Case 1:18-cv-00924-CFC-SRF Document 498 Filed 02/03/20 Page 1 of 17 PageID #:
`33879
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`GENENTECH, INC.,
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`AMGEN INC.,
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`v.
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`Plaintiff,
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`Defendant.
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`C.A. No. 18-924-CFC
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`PROPOSED JOINT PRELIMINARY JURY INSTRUCTIONS
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`ME1 32558646v.1
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`33879
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`GENENTECH, INC.,
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`AMGEN INC.,
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`v.
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`Plaintiff,
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`Defendant.
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`C.A. No. 18-924-CFC
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`PROPOSED JOINT PRELIMINARY JURY INSTRUCTIONS
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`ME1 32558646v.1
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`Case 1:18-cv-00924-CFC-SRF Document 498 Filed 02/03/20 Page 2 of 17 PageID #:
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`PROPOSED PRELIMINARY JURY INSTRUCTIONS
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`1. INTRODUCTION1
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`Members of the jury: Now that you have been sworn, I am now going to
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`give you some preliminary instructions to guide you in your participation in the
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`trial.
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`2. THE PARTIES AND THEIR CONTENTIONS2
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`I will now overview who the parties are and what each contends. This is a
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`civil action for patent infringement arising under the patent laws of the United
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`States.
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`The Plaintiff in this case is Genentech, Inc. I may refer to them as
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`“Plaintiff” or “Genentech” throughout the trial. The Defendant is Amgen, Inc. I
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`may refer to them as “Defendant” or “Amgen” throughout the trial.
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`This case is related to a cancer drug called Herceptin that was developed by
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`1 F’Real Foods, LLC v. Hamilton Beach Brands, Inc., C.A. No. 1:16-cv-00041-CFC, D.I. 235 (D. Del. Apr. 8, 2019)
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`at 1; Honeywell Int’l, Inc. v. Universal Avionics Sys., C.A. No. 1:02-cv-00359-MPT, D.I. 210 (D. Del. Oct. 21,
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`2003) at 1.
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`2 F’Real Foods, LLC v. Hamilton Beach Brands, Inc., C.A. No. 1:16-cv-00041-CFC, D.I. 235 (D. Del. Apr. 8, 2019)
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`at 1-2; Honeywell Int’l, Inc. v. Universal Avionics Sys., C.A. No. 1:02-cv-00359-MPT, D.I. 210 (D. Del. Oct. 21,
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`2003) at 1-2.
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`Genentech. The active ingredient of Herceptin is an antibody called trastuzumab.
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`There are four U.S. patents that are at issue in this case, which I will refer to as the
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`’196 patent, the ’379 patent, the ’811 patent (collectively the “Dosing Patents”),
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`and the ’869 Kao Manufacturing Patent. I will refer to these patents together as the
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`Patents-in-Suit. The subject matter claimed in the Dosing Patents are methods of
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`administering stated doses of trastuzumab at stated intervals. The subject matter
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`claimed in the ’869 Kao Manufacturing Patent is a method used in the manufacture
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`of an antibody. During the trial, the parties will offer testimony to familiarize you
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`with the relevant technology.
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`[GENENTECH’S PROPOSAL: Genentech alleges that Amgen infringes
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`the Patents-in-Suit because of its filing of an Biologics License Application
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`(“BLA”) for a trastuzumab product that is a biosimilar of Herceptin, and by its
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`importing, manufacturing, marketing, selling, or offering to sell that trastuzumab
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`product.] [AMGEN’S PROPOSAL: Genentech alleges that Amgen infringes the
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`Patents-in-Suit by its importing, manufacturing, marketing, selling, or offering to
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`sell that trastuzumab product.] Amgen markets its trastuzumab product under the
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`tradename Kanjinti. I may refer to Kanjinti as “ABP 980,” which is the active
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`ingredient in Kanjinti.
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`Specifically, Genentech alleges that Amgen infringes:
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`1. claims 11 and 22 of the ’196 Dosing Patent;
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`2. claims 11 and 21 of the ’379 Dosing Patent;
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`3. claims 6 and 7 of the ’811 Dosing Patent; and
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`4. claims 5 and 8 of the ’869 Kao Manufacturing Patent.
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`I will refer to these claims together as the Asserted Claims. Genentech also alleges
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`that Amgen’s infringement was willful.
