`
`
`
`
`
`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 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 IPR2018-01711
`Patent No. 9,884,907
`
`
`TABLE OF CONTENTS
`
`I.
`Teva is entitled to a presumption of nexus. ..................................................... 2
`Even without a presumption, Teva demonstrated nexus. ................................ 6
`II.
`III. Conclusion ....................................................................................................... 7
`
`- i-
`
`
`
`Case IPR2018-01711
`Patent No. 9,884,907
`
`
`Teva has presented strong objective evidence of nonobviousness of the
`
`challenged claims in multiple forms: widespread praise, long-felt need, unexpected
`
`results, and commercial acquiescence. POR, 49-58; Surreply, 26-28. And Teva’s
`
`objective evidence is tied to the claimed methods of using humanized anti-CGRP
`
`antagonist antibodies, such as Ajovy® (fremanezumab; Teva), Emgality®
`
`(galcanezumab; Lilly), and Alder’s eptinezumab (as yet unbranded), to treat
`
`migraine. “This showing—that the specific products are embodiments of the
`
`claimed invention and that the proffered objective evidence relates to these
`
`products—is sufficient to establish the presumption of nexus for the objective
`
`considerations.” WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1330 (Fed. Cir. 2016).
`
`Thus, Teva has met its burden in demonstrating a presumption of nexus.
`
`Fox Factory does not change that. Fox Factory, Inc. v. SRAM, LLC, 944
`
`F.3d 1366 (Fed. Cir. 2019). Fox Factory did not create new law; it merely applied
`
`the long-standing law on presumption to a unique set of facts. Id. at 1373-1374.
`
`There, the commercial product included an unclaimed feature that the patentee had
`
`admitted was “critical:” it “materially impact[ed] the product’s functionality” and
`
`was responsible for the objective indicia. Id. at 1375. Under those facts, the Court
`
`found that the commercial product was not coextensive with the challenged claims,
`
`even though it was “broadly cover[ed]” by the claims. Id. at 1376. Here, the record
`
`lacks any evidence of such an unclaimed, yet “critical,” feature responsible for the
`
`- 1 -
`
`
`
`Case IPR2018-01711
`Patent No. 9,884,907
`
`objective indicia, admitted or otherwise. Thus, Fox Factory does not apply.
`
`Not solely relying on a presumption, Teva also offered evidence
`
`demonstrating nexus between the challenged claims and objective indicia from a
`
`representative number of species. EX2272, ¶110; EX2263, ¶¶21-26; EX2275, ¶20;
`
`EX2257, 5. For this additional reason, Fox Factory—where patentee relied solely
`
`
`
`on the presumption—is inapposite.
`
`I.
`
`Teva is entitled to a presumption of nexus.
`
`Teva met its burden and demonstrated that nexus should be presumed. POR,
`
`49. Teva’s objective evidence is tied to treating migraine with a humanized anti-
`
`CGRP antagonist antibody, and this is “the invention disclosed and claimed:” “The
`
`present invention relates to the use of anti-CGRP antagonist antibodies for the
`
`prevention, amelioration, or treatment of … migraine.” WBIP, LLC, 829 F.3d at
`
`1329; EX1001, 1:34-37; POR, 49; EX2263, ¶¶21-26; EX2272, ¶110; EX2275,
`
`¶¶19-20, 23-24, 26; EX2257, 5. Thus, the methods that are the subject of the
`
`objective indicia here embody the claimed features and are coextensive1 with them,
`
`
`1 Teva did not state otherwise during Oral Argument in IPRs 2018-01422, -
`
`01423, -01424, -01425, -01426, and -01427 when it answered the Board’s claim
`
`scope question by describing Ajovy and Emgality as “a representative number of
`
`species within the [genus] claims.” OA (Nov. 22, 2019), 63:13-15. Fox Factory did
`
`- 2 -
`
`
`
`Case IPR2018-01711
`Patent No. 9,884,907
`
`and the presumption applies. Fox Factory, 944 F.3d at 1373.
`
`
`
`Fox Factory does not control here because its finding that there was a lack
`
`of coextensiveness turned on the fact—absent here—that unclaimed features were
`
`both material to a product’s functionality and responsible for the objective
`
`evidence. The commercial chainring that embodied the claims there was successful
`
`due to its “ability to ‘better retain the chain under many conditions.’” Id. at 1373-
`
`1375. The improved retention was admittedly due to four unclaimed features:
`
`“forwardly protruding tooth tips,” “hook features on the teeth,” “mud-clearing
`
`recesses,” and an “80% gap-filling feature,” which was “critical.” Id. at 1375-1376.
`
`Thus, not only did these unclaimed features materially impact the chainring’s
`
`functionality, they also indisputably were responsible for the chainring’s success.
`
`In stark contrast, the record here is devoid of evidence that the success of the
`
`claimed methods derives from any critical, non-recited feature. The challenged
`
`claims are directed to methods of treating migraine with humanized anti-CGRP
`
`antagonist antibodies. And all of the objective indicia evidence here relates to the
`
`methods of treating migraine with humanized anti-CGRP antagonist antibodies
`
`
`not concern genus/species claims and does not overrule the case law that a patentee
`
`can demonstrate nexus with a representative number of species. In re Kao, 639
`
`F.3d 1057, 1069 (Fed. Cir. 2011).
`
`- 3 -
`
`
`
`Case IPR2018-01711
`Patent No. 9,884,907
`
`(Ajovy, Emgality, and eptinezumab). POR, 49-58; Surreply, 26-28. Therefore, it is
`
`entirely proper to presume that the objective indicia of record demonstrates the
`
`nonobviousness of a claim that expressly recites such methods. POR, 49.
