`34854
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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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`v.
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`AMGEN INC.,
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`Plaintiff,
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`Defendant.
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`C.A. No. 18-924-CFC-SRF
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`PLAINTIFF GENENTECH, INC.’S ANSWER TO DEFENDANT AMGEN INC.’S
`COUNTERCLAIMS
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`Plaintiff and Counterclaim Defendant Genentech, Inc. (“Genentech” or “Plaintiff”)
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`hereby submits this Answer to the Counterclaims of Defendant and Counterclaim Plaintiff
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`Amgen Inc. (“Amgen” or “Defendant”) (D.I. 366, hereinafter “Counterclaims”).
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`Amgen’s Answer to Genentech’s Third Amended Complaint includes fourteen
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`affirmative defenses, to which no response is required. To the extent a response is required,
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`Genentech denies all of the allegations of Amgen’s affirmative defenses and reserves the right to
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`introduce evidence rebutting those allegations.
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`Each of the paragraphs below corresponds to the same numbered paragraphs (each a
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`“Paragraph”) in the Counterclaims. Genentech denies each and every allegation in the
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`Counterclaims, including without limitation allegations appearing in headings, subheadings, and
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`footnotes, except as expressly admitted herein, and specifically deny that Defendant is entitled to
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`the relief sought in its Prayer for Relief. Genentech reserves the right to amend or supplement
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`this Answer. Genentech responds to the Counterclaims as follows:
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`1
`CONFIDENTIAL – FILED UNDER SEAL
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`PUBLIC VERSION FILED: March 6, 2020
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`Case 1:18-cv-00924-CFC-SRF Document 529 Filed 03/06/20 Page 2 of 20 PageID #:
`34855
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`ANSWER TO DEFENDANT’S COUNTERCLAIMS
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`THE PARTIES
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`1. Admitted, upon information and belief.
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`2. Admitted.
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`JURISDICTION AND VENUE
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`3. Genentech admits that Amgen purports to base its Counterclaims on the cited sections of
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`the United States Code. The remaining allegations of Paragraph 3 are legal conclusions to which
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`no response is required. To the extent that a response is deemed required, Genentech admits that
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`the Court has subject matter jurisdiction over Amgen’s Counterclaims.
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`4. Genentech admits that it contends in its Complaint that venue is proper in this District.
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`The remaining allegations of Paragraph 4 are legal conclusions to which no response is required.
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`To the extent that a response is deemed required, Genentech admits that venue is proper in this
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`District.
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`FACTUAL BACKGROUND
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`5. Genentech admits that Paragraph 5 quotes from the source cited (FDA, What are
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`“Biologics” Questions and Answers (Aug. 5, 2015), http://www.fda.gov/aboutfda/centersoffices/
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`officeofmedicalproductsandtobacco/cber/ucm133077.htm), which speaks for itself. Upon
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`information and belief, Genentech admits that Amgen was founded in 1980. Genentech lacks
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`knowledge sufficient to admit or deny the remaining allegations set forth in Paragraph 5, and
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`therefore denies them.
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`6. Upon information and belief, Genentech admits that Amgen has developed biologic
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`medicines and has received FDA approval of drugs in the last twenty years. Genentech lacks
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`2
`CONFIDENTIAL – FILED UNDER SEAL
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`34856
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`knowledge sufficient to admit or deny the remaining allegations set forth in Paragraph 6, and
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`therefore denies them.
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`7. Upon information and belief, Genentech admits that the article cited in Paragraph 7
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`appears to be a press release dated December 19, 2011. Genentech refers to that document for its
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`contents. Genentech lacks knowledge sufficient to admit or deny the remaining assertions set
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`forth in Paragraph 7, and therefore denies them.
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`8. Genentech lacks knowledge sufficient to admit or deny the assertions set forth in
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`Paragraph 8, and therefore denies them.
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`Congress Enacts Legislation Creating a Regulatory Pathway for Biosimilar Biological
`Products
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`9. Genentech admits that the BPCIA provides a process through which an applicant may file
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`an abbreviated biologics license application, including FDA review and approval of biosimilar
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`products and a process for resolving patent disputes that may arise with respect to such products.
