`
`
`
`
`
`
`
`
`
`
`
`
`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 No. IPR2018-01426
`Patent No. 9,890,211 B2
`______________________
`
`PETITIONER’S RESPONSE TO TEVA’S SUPPLEMENTAL BRIEF
`REGARDING FOX FACTORY, INC. v. SRAM, LLC
`
`
`
`
`
`
`
`IPR2018-01426
`Patent No. 9,890,211
`
`I.
`II.
`
`Table of Contents
`Teva Failed to Meet Its Burden of Establishing Coextensiveness................. 1
`Teva Failed to Meet Its Burden of Showing Insignificance of
`Unclaimed Features and Other Patents ......................................................... 1
`III. Teva Failed to Establish Nexus .................................................................... 4
`
`i
`
`
`
`
`
`I.
`
`IPR2018-01426
`Patent No. 9,890,211
`Teva Failed to Meet Its Burden of Establishing Coextensiveness
`Fox Factory rejected changing the coextensiveness requirement to an analysis
`
`
`
`of whether a claim “cover[s]” products cited for secondary considerations. Fox
`
`Factory v. SRAM, LLC, 744 F.3d 1373, 1377 (Fed. Cir. 2019). Yet in its substantive
`
`briefing, Teva merely alleged that the claims “cover one or both of Ajovy® and
`
`Emgality®” without addressing coextensiveness, the broad scope of the claims, or
`
`the materiality of unclaimed features. POR, 51-52; Sur-reply, 25-26; Ex. 2226, ¶114.
`
`Although Teva reaffirmed at the oral hearing that its position was that the
`
`claims “cover” the products and that the claims are not coextensive, Teva now
`
`contends that coextensiveness exists because Ajovy® and Emgality® “are humanized
`
`anti-CGRP antagonist antibodies” within the broad scope of the claims. Br., 1-2, 5;
`
`Paper 69, 63 (“Your Honor, I’m not saying they’re co-extensive”). This is a
`
`distinction without a difference, as Teva fails to address the incredible breadth of the
`
`claims or its many admissions that unclaimed features materially impact function.
`
`II. Teva Failed to Meet Its Burden of Showing Insignificance of Unclaimed
`Features and Other Patents
`Lilly identified multiple features encompassed by the claims but not recited
`
`as limitations that materially affect function—such as amino acid sequence, pM-
`
`level binding affinity, and antibody class. Reply, 21-24. Despite bearing the burden
`
`of establishing that unclaimed features are “insignificant,” Fox Factory, 944 F.3d at
`
`1374-75, Teva offered no response. Sur-reply, 25-26.
`
`1
`
`
`
`
`
`IPR2018-01426
`Patent No. 9,890,211
`Indeed, Teva fails to offer any evidence contradicting the universally
`
`
`
`understood principle that sequence is critical and dictates antibody function. Teva
`
`represented to the FDA that it introduced multiple specific mutations into Ajovy®—
`
`out of more than 20220 possible mutations—to achieve pM-level binding affinity and
`
`eliminate ADCC and CDC. Ex. 1320, 8-9; Ex. 1142, 392 (mutating sequence to
`
`achieve “picomolar range” affinity can have “profound effects on the utility of
`
`antibodies as therapeutic and prophylactic agents”); Ex. 1301, 91:25-92:22. This is
`
`highly analogous to Fox Factory, where a patentee’s representations in its marketing
`
`materials confirmed lack of nexus due to unclaimed features. 944 F.3d at 1375-76.
`
`Emgality®’s specific sequence and resulting properties, with mutations to eliminate
`
`ADCC and CDC, were likewise highlighted to the FDA. Ex. 2216, 17, 21-22, 41.
`
`Teva concedes that Ajovy® and Emgality® have different sequences, but fails
`
`to support its baseless (and belated) assertion that sequence is insignificant to its
`
`secondary considerations evidence. Br., 4-5. Sequence matters: depending on their
`
`specific sequence, anti-CGRP antibodies within the broad scope of all challenged
`
`claims would have (1) binding affinity orders of magnitude worse than Ajovy® and
`
`Emgality®, (2) strong effector functions having the undesired side effect of killing
`
`cells (cytotoxicity), and/or (3) an antibody class never successfully used before in
`
`any FDA-approved antibody. Reply, 21-24; Ex. 1301, 34:9-35:1, 102:1-104:19; Ex.
`
`1012, ¶¶167, 178-179. These unclaimed features would lead to materially different
`
`2
`
`
`
`
`
`IPR2018-01426
`Patent No. 9,890,211
`properties (e.g., no efficacy or significant adverse events) as compared to Ajovy®
`
`
`
`and Emgality®. Reply, 21-24. Notably, even these antibodies have fundamentally
`
`different properties: Lilly’s Emgality® is FDA-approved to treat cluster headache
`
`while Teva’s Ajovy® failed clinically. Ex. 2153, 1.
`
`Teva newly argues that antibodies with different sequences are “associated
`
`with the same praise.” Br., 4. But this alleged praise is directed to only two high-
`
`affinity, sequence-optimized antibodies (Ajovy® and Emgality®) and is not
`
`representative of the broad challenged claims.1 See AbbVie Deutchsland GmbH v.
`
`Janssen Biotech, Inc., 759 F.3d 1285, 1291-92, 1301 (Fed. Cir. 2014) (concluding
`
`that even 300 antibodies do not represent a functionally defined genus). Moreover,
`
`the alleged praise extends to compounds outside the scope of the claims such as anti-
`
`CGRP receptor antibodies and small molecule inhibitors. Reply, 24-25. As Dr.
