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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`———————
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`REGENERON PHARMACEUTICALS, INC.,
`Petitioner,
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`v.
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`NOVARTIS PHARMA AG,
`NOVARTIS TECHNOLOGY LLC,
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Patent Owner.
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`———————
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`U.S. Patent No. 9,220,631
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`PETITIONER’S NOTICE RANKING PETITIONS
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`Petitioner concurrently filed two petitions challenging all claims of U.S.
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`Patent No. 9,220,631 (“the ’631 Patent”). As instructed in the Patent Trial and
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`Appeal Board Consolidated Trial Practice Guide (Nov. 2019) (“CTPG”), Petitioner
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`submits this Notice to provide (1) a ranking of the petitions in the order in which it
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`wishes the Board to consider the merits; and (2) a succinct explanation of the
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`differences between the petitions, why the issues addressed by the differences are
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`material, and why the Board should exercise its discretion to institute an additional
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`petition if it identifies one petition that satisfies Petitioner’s burden under 35
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`U.S.C. § 314(a). CTPG at 60.
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`Although Petitioner believes that both Petitions are meritorious and justified,
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`Petitioner requests the Board to consider the petitions according to the following
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`ranking:
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`Rank
`1
`2
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`Petition
`IPR2020-01317
`IPR2020-01318
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`Claims
`1-26
`1-26
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`Principal References
`Sigg1 and Boulange2
`Lam3 and Reuter4
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`1 PCT Patent Publication No. WO 2011/006877 to Sigg et al. (Ex. 1007)
`2 PCT Patent Publication No. WO 2009/030976 to Boulange et al. (Ex. 1008)
`3 PCT Patent Publication No. WO 2008/077155 to Lam et al. (Ex. 1029)
`4 Bruno Reuter & Claudia Petersen, Syringe Siliconization, 4 TECHNOPHARM 2,
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`238 (2012). (Ex. 1010)
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`1
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`The claims of the ’631 Patent are directed to a terminally sterilized pre-filled
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`glass syringe containing a VEGF-antagonist that includes low levels of silicone oil
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`(e.g., less than 100 µg) and a stopper break loose force less than 11 N. Petition #1
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`(Sigg + Boulange) and Petition #2 (Lam + Reuter) present different combinations
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`of terminal sterilization and siliconization prior art: Sigg and Lam disclose
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`different methods of terminal sterilization, while Boulange and Reuter disclose
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`siliconized pre-filled glass syringes having the claimed levels of silicone oil and
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`stopper break loose force. As explained below, there are several material
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`differences between the petitions and prior art that warrant the Board’s separate
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`consideration of each petition.
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`First, there is an issue regarding the priority date of the ’631 Patent that
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`merits the consideration of two petitions. CTPG at 59 (“the Board recognizes that
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`there may be circumstances in which more than one petition may be necessary,
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`including, for example, … when there is a dispute about priority date requiring
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`arguments under multiple prior art references.”). Although the ’631 Patent was
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`filed on January 25, 2013, the ’631 Patent claims priority to a foreign application
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`(EP12174860) filed on July 3, 2012.5 Petition #1, relies on publications—Sigg and
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`Boulange—that qualify as prior art under pre-AIA § 102(b) even if the ’631 Patent
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`5 There is a typo on the face of the ’631 Patent, which lists the earliest foreign
`application priority date as July 30, 2012.
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`2
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`is entitled to its earliest claimed priority date. Patent Owner cannot swear behind
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`Sigg and Boulange. In contrast, Petition #2 argues that the ’631 Patent is not
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`entitled to a July 3, 2012 priority date because EP12174860 fails to disclose the
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`break loose forces required by every challenged claim. For this reason, Reuter,
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`which was publicly available no later than August 14, 2012, is prior art to the ’631
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`Patent under pre-AIA § 102(a). Even if the claims of the ’631 Patent are not
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`entitled to a July 3, 2012 priority date, Patent Owner Novartis may still attempt to
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`swear behind Reuter. A single petition provided inadequate space to challenge the
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`priority date of the ’631 Patent, while also including grounds based on both
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`Sigg/Boulange and Lam/Reuter.
