Trials@uspto.gov
`571-272-7822
`
`
`
` Paper 15
`
`Date: January 15, 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.
`____________
`
`IPR2020-01317
`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
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314, 37 C.F.R. § 42.4
`
`
`
`
`571-272-7822
`
`
`
` Paper 15
`
`Date: January 15, 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.
`____________
`
`IPR2020-01317
`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
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314, 37 C.F.R. § 42.4
`
`
`
`
`
`IPR2020-01317
`Patent 9,220,631 B2
`
`I.
`
`INTRODUCTION
`
`Regeneron Pharmaceuticals, Inc. (“Petitioner”),1 on July 16, 2020,
`
`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 3
`
`(“Petition” or “Pet.”). Novartis Pharma, AG, et al., (“Patent Owner”)2 filed
`
`a Preliminary Response to the Petition. Paper 10 (“Preliminary Response”
`
`or “Prelim. Resp.”). Pursuant to our authorization, Petitioner filed a Reply
`
`(Paper 13, “Reply”) and Patent Owner filed a Sur-Reply (Paper 14, “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
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`the reasons set forth below, upon considering the Petition, Preliminary
`
`Response, Reply, Sur-Reply, and evidence of record, we exercise our
`
`discretion under 35 U.S.C. § 314(a) to deny institution.
`
`II.
`
`BACKGROUND
`
` Related Cases and Proceedings
`
`In addition to IPR2020-01317, the ’631 patent is involved in two
`
`district court cases and a proceeding pending before the International Trade
`
`
`
`1 Petitioner identifies Regeneron Pharmaceuticals, Inc. as the real party in
`interest. Pet. 4.
`2 Patent Owner identifies the named parties (Novartis Pharma AG,
`Novartis Technology LLC, and Novartis Pharmaceuticals Corporation) as
`the real parties in interest. Paper 6, 2.
`2
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`IPR2020-01317
`Patent 9,220,631 B2
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`Commission (“ITC”). Petitioner also filed a related petition requesting inter
`
`partes review in IPR2020-01318, challenging claims of the ’631 patent. We
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`address each below.
`
`1.
`
`ITC Proceeding
`
`The ’631 patent is asserted in Certain Pre-filled Syringes for
`
`Intravitreal Injection and Components Thereof II, Inv. No. 337-TA-1207,
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`filed June 19, 2020 (“the ITC Investigation”). Pet. 4; Paper 6, 2. On July
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`21, 2020, the ITC issued a notice of institution of the investigation. Ex.
`
`2042, 4–5.
`
`The ITC Investigation alleges that Petitioner infringes claims 1–6 and
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`11–26 of the ’631 patent. Pet. 4. The ITC Investigation has not been stayed
`
`and Petitioner did not request a stay. Reply 9. The “Procedural Schedule”
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`sets a hearing for April 19‒23, 2021, a final initial determination date of July
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`29, 2021, and a date of November 29, 2021, for completion of the
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`investigation. Ex. 2002, 3‒4. Petitioner notes that a “Presidential review
`
`period” will last until approximately January 29, 2022. Reply 13.
`
`2.
`
`Northern District of New York Patent Infringement
`
`The ’631 patent is asserted in Novartis Pharma AG v. Regeneron
`
`Pharm. Inc., 1:20-cv-00690 (N.D.N.Y.). Pet. 4; Paper 6, 2. On June 19,
`
`2020, Patent Owner filed a complaint for patent infringement against
`
`Petitioner. Ex. 2043, 2. The complaint alleges that Petitioner infringes at
`
`least claim 1 of the ’631 patent. See Pet. 4.
`
`The case was stayed pursuant to 28 U.S.C. § 1659 in view of the
`
`parallel ITC Investigation. See Exs. 2042, 2043.
`
`3
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`IPR2020-01317
`Patent 9,220,631 B2
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`3.
`
`Southern District of New York Antitrust
`
`The ’631 patent also is involved in Regeneron Pharmaceuticals Inc. v.
`
`Novartis Pharma AG, 1:20-cv- 05502-AJN (S.D.N.Y.). Paper 6, 2;
`
`Ex. 2057. On July 17, 2020, Petitioner filed a complaint against Patent
`
`Owner alleging that the ’631 patent was “fraudulently procured” and that
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`“Novartis deliberately withheld” key prior art “from the USPTO during
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`prosecution of the ’631 Patent.” Ex. 2057, 5, 6, 31.
