Amgen Inc. v. F. Hoffmann-LaRoche LTD et al
Filing
918
Proposed Document(s) submitted by Amgen Inc.. Document received: Amgen Inc.'s Proposed Jury Instruction. (Gottfried, Michael)
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Amgen Inc. v. F. Hoffmann-LaRoche LTD et al
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UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS ) ) ) Plaintiff, ) ) v. ) ) ) F. HOFFMANN-LAROCHE ) LTD., a Swiss Company, ROCHE ) DIAGNOSTICS GmbH, a German ) Company and HOFFMANN LAROCHE ) INC., a New Jersey Corporation, ) ) Defendants. ) __________________________________________) AMGEN INC.,
Civil Action No.: 05-12237 WGY
PRE-TRIAL AND POST-TRIAL JURY INSTRUCTIONS PROPOSED BY AMGEN INC.
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TABLE OF CONTENTS Page I. II. III. IV. V. VI. VII. VIII. IX. X. PRE-TRIAL JURY INSTRUCTIONS INTRODUCTION......................................... 1 THIS CASE ................................................................................................................. 4 THE PATENT SYSTEM, GENERALLY................................................................... 5 HOW A PATENT IS OBTAINED.............................................................................. 7 THE PARTS OF A PATENT...................................................................................... 8 THE SIGNIFICANCE OF PATENT CLAIMS ........................................................ 10 AMGEN'S CONTENTIONS .................................................................................... 11 ROCHE'S CONTENTIONS ..................................................................................... 14 CONCLUDING REMARKS..................................................................................... 18 POST-TRIAL FINAL INSTRUCTIONS INTRODUCTION................................... 19 A. B. Role Of The Jury............................................................................................ 21 Evidence......................................................................................................... 23 1. 2. 3. 4. C. XI. XII. Expert Witnesses................................................................................ 25 Testimony By Deposition .................................................................. 26 Exhibits .............................................................................................. 27 Stipulations ........................................................................................ 28
Deliberations.................................................................................................. 29
BURDEN OF PROOF ............................................................................................... 31 THE CLAIMS OF THE PATENTS-IN-SUIT .......................................................... 32 A. B. C. D. Construction of the Claims ............................................................................ 33 Independent and Dependent Claims .............................................................. 35 Process and Source Limitations in Product Claims ....................................... 36 "Comprising" Claims..................................................................................... 37 i
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E. XIII.
Limitations of the Claims at Issue ................................................................. 38
INFRINGEMENT ..................................................................................................... 39 A. B. C. D. E. F. G. H. Patent infringement generally direct infringement ..................................... 39 Infringement - every claim limitation must be present, either literally or under the doctrine of equivalents ................................................. 41 Infringement of open ended or "comprising" claims..................................... 43 Infringement of dependent claims ................................................................. 44 Infringement of process claims under 35 U.S.C. 271(g) ............................... 45 Infringement and improvements to patented invention ................................. 47 Determination of infringement ...................................................................... 48 Inducing Infringement ................................................................................... 49
XIV.
VALIDITY ................................................................................................................ 51 A. B. C. D. E. F. G. H. I. J. K. L. M. N. Presumption of validity.................................................................................. 51 Patent Validity Generally............................................................................ 53 Prior Art: definition ....................................................................................... 54 Conception and Reduction to Practice........................................................... 56 Prior Art--Prior Invention............................................................................. 57 Prior Art: printed publication......................................................................... 59 Prior Art: prior knowledge or use by another in the United States................ 60 Anticipation generally................................................................................. 61 Anticipation Effect of Process or Source Limitations ................................ 63 Anticipation Purified Compounds .............................................................. 64 Obviousness ................................................................................................... 65 Obviousness: scope and content of the prior art ............................................ 69 Obviousness: differences between the inventions of the claims and the prior art.............................................................................................. 70 Obviousness: level of ordinary skill .............................................................. 71 ii
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O. P.
Obviousness: Motivation to Combine ........................................................... 73 Obviousness: objective indications concerning obviousness ........................ 75 1. 2. 3. 4. 5. 6. 7. 8. 9. Long-Felt Need .................................................................................. 75 Failure of Others ................................................................................ 75 Skepticism.......................................................................................... 76 Unexpected Results............................................................................ 76 Expressions of Surprise ..................................................................... 76 Awards/Recognition by Others.......................................................... 76 Commercial Success .......................................................................... 77 Acceptances of Licenses.................................................................... 77 Copying.............................................................................................. 77
Q. R. S. T. U. XV.
Obviousness: Summary ................................................................................ 79 [Provisional Instruction] Obviousness-Type Double Patenting .................... 80 Written Description........................................................................................ 84 Enablement .................................................................................................... 85 Definiteness ................................................................................................... 87
[PROVISIONAL INSTRUCTION] INEQUITABLE CONDUCT .......................... 89 A. B. C. Materiality...................................................................................................... 91 Intent .............................................................................................................. 93 Balancing Of Materiality And Intent ............................................................. 94
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I.
