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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 IPR2018-01711
`Patent 9,884,907 B2
`_____________________
`
`
`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 IPR2018-01711
`Patent No. 9,884,907
`
`I.
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`TABLE OF CONTENTS
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`Fox Factory does not require a patentee to prove that all unclaimed
`features are “insignificant” to obtain a presumption of nexus. ....................... 1
`Ajovy and Emgality are coextensive with the claims and Lilly’s
`analysis vis-à-vis unclaimed features does not support finding
`otherwise. ......................................................................................................... 3
`III. Teva met its burden and demonstrated nexus. ................................................. 4
`IV. Conclusion ....................................................................................................... 5
`
`II.
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`- i-
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`Case IPR2018-01711
`Patent No. 9,884,907
`The record provides evidence of success and/or praise for three different
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`anti-CGRP antibodies, all of which embody the challenged claim elements: Teva’s
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`Ajovy®, Lilly’s Emgality®, and Alder’s eptinezumab. This evidence supports both
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`a presumption of nexus and actual nexus to the challenged claims. POR, 49;
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`EX2272, ¶110; EX2263, ¶¶21-26; EX2275, ¶20; EX2257, 5.
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`Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366 (Fed. Cir. 2019) does not
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`disrupt Teva’s presumption. The holding in that case turned on the fact that SRAM
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`only argued that the commercial products were “broadly covered” by the claims,
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`and admitted that the unclaimed features of the product were both material to its
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`functionality and drove the objective indicia. No such admissions or arguments
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`exist here. Lacking similar facts, Lilly relies on attorney argument that unclaimed
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`features of Ajovy and Emgality are responsible for the objective indicia. Br., 1.
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`The Board should reject these unfounded and late arguments.
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`Lilly is also wrong that “Teva relied solely on the presumption.” Br., 1. Teva
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`demonstrated a direct nexus between objective indicia from a representative
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`number of species and the challenged claims. EX2272, ¶110; EX2263, ¶¶21-26;
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`EX2275, ¶20; EX2257, 5. Thus, Teva independently demonstrated nexus.
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`I.
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`Fox Factory does not require a patentee to prove that all unclaimed
`features are “insignificant” to obtain a presumption of nexus.
`Federal Circuit precedent is clear: while unclaimed features may rebut a
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`presumption of nexus, their existence cannot prevent a finding of a presumption.
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`- 1 -
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`Case IPR2018-01711
`Patent No. 9,884,907
`Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1393-94 (Fed.
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`Cir. 1988); Ecolochem, Inc. v. Southern California Edison Co., 227 F.3d 1361,
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`1378 (Fed. Cir. 2000); PPC Broadband, Inc. v. Corning Optical Commc’ns RF,
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`LLC, 815 F.3d 734, 747 (Fed. Cir. 2016). Fox Factory confirmed as much: “[t]he
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`mere existence of one or more unclaimed features does not necessarily mean
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`presuming nexus is inappropriate.” Fox Factory, 944 F.3d at 1376.
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`Ignoring that the unclaimed features were “critical” in Fox Factory, Lilly
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`fashions a new rule to hold that a presumption does not apply where “patentee
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`failed to meet its burden of establishing that those unclaimed features were
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`‘insignificant’ to the [] products’ functionality.” Br., 2. Fox Factory includes no
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`such holding. Moreover, it did not overturn decades of Federal Circuit precedent
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`and place that burden on patentees. Demaco, 851 F.2d 1394 (“A patentee is not
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`required to prove as part of its prima facie case that the commercial success of the
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`patented invention is not due to factors other than the patented invention.”).
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`In Fox Factory, the Court unambiguously stated that the “patentee’s own
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`assertions about the significance of the unclaimed features” were the basis for its
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`finding of no coextensiveness. Fox Factory, 944 F.3d at 1375. Here, Teva has not
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`made any such admissions, and does not have to prove that all unclaimed features
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`of the products are “insignificant” to establish a presumption of nexus.
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`- 2 -
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`Case IPR2018-01711
`Patent No. 9,884,907
`II. Ajovy and Emgality are coextensive1 with the claims and Lilly’s analysis
`vis-à-vis unclaimed features does not support finding otherwise.
