6 MATERIAL CHANGE...................................................................................................................... 53 6.7 INFRINGEMENT BY DOCTRINE OF EQUIVALENTS................................................................... 55 6.8 LIMITATIONS ON DOCTRINE OF EQUIVALENTS - PRIOR ART ................................................ 57 6.9 LIMITATIONS ON DOCTRINE OF EQUIVALENTS - PROSECUTION HISTORY ESTOPPEL...... 58 6.10 LIMITATIONS ON DOCTRINE OF EQUIVALENTS -- CLAIM ELEMENTS MAY NOT BE READ OUT OF EXISTENCE ....................................................................................................................... 59 6.11 LIMITATIONS ON DOCTRINE OF EQUIVALENTS -- APPLIED ON AN ELEMENT BY ELEMENT BASIS 60 6.12 LIMITATIONS ON THE DOCTRINE OF EQUIVALENTS - SUBJECT MATTER DEDICATED TO THE PUBLIC .................................................................................................................................... 61 6.13 REVERSE DOCTRINE OF EQUIVALENTS..................................................................................... 62 6.14 SAFE HARBOR EXEMPTION ......................................................................................................... 63 6.15 SPECIFIC CLAIM INSTRUCTIONS ................................................................................................... 64 6.15.1 INFRINGEMENT OF U.S. PATENT NO. 5,441,868................................................................ 65 6.15.2 INFRINGEMENT OF U.S. PATENT NO. 5,547,933................................................................ 67 6.15.3 INFRINGEMENT OF U.S. PATENT NO. 5,618,698................................................................ 71 6.15.4 INFRINGEMENT OF U.S. PATENT NO. 5,756,349................................................................ 73 6.15.5 INFRINGEMENT OF U.S. PATENT NO. 5,955,422................................................................ 74 7 UNENFORCEABILITY (INEQUITABLE CONDUCT)......................................................................... 76 7.1 INEQUITABLE CONDUCT - GENERALLY .................................................................................... 76 7.2 MATERIALITY ................................................................................................................................. 79 7.3 INTENT....................................................................................................................... 81 7.4 BALANCING OF MATERIALITY AND INTENT................................................................... 83 8 DELIBERATION AND VERDICT.......................................................................................................... 84 8.1 INTRODUCTION ........................................................................................................... 84 8.2 UNANIMOUS VERDICT ................................................................................................. 85 8.3 DUTY TO DELIBERATE ................................................................................................. 86 8.4 THE COURT HAS NO OPINION........................................................................................ 87
6.2
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1 GENERAL INSTRUCTIONS1
1.1 INTRODUCTION Ladies and Gentlemen of the jury, you have heard the evidence and arguments in this case and the time has come for you to weigh the evidence, deliberate and reach a verdict. Now it is time for me to instruct you about the law that you must follow in deciding this case. I will start by explaining your duties and the general rules that apply in every civil case. Then I will explain some rules that you must use in evaluating particular testimony and evidence. Then I will explain the positions of the parties and the law you will apply. And last, I will explain the rules that you must follow during your deliberations in the jury room, and the possible verdicts that you may return. Please listen very carefully to everything I say all of my instructions. Do not pick out any particular part, but consider the instructions as a whole. The fact that I instruct you as to all aspects of the case does not mean that I think anything has been proved or not proved. I must instruct you as to all aspects of the case.
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The General Instructions, as well as other substantive Instructions, are adapted from the AIPLA 2005 Model Patent Jury Instructions and the Model Patent Jury Instructions from the District Court of the District of Delaware. 1
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1.2 JURORS' DUTIES You have two main duties as jurors. The first one is to decide what the facts are from the evidence that you saw and heard here in court. Deciding what the facts are is your job, not mine, and nothing that I have said or done during this trial was meant to influence your decision about the facts in any way. Your second duty is to take the law that I give you, apply it to the facts, and decide whether Amgen's asserted patents are valid, whether defendants have infringed them and whether anyone at Amgen or acting on Amgen's behalf misrepresented, omitted or buried material information before the Patent Office in obtaining the asserted patents, with an intent to deceive the Patent Office. It is my job to instruct you about the law, and you are bound by the oath that you took at the beginning of the trial to follow the instructions that I give you, even if you personally disagree with them. This includes the instructions that I gave you before and during the trial and these instructions. All the instructions are important, and you should consider them together as a whole. You are required to apply the law, and to do so you must truly understand it. If you do not understand any of my instructions, you may ask questions. During the recess that follows my instructions, you should write out any question about the law that you believe will help you understand the framework in which you are required to weigh the evidence before you, and I will answer them. Perform these duties fairly. Do not let any bias, sympathy or prejudice that you may feel toward one side or the other influence your decision in any way.
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1.3 EVIDENCE DEFINED You must make your decision based only on the evidence that you saw and heard here in court. Do not let rumors, suspicions, or anything else that you may have seen or heard outside of court influence your decision in any way. The evidence in this case includes only what the witnesses said while they were testifying under oath, the exhibits that I allowed into evidence, the stipulations that the lawyers agreed to, and the facts that I have judicially noticed. Nothing else is evidence. The lawyers' statements and arguments are not evidence. Their questions and objections are not evidence. My legal rulings are not evidence. None of my comments or questions is evidence. During the trial I may have not let you hear the answers to some of the questions that the lawyers asked. I also may have ruled that you could not see some of the exhibits that the lawyers wanted you to see. And sometimes I may have ordered you to disregard things that you saw or heard, or I struck things from the record. You must completely ignore anything that was excluded. Do not even think about them. Do not speculate about what a witness might have said or what an exhibit might have shown. These things are not evidence, and you are bound by your oath not to let them influence your decision in any way. Make your decision based only on the evidence, as I have defined it here, and nothing else.
