Case 1:18-cv-00924-CFC Document 326 Filed 07/25/19 Page 1 of 16 PageID #: 25711
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. 18-924-CFC
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`Plaintiffs,
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`Defendant.
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`GENENTECH, INC. and CITY OF HOPE,
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`v.
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`AMGEN, INC.,
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`GENENTECH’S COMBINED REPLY BRIEF IN SUPPORT
`OF ITS EMERGENCY MOTIONS FOR A TEMPORARY
`RESTRAINING ORDER AND A PRELIMINARY INJUNCTION
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`PUBLIC VERSION FILED: July 25, 2019
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`Case 1:18-cv-00924-CFC Document 326 Filed 07/25/19 Page 2 of 16 PageID #: 25712
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`TABLE OF CONTENTS
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`Page
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`Amgen’s reliance on testimony of inventors, Genentech employees,
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`TABLE OF AUTHORITIES ...................................................................................................... ii
`I.
`GENENTECH’S MOTIONS ARE TIMELY. ..................................................................1
`II.
`AMGEN FAILS TO REBUT GENENTECH’S LIKELIHOOD OF SUCCESS. ..............3
`A. Amgen’s Arguments Have Been Fully Considered and Rejected in IPRs. ............4
`B.
` Amgen Has Not Presented Any New Evidence or Arguments That Negate
`Genentech’s Likelihood of Success on Validity. ...................................................4
`1.
`Amgen’s arguments are not supported by any expert opinion....................4
`2.
`Amgen’s “new art” adds nothing to the substantial IPR record..................5
`3.
`and consultants misses the mark. ..............................................................6
`III. AMGEN’S INFRINGEMENT WILL IRREPARABLY HARM GENENTECH. .............7
`THE BALANCE OF HARDSHIPS FAVORS GENENTECH. ........................................9
`IV.
`GRANTING INJUNCTIVE RELIEF SERVES THE PUBLIC INTEREST. .................. 10
`V.
`CONCLUSION ............................................................................................................. 10
`VI.
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`i
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`Case 1:18-cv-00924-CFC Document 326 Filed 07/25/19 Page 3 of 16 PageID #: 25713
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`Cases
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`TABLE OF AUTHORITIES
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`Page(s)
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`Abbott Labs. v. Sandoz, Inc.,
`544 F.3d 1341 (Fed. Cir. 2008) .............................................................................................. 8
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`Allergan, Inc. v. Barr Labs., Inc.,
`501 F. App’x 965 (Fed. Cir. 2013) ......................................................................................... 5
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`Integra Lifesciences Corp. v. Hyperbranch Med. Tech., Inc.,
`2016 WL 4770244 (D. Del. Aug. 12, 2016) ........................................................................... 1
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`Millennium Pharm., Inc. v. Sandoz Inc.,
`862 F.3d 1356 (Fed. Cir. 2017) .............................................................................................. 6
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`Oxford Immunotec Ltd. v. Qiagen, Inc.,
`271 F. Supp. 3d 358, 366-67 (D. Mass. 2017) ........................................................................ 4
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`Sanofi-Synthelabo v. Apotex, Inc.,
`470 F.3d 1368 (Fed. Cir. 2006) ............................................................................................ 10
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`Statutes
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`35 U.S.C. § 102(e) ...................................................................................................................... 5
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`35 U.S.C. § 103(c) ...................................................................................................................... 5
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`ii
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`Case 1:18-cv-00924-CFC Document 326 Filed 07/25/19 Page 4 of 16 PageID #: 25714
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`The issues raised by these motions are sufficiently important that they should be decided
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`on the merits. Once Amgen launches, Genentech cannot be put back into the place that it would
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`have been in had its patent rights been respected. Doing so will not prejudice Amgen;
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` Genentech therefore
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`requests a TRO and ultimately a preliminary injunction to maintain the status quo.
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`Amgen’s opposition confirms that Genentech did not sit on its rights.
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` and, before that, made repeated representations to the
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`Court that no launch decision had been made. Amgen never informed the Court or Genentech of
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`its decision to launch and instead actively concealed its plans—for example, by unilaterally
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`cancelling a key deposition of a launch decisionmaker. Genentech filed these motions as soon as
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`it obtained market intelligence indicating that Amgen had in fact decided to launch imminently.
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`, and it has not raised a substantial question of invalidity.