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`Genentech further states that the remaining allegations of Paragraph 9 are legal conclusions to
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`which no response is required. Genentech further states that the BPCIA speaks for itself.
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`10. Genentech admits that Paragraph 10 quotes a sentence from Sandoz Inc. v. Amgen Inc.,
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`137 S. Ct. 1664, 1669 (2017), which speaks for itself.
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`11. Genentech admits that 42 U.S.C. § 262(k) describes the requirements for regulatory
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`approval of a biological product. Genentech further states that Paragraph 11 contains legal
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`conclusions to which no response is required. Genentech further states that the statute speaks for
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`itself.
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`12. Genentech admits that the BPCIA sets forth a process for resolving patent disputes that
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`may arise with respect to biosimilar products, and that Paragraph 12 quotes a sentence from
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`Sandoz Inc. v. Amgen Inc., 137 S. Ct. 1664, 1670 (2017), which speaks for itself. Genentech
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`3
`CONFIDENTIAL – FILED UNDER SEAL
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`further states that Paragraph 12 contains legal conclusions to which no response is required.
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`Genentech further states that the BPCIA statute speaks for itself. To the extent that a further
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`response is deemed required, Genentech denies the remaining allegations of Paragraph 12.
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`13. Genentech admits that the BPCIA sets forth a process for resolving patent disputes that
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`may arise with respect to biosimilar products. Genentech further states that Paragraph 13
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`contains legal conclusions to which no response is required. Genentech further states that the
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`BPCIA statute speaks for itself. To the extent that a further response is deemed required,
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`Genentech denies the remaining allegations of Paragraph 13.
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`14. Genentech admits that the BPCIA sets forth a process for resolving patent disputes that
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`may arise with respect to biosimilar products. Genentech further states that Paragraph 14
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`contains legal conclusions to which no response is required. Genentech further states that the
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`BPCIA statute speaks for itself. To the extent that a further response is deemed required,
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`Genentech denies the remaining allegations of Paragraph 14.
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`15. Genentech admits that the BPCIA sets forth a process for resolving patent disputes that
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`may arise with respect to biosimilar products. Genentech further states that Paragraph 15
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`contains legal conclusions to which no response is required. Genentech further states that the
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`BPCIA statute speaks for itself. To the extent that a further response is deemed required,
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`Genentech denies the remaining allegations of Paragraph 15.
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`The Parties’ Exchanges Following the Filing of Amgen’s Subsection (k) Application for
`Approval of Its Biosimilar Product
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`16. Genentech admits, upon information and belief, that the FDA notified Amgen that it had
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`accepted Amgen’s aBLA for review on
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` Genentech lacks knowledge
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`sufficient to admit or deny the remaining assertions set forth in Paragraph 16, and therefore
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`denies them.
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`4
`CONFIDENTIAL – FILED UNDER SEAL
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`Case 1:18-cv-00924-CFC-SRF Document 529 Filed 03/06/20 Page 5 of 20 PageID #:
`34858
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`17. Genentech admits that it received a letter from Amgen dated October 16, 2017 that
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`purported to provide Amgen’s disclosure of information pursuant to 42 U.S.C. § 262(l)(2)(A).
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`Genentech states that the letter speaks for itself. Genentech admits that Genentech received a
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` Genentech further states that Paragraph 17 contains legal conclusions to
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`which no response is required. Genentech denies the remaining allegations of Paragraph 17.
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`18. Genentech admits that it sent a letter to Amgen dated November 20, 2017 that identified
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`deficiencies in Amgen’s production of manufacturing information. Genentech states that the
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`letter speaks for itself. Genentech denies the remaining allegations of Paragraph 18.
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`19. Genentech admits that it received a letter from Amgen dated December 1, 2017.
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`Genentech states that the December 1, 2017 letter speaks for itself. Genentech admits that
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`Amgen provided an additional letter on
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`. Genentech states that the
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`
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` letter speaks for itself. Genentech denies the remaining allegations of Paragraph 19.
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`20. Genentech admits that it provided Amgen with a list of 36 patents pursuant to 42 U.S.C.