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1.4 DIRECT AND CIRCUMSTANTIAL EVIDENCE Now, some of you may have heard the terms "direct evidence" and "circumstantial evidence." Direct evidence is simply evidence like the testimony of an eyewitness, which, if you believe it, directly proves a fact. If a witness testified that he saw it raining outside, and you believed him, that would be direct evidence that it was raining. Circumstantial evidence is simply a chain of circumstances that indirectly proves a fact. If someone walked into the courtroom wearing a raincoat covered with drops of water and carrying a wet hat that would be circumstantial evidence from which you could conclude that it was raining. It is your job to decide how much weight to give the direct and circumstantial evidence. The law makes no distinction between the weight that you should give to either one, nor does it say that one is any better evidence than the other. You should consider all the evidence, both direct and circumstantial, and give it whatever weight you believe it deserves.
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1.5 CONSIDERATION OF EVIDENCE You should use your common sense in weighing the evidence. Consider it in light of your everyday experience with people and events, and give it whatever weight you believe it deserves. If your experience tells you that certain evidence reasonably leads to a conclusion, you are free to reach that conclusion. In considering the evidence and drawing conclusions, you must make reasonable inferences but you must not guess or speculate.
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1.6 CREDIBILITY OF WITNESSES As the jurors, you have the power to use everything you know about the witnesses who will testify on the witness stand. You are entitled to consider how they answered questions on both direct and cross examination. You may decide to believe or disbelieve everything any one of these witnesses has said to you, or you may decide to believe some parts of the witnesses' testimony but not others. In determining the weight to give to the testimony of a witness, you should ask yourself whether there was evidence tending to prove that the witness testified falsely about some important fact, or, whether there was evidence that at some other time the witness said or did something, or failed to say or do something that was different from the testimony he gave at the trial. Consider what interest any witness had in testifying as he or she so testified. Is the witness employed by, an advisor to, friendly with, hostile to, or opposed to one or the other parties in the case? In a case like this, it is frequent that some witnesses are employed or engaged by the parties, and that alone does not make their testimony implausible or not believable, but you may consider it. You should remember that a simple mistake by a witness does not necessarily mean that the witness was not telling the truth. People may tend to forget some things or remember other things inaccurately. On the other hand, if a witness testifies that he or she does not remember something and you do not believe him or her, you should take that into account when determining the witness's credibility. If a witness has made a misstatement or an omission, you must consider whether it was simply an innocent lapse of memory or an intentional falsehood, and that may depend upon whether it concerns an important fact or an unimportant detail.
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1.7 NUMBER OF WITNESSES One more point about the witnesses. witnesses who testified makes any difference. Do not make any decisions based only on the number of witnesses who testified. What is more important is how believable the witness was, and how much weight you think their testimony deserves. Concentrate on that, not the numbers. Sometimes jurors wonder if the number of
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1.8 EXPERT WITNESSES When knowledge of technical subject matter may be helpful to the jury, a person who has special training or experience in that technical field - he or she is called an expert witness - is permitted to state his or her opinion on those technical matters. You have heard testimony from several scientific experts in this case. These witnesses are just like any other witness, and, as with any other witness, you may choose to believe some, all, or none of their testimony. You are not required to accept any or all of their opinions. With respect to an expert witness, you will have in mind the opinion testified to--the expert's conclusions--and what data and analysis that opinion is based on. I suggest to you that you consider whether you believe the data is accurate and whether the analysis makes sense to you. If it does, then you decide for yourselves whether the opinions based on those data and analyses persuade you. Consider whether the opinions follow logically. Consider how they compare with other evidence in the case. In short, you may sum up these witnesses' testimony and decide what you believe or what you don't want to believe.
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1.9 DOCUMENTS A number of documents have been admitted as exhibits, and they will be made available to you in the jury room while you deliberate. Like the testimony of witnesses, you may choose to believe some, or all or none of what a document says.
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2 THE PARTIES AND THEIR CONTENTIONS
2.1 THE PARTIES As you now undoubtedly know, the Plaintiff is Amgen Incorporated, hereinafter "Amgen." The Defendants are Hoffman-LaRoche Ltd., Roche Diagnostics, GmbH, and Hoffman LaRoche Inc., whom I will refer to collectively as "Roche."
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2.2 SUMMARY OF PLAINTIFF'S CONTENTIONS Ladies and Gentlemen of the jury, in the beginning of the case I explained to you the issues that you must decide. I will repeat them for you generally now and will give you more detailed instruction on the law that you must follow in reaching your decision in this case. Plaintiff Amgen contends that Defendant Roche has imported and is currently importing into the United States a pharmaceutical composition, called MIRCERAŽ , that Amgen alleges infringes its various patents directed to erythropoietin ("EPO"), a protein used to treat anemia and related blood disorders. As of the filing of this lawsuit and up to today, MIRCERAŽ has yet to be approved by the FDA and has never been nor is currently on the market. Amgen thus seeks a declaratory judgment that Roche is currently infringing or, upon FDA approval, will infringe claims 1 and 2 of the `868 patent, claims 3, 7-9, 11, 12, and 14 of the `933 patent, claims 6-9 of the `698 patent, claim 7 of the `349 patent and claim 1 of the `422 patent.
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2.3 SUMMARY OF DEFENDANTS' CONTENTIONS Roche contends that it does not infringe any of the asserted claims of Amgen's `868, `933, `698, `349, or `422 patents. Roche also contends that asserting these claims and patents is improper as the patents-in-suit are all invalid. With regard to non-infringement, Roche contends that it has not infringed and is not infringing any of Amgen's asserted claims, either directly or indirectly, or literally or under the doctrine of equivalents or due to the reverse doctrine of equivalents. Roche further contends that all allegedly infringing activities cannot constitute infringement as a matter of law as such activities are protected under 35 U.S.C. § 271(e)(1). This provision is often referred to as the "safe harbor provision." It allows otherwise infringing activities to be exempt from liability if said activities are pursuant to clinical trials pursuant to gaining FDA approval. With regard to invalidity, Roche contends that various claims of the asserted patents are invalid because they fail to satisfy the legal conditions for patentability, including nonant icipat ion, non-obviousness, adequate written description, enablement, and definiteness. Roche further contends that some of the asserted patents are invalid as they cover the same subject matter for which Amgen holds other patents, namely the expired `008 patent, the `868 patent and the `698 patent. Roche contends that the asserted patents are an improper attempt at prolonging a monopoly whose time has lapsed. Additionally, Roche contends that the patents-in-suit are not enforceable, in whole or in part, due to Amgen's wrongful and improper conduct in attaining the patents-in-suit.
