Trials@uspto.gov
`571-272-7822
`
` Paper 13
`
`Date: October 26, 2021
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`REGENERON PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`NOVARTIS PHARMA AG,
`NOVARTIS TECHNOLOGY LLC,
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Patent Owner.
`____________
`
`IPR2021-00816
`Patent 9,220,631 B2
`____________
`
`
`
`Before ERICA A. FRANKLIN, ROBERT L. KINDER, and
`KRISTI L. R. SAWERT, Administrative Patent Judges.
`
`KINDER, Administrative Patent Judge.
`
`
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314, 37 C.F.R. § 42.4
`
`
`
`
`571-272-7822
`
` Paper 13
`
`Date: October 26, 2021
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`REGENERON PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`NOVARTIS PHARMA AG,
`NOVARTIS TECHNOLOGY LLC,
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Patent Owner.
`____________
`
`IPR2021-00816
`Patent 9,220,631 B2
`____________
`
`
`
`Before ERICA A. FRANKLIN, ROBERT L. KINDER, and
`KRISTI L. R. SAWERT, Administrative Patent Judges.
`
`KINDER, Administrative Patent Judge.
`
`
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314, 37 C.F.R. § 42.4
`
`
`
`
`
`IPR2021-00816
`Patent 9,220,631 B2
`
`INTRODUCTION
`I.
`On April 16, 2021, Regeneron Pharmaceuticals, Inc. (“Petitioner” or
`“Regeneron”)1 filed a Petition to institute inter partes review of claims 1–26
`(all claims) of U.S. Patent No. 9,220,631 B2 (Ex. 1001, “the ’631 patent”).
`Paper 1 (“Petition” or “Pet.”). Novartis Pharma, AG, et al., (“Patent Owner”
`or “Novartis”)2 filed a Preliminary Response to the Petition. Paper 8
`(“Preliminary Response” or “Prelim. Resp.”). Pursuant to our authorization,
`Petitioner filed a Reply (Paper 11, “Reply”) and Patent Owner filed a Sur-
`Reply (Paper 12, “Sur-Reply”).
`An inter partes review may not be instituted unless the information
`presented in the petition and the preliminary response shows “there is a
`reasonable likelihood that the petitioner would prevail with respect to at least
`1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). For
`the reasons set forth below, upon considering the Petition, Preliminary
`Response, Reply, Sur-Reply, and evidence of record, we are persuaded that
`Petitioner has demonstrated, under 35 U.S.C. § 314(a), a reasonable
`likelihood that it would prevail in showing the unpatentability of at least one
`of the challenged claims. Accordingly, we institute an inter partes review of
`the challenged claims.
`
`
`1 Petitioner identifies Regeneron Pharmaceuticals, Inc. as the real party in
`interest. Pet. 1.
`2 Patent Owner identifies the named parties (Novartis Pharma AG, Novartis
`Technology LLC, and Novartis Pharmaceuticals Corporation) as the real
`parties in interest. Paper 4, 2.
`
`2
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`II. BACKGROUND
`A. Related Cases and Proceedings
`The ’631 patent is involved in two district court cases. Pet. 1–2. On
`June 19, 2020, Patent Owner filed a complaint3 in the United States District
`Court for the Northern District of New York (NDNY) alleging that
`Petitioner infringes at least claim 1 of the ’631 patent. Pet. 2 (“parallel
`district court litigation”). On July 17, 2020, Regeneron filed a complaint4 in
`the Southern District of New York (SDNY) against Novartis and Vetter
`Pharma International GmbH seeking judgment that (i) Novartis’s and
`Vetter’s conduct violates Section 1 of the Sherman Act, (ii) Novartis’s
`conduct violates Section 2 of the Sherman Act, and (iii) the ’631 patent be
`declared unenforceable. Pet. 2–3 (“antitrust litigation”).
