`
`
`
`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 IPR2018-01425
`Patent 9,890,210
`_____________________
`
`
`PATENT OWNER’S SUPPLEMENTAL 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 IPR2018-01425
`Patent No. 9,890,210
`
`
`TABLE OF CONTENTS
`
`Teva’s presumption of nexus is sound. ........................................................... 2
`Teva also has demonstrated nexus between the objective indicia and
`the challenged claims. ...................................................................................... 6
`III. Conclusion ....................................................................................................... 7
`
`I.
`II.
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`- i-
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`Case IPR2018-01425
`Patent No. 9,890,210
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`Teva has presented strong evidence of objective indicia of nonobviousness
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`of the challenged claims in the form of widespread praise, long-felt need,
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`unexpected results, and commercial acquiescence. All challenged claims recite
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`humanized anti-CGRP antagonist antibodies. POR, 44-54; Surreply, 25-27. And
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`Teva’s evidence of objective indicia is tied to the humanized anti-CGRP antagonist
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`antibody products Ajovy® (fremanezumab; Teva), Emgality® (galcanezumab;
`
`Lilly), and Alder’s eptinezumab (as yet unbranded). The present record does not
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`identify any critical, unclaimed features of these products that are responsible for
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`any objective indicia that Teva has provided evidence of in this case. Rather, these
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`products embody the claimed features (they are humanized anti-CGRP antagonist
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`antibodies) and are coextensive with them. Thus, Teva is entitled to a presumption
`
`of nexus. The Federal Circuit’s recent opinion in Fox Factory does not change that
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`and in fact supports such a determination. Fox Factory, Inc. v. SRAM, LLC, 2019
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`WL 6884530, Case Nos. 2018-2024, -2025 (Fed. Cir. 2019).
`
`As the Federal Circuit stated in Fox Factory, a presumption of nexus applies
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`“when the patentee shows that the asserted objective evidence is tied to a specific
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`product and that product ‘embodies the claimed features, and is coextensive with
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`them.’” Fox Factory, *5. This is not new law. In Fox Factory, the Board erred by
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`presuming nexus simply because the product at issue was “broadly covered” by the
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`claims at issue. Fox Factory, *6-7. But, in Fox Factory, the commercial product
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`- 1 -
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`Case IPR2018-01425
`Patent No. 9,890,210
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`included an unclaimed feature that the patentee had admitted was “critical,” i.e., it
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`“materially impact[ed] the product’s functionality” and was responsible for the
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`praise and success relied on as evidence of objective indicia: “the product’s ability
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`to ‘better retain the chain under many conditions.’” Id. Thus, the commercial
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`
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`products were not coextensive with the challenged claims. Id. Here, in contrast, the
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`record lacks any evidence of such an unclaimed, yet “critical” feature responsible
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`for the objective indicia of nonobviousness. Thus, the products embodying Teva’s
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`claimed invention—humanized anti-CGRP antagonist antibodies—are coextensive
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`with the claims, meaning that the presumption applies here.
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`Teva also offered evidence, supported by expert testimony, demonstrating
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`nexus between the challenged claims and objective indicia from a representative
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`number of species: Ajovy, Emgality, and Alder’s eptinezumab. EX2225, ¶102;
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`EX2242, ¶20; EX2257, 5. For this additional reason, Fox Factory—where patentee
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`relied solely on the presumption—is inapposite.
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`I.
`
`Teva’s presumption of nexus is sound.
`
`Teva is entitled to a presumption of nexus. POR, 45. “[T]here is a
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`presumption of nexus for objective considerations when the patentee shows that
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`the asserted objective evidence is tied to a specific product and that product ‘is the
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`invention disclosed and claimed in the patent.’” WBIP, LLC v. Kohler Co., 829
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`F.3d 1317, 1329 (Fed. Cir. 2016). Consistent with the law, Teva’s objective
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`- 2 -
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`Case IPR2018-01425
`Patent No. 9,890,210
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`evidence is tied to three humanized anti-CGRP antagonist antibody products,
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`which are “the invention disclosed and claimed.” POR, 45; EX2225, ¶102;
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`EX2236, ¶¶21-24; EX2242, ¶¶19-22, 25; EX2257, 5. Thus, the presumption
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`applies.
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`To the extent that Fox Factory has further clarified the law of presumption,
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`that clarification does not apply here because the facts on which Fox Factory was
`
`decided are entirely distinguishable. In Fox Factory, the product in question was a
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`bicycle chainring. Fox Factory, *2. That chainring had four unclaimed features
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`that the patentee admitted materially impacted the chainring’s functionality—an
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`“80% gap-filling feature,” “forwardly protruding tooth tips,” “hook features on the
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`teeth,” and “mud-clearing recesses.” Id., *6, 7. Of these, patentee admitted the
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`“80%” feature was “critical” to the functionality that drove the objective indicia.
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`Id. Not surprisingly, the Court thus found that the chainring was not coextensive
`
`with the independent claims. Id. Where the objective indicia evidence is that
`
`people praise and pay for a chainring with improved chain retention that is
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`admittedly due to an “80% gap-filling feature,” it would be incongruous for the
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`praise and success of the chainring to be presumed to support nonobviousness of a
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`patent that does not claim the touted “80% gap-filling feature.” In other words,
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`where a Patent Owner concedes that objective indicia are due to something other
`
`than the claimed invention, it is common sense that a nexus cannot be presumed.
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`- 3 -
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`Case IPR2018-01425
`Patent No. 9,890,210
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`All of the objective indicia evidence here relates to the use of humanized
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`anti-CGRP antagonist antibodies (Ajovy, Emgality, and Alder’s product) to treat
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`migraine. POR, 44-54; Surreply, 25-27.1 Because the challenged claims are
`
`indisputably directed to humanized anti-CGRP antagonist antibodies, it is entirely
`
`logical to presume that the praise for and success of such antibodies demonstrates
`
`the nonobviousness of a claim that expressly recites such antibodies. POR, 45.