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`Amgen merely offers attorney argument unsupported by any expert testimony that Genentech’s
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`patents are invalid as obvious—a position recently rejected under a lower burden of proof after
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`full IPR trials. The fact that Genentech’s settlements of other lawsuits allowed those defendants
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`to launch in the future does not diminish the irreparable harm of Amgen launching now. Nor
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`does disruption to Amgen’s recent efforts to launch at risk support Amgen in the balance of
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`hardships. And Amgen cannot rely on the non-infringing indications in its product label to argue
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`that its launch is in the public interest, where Amgen could have but has refused to remove the
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`infringing indications,
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`.
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`I.
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`GENENTECH’S MOTIONS ARE TIMELY.
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`Delay in bringing a preliminary injunction motion does not accrue “until the infringer
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`actually started to (or was about to) commit [the] particular infringing act.” Integra Lifesciences
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`Corp. v. Hyperbranch Med. Tech., Inc., 2016 WL 4770244, at *9 (D. Del. Aug. 12, 2016). There
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`1
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`Case 1:18-cv-00924-CFC Document 326 Filed 07/25/19 Page 5 of 16 PageID #: 25715
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`was no such delay here. Genentech filed its motions within weeks of FDA approval of Kanjinti
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`and just two days after Amgen’s launch decision—notwithstanding that Amgen made every
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`effort to conceal its actual launch plans from the Court and Genentech.1
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`It made no sense for Genentech to seek injunctive relief earlier. Kanjinti was not FDA-
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`approved until June 13, 2019, and until last week Amgen consistently represented that it had not
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`decided whether or when to launch. For example, just a few weeks ago, Amgen’s counsel flatly
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`told the Court that no launch decision had been made:
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`Part of the problem is we have not made that ultimate decision yet
`because we have not launched yet. We have not launched yet.
`That’s what I’m saying. Those decisions are ongoing.
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`June 18, 2019 Hr’g Tr. 78:22-25; id. at 31:4-11 (“So it may not be ripe. It’s all future activity.”).
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`Amgen then reiterated the following week that its launch decision was “something that has not
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`occurred.” D.I. 266 at 1. On June 26-27, 2019,
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`—Amgen’s Rule 30(b)(6) witness
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`on Amgen’s “anticipated launch date”—
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`testified similarly.
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`. Amgen’s other witnesses
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`To be sure, Amgen provided Genentech with discovery indicating that Amgen intended
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`to be “ready” to launch by July 2019. But Amgen’s counsel made clear at the June 18, 2019
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`hearing that planning to be ready to launch is very different from a decision to launch:
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`1 For example, Amgen unilaterally cancelled (for the second time) the June 19, 2019 deposition
`of
`—the decisionmaker to whom Amgen’s opinion letters are addressed—and
`refused to make her available until after Amgen intended to launch. See Ex. 233.
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`2
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`Case 1:18-cv-00924-CFC Document 326 Filed 07/25/19 Page 6 of 16 PageID #: 25716
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`June 18, 2019 Hr’g Tr. 29:10-17. It would have been premature for Genentech to seek injunctive
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`relief based solely on Amgen’s plans to be “ready” to launch. As Amgen’s counsel explained,
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`Amgen was making preparations even though its actual launch might occur “two months,” “six
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`months,” or even “a year” later, mooting such a request. Id. at 30:3-8.
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`Amgen’s May 15, 2018 notice of commercial marketing did not require filing for a
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`preliminary injunction notwithstanding the above facts; Amgen was not even FDA-approved
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`until 13 months later. And until recently,
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`. Genentech cannot be faulted for not seeking a
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`preliminary injunction while it remained unclear what Amgen was going to do and when.
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`Amgen suggests that Genentech indicated at the May 16, 2019 discovery hearing that it
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`would not seek a preliminary injunction. D.I. 285 at 6-7. To the contrary, Genentech has been
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`clear from the outset of this case that it would seek a preliminary injunction in these
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`circumstances: “Your Honor, if there’s a launch, we’re going to request a preliminary
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`injunction.” Oct. 16, 2018 Hr’g Tr. 87:20-21. Nor is Amgen prejudiced because Genentech
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`previously produced its trastuzumab settlement agreements with the third-party launch dates
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`redacted.