`
`Petitioner further alleges in this complaint that the ’631 patent is
`
`unenforceable due to inequitable conduct because material prior art was
`
`withheld with an intent to deceive the USPTO. Id. at 32–33. Petitioner’s
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`232-count complaint asserts various antitrust-based harms allegedly caused
`
`by Patent Owner, including attempted monopolization through Walker
`
`Process fraud in violation of Section 2 of the Sherman Act. See id. at 73
`
`(asserting that “[t]he ’631 Patent is unenforceable because Novartis
`
`committed fraud on the USPTO in order to obtain the ’631 Patent.”).
`
`As of January 5, 2021, this case has not been stayed by the district
`
`court. See Ex. 3002.
`
`4.
`
`IPR2020-01318
`
`Petitioner filed a petition in IPR2020-01318 also challenging all
`
`claims of the ’631 patent. See Regeneron Pharmaceuticals, Inc. v. Novartis
`
`Pharma AG, IPR2020-01318, Paper 3 (“the IPR1318 proceeding”). On
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`December 7, 2020, we granted Petitioner’s Unopposed Motion to Terminate
`
`the IPR1318 proceeding. Id., Paper 17.
`
`
`
`4
`
`
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`IPR2020-01317
`Patent 9,220,631 B2
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` The ’631 Patent
`
`The ’631 patent is titled “SYRINGE.” Ex. 1001, code (54). The ’631
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`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, and
`
`identifies multiple foreign priority applications, the earliest of which was
`
`purportedly filed on July 3, 2012. Ex. 1002, 226; Pet. 13–14.
`
`The Specification notes that for small volume syringes intended for
`
`eye injections, sterilization can present issues that are not necessarily
`
`associated with larger syringes. Ex. 1001, 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.
`
`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.
`
`
`
`5
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`IPR2020-01317
`Patent 9,220,631 B2
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`Syringe 1 comprises body 2, stopper 10 and plunger 4. Id. at 10:61–67.
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`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
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`volume chamber 18 contains injectable medicament 20 comprising an
`
`ophthalmic solution comprising a VEGF antagonist. Id. at 10:67–11:2.
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`Injectable fluid 20 can be expelled though outlet 12 by movement of stopper
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`10 towards outlet end 14 thereby reducing the volume of variable volume
`
`chamber 18. Id. at 11:3–5.
`
`
`
` Challenged Claims
`
`The ’631 patent includes twenty-six claims, and Petitioner challenges
`
`each claim. Claim 1 is illustrative and reads as follows:
`
`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.
`
`6
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`
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`IPR2020-01317
`Patent 9,220,631 B2
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` Asserted Grounds of Unpatentability
`
`Petitioner asserts several grounds of unpatentability (Pet. 22–23),
`
`which are provided in the table below:
`
`Claim(s) Challenged
`1–3, 5–9, 14–22, 24
`
`35 U.S.C. §
`103(a)3
`
`4, 10, 23
`
`11–13
`
`25
`
`26
`
`103(a)
`
`103(a)
`
`103(a)
`
`103(a)
`
`Reference(s)
`Sigg,4 Boulange,5 “and if
`necessary USP789”6
`Sigg, Boulange, Fries,7 “and if
`necessary USP789”
`Sigg, Boulange, Furfine,8 “and if
`necessary USP789”
`Sigg, Boulange, Macugen Label,9
`“and if necessary USP789”
`Sigg, Boulange, Dixon,10 “and if
`necessary USP789”
`
`
`
`3 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.
`4 PCT Patent Publication No. WO 2011/006877 (Ex. 1007).
`5 PCT Patent Publication No. WO 2009/030976 (Ex. 1008).
`6 U.S. Pharmacopeia, USP 789, Particulate Matter in Ophthalmic
`Solutions, USP 34 NF 29 (2011) (“USP789”) (Ex. 1019).
`7 Arno Fries, Drug Delivery of Sensitive Biopharmaceuticals With
`Prefilled Syringes, 9(5) DRUG DELIVERY TECH. 22 (2009) (Ex. 1012).
`8 PCT Patent Publication No. WO 2007/149334 (Ex. 1021).