`
`Fox Factory is fully distinguishable, as is illustrated in the schematic below:
`
`
`
`there, the product’s critical feature was not
`
`expressly recited in the claims; thus the product
`
`was not coextensive with the claims. By contrast,
`
`the record here is devoid of such a critical feature,
`
`and the product and the claims are coextensive.
`
`The fact that Ajovy, Emgality, and eptinezumab have unclaimed features
`
`does not preclude the finding of a presumption here. It is well established law that
`
`unclaimed features may rebut a presumption, but cannot prevent a finding of a
`
`presumption. Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387,
`
`1393 (Fed. Cir. 1988); Ecolochem, Inc. v. Southern California Edison Co., 227
`
`F.3d 1361, 1378 (Fed. Cir. 2000); PPC Broadband, Inc. v. Corning Optical
`
`Commc’ns RF, LLC, 815 F.3d 734, 747 (Fed. Cir. 2016).2 And the Fox Factory
`
`
`2 Fox Factory cannot overrule this law. Deckers Corp. v. U.S., 752 F.3d 949,
`
`964 (2014) (indicating that precedential decisions can only be overruled by a
`
`Supreme Court or en banc decision).
`
`- 4 -
`
`
`
`Case IPR2018-01711
`Patent No. 9,884,907
`
`Court agrees with the precedent: “[t]he mere existence of one or more unclaimed
`
`features does not necessarily mean presuming nexus is inappropriate.” Fox
`
`
`
`Factory, 944 F.3d at 1376. What is “require[d] is that the patentee demonstrate that
`
`the product is essentially the claimed invention.” Id. Teva has fully met its burden
`
`in demonstrating as much. POR, 49; EX1001, 1:34-37; EX2263, ¶¶21-26;
`
`EX2272, ¶110; EX2275, ¶¶19-20, 23-24, 26; EX2257, 5.
`
`There is simply no evidence that any unclaimed features that the antibody
`
`products may possess are significant for the objective indicia, as required by law.
`
`Fox Factory, 944 F.3d at 1375. To the contrary, the fact that Ajovy, Emgality, and
`
`eptinezumab indisputably each have a different sequence, but all have received the
`
`same praise, shows that sequences are not driving the praise. The same is true of
`
`other variations (antibody isotype, antibody affinity): there is no evidence of record
`
`that any of these features drive the objective indicia. And to require Teva to prove
`
`“insignificance” of any and every feature Lilly decides to point to, in the absence
`
`of any evidence of the “significance” of such features to the invention and the
`
`objective indicia, is to ask Teva to engage in a futile task of proving a negative.
`
`The fact that some of the challenged claims are directed to a genus and not
`
`species makes no difference. Praise and long-felt need here is not limited to any
`
`single species. Indeed, the field praised all three antibodies—Ajovy, Emgality, and
`
`eptinezumab—for the same reasons. EX2263, ¶¶49-60; POR, 49-51. And the fact
`
`- 5 -
`
`
`
`Case IPR2018-01711
`Patent No. 9,884,907
`
`
`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 can apply to multiple
`
`patents as long as they “generally cover the same invention.” Fox Factory, 944
`
`F.3d at 1377. There is no dispute that the claims in IPR2018-01422, -01423, -
`
`01424, -01425, -01426, -01427, -01710, -01711, and -01712 generally cover the
`
`same invention—humanized anti-CGRP antagonist antibodies and their use—
`
`through claims of varying scope. Therefore, the presumption of nexus applies.
`
`II. Even without a presumption, Teva demonstrated nexus.
`Regardless of presumption, Teva demonstrated that the objective indicia are
`
`tied to the challenged claims. “A finding that a presumption of nexus is
`
`inappropriate does not end the inquiry into secondary considerations.” Fox
`
`Factory, 944 F.3d at 1373. To show nexus, a patentee must show that secondary
`
`indicia results from something that is “both claimed and novel in the claim[s].” In
`
`re Kao, 639 F.3d at 1068 (emphasis in original). Teva has done that. Dr.
`
`Tomlinson testified that Ajovy and Emgality “have the structure and properties
`
`required by the ’907 patent’s claims,” and “are used … to treat headache”—the
`
`basis for their praise and success. EX2272, ¶110; POR, 49. Further, Alder
`
`conceded infringement, demonstrating that the use of its antibody is a claimed
`
`embodiment. EX2275, ¶20; EX2257, 5. And it is undisputed that treating migraine
`
`- 6 -
`
`
`
`Case IPR2018-01711
`Patent No. 9,884,907
`
`with humanized anti-CGRP antibodies is a novel feature.
`
`
`
`It is also undisputed that methods of treating migraine with Ajovy, Emgality,
`
`and eptinezumab are each a species “within the scope of the claims.” In re Kao,
`
`639 F.3d at 1069. Because all of these products behave in the same manner—all
`
`are effective in treating migraine—they establish that the objective indicia is
`
`commensurate with claim scope. Id. at 1068 (“[A]n adequate basis to support the
`
`conclusion that other embodiments falling within the claim will behave in the same
`
`manner . . . will generally establish that the evidence is commensurate with
`
`scope.”). Hence, even without the benefit of a presumption, record evidence
`
`establishes nexus between the objective indicia and the full scope of Teva’s claims.
`
`III. Conclusion
`Fox Factory does not change the fact that Teva is entitled to a presumption
`
`of nexus. 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 24, 2020
`
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`
`Deborah A. Sterling, Ph.D.
`Registration No. 62,732
`
`- 7 -
`
`
`
`
`
`
`
`
`
`
`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
`
`entirety on January 24, 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 24, 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
`
`14469331
`
`
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
