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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`ELI LILLY AND COMPANY,
`Petitioner,
`
`v.
`
`TEVA PHARMACEUTICALS INTERNATIONAL GMBH,
`Patent Owner.
`_____________________
`
`CASE IPR2018-01423
`Patent 9,266,951
`_____________________
`
`
`PATENT OWNER’S REPLY BRIEF REGARDING
` FOX FACTORY, INC. V. SRAM, LLC
`
`
`
`
`
`Mail Stop "PATENT BOARD"
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`Case IPR2018-01423
`Patent No. 9,266,951
`
`I.
`
`TABLE OF CONTENTS
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`Lilly’s analysis misapplies the Fox Factory holding and actually
`supports a finding of presumption here. .......................................................... 2
`Lilly is wrong: Teva met its burden and demonstrated nexus in
`addition to a presumption. ............................................................................... 4
`III. Conclusion ....................................................................................................... 5
`
`II.
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`- i-
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`
`
`Case IPR2018-01423
`Patent No. 9,266,951
`Record evidence shows praise and success for three different anti-CGRP
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`antibodies, all of which embody the challenged claim elements: Teva’s Ajovy®,
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`Lilly’s Emgality®, and Alder’s eptinezumab. This evidence demonstrates both a
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`presumption of nexus and actual nexus to the challenged claims. POR, 48.
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`Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366 (Fed. Cir. 2019), does not
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`disturb Teva’s presumption. Fox Factory’s holding of no presumption turned on
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`the fact that unclaimed features were both material to a product’s functionality and
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`responsible for the objective evidence. Lilly provides no evidence that any
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`unclaimed features of Ajovy and Emgality are responsible for the objective indicia.
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`Instead, Lilly asserts that Ajovy and Emgality have different “unclaimed features”
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`and are equally praised and successful. But this argument supports Teva’s
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`presumption because, unlike Fox Factory, no evidence shows that any one or
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`combination of unclaimed features is responsible for the objective indicia. Thus,
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`Teva is entitled to a presumption of nexus.
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`Lilly is also wrong that “Teva relied solely on the presumption.” Lilly’s
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`Brief, 1. The opposite is true: Teva offered evidence, supported by expert
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`testimony, that demonstrates nexus between objective indicia from a representative
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`number of species—Ajovy, Emgality, and eptinezumab—and the challenged
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`claims. EX2223, ¶106; EX2240, ¶20; EX2257, 5. For this additional reason,
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`Lilly’s arguments fail and Teva’s nexus is sound.
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`- 1 -
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`
`
`Case IPR2018-01423
`Patent No. 9,266,951
`I.
`Lilly’s analysis misapplies the Fox Factory holding and actually
`supports a finding of presumption here.
`
`Lilly wrongly argues that because Ajovy and Emgality have features that
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`“‘materially impact’ their functionality but are not recited as limitations,” Teva
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`failed to satisfy the coextensiveness requirement.”1, 2 Lilly’s Brief, 1. But Teva
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`fully met its burden to show the presumption. POR, 48. Lilly’s analysis under Fox
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`Factory is incomplete and actually supports finding a presumption here.
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`In Fox Factory, the prior art chainrings were deficient in that chains were
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`“susceptible to disengaging from the chainring.” Fox Factory, 944 F.3d at 1369.
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`SRAM’s chainring products were successful due to their “ability to ‘better retain
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`the chain under many conditions.’” Id., 1374-1375. The improved retention was
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`admittedly due to four features: “forwardly protruding tooth tips,” “hook features
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`on the teeth,” “mud-clearing recesses,” and an “80% gap-filling feature,” which
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`was “critical” to the objective indicia. Id., 1375-1376. Thus, not only did these
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`1 Lilly does not dispute that the asserted objective evidence is tied to Ajovy,
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`Emgality, and eptinezumab, or that these antibodies embody the claimed features.
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`2 By arguing “no presumption” now, Lilly attempts to recast its Reply’s
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`“commensurate in scope” argument. Lilly’s Brief, 3-6. But Fox Factory has not
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`changed the law—it merely “reaffirmed and clarified” it. Lilly’s Brief, 1. Lilly
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`waived its opportunity to contest Teva’s presumption of nexus.
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`- 2 -
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`Case IPR2018-01423
`Patent No. 9,266,951
`features (i) materially impact the chainring’s functionality, they also indisputably
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`were (ii) responsible for the chainring’s success. And the Court held that the
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`chainrings were not co-extensive with claims that did not recite these features. Id.
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`Here, Lilly’s argument and evidence stop well short of those in Fox Factory.
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`Lilly points to no evidence that the asserted “unclaimed features”—sequences and
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`mutations” and “pm-level binding affinity, antibody format, and antibody class”—
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`are responsible for the praise for and success of Ajovy and Emgality. Lilly’s Brief,
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`3-6. Thus, Lilly’s assertion that Fox Factory applies here is wrong3.
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`Moreover, Lilly’s arguments that Ajovy and Emgality each have different
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`“unclaimed features” but are both equally praised underscores the fact that
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`differences in sequence, class, affinity, etc., do not drive the objective indicia. This
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`squarely undercuts Lilly’s argument and instead supports a presumption here.