`9 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).
`10 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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`IPR2020-01317
`Patent 9,220,631 B2
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`Petitioner also relies on the declarations of Horst Koller (Ex. 1003)
`
`and James Agalloco (Ex. 1005). Patent Owner relies on the declaration of
`
`Karl R. Leinsing (Ex. 2001). The parties rely on numerous other exhibits
`
`relevant to our determination as we examine below.
`
`III. DISCRETIONARY DENIAL UNDER 35 U.S.C. § 314(a)
`
`Under 35 U.S.C. § 314(a), the Director has discretion to deny
`
`institution of an inter partes review. Cuozzo Speed Techs., LLC v. Lee, 136
`
`S. Ct. 2131, 2140 (2016) (“[T]he agency’s decision to deny a petition is a
`
`matter committed to the Patent Office’s discretion.”); SAS Inst. Inc. v. Iancu,
`
`138 S. Ct. 1348, 1356 (2018) (“SAS”) (“[Section] 314(a) invests the Director
`
`with discretion on the question whether to institute review.” (emphasis
`
`omitted)); Harmonic 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.”).
`
`Patent Owner argues that we should exercise discretion under 35
`
`U.S.C. § 314 and deny institution, because the ’631 patent is the subject of a
`
`pending ITC proceeding involving the same parties with a trial scheduled to
`
`begin on “April 19, 2021,” and “the ITC is set to issue a decision on the
`
`validity of the ’631 patent by July 29, 2021.” Prelim. Resp. 1, 8–9 (citing
`
`Ex. 2002); see generally PO Sur-Reply 1–7.
`
`In the Petition, Petitioner elected not to address discretionary denial or
`
`the Board’s precedential Fintiv11 decision, which issued about two months
`
`
`
`11 Apple Inc. v. Fintiv, Inc., IPR2020–00019, Paper 11 (Mar. 20, 2020)
`(designated precedential May 5, 2020) (“Fintiv”).
`8
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`IPR2020-01317
`Patent 9,220,631 B2
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`prior to the filing of the Petition. For reasons stated in Paper 12, we allowed
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`Petitioner to file a Reply to the Preliminary Response.
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`In its Reply, Petitioner disagrees, and argues that the Board should not
`
`exercise discretion to deny institution because Petitioner filed its Petition
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`less than a month after Patent Owner filed its ITC complaint. Reply 1.
`
`Petitioner also notes that “the NDNY district court litigation was stayed.”
`
`Id. Further, Petitioner “has stipulated that if the Board institutes trial, it will
`
`not pursue at the ITC the invalidity grounds set forth in both petitions.” Id.
`
`(citing Ex. 1067).
`
` Parallel Proceedings
`
`As previously described, Patent Owner has asserted the ’631 patent
`
`against Petitioner in the ITC Investigation as well as in the Northern District
`
`of New York (“NDNY Patent Litigation”). Paper 5, 2; Paper 6, 2.
`
`Petitioner challenges the enforceability of the ’631 patent in the Southern
`
`District of New York antitrust litigation (“SDNY Antitrust Litigation”).12
`
`In the ITC Investigation, the evidentiary hearing is scheduled to be
`
`completed by April 23, 2021, and the initial determination is scheduled for
`
`
`
`12 Patent Owner asserts that the SDNY Antitrust Litigation provides
`additional support for denying institution because “[t]he complaint relies on
`the same basic argument advanced in its Petition—i.e., that Novartis’s ’631
`patent would not have issued had the examiner known about the Sigg
`reference” and because this additional litigation also calls for analyzing Sigg
`in the context of the ’631 patent’s enforceability. Sur-reply 3 n.1. We do
`not reach that additional argument because we conclude that discretionary
`denial is warranted based upon our analysis of the ITC Investigation and the
`NDNY Patent Litigation.
`
`9
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`
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`IPR2020-01317
`Patent 9,220,631 B2
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`July 29, 2021. Ex. 2002, 3–4. The ITC Investigation is slated to be
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`completed by November 29, 2021. Id. According to Petitioner, the
`
`proceeding has not, and will not, be stayed. Pet. 4.