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` Genentech provided Mylan’s launch date
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`when it filed its motions. In view of these motions, Genentech has no objection to providing the
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`remaining U.S. launch dates and other U.S. terms, and has been seeking consent to do so.
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`II.
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`AMGEN FAILS TO REBUT GENENTECH’S LIKELIHOOD OF SUCCESS.
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`Having conceded infringement, Amgen’s sole rebuttal to Genentech’s likelihood of
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`success is the assertion, unsupported by any expert testimony, that the claims of Genentech’s
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`3
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`Case 1:18-cv-00924-CFC Document 326 Filed 07/25/19 Page 7 of 16 PageID #: 25717
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`dosing patents would have been obvious. But obviousness has already been fully considered and
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`rejected in multiple IPRs, and Amgen has offered nothing to warrant a different result here.2
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`A.
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`Amgen’s Arguments Have Been Fully Considered and Rejected in IPRs.
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`After a full trial on the merits, a three-judge panel of the Patent Trial and Appeal Board
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`expressly rejected the arguments Amgen makes here. For example:
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`• Amgen argues that “long established modeling tools were available to estimate
`Herceptin dosing at higher levels and longer intervals” (D.I. 285 at 15, 17), but the
`PTAB rejected that argument noting the relative novelty of using antibodies to treat
`cancer and the “inherent uncertainty associated with using mathematical models to
`predict the pharmacokinetic behavior of antibodies.” Amgen Ex. 10 at 23, 33.
`• Amgen argues that a skilled artisan would have relied upon “trivial mathematics” to
`predict that a once-every-three-week dosing regimen would work. D.I. 285 at 17.
`The PTAB rejected that argument, finding that the prior art did not support the
`conclusion that a simple, linear model could be used. Amgen Ex. 10 at 25.
`• Amgen argues that “there was no correlation between shed HER2 antigen levels and
`response to Herceptin treatment.” D.I. 285 at 18. The PTAB rejected that argument
`finding that the prior art “highlight[ed] the uncertainty caused by the presence of shed
`antigens on the pharmacokinetics of trastuzumab.” Amgen Ex. 10 at 26.
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`In short, Amgen cannot demonstrate a likelihood of success when its arguments have been
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`conclusively rejected by the PTAB in multiple IPR proceedings. See Oxford Immunotec Ltd. v.
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`Qiagen, Inc., 271 F. Supp. 3d 358, 366-67 (D. Mass. 2017) (patentee likely to succeed, in
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`preliminary injunction context, where infringer made invalidity arguments rejected in IPRs).
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`B.
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`Amgen Has Not Presented Any New Evidence or Arguments That Negate
`Genentech’s Likelihood of Success on Validity.
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`1.
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`Amgen’s arguments are not supported by any expert opinion.
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`Notably absent from Amgen’s response (as well as the opinion letter upon which it
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`purports to rely) is any expert declaration. In rendering its decisions, the PTAB considered
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`2 Amgen also has not complied with the Court’s order (D.I. 259) requiring production of
`Amgen’s assessments of the validity of these patents. Amgen cannot raise a substantial question
`as to invalidity while withholding ordered discovery that may undermine that position.
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`4
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`Case 1:18-cv-00924-CFC Document 326 Filed 07/25/19 Page 8 of 16 PageID #: 25718
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`declarations from five experts—three oncologists and two pharmacokineticists. These expert
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`declarations have been publicly available since 2017.
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`Amgen has nevertheless provided no expert opinion to support its conclusory assertions
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`of obviousness.3 In a case like this involving a complex technology, expert testimony is critical
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`to the proof of obviousness. See, e.g., Allergan, Inc. v. Barr Labs., Inc., 501 F. App’x 965, 972
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`(Fed. Cir. 2013) (“In complex cases where invalidity on the grounds of obviousness is asserted,
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`‘expert testimony may be critical, for example, to establish the existence of certain features in the
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`prior art or the existence (or lack thereof) of a motivation to combine references.’”). Genentech
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`submits an expert declaration from Dr. George Grass with this reply explaining that the
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`experience and data available to skilled artisans failed to establish a reasonable expectation of
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`success. See Grass Decl. ¶¶ 53-77. Amgen cannot raise a substantial question of invalidity
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`based upon attorney argument alone.
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`2.
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`Amgen’s “new art” adds nothing to the substantial IPR record.
