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

Filing 1343

Supplemental Proposed Jury Instructions by F. Hoffmann-LaRoche LTD, Roche Diagnostics GmbH, Hoffmann LaRoche Inc.. (Drozdoff, Vladimir)

Download PDF
Amgen Inc. v. F. Hoffmann-LaRoche LTD et al Doc. 1343 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 1 of 93 UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS ) ) ) ) ) CIVIL ACTION No.: 05-CV-12237WGY ) ) ) ) ) ) AMGEN INC., Plaintiff, v. F. HOFFMANN-LA ROCHE LTD; ROCHE DIAGNOSTICS GmbH; and HOFFMANN-LA ROCHE INC., Defendants. DEFENDANTS' SUPPLEMENTAL PROPOSED FINAL JURY INSTRUCTIONS Defendants, F. Hoffman-La Roche Ltd, Roche Diagnostics GmbH, and Hoffmann-La Roche Inc., respectfully request that the Court read the attached final jury instructions to the jury at the conclusion of trial. Dated: October 10, 2007 Boston, Massachusetts Respectfully submitted, F. HOFFMANN-LA ROCHE LTD, ROCHE DIAGNOSTICS GMBH, and HOFFMANN-LA ROCHE INC. By their attorneys, /s/ Vladimir Drozdoff 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) Vladimir Drozdoff (pro hac vice) KAYE SCHOLER LLP 425 Park Avenue New York, New York 10022 Tel. (212) 836-8000 Dockets.Justia.com Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 2 of 93 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 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 3 of 93 DEFENDANTS' PROPOSED JURY INSTRUCTIONS TABLE OF CONTENTS 1 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 2 2.1 2.2 2.3 2.4 2.5 3 4 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 GENERAL INSTRUCTIONS......................................................................................................................1 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 OPINION WITNESSES..................................................................................................................................8 DOCUMENTS ................................................................................................................................................9 THE PARTIES AND THEIR CONTENTIONS ......................................................................................10 THE PARTIES..............................................................................................................................................10 SUMMARY OF PLAINTIFF'S CONTENTIONS .......................................................................................11 SUMMARY OF DEFENDANTS' CONTENTIONS ...................................................................................12 SUMMARY OF PARTIES' ISSUES ...........................................................................................................13 ISSUES ESTABLISHED..............................................................................................................................15 BURDEN OF PROOF.................................................................................................................................16 VALIDITY DEFENSES .............................................................................................................................17 PRIOR ART DEFINED ................................................................................................................................18 ANTICIPATION ..........................................................................................................................................19 EFFECTIVE FILING DATE AND DATE OF INVENTION ......................................................................22 PRIOR PUBLIC USE ...................................................................................................................................23 PRIOR INVENTION ....................................................................................................................................24 PRIOR PUBLIC KNOWLEDGE..................................................................................................................25 PRINTED PUBLICATION ..........................................................................................................................26 OBVIOUSNESS ...........................................................................................................................................27 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 4 of 93 4.9 OBVIOUSNESS DECISION........................................................................................................................29 4.10 SCOPE AND CONTENT OF THE PRIOR ART.........................................................................................31 4.11 OBJECTIVE FACTORS...............................................................................................................................32 4.12 LEVEL OF ORDINARY SKILL IN THE ART ...........................................................................................33 4.13 FACTORS INDICATING OBVIOUSNESS ................................................................................................34 4.14 AMGEN'S ADMISSIONS FROM THE PATENT SPECIFICATION........................................................35 4.15 DERIVATION OF INVENTION .................................................................................................................42 4.16 EXPERIMENTAL DATA ............................................................................................................................43 4.17 WRITTEN DESCRIPTION ..........................................................................................................................44 4.18 ENABLEMENT............................................................................................................................................46 4.19 INDEFINITENESS.......................................................................................................................................47 5 5.1 5.2 6 6.1 6.2 6.3 6.4 6.5 CONSTRUCTION OF CLAIMS...............................................................................................................49 GENERAL PRINCIPLES.............................................................................................................................49 