PRE-TRIAL JURY INSTRUCTIONS INTRODUCTION Ladies and gentlemen, at this time in this courtroom there are thirteen judges. You
twelve men and women are the judges of the facts. You are the only judges of the facts. That is not my function. I am the judge of the law. You are going to determine the facts in this case based solely and entirely on the evidence as you see it and hear it here in this courtroom and on nothing else whatsoever. No bias. No prejudice. No sympathy for anyone. No desire that anyone be punished or have revenge. No consideration of which company is better or which company makes a better product. No consideration of whether your decision will impact consumer choice or the availability of products in the market place. Your decision of the facts must be guided by the law as I explain it to you. You can take notes during this case. Ms. Smith is passing out to you now notebooks and pens. Put your names on them. We will lock them up after every court session. You just carry them out with you, or leave them on the table in the jury room. Ms. Smith will collect them, lock them up, and we will give them back to you the next day. So you have the right to take notes. Now, while you are allowed to take notes, no one says you have to take notes. It's not a test. If you are one of those people who by background and life experience you get your best judgment about people by watching them very closely, no one says you have to take notes. But this case is going to take awhile and maybe you would want to keep the names of witnesses or particular things, dates or data that you think is of significance, feel free to take notes. Your notes are private to you. No one will ever see them. When the trial is over, Ms. Smith will destroy the notes. You should not pass your notes among the jurors. And the reason for that is they are not evidence of anything. They are your notes to refresh your recollection. The lawyers have also put together notebooks of exhibits as to which there is no
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objection and I will pass those out to you now. These exhibits are ones we will be talking about during the first days. There may be additional notebooks with exhibits as we move forward with the case. You can ask questions. It's a formal proceeding, so if you have a question write your question out, rip it out of your notebook, pass it down to the foreperson. Ms. Smith and I will be watching. We'll come collect it. The question will get to me and I'll read it. Now, I may not ask it. The reason I may not ask it is because it is a question that I would not let the lawyers ask, or I think it is a question that does not legally make a difference, or the rules of evidence won't let the witness answer or for some other legal reason. If I decide to ask the question, I may not ask it exactly as you've written it but rather will ask it or a series of questions to elicit the information in a neutral manner. All questions that you pass to me will, whether they are asked or not, will be put on Ms. Smith's bench so that the attorneys can review them The acoustics are quite good in this courtroom. We give the witnesses microphones, but if you do not hear the witness's testimony raise your hand. I'll have it repeated for you. Now, I'm the judge of the law. You were carefully chosen to be the judges of the fact. But you were not chosen to make up your own law. It is my job to teach you the law. I will tell you who has to prove what and what the standard of proof is by which they must prove it. And it's your job to follow the law as I have explained it to you. You cannot make up your own law. You can't decide that one of the parties has to prove something else in addition to what I tell you or that some other factor, like the ones I mentioned before such as prejudice or which company or product is better or the impact on consumer choice, which is not part of the law, should be considered. The attorneys are also teachers. They are teachers through evidence. They only get limited chances to talk to you directly and even then I will always caution you and say, well now,
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remember, these lawyers were not there. They do not know what happened. They are teachers. They got into this after there was a dispute. Their job is to marshal, to present the evidence to you. They, themselves, are not sources of evidence. At times during a lawyer's questioning of a witness, the other lawyer may object. It's perfectly appropriate for a lawyer to object to another lawyer's question. I will then say sustained, which means that the lawyer cannot ask that question, the lawyer must ask another question; or I will say overruled, which means no, that question is all right, and the witness may answer it. After I rule on an objection, one side or the other may want to address the matter further with me. They may want to make a little argument on it. And I'm receptive to that so they will say May I approach? May I come to the side bar. What that means is the lawyers will come up and we will huddle over here. Now if we go over there, we are talking about things like the rules of evidence. We could go back and forth in front of you but it is distracting from the evidence so I do not do it that way. I will then decide the matter and we will proceed with the questioning.
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II.
THIS CASE Amgen is the plaintiff in this patent case, and that means Amgen filed the case against the
defendants F. Hoffmann-LaRoche LTD, Roche Diagnostics GMBH, and Hoffmann LaRoche, Inc. who I will collectively refer to as "Roche." It is a civil case. There is no criminal conduct charged here or involved. This is a civil dispute between these two companies who stand equal before the law. As I said, the suit is brought by Amgen. And it's brought with respect to five patents held by Amgen that cover a medical drug that it markets and sells. What is a patent? Well, I have the five patents that are at issue in this case right here. [Note: Amgen will make available the ribbon copies of the five patents-at-issue for the Court's use in court on September 4, 2007.] We've had patents as long as we've had a country. Patents are mentioned in the Constitution. And our patent law is designed to accomplish two related ends. On the one hand it's designed to encourage useful inventions that will help everyone; and on the other hand, it's designed to spread the knowledge of those inventions to everyone. Not just to keep them to the inventor himself.
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III.
THE PATENT SYSTEM, GENERALLY What happens with a patent, is that the inventor or the company that employs the
inventor, submits a patent application to the United States Patent and Trademark Office, which is a part of the Executive Branch of the government. The government is authorized by the United States Constitution to enact patent laws and issue patents to protect inventions. Inventions that are protected by patents may be products, compositions, or methods for doing something, or for using or making a product or composition. The owner of a patent has the right, for the life of the patent, to prevent others from making, using, offering for sale, selling or importing the invention covered by the patent. A patent is granted for a set period of time, which, in this case, is up to17 years from the date each patent issued. Once a patent expires, anyone is free to use the invention covered by the patent. During the term of the patent, however, if another person makes, uses, offers to sell, sells or imports something that is covered by the patent without the patent owner's consent, that person is said to infringe the patent. The patent owner enforces a patent against persons believed to be infringers in a lawsuit in federal court, such as in this case. To be entitled to patent protection an invention must be new, useful and nonobvious. A patent cannot legally take away from people their right to use that which was known, or that which was obvious from what was known, before the invention was made. Thus, a patent will not be valid if it deprives people of the right to use old or known products or processes, or of their right to use products or processes that were obvious at the time the invention was made. That which was already known at the time of the invention is called the "prior art." You will hear about the prior art relating to the patents-in-suit during the trial, and I will give you more instructions about what constitutes prior art at the end of the case.
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SOURCES & AUTHORITIES: Fed. Cir. Bar Assoc. Model Jury Instruction 2.2
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IV.
HOW A PATENT IS OBTAINED The U.S. Patent and Trademark Office is the agency of our government that examines
patent applications and issues patents. When an applicant for a patent files a patent application with the Patent and Trademark Office, the application is assigned to a Patent Examiner. The Patent Examiner examines the application to determine whether or not the inventions described in the patent application meets the requirements of the patent laws. The Patent Examiner advises the applicant of his or her findings in a paper called an "office action." The Examiner may "reject" the claims describing the inventions if he or she believes they do not meet the requirements for patentable inventions. The applicant may respond to the rejection with arguments to support the claims by making changes or amendments to the claims, or by submitting new claims. If the Examiner concludes that the legal requirements for a patent have all been satisfied, he or she "allows" the claims and the application issues as a patent. This process, from the filing of the patent application to the issuance of the patent, is called "patent prosecution." The record of papers relating to the patent prosecution is referred to as the prosecution history or file history. The prosecution history becomes available to the public when the patent issues. SOURCES & AUTHORITIES: Fed. Cir. Bar Assoc. Model Jury Instruction 2.5
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V.
