IPR2016-00383
`Petitioner's Reply to Patent
`Owners' Preliminary Response
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________________________
`
`GENZYME CORPORATION,
`Petitioner
`v.
`
`GENENTECH, INC. AND CITY OF HOPE,
`Patent Owners
`
`Case No. IPR2016-00383
`U. S. Patent No. 6,331,415
`
`Petitioner's Reply to Patent Owners' Preliminary Response
`
`
`Petitioner's Reply to Patent
`Owners' Preliminary Response
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________________________
`
`GENZYME CORPORATION,
`Petitioner
`v.
`
`GENENTECH, INC. AND CITY OF HOPE,
`Patent Owners
`
`Case No. IPR2016-00383
`U. S. Patent No. 6,331,415
`
`Petitioner's Reply to Patent Owners' Preliminary Response
`
`
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`As authorized by the Board (Paper 11), Petitioner Genzyme Corp. submits
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`this Reply to Patent Owners' Preliminary Response ("POPR"), addressing the
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`limited issue of the applicability of 35 U.S.C. §§ 315(e)(1) and 325(d) to
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`Genzyme's Petition for Inter Partes Review of U.S. Patent No. 6,331,415 ("Cabilly
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`II patent"). Patent Owners seek summary dismissal of Genzyme's IPR under
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`§§ 315(e)(1) and 325(d), precluding the Board from reaching the significant new
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`questions of patentability (based on a new prior art reference, the Salser patent) of
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`the challenged "Cabilly II" patent claims presented by Genzyme. That Patent
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`Owners dedicated nearly one-third of the POPR to these non-merit, threshold
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`arguments telegraphs little faith in the validity of their patent. This is not
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`surprising. The Salser patent has substantially different (but equally compelling)
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`teachings—in both detail and functionality—than the prior art Bujard patent that
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`was already considered favorably by the Board in instituting trial. The Board
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`should therefore decline to dismiss the proceedings and agree to hear Genzyme's
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`substantive arguments on invalidity. At a minimum, the Board should permit
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`Genzyme's IPR to proceed to trial on the claims that were not instituted previously.
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`I. Sanofi and Regeneron's IPR Challenge to the Cabilly II Patent,
`the Decision Instituting Trial, and Genzyme's IPR
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`Sanofi-aventis U.S. LLC ("Sanofi U.S.") and Regeneron Pharmaceuticals
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`filed IPR2015-01624 on July 27, 2016 ("Sanofi/Regeneron IPR"), challenging the
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`validity of claims 1-4, 9, 11, 12, 14-20 and 33 of the Cabilly II patent. The petition
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`1
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`relied primarily on the Bujard patent as the base prior art reference and was
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`supported by the expert declaration of Jefferson Foote. Sanofi U.S. identified
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`Sanofi SA—the ultimate parent company (based in France) of Sanofi U.S.—as a
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`real party-in-interest. This Panel issued an Institution Decision on February 5,
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`2016, permitting the matter to proceed to trial on Grounds 2 and 3, covering claims
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`1-4, 11, 12, 14, 18-20 and 33. IPR2015-01624, Paper 15, at 17-22. The Panel did
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`not institute trial on Ground 1 and found Ground 4 to be redundant of Ground 2.
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`Id. at 13-16, 23-24. Because claims 9 and 15-17 ("non-instituted claims") were not
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`part of Grounds 2 and 3, they were not instituted on any ground.
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`On December 30, 2016—after IPR2015-01624 was filed, but before the
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`Institution Decision was issued—Genzyme Corporation filed the present IPR.
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`Genzyme identified Sanofi SA, its ultimate parent company, as a real party-in-
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`interest. The Genzyme Petition challenged the same Cabilly II patent claims as the
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`Sanofi/Regeneron Petition, but relied on a different base prior art reference (the
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`Salser patent) for anticipation, and different grounds for the obviousness
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`combinations, supported by the declaration of a different expert, Margaret Baron.
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`The table below sets out the challenged claims and grounds in both IPRs, as
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`well as their present disposition following the Sanofi/Regeneron Institution
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`Decision. Claims and grounds in green were instituted in the Sanofi/Regeneron
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`IPR; claims and grounds in red were not. The claims in yellow are Genzyme's
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`2
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`§ 103 challenge to the non-instituted claims—a statutory ground for invalidity
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`never presented (by any combination of references) in the Sanofi/Regeneron IPR
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`for these claims.