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`Amgen denies that it infringes any of the Asserted Claims. Amgen also
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`denies that it has knowingly encouraged or enabled others, including doctors and
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`patients, to infringe any of the Asserted Claims. Amgen also denies that any
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`infringement of the Asserted Claims was willful.
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`Amgen also alleges that the Asserted Claims are invalid because the claimed
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`inventions were not new and were obvious from what was already known in the
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`prior art and that the U.S. Patent and Trademark Office should not have granted
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`any of the Patents-in-Suit. [GENENTECH’S PROPOSAL: No instruction
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`regarding derivation or inventorship is proper as those defenses should be stricken.
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`See D.I. 426. To the extent any instruction is given, Genentech proposes: “Amgen
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`also contends that the Asserted Claims of the Dosing Patents fail to name the
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`correct inventors and are invalid because the claimed inventions were derived from
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`another.”] [AMGEN’S PROPOSAL: Amgen also contends that the Asserted
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`Claims of the Dosing Patents, if they represent any invention at all, are invalid for
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`failing to name the correct inventors and because the claimed inventions were
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`derived from Dr. Brian Leyland-Jones.]
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`Amgen also contends that the Asserted Claims of the ’196 Dosing Patent,
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`the ’379 Dosing Patent, and the ’869 Kao Manufacturing Patent are invalid due to
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`lack of sufficient written description, and lack of enablement. You will resolve
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`questions of infringement and invalidity for the Asserted Claims. You will also
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`resolve questions of willful infringement.
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`Genentech additionally alleges it is entitled to damages for Amgen’s
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`infringement. Amgen denies that Genentech is entitled to any damages award. To
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`the extent you find any Asserted Claims both infringed and not invalid, you will
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`also resolve questions of the quantity of damages for those claims.
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`During the course of this case, you will hear references to certain terms and
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`phrases from the Asserted Claims. I will give you a list of those terms and phrases
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`for which I have provided a definition that you are to use in deciding the issues
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`presented to you. Any other terms and phrases that are not included on the list
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`should be given their plain and ordinary meaning.
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`3. JURORS’ DUTIES3
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`You may be wondering what role you will play as jurors in this case. I will
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`now explain the general rules that will govern the discharge of your duties as jurors
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`in this case.
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`It will be your duty to decide what the facts are from the evidence. You and
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`you alone will be the judges of the facts. You will then have to apply those facts to
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`the law as I will give it to you both during these preliminary instructions and at the
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`close of the evidence. You must follow that law whether you agree with it or not.
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`You are bound by your oath as jurors to follow these and all the instructions that I
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`give you, even if you personally disagree with them. All the instructions are
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`important, and you should consider them together as a whole.
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`Perform these duties fairly. Do not let any bias, sympathy, or prejudice that
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`you may feel toward one side or the other influence your decision in any way.
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`Also, do not let anything that I may say or do during the course of the trial
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`influence you. Nothing that I may say or do is intended to indicate, or should be
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`taken by you as indicating, what your verdict should be.
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`3 F’Real Foods, LLC v. Hamilton Beach Brands, Inc., C.A. No. 1:16-cv-00041-CFC, D.I. 235 (D. Del. Apr. 8, 2019)
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`at 3; Honeywell Int’l, Inc. v. Universal Avionics Sys., C.A. No. 1:02-cv-00359-MPT, D.I. 210 (D. Del. Oct. 21,
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`2003) at 2-3.
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`4. EVIDENCE4
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`You must make your decision based only on the evidence that you see and
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`hear in the courtroom. Do not let rumors, suspicions, or anything else that you
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`may have seen or heard outside of court influence your decision in any way.
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`The evidence in this case includes only what the witnesses say while they
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`are testifying under oath (including deposition testimony that will be played or
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`read to you), the exhibits that I allow into evidence, any facts that the parties
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`agreed to by stipulation, and any other evidence that I have judicially noticed.
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`Nothing else is evidence. The lawyers’ statements and arguments are not
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`evidence. Their questions and objections are not evidence. My legal rulings are
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`not evidence. None of my comments or questions are evidence.
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`There are two types of evidence that you may properly consider: direct and
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`circumstantial. Direct evidence is straightforward proof of a fact, such as
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`testimony of an eyewitness. Circumstantial or indirect evidence is proof of a fact
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`or facts from which you may infer or conclude that other facts exist or do not exist.
