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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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`__________
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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 Owners
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`__________
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`
`Case IPR2020-01318
`Patent 9,220,631
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`__________
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`PATENT OWNERS’ RESPONSE TO PETITIONER’S
`NOTICE RANKING PETITIONS
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`1
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`U.S. Patent No. 9,220,631
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`Petitioner filed two, largely duplicative, petitions challenging U.S. Patent
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`No. 9,220,631 (“the ’631 Patent”). IPR2020-01317, Paper 3 (“-01317 Petition”);
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`IPR2020-01318, Paper 3 (“-01318 Petition”). As explained in Patent Owner’s
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`Preliminary Responses, the Board should decline to institute both petitions. If the
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`Board decides to institute review of the ’631 Patent, however, it should only
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`institute one petition.
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`In most cases, one petition is sufficient to challenge the claims of a patent.
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`Consolidated Trial Practice Guide November 2019 (“TPG”) at 59 (“[M]ultiple
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`petitions by a petitioner are not necessary in the vast majority of cases.”).
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`Addressing two petitions at the same time places an unnecessary burden on the
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`Board and Patent Owner. Id. Petitioner argues that both of these petitions should be
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`instituted because they fall within the scope of the two scenarios contemplated in
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`the TPG where a second petition might be warranted—a potential dispute
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`regarding priority date, and Patent Owner’s assertion of a large number of claims.
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`Petitioner, however, only states that these issues may be present, but does not
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`provide any explanation of why these circumstances warrant a second petition here.
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`First, the mere presence of a potential priority dispute does not justify
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`multiple petitions, and in fact, the need for multiple petitions in these cases “should
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`be rare.” TPG at 59; Square, Inc. v. 4361423 Canada Inc., IPR2019-01626, Paper
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`14 at 10 (March 30, 2020) (“[T]he November 2019 TPG does not contemplate that
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`2
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`U.S. Patent No. 9,220,631
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`whenever there is a priority dispute, Petitioner is justified in filing two petitions
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`against the same patent.”). Here, Petitioner’s second petition is completely
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`unnecessary and a problem of Petitioner’s own making.
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`Petitioner ranked IPR2020-01317 (Sigg and Boulange) first and IPR2020-
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`01318 (Lam and Reuter) second. Paper 2 at 1. Petitioner suggests its second
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`petition is warranted because there is a possible priority dispute implicating the
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`applicability of Reuter (asserted as 102(a) prior art). Id. at 2-3. But that gets it
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`backwards—it is Petitioner’s second petition that has a possible priority question,
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`not Petitioner’s first petition. Notably, Petitioner identifies no material differences
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`between Boulange (asserted as 102(b) art) and Reuter except that “Reuter
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`explicitly discloses the use of DC 365 silicone oil emulsion.” Id. at 4. This alleged
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`distinction is applicable to just three dependent claims, and Petitioner separately
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`alleges “was a known, commercially available silicone oil emulsion” in its first
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`petition. See -01317 Petition at 59-61. Petitioner does not identify any other
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`perceived strengths in the disclosure of Reuter compared to the disclosure in
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`Boulange that would necessitate a second petition. Simply choosing to raise a set
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`of duplicative arguments should not entitle Petitioner to two petitions. Nor does it
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`justify burdening the Patent Owner and the Board. See Dropbox, Inc. v. WhitServe
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`LLC, IPR2019-01018, Paper 13 at 8-9 (Nov. 1, 2019) (rejecting a second petition
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`where petitioner presented another petition with alternative arguments that could
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`3
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`U.S. Patent No. 9,220,631
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`not be antedated).
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`Second, Petitioner’s only other justification for the second petition is that a
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`single petition did not provide enough space to present its alternative arguments.
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`Paper 2 at 3. But Petitioner does not provide any explanation of why its arguments
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`present the rare circumstance that justifies a second review. For example,
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`Petitioner does not address only a subset of claims in the first petition and a
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`different subset in the second petition. Nor does Petitioner allege that claim
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`construction issues make some asserted references more (or less) relevant.
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`Moreover, Petitioner was able to challenge all 26 claims in each of the petitions,
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`eliminating any risk of prejudice to Petitioner and demonstrating that the number
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`of claims did not make a challenge in a single petition impossible. See Square at 10
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`(rejecting multiple petitions were “Petitioner was able to assert multiple grounds
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`against all eighteen challenged claims in a single petition”); Dropbox, IPR2019-
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`01018, Paper 13 at 6 (“Th[e] duplication of challenges undermines Petitioner’s
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`argument that the number . . . of the claims requires two petitions.”). Additionally,
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`the number of claims is not a deciding factor, as the Board has denied multiple
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`petitions where Petitioners have challenged more than 26 claims. Comcast Cable
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`Commc’ns, LLC, v. Rovi Guides, Inc., IPR2019-01377, Paper 9 at 8-9 (Feb. 10,
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`2020) (denying institution of two of three petitions challenging 30 claims); Nalox-1
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`Pharms., LLC, v. Opiant Pharms., Inc., IPR2019-00686, Paper 11 at 6-7 (Aug. 27,
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`4
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`U.S. Patent No. 9,220,631
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`2019) (denying two of three petitions challenging 29 claims); Nalox-1 Pharms.,
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`LLC, v. Opiant Pharms., Inc., IPR2019-00689, Paper 11, 6-7 (Sept. 9, 2019)
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`(denying two of three petitions challenging all 45 claims in patent); Nalox-1
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`Pharms., LLC, v. Opiant Pharms., Inc., IPR2019-00695, Paper 10, 6 (Oct. 1, 2019)
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`(denying two of three petitions challenging all 30 claims in patent).