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`II. The Board Should Not Dismiss the Petition Under 35 U.S.C. § 315(e)(1)
`The relief that Patent Owners seek under § 315(e)(1)1 is premature and
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`overbroad. Patent Owners ask for immediate dismissal2 of the entirety of
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`1 Patent Owners cite to 35 U.S.C. § 325(e)(1) as the basis for dismissal. See POPR
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`at 20-21. Because § 325(e) is the estoppel provision for post-grant reviews,
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`Genzyme assumes Patent Owners intended to rely on 315(e)(1), which contains
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`identical estoppel language in the IPR context.
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`2 No later than July 7, 2016, the deadline for institution under § 314(b)(1).
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`Genzyme's IPR based on the possibility that the earlier-filed Sanofi/Regeneron IPR
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`will reach a final written decision nine months from now3 on no more than a subset
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`of the Cabilly II patent claims in Genzyme's Petition. This extraordinary request is
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`not warranted by the text of § 315(e)(1) or the decisions of the Board. Indeed,
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`Patent Owners invite this Panel to improperly ignore the temporal limitations of
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`the statute, which require that there be a final written decision on a first IPR before
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`the second IPR can be subject to estoppel. See § 315(e)(1).
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`Genzyme is aware of no panel that has granted dismissal of a second petition
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`under 315(e)(1) based on a first petition that had not yet reached a final
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`determination.4 Even when a final written decision in an earlier IPR was imminent
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`(five weeks away), the Board has declined to dismiss a later-filed IPR, finding
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`patent owner's request "premature." Kofax. Inc. v. Uniloc USA, Inc., IPR2015-
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`3 February 7, 2017, is the § 316(a)(11) one-year deadline for the final written
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`decision in the Sanofi/Regeneron IPR.
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`4 Patent Owners (POPR at page 21) rely on Toyota Motor Corp. v. Cellport
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`Systems, Inc., IPR2015-01422, Paper 8, in support of their argument. That decision
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`incorrectly cites § 325(e)(1) as the applicable estoppel provision for IPRs.
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`Nevertheless, the panel appears to have relied on the possibility of a future
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`estoppel only as a basis to exercise discretion to deny institution under other
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`statutory and regulatory grounds. IPR2015-01422, Paper 8, at 19-20.
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`4
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`01207, Paper 14, at 2; see also Westlake Servs. LLC v. Credit Acceptance Corp.,
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`CBM2014-00176, Paper 15, at 21 (declining to terminate a subsequent CBM under
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`§ 325(e)(1) when the final determination for an earlier CBM was six weeks away,
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`finding patent owner's request "unripe" for adjudication).
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`The untimeliness of Patent Owners' request for relief under 315(e)(1) is
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`borne out by recent statistics from the Board showing that nearly 40% of instituted
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`IPRs never proceed to a final written decision, for one reason or another (typically
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`settlement). See Patent Trial and Appeal Board Statistics (March 31, 2016),
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`http://www.uspto.gov/sites/default/files/documents/2016-3-31%20PTAB.pdf.
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`Furthermore, the parties to the Sanofi/Regeneron IPR continue to engage in
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`mediation settlement talks (ADR Statement, IPR2015-01624, Paper No. 24),
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`increasing the statistical likelihood that the Sanofi/Regeneron IPR will not reach a
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`final written decision. Granting Patent Owners their requested relief for what
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`effectively amounts to a "preemptive" estoppel therefore runs the significant risk
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`that Genzyme's IPR will have been needlessly terminated if the statutory
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`contingency of a final determination in the Sanofi/Regeneron IPR is never reached.
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`Lastly, even if the Sanofi/Regeneron IPR proceeds to a final determination
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`next February, no estoppel can ever attach under § 315(e)(1) to Genzyme's IPR
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`with respect to the non-instituted Cabilly II patent claims (9, 15-17) because those
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`claims will not and can not be the subject of any final written decision in the
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`Sanofi/Regeneron IPR. See § 315(e)(1) ("The petitioner in an inter partes review of
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`a claim in a patent… that results in a final written decision… may not request or
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`maintain a proceeding before the Office with respect to that claim…."). On similar
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`facts, the Board's precedential decision in Westlake Servs. LLC held that the
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`estoppel provision of § 325(e)(1) applied on a claim-by-claim basis and therefore
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`had no effect on claims not instituted and therefore not addressed in a earlier final
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`written decision. CBM2014-00176, Paper 28, at 3-5.