`
`The NDNY Patent Litigation alleging infringement of the ’631 patent
`
`was filed by Patent Owner on June 19, 2020, but the case was stayed on July
`
`30, 2020, pending completion of the ITC Investigation. See Pet. 4;
`
`Exs. 2042, 2043.
`
`
`
` Analysis
`
`The Board’s precedential decision in NHK Spring Co. v. Intri-Plex
`
`Techs, Inc., IPR2018-00752, Paper 8 (PTAB Sept. 12, 2018) (precedential)
`
`guides us in determining whether to exercise discretion to deny institution on
`
`behalf of the Director. In NHK, the Board found that the “advanced state of
`
`[a] district court proceeding” was a “factor that weighs in favor of denying”
`
`the petition under § 314(a). NHK, Paper 8 at 20. The Board determined that
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`“[i]nstitution of an inter partes review under these circumstances would not
`
`be consistent with ‘an objective of the AIA . . . to provide an effective and
`
`efficient alternative to district court litigation.’” Id. (citing Gen. Plastic
`
`Indus. Co., Ltd. v. Canon Kabushuki Kaisha, IPR2016-01357, Paper 19, 16–
`
`17 (PTAB Sept. 6, 2017) (precedential in relevant part)).
`
`The Board’s precedential decision in Fintiv sets forth six factors that
`
`we consider when determining whether to use our discretion to deny
`
`institution due to the advanced state of a parallel proceeding:
`
`1. whether the court granted a stay or evidence exists that one may be
`
`granted if a proceeding is instituted;
`
`10
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`IPR2020-01317
`Patent 9,220,631 B2
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`2. proximity of the court’s trial date to the Board’s projected statutory
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`deadline for a final written decision;
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`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;
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`5. whether the petitioner and the defendant in the parallel proceeding
`
`are the same party; and
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`6. other circumstances that impact the Board’s exercise of discretion,
`
`including the merits.
`
`Fintiv, Paper 11 at 6. Fintiv is a precedential decision establishing binding
`
`authority on all members of the Board.
`
`“These factors relate to whether efficiency, fairness, and the merits
`
`support the exercise of authority to deny institution in view of an earlier trial
`
`date in the parallel proceeding.” Id. 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. (citing Consolidated Trial
`
`Guide 58). We discuss the parties’ arguments below in the context of
`
`considering the above factors.
`
`1. Whether a Stay Exists or Is Likely to Be Granted if a
`Proceeding Is Instituted
`
`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.
`
`Petitioner recognizes that the ITC proceeding was not stayed but
`
`11
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`IPR2020-01317
`Patent 9,220,631 B2
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`Petitioner contends that “[a]sking for a stay of the ITC investigation would
`
`have been futile.” Reply 9. Petitioner points out that the NDNY Patent
`
`Litigation has been stayed pending the outcome in the ITC investigation. Id.
`
`Patent Owner argues that when parallel litigation has not been stayed,
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`this factor favors denial of institution because institution of an IPR while
`
`parallel litigation on the same patent is ongoing leads to inefficiencies and
`
`duplication of efforts. Prelim. Resp. 8 (citing Fintiv, IPR2020-00019, Paper
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`11 at 6–8). Patent Owner contends that there is no possibility of a stay of the
`
`parallel ITC Investigation and the Board has recognized that Fintiv applies
`
`to parallel ITC Investigations the same as it does to district court cases. Sur-
`
`Reply 2 (citing in part Google LLC v. EcoFactor, Inc., IPR2020-00968,
`
`Paper 10 at 10–11 (PTAB Nov. 18, 2020); Fitbit, Inc. v. Koninklijke Philips
`
`N.V., IPR2020-00772, Paper 14 at 14–15 (PTAB Oct. 19, 2020) (“Fitbit”)).
`
`Further, Patent Owner notes our precedential decision in Fintiv states, “as a
`
`practical matter, it is difficult to maintain a district court proceeding on
`
`patent claims determined to be invalid at the ITC.” Fintiv, IPR2020-00019,
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`Paper 11 at 8–9.
`
`Patent Owner notes the NDNY Patent Litigation has been stayed, but
`
`will proceed after the ITC Investigation is complete. Prelim. Resp. 9.