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`The Hellman patent Amgen now touts as “new art” was not even mentioned in the
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`opinion of counsel upon which Amgen now relies, calling into question Amgen’s assertion that it
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`provides an “independent basis” for obviousness. In any event, the Hellman patent adds nothing
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`of substance to the substantial prior art record that was already considered by the PTAB.4
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`The Hellman patent is directed to methods of treating cancer by administering anti-ErbB2
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`antibodies, including trastuzumab, with chemotherapeutic agents other than anthracycline. The
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`3 Amgen’s invalidity expert reports are currently due just ten days from now. Given the schedule,
`it is telling that Amgen has not provided any expert support for its assertions.
`4 Amgen has not even established that the Hellman patent may be used as prior art to support
`obviousness. In its invalidity contentions, Amgen asserted that the Hellman patent was an
`anticipation reference under 35 U.S.C. § 102(e) because the application was filed before the
`dosing patents. But there is a statutory exception that does not permit the use of such patents as
`obviousness references if they are owned by the same entity. See 35 U.S.C. § 103(c).
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`5
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`Case 1:18-cv-00924-CFC Document 326 Filed 07/25/19 Page 9 of 16 PageID #: 25719
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`patent describes a clinical study in which trastuzumab was administered weekly with
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`chemotherapy. Amgen Ex. 36, 4:7-14, 30:61-31:32. It does not contain any discussion
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`whatsoever of extended dosing intervals or any pharmacokinetic data. Id. Moreover, the “range”
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`of doses covered in Hellman includes an initial dose of 1 µg/kg to 15 mg/kg and daily doses of 1
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`µg/kg to 100 mg/kg or more; it does not disclose or suggest the claimed 8 mg/kg loading dose or
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`6 mg/kg maintenance dose. Id. at 28:24-30; Grass Decl. ¶ 25.
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`Hellman is thus just one more reference describing weekly dosing of trastuzumab and, if
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`anything, contains less relevant information than the references already considered in the IPRs.
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`Grass Decl. ¶¶ 9, 25. As in the IPRs, Amgen has “not pointed to any prior art reference
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`discussing the feasibility or viability of a tri-weekly antibody dosing regimen.” Amgen Ex. 10 at
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`23.
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`3.
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`Amgen’s reliance on testimony of inventors, Genentech employees,
`and consultants misses the mark.
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`Amgen seeks to support its obviousness theory by cobbling together snippets of
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`deposition testimony from the named inventors and other researchers who were employed by or
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`working with Genentech. The problem with this approach is that the inventors and others with
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`access to Genentech’s confidential information are not proxies for skilled artisans: these
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`individuals have insights that an ordinarily skilled artisan would not. “‘The inventor’s own path
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`itself never leads to a conclusion of obviousness; that is hindsight. What matters is the path that
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`the person of ordinary skill in the art would have followed, as evidenced by the pertinent prior
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`art.’” Millennium Pharm., Inc. v. Sandoz Inc., 862 F.3d 1356, 1367 (Fed. Cir. 2017).
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`Amgen’s reliance upon specific pharmacokinetic modeling done by the named inventors
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`and other researchers working with Genentech (D.I. 285 at 14-15, 17-18) is thus irrelevant to the
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`obviousness inquiry. The inventors and Genentech consultants like Dr. Norton had vastly more
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`Case 1:18-cv-00924-CFC Document 326 Filed 07/25/19 Page 10 of 16 PageID #: 25720
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`data and information about the pharmacokinetics of trastuzumab than was available in the prior
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`art.
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` Her testimony about modeling done
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`with the benefit of this non-public data is not relevant to the modeling a skilled artisan could
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`have done based on the limited information that was in the prior art. Grass Decl. ¶¶ 14, 61-70.
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` Similarly, while Amgen highlights Dr. Norton’s recollection that
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`he modeled the three-week dosing regimen on a scrap of paper, it fails to note that following the
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`Phase III trials Dr. Norton did not seek to administer trastuzumab every three weeks to match
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`three-week chemotherapy administration but instead chose to study weekly trastuzumab with
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`weekly paclitaxel. Ex. 240 at 136:15-137:24.
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` Ex. 238 at 66:12-23, 88:1-24; Ex. 239 at 87:18-89:19.
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`III. AMGEN’S INFRINGEMENT WILL IRREPARABLY HARM GENENTECH.