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`For these reasons, the Board should not dismiss at this time any of the
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`challenged Cabilly II patent claims in Genzyme's petition under § 315(e)(1). If the
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`Sanofi/Regeneron IPR reaches a final written decision, the Board should allow the
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`non-instituted claims to survive any estoppel that might otherwise apply.
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`III. The Board Should Not Dismiss the Petition Under 35 U.S.C. § 325(d)
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`A. The Prior Art and Arguments in the Petition Are Not Substantially
`the Same as Those in the Sanofi/Regeneron Petition
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`Patent Owners set up a false equivalency between the Salser patent in the
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`Genzyme IPR and Bujard patent in the Sanofi/Regeneron IPR—it is in essence the
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`same § 325(d) argument about plural references to "genes" that this Panel has
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`already rejected in the Sanofi/Regeneron Institution Decision.5 It is irrelevant that
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`5 In the Preliminary Response in the Sanofi/Regeneron IPR, Patent Owners argued
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`that the disclosure of "more than one gene" in Bujard was no different than the
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`both prior art references appear similar simply because they both generally disclose
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`multiple genes (in a variety of different wordings). That "would be expected when
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`challenging the same claims," but it does not make Salser and Bujard "substantially
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`the same." See Ericsson Inc. v. Intellectual Ventures II L.L.C., IPR2015-01664,
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`Paper 7, at 5-6. Likewise, a "high-level similarity in the structure of the arguments"
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`between the Genzyme Petition and Sanofi/Regeneron Petition would not justify a
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`finding that the arguments are "substantially the same." See Caterpillar, Inc. v.
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`Esco Corp., IPR2015-01032, Paper 12, at 5. The subject matter of the challenged
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`Cabilly II patent claims is not a moving target, so the invalidity arguments across
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`two IPRs should not have to be fundamentally divergent to survive § 325(d), as
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`Patent Owners' arguments suggest they must be.
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`In fact, as similar as Salser's disclosures are to Bujard's, they are also
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`meaningfully different, both in the level of detail provided and in the functionality
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`of the Salser invention; and these differences result in substantially different
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`disclosure of "gene or genes" in the Axel patent, which was a prior art reference
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`considered during reexamination of the Cabilly II patent. IPR2015-01624, Paper
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`14, at 34-37. On this basis, Patent Owners sought dismissal under § 325(d). Id. at
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`58-59. The Board declined. Sanofi/Regeneron Institution Decision, at 16, 24.
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`arguments between the Genzyme and Sanofi/Regeneron IPRs. For example, where
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`Patent Owners argued previously that Bujard's teaching of the plural term "genes"
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`would have been understood to be a reference to "multiple repeating units of the
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`same gene" (POPR, IPR2015-01624, Paper 14, at 45 (emphasis added)), Salser
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`removes any doubt on that point by disclosing the additional detail of a "plurality
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`of unrelated genes" (Genzyme Pet., at 37-38 (emphasis added)). And where Bujard
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`teaches the creation of recombinant cells capable of producing foreign proteins
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`(Sanofi/Regeneron Pet., at 45), Salser adds the functionality of using these cells "in
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`the field of gene replacement therapy," not merely for "the production of proteins
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`per se, but [for] the production of those proteins in living subjects in need of the
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`protein to correct a genetic deficiency" (Genzyme Pet., at 59).
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`These differences are sufficient for the Panel to conclude that the prior art
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`and arguments between the Genzyme Petition and Sanofi/Regeneron Petition are
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`not substantially the same. 6 See Actifio, Inc. v. Delphix Corp., IPR2015-00100,
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`Paper 7, at 27-28 (greater "level of detail" precludes finding "substantially the
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`same arguments" between petitions); Valeo North Am., Inc. v. Magna Elecs. Inc.,
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`IPR2015-01410, Paper 7, at 13 (different "functionality" of references persuades
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`6 This Panel has already concluded in the Sanofi/Regeneron Institution Decision (at
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`pages 16, 24) that a "more specific and robust" teaching renders § 325(d)
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`inapplicable.