`
`At the outset, we note that Patent Owner is correct that Fintiv
`
`expressly addresses ITC investigations, and the Board has considered ITC
`
`investigations in weighing whether or not to exercise its discretion under 35
`
`U.S.C. § 314. Fintiv, Paper 11 at 8 (“[E]ven though the Office and the
`
`district court would not be bound by the ITC’s decision, an earlier ITC trial
`
`date may favor exercising authority to deny institution under NHK if the ITC
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`12
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`IPR2020-01317
`Patent 9,220,631 B2
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`is going to decide the same or substantially similar issues to those presented
`
`in the petition.”) (emphasis added); Garmin International, Inc. v. Koninklijke
`
`Philips N.V, IPR2020-00754, Paper 11 (PTAB Oct. 27, 2020). Further, the
`
`November 2019 Patent Trial and Appeal Board Consolidated Trial Practice
`
`Guide (“Consolidated Trial Guide”) specifically identifies parallel ITC
`
`proceedings as an example of a proceeding that favors denying a petition
`
`because of their “‘effect . . . on the economy, the integrity of the patent
`
`system, the efficient administration of the Office, and the ability of the
`
`Office to timely complete proceedings.’” Id. at 56.
`
`With regard to this factor, we agree with Patent Owner that a stay of
`
`the ITC Investigation is unlikely given that the hearing in the ITC
`
`Investigation is scheduled to occur in April 2021. Ex. 2001, 4.
`
`For the reasons set forth above, we determine that this factor weighs
`
`in favor of exercising authority to deny institution.
`
`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
`
`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).
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`13
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`IPR2020-01317
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`Patent Owner contends this factor strongly weighs in favor of denial
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`because the parallel ITC hearing is set to begin on April 19, 2021, and the
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`ITC is set to issue an initial determination on the validity of the ’631 patent
`
`by July 29, 2021. Prelim. Resp. 9 (citing Ex. 2002). Patent Owner further
`
`notes that, because the final determination from the Commission will be
`
`made no later than November 29, 2021, the ITC will issue its final decision
`
`months before our January 2022 statutory deadline. Sur-Reply 3 (citing Ex.
`
`2047). Patent Owner argues that the “trial date” is the key date of
`
`consideration for this factor and, for ITC proceedings, the Board examines
`
`primarily the initial determination and final commission determination dates:
`
`Unsurprisingly then, the Board has considered both the ALJ’s
`determination date and the ITC’s final determination date. See
`Fitbit at 16, 23 (“We weigh heavily the fact that in the ITC
`proceeding, both the Initial Determination and the final
`commission determination will pre-date a final written decision”
`(emphasis added)).
`
`Id. at 4 (quoting Fitbit, Inc. v. Koninklijke Philips N.V., IPR2020-00772,
`
`Paper 14 (PTAB Oct. 19, 2020)).
`
`Petitioner contends “[t]he Board and ITC schedules are as close in
`
`proximity as practicably possible because Regeneron filed its petition less
`
`than a month after Novartis filed its ITC complaint and before institution of
`
`the ITC proceedings.” Reply 13. Petitioner makes several policy arguments
`
`as to why we should consider the expedience of its IPR filing date. See id. at
`
`14. Petitioner argues that if its expediency does not favor institution “then
`
`this factor could never weigh in favor of a petitioner unless the petition were
`
`filed preemptively and well before any ITC complaint.” Id. Petitioner,
`
`14
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`IPR2020-01317
`Patent 9,220,631 B2
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`however, does not point us to any Board decision considering this Fintiv
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`factor to take into account diligence in filing for this factor. Instead, as
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`noted above, this Fintiv factor compares the “trial date” to our statutory date
`
`for issuing a final written decision.
`
`We agree with Patent Owner that the advanced stage of the ITC
`
`investigation weighs in its favor for this factor. The evidentiary hearing in
`
`the ITC Investigation is set for April 19, 2021, and the proceeding will reach
`
`a final determination on or before November 29, 2021. Our final written
`
`decision is due about two months later in January 2022. These facts weigh
`
`against institution.
`
`As noted above, the NDNY Patent Litigation is stayed, and, thus, has
`
`no trial date.
`
`For the reasons set forth above, we determine that this factor weighs
`
`in favor of our exercise of discretion to deny against institution.
`
`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.