THE PARTS OF A PATENT A patent includes two basic parts, a written description of the invention and the patent
claims. The written description, which may include drawings, is often referred to as the "specification" of the patent. You have been provided with copies of the patents at issue in this case. Please refer to the `933 patent, which is in your juror notebook at Tab ___ as an example as I identify its different sections. The cover page of the `933 patent provides identifying information, including the date the patent issued and patent number along the top right, as well as in the left-hand column the inventor's name, the filing date, the assignee, history of the applications that were filed and led to issuance of the patent, and a list of the prior art publications considered by the examiner who reviewed Dr. Lin's patent applications in the Patent Office. This list of prior art considered extends for several more pages to page 10. The "Related U.S. Application Data" explains that this patent issued from a series of related patent applications filed by the inventor, Dr. Lin, the first of which was filed on Dec. 13, 1983. Each claimed invention may have a different effective filing date, depending on which of Dr. Lin's patent applications first disclosed that particular claimed invention. The last application in the series that led to this final issued `933 patent was filed on Jun. 7, 1995. The "Date of Patent" on the top indicates the date on which the `933patent issued. The specification of the `933 patent begins with an abstract, found on the cover page in the lower right. The abstract is a brief statement about the general subject matter of the invention. After the list of prior art, next are the drawings, which appear as Figures 1 to 21 on the next 27 pages. The drawings depict various aspects, features or examples of the inventions.
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They are described in words later in the patent specification. The written description of the inventions appears next. In this portion of the patent, each page is divided into two columns, which are numbered at the top of the page. The lines in each column are also numbered. The written description of the `933 patent begins at column 1, line 1, and continues to column 38, line 16. It includes a description of the application filing history of the patent there in column 1, a "background" section that starts just below that and continues over to column 10, and a section entitled "brief summary" that begins in column 10 and extends over to column 38, which contains a detailed description of the inventions, including some specific examples. The specification ends with one or more numbered paragraphs. These are called the claims. The claims may be divided into a number of parts or steps, referred to as "claim limitations" or claim elements. In the `933 patent, the claims begin at column 38, line 17 and continue to the end of the patent, at column 40, line 9. As you can see, there are 14 claims in this `933 patent. Each of those claims addresses a different invention. Not all of those claims are being asserted by Amgen against Roche in this case. We'll talk more about that later. SOURCES & AUTHORITIES: Fed. Cir. Bar Assoc. Model Patent Jury Instruction 2.3
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VI.
THE SIGNIFICANCE OF PATENT CLAIMS The claims of a patent are the main focus of a patent case because it is the claims that
define the patent owner's rights under the law. That is, the claims define what the patent owner may exclude others from doing during the term of the patent. The claims of a patent serve two purposes. First, they set out the boundaries of the inventions covered by the patent. Second, they provide notice to the public of those boundaries. Thus, when a product or process is accused of infringing a patent, it is the patent claims that must be compared to the accused product or process to determine whether or not there is infringement. It is the claims of the patent that are infringed when patent infringement occurs. The claims are at issue as well when the validity of a patent is challenged. In reaching your determinations with respect to infringement and invalidity, you must consider each claim separately. Before trial, I decided the meaning of certain, not all, but certain terms that are used in the five patents that we are concerned with here. I am now going to give to you a glossary that contains the terms that I have defined prior to trial. You must use these meanings when you decide the issues of infringement and validity. SOURCES & AUTHORITIES: Fed. Cir. Bar Assoc. Model Jury Instructions 2.4
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VII.
AMGEN'S CONTENTIONS Here, Amgen contends that Roche will infringe certain claims of the five patents that
Amgen owns which describe and claim inventions relating to erythropoietin, or "EPO" for short and to methods of making EPO. Dr. Lin's inventions with respect to EPO have resulted in the development of a treatment for anemia and related blood disorders. Under the protection of these five patents, which I discussed a few minutes ago, Amgen markets and sells a product called EPOGEN®. The five specific patents at issue here are (1) U.S. Patent No. 5,441,868 (the "`868 Patent"); (2) U.S. Patent No. 5,547,933 (the "`933 Patent"); (3) U.S. Patent No. 5,618,698 (the "`698 Patent"); (4) U.S. Patent No. 5,955,422 (the "`422 Patent"); and (5) U.S. Patent No. 5,756,349 (the "`349 Patent"). And the specific claims of these patents that Amgen asserts Roche will infringe are as follows: · · · · · Claims 1 and 2 of the `868 Patent Claims 6, 7, 8 and 9 of the `698 Patent Claim 7 of the `349 Patent Claims 3, 7, 8, 9, 11, 12 and 14 of the `933 Patent Claim 1 of the `422 Patent
Amgen contends that these claims will be infringed if Roche is permitted to market its accused product in the United States. I have already determined as a matter of law that Roche will infringe Claim 1 of the `422 patent, so you do not have to consider or deliberate on that issue. But you should not let that affect your determination as to whether the other claims are infringed by Roche's product or processes. Other than for Claim 1 of the `422 patent, Roche contends that all the other claims are not infringed. Roche contends that all the claims are invalid and unenforceable.