DEPENDENT AND INDEPENDENT CLAIMS .........................................................................................50 INFRINGEMENT.......................................................................................................................................51 GENERAL PRINCIPLES.............................................................................................................................51 LITERAL INFRINGEMENT .......................................................................................................................52 INFRINGEMENT OF DEPENDENT CLAIMS ..........................................................................................53 MATERIAL CHANGE.................................................................................................................................54 EVIDENCE OF MATERIAL CHANGE OF OTHER PRODUCTS IS RELEVANT TO DETERMINING MATERIAL CHANGE OF CERA AND MIRCERAŽ (NEW)...................................................................56 6.6 6.7 INFRINGEMENT BY DOCTRINE OF EQUIVALENTS...........................................................................57 LIMITATIONS ON DOCTRINE OF EQUIVALENTS ­ APPLIED ON AN ELEMENT BY ELEMENT BASIS ...........................................................................................................................................................59 6.8 6.9 LIMITATIONS ON DOCTRINE OF EQUIVALENTS - PROSECUTION HISTORY ESTOPPEL..........60 LIMITATIONS ON DOCTRINE OF EQUIVALENTS -- CLAIM ELEMENTS MAY NOT BE READ OUT OF EXISTENCE..................................................................................................................................61 6.10 ROCHE'S PATENTS ON MIRCERAŽ ARE RELEVANT TO THE DOCTRINE OF EQUIVALENTS INQUIRY (NEW) .........................................................................................................................................62 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 5 of 93 6.11 LIMITATIONS ON THE DOCTRINE OF EQUIVALENTS ­ SUBJECT MATTER DEDICATED TO THE PUBLIC................................................................................................................................................63 6.12 REVERSE DOCTRINE OF EQUIVALENTS .............................................................................................64 6.13 SAFE HARBOR EXEMPTION....................................................................................................................65 6.14 SPECIFIC CLAIM INSTRUCTIONS ..........................................................................................................66 6.15 INFRINGEMENT OF U.S. PATENT NO. 5,441,868 ..................................................................................67 6.15.1 6.15.2 6.15.3 7 7.1 7.2 7.3 7.4 8 8.1 8.2 8.3 8.4 INFRINGEMENT OF U.S. PATENT NO. 5,547,933....................................................................69 INFRINGEMENT OF U.S. PATENT NO. 5,618,698....................................................................72 INFRINGEMENT OF U.S. PATENT NO. 5,756,349....................................................................74 UNENFORCEABILITY (INEQUITABLE CONDUCT) ........................................................................75 INEQUITABLE CONDUCT - GENERALLY.............................................................................................75 MATERIALITY............................................................................................................................................78 INTENT ........................................................................................................................................................80 BALANCING OF MATERIALITY AND INTENT ....................................................................................82 DELIBERATION AND VERDICT...........................................................................................................83 INTRODUCTION.........................................................................................................................................83 UNANIMOUS VERDICT ............................................................................................................................84 DUTY TO DELIBERATE............................................................................................................................85 THE COURT HAS NO OPINION................................................................................................................86 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 6 of 93 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 in 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. 1 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 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 7 of 93 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. 2 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 8 of 93 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. 3 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 9 of 93 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. 4 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 10 of 93 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. 5 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 11 of 93 1.6 CREDIBILITY OF WITNESSES As the jurors, you have the power to use everything you know about the witnesses who have testified 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. 6 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 12 of 93 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 7 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 13 of 93 1.8 OPINION 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 opinion witness - is permitted to state his or her opinion on those technical matters. You have heard testimony from several scientific opinion witnesses 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 opinion witness, you will have in mind the opinion testified to--the witnesses' 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. 