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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
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`ELI LILLY AND COMPANY,
`Petitioner,
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`v.
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`TEVA PHARMACEUTICALS INTERNATIONAL GMBH,
`Patent Owner.
`_____________________
`
`CASE IPR2018-01712
`Patent 9,884,908 B2
`_____________________
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`
`PATENT OWNER’S SUPPLEMENTAL BRIEF REGARDING
` FOX FACTORY, INC. V. SRAM, LLC
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`Mail Stop "PATENT BOARD"
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`
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`Case IPR2018-01712
`Patent No. 9,884,908
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`TABLE OF CONTENTS
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`I.
`Teva is entitled to a presumption of nexus. ..................................................... 2
`Even without a presumption, Teva demonstrated nexus. ................................ 6
`II.
`III. Conclusion ....................................................................................................... 7
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`Case IPR2018-01712
`Patent No. 9,884,908
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`Teva has presented strong objective evidence of nonobviousness of the
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`challenged claims in multiple forms: widespread praise, long-felt need, unexpected
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`results, and commercial acquiescence. POR, 55-63; Surreply, 27-29. And Teva’s
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`objective evidence is tied to the claimed methods of using humanized anti-CGRP
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`antagonist antibodies, such as Ajovy® (fremanezumab; Teva), Emgality®
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`(galcanezumab; Lilly), and Alder’s eptinezumab (as yet unbranded), to treat
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`migraine. “This showing—that the specific products are embodiments of the
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`claimed invention and that the proffered objective evidence relates to these
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`products—is sufficient to establish the presumption of nexus for the objective
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`considerations.” WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1330 (Fed. Cir. 2016).
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`Thus, Teva has met its burden in demonstrating a presumption of nexus.
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`Fox Factory does not change that. Fox Factory, Inc. v. SRAM, LLC, 944
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`F.3d 1366 (Fed. Cir. 2019). Fox Factory did not create new law; it merely applied
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`the long-standing law on presumption to a unique set of facts. Id. at 1373-1374.
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`There, the commercial product included an unclaimed feature that the patentee had
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`admitted was “critical:” it “materially impact[ed] the product’s functionality” and
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`was responsible for the objective indicia. Id. at 1375. Under those facts, the Court
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`found that the commercial product was not coextensive with the challenged claims,
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`even though it was “broadly cover[ed]” by the claims. Id. at 1376. Here, the record
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`lacks any evidence of such an unclaimed, yet “critical,” feature responsible for the
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`Case IPR2018-0712
`Patent No. 9,884,908
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`objective indicia, admitted or otherwise. Thus, Fox Factory does not apply.
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`Not solely relying on a presumption, Teva also offered evidence
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`demonstrating nexus between the challenged claims and objective indicia from a
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`representative number of species. EX2273, ¶123; EX2264, ¶¶21-26; EX2276, ¶20;
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`EX2257, 5. For this additional reason, Fox Factory—where patentee relied solely
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`on the presumption—is inapposite.
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`I.
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`Teva is entitled to a presumption of nexus.
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`Teva met its burden and demonstrated that nexus should be presumed. POR,
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`54-55. Teva’s objective evidence is tied to treating migraine with a humanized
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`anti-CGRP antagonist antibody, and this is “the invention disclosed and claimed:”
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`“The present invention relates to the use of anti-CGRP antagonist antibodies for
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`the prevention, amelioration, or treatment of … migraine.” WBIP, LLC, 829 F.3d
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`at 1329; EX1001, 1:34-37; POR, 54-55; EX2264, ¶¶21-26; EX2273, ¶123;
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`EX2276, ¶¶19-20, 23-24, 26; EX2257, 5. Thus, the methods that are the subject of
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`the objective indicia here embody the claimed features and are coextensive1 with
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`1 Teva did not state otherwise during Oral Argument in IPRs 2018-01422, -
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`01423, -01424, -01425, -01426, and -01427 when it answered the Board’s claim
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`scope question by describing Ajovy and Emgality as “a representative number of
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`species within the [genus] claims.” OA (Nov. 22, 2019), 63:13-15. Fox Factory did
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`Patent No. 9,884,908
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`them, and the presumption applies. Fox Factory, 944 F.3d at 1373.
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`Fox Factory does not control here because its finding that there was a lack
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`of coextensiveness turned on the fact—absent here—that unclaimed features were
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`both material to a product’s functionality and responsible for the objective
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`evidence. The commercial chainring that embodied the claims there was successful
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`due to its “ability to ‘better retain the chain under many conditions.’” Id. at 1373-
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`1375. The improved retention was admittedly due to four unclaimed features:
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`“forwardly protruding tooth tips,” “hook features on the teeth,” “mud-clearing
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`recesses,” and an “80% gap-filling feature,” which was “critical.” Id. at 1375-1376.
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`Thus, not only did these unclaimed features materially impact the chainring’s
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`functionality, they also indisputably were responsible for the chainring’s success.
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`In stark contrast, the record here is devoid of evidence that the success of the
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`claimed methods derives from any critical, non-recited feature. The challenged
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`claims are directed to methods of treating migraine with humanized anti-CGRP
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`antagonist antibodies. And all of the objective indicia evidence here relates to the
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`methods of treating migraine with humanized anti-CGRP antagonist antibodies
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`not concern genus/species claims and does not overrule the case law that a patentee
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`can demonstrate nexus with a representative number of species. In re Kao, 639
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`F.3d 1057, 1069 (Fed. Cir. 2011).
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`Case IPR2018-0712
`Patent No. 9,884,908
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`(Ajovy, Emgality, and eptinezumab). POR, 55-63; Surreply, 27-29. Therefore, it is
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`entirely proper to presume that the objective indicia of record demonstrates the
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`nonobviousness of a claim that expressly recites such methods. POR, 54-55.