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`§ 262(l)(3)(A) on December 15, 2017. Genentech admits that it supplemented its § 262(l)(3)(A)
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`list to include U.S. Patent No. 9.868,760 on February 6, 2018. Genentech admits that after its
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`February 6, 2018 supplement, its § 262(l)(3)(A) list included a total of 37 patents. Genentech
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`admits that it maintains that Amgen did not comply with Amgen’s disclosure obligations under
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`§ 262(l)(2)(A). Genentech denies the remaining allegations of Paragraph 20.
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`21. Genentech admits that it received letters from Amgen dated
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`
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` Genentech
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`denies the remaining allegations of Paragraph 21.
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`5
`CONFIDENTIAL – FILED UNDER SEAL
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`22. Genentech admits that it received a letter from Amgen dated February 13, 2018
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`purporting to provide Amgen’s detailed statement concerning non-infringement and invalidity
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`pursuant to 42 U.S.C. § 262(l)(3)(B). Genentech admits that it received a letter from Amgen
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`dated March 8, 2018 purporting to constitute, with the February 13, 2018 letter, Amgen’s
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`detailed statement concerning non-infringement and invalidity with respect to the claims of U.S.
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`Patent No. 9,868,760 pursuant to 42 U.S.C. § 262(l)(3)(B). Genentech states that Amgen’s
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`February 13, 2018 and March 8, 2018 letters speaks for themselves. Genentech denies the
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`remaining allegations of Paragraph 22.
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`23. Genentech admits that it provided its response to Amgen’s February 13, 2018 and March
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`8, 2018 letters pursuant to 42 U.S.C. § 262(l)(3)(C) on April 13, 2018 (“3C Statement”).
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`Genentech states that its 3C Statement speaks for itself. Genentech denies the remaining
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`allegations of Paragraph 23.
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`24. Admitted.
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`25. Genentech admits that, on
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`, Genentech received a letter from Amgen
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`purporting to provide notice pursuant to 42 U.S.C. § 262(l)(8)(A) that the “first commercial
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`marketing of the biological product licensed under Amgen’s 42 U.S.C. § 262(k) Biologics
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`License Application
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` will commence no earlier than 180 days from the date of the
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`notice.”
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`26. Admitted.
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`27. Admitted.
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`28. Admitted.
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`29. Admitted.
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`30. Admitted.
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`6
`CONFIDENTIAL – FILED UNDER SEAL
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`31. Admitted.
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`32. Upon information and belief, admitted.
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`33. Upon information and belief, admitted.
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`34. Admitted.
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`35. Genentech admits that on August 2, 2019, following the Court’s June 14, 2019
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`Memorandum Opinion construing certain disputed terms, the Parties stipulated to a judgment of
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`non-infringement of U.S. Patent Nos. 8,512,983 and 9,714,293 under the Court’s claim
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`construction of “a glutamine-free production culture medium,” while preserving Genentech’s
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`ability to challenge that construction on appeal. Genentech admits that the Court ordered the
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`entry of that stipulation on August 20, 2019.
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`36. Admitted.
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`37. Admitted.
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`THE PATENTS-IN-SUIT
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`38. Genentech denies that December 12, 1997 is the earliest possible priority date for U.S.
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`Patent No. 7,846,441. Genentech admits the remaining allegations in Paragraph 38.
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`39. Genentech denies that February 3, 2003 is the earliest possible priority date for U.S.
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`Patent No. 7,892,549. Genentech admits the remaining allegations in Paragraph 39.
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`40. Genentech denies that August 27, 1999 is the earliest possible priority date for U.S.
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`Patent No. 6,627,196. Genentech admits the remaining allegations in Paragraph 40.
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`41. Genentech denies that August 27, 1999 is the earliest possible priority date for U.S.
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`Patent No. 7,371,379. Genentech admits the remaining allegations in Paragraph 41.
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`42. Genentech denies that August 27, 1999 is the earliest possible priority date for U.S.
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`Patent No. 10,160,811. Genentech admits the remaining allegations in Paragraph 42.
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`7
`CONFIDENTIAL – FILED UNDER SEAL
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`43. Genentech denies that July 9, 2007 is the earliest possible priority date for U.S. Patent
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`No. 8,574,869. Genentech admits the remaining allegations in Paragraph 43.