`On June 19, 2020, Novartis filed a complaint at the International
`Trade Commission (“ITC”) alleging that Regeneron infringed claims 1–6
`and 11–26 of the ’631 patent. Pet. 1–2 (“ITC Investigation”). On April 8,
`2021, Novartis filed a motion to terminate the ITC Investigation on the basis
`of withdrawal of the complaint. Pet. 2; Ex. 1006. On April 8, 2021, the
`Administrative Law Judge issued an initial determination terminating the
`ITC Investigation. Ex. 1010.
`On July 16, 2020, Petitioner filed petitions in IPR2020-01317
`(IPR’1317) and IPR2020-01318 (IPR’1318) challenging claims 1–26 of the
`
`
`3 Novartis Pharma AG et al. v. Regeneron Pharms., Inc., No. 20-cv-690
`(N.D.N.Y.) (filed Jun. 19, 2020).
`4 Regeneron Pharms., Inc. v. Novartis Pharma AG et al., No. 20-cv-5502
`(S.D.N.Y.) (filed July 17, 2020).
`
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`’631 patent. Pet. 2. On December 2, 2020, Petitioner filed a motion to
`terminate IPR’1318 and the Board issued an order terminating the
`proceeding on December 7, 2020. On January 15, 2021, the Board exercised
`its discretion under 35 U.S.C. § 314(a) and denied institution of IPR’1317
`based on the ITC Investigation that was co-pending at that time.
`B. The ’631 Patent
`The ’631 patent is titled “SYRINGE.” Ex. 1001, code (54). The ’631
`patent “relates to a syringe, particularly to a small volume syringe such as a
`syringe suitable for ophthalmic injections.” Id. at code (57). The U.S.
`application resulting in the ’631 patent was filed on January 25, 2013 (id. at
`code (22)), and identifies multiple purported foreign priority applications,
`the earliest of which was filed in July 2012 (id. at code (30)).
`The Specification notes that for small volume syringes intended for
`eye injections, sterilization can present issues that are not necessarily
`associated with larger syringes. Id. at 1:22–30. Further, certain therapeutics
`are particularly sensitive to sterilization techniques, thus it is important for
`the syringe to remain robustly sealed but also easy to use in that the force
`required to depress the plunger to administer the medicament must not be
`too high. Id. at 1:31–40.
`
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`Figure 2 of the ’631 patent, reproduced below, illustrates a cross
`section through the syringe. Id. at 10:60–67.
`
`
`Figure 2 (above) depicts a cross section of a top down view of a syringe. Id.
`at 10:48–49.
`As described, syringe 1 comprises body 2, stopper 10 and plunger 4. Id. at
`10:61–67. Syringe 1 extends along first axis A, and body 2 comprises outlet
`12 at outlet end 14. Id. Stopper 10 is arranged within body 2 such that front
`surface 16 of stopper 10 and body 2 define variable volume chamber 18. Id.
`Variable volume chamber 18 contains injectable medicament 20 comprising
`an ophthalmic solution comprising a VEGF antagonist. Id. at 10:67–11:2.
`Injectable fluid 20 can be expelled though outlet 12 by movement of stopper
`10 towards outlet end 14 thereby reducing the volume of variable volume
`chamber 18. Id. at 11:3–5.
`
`
`C. Challenged Claims
`The ’631 patent includes twenty-six claims, and Petitioner challenges
`each claim. Claim 1 is illustrative and reads as follows:
`
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`1. A pre-filled, terminally sterilized syringe for intravitreal
`injection, the syringe comprising a glass body forming a barrel,
`a stopper and a plunger and containing an ophthalmic solution
`which comprises a VEGF-antagonist, wherein:
`a) the syringe has a nominal maximum fill volume of between
`about 0.5 ml and about 1 ml,
`(b) the syringe barrel comprises from about 1 µg to 100 µg
`silicone oil,
`(c) the VEGF-antagonist solution comprises no more than 2
`particles >50 μm in diameter per ml and wherein the syringe has
`a stopper break loose force of less than about 11N.
`Ex. 1001, 19:2–13.