8 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 14 of 93 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, all or none of what a document says. 9 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 15 of 93 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 F. Hoffmann-La Roche Ltd, Roche Diagnostics, GmbH, and Hoffmann La Roche Inc., whom I will refer to collectively as "Roche." 10 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 16 of 93 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 been approved for sale outside the United States and is being used by patients, but it is yet to be approved by the FDA although approval is expected next month, and it is currently not on the market in the United States. 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, and 12, of the `933 patent, claims 6-9 of the `698 patent, claim 7 of the `349 patent. 11 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 17 of 93 2.3 SUMMARY OF DEFENDANTS' CONTENTIONS Roche contends that it does not infringe any of the asserted claims of Amgen's patents. Roche also contends that asserting these claims and patents is improper as the patents-in-suit are all invalid, and unenforceable. With regard to non-infringement, Roche contends that it has not infringed and is not infringing any of Amgen's asserted claims, either 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 asserted claims of the patents-insuit are invalid because they fail to satisfy the legal conditions for patentability, including anticipation, obviousness, lack of adequate written description, lack of enablement, and indefiniteness. 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 before the U.S. Patent Office. 12 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 18 of 93 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 whether references in the prior art anticipate any of the asserted claims of the patents in suit ˇ whether the subject matter of an asserted claim was used publicly more than a year before the patent for the asserted claim was filed (November 30, 1984) ˇ whether the subject matter of an asserted claim was invented by another before Lin invented the subject matter of the asserted claims which date is November 30, 1984 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 (November 30, 1984) 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 (November 30, 1984) ˇ whether Dr. Lin derived all or part of the claimed subject matter from another not named as an inventor on the patents-in-suit ˇ whether the asserted claims would have been obvious to one of ordinary skill in the art as of November 30, 1984 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 as of November 30, 1984 13 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 19 of 93 ˇ whether the asserted claims were described adequately in the patents-in-suit as of November 30, 1984 ˇ whether the asserted claims were definite such that one skilled in the art could determine the precise limits of the claimed invention as of November 30, 1984 For the issue of infringement, you must determine: ˇ ˇ whether Roche literally infringes the asserted claims of the `933 patent whether Amgen has proven that products imported by Roche are not materially changed by subsequent processes from the direct product of the asserted process claims ˇ whether Roche infringes the asserted claims of the `933 patent by the doctrine of equivalents ˇ 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 as I will instruct you about 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 from 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. 14 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 20 of 93 2.5 ISSUES ESTABLISHED In this case, I have determined that there are certain issues that have been established 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.2 2. The claims of the patents-in-suit cannot cover analogs beyond the handful disclosed in the specification.3 [Do not read footnotes, only for Court's consideration.] Because these facts are considered conclusively established, you may not consider any argument, testimony or evidence to the contrary. 2 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). 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.); ("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). 3 15 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 21 of 93 3 BURDEN OF PROOF I will instruct you now on 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 shows it is highly probable that the claims are invalid; it is a higher burden than proof by a preponderance of the evidence.4 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. 4 2007 AIPLA Model Jury Instructions, p.9. 16 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 22 of 93 4 VALIDITY DEFENSES Roche contends that the asserted claims of the patents-in-suit are invalid. 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 references in the prior art anticipate the asserted claims of the patents-in-suit the subject matter of asserted claims were used publicly one year before November 30, 1984 ˇ the subject matter of asserted claims were invented by another before Dr. Lin invented the subject matter of the asserted claims ˇ ˇ the subject matter of asserted claims were known one year before November 30, 1984 the asserted claims would have been obvious to one of ordinary skill in the art prior to November 30, 1984 ˇ Dr. Lin derived all or part 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 as of November, 30, 1984 (See D.I. 1332) ˇ the full scope of the asserted claims is not adequately described in the patents-in-suit as of November, 30, 1984 ˇ the asserted claims were indefinite such that one of ordinary skill in the art could not determine the precise limits of the claimed invention as of November, 30, 1984 17 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 23 of 93 4.1 PRIOR ART DEFINED Prior art includes any of the following items received into evidence during trial: 1. any product or method that was publicly known or used in the United States by a person other than Dr. Lin before the date of his alleged invention for each claim, here November 30, 1984; 2. patents or printed publications by anyone that issued or were published one year before November 30, 1984; 3. patents, published patents applications, or printed publications by a person other than Dr. Lin that issued or published before the date of his alleged invention for each claim, here November 30, 1984; 4. any product or method that was in public use or on sale in the United States more than one year before November 30, 1984; 5. patents filed by a person other than Dr. Lin before November 30, 1984 regardless of when the patent issued; 6. any product or method that was made by a person other than Dr. Lin before Dr. Lin completed his alleged inventions in the asserted claims, where the product or method was not abandoned, suppressed, or concealed; and 7. any disclosure to Dr. Lin before Lin's date of invention, by another who is not a named inventor on the asserted claims of the patents. In this case, prior art includes any of the foregoing items received into evidence during trial.5 5 35 U.S.C. § 102. 