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`I will give you further instructions on direct and circumstantial evidence, as well as
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`4 F’Real Foods, LLC v. Hamilton Beach Brands, Inc., C.A. No. 1:16-cv-00041-CFC, D.I. 235 (D. Del. Apr. 8, 2019)
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`at 3-4; Honeywell Int’l, Inc. v. Universal Avionics Sys., C.A. No. 1:02-cv-00359-MPT, D.I. 210 (D. Del. Oct. 21,
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`2003) at 3-4.
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`other matters, at the end of the case, but keep in mind you may consider both kinds
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`of evidence.
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`During the trial I may not let you hear the answers to some of the questions
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`that the lawyers ask. I also may rule that you could not see some of the exhibits
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`that the lawyers wanted you to see. And sometimes I may order you to disregard
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`things that you saw or heard. When I provide such an instruction, you must
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`completely ignore those things. Do not speculate about what a witness might say
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`or what an exhibit might show. These things are not evidence, and you are bound
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`by your oath not to let them influence your decision in any way. Do not consider
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`my rulings on whether you can hear certain testimony or see certain exhibits as any
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`indication of my opinion of the case or of what your verdict should be.
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`5. CREDIBILITY OF WITNESSES5
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`You are the sole judges of each witness’s credibility. You should consider
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`each witness’s means of knowledge; strength of memory; opportunity to observe;
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`how reasonable or unreasonable the testimony is; whether it is consistent or
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`inconsistent; whether it has been contradicted; the witness’s biases, prejudices, or
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`interests; the witness’s manner or demeanor on the witness stand; and all
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`5 F’Real Foods, LLC v. Hamilton Beach Brands, Inc., C.A. No. 1:16-cv-00041-CFC, D.I. 235 (D. Del. Apr. 8, 2019)
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`at 4-5.
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`circumstances that, according to the evidence, could affect the credibility of the
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`testimony.
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`You may determine how much of any witness’s testimony to accept or reject
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`and choose to reject some parts of a witness’s testimony while accepting other
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`parts. I will give you further guidelines for deciding the credibility of witnesses
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`during my instructions at the end of the case.
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`6. DEPOSITION TESTIMONY6
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`You may hear witnesses testify through deposition testimony. A deposition
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`is the sworn testimony of a witness taken before trial. The witness is placed under
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`oath and swears to tell the truth, and lawyers for each party may ask questions. A
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`court reporter is present and records the questions and answers. The deposition
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`may or may not be recorded on videotape. Deposition testimony is entitled to the
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`same consideration and is to be judged, insofar as possible, in the same way as if
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`the witness had been present to testify.
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`7. EXPERT WITNESSES7
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`During the trial, you may also hear testimony from expert witnesses. When
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`6 F’Real Foods, LLC v. Hamilton Beach Brands, Inc., C.A. No. 1:16-cv-00041-CFC, D.I. 235 (D. Del. Apr. 8, 2019)
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`at 5.
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`7 F’Real Foods, LLC v. Hamilton Beach Brands, Inc., C.A. No. 1:16-cv-00041-CFC, D.I. 235 (D. Del. Apr. 8, 2019)
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`at 5-6.
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`knowledge of technical subject matter might be helpful to the jury, a person who
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`has special training or experience in that technical field—he or she is called an
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`expert witness—is permitted to state his or her opinion on those technical matters.
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`However, you are not required to accept that opinion. As with any other witness, it
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`is up to you to judge the credibility of the expert witness and decide whether to
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`rely upon his or her testimony. I will give you further instructions on how to
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`weigh the testimony of expert witnesses at the end of the trial.
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`8. BURDENS OF PROOF8
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`As I mentioned earlier, this is a civil case in which Genentech is alleging
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`patent infringement by Amgen.
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`Genentech has the burden of proving infringement, both direct and indirect,
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`by what is called a preponderance of the evidence. That means Genentech has to
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`produce evidence which, when considered in light of all of the facts, leads you to
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`believe that what Genentech claims is more likely true than not. To put it
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`differently, if you were to put Genentech’s and Amgen’s evidence on the opposite
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`sides of a scale, the evidence supporting Genentech’s claims would have to make
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`the scales tip [GENENTECH’S PROPOSAL: somewhat on the side of
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`8 F’Real Foods, LLC v. Hamilton Beach Brands, Inc., C.A. No. 1:16-cv-00041-CFC, D.I. 235 (D. Del. Apr. 8, 2019)
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`at 6.