`D. Asserted Grounds of Unpatentability
`Petitioner asserts several grounds of unpatentability (Pet. 21–23),
`which are provided in the table below:
`Claim(s) Challenged 35 U.S.C. §
`1–3, 5–9, 14–22, 24
`103(a)5
`
`Reference(s)/Basis
`Sigg, 6 Boulange, 7 “and if
`necessary USP789”8
`
`
`5 The Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284
`(2011) (“AIA”), amended 35 U.S.C. § 103. Because the challenged claims
`of the ’631 patent have an effective filing date before the effective date of
`the applicable AIA amendments, we refer to the pre-AIA version of 35
`U.S.C. § 103 in this Decision.
`6 PCT Patent Publication No. WO 2011/006877 (Ex. 1007).
`7 PCT Patent Publication No. WO 2009/030976 (Ex. 1008).
`8 U.S. Pharmacopeia, USP 789, Particulate Matter in Ophthalmic
`Solutions, USP 34 NF 29 (2011) (“USP789”) (Ex. 1019). Petitioner
`contends that “USP789 demonstrates a POSITA would have known that
`Sigg and Lam were required to meet the claimed particle amounts. . . .
`
`6
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`Claim(s) Challenged 35 U.S.C. §
`1–3, 5–9, 14–22, 24
`103(a)
`
`Reference(s)/Basis
`Lam9 and Boulange
`
`4, 10, 23
`
`4, 10, 23
`
`11–13
`
`11–13
`
`25
`
`25
`
`26
`
`26
`
`103(a)
`
`103(a)
`
`103(a)
`
`103(a)
`
`103(a)
`
`103(a)
`
`103(a)
`
`103(a)
`
`Sigg, Boulange, Fries10
`
`Lam, Boulange, Fries
`
`Sigg, Boulange, Furfine11
`
`Lam, Boulange, Furfine
`
`Sigg, Boulange, 2008 Macugen
`Label12
`Lam, Boulange, 2008 Macugen
`Label
`Sigg, Boulange, Dixon13
`
`Lam, Boulange, Dixon
`
`Petitioner also relies on the declarations of Horst Koller (Ex. 1003)
`and Szilárd Kiss, M.D. (Ex. 1031). Patent Owner relies on the declaration of
`
`Petitioner’s obviousness arguments remain the same if USP789 should be
`explicitly listed in Grounds 1-10.” Pet. 21 n.7.
`9 PCT Patent Publication No. WO 2008/077155 (Ex. 1029).
`10 Arno Fries, Drug Delivery of Sensitive Biopharmaceuticals With
`Prefilled Syringes, 9(5) DRUG DELIVERY TECH. 22 (2009) (Ex. 1012).
`11 PCT Patent Publication No. WO 2007/149334 (Ex. 1021).
`12 Internet Archive WayBack Machine, March 7, 2011 Record of
`Drugs.com, Macugen Prescribing Information, available at
`https://web.archive.org/web/20110307065238/http://www.drugs.com:
`80/pro/macugen.html (Ex. 1009).
`13 James A. Dixon, et al. “VEGF Trap-Eye for the treatment of
`neovascular age-related macular degeneration.” Expert opinion on
`investigational drugs 18.10 (2009): 1573–1580 (Ex. 1030).
`7
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`Karl R. Leinsing (Ex. 2001). The parties rely on numerous other exhibits
`relevant to our determination as we examine below.
`
`III. ANALYSIS
`A. Discretionary Denial of Institution Under 35 U.S.C. § 314(a)
`Patent Owner argues that we should exercise discretion under
`35 U.S.C. § 314 and deny institution under the Board’s precedential decision
`in Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB Mar. 20,
`2020), because the ’631 patent is the subject of the parallel district court
`litigation involving the same parties. Prelim. Resp. 16–22. For the reasons
`discussed below, we decline to exercise discretion under 35 U.S.C. § 314(a)
`to deny institution of inter partes review.
`Legal Standards
`1.
`Institution of inter partes review is discretionary. See Harmonic Inc.
`v. Avid Tech., Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016) (“[T]he PTO is
`permitted, but never compelled, to institute an IPR proceeding.”); 35 U.S.C.