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Amgen has to prove by a preponderance of the evidence that Roche in fact has infringed or will infringe a particular claim or claims. And a preponderance of the evidence simply means more likely to be true than not true. If based upon all the evidence you believe it's more likely to be true than not true that Roche has infringed a specific claim of one of the five patents, then you must find infringement as to that claim. What do we mean by infringement? In order to infringe Roche has to have taken steps to produce or sell a product that has every one of the elements in a particular claim. Each claim of each patent that is in issue here is comprised of elements. So when you are looking at infringement, you must determine whether Roche's product has every one of the elements in the claim that is being asserted as infringed or whether Roche's method of making or administering its product has every one of the steps included in the asserted claims. So if Roche's product or process has all of the elements of the claim or performs all of the steps of a claim, even if there are additional elements or additional steps, it is said to infringe. If Roche's product does not have all the elements of the claim or it does not perform all of the steps of the claim than it is said not to infringe. This is called literal infringement. For this analysis, you do not compare Amgen's product to Roche's product, that is not the relevant analysis. The relevant analysis is for you to compare separately each claim that Amgen asserts is infringed to Roche's product or method of making or using its product to see if Roche infringes that specific claim. When you get the jury verdict form you will see that it goes claim by claim and asks separately for each claim whether Roche infringes. Amgen also asserts that even if Roche does not literally infringe there is infringement by the doctrine of equivalents. Now, what that means is that Roche's product is so close that although it does not literally have one of the elements in the claim, there is something in the Roche product or process that accomplishes substantially the same function, in substantially the
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same way, with substantially the same result as that element. So this means that Amgen must prove that it is more probable than not that, for each claim element not literally found in Roche's product or method of making or using its product, that the product or method contains an equivalent structure or step. In order to be equivalent, the differences between that missing claim element and Roche's structure or step must be insubstantial. I will explain in more detail in my final instructions the various ways by which you may determine whether or not these differences, if they exist, are insubstantial.
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VIII. ROCHE'S CONTENTIONS Roche denies that it infringes. Roche also asserts even if it does infringe, it does not matter because the patents are invalid. Because the US Patent and Trademark Office already examined all these patents and granted them, you are to presume the Patent Office did its job correctly. Thus, the patents are presumed to be valid because the United States Patent Office issued the patents-in-suit, and the law presumes that each invention recited in each claim in each patent was new, useful and constituted an advance which was not, at the time of the invention, obvious to one of ordinary skill in the art. However, Roche asserts the patents are invalid for several reasons. Roche must prove that each asserted claim in the patents is invalid by clear and convincing evidence. Clear and convincing evidence means evidence which produces in your minds an abiding conviction that the truth of what Roche contends is highly probable. First, Roche asserts that the patents are invalid because they were obvious. The standard by which Roche must prove that a claim is obvious is the higher standard of clear and convincing evidence because, as I have indicated, the Patent Office issued the patents so the claims are presumed valid. What is obviousness? The test of whether something is obvious is whether the subject matter of the specific patent claim when viewed in light of the prior art would have been obvious to a person having ordinary skill in the art at the time the invention was made. In this case, Amgen contends the inventions were made prior to November 30, 1984. The prior art that you use in your comparison consists of what was publicly known before Dr. Lin made the invention. It includes patents, printed publications, commercial products in the United States, and certain other publicly available information in the United States. You compare each asserted claim
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separately to the prior art and then decide whether it would have been obvious, to a person having ordinary skill in the art that is the subject of the patent. When I say the art, I mean the specific area of knowledge which is the subject of the patent. Now in figuring out whether something's obvious, you do not use hindsight, you don't look at what is known by these people of ordinary skill today, who would have, for example, the benefit of the teachings of the patent, you look at what was known at the time the patent was applied for, what was known to a person reasonably skilled in the art at the time the patent was applied for. Prior art has to be public, it cannot just be privately known to someone, it has to be out there where people can know it. Second, Roche asserts that some of the patent claims are invalid for obviousness-type double patenting. What does that mean? It means that the inventions defined by these patent claims must be patentably distinct from the inventions defined by the claims in other, earlierissued patents owned by Amgen.1 Third, Roche asserts that some or all of the patents were anticipated. What does that mean? That means that somewhere in the literature, somewhere in the publicly known data there was what we call a reference. It simply means a document. And to anticipate one of the asserted claims, that document had to have taught every particular element in the claim. If that document was out there publicly or someone else invented it or someone else knew it, then the claim was As noted in the Joint Pretrial Memorandum (D.I. 807), it is Amgen's position that ODP is a matter of law purely for the Court to decide. See In re Metoprolol Succinate Patent Litig., 2007 U.S. App. LEXIS 17463, at *10-11 (Fed. Cir. July 23, 2007). Amgen maintains this position, and offers these provisional jury instructions regarding ODP in the alternative, should the Court decide to submit ODP issues to the jury. Amgen reserves the right to contest the submission of ODP issues to the jury. ODP is not addressed in the model patent jury instructions from the Federal Circuit Bar Association, the American Intellectual Property Law Association (AIPLA), or the Northern District of California.
1
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anticipated. Again because the patents are presumed valid, Roche bears the burden of showing anticipation of each claim by clear and convincing evidence. Fourth, Roche asserts that some or all of the asserted claims were not enabled. What does that mean? It simply means that teachings in the patent combined with what the person of ordinary skill knew at the time, were not enough to let that person of skill practice the invention. Recited in the claim without undue experimentation. Because the exchange involved in the Patent Office granting a patent is that the inventor gets this exclusivity over a period of time in return for teaching the world the technology so that the world can practice that technology when the patent expires. Again, because the patent claims are presumed valid, it is Roche's burden to prove that a claim was not enabled by clear and convincing evidence. Fifth, Roche asserts that the patents are invalid because the written description of the patents is inadequate. What does that mean? It means the description of the invention must be sufficiently clear and informative so that a person skilled in the art would recognize, at the time of the application, that the inventor in fact possessed a means to make and use the claimed invention. The patent laws do not require any particular form of written description, nor do they require that the exact words found in the claims be found in the specification. Because the patent claims are presumed valid, it is Roche's burden to prove that a claim was not adequately described in the patents by clear and convincing evidence. Lastly, Roche asserts that some or all of the asserted claims are invalid because they are indefinite. What does that mean? The claims of a patent must be written in a way that this person of ordinary skill reading them would have known what was covered by the claims, and what is not. Because the patent claims are presumed valid, it is Roche's burden to prove that a claim is indefinite by clear and convincing evidence.