`
`Patent Owner contends this factor favors denial. Prelim. Resp. 11–12;
`
`Sur-Reply 1–3. Patent Owner argues that, “[b]y the time an institution
`
`decision is due on January 22, 2021, the ITC and the parties will have
`
`already invested significant resources in the investigation.” Id. at 11.
`
`According to Patent Owner:
`
`Fact discovery is set to close on December 18, 2020. As of the
`
`15
`
`
`
`IPR2020-01317
`Patent 9,220,631 B2
`
`date of this Preliminary Response, the parties have already
`served responses to 365 requests for production and 43
`interrogatories; collected, reviewed, and produced more than
`59,606 documents; served 3,710 pages of initial invalidity and
`infringement contentions; served subpoenas on seven third
`parties; and have received 2,121 pages of production from those
`third parties. By the time the institution decision is due, the
`parties will likely have produced thousands more documents and
`will likely have taken more than a dozen fact depositions.
`
`Prelim. Resp. 11. Patent Owner further notes that “[b]y the time of an
`
`institution decision, claim construction will be complete: the parties will
`
`have already fully briefed claim construction, taken depositions of claim
`
`construction declarants, and participated in the scheduled December 10,
`
`2020 Markman hearing.” Id. Similarly, “[o]pening expert reports are due
`
`on January 22, 2021, and summary determination motions on February 18,
`
`2021.” Sur-Reply 5. Patent Owner also notes that the parties “have
`
`exchanged detailed invalidity contentions on §§ 102–103, which overlap
`
`with the grounds in this petition.” Id.
`
`Addressing Petitioner’s diligence in filing its IPR Petition, Patent
`
`Owner argues that Petitioner knew of the ’631 patent as early as 2015, when
`
`it was approached with potential licensing offers. Id. at 6 (citing Ex. 2057
`
`¶¶ 137, 146). Patent Owner then argues that Petitioner “started to
`
`investigate an IPR challenge no later than July 2018.” Id. (citing Ex. 1033,
`
`43). Next, quoting the Board’s Fitbit decision, Patent Owner argues “[i]n
`
`any event, even in cases where the petitioner was diligent, the Board has
`
`found that investments by ‘[t]he parties and the ALJ and staff of the ITC’
`
`still weigh ‘somewhat against institution.’” Id. (quoting Fitbit at 17–18).
`
`Petitioner contends this factor weighs in favor of institution.
`
`16
`
`
`
`IPR2020-01317
`Patent 9,220,631 B2
`
`Reply 11–12. Petitioner argues that it could not have brought its challenge
`
`faster than it did in this IPR proceeding and when it filed its petition, the ITC
`
`had not even instituted an investigation. Id. at 11. According to Petitioner,
`
`“ITC proceedings are statutorily required to be completed expeditiously . . .
`
`and it is thus inevitable that the parties will have invested resources in the
`
`ongoing ITC investigation.” Id. at 12. Petitioner notes that it “also invested
`
`enormous time and resources in preparing and filing the two IPR petitions
`
`less than a month after learning of the complaints.” Id.
`
`We weigh this factor somewhat against institution. We acknowledge
`
`Petitioner’s diligence in bringing this IPR proceeding, but the investment by
`
`the parties and the ITC in the parallel proceeding outweighs the effort
`
`expended so far in this proceeding.
`
`More to the point, we agree with Patent Owner that the parties, the
`
`ALJ, and the staff of the ITC have expended considerable resources to date
`
`on the ITC investigation, in the form of addressing claim construction,
`
`completing substantial fact discovery, and preparing for expert reports and
`
`discovery. Ex. 2002, 2–3. In fact, under the current ITC schedule (see Ex.
`
`2002), summary determination motions will be filed within a few weeks
`
`after this decision and the parties will complete substantially all pre-trial
`
`work within two months of this initial determination. Id.
`
`Based on the record before us, we determine that the ITC has invested
`
`greater resources in evaluating the ’631 patent’s claims at issue than in the
`
`current proceeding. The amount and type of work already completed in the
`
`parallel ITC Investigation at the time of the institution decision weighs
`
`somewhat in favor of exercising our discretion to deny institution.
`
`17
`
`
`
`IPR2020-01317
`Patent 9,220,631 B2
`
`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
`
`11 at 12 (emphasis added).