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`Genentech] [AMGEN’S PROPOSAL: in favor of Genentech]. Genentech also
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`has the burden to prove willful infringement and the amount of damages by a
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`preponderance of the evidence.
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`Amgen contends that the Asserted Claims are invalid. Amgen has the
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`burden of proving invalidity by clear and convincing evidence. Clear and
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`convincing evidence is evidence that produces an abiding conviction that the truth
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`of a factual contention is highly probable. Proof by clear and convincing evidence
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`is a higher burden than proof by a preponderance of the evidence.
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`Those of you who are familiar with criminal cases will have heard the term
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`“proof beyond a reasonable doubt.” That requirement does not apply in a civil
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`case and you should, therefore, put it out of your mind in considering whether or
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`not the plaintiffs have met their burden of proof by a preponderance of the
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`evidence or the defendants have met their burden of proof by clear and convincing
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`evidence in this case.
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`9. GENERAL GUIDANCE REGARDING PATENTS9
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`Before I describe the parties’ contentions further, at this time, we are going
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`9 F’Real Foods, LLC v. Hamilton Beach Brands, Inc., C.A. No. 1:16-cv-00041-CFC, D.I. 235 (D. Del. Apr. 8, 2019)
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`at 7; Honeywell Int’l, Inc. v. Universal Avionics Sys., C.A. No. 1:02-cv-00359-MPT, D.I. 210 (D. Del. Oct. 21,
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`2003) at 4.
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`to show a 17- minute video that will provide background information to help you
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`understand what patents are, why they are needed, the role of the Patent Office,
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`and why disputes over patents arise. This video was prepared by the Federal
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`Judicial Center, not the parties in this case, to help introduce you to the patent
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`system. During the video, reference will be made to a sample patent.
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`You will also be provided a Glossary of Patent Terms. Please feel free to
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`refer to this Glossary throughout the trial.
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`[The video will be played.]
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`10. SUMMARY OF THE PATENT ISSUES10
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`In this case, you must decide several things according to the instructions that
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`I will give you at the end of the trial. Those instructions will provide more detail.
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`In essence, you must decide:
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`1. Whether Genentech has proven by a preponderance of the
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`evidence that Amgen infringes any of the Asserted Claims.
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`2. Whether Amgen has proven by clear and convincing evidence
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`that any of the Asserted Claims are invalid.
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`3.
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`If you find that Genentech has proven Amgen has infringed an
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`10 F’Real Foods, LLC v. Hamilton Beach Brands, Inc., C.A. No. 1:16-cv-00041-CFC, D.I. 235 (D. Del. Apr. 8,
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`2019) at 7.
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`Asserted Claim and that Amgen has not proven that the Asserted
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`Claim is invalid, you must also decide the amount of damages Amgen
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`owes to Genentech.
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`4.
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`If you find that Genentech has proven Amgen has infringed an
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`Asserted Claim and that Amgen has not proven that the Asserted
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`Claim is invalid, you must also decide whether Genentech has proven
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`by a preponderance of the evidence that Amgen’s infringement of that
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`Asserted Claim has been willful.
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`11. CONDUCT OF THE JURY11
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`Now, a few words about your conduct as jurors: First, during the trial you
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`are not to discuss the case with anyone or allow anyone to discuss it with you.
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`You cannot talk about the case at all until you retire to the jury room at the end of
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`the trial to deliberate on your verdict. If any lawyer, party, or witness does not
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`speak to you when you pass in the hall, ride the elevator, or the like, remember it is
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`11 F’Real Foods, LLC v. Hamilton Beach Brands, Inc., C.A. No. 1:16-cv-00041-CFC, D.I. 235 (D. Del. Apr. 8,
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`2019) at 7-9; Honeywell Int’l, Inc. v. Universal Avionics Sys., C.A. No. 1:02-cv-00359-MPT, D.I. 210 (D. Del. Oct.
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`21, 2003) at 4-5.
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`because they are not supposed to talk with you nor you with them. If anyone
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`should try to talk to you about this case, bring it to my attention promptly. There
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`are good reasons for this ban on discussions. The most important is the need for
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`you to keep an open mind throughout the presentation of the evidence.