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`COUNT 1
`Non-Infringement and Invalidity of U.S. Patent No. 7,846,441
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`44. Genentech repeats and reasserts all responses to the preceding paragraphs as if fully
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`stated herein.
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`45. Admitted.
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`46. Paragraph 46 contains legal conclusions to which no response is required. To the extent
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`that a response is deemed required, Genentech admits that there is a justiciable controversy
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`between the parties as to the infringement of U.S. Patent No. 7,846,441.
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`47. Denied.
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`48. Denied.
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`49. Denied.
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`50. Denied.
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`COUNT 2
`Non-Infringement and Invalidity of U.S. Patent No. 7,892,549
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`51. Genentech repeats and reasserts all responses to the preceding paragraphs as if fully
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`stated herein.
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`52. Admitted.
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`53. Paragraph 53 contains legal conclusions to which no response is required. To the extent
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`that a response is deemed required, Genentech admits that there is a justiciable controversy
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`between the parties as to the infringement of U.S. Patent No. 7,892,549.
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`54. Denied.
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`55. Denied.
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`8
`CONFIDENTIAL – FILED UNDER SEAL
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`Case 1:18-cv-00924-CFC-SRF Document 529 Filed 03/06/20 Page 9 of 20 PageID #:
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`56. Denied.
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`57. Denied.
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`COUNT 3
`Non-Infringement and Invalidity of U.S. Patent No. 6,627,196
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`58. Genentech repeats and reasserts all responses to the preceding paragraphs as if fully
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`stated herein.
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`59. Admitted.
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`60. Paragraph 60 contains legal conclusions to which no response is required. To the extent
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`that a response is deemed required, Genentech admits that there is a justiciable controversy
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`between the parties as to the infringement of U.S. Patent No. 6,627,196.
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`61. Denied. To the extent a further response is required, Genentech incorporates by
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`reference its 3C Statement as well as the August 20, 2019 Corrected Expert Report of Susan
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`Tannenbaum on Induced and Willful Infringement of the Dosing Patents.
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`62. Denied.
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`63. Denied. To the extent a further response is required, Genentech states that Amgen has not
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`shown, by clear and convincing evidence, that any claim of the ʼ196 Patent is invalid for failure
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`to comply with one or more conditions of patentability set forth in one or more provisions of 35
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`U.S.C. §§ 101, 102, 103, and/or 112, or under other judicially-created bases for invalidation, for
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`at least the reasons set forth in Genentech’s 3C Statement, and Genentech’s rebuttal expert
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`reports filed in in this action, including Genentech Inc.’s Rebuttal Expert Report of Karen
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`Gelmon, M.D.; Corrected Genentech Inc.’s Rebuttal Expert Report of George M. Grass, Ph.D.;
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`and the Rebuttal Expert Report of Anupam B. Jena, M.D., Ph.D.
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`Genentech further denies any contention pursuant to 35 U.S.C. §§ 100, 102(f) (pre-AIA),
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`111, or 115 that the patent is invalid for failure to correctly name Dr. Brian Leyland-Jones as an
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`9
`CONFIDENTIAL – FILED UNDER SEAL
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`Case 1:18-cv-00924-CFC-SRF Document 529 Filed 03/06/20 Page 10 of 20 PageID
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`inventor and/or that the invention of the asserted claims was derived from Dr. Leyland-Jones for
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`at least the following reasons.
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`The named inventors of the ’196 Patent, Dr. Steven Shak and Dr. Sharon Baughman,
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`conceived of the invention of the asserted claims of the ’196 Patent
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`,
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`which is prior to any purported contribution and/or invention by Dr. Leyland-Jones.
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`Dr. Leyland-Jones did not conceive of and/or contribute to any of the inventions claimed
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`in the ’196 Patent. None of the documents cited by Amgen corroborate Amgen’s assertion that
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`“Dr. Leyland-Jones had a complete conception of the dosing regimens recited in the asserted
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`claims.” See Amgen’s Answer, ¶ 120. Nor do these documents corroborate that Dr. Leyland-
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`Jones conceived of one or more limitations of the asserted claims of the ’196 Patent. The
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`documents that Amgen produced from Dr. Leyland-Jones
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`10
`CONFIDENTIAL – FILED UNDER SEAL
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`Case 1:18-cv-00924-CFC-SRF Document 529 Filed 03/06/20 Page 11 of 20 PageID
`#: 34864
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` As a result, even if Dr. Leyland-Jones independently conceived of
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`any aspect of the inventions, such conception was after Dr. Baughman’s and Dr. Shak’s
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`conception of the inventions of the ’196 Patent. Amgen has also failed to present any
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`corroborating evidence that Dr. Leyland-Jones communicated any aspect of the invention to Dr.