`
`Rapoport admitted, the only property he considered for nexus is the ability of
`
`antibodies to “block the CGRP pathway,” which is legally insufficient because this
`
`mechanism of action was already disclosed to treat migraine. Reply, 23-24; Ex.
`
`1304, 142:1-8.
`
`
`1 Teva argued Alder only in the context of a license agreement. POR, 60-61. Teva’s
`
`new arguments alleging praise and success for Alder’s antibody should be rejected.
`
`Cablz, Inc. v. Chums, Inc., 708 F. App’x 1006, 1011-12 (Fed. Cir. 2017).
`
`3
`
`
`
`
`
`IPR2018-01426
`Patent No. 9,890,211
`Teva also newly argues that its nine challenged patents “generally cover the
`
`
`
`same invention” without any significant differences. Br., 5-6. Ignoring its burden,
`
`Teva neither analyzed any of the specific combinations of recited features nor
`
`established that the challenged claims of these nine patents are the only relevant
`
`claims for analyzing nexus. Indeed, Teva flatly ignored the unchallenged sequence-
`
`specific claims of the ’794, ’614, ’881, and ’951 patents. Teva also failed to address
`
`the 188 patents and 8 patent families listed in the Alder agreement. Ex. 2257, 20-28.
`
`Teva’s large patent portfolio further shows that no presumption applies.
`
`Teva incorrectly implies that Fox Factory requires an admission of criticality
`
`to find the presumption inapplicable, rather than the existence of just one unclaimed
`
`material feature. Br., 3. Regardless, Teva and its experts admitted that sequence,
`
`antibody class, and affinity all materially affect function, and moreover that Teva’s
`
`claims are not coextensive with Ajovy® and Emgality®. Paper 69, 63; Ex. 1320, 8-9;
`
`Ex. 1301, 34:9-35:1, 102:1-104:19. Thus, Fox Factory confirms that the
`
`presumption does not apply.
`
`III. Teva Failed to Establish Nexus
`Teva chose to rely on the presumption rather than argue that its purported
`
`secondary considerations were attributable to what Teva actually claimed. Sur-reply,
`
`25. Teva’s belated argument to show nexus outside the presumption is thus waived.
`
`It also lacks merit. While Teva cites Drs. Tomlinson and Stoner (Br., 6-7), they
`
`4
`
`
`
`
`
`IPR2018-01426
`Patent No. 9,890,211
`merely testified that the claims “cover” Ajovy® and Emgality® and that the Alder
`
`
`
`license “included”
`
`the ’211 patent—not
`
`that Teva’s purported secondary
`
`considerations evidence is attributable to what is both claimed and novel in the
`
`claims. Ex. 2226, ¶114; Ex. 2243, ¶19. Moreover, as explained above, the cited
`
`products do not represent the countless number of antibodies encompassed by the
`
`claims. As held in Celltrion, Inc. v. Genentech, Inc., therapeutic antibodies lack
`
`nexus to broader claims encompassing multiple sequence mutations. IPR2017-
`
`01374, Paper 85 at 45, 48 (PTAB Nov. 29, 2018) (relying on “one (or a small number
`
`of) species” is “inadequate proof” because “objective evidence … must be
`
`commensurate in scope with the claims which the evidence is offered to support.”).
`
`Alleging that the only critical feature is that the cited products are “humanized
`
`anti-CGRP antagonist antibodies,” Teva forecloses any possibility of establishing
`
`nexus (irrespective of the presumption). Br., 4-5. Indeed, this is not novel—multiple
`
`references taught humanized anti-CGRP antagonist antibodies. Ex. 1096, 567, 570;
`
`Ex. 1287, 247. As stated by the Federal Circuit, it is a “fundamental requirement”
`
`that secondary indicia must result from something that is “both claimed and novel in
`
`the claim.” In re Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011) (emphasis in original).
`
`Because Teva relies exclusively on a non-novel feature, there can be no nexus.
`
`Respectfully submitted,
`
`Date: January 17, 2020
`
`By: / William B. Raich /
`William B. Raich (Reg. No. 54,386)
`
`
`
`5
`
`
`
`
`
`
`
`IPR2018-01426
`Patent No. 9,890,211
`
`CERTIFICATE OF SERVICE
`The undersigned certifies that a copy of the foregoing Petitioner’s
`
`Response to Teva’s Supplemental Brief Regarding Fox Factory, Inc. v. SRAM,
`
`LLC was served electronically via email on January 17, 2020, in its entirety on the
`
`following:
`
`Deborah A. Sterling
`Robert C. Millonig
`Gaby L. Longsworth
`Jeremiah B. Frueauf
`Olga A. Partington
`Dennies Varughese
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`1100 New York Avenue, NW
`Washington, DC 20005
`dsterling-PTAB@sternekessler.com
`bobm-PTAB@sternekessler.com
`glongs-PTAB@sternekessler.com
`jfrueauf-PTAB@sternekessler.com
`opartington-PTAB@sternekessler.com
`dvarughe-PTAB@sternekessler.com
`
`
`Patent Owner has consented to service by email.
`
`
`Date: January 17, 2020
`
`
`
`
`
`
`
`
`
`By: / William Esper /
`William Esper
`Litigation Legal Assistant
`
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`
`
`
`
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