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With respect to enforcing the patents, Roche also asserts that Amgen may not enforce these five patents against Roche, because Dr. Lin engaged in inequitable conduct before the Patent and Trademark Office when Dr. Lin was seeking to get the patents issued by the Patent Office. Roche must prove inequitable conduct by the higher clear and convincing evidence standard. Thus Roche must prove that it is highly probable that Dr. Lin, or his attorney or representative, withheld or misrepresented material information, and did so with an intent to mislead or deceive the Patent and Trademark Office. I will provide you with more details about inequitable conduct at the end of the case.2
As noted in the Joint Pretrial Memorandum, D.I. 807, it is Amgen's position that inequitable conduct is an equitable issue that should be decided by the Court without an advisory jury. Amgen maintains this position, and offers these provisional jury instructions regarding the law of inequitable conduct in the alternative, should the Court decide to submit inequitable conduct issues to an advisory jury over Amgen's objection. Amgen reserves the right to contest the submission of inequitable conduct issues to the jury.
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IX.
CONCLUDING REMARKS These are the preliminary instructions I will provide to you regarding the law. There is
one other matter I want to explain and that is the fact that I have decided that this case will be presented to you in three phases. The first phase will focus Roche's contentions that the patents are invalid. The second phase will focus on Amgen's contentions that the patents are infringed. The last phase will focus on Roche's contentions that the patents are not enforceable because Dr. Lin or Amgen committed inequitable conduct. Because I have decided to have the evidence presented to you in these three phases, the lawyers will provide a 15-minute opening statement about each phase at the start of that phase. So the first opening statements you will hear will be about invalidity. Now because it is, as I have explained, Roche's burden to prove invalidity, Roche's counsel will go first.
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X. POST-TRIAL FINAL INSTRUCTIONS INTRODUCTION Now the way the lawyers and I have worked this out, the way we think this makes this most intelligible for you, is to have me go first and explain to you in detail the law which you must follow in this case. When I'm done explaining the law we'll take a break. Then the lawyers will get a chance to give their closing arguments to talk about the evidence and urge you to certain conclusions within the legal framework as I describe it. When that's done I'll just give you some explanation about how you may deliberate together, how juries deliberate together, and then the case is yours. So we start this morning with my explanation as to the law which must govern in this particular case. You must listen carefully now because this is a form of law teaching. This is like a law class here. And it's a little stilted because you can't raise your hand now and say, well, you didn't explain that very well, explain that a little better. But what you can do if you don't understand any aspect of the law, write out your question, write it out, there will be a court security officer outside the door here, come out the door, give the question to the court security officer, we'll set things all up in here, we'll have you back in the courtroom and I will explain it better. Don't hesitate to do that. If justice is to be done here you people must understand the law in the case, and I must be good enough to teach it to you. So if you have any questions about the law be sure to ask them, don't just go ahead without understanding what the law is. I start my charges by a brief explanation of what our separate roles are, and then from there we'll go into what the evidence has been, at least the tools you have to do the job, and then from there we'll go directly into what the law is that governs this case.
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SOURCES & AUTHORITIES: Jury Instructions in Read Corp. v. Powerscreen of America, Inc., Civ. Action No. 96-11025WGY ("Read Instructions"), p 3.
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A.
ROLE OF THE JURY
First your role. You are the judges of the facts. The only judges of the facts. Though I will necessarily have to make mention of evidence and make mention of particular witnesses, that's only to remind you of testimony or evidence that may, it's entirely up to you, bear on certain aspects of the case. You're the judges of the evidence. I have nothing to say about the evidence. Now, you're going to judge the evidence as I said at the beginning of the case fairly and impartially without any bias or prejudice, without any sympathy for anyone, without any desire that anyone be punished or have revenge. Carefully and coolly sifting through this evidence to see that justice may be done. Your verdict must be unanimous. We're going to ask you certain questions that can be answered yes or no. So you must be unanimous as to a yes, you must be unanimous as to a no. And unanimous means that you all come genuinely to agree. And you'll deliberate. Not that ten of you think this and the other couple go along with it. It must be a genuinely unanimous verdict. And your verdict must be concentrated entirely on the evidence. You can, and I know how carefully you will listen to the lawyers to better to understand the evidence. You may look at the demonstrative aids to better to understand the evidence. But the evidence is what governs and you, and you alone, decide what you believe about the evidence. Now, I'm the judge of the law. I've said that a number of times. I simply mean to point out to you that in this courtroom I'm the one who has the responsibility of teaching you the law. We make a careful record of what I've said. And that's the fair way. You cannot quarrel with the law as I explain it to you. I'm going to tell you who has to prove what in this case. I'm going to tell you the burden of proof that that side bears. But you can't add to the parties' burden. You
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can't say gee, I, I really want them to show us this or that. But likewise you can't subtract from their burden. When I say they've got to prove something, then they have to prove that. You can't say, well, forget about that because this or that, something else is proved. I'll tell you what has to be proved and what the burden, what the standard of proof is. Listen to my whole charge start to finish. Don't seize on one part of it and say, "Aha, the case turns on this or that." Listen to the whole charge and consider all aspects of the charge together. Likewise, don't think that because I charge you as to all aspects of the case that I think anything is proved or not proved. I have nothing to say about that. I simply am trying to build for you a complete mental framework so that you will understand the law which you have to follow. That's my role. Now, I emphasize that you must confine your analysis to the evidence. So let's take a moment and go over the evidence in this case, not witness by witness but rather type by type, so that you know what tools you have. SOURCES & AUTHORITIES: Read Instructions, pp. 4-6.
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B.
EVIDENCE
The first thing I think of is the testimony of the witnesses. You have the power to believe everything of the witnesses. You have the power to believe everything that any witness said to you here from the witness stand. To believe it all. Equally, you have the power to disbelieve and disregard everything a witness said as though that witness never testified. Between those two extremes you have the power to believe some things a witness says but to disbelieve other things the witness says. You are not prevented from reaching a verdict because one witness has testified to one version of an event and another witness has testified to another version of the same event and both witnesses were under oath. You can believe one or believe the other. You can decide where the truth lies. How do you do it? You use your common sense as you are reasonable men and women. You may use everything. You know about the witness. How did the witness impress you testifying on the witness stand? How did the witness respond to questions both on direct and on cross-examination? What was the opportunity of the witness to observe, to comprehend, to understand, to recall those matters about which the witness testified? Does the witness stand to gain or lose anything depending upon how the case comes out? Is the witness allied with, employed by one side or the other in the case? Do those things affect the witness' testimony? Is the testimony of the witness backed up lawyers say corroborated by other evidence in the case? The exhibits or depositions or any other evidence in the case? Or, does the other evidence in the case undercut, take away from, make less believable the testimony of the witness who is before you? In short, you can sum up a witness' testimony and as reasonable men and women you can decide what you believe.