`§ 314(a). The Board has held that the advanced state of a parallel district
`court action is a factor that may weigh in favor of denying a petition under
`§ 314(a). See NHK Spring Co. v. Intri-Plex Techs., Inc., IPR2018-00752,
`Paper 8 at 20 (PTAB Sept. 12, 2018) (precedential); Patent Trial and Appeal
`Board, Consolidated Trial Practice Guide, 58 & n.2 (Nov. 2019) (“Trial
`Practice Guide”). 14 We consider the following factors to assess “whether
`
`
`14 Available at https://www.uspto.gov/TrialPracticeGuideConsolidated.
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`efficiency, fairness, and the merits support the exercise of authority to deny
`institution in view of an earlier trial date in the parallel proceeding:”
`1. whether the court granted a stay or evidence exists that one
`may be granted if a proceeding is instituted;
`2. proximity of the court’s trial date to the Board’s projected
`statutory deadline for a final written decision;
`3. investment in the parallel proceeding by the court and the
`parties;
`4. overlap between issues raised in the petition and in the parallel
`proceeding;
`5. whether the petitioner and the defendant in the parallel
`proceeding are the same party; and
`6. other circumstances that impact the Board’s exercise of
`discretion, including the merits.
`Fintiv, Paper 11 at 5–6. In evaluating these factors, we “take[] a holistic
`view of whether efficiency and integrity of the system are best served by
`denying or instituting review.” Id. at 6.
`
`Facts
`2.
`As noted above in Section II.A., the ITC Investigation filed on
`June 19, 2020, was terminated on April 8, 2021, at the request of Novartis
`just before the commencement of the trial for that proceeding. Ex. 1006, 1.
`On March 26, 2021, the ITC Staff submitted its pretrial brief arguing, inter
`alia, that “the asserted claims [of the ʼ631 patent] are invalid,” because “the
`claimed invention of the ʼ631 patent would have been obvious over the
`asserted combinations,” which included Sigg in view of Boulange and Lam
`in view of Boulange. Ex. 1005, 13, 25, 44–45, 57–81, 89–94.
`
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`Less than one month after Novartis filed its complaint in the ITC,
`Regeneron filed IPR’1317 and IPR’1318. Regeneron voluntarily dismissed
`IPR’1318 (December 2020) and we later exercised our discretion under
`35 U.S.C. § 314(a) to deny institution in IPR’1317 (January 2021), mainly
`because of the ITC proceeding would proceed to a final determination before
`we could enter a final written decision. Ex. 1064, 2–3, 8–24. Our decision
`to deny institution was based largely upon Novartis’s assurance that the ITC
`“will produce a final determination before the Board’s [FWD].” Ex. 1051,
`1. On February 12, 2021, Petitioner filed a request for rehearing of our
`January 2021 denial of institution. Petitioner later withdrew this request on
`April 27, 2021. Petitioner filed the instant proceeding (IPR2021-00816) on
`April 16, 2021.
`As also noted above in Section II.A., the parallel district court
`litigation between Petitioner and Patent Owner also involves the ’631 patent.
`The Complaint in the parallel district court litigation was filed by Patent
`Owner in June 2020. Ex. 1083. Petitioner filed its Answer on July 11,
`2021. Prelim. Resp. 17. At the Rule 16 conference on August 18, 2021, the
`district court, consistent with local patent rules, adopted a schedule without
`setting a trial date. Exs. 1090, 2093, 2094. Recent data from the NDNY
`shows that the time to trial in civil cases is about forty months. Ex. 1078, 2
`(National Judicial Caseload Profile year ending Sept. 30, 2020). At no time
`in the past five years has the median time from filing to trial been less than
`thirty-nine months in the NDNY. Id. Claim construction briefing has not
`yet begun and fact and expert discovery deadlines will not be set until after
`the district court issues a Markman Order. Ex. 2094, 19 (stating “Opening
`10
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`Markman Briefs” are due “December 24, 2021,” and “Initial Expert
`Reports” are due “60 days after claim construction decision,” with “All
`Discovery” to be completed by “90 days after claim construction decision”);
`Ex. 1090 (“A Scheduling Order will be issued.”).