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`Moreover, the fact that the asserted references may be different is not
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`enough to merit a second petition. See Volkswagen Grp. of Am., Inc. v. Mich.
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`Motor Techs. LLC, IPR2020-00161, Paper 8 at 10 (PTAB June 2, 2020) (“A
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`petition that presents alternative arguments directed to the same claims is not
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`sufficient to show, in accordance with the [TPG], that the differences between the
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`petitions warrant institution of both proceedings.”). Nonetheless, the grounds
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`raised here in each IPR are essentially the same: the combination of a reference
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`allegedly disclosing terminal sterilization of a pre-filled syringe with another
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`reference allegedly disclosing siliconization of a pre-filled syringe. For example,
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`the only difference Petitioner identifies between Sigg (Petitioner’s lead reference
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`in the -01317 Petition) and Lam (Petitioner’s lead reference in the -01318 Petition)
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`is the different specific processes for terminal sterilization. Paper 2 at 3. However,
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`none of the claims of the ’631 patent is limited to either one of these processes, and
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`this difference does not impact Patent Owners’ position that these references would
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`not have rendered the challenged claims unpatentable.
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`5
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`U.S. Patent No. 9,220,631
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`This duplication is also evident because the two petitions rely on the exact
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`same supporting references, compare -01317 Grounds 3-5 with -01318 Grounds 2-
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`4, and Petitioner’s allegations of the motivation to combine the asserted references
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`are virtually identical, compare, e.g., -01317 Petition at 37 with -01318 Petition at
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`34. Here again, the two petitions present nothing more than alternative references
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`supporting the same argument. And Petitioner does not present a compelling
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`reason why these combinations need to be addressed in separate proceedings.
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`Comcast Cable Comms, LLC v. Rovi Guides, Inc., IPR2019-00279, Paper 10 at 7
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`(July 1, 2019) (rejecting multiple petitions because the differences between the
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`references cited were not “sufficiently material and in dispute to support the
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`inefficiencies and costs associated with instituting an additional [IPR].”).
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`As explained in Patent Owner’s Preliminary Responses, neither petition
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`challenging the ’631 patent should be instituted on its merits. However, if the
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`Board decides in favor of institution, it should only institute a single proceeding.
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`Petitioner’s arguments for multiple petitions do not provide sufficient justification
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`for the rare institution of parallel challenges to a single patent, and should,
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`therefore, be rejected.
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`Dated: October 22, 2020
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`By:
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`
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`
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`/Elizabeth J. Holland/
`Elizabeth J. Holland (Reg. No. 47,657)
`Lead Counsel for Patent Owners
`Goodwin Procter LLP
`620 Eighth Avenue
`New York, NY 10018
`6
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`U.S. Patent No. 9,220,631
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`CERTIFICATE OF SERVICE
`A copy of this Novartis Pharma AG, Novartis Technology LLC, and
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`Novartis Pharmaceuticals Corporation’s Response to Petitioner’s Notice Ranking
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`Petitions has been served on Petitioner’s attorneys of record as follows via
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`electronic mail:
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`Elizabeth Stotland Weiswasser
`Weil, Gotshal & Manges LLP
`767 Fifth Avenue
`New York, NY 10153
`T: 212-310-8022
`F: 212-310-8007
`elizabeth.weiswasser@weil.com
`USPTO Reg. No. 55,721
`Anish R. Desai
`Weil, Gotshal & Manges LLP
`767 Fifth Avenue
`New York, NY 10153
`T: 212-310-8730
`F: 212-310-8007
`anish.desai@weil.com
`USPTO Reg. No. 73,760
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`Natalie Kennedy
`Weil, Gotshal & Manges LLP
`767 Fifth Avenue
`New York, NY 10153
`T: 212-310-8730
`F: 212-310-8007
`natalie.kennedy@weil.com
`USPTO Reg. No. 68,511
`Andrew Gesior
`Weil, Gotshal & Manges LLP
`767 Fifth Avenue
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`
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`7
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`U.S. Patent No. 9,220,631
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`New York, NY 10153
`T: 212-310-8730
`F: 212-310-8007
`andrew.gesior@weil.com
`USPTO Reg. No. 76,588
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`Brian E. Ferguson
`Weil, Gotshal & Manges LLP
`2001 M Street, N.W., Suite 600
`Washington, D.C. 20036
`T: 202-682-7000
`F: 202-857-0940
`brian.ferguson@weil.com
`USPTO Reg. No. 36,801
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`Christopher M. Pepe
`Weil, Gotshal & Manges LLP
`2001 M Street, N.W., Suite 600
`Washington, D.C. 20036
`T: 202-682-7000
`F: 202-857-0940
`christopher.pepe@weil.com
`USPTO Reg. No. 73,851
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`Regeneron.IPR.Service@weil.com
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`Attorneys for Regeneron Pharmaceuticals, Inc.
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`
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`Dated: October 22, 2020
`By:
`/Elizabeth J. Holland/
`Elizabeth J. Holland (Reg. No. 47,657)
`Lead Counsel for Patent Owners
`Goodwin Procter LLP
`620 Eighth Avenue
`New York, NY 10018
`Phone: (212) 813-8800
`Fax: (212) 355-3333
`EHolland@goodwinlaw.com
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`8
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