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`panel that analysis is not substantially the same). But the Board should also
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`consider this additional, singular difference between Salser and Bujard: Salser does
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`not disclose the option of expressing different subunits of a multimeric protein in
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`different host cells. In the Panel's view, this option was expressly presented in
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`Bujard patent, and it was this disclosure that persuaded the Panel not to institute
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`trial on Ground 1 (anticipation). Sanofi/Regeneron Institution Decision, at 15-16.
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`The absence of such an option in Salser should, respectfully, be dispositive in
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`distinguishing Genzyme's anticipation argument (Ground 1) and the associated
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`obviousness arguments (Grounds 2 and 3) from Sanofi/Regeneron's Bujard-based
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`arguments for purposes of § 325(d).
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`Finally, notwithstanding the § 325(d) threshold issue, if the Board is at all
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`inclined to institute a trial on any or all of the § 102 grounds in the petition—as
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`Genzyme believes they should be—this would tend to show that Genzyme's
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`anticipation arguments with respect to the Salser patent, and the various
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`combinations under § 103, are not substantially the same as those in the
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`Sanofi/Regeneron IPR. See Ericsson Inc. v. Intellectual Ventures II L.L.C.,
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`IPR2015-01872, Paper 10, at 15-16 (institution of trial based on new reference on
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`grounds not instituted previously demonstrated that later petition did not present
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`substantially the same arguments); Oxford Nanopore v. Univ. of Wash., IPR2015-
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`00057, Paper 10, at 21 (same).
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`For these reasons, the Board should find that the Salser patent and associated
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`arguments in the Genzyme IPR are not "substantially the same" as the Bujard
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`patent and arguments and that § 325(d) therefore does not apply. At a minimum,
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`the Board should permit Genzyme's Ground 2 on the obviousness of the non-
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`instituted claims (9, 15-17) to proceed to trial because no obviousness argument for
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`these claims was "previously… presented to Office" in the Sanofi/Regeneron IPR,
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`as would be required for rejection under § 325(d).
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`B. The Board Should Not Exercise Its Discretion to
`Reject Genzyme's Petition Under § 325(d)
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`Even if the Board finds that the Genzyme presents substantially the same
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`arguments as Sanofi/Regeneron, the Board should not dismiss Genzyme's IPR. The
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`principal factors that the Board typically considers in the discretionary analysis
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`under § 325(d) weigh in favor of instituting trial.
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`1. Genzyme Formulated the Salser Invalidity Arguments; They
`Were Not Available to Sanofi SA and Sanofi U.S. in July 2015
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`Although Salser was nominally "known" to Sanofi U.S. and Sanofi SA (as
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`was Ochi(I)), this alone is insufficient for the Board to exercise its discretion to
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`dismiss Genzyme's Petition.7 There are numerous instances in Board decisions
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`7 Salser and Ochi(I) were briefly mentioned in the "Technology Background"
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`section of the Sanofi/Regeneron Petition, among a crowded field of other prior art
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`references, to show the advanced state of the art at the time of filing of the Cabilly
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`
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`where a prior art reference was relied upon in sequential proceedings without
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`resulting in dismissal under § 325(d). See, e.g., Samsung Elecs. Am., Inc. v. LED
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`Tech. Dev., LLC, IPR2014-00590, Paper 23, at 8 (discretion to dismiss not
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`exercised where different disclosures of the same reference were relied upon in
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`separate petitions); Palo Alto Networks, Inc. v. Finjan, Inc., IPR2016-00151, Paper
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`10, at 5-6 (no dismissal when the same reference, but on different invalidity
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`grounds (§ 102 versus § 103) was relied upon in different petitions).