`With respect to the SDNY antitrust ligation, the enforceability — not
`invalidity — of the ʼ631 patent is at issue. Unenforceability and invalidity
`are separate legal defenses. Smith Int’l, Inc. v. Hughes Tool Co., 759 F.2d
`1572, 1578 (Fed. Cir. 1985). Accordingly, even if similar issues may be
`addressed in the antitrust litigation as in this proceeding, the legal defenses
`are distinct and not dependent on one another. Thus, we determine that it is
`unnecessary to address this antitrust litigation in the Fintiv analysis below.
`
`Factor 1: Whether the court granted, or will grant, a stay
`3.
`A stay of a parallel proceeding pending resolution of the PTAB trial
`allays concerns about inefficiency and duplication of efforts, and, as such,
`this fact has strongly weighed against exercising the authority to deny
`institution. Fintiv, Paper 11 at 6. Patent Owner argues that parallel district
`court litigation is not currently stayed and will not be stayed. Prelim. Resp.
`17. There is no evidence before us to suggest whether the district court will
`consider a stay. We determine that this factor weighs in favor of exercising
`authority to deny institution.
`
`4.
`
`Factor 2: Proximity of the Court’s Trial Date to the Board’s
`Projected Statutory Deadline
`According to Fintiv, we must consider the “trial date” of the parallel
`proceeding compared to our projected statutory deadline for our final
`decision. Fintiv, Paper 11 at 9 (“If the court’s trial date is earlier than the
`11
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`projected statutory deadline, the Board generally has weighed this fact in
`favor of exercising authority to deny institution under NHK.”). “This factor
`looks at the proximity of the district court’s trial date to the expected
`statutory deadline for the Board’s final decision.” Philip Morris Prods., S.A.
`v. RAI Strategic Holdings, Inc., IPR2020-00921, Paper 9 at 16 (PTAB Nov.
`16, 2020).
`No trial date has been set in the parallel district court litigation.
`Petitioner estimates that the earliest trial date would be up to two years after
`a final written decision in this proceeding because the most recent data from
`the NDNY shows that the time to trial in civil cases is forty months from the
`date a complaint is filed. Pet. 6 (citing Ex. 1078, 2).
`Patent Owner contends this factor weighs in favor of denial because
`the parallel district court litigation could go to trial concurrently with our
`final written decision. Patent Owner relies on two scheduling orders issued
`over six years ago by the presiding district court judge that suggest a 14–18
`month trial date from the initial Rule 16 scheduling order, which to our
`knowledge has not yet issued. See Exs. 2060, 2061.
`Based on the record before us, we believe it very unlikely that the
`district court trial would begin before the Board issues its final written
`decision. Our final written decision should issue on or before one year from
`this Decision (October 2022). See Sand Revolution II, LLC v. Continental
`Intermodal Grp.—Trucking LLC, IPR2019-01393, Paper No. 24 at 9 (PTAB
`June 16, 2020) (informative) (“[G]enerally, barring exceptional
`circumstances, the Board adheres to a one-year statutory deadline prescribed
`by 35 U.S.C. § 316(a)(11) for entry of final decisions in instituted inter
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`partes reviews.”). No date is set for the district court trial, and we decline to
`speculate further about when the district court trial will take place.
`For the reasons set forth above, we determine that this factor weighs
`against our exercise of discretion to deny institution.
`
`5.
`
`Factor 3: Investment in the Parallel Proceeding by the Court
`and Parties
`We consider the amount and type of work already completed in the
`parallel litigation or proceeding by the court and the parties at the time of the
`institution decision. Fintiv, Paper 11 at 9. If, at the time of the institution
`decision, the district court has issued substantive orders related to the
`validity of the challenged patent, this fact weighs in favor of denial. See
`Fintiv, Paper 11 at 9–10. On the other hand, if the district court has not
`issued such orders, this fact weighs against discretionary denial. Id. at 10.