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SOURCES & AUTHORITIES: Read Instructions, pp. 4-6.
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1.
EXPERT WITNESSES
Some witnesses have been allowed to give their opinion about certain things. The law provides that when a witness has background, experience, and training that the judges and juries don't have, we'll let that witness render his or her opinion to the jury to aid the jury in doing their function. Like any other witness, your powers with respect to opinions given by these witnesses are no different. That is, if I've allowed you to hear an opinion you may believe it; but equally you may disregard it. You may decide that's just not believable, that's not credible. Or you could believe part of what a witness says and disbelieve other parts of an opinion given by a witness. It's left to your good judgment. I suggest to you that in evaluating opinion given by these witnesses you want to look at what undergirds them or underlies them. What was the witness relying on? How did the witness come to that opinion? Both by their experience, generally having nothing to do with this case, but also what do they know about things having to do with this case upon which their opinion rests. You're the judge of that. So with respect to opinions you may believe them, but you may disbelieve them or believe them in part. SOURCES & AUTHORITIES: Read Instructions, pp. 7-8.
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2.
TESTIMONY BY DEPOSITION
Now, not all the witnesses in this case testified live, that is, were here in court. Some witnesses, because of the geographical distance here, or for whatever other legal reasons, testified by way of videotaped deposition or lawyers reading portions of a deposition. The fact that a witness testifies by way of deposition doesn't make that witness any more believable or less believable than a witness testifying in court. That testimony as a matter of law starts even. And like any other testimony in the case, you may believe it, disbelieve it, believe parts of it. Now, with respect to witnesses who testified by way of deposition, you listened very carefully to their testimony, and you should compare that testimony with the testimony of other witnesses, including testimony in other depositions. It's evidence in the case. You may believe it, disbelieve it, or believe part of it. SOURCES & AUTHORITIES: Read Instructions, pp. 9-10.
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3.
EXHIBITS
Now, in this case also there are a large number of exhibits. And shortly after we send you out, once the arguments are over, when we send you out to begin your deliberations, those exhibits will be brought into the jury room. Well, they're evidence. Now, I'm talking about the exhibits that are evidence, not the charts that are not evidence, though some charts are evidence. Exhibits are like the testimony of witnesses and your powers are exactly the same. That is, you may read, look at, view an exhibit, and if it persuades you of some aspect of the case that's perfectly appropriate because it's evidence. But equally, if you don't find an exhibit believable, either because you think it's a fake, I'm not suggesting anything is a fake, but if you don't think it's genuine, or if you come to believe that even though this may be genuine, it's either inaccurate or it doesn't help you, disregard it. That's your power. You're the judges of the facts. And as with any other evidence in the case you could take part of an exhibit and say, well, this is persuasive, but another part is not persuasive. SOURCES & AUTHORITIES: Read Instructions, pp. 9-10.
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4.
STIPULATIONS
Lastly, you have some stipulations in this case. I've read them. The lawyers read them. And they're designed to shorten the time and make things clear to you. Stipulations are agreements among the lawyers, as they represent their clients. That's evidence. But that is special. That evidence is not disputed. So you don't have the right just to disregard it. You take that as given. The lawyers have agreed to that so we'll start out with that taken as given. It's evidence. SOURCES & AUTHORITIES: Read Instructions, p. 10.
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C.
DELIBERATIONS
Now, that's the body of evidence that you have in this case. A few words about what you do with it, how you analyze it. You use your common sense. You don't check your common sense at the door to the jury room. Rather I charge you to apply your common sense to the evidence in this case to the end that justice may be done. At the same time, you don't go in there and guess or speculate or maybe or perhaps or even probably. But you can use your common sense as you are reasonable men and women and you can draw what are called reasonable inferences. Now, a reasonable inference is a logical deduction. It's common sense. And I'm going to give you an example that has nothing to do with this case better to illustrate what a reasonable inference is and also to illustrate how far you can take it. Let's say we have a witness and she testifies that she's walking along a road and she looks out and there's a field of tall grass . . . and she sees through the grass the grass is all knocked down in an irregular course through the field. And suppose you believe that testimony. From that alone you could infer something went through the field. I mean, it just doesn't happen that grass falls down along a path unless something knocks it down. It isn't all fallen down in a windstorm, it's fallen down in a course through the field. So it's a reasonable inference that something went through the field. We don't have a witness who saw the something, but there's a reasonable inference something went through that field. Now, that's a reasonable inference. But unless you had other evidence from some other source in the case you wouldn't know what went through the field. A child. An adult. A big animal. A small animal. You just wouldn't know. That would be guessing.
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Now, there might be other evidence and you can draw inferences from it. But the reasonable inference, if you believe the witness I gave you as an example, is something went through the field. But you can't guess about it unless there's other evidence. That's reasonable inferences. Okay. We've talked about our roles. We've talked about the tools that you have to resolve this case. I want to say just a very few words about what's not evidence in the case, not to emphasize it but just point out to you what's not evidence in the case. You're not going to judge this case in any way, shape or form based upon how you react to the lawyers as human beings. They've done their job, and they will later on this morning keep on doing it for their respective clients, and so far they've done a fine job. I mean that. But it plays no role in what you do. You've got to focus on the evidence. The lawyers are not sources of the evidence. And your reaction to them plays no role. Equally important. If you somehow think that I think something about this case based upon the manner in which I have presided over it, I most earnestly instruct you to disregard it, I don't. And I tell you candidly I have no idea how this case will come out, nor is it my business. My business is to teach you the law. This, however, I tell you and this I believe passionately. I believe in the jury system. I believe that you will do justice in this case. But I, clear as I am about constantly saying, oh, yes, I'm the judge of the law, I have nothing to say about the facts in this case. I believe that you will justly and impartially decide the facts in this case. Now let's get to it. SOURCES & AUTHORITIES: Read Instructions, pp. 13-14.