18 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 24 of 93 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 that shows it is highly probable that each and every element in the claim is present in a single prior art reference.7 In this case, Roche contends that the asserted claims of the `933, `698, `868 and `349 patents are anticipated. Specifically, Roche contends for those claims: Miyake Gold NIH -1 Goldwasser TrialGoldwasser IND Gold NIH-2 Gold NIH-3 Goldwasser Protein Eschbach Essers Fritsch 933-3 X X X X X X X X X X 933-7 X X X X X X X X X X 933-8 X X X X X X X X X X 933-9 X X X X X X X X 933-11 X X X X X 933-12 X X X X X X X X X X X X X X 933-14 X X X X X 349-7 868-1 868-2 698-6 698-7 698-8 698-9 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 6 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)). 7 19 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 25 of 93 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.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 claimed by Lin, or are from a different source, is immaterial when determining the validity of Lin's product-byprocess claims. For that determination, the focus remains at all times on Lin'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 reference. Product by process claims, such as the claims of the `933 patent simply claim a product and if that product is shown to be present in the prior art, the claim is invalid despite the 8 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). 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). 9 10 11 20 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 26 of 93 recitation of process steps. A product by process claim is not rendered patentable by the recited process steps. In other words, you cannot patent a car just because you figured out a different way to assemble a car. Claim 1 of the `422 patent is simply a product claim that recites a source limitation. Recitation of a source, e.g., "mammalian cells grown in culture" does not serve to distinguish the claimed product from products in the prior art unless the claim or patent specification discloses structural features of products obtained from the recited source that are not present in the prior art. In other words, unless the source imparts a new structure that is different from the structure of the prior art products, the claimed product is not patentable over the prior art products. Since Amgen chose to draft its claims in these formats it is Amgen's burden to prove that the source or process limitations impart a structural distinction over the prior art. 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-insuit. In this case, that date is before November 30, 1984. You must keep these requirements in mind and apply them to each kind of anticipation you consider in this case. 21 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 27 of 93 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. (See D.I. 1332) If Amgen asserts a date of invention earlier than the date Amgen's application was filed (November 30, 1984) with the Patent and Trademark Office, Amgen must prove such an earlier date of invention by Dr. Lin by proof that is clear and convincing. The proof must show that Lin conceived the invention at a date prior to Amgen's filing date, that is November 30, 1984, and then reduced the invention to practice, having exercised reasonable diligence from the date of conception to the date of reduction to practice. Amgen must provide support for the testimony of its witnesses. The unsupported testimony of Lin's alleged conception, diligence, or reduction to practice prior to the filing date is not enough. To prove an actual reduction to practice prior to the filing date, you must find evidence that Dr. Lin himself recognized that he possessed an invention that worked for its intended purpose of treating anemia in humans. In the absence of such proof, the filing date is the only invention date you should consider. 22 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 28 of 93 4.4 PRIOR PUBLIC USE Roche contends that claims 3, 7, 8, 9, 11, 12, and 14 of the `933 patent were anticipated because the invention defined in those claims were publicly used in the United States before Lin's date of invention, or one year before November 30, 1984. Roche contends that such anticipating prior use includes the Baron/Goldwasser clinical trial and the Eschbach human patient trial and the Essers human trial. An invention is publicly used if it is used by a person who is not under any limitation, restriction, or obligation of secrecy to the inventor. 23 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 29 of 93 4.5 PRIOR INVENTION Roche contends that claims 3, 7, 8, 9, 11, 12, and 14 of the `933 patent and claims 1 and 2 of the `868, 6-9 of the `698 and claim 7 of the `349 patent were anticipated because the inventions defined in those claims were invented by another person before Amgen's date of invention. Roche contends that the asserted claims of the `933 patent were invented earlier by either Drs. Baron, Goldwasser, Eschbach, Essers, or Fritsch. As to the asserted claims of the '868, `698 and `349 patents, Roche also contends that those claims were invented earlier by the work of Dr. Fritsch. 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). 