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`Lilly also improperly argues that “[w]hen a product is covered by more than
`
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`3 Celltrion v. Genentech did not mandate that a presumption never applies to
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`a genus. IPR2017-01374, Paper 85 at 46 (PTAB Nov. 29, 2018). There, the claims
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`were directed “to specific antibodies with specific framework region substitutions”
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`that admittedly “critically affect[ed]” antigen binding. Id., 6. But the objective
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`indicia was associated with only one antibody having one claimed substitution. Id.,
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`46. Here, there is no such admission, and the objective indicia is not for only one
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`antibody.
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`- 3 -
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`
`
`Case IPR2018-01423
`Patent No. 9,266,951
`one patent, the patentee has the burden to show that the secondary considerations
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`are due to the challenged claims rather than the other patents.” Lilly’s Brief, 24. To
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`the contrary, Fox Factory recognized that a presumption can apply to multiple
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`patents that “generally cover the same invention.” Fox Factory, 944 F.3d at 1377.
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`And there is no dispute that the challenged claims in IPR2018-01422, -01423, -
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`01424, -01425, -01426, -01427, -01710, -01711, and -01712 generally cover the
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`same invention: humanized anti-CGRP antagonist antibodies and their use.
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`II. Lilly is wrong: Teva met its burden and demonstrated nexus in addition
`to a presumption.
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`Lilly’s repeated “commensurate in scope” arguments on Reply belie its
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`assertion now that “Teva made no attempt to meet its burden of proving that …
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`nexus applies outside of the presumption.” Lilly’s Brief, 6. POR, 48. Also, Teva
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`did not argue simply that “the claims ‘cover’ Ajovy® and Emgality®,” as Lilly
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`asserts. Lilly’s Brief, 6. Instead, Teva’s expert Dr. Tomlinson showed that the
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`specific components of Ajovy and Emgality “have the required structure and
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`properties required by the challenged claims,” and therefore are tied to the claims.
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`EX2223, ¶106. And Alder conceded infringement. EX2257, 5. Lilly then contested
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`Teva’s actual nexus on Reply with its “commensurate in scope” argument. Reply,
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`4 Lilly also errs by addressing only claim 1, waiving its right to address
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`dependent claims. Teva demonstrated nexus for each challenged claim, which
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`vary in scope, and each claim should be addressed individually. EX2223, ¶106.
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`- 4 -
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`
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`Case IPR2018-01423
`Patent No. 9,266,951
`21-23. Its assertion that Teva “made no attempt” to show nexus is thus baseless.
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`That aside, Lilly’s commensurate in scope arguments fails. Teva showed
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`that multiple antibodies within the claim scope—Ajovy, Emgality, and
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`eptinezumab—behave in the same manner and receive the same praise, which
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`demonstrates the required nexus between the objective indicia and the full scope of
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`Teva’s claims. In re Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011).
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`Alder’s license evidences strong objective indicia. Alder conceded
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`infringement, demonstrating that its antibody is a claimed embodiment. EX2252,
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`5. No further technical analysis is needed. Lilly presents only attorney argument in
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`response to Dr. Stoner’s expert testimony. And Alder’s payment under the license
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`also would not change if every patent except for the ’951 patent was held
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`unpatentable. Thus, the license evidences strong objective indicia having nexus to
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`every challenged claim.
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`III. Conclusion
`Fox Factory does not change Teva’s entitlement to a presumption of nexus.
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`Furthermore, even if the presumption did not apply, Teva has demonstrated nexus
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`to multiple objective indicia that support nonobviousness of the challenged claims.
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`Respectfully submitted,
`
`Date: January 17, 2020
`
`
`
`By: /Deborah Sterling/
` Deborah A. Sterling, Ph.D. (Reg. No. 62,732)
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`- 5 -
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`CERTIFICATE OF SERVICE (37 C.F.R. §§ 42.6(e))
`
`The undersigned hereby certifies that the above-captioned “Patent Owner’s
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`Supplemental Brief Regarding Fox Factory, Inc. v. SRAM, LLC” was served in its
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`entirety on January 17, 2020, via email on the following:
`
`Sanjay M. Jivraj
`Mark J. Stewart
`Eli Lilly and Company
`Lilly Corporate Center Patent Dept.
`Indianapolis, IN 46285
`jivraj_sanjay@lilly.com
`stewart_mark@lilly.com
`
`William B. Raich
`Erin M. Sommers
`Pier D. DeRoo
`Yieyie Yang
`John Williamson
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, LLP
`901 New York Avenue, NW
`Washington, DC 20001
`william.raich@finnegan.com
`erin.sommers@finnegan.com
`pier.deroo@finnegan.com
`yieyie.yang@finnegan.com
`john.williamson@finnegan.com
`
`
`
`
`
`
` STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`
`Date: January 17, 2020
`1100 New York Avenue, N.W.
`Washington, D.C. 20005-3934
`(202) 371-2600
`
`
`
`
` Deborah A. Sterling, Ph.D.
` Registration No. 62,732
` Lead Counsel for Patent Owner
`
`14420100
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