`At this juncture, the district court has not issued any substantive
`orders related to the challenged patent, there is no trial date, and a Rule 16
`conference was just held in August 2021. See Exs. 1090, 2093, 2094.
`Patent Owner contends “the parties are well positioned to move the
`NDNY action forward because much of discovery is complete” and “[t]he
`parties have agreed to cross-designate discovery from the ITC Investigation
`(i.e., all interrogatory responses, expert reports, deposition transcripts, and
`filings) in the NDNY action and the SDNY Antitrust Litigation.” Prelim.
`Resp. 18 (citing Ex. 2058, 3; Ex. 2089, 1). Thus, Patent Owner argues
`“Factor 3 favors denial of institution because of the parties’ extensive
`investment in discovery that will be used in the NDNY action.” Id. at 19.
`Patent Owner also contends that Petitioner was not diligent in filing its
`
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`Petition in this proceeding after withdrawing its motion for rehearing in
`IPR’1317, and this also weighs against institution under this factor. Id.
`Petitioner contends that “[c]laim construction briefing will begin on
`December 24, 2021, while fact and expert discovery deadlines will not be set
`until after the Court issues a Markman Order,” and “[a]s such, the parties
`will have invested little in the NDNY case by the institution deadline.”
`Reply 5.
`We weigh this factor against exercising our discretion to deny
`institution. We acknowledge that some of the investment by the parties in
`the ITC will carry over to the parallel district court litigation. However,
`there appears to have been very little work already completed in the parallel
`district court litigation, e.g., no substantive decisions on validity have been
`made, and claim construction briefing is not scheduled to begin until after
`the deadline for a decision on institution in this proceeding. Based on the
`record before us, we determine that the district court is not likely to expend
`substantial resources in the parallel district court litigation before we issue
`our final decision.
`For the reasons set forth above, we determine that this factor weighs
`against our exercise of discretion to deny institution.
`
`6.
`
`Factor 4: Overlap Between Issues Raised in the Petition
`and in the Parallel Proceeding
`“[I]f the petition includes the same or substantially the same claims,
`grounds, arguments, and evidence as presented in the parallel proceeding,
`this fact has favored denial” because “concerns of inefficiency and the
`possibility of conflicting decisions [are] particularly strong.” Fintiv, Paper
`
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`11 at 12 (emphasis added).
`In this proceeding, Petitioner challenges at least the same independent
`claim (claim 1) challenged in the parallel district court litigation with
`substantially the same evidence and arguments. See Ex. 2006, 10–12, 49–
`50. We agree with Petitioner that the Board could reach the validity
`argument for ’631 patent before the trial in the NDNY, and this could create
`estoppel under 35 U.S.C. § 315(e). Pet. 7. Although we would likely to
`reach the validity arguments before the district court, and such an outcome
`favors us not exercising our discretion to deny institution, we believe the
`substantial overlap of issues with this proceeding weighs more in favor of
`exercising our discretion to deny institution.
`Accordingly, this factor weighs in favor of exercising our discretion to
`deny institution.
`
`7.
`
`Factor 5: Whether the Petitioner and the Defendant in the
`Parallel Proceeding Are the Same Party
`The parties involved in the present proceeding are also involved in the
`parallel district court litigation.
`Accordingly, this factor weighs in favor of exercising our discretion to
`deny institution. Fintiv, Paper 11 at 6.
`
`8.
`
`Factor 6: Other Circumstances that Impact the Board’s
`Exercise of Discretion, Including the Merits
`As detailed below, the Petition demonstrates a reasonable likelihood
`of prevailing in showing the unpatentability of at least one challenged claim.
`Patent Owner raises some viable arguments with respect to whether the prior
`art is properly enabled, and other issues, but at this phase of the proceedings,
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`based on the current record, we find Petitioner’s argument and evidence
`sufficient for institution.
`We determine that in these proceedings, “other circumstances” exist
`that weigh strongly against exercising our discretion to deny institution.