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`Baughman and Dr. Shak, and that such communication was prior to Dr. Baughman’s and Dr.
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`Shak’s conception of the inventions of the ’196 Patent.
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`In any event, any contributions made by Dr. Leyland-Jones were made based on
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`Roche/Genentech confidential information and in furtherance of his duties to Roche/Genentech.
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`
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`Genentech denies the remaining allegations in Paragraph 63.
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`64. Denied.
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`COUNT 4
`Non-Infringement and Invalidity of U.S. Patent No. 7,371,379
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`65. Genentech repeats and reasserts all responses to the preceding paragraphs as if fully
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`stated herein.
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`66. Admitted.
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`67. Paragraph 67 contains legal conclusions to which no response is required. To the extent
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`that a response is deemed required, Genentech admits that there is a justiciable controversy
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`between the parties as to the infringement of U.S. Patent No. 7,371,379.
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`68. Denied. To the extent a further response is required, Genentech incorporates by
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`reference its 3C Statement as well as the August 20, 2019 Corrected Expert Report of Susan
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`Tannenbaum on Induced and Willful Infringement of the Dosing Patents.
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`69. Denied.
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`11
`CONFIDENTIAL – FILED UNDER SEAL
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`Case 1:18-cv-00924-CFC-SRF Document 529 Filed 03/06/20 Page 12 of 20 PageID
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`70. Denied. To the extent a further response is required, Genentech states that Amgen has not
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`shown, by clear and convincing evidence, that any claim of the ʼ379 Patent is invalid for failure
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`to comply with one or more conditions of patentability set forth in one or more provisions of 35
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`U.S.C. §§ 101, 102, 103, and/or 112, or under other judicially-created bases for invalidation, for
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`at least the reasons set forth in Genentech’s 3C Statement, and Genentech’s rebuttal expert
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`reports filed in in this action, including Genentech Inc.’s Rebuttal Expert Report of Karen
`
`Gelmon, M.D.; Corrected Genentech Inc.’s Rebuttal Expert Report of George M. Grass, Ph.D.;
`
`and the Rebuttal Expert Report of Anupam B. Jena, M.D., Ph.D.
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`Genentech further denies any contention pursuant to 35 U.S.C. §§ 100, 102(f) (pre-AIA),
`
`111, or 115 that the patent is invalid for failure to correctly name Dr. Brian Leyland-Jones as an
`
`inventor and/or that the invention of the asserted claims was derived from Dr. Leyland-Jones for
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`at least the following reasons.
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`The named inventors of the ’379 Patent, Dr. Steven Shak and Dr. Sharon Baughman,
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`conceived of the invention of the asserted claims of the ’379 Patent
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`,
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`which is prior to any purported contribution and/or invention by Dr. Leyland-Jones.
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`12
`CONFIDENTIAL – FILED UNDER SEAL
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`Case 1:18-cv-00924-CFC-SRF Document 529 Filed 03/06/20 Page 13 of 20 PageID
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`.
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`Dr. Leyland-Jones did not conceive of and/or contribute to any of the inventions claimed
`
`in the ’379 Patent. None of the documents cited by Amgen corroborate Amgen’s assertion that
`
`“Dr. Leyland-Jones had a complete conception of the dosing regimens recited in the asserted
`
`claims.” See Amgen’s Answer, ¶ 140. Nor do these documents corroborate that Dr. Leyland-
`
`Jones conceived of one or more limitations of the asserted claims of the ’379 Patent. The
`
`documents that Amgen produced from Dr. Leyland-Jones
`
`
`
`
`
`
`
`
`
`. As a result, even if Dr. Leyland-Jones independently conceived of
`
`any aspect of the inventions, such conception was after Dr. Baughman’s and Dr. Shak’s
`
`conception of the inventions of the ’379 Patent. Amgen has also failed to present any
`
`corroborating evidence that Dr. Leyland-Jones communicated any aspect of the invention to Dr.