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`Second, there are differences between the principal references asserted in
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`Petition #1 and Petition #2 that warrant consideration of both petitions. Sigg and
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`Lam disclose different processes for terminal sterilization of a pre-filled syringe—
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`ethylene oxide (EtO) v. hydrogen peroxide (H2O2). Petitioner cannot predict
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`whether Patent Owner may argue that this distinction is relevant to the obviousness
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`combinations proposed in the petitions. Accordingly, Petitioner should be
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`permitted to include grounds based on both Sigg and Lam. In addition, with
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`respect to dependent claims 18 and 19 of the ’631 Patent, Lam discloses explicit
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`data regarding the amount of EtO residue remaining (Ex. 1029 at 13:10-16:3),
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`3
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`whereas Sigg discloses “degrad[ing] all potentially remaining hydrogen peroxide
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`residue” (Ex. 1007 at 3:22-24).
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`Third, there are differences between the secondary references asserted in
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`Petition #1 and Petition #2 that warrant consideration of both petitions. While
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`Boulange and Reuter both disclose siliconizing a pre-filled glass syringe with low
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`levels of silicone oil, only Reuter explicitly discloses the use of DC 365 silicone oil
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`emulsion with a silicone oil having a viscosity of 350 cP as required by dependent
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`claims 4, 10, and 23 of the ’631 Patent. In Petition #1, the ground addressing
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`dependent claims 4, 10 and 23 introduces an additional reference (Fries). For this
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`reason, Petition #1 requires five grounds to address all of the challenged claims,
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`while Petition #2 requires only four grounds.
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`Fourth, consideration of both petitions is warranted due to the large number
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`of claims in the ’631 Patent asserted by Patent Owner. CTPG at 59 (“the Board
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`recognizes that there may be circumstances in which more than one petition may
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`be necessary, including, for example, when the Patent Owner has asserted a large
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`number of claims in litigation …”). In an ITC complaint filed on June 19, 2020,
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`Patent Owner alleged infringement of claims 1-6 and 11-26, and a domestic
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`industry based on claims 1-10 and 14-26. Patent Owner has not yet identified
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`asserted claims for the NDNY action. Given that all twenty-six claims are at issue
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`in the co-pending litigation and the number of grounds required to address all
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`4
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`twenty-six claims, it would not have been feasible for Petitioner to effectively
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`present its prior art challenges in a single petition while also addressing the priority
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`issue.
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`In view of the differences described above, the Board should exercise its
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`discretion to institute both petitions. The materiality of the differences may be
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`amplified by whether Patent Owner attempts to eliminate prior art (e.g., on the
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`basis of priority) or contests the teachings of the prior art. The Grounds set forth in
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`the petitions are not redundant, duplicative, or substantially similar. Moreover,
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`each petition provides a strong showing of obviousness based on prior art that was
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`not of record during prosecution of the ’631 Patent. Accordingly, Petitioner
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`requests that the Board institute trial on both petitions.
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`5
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`Dated: July 16, 2020
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`Respectfully submitted,
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`/Elizabeth S. Weiswasser/
`Elizabeth S. Weiswasser (Reg. No. 55,721)
`Anish R. Desai (Reg. No. 73,760)
`Natalie Kennedy (Reg. No. 68,511)
`Andrew Gesior (Reg. No. 76,588)
`WEIL, GOTSHAL & MANGES LLP
`767 Fifth Avenue
`New York, NY 10153
`T: 212-310-8000
`F: 212-310-8007
`E: Regeneron.IPR.Service@weil.com
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`Brian E. Ferguson (Reg. No. 36,801)
`Christopher Pepe (Reg. No. 73,851)
`WEIL, GOTSHAL & MANGES LLP
`2001 M Street NW, Suite 600
`Washington, DC 20036
`T: 202-682-7000
`F: 202-857-0940
`E: Regeneron.IPR.Service@weil.com
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`6
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.105 and § 42.6(e), the undersigned certifies that
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`on July 16, 2020, a complete and entire copy of this Petitioner’s Notice Ranking
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`Petitions was provided via Federal Express to the Patent Owner by serving the
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`correspondence address of record as follows:
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`Michael Mazza
`Daniel Woods
`Novartis Pharmaceutical Corporation
`Intellectual Property Department
`One Health Plaza 433
`East Hanover, NJ 07936-1080
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`/Timothy J. Andersen/
`Timothy J. Andersen
`Case Manager
`Weil, Gotshal & Manges LLP
`2001 M Street, N.W., Suite 600
`Washington, D.C. 20036
`202-682-7000
`timothy.andersen@weil.com
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