`First, as detailed above, Novartis represented in the IPR’1317 that the ITC
`would issue a final determination addressing the validity of the ʼ631 patent.
`Relying on those representations, we exercised our discretion to deny
`institution in that case in favor of the ITC Investigation. Patent Owner,
`however, moved to withdraw the ITC Investigation after the petition was
`denied.
`Patent Owner argues that Regeneron should have brought the
`termination of the ITC Investigation to our attention in its pending motion
`for rehearing of the IPR’1317 denial, but did not, and this weighs in favor of
`exercising our discretion to deny institution. Sur-Reply 1–2. Although
`Patent Owner is correct that the Board has entertained requests to reconsider
`institution denials under Fintiv based on post-decision developments, see id.,
`the plain language of our regulations did not require Petitioner to do so. See
`37 C.F.R. § 42.71(e) (“The request must specifically identify all matters the
`party believes the Board misapprehended or overlooked, and the place
`where each matter was previously addressed in a motion.”) (emphases
`added). Based on the unique circumstances before us, Petitioner’s decision
`to essentially refile its evidence and arguments from the IPR’1317 and
`IPR’1318 petitions in this proceeding is understandable.
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`On balance, and based on the merits of the Petition being sufficient,
`we determine that the facts underlying the sixth factor do not weigh in favor
`of exercising discretion to deny institution under § 314.
`
`Holistic assessment of factors.
`9.
`We have considered the circumstances and facts before us in view of
`the Fintiv factors. Our analysis is fact driven and no single factor is
`determinative of whether we exercise our discretion to deny institution under
`§ 314(a). In our holistic review of all the Fintiv factors, the weight of the
`evidence sufficiently tips the balance in favor of not exercising our
`discretion to deny institution under § 314(a).
`
`
`B. Discretionary Denial Under General Plastic
`Legal Standards
`1.
`When determining whether to exercise our discretion under § 314(a)
`in a “serial petition” situation, we may consider the following non-
`exhaustive factors:
`1. whether the same petitioner previously filed a petition
`directed to the same claims of the same patent;
`2. whether at the time of filing of the first petition the
`petitioner knew of the prior art asserted in the second
`petition or should have known of it;
`3. whether at the time of filing of the second petition the
`petitioner already received the patent owner’s
`preliminary response to the first petition or received
`the Board’s decision on whether to institute review in
`the first petition;
`
`17
`
`
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`IPR2021-00816
`Patent 9,220,631 B2
`
`4. the length of time that elapsed between the time the
`petitioner learned of the prior art asserted in the second
`petition and the filing of the second petition;
`5. whether the petitioner provides adequate explanation
`for the time elapsed between the filings of multiple
`petitions directed to the same claims of the same
`patent;
`6. the finite resources of the Board; and
`7. the requirement under 35 U.S.C. § 316(a)(11) to issue
`a final determination not later than 1 year after the date
`on which the Director notices institution of review.
`Gen. Plastic Indus. Co. v. Canon Kabushiki Kaisha, IPR2016-01357,
`Paper19 at 15–16 (PTAB Sept. 6, 2017) (precedential). The General Plastic
`factors are not dispositive, but part of a balanced assessment of the relevant
`circumstances in a proceeding, including the merits. See Trial Practice
`Guide, 58.
`
`Analysis
`2.
`The present proceeding is virtually the same petition challenging the
`same claims based on the same prior art except for a modified combination
`of references –– Lam/Boulange instead of Lam/Reuter, with Reuter being
`dropped. See Reply 3–4 (“[T]he Lam/Boulange ground is not a shift in prior
`art arguments because both references and the corresponding motivation to
`combine were already presented in the original IPRs, but never addressed on
`the merits.”). The current situation is distinct from the typical serial petition
`circumstance. First, the grounds asserted in the instant proceeding are
`essentially the same as those in IPR’1317 and IPR’1318, with the exception
`of one reference. Id. Second, we never reached the merits of unpatentability
`
`18
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`IPR2021-00816
`Patent 9,220,631 B2
`
`in IPR’1317 and IPR’1318. See id. at 2 (“Regeneron is asserting the same
`prior art references from the original IPRs, which were never addressed on
`the merits.”). Accordingly, many of the General Plastic factors are not
`directly applicable to the situation before us.