`
`Baughman and Dr. Shak, and that such communication was prior to Dr. Baughman’s and Dr.
`
`Shak’s conception of the inventions of the ’379 Patent.
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`In any event, any contributions made by Dr. Leyland-Jones were made based on
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`Roche/Genentech confidential information and in furtherance of his duties to Roche/Genentech.
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`Genentech denies the remaining allegations in Paragraph 70.
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`71. Denied.
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`COUNT 5
`Non-Infringement and Invalidity of U.S. Patent No. 10,160,811
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`72. Genentech repeats and reasserts all responses to the preceding paragraphs as if fully
`
`stated herein.
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`73. Admitted.
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`74. Paragraph 74 contains legal conclusions to which no response is required. To the extent
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`that a response is deemed required, Genentech admits that there is a justiciable controversy
`
`between the parties as to the infringement of U.S. Patent No. 10,160,811.
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`75. Denied. To the extent a further response is required, Genentech incorporates by
`
`reference its 3C Statement as well as the August 20, 2019 Corrected Expert Report of Susan
`
`Tannenbaum on Induced and Willful Infringement of the Dosing Patents.
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`76. Denied.
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`77. Denied. To the extent a further response is required, Genentech states that Amgen has not
`
`shown, by clear and convincing evidence, that any claim of the ʼ811 Patent is invalid for failure
`
`to comply with one or more conditions of patentability set forth in one or more provisions of 35
`
`U.S.C. §§ 101, 102, 103, and/or 112, or under other judicially-created bases for invalidation, for
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`at least the reasons set forth in Genentech’s 3C Statement, and Genentech’s rebuttal expert
`
`reports filed in in this action, including Genentech Inc.’s Rebuttal Expert Report of Karen
`
`Gelmon, M.D.; Corrected Genentech Inc.’s Rebuttal Expert Report of George M. Grass, Ph.D.;
`
`and the Rebuttal Expert Report of Anupam B. Jena, M.D., Ph.D.
`
`Genentech further denies any contention pursuant to 35 U.S.C. §§ 100, 102(f) (pre-AIA),
`
`111, or 115 that the patent is invalid for failure to correctly name Dr. Brian Leyland-Jones as an
`
`inventor and/or that the invention of the asserted claims was derived from Dr. Leyland-Jones for
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`at least the following reasons.
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`The named inventors of the ’811 Patent, Dr. Steven Shak and Dr. Sharon Baughman,
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`conceived of the invention of the asserted claims of the ’811 Patent
`
`,
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`which is prior to any purported contribution and/or invention by Dr. Leyland-Jones.
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`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`.
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`Dr. Leyland-Jones did not conceive of and/or contribute to any of the inventions claimed
`
`in the ’811 Patent. None of the documents cited by Amgen corroborate Amgen’s assertion that
`
`“Dr. Leyland-Jones had a complete conception of the dosing regimens recited in the asserted
`
`claims.” See Amgen’s Answer, ¶ 161. Nor do these documents corroborate that Dr. Leyland-
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`Jones conceived of one or more limitations of the asserted claims of the ’811 Patent. The
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`documents that Amgen produced from Dr. Leyland-Jones l
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`. As a result, even if Dr. Leyland-Jones independently conceived of
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`any aspect of the inventions, such conception was after Dr. Baughman’s and Dr. Shak’s
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`conception of the inventions of the ’811 Patent. Amgen has also failed to present any
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`corroborating evidence that Dr. Leyland-Jones communicated any aspect of the invention to Dr.
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`Baughman and Dr. Shak, and that such communication was prior to Dr. Baughman’s and Dr.
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`Shak’s conception of the inventions of the ’811 Patent.
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`In any event, any contributions made by Dr. Leyland-Jones were made based on
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`Roche/Genentech confidential information and in furtherance of his duties to Roche/Genentech.
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`See, e.g., GNE-HER_000097894-895; GNE-HER_000430759-762.