24 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 30 of 93 4.6 PRIOR PUBLIC KNOWLEDGE Roche contends that the asserted claims of the `933 patent were anticipated because the inventions defined in those claims were publicly known in the United States before Lin's date of invention, by virtue of the work of Drs. Goldwasser, Baron, Eschbach and Essers. 25 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 31 of 93 4.7 PRINTED PUBLICATION Roche contends that the asserted claims of the `933 patent were anticipated because the invention defined in those claims were described in a printed publication before Lin's date of invention, or one year before November 30, 1984. However, a printed publication dated after Amgen's date of invention, or after November 30, 1983, may be used when it describes what a person of ordinary skill in the art knew existed before Amgen's date of invention, or before November 30, 1983.13 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. It is Amgen's burden to prove non-enablement of such a reference. 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 13 In re Killer, 613 F.2d 819, 824 (C.C.P.A. 1980); In re Wilson, 311 F.2d 266, 269 (C.C.P.A. 1962). 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. 14 26 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 32 of 93 4.8 OBVIOUSNESS Even if a claim is not anticipated by a single prior art reference, you may still find that claim to be invalid for 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.15 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.16 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.17 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."18 Evidence concerning the inventor's expectations regarding his alleged inventions is also relevant to your analysis of obviousness.19 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). 15 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). Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 809 (Fed. Cir. 1989). See also Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir. 2007), reh'g denied, 488 F.3d 1377 (Fed. Cir. 2007). 16 17 18 19 27 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 33 of 93 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 3. 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.20 As long as there is a reasonable probability of success in combining two or more prior art references to obtain a particular result, a finding of obviousness is proper.21 Many techniques that require extensive time, money, and effort to carry out may nevertheless be routine to one of ordinary skill in the art and do not equate to a conclusion that an expectation of success was unlikely.22 20 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). 21 22 28 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 34 of 93 4.9 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.23 In determining whether a claimed invention is obvious, you should not attribute the work of other people to the sole listed inventor, Dr. Lin. For example, you should not consider the work done by Dr. Goldwasser, which is described in Example 1 of the patents-in-suit, as work done by Dr. Lin because Dr. Lin has admitted that work described in Example 1 was done by Dr. Goldwasser. Also, you should not consider the selection of CHO cells as work done by Dr. Lin because, as you have heard, people outside of Amgen suggested and provided the CHO cells to Dr. Lin. Further, you should not consider the work done by other Amgen employees as work done by Dr. Lin since the evidence was that this was routine and non-inventive. In determining 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 Since the evidence shows that this was routine and our incentive. In a determination of whether a claimed invention is obvious it is proper to consider "the background knowledge possessed by a person having ordinary skill in the art; and the inferences 23 In re Napier, 55 F.3d 610, 613 (Fed. Cir. 1995). In re Napier, 55 F.3d 610, 613 (Fed. Cir. 1995). 24 29 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 35 of 93 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 need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, such as the human trials of Drs. Baron, Eschbach or Essers, 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 All that is required is a reasonable expectation of success, not a certainty. 25 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). 26 27 30 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 36 of 93 4.10 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; for an element to be inherent, it must be proven to necessarily always occur, mere probability is not sufficient.28 Remember, however, that for obviousness inquiries, you may consider multiple pieces of prior art simultaneously. All prior art does not have to be publicly known at the time of Dr. Lin's invention, here November 30, 1984. You as fact finders must also consider what is known in the law as "non-published prior art," such as what someone may have done in their garage and later disclosed. This means people working in the field in 1983-1984 may not have been generally aware, but under the law you must assume that "hypothetical person of skill in the art" would have this information. Such prior art includes: ˇ ˇ ˇ ˇ information and materials disclosed to Dr. Lin and not to others information or materials disclosed to any person information in patent applications things invented by others prior to Lin's invention A prior art patent is presumed to teach everything disclosed. Amgen has the burden of showing otherwise. 28 In re Napier, 55 F.3d 610, 613 (Fed. Cir. 1995). 31 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 37 of 93 4.11 OBJECTIVE FACTORS You must also consider, where they exist, and have been demonstrated by evidence from Amgen, certain objective factors including long-felt but unresolved need and failure of others similarly situated as Dr. Lin, which support a finding of non-obviousness. Amgen must demonstrate a nexus between the evidence offered for the supposed objective factors and each of the asserted claims. In the absence of such a nexus or evidence of a direct connection to each of the claims, you should give this evidence little weight. You may also consider whether the claims of another patent, Amgen's expired U.S. Patent No. 4,703,008 (the "'008 patent"), or the Strickland/Lai `016 purification patent and not the asserted claims in this case, were responsible for these objective factors, such as meeting a long-felt need. If you find that these factors were the result of the '008 patent or the `016 patent, then Amgen cannot rely upon these factors as evidence of non-obviousness.29 29 Weatherchem Corp. v. J.L. Clark, 163 F.3d 1326 (Fed. Cir. 1998). 