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2.4 SUMMARY OF PARTIES' ISSUES I will now summarize the issues that you must decide, as I instructed you in the beginning of the case, and for which I will provide further instructions on the law to guide your deliberations. You must decide the following issues: For the issue of invalidity, you must determine: ˇ ˇ whether references in the prior art anticipate the asserted patents whether the subject matter of an asserted claim was used publicly more than a year before the patent for the asserted claim was filed ˇ whether the subject matter of an asserted claim was invented by another before Lin invented the subject matter of the asserted claims ˇ whether the subject matter of an asserted claim was known publicly more than a year before the patent for the asserted claim was filed ˇ whether the subject matter of an asserted claim was sold in the U.S. more than a year before the patent for the asserted claim was filed ˇ whether the subject matter of an asserted claim was patented in the U.S. or a foreign country more than a year before the patent for the asserted claim was filed ˇ whether the asserted claims would have been obvious to one of ordinary skill in the art at the time of filing ˇ whether the asserted claims were enabled at the time of filing, such that one skilled in the field of the invention could make and use the claimed invention ˇ ˇ whether the asserted claims were described adequately in the patents-in-suit whether the asserted claims were definite such that one skilled in the art could determine the precise limits of the claimed invention ˇ whether some of the claims-in-suit are mere obvious variations of Amgen's expired `008 patent , the `868 patent, or the `698 patent 13
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whether, during the prosecution of the patent application that led to the `349 patent, Amgen elected to proceed under 35 U.S.C. Sec. 103(b), and thus the `349 patent should have expired when the `008 patent expired For the issue of infringement, you must determine:
ˇ ˇ ˇ ˇ
whether Roche directly infringed the patents-in-suit whether Roche induced infringement on the patents-in-suit whether Roche literally infringed the patents-in-suit whether Amgen has proven that products imported by Roche allegedly infringing the asserted process claims were not materially changed such that they do not infringe any of the asserted claims
ˇ ˇ
whether Roche infringed the patents-in-suit by the doctrine of equivalents whether the doctrine of equivalents should not apply due to limitations in the prior art, prosecution history estoppel, or subject matter dedicated to the public
ˇ
whether Roche has proven by the reverse doctrine of equivalents that its products and processes are so different from the asserted claims that they are non-infringing
ˇ
whether all of Roche's allegedly infringing activity is protected under the safe harbor exemption
For the issue of unenforceability, you must determine: ˇ whether information material to the Lin patents was misrepresented, omitted, and/or buried to the United States Patent and Trademark Office (USPTO) ˇ whether any person substantially involved in the prosecution of the Lin patents had the intent to mislead the USPTO ˇ whether Amgen committed fraud on the USPTO to obtain the Lin patents.
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2.5 ISSUES ESTABLISHED BY PRIOR LITIGATIONS In the law, once a party has had the opportunity to litigate an issue fully and that issue has been conclusively decided, that party may not relitigate that same issue. The legal term for this rule is "issue preclusion."2 In this case, I have determined that there are certain issues that have been established in prior litigation involving Amgen and are not appropriately reconsidered as open issues in this case. I therefore instruct you to consider the following facts as conclusively established: 1. Recombinant erythropoietin cannot be distinguished from urinary erythropoietin on the basis of glycosylation.3 2. The claims of the patents-in-suit cannot cover analogs beyond the handful disclosed in the specification.4
2
Issue preclusion is invoked when the following four-part test is satisfied:
1. 2. 3. 4. the issue is identical to one decided in the first action; the issue was actually litigated in the first action; resolution of the issue was essential to a final judgment in the first action; and the party against whom estoppel is invoked had a full and fair opportunity to litigate the issue in the first action
Amgen, Inc. v. F. Hoffman-La Roche Ltd., ---F.Supp.2d---, 2007 WL 1893058 *2 (D. Mass. 2007) (citing Innovad Inc. v. Microsoft Corp., 260 F.3d 1326, 1334 (Fed. Cir. 2001)).
Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1341 (Fed. Cir. 2003) ("In its discussion characterizing recombinant glycoprotein products, the specification of the `933 patent does not direct those of ordinary skill in the art to a standard by which the appropriate comparison can be made."); Amgen, Inc. v. Hoechst Marion Roussel, Inc., 126 F.Supp.2d 69, 155-56, 165 (D. Mass. 2001) ("The glycosylation of human urinary erythropoietin is a standardless standard... As a result, making comparisons between the glycosylation of recombinant EPO and that of human urinary EPO is virtually impossible."); ("Dr. Lin's specification falters ... because it fails to enable one of ordinary skill in the art to compare the glycoyslation of the recombinant EPO product with that of human urinary erythropoietin."); see also Exhibit A to Defendants' Memorandum of Law in Support of Motion In Limine to Invoke Issue Preclusion as to Findings from Prior Litigation (D.N. 821-2) (quoting numerous additional statements).
3
Amgen, Inc. v. Chugai Pharmaceutical Co., Ltd., 927 F.2d 1200, 1213-14 (Fed. Cir. 1991) ("Details for preparing only a few EPO analog genes are disclosed" in the patents-in-suit.); 15
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Because these facts are considered conclusively established, you may not consider any argument, testimony or evidence to the contrary.