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`Genentech denies the remaining allegations in Paragraph 77.
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`78. Denied.
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`COUNT 6
`Non-Infringement and Invalidity of U.S. Patent No. 8,574,869
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`79. Genentech repeats and reasserts all responses to the preceding paragraphs as if fully
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`stated herein.
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`80. Admitted.
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`81. Paragraph 81 contains legal conclusions to which no response is required. To the extent
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`that a response is deemed required, Genentech admits that there is a justiciable controversy
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`between the parties as to the infringement of U.S. Patent No. 8,574,869.
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`82. Denied.
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`83. Denied.
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`84. Denied. To the extent a further response is required, Genentech states that Amgen has
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`not shown, by clear and convincing evidence, that any claim of the ʼ869 Patent is invalid for
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`failure to comply with one or more conditions of patentability set forth in one or more provisions
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`of 35 U.S.C. §§ 101, 102, 103, and/or 112, or under other judicially-created bases for
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`invalidation or unenforceability, for at least the reasons set forth in Genentech’s rebuttal expert
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`reports.
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`Genentech further denies any contention that any claim of the ʼ869 Patent is
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`unenforceable due to Genentech’s alleged inequitable conduct.
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`85. Denied.
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`PRAYER FOR RELIEF
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`Defendant’s prayer for relief does not require a response. To the extent a response is
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`required, Genentech denies that Defendant is entitled to any remedy or relief.
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`AFFIRMATIVE AND OTHER DEFENSES
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`Without any admission as to the burden of proof, burden of persuasion, or truth of any
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`allegation in the Counterclaims, Genentech relies upon the following defenses:
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`FIRST DEFENSE
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`Amgen’s Counterclaims fail to state a claim upon which relief can be granted.
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`SECOND DEFENSE
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`Amgen’s Counterclaims fail to state facts sufficient to entitle Amgen to recovery of
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`attorneys’ fees.
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`THIRD DEFENSE
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`Amgen’s Counterclaims fail to state facts sufficient to entitle Amgen to recovery of costs.
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`FOURTH DEFENSE
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`The ʼ196, ʼ379, and ʼ811 Patents are not invalid, because if it is determined that
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`inventorship is incorrect, inventorship may be corrected pursuant to 35 U.S.C. § 256 or by any
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`other applicable statute, regulation, rule, or doctrine.
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`FIFTH DEFENSE
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`Amgen’s Counterclaims asserting invalidity of the ʼ196, ʼ379, and ʼ811 Patents based on
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`incorrect inventorship and/or derivation are barred by laches and inexcusable delay by Amgen
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`and/or Dr. Leyland-Jones in raising this assertion.
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`SIXTH DEFENSE
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`Amgen’s Counterclaims asserting invalidity based on incorrect inventorship and/or
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`derivation of the ʼ196, ʼ379, and ʼ811 Patents are barred by equitable estoppel.
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`SEVENTH DEFENSE
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`Amgen’s Counterclaims asserting invalidity of the ʼ196, ʼ379, and ʼ811 Patents based on
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`incorrect inventorship and/or derivation fail due to the prior conception of the inventions by
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`named inventors Sharon Baughman and Steven Shak.
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`RESERVATION OF DEFENSES
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`Genentech reserves its rights to assert any additional defenses, at law or equity, which
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`may exist.
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`ANSWER TO DEFENDANT’S PRAYER FOR RELIEF
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`Genentech denies that Defendant is entitled to any of the relief sought in its
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`Counterclaims or to any relief whatsoever. WHEREFORE Genentech respectfully requests that
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`this Court enter judgment in its favor against Defendant and grant the following relief:
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`A.
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`A judgment that Defendant is not entitled to any relief under the Counterclaims;
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`B.
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`A declaration that this is an exceptional case and an award to Genentech of its
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`attorneys’ fees, costs, and expenses pursuant to 35 U.S.C. § 285; and
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`C.
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`Such other relief as this Court may deem just and proper.
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`Respectfully submitted,
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`
`/s/ Daniel M. Silver
`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
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`Counsel for Plaintiff Genentech, Inc.
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`Dated: March 2, 2020
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`
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`Of Counsel:
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`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
`
`
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