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`Under Fox Factory, nexus is not presumed where a product’s unclaimed
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`features “materially impact[] the product’s functionality” and are responsible for
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`the objective indicia. Fox Factory, 944 F.3d at 1375. Lilly baldly asserts that
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`“numerous [unclaimed] features” of Ajovy and Emgality are “responsible for
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`Teva’s alleged secondary considerations evidence.”2 Br., 1, 3-6. But Lilly relies
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`purely on attorney argument, belatedly cobbling together cites from a record
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`without any evidence that the features drive the objective indicia. Br., 1, 3-6. Thus,
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`Lilly’s assertion that Ajovy and Emgality are “not coextensive” with the
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`challenged claims is baseless3.
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`1 Teva did not state otherwise. OA (Nov. 22, 2019), 63:13-15. Fox Factory
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`does not overrule the case law that a patentee can demonstrate nexus with a
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`representative number of species. In re Kao, 639 F.3d 1057, 1069 (Fed. Cir. 2011).
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`2 Lilly waived its opportunity to contest Teva’s presumption of nexus
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`because it failed to do so on Reply.
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`3 Celltrion v. Genentech did not hold that a presumption never applies to a
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`genus. IPR2017-01374, Paper 85 at 46 (PTAB Nov. 29, 2018). There, the claims
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`challenged as obvious were directed “to specific antibodies with specific
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`framework region substitutions” that admittedly “critically affect[ed]” antigen
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`- 3 -
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`
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`Case IPR2018-01711
`Patent No. 9,884,907
`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 of nexus.
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`Lilly also improperly argues that “[w]hen a product is covered by multiple
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`patents, the patentee must also show that the secondary considerations are due to
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`the challenged claims, not other patents.” Br., 24. To the contrary, Fox Factory
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`recognized that a presumption can apply to multiple patents that “generally cover
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`the same invention.” Fox Factory, 944 F.3d at 1377. And there is no dispute that
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`the challenged claims in the related challenged patents generally cover the same
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`invention: humanized anti-CGRP antagonist antibodies and their use.
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`III. Teva met its burden and demonstrated nexus.
`Lilly’s argument that “Teva failed to prove nexus” is wrong. Br., 6-7. Teva
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`showed 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. EX2272,
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`¶110; EX2257, 5; POR, 49. This evidence demonstrates the required nexus
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`binding, and the objective indicia were associated with one antibody having one
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`claimed substitution. Id., 6, 46. The record here is devoid of such facts.
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`4 Teva demonstrated nexus for each challenged claim. EX2272, ¶110. Lilly
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`waived its right to address a presumption for dependent claims.
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`- 4 -
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`
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`Case IPR2018-01711
`Patent No. 9,884,907
`between the objective indicia and the full scope of Teva’s claims. In re Kao, 639
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`F.3d at 1068. Lilly now relies on the inapposite AbbVie and Celltrion cases to
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`challenge Teva’s showing. Br., 7. But neither is relevant either factually or legally.
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`Celltrion, IPR2017-01374, Paper 85 at 46; Abbvie Deutschland GmbH v. Janssen
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`Biotech, Inc., 759 F.3d 1285, 1299-1300 (Fed. Cir. 2014) (a written description
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`case). As Lilly admitted, Ajovy and Emgality each have different “unclaimed
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`features.” Br., 5-6. Lilly failed to demonstrate that these antibodies are not
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`representative of the claimed genus. Thus, Teva has proven a nexus to the claims.
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`IV. Conclusion
`In sum, the Board should reject Lilly’s attempts to overextend the holding of
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`Fox Factory to create a new rule that a presumption can never apply to a genus
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`claim. All Fox Factory did was to apply long-standing law to a unique set of facts:
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`the patentee’s admission of the criticality of the unclaimed features. Fox Factory,
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`944 F.3d at 1375. Such facts are absent here. Thus, Fox Factory does not apply and
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`does not change Teva’s entitlement to a presumption of nexus. Furthermore, even
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`if the presumption did not apply, Teva has demonstrated nexus to multiple
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`objective indicia that support nonobviousness of the challenged claims.
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`Respectfully submitted,
`
`Date: January 31, 2020
`
`
`
`By: /Deborah A. 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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`Reply Brief Regarding Fox Factory, Inc. v. SRAM, LLC” was served in its entirety
`
`on January 31, 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 31, 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
`
`14500065
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