("There may be many other genetic sequences that code for EPO-type products. Amgen has told how to make and use only a few of them and is therefore not entitled to claim all of them."); ("Considering the structural complexity of the EPO gene, the manifold possibilities for change in its structure, with attendant uncertainty as to what utility will be possessed by these analogs, ... more is needed concerning identifying the various analogs that are within the scope of the claim, methods for making them, and structural requirements for producing compounds with EPO-like activity. It is not sufficient, having made the gene and a handful of analogs whose activity has not been clearly ascertained, to claim all possible genetic sequences that have EPO-like activity."); see also Exhibit A to Defendants' Memorandum of Law in Support of Motion In Limine to Invoke Issue Preclusion as to Findings from Prior Litigation (D.N. 821-2)(quoting numerous additional statements). 16
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3 BURDEN OF PROOF
I will instruct you now of the burdens of proof associated with the issues presented to you. As I instructed you earlier, Amgen bears the burden of proving that Roche has infringed. Amgen must meet this burden by what is called a preponderance of the evidence. That means that Amgen has to produce evidence which, when considered in light of all the facts, leads you to believe that what Amgen claims is more likely true than not. To put it differently, if you were to put the plaintiff's and the defendant's evidence on opposite sides of a scale, the evidence supporting the plaintiff's claims would have to make the scales tip on the plaintiff's side. Additionally, defendant urges that plaintiff's patents are invalid. A patent is presumed to be valid. Accordingly, defendant has the burden of proving that the patents-in-suit are invalid by clear and convincing evidence. Clear and convincing evidence is evidence that produces an abiding conviction that the truth of a factual contention is highly probable; it is a higher burden than proof by a preponderance of the evidence. Those of who you are familiar with criminal cases will have heard the term "proof beyond a reasonable doubt." That burden does not apply in a civil case and you should, therefore, put it out of your mind in considering whether or not the plaintiff or defendant has met its burden of proof.
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4 VALIDITY DEFENSES
Roche contends that the asserted claims of the patents-in-suit are invalid, as well as claims 4 and 5 of the `698 patent. Roche has the burden of proving by clear and convincing evidence that each is invalid. Roche contends that the asserted claims are invalid for the following reasons: ˇ ˇ ˇ references in the prior art anticipate the asserted patents the subject matter of asserted claims were used publicly before November 30, 1983 the subject matter of asserted claims were invented by another before Dr. Lin invented the subject matter of the asserted claims ˇ ˇ ˇ the subject matter of asserted claims were known before November 30, 1983 the subject matter of asserted claims were sold in the U.S. before November 30, 1983 the subject matter of asserted claims were patented in the U.S. or a foreign country before November 30, 1983 ˇ ˇ the asserted claims would have been obvious to one of ordinary skill in the art Dr. Lin derived enough of the subject matter of the asserted claims to render the rest of the claimed subject matter obvious ˇ the asserted claims were not fully enabled at the time of filing, such that one of ordinary skill in the art could make and use the claimed invention ˇ ˇ the full scope of the asserted claims were not adequately described in the patents-in-suit the asserted claims were indefinite such that one of ordinary skill in the art could not determine the precise limits of the claimed invention ˇ the claims-in-suit are obvious variations of the claims of Amgen's expired `008 patent, or the `868 patent and the `698 patent ˇ Amgen elected to proceed under 35 U.S.C. Sec. 103(b), and thus the `349 patent should have expired when the `008 patent expired 18
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4.1 PRIOR ART DEFINED In this case, prior art includes any of the following items received into evidence during trial:5 1. any product or method that was publicly known or used by others in the United
States before Amgen's invention date; 2. 1983; 3. 30, 1983; 4. any product or method that was in public use or on sale in the United States publications having a date before Amgen's date of invention, or before November patents that issued before Amgen's date of invention, or before November 30,
before November 30, 1983; 5. any product or method that was invented by anyone before Amgen's date of
invention, where the product or method was not abandoned, suppressed, or concealed; and 6. any disclosure to Dr. Lin before Amgen's date of invention, by another who is not
a named inventor on the asserted patents.
5
35 U.S.C. § 102. 19
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4.2 ANTICIPATION 6 A person cannot obtain a patent if someone else already has made an identical invention. Simply put, the invention must be new. An invention that is not new or novel is said to be "anticipated" by the prior art. To prove anticipation, Roche must present clear and convincing evidence showing that each and every element in the claim is present in a single prior art reference.7 In this case, Roche contends that claims of the `933 and `422 patents are anticipated. Specifically, Roche contends for claims 3, 7, and 8 of the `933 patent: ˇ a substance satisfying the elements of these claims was known or used before Amgen's date of invention ˇ a substance satisfying the elements of these claims was patented or described in a printed publication before Amgen's date of invention, or before November 30, 1983 ˇ a substance satisfying the elements of these claims was in public use or on sale in the U.S. before November 30, 1983 ˇ a substance satisfying the elements of these claims was made in the U.S. by another inventor before Amgen's date of invention ˇ a substance satisfying the elements of these claims was described in a patent granted on an application for patent by another, filed in the U.S. before Amgen's date of invention For claims 9 and 12 of the `933 patent and claim 1 of the `422 patent, Roche contends: ˇ a pharmaceutical composition satisfying the elements of these claims was known or used before Amgen's date of invention
6 7
35 U.S.C. § 102; AIPLA 2005 Model Patent Jury Instructions, 6.0. IPXL Holdings, LLC v. Amazon.com, Inc., 430 F.3d 1377, 1381 (Fed. Cir. 2005), (quoting Brisol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1373 (Fed. Cir. 2001)). 20
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a pharmaceutical composition satisfying the elements of these claims was patented or described in a printed publication before Amgen's date of invention or before November 30, 1983
ˇ
a pharmaceutical composition satisfying the elements of these claims was publicly used or sold in the U.S. before November 30, 1983
ˇ
a pharmaceutical composition satisfying the elements of these claims was made in the U.S. by another inventor before Amgen's date of invention
ˇ
a pharmaceutical composition satisfying the elements of these claims was described in a patent granted on an application by another filed in the U.S. before Amgen's date of invention In determining whether all the elements of the claimed invention is found in the prior art
reference, you should take into account what a person of ordinary skill in the art would have understood from his or her examination of the particular item of prior art. If the prior art reference was properly before the PTO at the time of issuance, a patent nevertheless may be found to be anticipated on the basis of that reference.8 If, on the other hand, the prior art reference was not before the PTO, the presumption of validity of the patent is weakened because the rationale underlying the presumption -- that the PTO, using its expertise, had approved the claim -- is diminished.9 A product-by-process claim covers the product, not the process. Amgen's product-byprocess claims are anticipated if the products of those claims existed in the prior art. Whether such prior art products were produced by a process different from the process employed by Amgen, or are from a different source, is immaterial when determining the validity of Amgen's
8 9
IPXL Holdings, LLC. v. Amazon.com, Inc., 430 F.3d 1377, 1381 (Fed. Cir. 2005). KSR Int'l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1745 (2007). 21
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product-by-process claims. For that determination, the focus remains at all times on Amgen's claimed product and the products of the prior art..10 In determining whether the single item of prior art anticipates a patent claim, you should take into consideration not only what is expressly disclosed in the particular item but also what inherently occurred as a natural result of its practice. This is called "inherency." A party claiming inherency must prove it by clear and convincing evidence. To establish inherency, the evidence must make clear that the missing descriptive matter is necessarily present in the reference. Inherency, however, does not require that a person of ordinary skill in the art at the time of the disclosure or occurrence of the anticipating subject matter would have recognized the inherent disclosure.11 Thus, the prior use of the patented invention that was accidental or unrecognized and unappreciated can still be an invalidating anticipation. You must keep these requirements in mind and apply them to each kind of anticipation you consider in this case.