`
`
`
`And, in stark contrast to Fox Factory, the record here is devoid of evidence that the
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`praise for and success of the antibody products depends critically on any subsidiary
`
`features not recited in the claims. Thus, Fox Factory is inapplicable.
`
`Lilly has argued that the particular amino acid sequence of an antibody “can
`
`meaningfully affect an antibody’s function.” Reply, 21-22. But there is no record
`
`evidence that demonstrates that any one particular antibody sequence drives the
`
`objective indicia. Indeed, the fact that Ajovy, Emgality, and Alder’s product
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`indisputably each have a different sequence, but are all associated with the same
`
`praise, underscores the fact that differences in sequence among embodiments of
`
`
`1 It is irrelevant that the objective indicia evidence derives from the
`
`therapeutic properties of the claimed antibodies, because “[f]rom the standpoint of
`
`patent law, a compound and all of its properties are inseparable.” In re Sullivan,
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`498 F.3d 1345, 1353 (Fed. Cir. 2007).
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`- 4 -
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`Case IPR2018-01425
`Patent No. 9,890,210
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`the claimed invention are not “critical” to the objective indicia. The same is true of
`
`other variations, such as antibody isotype or antibody affinity: Lilly has not shown
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`any of these features to be “critical” to the objective indicia of Ajovy, Emgality, or
`
`Alder’s product.
`
`
`
` “The mere existence of one or more unclaimed features does not necessarily
`
`mean presuming nexus is inappropriate.” Fox Factory, *7. “Indeed, there is rarely
`
`a perfect correspondence between the claimed invention and the product.” Id., *6.
`
`What is “require[d] is that the patentee demonstrate that the product is essentially
`
`the claimed invention.” Id. Teva has amply done so here. EX2225, ¶102; EX2236,
`
`¶¶21-24; EX2242, ¶¶19, 23-24, 26; EX2257, 5; POR, 45. The products are all
`
`humanized anti-CGRP antagonist antibodies, and the claimed invention is a
`
`humanized anti-CGRP antagonist antibody.
`
`The fact that some of the challenged claims are directed to a genus rather
`
`than to individual species also makes no difference, for two reasons. First, the
`
`evidence of praise and long-felt need is itself directed to the genus rather than to
`
`any single species. Indeed, the field praised all three antibodies—Ajovy, Emgality,
`
`and Alder’s eptinezumab—for the same reasons. EX2236, ¶¶45-58; POR, 47-48.
`
`Second, the fact that several representative species all shared the same praise and
`
`success illustrates that no single species is critical to the objective indicia.
`
`Further, Fox Factory recognized that the presumption of nexus can apply to
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`- 5 -
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`
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`Case IPR2018-01425
`Patent No. 9,890,210
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`multiple patents as long as those “patents generally cover the same invention.” Id.,
`
`at *8. Therefore, the presumption of nexus applies to the challenged claims in
`
`IPR2018-01422, -01423, -01424, -01425, -01426, -01427, -01710, -01711, and -
`
`01712, which indisputably cover humanized anti-CGRP antagonist antibodies and
`
`their use.
`
`
`
`In sum, Fox Factory held that evidence of objective indicia could not be
`
`presumed to support the nonobviousness of claims that did not recite the product
`
`features that drove the objective indicia. In contrast, here, humanized anti-CGRP
`
`antagonist antibodies are recited in the challenged claims and drive the praise and
`
`underlying success. The nexus between those antibodies and the evidence of
`
`objective indicia of non-obviousness, therefore, should be presumed.
`
`II. Teva also has demonstrated nexus between the objective indicia and the
`challenged claims.
`
`Regardless of presumption, Teva demonstrated that the objective indicia of
`
`nonobviousness is tied to the challenged claimed. “A finding that a presumption of
`
`nexus is inappropriate does not end the inquiry into secondary considerations.” Fox
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`Factory, *5. A patentee may “show[] that the evidence of secondary considerations
`
`is the ‘direct result of the unique characteristics of the claimed invention.’” Id.
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`Teva has presented evidence sufficient to demonstrate nexus, even if not presumed.
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`For example, Dr. Tomlinson testified that “[t]he literature indicates that these
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`- 6 -
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`Case IPR2018-01425
`Patent No. 9,890,210
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`antagonistic antibodies have the required structure and properties required by the
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`challenged claims.” EX2225, ¶102. Further, Dr. Stoner testified that “AlderBio
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`acknowledged that … [it] would otherwise infringe [the ‘210 patent] absent the
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`granted license.” EX2242, ¶20; EX2257, 5.
`
`
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`It is undisputed that Ajovy, Emgality, and Alder’s product are each a species
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`“within the scope of the claims.” In re Kao, 639 F.3d 1057, 1069 (Fed. Cir. 2011).
`
`Because all of these antibody products behave in the same manner—i.e., all are
`
`effective in treating migraine—they establish that the evidence of objective indicia
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`is 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
`
`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 Teva’s entitlement to a presumption of nexus.
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`Furthermore, even if the presumption did not apply, Teva has demonstrated nexus
`
`to multiple objective indicia that support nonobviousness of the challenged claims.
`
`
`
`
` Date: January 13, 2020
`
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`/Deborah A. Sterling/
`Deborah A. Sterling, Ph.D.
`Registration No. 62,732
`
`- 7 -
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`
`
`
`
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`
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`
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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
`
`Supplemental Brief Regarding Fox Factory, Inc. v. SRAM, LLC” was served in its
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`entirety on January 13, 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 13, 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
`
`14410765
`
`
`
`
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