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`Amgen does not dispute that its launch of Kanjinti will cause Genentech to suffer price
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`erosion and lost market share, or that such injuries are irreparable. Instead, Amgen insists that
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`Case 1:18-cv-00924-CFC Document 326 Filed 07/25/19 Page 11 of 16 PageID #: 25721
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`those injuries should be ignored because Genentech has licensed other trastuzumab biosimilars.
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`But “the fact that a patentee has licensed others under its patents does not mean that unlicensed
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`infringement must be permitted while the patents are litigated.” Abbott Labs. v. Sandoz, Inc.,
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`544 F.3d 1341, 1362 (Fed. Cir. 2008). Indeed, that would have a chilling effect on litigation
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`settlements; under Amgen’s view, a patentee could never settle litigation by permitting licensed
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`entry without effectively allowing entry to anyone else who chooses to launch at risk. Moreover,
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`as Genentech has explained (D.I. 275 at 12)—and Amgen does not dispute in its opposition—
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`Amgen is in a unique position to cause harms to Genentech, including harms of a type (price
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`erosion and lost market share) that Amgen does not dispute are irreparable. Genentech’s
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`settlements of other lawsuits does not demonstrate the lack of such harms.
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`Amgen argues that Genentech’s injuries are quantifiable because they will be limited in
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`duration
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`. But Amgen does not contest
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`Genentech’s expert testimony showing that its injuries will neither be quantifiable nor end when
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`other parties launch. Jena Decl. ¶¶ 99-101. If anything, the harm to Genentech due to Amgen
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`will be even more difficult to quantify after other biosimilars have launched. Id. ¶¶ 70-72.
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`Amgen’s suggestion that
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`. As a threshold matter, Amgen’s assertion makes no
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`sense—business planning around potential biosimilar competition does not eliminate the effects
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`of such competition. And regardless, Amgen misstates the nature of Genentech’s planning;
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`Case 1:18-cv-00924-CFC Document 326 Filed 07/25/19 Page 12 of 16 PageID #: 25722
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`Ex. 242 at 28:3-9; Ex. 244 at 1.
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`Amgen points to Ms. Oliger’s deposition testimony that
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`Amgen also suggests that Genentech will not suffer a loss of goodwill or reputational
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`harm from the launch of biosimilar trastuzumab. In doing so, however, Amgen disregards
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`Finally, Amgen argues that the effects of its launch on other Genentech products, layoffs,
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`and R&D spending should be disregarded
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`IV.
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`THE BALANCE OF HARDSHIPS FAVORS GENENTECH.
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`Genentech would suffer immediate and irreversible injuries from Amgen’s launch in
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`violation of Genentech’s patent rights. See D.I. 275 at 10-16. By contrast, Amgen would suffer
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`9
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`Case 1:18-cv-00924-CFC Document 326 Filed 07/25/19 Page 13 of 16 PageID #: 25723
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`no hardship from briefly maintaining the status quo to permit a decision on the merits;
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`),
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` Amgen also
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`has not disputed the sufficiency of Genentech’s proposed $10 million bond.
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`Amgen’s inability to proceed with its infringement is not a harm that supports Amgen’s
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`position. Sanofi-Synthelabo v. Apotex, Inc., 470 F.3d 1368, 1383 (Fed. Cir. 2006). Indeed, in
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`cases in this District where Amgen is the patentee, Amgen has argued that an infringer’s injuries
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`stemming from it taking the “calculated business risk” to launch “weigh[] against the infringer in
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`the balance of hardships analysis.” Ex. 243 at 16-19 & n.10.
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`V.
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`GRANTING INJUNCTIVE RELIEF SERVES THE PUBLIC INTEREST.
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`Amgen does not dispute that the public interest favors the enforcement of patent rights to
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`encourage innovation—a position Amgen has repeatedly endorsed in other cases. See D.I. 275 at
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`18. Nor does Amgen contend that an injunction will adversely affect patient care.
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`Amgen’s only argument as to the public interest is that an injunction would deprive the
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`public of access to non-infringing uses of Kanjinti.
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` And if Amgen were
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`truly concerned with public access to non-infringing uses of Kanjinti, it would have tried to
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`eliminate the infringing indications from its label—
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`VI. CONCLUSION
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`Genentech respectfully requests that the Court grant a TRO and ultimately a preliminary
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`injunction to maintain the status quo.