10
SmithKline Beecham Corp. v. Apotex Corp., 439 F.3d 1312, 1317 (Fed. Cir. 2006 ); Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1354 n.20 (Fed. Cir. 2003); Gen. Elec. Co. v. Wabash Appliance Corp., 304 U.S. 364, 373 (1938); Diamond v. Chakrabarty, 447 U.S. 303, 309-10 (1980). See Toro Co. v. Deere & Co., 355 F.3d 1313, 1321 (Fed. Cir. 2004). 22
11
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4.3 EFFECTIVE FILING DATE AND DATE OF INVENTION The effective filing date of the asserted claims is November 30, 1984. Amgen's date of invention is the effective filing date -- November 30, 1984 -- unless you find that Amgen has proven the conception and actual reduction to practice of the invention earlier than that.
23
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4.4 PRIOR PUBLIC USE Roche contends that claims 3, 7, 8, 9 and 12 of the `933 patent and claim 1 of the `422 patent were anticipated because the invention defined in those claims were publicly used in the United States before Amgen's date of invention, or before November 30, 1983. An invention is publicly used if it is used by the inventor or by a person who is not under any limitation, restriction, or obligation of secrecy to the inventor.
24
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4.5 PRIOR INVENTION Roche contends that claims 3, 7, 8, 9 and 12 of the `933 patent and claim 1 of the `422 patent were anticipated because the inventions defined in those claims were invented by another person before Amgen's date of invention. Roche must show by clear and convincing evidence either (1) before Amgen's date of invention, a third party reduced to practice a product or method that includes all of the elements of the relevant claims or (2) that a third party was the first to conceive of the invention and that he exercised reasonable diligence in later reducing the invention to practice. In addition, Roche must show that the third party's invention was sufficiently developed that one skilled in the art would have recognized that it would work for its intended purpose. If the prior invention was abandoned, suppressed, or concealed, it does not anticipate Amgen's patent. An invention was not abandoned, suppressed, or concealed if the invention was made public, sold, or offered for sale, or otherwise used for a commercial purpose. A period of delay does not constitute abandonment, suppression, or concealment if the prior inventor was engaged in reasonable efforts to bring the invention to market.12
12
AIPLA Model Patent Jury Instruction 6.5; 35 U.S.C. § 102; Rosco, Inc. v. Mirror Lite Co., 304 F.3d 1373 (Fed. Cir. 2002); Monsanto Co. v. Mycogen Plant Sci., Inc., 261 F.3d 1356 (Fed. Cir. 2001); Apotex USA, Inc. v. Merck & Co., 254 F.3d 1031 (Fed. Cir. 2001); RCA Corp. v. Data Gen. Corp., 887 F.2d 1056 (Fed. Cir. 1989); E.I. du Pont de Nemours & Co. v. Phillips Petroleum Co., 849 F.2d 1430 (Fed. Cir.1988); Kimberly-Clark Corp. v. Johnson & Johnson, 745 F.2d 1437 (Fed. Cir. 1984); Gen. Motors Corp. v. Toyota Motor Co., 467 F. Supp. 1142 (S.D. Ohio1979), aff'd in part & rev'd in part, 667 F.2d 504 (6th Cir. 1981). 25
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4.6 PRIOR PUBLIC KNOWLEDGE Roche contends that claims 3, 7, 8, 9 and 12 of the `933 patent and claim 1 of the `422 patent were anticipated because the inventions defined in those claims were publicly known in the United States before Amgen's date of invention. Private or secret knowledge does not invalidate a patent claim. Similarly, if something is only publicly known outside of the United States, this is not invalidating public knowledge.13
13
35 U.S.C. § 102; Rosemount, Inc. v. Beckman Instruments, Inc., 727 F.2d 1540 (Fed. Cir. 1984); Trend Prods. Co. v. Metro Indus., Inc., 10 U.S.P.Q. 2d 1531 (C.D. Cal. 1989). 26
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4.7 PRINTED PUBLICATION Roche contends that claims 3, 7, 8, 9 and 12 of the `933 patent and claim 1 of the `422 patent were anticipated because the invention defined in those claims were described in a printed publication Amgen's date of invention, or before November 30, 1983. A printed publication must be reasonably accessible to those members of the public who would be interested in its contents. It is not necessary that the printed publication be available to every member of the public. An issued patent is a printed publication. A published patent application is a printed publication as of its publication date. For a printed publication to anticipate a patent claim, it must, when read by a person of ordinary skill in the art, expressly or inherently disclose each element of the claimed invention to the reader, and must be complete enough to enable one of ordinary skill in the art to practice the invention without undue experimentation. In determining whether the disclosure is enabling, you should take into account what would have been within the knowledge of a person of ordinary skill in the art one year before the application for the patent was filed and/or at the time the invention of the patents were made; you may consider evidence that sheds light on the knowledge such a person would have had.14
14
AIPLA Model Jury Instruction 6.4; 35 U.S.C. § 102; In re Carol F. Klopfenstein, 380 F.3d 1345, 1352 (Fed. Cir. 2004); Glaverbel Societe Anonyme v. Northlake Mktg. & Supply, Inc., 45 F.3d 1550 (Fed. Cir. 1995); Scripps Clinic & Research Found. v. Genentech, Inc., 927 F.2d 1565 (Fed. Cir. ), clarif. on recon., 927 F.2d 1565 (Fed. Cir. 1991); Constant v. Advanced Micro-Devices, Inc., 848 F.2d 1560 (Fed. Cir. 1988); Akzo N.V. v. U.S. Int'l Trade Comm'n, 808 F.2d 1471 (Fed. Cir. 1986); In re Hall, 781 F.2d 897 (Fed. Cir. 1986); In re Donohue, 766 F.2d 531 (Fed. Cir. 1985); Studiengesellschaft Kohle mbH v. Dart Indus., Inc., 726 F.2d 724 (Fed. Cir. 1984); In re Wyer, 655 F.2d 221 (C.C.P.A. 1981); In re Donohue, 632 F.2d 123 (C.C.P.A. 1980); In re Samour, 571 F.2d 559 (C.C.P.A. 1978); In re Coker, 463 F.2d 1344 (C.C.P.A. 1972); Deep Welding, Inc. v. Sciaky Bros., Inc., 417 F.2d 1227 (7th Cir. 1969); Phillips Petroleum Co. v. Ladd, 219 F. Supp. 366 (D.D.C. 1963); Garrett Corp. v. United States, 422 F.2d 874 (Ct. Cl. 1970); Honeywell, Inc. v. Sperry Rand Corp., 180 U.S.P.Q. 673 (D. Minn. 1973); Tyler Refrigeration Corp. v. Kysor Indus. Corp., 553 F. Supp. 279 (D. Del. 1982). 27