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`Furthermore, when the Sanofi/Regeneron Petition was filed in July 2015, the
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`arguments for relying on Salser as a basis for invalidity were not known to Sanofi
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`SA or Sanofi U.S. These were independently formulated and developed by
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`Genzyme in preparation for filing its own IPR, five months later. Ex. 1061,
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`Creagan Decl., ¶¶ 5-6. At no time before the filing of the Sanofi/Regeneron
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`Petition and during the period leading up to the filing of the Genzyme Petition did
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`Genzyme seek authorization from Sanofi SA or Sanofi U.S. regarding the
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`II patent. Sanofi/Regeneron Pet., at 21, 23. Ochi(I) was also cited in passing in the
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`overview of the Cabilly II patent reexamination. Id. at 9-10. All told, the
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`Sanofi/Regeneron Petition allotted only six sentences to both references. They
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`were therefore not the basis for any argument of invalidity, nor were they
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`otherwise "significantly feature[d]" to warrant dismissal under §325(d). See
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`Unilever v. Procter & Gamble, IPR2014-00628, Paper 21, at 10-11.
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`substance of its invalidity arguments based on Salser or the timing of filing of
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`Genzyme's IPR. Id. ¶ 6. Neither Sanofi SA nor Sanofi U.S. therefore could have
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`presented previously the Salser challenges now in Genzyme's Petition.8
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`Although Genzyme has been a wholly owned subsidiary of Sanofi SA since
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`2011, it was a separate, independent business unit of its parent until January 1,
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`2016, when a corporate reorganization took effect. Ex. 1061, Creagan Decl., ¶¶ 2-
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`3. At the time the Sanofi/Regeneron Petition was filed, and through the end of the
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`2015, Genzyme's legal department functioned with a large extent of autonomy
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`from Sanofi SA: it paid for its own IPRs, litigations and related patent matters
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`through its own budget; it made the ultimate decisions of whether and when patent-
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`related legal proceedings would be filed (seeking the authorization only of
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`Genzyme management); and it controlled the strategies and manner in which the
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`proceedings were prosecuted or defended against. Id. ¶ 4. Moreover, nobody
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`within Genzyme's legal department had any direct reporting requirement to anyone
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`8 Even if Sanofi SA was advised of Genzyme's arguments, the 60-page limit would
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`have been a practical impediment to adding to the Sanofi/Regeneron Petition an
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`entire new set of grounds based on Salser. See Ford Motor Co. v. Paice LLC,
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`IPR2015-00767, Paper 14, at 8-9 ("[M]uch of what is presented in the instant
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`Petition could have been presented in [the earlier petition]" because "the [instant]
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`Petition… was 42 pages long, 18 pages shy of the 60 page limit.").
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`(either legal or management) in Sanofi SA. Id.
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`By any of the traditional criteria considered in determining a real party-in-
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`interest ("RPI"), Sanofi SA was therefore not the RPI for Genzyme in July 2015.
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`See generally Trial Practice Guide, 77 Fed. Reg. 48756, 48759-60 (Aug. 14, 2012).
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`The parent-subsidiary relationship between the companies alone is insufficient to
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`find a RPI relationship here. See TRW Automotive U.S. v. Magna Elec. Inc.,
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`IPR2014-01499, Paper 7, at 11. As a practical matter, Sanofi SA could not have
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`taken possession or control over Genzyme's IPR and arguments when the
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`Sanofi/Regeneron Petition was filed. With respect to Genzyme's Petition, it was
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`always Genzyme that "desired review" of the Cabilly II patent and had the power
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`to "call the shots" about the substance of its arguments and the timing of filing. See
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`77 Fed. Reg. at 48759; Gonzalez v. Banco Cent. Corp., 27 F.3d 751, 758 (1st Cir.
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`1994); Ex. 1061, Creagan Decl., ¶¶ 4-6.
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`This, of course, changed on January 1, 2016,9 as reflected in Genzyme's
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`Petition filed on December 30, 2015, identifying Sanofi SA as the RPI in light of
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`9 The reorganization was prospectively announced by Sanofi SA in July 2015. Ex.
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`1061, Creagan Decl., ¶ 7. As part of the restructuring, the reporting structure
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`between Genzyme and Sanofi SA also changed, with the heads of certain Genzyme
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`departments (including legal, and Intellectual Property in particular) now reporting
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`out of Genzyme directly to their Sanofi SA counterparts. Id.
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`the imminent corporate restructuring. Ex. 1061, Creagan Decl., ¶ 7. But in July
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`2015, and in the months and weeks leading up to Genzyme's Petition, Sanofi SA
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`had no involvement in or control of the preparation or filing of Genzyme's IPR. Id.