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`Second, do not read or listen to anything related to this case in any way. By
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`that I mean, if there may be a newspaper article or radio or television report
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`relating to this case, do not read the article or watch or listen to the report. You
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`also cannot try to do any independent research or investigation on your own on
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`matters relating to the case. This includes researching the case, parties, or issues
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`on the Internet.
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`I know that many of you use cell phones, smart phones, tablets, and other
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`portable electronic devices; laptops, netbooks, and other computers. You must not
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`talk to anyone at any time about this case or otherwise use these or other electronic
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`devices to communicate with anyone about the case or, as I noted, get information
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`about the case, the parties or any of the witnesses or lawyers involved in the case.
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`This includes your family and friends. You may not communicate with anyone
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`about the case on your cell phone, through e-mail, text messaging, Facebook,
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`Snapchat, Twitter, or any other social media.
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`Finally, do not form any opinion until all the evidence is in. Keep an open
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`mind until you start your deliberations at the end of the case. After you retire to
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`deliberate, you may begin to discuss the case with your fellow jurors, but you
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`cannot discuss the case with anyone else until you have returned a verdict and are
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`dismissed by the Court.
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`The courtroom deputy will now distribute your jury notebooks. You are free
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`to use them to take notes at any point during the trial. Everything you write will be
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`kept confidential; at the end of each day, you will leave it in the jury room, where
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`it will be kept overnight. At the end of the trial your notes will be shredded. You
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`do not have to take notes, but you may, if you wish to. If you do take notes, be
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`careful not to get so involved that you become distracted and miss part of the
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`testimony. A word of caution is in order. There is generally I think a tendency to
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`attach undue importance to matters which one has written down. Some testimony
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`which is considered unimportant at the time presented, and thus not written down,
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`takes on greater importance later in the trial in light of all the evidence presented.
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`Therefore, you are instructed that your notes are only a tool to aid your own
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`individual memory and you should not compare your notes with other jurors in
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`determining the content of any testimony or in evaluating the importance of any
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`evidence. Your notes are not evidence and will by no means be a complete outline
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`of the proceedings or a list of the highlights of the trial. Also, keep in mind that
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`you will not have a transcript of the testimony to review. So, above all, your
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`memory will be your greatest asset when it comes time to deliberate and render a
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`decision in this case.
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`In addition to some blank pages for notes, you will find in your notebooks
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`copies of the Patents-in-Suit and a list of claim terms of the Patents-in-Suit that
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`have been construed (i.e., interpreted) by the Court and their constructions. You
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`can put the notebooks away for now.
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`12. COURSE OF THE TRIAL12
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`The trial will now begin. First, each side may make an opening statement.
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`An opening statement is not evidence. It is simply an opportunity for the lawyers
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`to explain what they expect the evidence will show.
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`After the opening statements, the parties will present evidence which may
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`include testimony from live witnesses, deposition testimony, and documents and
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`things.
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`During the trial, it may be necessary for me to talk with the lawyers out of
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`your hearing by having a bench conference, which is also called a sidebar. If that
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`happens, please be patient. We are not trying to keep important information from
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`12 F’Real Foods, LLC v. Hamilton Beach Brands, Inc., C.A. No. 1:16-cv-00041-CFC, D.I. 235 (D. Del. Apr. 8,
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`2019) at 10; Federal Circuit Bar Association, Model Patent Jury Instructions § A.5.
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`ME1 32558646v.1
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`15
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`Case 1:18-cv-00924-CFC-SRF Document 498 Filed 02/03/20 Page 17 of 17 PageID
`#: 33895
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`you. These conferences are necessary for me to fulfill my responsibility to be sure
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`that evidence is presented to you correctly under the law. We will, of course, do
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`what we can to keep the number and length of these conferences to a minimum.
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`While we meet, feel free to stand up and stretch and walk around the jury box, if
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`you wish. I may not always grant an attorney’s request for a sidebar. Do not
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`consider my granting or denying a request for a conference as any indication of my
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`opinion of the case or of what your verdict should be.
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`After all of the evidence is presented, I will give you instructions on the law
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`and describe for you the matters you must decide. Then, the attorneys will make
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`their closing arguments to summarize and interpret the evidence for you. You will
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`then retire to the jury room to deliberate on your verdict.
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`ME1 32558646v.1
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