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XI.
BURDEN OF PROOF In any legal action, facts must be proved by a required standard of evidence, known as
the "burden of proof." In a patent case such as this, there are two different burdens of proof that are used, which I mentioned at the beginning of the trial. The first burden of proof standard ("preponderance of the evidence") requires that, in order for a party to prevail, you must be persuaded that what the party seeks to prove is more probably true than not true. The second burden of proof standard ("clear and convincing evidence") is a higher one. Clear and convincing evidence is evidence which produces in your mind an abiding conviction that the truth of the factual contentions is highly probable. You may have heard of a burden of proof that is used in criminal cases called "beyond a reasonable doubt." That requirement is the highest burden of proof. It does not apply to a patent case such as this one, and you should, therefore, put it out of your mind. SOURCES & AUTHORITIES: Fed. Cir. Bar Assoc. Model Patent Jury Instruction 1.1; Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1360 (Fed. Cir. 2007) (citations omitted).
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XII.
THE CLAIMS OF THE PATENTS-IN-SUIT As I told you at the beginning of the trial, the claims of a patent are the numbered
sentences at the end of the patent. The claims describe the inventions made by the inventor and describe what the patent owner owns and what the patent owner may prevent others from doing. Claims may describe products, such as machines or chemical compounds, or processes for making or using a product. Claims are usually divided into parts or steps, called elements or "limitations." For example, a claim that covers the invention of a table may recite the tabletop, four legs and the glue that secures the legs to the tabletop. The tabletop, legs and glue are each a separate element of the claim. SOURCES & AUTHORITIES: Fed. Cir. Bar Assoc. Model Patent Jury Instruction 7.
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A.
CONSTRUCTION OF THE CLAIMS
I will instruct you now about the meaning of some of the claim language. In deciding whether or not an accused process or product infringes a patent, the first step is to understand the meaning of the words used in the patent claims. It is my job as Judge to determine what the patent claims mean and to instruct you about that meaning. You must accept the meanings I give you and use them when you decide whether or not the patent is infringed, and whether or not it is invalid. At the start of the trial, I instructed you about the meaning of the words of the claims and the different types of claims that are at issue in this case. I will now review those instructions with you again. It may be helpful to refer to the copy of the `933 patent that you have been given as I discuss the claims at issue here. The claims are at the end of the `933 patent, starting in column 38. I will be giving you a list of the claims of the `933 patent, the `868 patent, the `698 patent, the `349 patent and the `422 patent at issue as part of the verdict form when I conclude my instructions. [NOTE:] If the claim constructions are included in the pre-trial instructions, Instructions XII. A-E may be included as well. SOURCES & AUTHORITIES: Fed. Cir. Bar Assoc. Model Patent Jury Instruction 7.1; Markman v. Westview Instruments, Inc., 517 U.S. 370, 384-391 (1996); Bell Atlantic Network Servs., Inc. v. Covad Communications Group, Inc., 262 F.3d 1258, 1267 (Fed. Cir. 2001); Interactive Gift Express, Inc. v. Compuserve, Inc., 256 F.3d 1323, 1331 (Fed. Cir. 2001); SciMed Life Systems, Inc. v. Advanced Cardiovascular Sys., 242 F.3d 1337, 1341 (Fed. Cir. 2001); AFG Indus., Inc. v. Cardinal IG Co., 239 F.3d 1239, 1244-45 (Fed. Cir. 2001); Hill-Rom Co. v. Kinetic Concepts, Inc., 209 F.3d 1337, 1340-41 (Fed. Cir. 2000); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1304-06 (Fed. Cir. 1999); Johnson Worldwide Assocs., Inc. v. Zebco Corp., 175 F.3d 985, 988-90 (Fed. Cir. 1999); Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1455-56 (Fed. Cir. 1998); Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1581-84 (Fed. Cir. 1996); Markman v. Westview
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April 11, 1997).
Instruments, Inc., 52 F.3d 967, 977 (Fed. Cir. 1995) (en Banc); Rival Co. v. Sunbeam Corp., 987 F. Supp. 1167, 1171 (W.D. Miss. 1997) affd without op., 185 F.3d 885 (Fed. Cir. 1999); Minuteman Int'l, Inc. v. Critical-Vac Filtration Corp., No. 95C 7255, 1997 WL 187326, at *2 (N .D. Ill.
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B.
INDEPENDENT AND DEPENDENT CLAIMS
Patent claims may exist in two forms, referred to as independent claims and dependent claims. An independent claim does not refer to any other claim of the patent. Thus it is not necessary to look at any other claim to determine what an independent claim covers. Claim 3 of the `933 patent, for example, is an independent claim. A dependent claim refers to at least one other claim in the patent A dependent claim includes each of the limitations of the other claim or claims to which it refers, as well as the additional limitations recited in the dependent claim itself. Therefore, to determine what a dependent claim covers, it is necessary to look at both the dependent claim and the other claim or claims to which it refers. For example, claims 7, 8 and 9 of the `933 patent are dependent claims because they each refer to previous claims in the patent. To determine what dependent claim 7 covers, for example, the words of that claim and the words of either claims 3, 4 5, or 6 must be read together. Here, however, Amgen is only asserting claim 7 as it depends from claim 3, so you need not consider claim 7 as it depends from claim 4, 5, or 6. NOTE: Consider providing the jurors with a table setting out the relationship of the asserted claims to each other. SOURCES & AUTHORITIES: Fed. Cir. Bar Assoc. Model Patent Jury Instruction 7.2; 35 U.S.C. § 112 ¶ 4 (1984); Globetrotter Software, Inc. v. Elan Computer Group, Inc., 236 F.3d 1363, 1369-70 (Fed. Cir. 2001); Dow Chem. Co. v. United States, 226 F.3d 1334, 1341-42 (Fed. Cir. 2000); Sibia Neurosciences, Inc. v. Cadus Pharm. Corp., 225 F.3d 1349, 1359 (Fed. Cir. 2000); Wolverine World Wide, Inc. v. Nike, Inc., 38 F.3d 1192, 1199 (Fed. Cir. 1994); Carroll Touch, Inc. v. Electro Mech. Sys., Inc., 15 F.3d 1573, 1576 (Fed. Cir. 1993); Marsh-McBirney, Inc. v. Montedoro-Whitney Corp., 882 F.2d 498, 504 (Fed. Cir . 1989); Wahpeton Canvas Co., Inc. v. Frontier, Inc., 870 F.2d 1546, 1552-23 (Fed. Cir. 1989).