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`¶¶ 5-6. For these reasons, Sanofi SA could not have presented the Salser invalidity
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`grounds in its petition, and the Board should exercise its discretion accordingly and
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`hear the merits of Genzyme's Petition.
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`2. Neither Genzyme Nor Sanofi SA Engaged in Gamesmanship
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`Genzyme's Petition was not an opportunity for Sanofi SA to improperly
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`"perfect its challenges through a subsequent filing." See Travelocity.com L.P. v.
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`Cronos Techs, LLC, CBM2015-00047, Paper 7, at 13. It was filed before the
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`Sanofi/Regeneron Institution Decision and without the benefit of knowing which
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`grounds and claims would be instituted. The Salser-based invalidity grounds
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`asserted in the Genzyme Petition therefore were not intended, and could not be
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`intended, to "squarely address[] the alleged deficiencies identified by the Board"
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`using the institution decision as a roadmap to remedy the Petition.10 See Butamax
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`Advanced Biofuels LLC v. Gevo, Inc., IPR2014-00581, Paper 8, at 12.
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`10 At least one panel has found that this practice does not, in any event, run afoul of
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`Board rules. Coalition for Affordable Drugs V LLC v. Biogen MA Inc., IPR2015-
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`01136, Paper 20, at 23 ("We are unaware of any established per se rule of this
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`Insofar as Patent Owners complain (POPR at 18) that Genzyme relied on
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`their Preliminary Response to present certain arguments about the Axel patent and
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`the reexamination, this amounts to much protesting about very little—at most, a
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`collateral issue. There were no substantive arguments about Salser in the
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`Preliminary Response that would give Genzyme any insight into Patent Owners'
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`views of the patent for purposes of anticipation or obviousness. Furthermore, the
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`Sanofi/Regeneron Petition itself had already previewed the issue of why the
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`reexamination and the Axel patent did not foreclose invalidity of the Cabilly II
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`patent claims based on new prior art (Bujard) never considered by the Patent
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`Office. Sanofi/Regeneron Pet., at 27, 30. There is therefore no legitimate reason
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`here for the Board to exercise its discretion to dismiss Genzyme's Petition.
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`Dated: May 20, 2016
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`Respectfully submitted,
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`By: ________________________
`Richard McCormick (Reg. No. 55,902)
`Lisa M. Ferri (pro hac vice)
`Brian W. Nolan (Reg. No. 45,821)
`MAYER BROWN LLP
`1221 Avenue of the Americas
`New York, NY 10020-1001
`Attorneys for Petitioner Genzyme
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`Board declining to institute based on so-called 'how-to guide(s)' [from prior failed
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`institution attempts].").
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`CERTIFICATE OF SERVICE
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`I hereby certify that true and correct copies of the Petitioner’s Reply to Patent Owner’s
`Preliminary Response, Genzyme Exhibit 1061 – Declaration of Timohty Creagan in Support of
`Petitioner’s Reply to Patent Owner’s Preliminary Response, and Modified Petition Exhibit List,
`were served May 20, 2016 via electronic mail on counsel of record for the Patent Owners of U.S.
`Patent No. 6,331,415 in IPR2016-00383, pursuant to Paper Nos. 4-6 and 37 C.F.R. § 42.6(e), at
`the following addresses:
`
`David L. Cavanaugh, Reg. No. 36,476
`David.Cavanaugh@wilmerhale.com
`
`Robert J. Gunther, Jr., pro hac vice motion pending
`Robert.Gunther@wilmerhale.com
`
`Heather M. Petruzzi, Reg. No. 71,270
`Heather.Petruzzi@wilmerhale.com
`
`Adam R. Brausa, Reg. No. 60,287
`abrausa@durietangri.com
`
`Daralyn J. Durie, pro hac vice motion pending
`ddurie@durietangri.com
`
`Jeffrey P. Kushan, Reg. No. 43,401
`jkushan@sidley.com
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`Dated: May 20, 2016
`
`/Richard J. McCormick/
`
`Richard J. McCormick, (No. 55,902)
`rmccormick@mayerbrown.com
`MAYER BROWN LLP
`1221 Avenue of the Americas
`New York, NY 10020-1001
`Telephone: (212) 506-2382
`Fax: (212) 849 5682
`
`720506337
`
`16
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