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4.8 PRIOR PATENT Roche contends that claims 3, 7, 8, 9 and 12 of the `933 patent and claim 1 of the `422 patent were anticipated because the invention defined in those claims were patented by a third party. To show anticipation of the patented invention, Roche must show by clear and convincing evidence that a third party patented an invention anywhere in the world that included all of the elements of the claims above, before Amgen's date of invention, or before November 30, 1983.15 A prior patent is presumed to be enabled as to both its claims and its unclaimed disclosures. 16
15
AIPLA Model Jury Instruction 6.6; 35 U.S.C. § 102; In re Monks, 588 F.2d 308 (C.C.P.A. 1978); In re Fuge, 272 F.2d 954 (C.C.P.A. 1959); In re Ekenstam, 256 F.2d 321 (C.C.P.A. 1958); Bendix Corp. v. Balax, Inc., 421 F.2d 809 (7th Cir. 1970). Amgen v. Hoechst Marion Roussel, Inc., 457 F.3d 1293, 1307 (Fed. Cir. 2006). 28
16
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4.9 OBVIOUSNESS Roche contends that the claims of all of the asserted patents are invalid because the claimed subject matter would have been obvious to one of ordinary skill in the art at the time the invention was made.17 Roche bears the burden of proving this defense by clear and convincing evidence. Each claim must be considered separately. For obviousness, a person of ordinary skill in the art may combine two or more items of prior art. The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.18 When a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.19 You must consider all of the prior art references and evaluate obviousness from the perspective of one of ordinary skill in the art at the time the invention was filed (not from the perspective of a layman or a genius in the art). However, "A person of ordinary skill is also a person of ordinary creativity, not an automaton."20 Before determining whether or not Roche has established obviousness of the claimed invention, you must determine the following factual matters: 1. 2. The scope and content of the prior art relied upon by Roche; The difference or differences, if any, between each claim of the asserted patents
and the prior art; and
17 18
See 35 U.S.C. § 103 KSR Intern. Co. v. Teleflex Inc., 127 S. Ct. 1727, 1739 (2007); see also Leapfrog Enterprises, Inc. v. Fisher-Price, Inc., 485 F.3d 1157, 1161 (Fed. Cir. 2007). KSR Intern. Co. v. Teleflex Inc., 127 S. Ct. 1727, 1740 (2007) (quoting Sakraida v. Ag Pro, Inc. 425 U.S. 273, 282 (1976)). KSR Intern. Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742 (2007). 29
19
20
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The level of ordinary skill in the art at the time the inventions of the asserted
patents were made. 4. Objective factors indicating non-obviousness, including commercial success,
long-felt need, failure of others, copying, unexpected results, acceptance of licenses. Against this background of facts, you will then make your conclusion whether or not the claimed subject matter would have been obvious to a person of ordinary skill in the art at the time the invention was made.21 Just because there is unpredictability in the applicable art, that doesn't mean that obviousness is necessarily avoided. As long as there is reasonable probability of success, a finding of obviousness is proper.22 Many techniques that require extensive time, money, and effort to carry out may nevertheless be arguably routine to one of ordinary skill in the art and do not equate to a conclusion that an expectation of success was unlikely.23
21
AIPLA Model Jury Instruction 7.0; Graham v. John Deere Co., 383 U.S. 1 (1966); Ruiz v. A.B. Chance Co., 234 F.3d 654 (Fed. Cir. 2000); Arkies Lures, Inc. v. Gene Larew Tackle, Inc., 119 F.3d 953 (Fed. Cir. 1997); Ryko Mfg. Co. v. Nu-Star, Inc., 950 F.2d 714, 716 (Fed. Cir. 1991); Nutrition 21 v. United States, 930 F.2d 867, 871 n.2 (Fed. Cir. 1991); Newell Cos. v. Kenney Mfg. Co., 864 F.2d 757, 764 (Fed. Cir. 1988); Structural Rubber Prods. Co. v. Park Rubber Co., 749 F.2d 707 (Fed. Cir. 1984); Orthopedic Equip. Co. v. All Orthopedic Appliances, Inc., 707 F.2d 1376 (Fed. Cir. 1983); Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530 (Fed. Cir. 1983). Pfizer v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007); (citing In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985) Brown v. Williamson Tobacco Corp. v. Philip Morris Inc., 229 F.3d 1120, 1125 (Fed. Cir. 2000); Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 809 (Fed. Cir. 1989); In re Merck & Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Pfizer Inc. v. Apotex, Inc., 480 F.3d 1348, 1367-68 (Fed. Cir. 2007); Velander v. Garner, 348 F.3d 1359, 1368 (Fed. Cir. 2003). 30
22
23
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4.10 OBVIOUSNESS DECISION In determining whether the invention of the asserted patents would have been obvious to a person of ordinary skill in the art, you must presume that person would have known about all relevant prior art. In examining the prior publication, inventions, etc., you should take into account not only what they expressly disclose, but also anything that inherently occurred as a result of practicing what was expressly disclosed in that prior art.24 In a determination of whether a claimed invention is obvious it is proper to consider "the effects of demands known to the design community or present in the marketplace; the background knowledge possessed by a person having ordinary skill in the art; and the inferences and creative steps that a person of ordinary skill in the art would employ."25 It often may be the case that market demand, rather than scientific literature, will provide the motivation to create a particular combination that renders the claimed invention obvious.26 When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious and therefore invalid.27