32 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 38 of 93 4.12 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, an MD or Ph.D. in the fields of molecular biology, biotechnology, protein chemistry or nephrology with two years of laboratory experience.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). 33 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 39 of 93 4.13 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. 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.31 Also, others skilled in the art working toward the same solution to the same problem, or working on a finite number of predictable solutions to the same problem such as Drs. Baron, Eschbach or Essers, is also evidence supporting a conclusion of obviousness.32 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). KSR Intern. Co., 127 S.Ct. at 1742. 32 34 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 40 of 93 4.14 AMGEN'S ADMISSIONS FROM THE PATENT SPECIFICATION In conducting your analysis of anticipation and obviousness of the asserted claims, you should also consider the following statements by the Inventor set forth in the specification of the patents. These constitute binding admissions on Amgen.33 The patent specification states the following: "A focus of microbiological processing for the last decade has been the attempt to manufacture industrially and pharmaceutically significant substances using organisms which either do not initially have genetically coded information concerning the desired product included in their DNA, or (in the case of mammalian cells in culture) do not ordinarily express a chromosomal gene at appreciable levels." `933 patent, TRX 1, Col. 2, lns. 16-22 "Once this is done, the existing machinery for gene expression in the `transformed' or `transfected' microbial host cells operates to construct the desired product, using the exogenous DNA as a template for transcription of mRNA which is then translated into a continuous sequence of amino acid residues. The art is rich in patent and literature publications relating to "recombinant DNA" methodologies for the isolation, synthesis, purification and amplification of genetic materials for use in the transformation of selected host organisms." `933 patent, TRX 1, Col. 2, lns. 28-37 "More frequently, the goal of transformation is the expression by the host cells of exogenous DNA in the form of large scale synthesis of isolatable quantities of commercially 33 PharmaStem Therapeutics, Inc. v. Viacell, Inc., --- F.3d ---, 2007 WL 1964863 at *17 (Fed. Cir. 2007) ("Admissions in the specification regarding the prior art are binding on the patentee for purposes of a later inquiry into obviousness."); Constant v. Advanced Micro-Devices, Inc., 848 F.2d 1560, 1570 (Fed.Cir.1988) ("A statement in the patent that something is in the prior art is binding on the applicant and patentee for determinations of anticipation and obviousness."); Sjolund v. Musland, 847 F.2d 1573, 157779 (Fed.Cir.1988) (patent specification admitted that certain matter was prior art, and thus "the jury was not free to disregard [that matter]" and "must have accepted [it] as prior art, as a matter of law"); In re Fout, 675 F.2d 297, 300 (CCPA 1982); In re Nomiya, 509 F.2d 566, 571 (CCPA 1975). 35 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 41 of 93 significant protein or polypeptide fragments coded for by the foreign DNA." `933 patent, TRX 1, Col. 2, lns. 58-62. "At the risk of over-simplification, it can be stated that three alternative principal methods can be employed: (1) the "isolation" of double-stranded DNA sequence from the genomic DNA of the donor; (2) the chemical manufacture of a DNA sequence providing a code for a polypeptide of interest; and (3) the in vitro synthesis of a double-stranded DNA sequence by enzymatic "reverse transcription" of mRNA isolated from donor cells. The last-mentioned methods which involve formation of a DNA "complement" of mRNA are generally referred to as "cDNA" methods. Manufacture of DNA sequences is frequently the method of choice when the entire sequence of amino acid residues of the desired polypeptide product is known. DNA manufacturing procedures of co-owned, co-pending U.S. patent application Ser. No. 483,451, by Alton, et al., (filed Apr. 15, 1983 and corresponding to PCT U.S.83/00605, published Nov. 24, 1983 as WO83/04053), for example, provide a superior means for accomplishing such highly desirable results as: providing for the presence of alternate codons commonly found in genes which are highly expressed in the host organism selected for expression (e.g., providing yeast or E.coli "preference" codons); avoiding the presence of untranslated "intron" sequences (commonly present in mammalian genomic DNA sequences and mRNA transcripts thereof) which are not readily processed by procaryotic host cells; avoiding expression of undesired "leader" polypeptide sequences commonly coded for by genomic DNA and cDNA sequences but frequently not readily cleaved from the polypeptide of interest by bacterial or yeast host cells; providing for ready insertion of the DNA in convenient expression vectors in association with desired promoter/regulator and terminator sequences; and providing for ready construction of genes coding for polypeptide fragments and analogs of the desired polypeptides." `933 patent, TRX 1, Col. 3, lns. 3-37. 36 Case 1:05-cv-12237-WGY Document 1343 Filed 10/10/2007 Page 42 of 93 "Wh

Disclaimer: Justia Dockets & Filings provides public litigation records from the federal appellate and district courts. These filings and docket sheets should not be considered findings of fact or liability, nor do they necessarily reflect the view of Justia.


Why Is My Information Online?