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`Fox Factory is fully distinguishable, as is illustrated in the schematic below:
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`there, the product’s critical feature was not
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`expressly recited in the claims; thus the product
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`was not coextensive with the claims. By contrast,
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`the record here is devoid of such a critical feature,
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`and the product and the claims are coextensive.
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`The fact that Ajovy, Emgality, and eptinezumab have unclaimed features
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`does not preclude the finding of a presumption here. It is well established law that
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`unclaimed features may rebut a presumption, but cannot prevent a finding of a
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`presumption. Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387,
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`1393 (Fed. Cir. 1988); Ecolochem, Inc. v. Southern California Edison Co., 227
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`F.3d 1361, 1378 (Fed. Cir. 2000); PPC Broadband, Inc. v. Corning Optical
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`Commc’ns RF, LLC, 815 F.3d 734, 747 (Fed. Cir. 2016).2 And the Fox Factory
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`2 Fox Factory cannot overrule this law. Deckers Corp. v. U.S., 752 F.3d 949,
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`964 (2014) (indicating that precedential decisions can only be overruled by a
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`Supreme Court or en banc decision).
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`Case IPR2018-0712
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`Court agrees with the precedent: “[t]he mere existence of one or more unclaimed
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`features does not necessarily mean presuming nexus is inappropriate.” Fox
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`Factory, 944 F.3d at 1376. What is “require[d] is that the patentee demonstrate that
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`the product is essentially the claimed invention.” Id. Teva has fully met its burden
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`in demonstrating as much. POR, 54-55; EX1001, 1:34-37; EX2264, ¶¶21-26;
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`EX2273, ¶123; EX2276, ¶¶19-20, 23-24, 26; EX2257, 5.
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`There is simply no evidence that any unclaimed features that the antibody
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`products may possess are significant for the objective indicia, as required by law.
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`Fox Factory, 944 F.3d at 1375. To the contrary, the fact that Ajovy, Emgality, and
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`eptinezumab indisputably each have a different sequence, but all have received the
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`same praise, shows that sequences are not driving the praise. The same is true of
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`other variations (antibody isotype, antibody affinity): there is no evidence of record
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`that any of these features drive the objective indicia. And to require Teva to prove
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`“insignificance” of any and every feature Lilly decides to point to, in the absence
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`of any evidence of the “significance” of such features to the invention and the
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`objective indicia, is to ask Teva to engage in a futile task of proving a negative.
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`The fact that some of the challenged claims are directed to a genus and not
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`species makes no difference. Praise and long-felt need here is not limited to any
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`single species. Indeed, the field praised all three antibodies—Ajovy, Emgality, and
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`eptinezumab—for the same reasons. EX2264, ¶¶49-60; POR, 55-57. And the fact
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`that several representative species all shared the same praise and success illustrates
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`that no single species is critical to the objective indicia.
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`Further, Fox Factory recognized that the presumption can apply to multiple
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`patents as long as they “generally cover the same invention.” Fox Factory, 944
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`F.3d at 1377. There is no dispute that the 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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`through claims of varying scope. Therefore, the presumption of nexus applies.
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`II. Even without a presumption, Teva demonstrated nexus.
`Regardless of presumption, Teva demonstrated that the objective indicia are
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`tied to the challenged claims. “A finding that a presumption of nexus is
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`inappropriate does not end the inquiry into secondary considerations.” Fox
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`Factory, 944 F.3d at 1373. To show nexus, a patentee must show that secondary
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`indicia results from something that is “both claimed and novel in the claim[s].” In
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`re Kao, 639 F.3d at 1068 (emphasis in original). Teva has done that. Dr.
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`Tomlinson testified that Ajovy and Emgality “have the structure and properties
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`required by the ’908 patent’s claims,” and “are used … to treat headache”—the
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`basis for their praise and success. EX2273, ¶123; POR, 54-55. Further, Alder
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`conceded infringement, demonstrating that the use of its antibody is a claimed
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`embodiment. EX2276, ¶20; EX2257, 5. And it is undisputed that treating migraine
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`Patent No. 9,884,908
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`with humanized anti-CGRP antibodies is a novel feature.
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`It is also undisputed that methods of treating migraine with Ajovy, Emgality,
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`and eptinezumab are each a species “within the scope of the claims.” In re Kao,
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`639 F.3d at 1069. Because all of these products behave in the same manner—all
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`are effective in treating migraine—they establish that the objective indicia is
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`commensurate with claim scope. Id. at 1068 (“[A]n adequate basis to support the
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`conclusion that other embodiments falling within the claim will behave in the same
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`manner . . . will generally establish that the evidence is commensurate with
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`scope.”). Hence, even without the benefit of a presumption, record evidence
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`establishes nexus between the objective indicia and the full scope of Teva’s claims.
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`III. Conclusion
`Fox Factory does not change the fact that Teva is entitled to a presumption
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`of nexus. Furthermore, even if the presumption did not apply, Teva has
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`demonstrated nexus to multiple objective indicia that support nonobviousness of
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`the challenged claims.
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` Date: January 24, 2020
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`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
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`
`Deborah A. Sterling, Ph.D.
`Registration No. 62,732
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`CERTIFICATE OF SERVICE (37 C.F.R. §§ 42.6(e))
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`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 24, 2020, via email on the following:
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`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
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` STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
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`Date: January 24, 2020
`1100 New York Avenue, N.W.
`Washington, D.C. 20005-3934
`(202) 371-2600
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` Deborah A. Sterling, Ph.D.
` Registration No. 62,732
` Lead Counsel for Patent Owner
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`14468799
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