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`10
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`Case 1:18-cv-00924-CFC Document 326 Filed 07/25/19 Page 14 of 16 PageID #: 25724
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`Respectfully Submitted,
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`
`/s/ Michael P. Kelly
`Michael P. Kelly (#2295)
`Daniel M. Silver (#4758)
`MCCARTER & ENGLISH, LLP
`Renaissance Centre
`405 North King Street, 8th Floor
`Wilmington, DE 19801
`(302) 984-6300
`mkelly@mccarter.com
`dsilver@mccarter.com
`
`Attorneys for Genentech, Inc. and
`City of Hope
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`
`
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`Of Counsel:
`
`William F. Lee
`Lisa J. Pirozzolo
`Emily R. Whelan
`Kevin S. Prussia
`Andrew J. Danford
`WILMER CUTLER PICKERING
`HALE AND DORR LLP
`60 State Street
`Boston, MA 02109
`(627) 526-6000
`william.lee@wilmerhale.com
`lisa.pirozzolo@wilmerhale.com
`emily.whelan@wilmerhale.com
`kevin.prussia@wilmerhale.com
`andrew.danford@wilmerhale.com
`
`Robert J. Gunther Jr.
`WILMER CUTLER PICKERING
`HALE AND DORR LLP
`7 World Trade Center
`250 Greenwich Street
`New York, NY 10007
`(212) 230-8800
`robert.gunther@wilmerhale.com
`
`Daralyn J. Durie
`Adam R. Brausa
`DURIE TANGRI LLP
`217 Leidesdorff St.
`San Francisco, CA 94111
`(415) 362-6666
`ddurie@durietangri.com
`abrausa@durietangri.com
`
`Dated: July 16, 2019
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`11
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`Case 1:18-cv-00924-CFC Document 326 Filed 07/25/19 Page 15 of 16 PageID #: 25725
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`CERTIFICATE OF SERVICE
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`The undersigned counsel hereby certifies that true and correct copies of the foregoing
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`document were caused to be served on July 16, 2019 on the following counsel in the manner
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`indicated:
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`VIA EMAIL:
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`Neal C. Belgam
`Eve H. Ormerod
`Jennifer M. Rutter
`SMITH, KATZENSTEIN & JENKINS, LLP
`1000 West Street, Suite 1501
`Wilmington, DE 19801
`(302) 652-8400
`nbelgam@skjlaw.com
`eormerod@skjlaw.com
`jrutter@skjlaw.com
`
`
`Orion Armon
`COOLEY, LLP
`380 Interlocken Crescent, Suite 900
`Broomfield, CO 80021-8023
`(720) 566-4119
`oarmon@cooley.com
`
`
`Eamonn Gardner
`COOLEY, LLP
`4401 Eastgate Mall
`San Diego, CA 92121-1909
`(858) 550-6086
`egardner@cooley.com
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`ME1 30942553v.1
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`Case 1:18-cv-00924-CFC Document 326 Filed 07/25/19 Page 16 of 16 PageID #: 25726
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`Michelle Rhyu
`Susan Krumplitsch
`Daniel Knauss
`Philip H. Mao
`Alexandra Leeper
`Lauren Krickl
`Benjamin S. Lin
`Alissa M. Wood
`COOLEY, LLP
`3175 Hanover Street
`Palo Alto, CA 94304-1130
`(650) 843-5287
`rhyums@cooley.com
`skrumplitsch@cooley.com
`dknauss@cooley.com
`pmao@cooley.com
`aleeper@cooley.com
`lkrickl@cooley.com
`blin@cooley.com
`amwood@cooley.com
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`Nancy Gettel
`Brian Kao
`Lois Kwasigroch
`AMGEN, INC.
`One Amgen Center Drive
`Thousand Oaks, CA 91320-1799
`(805) 447-1000
`ngettel@amgen.com
`bkao@amgen.com
`loisk@amgen.com
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`Xiaoxiao Xue
`1299 Pennsylvania Avenue, NW, Suite 700
`Washington, DC 20004-2400
`(202) 842-7809
`xxue@cooley.com
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`Attorneys for Defendant Amgen Inc.
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`Dated: July 16, 2019
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`/s/ Michael P. Kelly
`Michael P. Kelly (#2295)
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`ME1 30942553v.1
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