24 25 26 27
In re Napier, 55 F.3d 610, 613 (Fed. Cir. 1995). KSR Intern. Co. v. Teleflex Inc., 127 S.Ct. 1727, 1740-41 (2007). Id. KSR Intern. Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742 (2007). 31
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4.11 SCOPE AND CONTENT OF THE PRIOR ART The prior art that you considered previously for anticipation purposes is also prior art for obviousness purposes. As with anticipation, you should take into consideration not only what is expressly disclosed in the particular item but also what inherently occurred as a natural result of its practice.28 Remember, however, that for obviousness inquiries, you may consider multiple pieces of prior art simultaneously.
28
In re Napier, 55 F.3d 610, 613 (Fed. Cir. 1995). 32
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4.12 OBJECTIVE FACTORS You must also consider, where they exist, the objective factors I mentioned before, including commercial success, long-felt need, failure of others, copying, unexpected results, and/or the acceptance of licenses support a finding of non-obviousness. Amgen must demonstrate a nexus between the merits of invention and evidence of objective factors. Thus, in the context of objective factors of non-obviousness, praise by others for the inventors' work must be directly tied to an actual inventive contribution rather than confirmation of what the state of knowledge in the art was already indicating.29
29
PharmaStem Therapeutics, Inc. v. Viacell, Inc., 2007 WL 1964863, *20 (Fed. Cir. 2007). 33
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4.13 LEVEL OF ORDINARY SKILL IN THE ART In reaching your determination as to whether or not the claimed invention would have been obvious, you should consider the level of ordinary skill in the pertinent art. When
determining the level of ordinary skill in the art, you should consider all the evidence submitted by Amgen and Roche to show: 1. the level of education and experience of persons actively working in the field at
the time of the invention; 2. 3. 4. 5. 6. the types of problems encountered in the art at the time of the invention; the prior art patents and publications; the activities of others; prior art solutions to the problems; and the sophistication of the technology.
Based on the factors listed and the evidence presented, you must determine the level of ordinary skill in the art at the time of the invention. When you decide the issue of obviousness, you must decide whether or not the invention would have been obvious to one having this ordinary level of skill in the fields of molecular biology, biotechnology, protein chemistry or nephrology.30
30
AIPLA Model Jury Instruction 7.4; Graham v. John Deere Co., 383 U.S. 1 (1966); Ruiz v. A.B. Chance Co., 234 F.3d 654 (Fed. Cir. 2000); Orthopedic Equip. Co. v. United States, 702 F.2d 1005 (Fed. Cir. 1983); Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693 (Fed. Cir. 1983). 34
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4.14 FACTORS INDICATING OBVIOUSNESS Additionally, other objective evidence may favor a finding of obviousness. For example the simultaneous or near simultaneous invention by others of the patented subject matter is a secondary consideration supporting a conclusion of obviousness. Just as the failure of others to make the invention may be evidence that an invention would not have been obvious, independent making of the invention by persons other than the inventor at about the same time may be evidence that the invention would have been obvious, depending on the circumstances.31
31
AIPLA Model Jury Instruction 7.8; Ecolochem, Inc. v. S. Cal. Edison Co, 227 F.3d 1361, 1379 (Fed. Cir. 2000); Monarch Knitting Machinery Corp. v. Sulzer Morat GmbH, 139 F.3d 877, 883-84 (Fed. Cir. 1998); Stewart-Warner Corp. v. City of Pontiac, 767 F.2d 1563 (Fed. Cir. 1985); Lindemann Maschinenfabrik GmbH v. Am. Hoist & Derrick Co., 730 F.2d 1452 (Fed. Cir. 1984); In re Farrenkopf, 713 F.2d 714 (Fed. Cir. 1983); Orthopedic Equip. Co. v. United States, 702 F.2d 1005 (Fed. Cir. 1983); Simmonds Precision Prods., Inc. v. United States, 153 U.S.P.Q. 465 (Ct. Cl. 1967). 35
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4.15 DERIVATION OF INVENTION You may also find the asserted patents to be invalid for derivation of invention if Roche proves that Dr. Lin acquired knowledge of the claimed invention from another, or so much of the claimed invention as would have made it obvious to one of ordinary skill in the art.32
32
Oddzon Products, Inc. v. Just Toys, Inc., 122 F.3d 1396, 1403-04 (Fed. Cir. 1997); New England Braiding Co., Inc. v. A.W. Chesterson Co., 970 F.2d 878, 883 (Fed. Cir. 1992). 36