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C.
PROCESS AND SOURCE LIMITATIONS IN PRODUCT CLAIMS
Sometimes a product may best be described by the process by which it is made, or by the source from which it is derived, instead of by describing its structure or chemical characteristics. Claims which describe a product by describing the process by which it is made are called "product-by-process" claims. Claims 3, 7-9, 11, 12 and 14 of the `933 patent are product-by-process claims or depend from product-by-process claims. Claim 1 of the `422 patent is not, however, a product-byprocess claim; it is a product claim with a source limitation. The "purified from mammalian cells grown in culture" limitation of `422 Claim 1 "only speaks to the source of the EPO and does not limit the process by which the EPO is expressed." Amgen Inc. v. Hoechst Marion Roussel, 314 F.3d 13131, 1329 (Fed. Cir. 2003). SOURCES & AUTHORITIES: Fed. Cir. Bar Assoc. Model Patent Jury Instructions 7.3; Vanguard Prods. Corp. v. Parker Hannifin Corp., 234 F.3d 1370, 1372-73 (Fed. Cir. 2000); Exxon Chem. Patents, Inc. v. Lubrizol Corp., 64 F.3d 1553, 1557-58 (Fed. Cir. 1995); Mentor Corp. v. Colopast, Inc., 998 F.2d 992, 997 (Fed. Cir. 1993); All. Thermoplastics Co. v. Faytex Corp., 970 F.2d 834, 837 (Fed. Cir. 1992), reh'g en Banc denied, 974 F.2d 1279 (Fed. Cir. 1992); Scripps Clinic & Research Found. v. Genentech, Inc., 927 F.2d 1565, 1583 (Fed. Cir. 1991).
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D.
"COMPRISING" CLAIMS
The beginning portion, or preamble, of the claims of the patents use the words "comprising," "comprising the steps of" or "comprises." "Comprising" means "including" or "containing." A claim that uses the word "comprising" or "comprises" is not limited to products or processes having only the elements or steps that are recited in the claim, but also covers products or processes that have additional elements or steps. Let's take our example of the claim that covers a table. If the claim recites a table "comprising" a tabletop, legs and glue, the claim will cover any table that contains these structures, even if the table also contains other structures, such as a leaf or wheels on the legs. All of the claims at issue use the "comprising" language. SOURCE & AUTHORITIES Fed. Cir. Bar Assoc. Model Patent Jury Instruction 7.4; Vehicular Techs. Corp. v. Titan Wheel Intl, Inc., 212 F.3d 1377, 1382-83 (Fed. Cir. 2000); Vivid Techs., Inc. v. Am. Sci. & Eng'g, Inc., 200 F.3d 795, 811-12 (Fed. Cir. 1999); Georgia-Pacific Corp. v. United States Gypsum Co., 195 F.3d 1322, 1327-29 (Fed. Cir. 1999); Elkay Mfg. Co. v. Ebco Mfg. Co., 192 F.3d 973, 977 (Fed. Cir . 1999); Spectrum Intl, Inc. v . Sterilite Corp., 164 F.3d 1372,1379-80 (Fed . Cir. 1998); Phillips Petroleum Co. v. Huntsman Polymers Corp., 157 F.3d 866, 874 (Fed. Cir. 1998); Stiftung v. Renishaw PLC, 945 F .2d 1173, 1177-79 (Fed. Cir. 1991).
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E.
LIMITATIONS OF THE CLAIMS AT ISSUE
I have now instructed you as to the types of claims at issue in this case. I have already provided you with a glossary defining the meaning of the words used in the patent claims at issue. You must use the definitions I provided to you in your consideration of infringement and invalidity issues. [Construction of the claims to be supplied in juror notebooks.]
SOURCES & AUTHORITIES: Fed. Cir. Bar Assoc. Model Patent Jury Instruction 7.8
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XIII. INFRINGEMENT A. PATENT INFRINGEMENT GENERALLY DIRECT INFRINGEMENT
A patent owner has the right to stop others from using the inventions covered by its patent claims during the life of the patent. If any person makes, uses, sells or offers to sell or imports what is covered by the patent claims without the patent owner's permission, that person is said to infringe the patent. This type of infringement is called "direct infringement." In addition to enforcing a patent against a direct infringer, a patent owner also has the right to enforce the patent against those who are known as "indirect infringers." In reaching your decision on infringement, keep in mind that only the claims of a patent can be infringed. You must compare the asserted patent claims, as I have defined them, to Roche's peg-EPO product and process for making peg-EPO, and determine whether or not there will be infringement. You should not compare Roche's peg-EPO product and process with any specific example set out in the Lin patents, or with Amgen's commercial EPO product or process. The fact that there may be differences between Roche's peg-EPO product and Amgen's commercial products, Epogen® or Aranesp®, is irrelevant. The only correct comparison is with the language of the claim itself, as I have explained its meaning to you. You must consider each claim individually and must reach your decision as to each assertion of infringement based on my instructions about the meaning and scope of the claims, the legal requirements for infringement, and the evidence presented to you by the parties. I will first discuss direct infringement. Whether or not Roche knew that what it was doing was an infringement does not matter. A person may be found to be a direct infringer of a patent even if he or she believes in good faith that what he or she is doing is not an infringement of any patent, and even if he or she does not even know of the patent.
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In this case, Amgen asserts that Roche's peg-EPO product and process will directly infringe the asserted claims. It is your job to determine whether or not Amgen has proved by the more probable than not standard that Roche will directly infringe any of the asserted claims. SOURCES & AUTHORITIES: Fed. Cir. Bar Assoc. Model Patent Jury Instruction 8.1
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