`
`Patent Owner argues that the current petition could have been avoided
`if Petitioner would have brought the ITC dismissal to our attention in
`Petitioner’s then-pending request for rehearing. Prelim. Resp. 8; Sur-
`Reply 2. As noted above, however, the plain language of 37 C.F.R.
`§ 42.71(d) states that a request for rehearing should argue issues that were
`“previously addressed in a motion.” Further, a party may “file a single
`request for rehearing,” but only within “30 days of the entry of a final
`decision.” 37 C.F.R. § 42.71(d). Thus, although the Board has allowed
`additional evidence and briefing during other unrelated rehearing
`proceedings (see Sur-Reply 2), our rules do not mandate such a course of
`action. In this instance, Petitioner was still within the one-year statutory
`deadline for filing another petition for inter partes review. As such, we do
`not find anything inherently wrong with the course of action taken by
`Petitioner.
`We are aware that Petitioner has the advantage of receiving two
`preliminary responses (Prelim. Resp. 11–12), but we never commented upon
`the merits of patentability addressed in those preliminary responses. As
`such, Petitioner has not gained any advantage by using our decisions as a
`roadmap, as we have not issued a decision. Petitioner has also modified
`some of its arguments. For one example, Petitioner addresses secondary
`considerations for the first time after this evidence was produced during the
`19
`
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`IPR2021-00816
`Patent 9,220,631 B2
`
`ITC Investigation. See id. at 7, 11–13, 15 (“Petitioner’s course of action can
`only be explained by its attempts to leverage what it learned about Patent
`Owner’s position from the earlier IPR responses and the ITC proceeding.”).
`We recognize Petitioner does gain a few advantages, but from our
`observations the petitions have not changed remarkably and the underlying
`theories are substantially the same. See id. at 13 (pointing out changes
`between petitions). We are also cognizant that Petitioner’s advantages were
`precipitated by Patent Owner’s motion to terminate the ITC Investigation
`after we denied institution in the prior IPR’1317.
`According to Petitioner, it filed the current petition for inter partes
`review because Patent Owner dismissed its ITC Investigation on the eve of
`trial:
`Novartis avoided institution of Regeneron’s original IPR by
`representing that the ITC would decide the validity of the 631
`Patent before a FWD. Novartis, however, abandoned the ITC
`Investigation days after learning that the ITC Staff concluded
`there was clear and convincing evidence that the 631 Patent is
`invalid as obvious. Regeneron subsequently filed this Petition to
`obtain an expeditious
`invalidity determination and stop
`Novartis’s attempt to forum shop the determination of invalidity
`to the NDNY. This unique situation, created solely by Novartis’s
`gamesmanship, would make denial under General Plastic unjust.
`Reply 1 (citations omitted). Although we will not speculate on Novartis’s
`reasons for withdrawing the ITC Investigation on the eve of trial, we agree
`with Petitioner that this is a unique situation created solely by Novartis’s
`actions. Thus, we find that denying the Petition under these circumstances is
`not warranted.
`
`20
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`IPR2021-00816
`Patent 9,220,631 B2
`
`C. Discretionary Denial Under Section 325(d)
`Legal Standards
`1.
`Section 325(d) of Title 35 of the United States Code provides, in
`relevant part: “In determining whether to institute or order a proceeding
`under this chapter, chapter 30, or chapter 31, the Director may take into
`account whether, and reject the petition or request because, the same or
`substantially the same prior art or arguments previously were presented to
`the Office.” The Board uses a two-part framework for evaluating arguments
`under § 325(d):
`(1) whether the same or substantially the same art previously was
`presented to the Office or whether the same or substantially
`the same arguments previously were presented to the Office;
`and
`(2) if either condition of first part of the framework is satisfied,
`whether the
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