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4.16 ENABLEMENT The written description set forth in a patent must disclose sufficient information to enable or teach one skilled in the field of the invention to make and use the full scope of claimed invention. This requirement is known as the enablement requirement. If a patent claim is not enabled, it is invalid. A patent is enabling if its disclosure is sufficient to enable a person of ordinary skill in the art to make and use the claimed invention. Roche bears the burden of establishing lack of enablement by clear and convincing evidence. Roche contends that the `422, `933, `698, `868 and `349 patents are invalid for lack of enablement. The fact that some experimentation may be required for a skilled person to practice the full scope of the claimed invention does not mean that a patent's written description fails to meet the enablement requirement. Factors that you may consider in determining whether the written description would require undue experimentation include: (1) the quantity of experimentation necessary; (2) the amount of direction or guidance disclosed in the patent; (3) the presence or absence of working examples in the patent; (4) the nature of the invention; (5) the state of the prior art; (6) the relative skill of those in the art; (7) the predictability of the art; and (8) the breadth of the claims.33
33
AIPLA Model Jury Instruction 8; Durel Corp. v. Osram Sylvania Inc., 256 F.3d 1298, 1306 (Fed. Cir. 2001); Union Pac. Res. Co. v. Chesapeake Energy Corp., 236 F.3d 684, 690-92 (Fed. Cir. 2001); Ajinomoto Co. v. Archer-Daniels-Midland Co., 228 F.3d 1338, 1345-46 (Fed. Cir. 2000); Nat'l Recovery Techs., Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1195-98 (Fed. Cir. 1999); Enzo Biochem, Inc. v. Calgene, Inc., 188 F.3d 1362, 1371 (Fed. Cir. 1999); In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988); SpectraPhysics, Inc. v. Coherent, Inc., 827 F.2d 1524, 1533 (Fed. Cir.1987); Hybritech Inc. v. Monolonal Antibodies, Inc., 802 F.2d 1367, 1384 (Fed. Cir. 1986); Ralston Purina Co. v. Far-Mar Co., 772 F.2d 1570, 1573-74 (Fed. Cir. 1985); Linedmann Maschinenfabrik GmbH v. Am. Hoist & Derrick Co., 730 F.2d 1452, 1463 (Fed. Cir. 1984); White Consol. Indus., Inc. v. Vega Servo Control, Inc., 713 F.2d 788, 791 (Fed. Cir. 1983). 37
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In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the more unpredictable the area of technology, the more the patentee must disclose.34
34
In re Fisher, 427 F.2d 833, 839 (C.C.P.A. 1970). 38
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4.17 WRITTEN DESCRIPTION A patent must contain a written description of the product or method claimed in the patent. The written description is the "technologic disclosure of the invention."35 Roche can
meet its burden of proving that a patent claim is invalid by showing that the patent does not contain an adequate written description of the full scope of claimed invention. Roche contends that the `422, `933, `698, `868 and `349 patents are invalid for failure to satisfy the written description requirement. Roche bears the burden of establishing lack of written description by clear and convincing evidence. The written description must show that the applicant was in full possession of the claimed subject matter on the application filing date and to allow other inventors to develop and obtain patent protection for later improvements and subservient inventions that build on applicant's teachings.36 To satisfy the written description requirement, the patent must describe each and every limitation of a patent claim, although the exact words found in the claim need not be used. The written description requirement is not satisfied if a person of ordinary skill in the field, reading the patent application as originally filed, would not recognize that the patent application described the invention as finally claimed in the patent.37
35 36
Space Sys/Loral, Inc. v. Lockheed Martin Corp., 405 F.3d 985 (Fed. Cir. 2005). 35 U.S.C § 112(1) and (2); 3 Donald S. Chisum, Chisum on Patents § 7.04 (2007) (internal citations omitted); Northern District of California Model Jury Instruction No. 4.2a (September 20, 2004); Chiron Corp. v. Genentech, Inc., 363 F.3d 1247, 1255 (Fed. Cir. 2004); Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473, 1478-80 (Fed. Cir. 1998); Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319-20 (Fed. Cir. 2003). Purdue Pharma L.P. v. Faulding, Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000) ("...one skilled in the art, reading the disclosure, must immediately discern the limitation at issue in the claims.") 39
37
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If you find that Roche has proved that the claims of the above patents do not contain a complete written description of the invention covered by any of its claims, then you must find that the claim is invalid.38 When I construed the claims at issue, I did not make any decision as to whether or not the claims were adequately described.
38
AIPLA Model Jury Instruction 9; Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916 (Fed. Cir. 2004); Turbocare Div. of Demag Delaval Turbomach. Corp., v. Gen. Elec. Co., 264 F.3d 1111, 1118 (Fed. Cir. 2002); Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956 (Fed. Cir. 2002) (en banc); Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320 (Fed. Cir. 2000); Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345-46 (Fed. Cir. 2000); Union Oil Co. of Cal. v. Atl. Richfield Co., 20 F.3d 989, 996-1001 (Fed. Cir. 2000); Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473, 1478-90 (Fed. Cir. 1998); VasCath, Inc. v. Mahurkar, 935 F.2d 1555 (Fed. Cir. 1991). 40
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4.18 INDEFINITENESS The claims of a patent to be sufficiently definite that one skilled in the art could determine the precise limits of the claimed invention. If a claim is found to be indefinite the claim is invalid. The amount of detail required to be included in claims depends on the particular invention and the prior art, and is not to be evaluated in the abstract but in conjunction with the patent's disclosure. Roche contends that the `422, `933, `698, `868 and `349 patents are invalid for indefiniteness. You must decide if the claims of these patents, read in light of the disclosure, reasonably apprised those skilled in the art of the proper
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