`
`To address this factor, Petitioner sent a “letter” to counsel for Patent
`
`Owner on November 25, 2020. See Ex. 1067. In this letter,13 Petitioner
`
`writes:
`
`Respondent Regeneron Pharmaceuticals, Inc. hereby
`stipulates that, if the Patent Trial and Appeal Board (“Board”)
`institutes one or both of the pending IPR petitions in IPR2020-
`01317 and IPR2020-[0]1318 challenging the patentability of the
`claims of U.S. Patent No. 9,220,631, then Regeneron will not
`pursue the instituted invalidity grounds in the ITC investigation
`337-TA-1207.
`
`Ex. 1067, 1. Petitioner notes the specific grounds challenged in each of
`
`IPR2020-01317 and IPR2020-01318. Id. at 1–2. Petitioner then states that
`
`“[i]f, however, the Board grants Regeneron’s motion to terminate IPR2020-
`
`01318 and also institutes trial in IPR2020-01317, this stipulation applies and
`
`Regeneron will not pursue the above identified grounds in the ITC
`
`investigation.” Id. at 2.
`
`The stipulation does not address whether it would apply to any district
`
`
`
`13 There is no indication that this letter was filed with the ITC or any district
`court. For purposes of this decision, we presume Petitioner would be bound
`by this letter, and as such we refer to it as a “stipulation.”
`18
`
`
`
`IPR2020-01317
`Patent 9,220,631 B2
`
`court proceeding. Based on the specific language quoted above, we
`
`determine it would only apply to the ITC Investigation.
`
`Based upon its stipulation, Petitioner argues in its Reply that “the
`
`Board and the ITC thus will not address the same invalidity arguments.”
`
`Reply 12. Further, Petitioner contends “[t]here is also no risk of inconsistent
`
`claim construction positions between the Board and the ITC, as there is no
`
`overlap between the terms identified in the Parties’ ITC Markman briefing
`
`and the terms identified in the petition.” Id.; compare Ex. 1071 with Pet.
`
`27–28). Based on these two points, Petitioner concludes that “there are no
`
`‘concerns of inefficiency and the possibility of conflicting decisions’
`
`between the Board and ITC.” Id. at 12–13 (quoting Fintiv at 12).
`
`Patent Owner alleges that “[f]actor 4 weighs against institution
`
`because the petition asks the Board to review the same patent claims, based
`
`on the same prior art, that are at issue in the ITC investigation.” Sur-Reply
`
`7. Patent Owner contends that “the narrow stipulation that Regeneron touts .
`
`. . would not meaningfully reduce the overlap between its petition and its
`
`ITC invalidity contentions.” Id. at 1. Patent Owner argues that such a
`
`narrow stipulation does not overcome the factors that favor denying
`
`institution. Id.
`
`Patent Owner cites several of our recent proceedings for the
`
`proposition that a narrow stipulation like Petitioner’s—i.e., a promise not to
`
`pursue the identical grounds for invalidity in a parallel proceeding—at most
`
`weighs marginally against exercising discretion to deny institution. Id. at 7
`
`(quotation and citations omitted). Patent Owner also contends that
`
`“Regeneron’s narrow stipulation would not meaningfully limit the overlap
`
`19
`
`
`
`IPR2020-01317
`Patent 9,220,631 B2
`
`between an IPR and the ITC proceeding (and it does not apply to the district
`
`court litigation).” Id. Patent Owner notes that Petitioner’s “theory is that a
`
`skilled artisan would have combined references that teach a method for
`
`terminal sterilization of PFS with a method for baked-on siliconization of
`
`PFS.” Id. (citing Pet. 29). Patent Owner contends that Petitioner “has cited
`
`numerous, cumulative references that it asserts can be used for each half of
`
`that argument.” Id. at 7–8 (citing Prelim. Resp. 18–22). Patent Owner
`
`argues that Petitioner’s “stipulation would not preclude it from relying on
`
`different combinations of the asserted references.” Id. at 8.
`
`More specifically, Patent Owner points to the two IPR proceedings
`
`filed currently (IPR1317 and IPR1318) and notes that each has a lead
`
`reference that discloses terminal sterilization methods (Sigg and Lam) and
`
`two lead references that disclose siliconization methods (Boulange and
`
`Reuter). Id. at 7–8; Paper 2, 2. Patent Owner contends that “[t]he
`
`differences between the references in each category are modest and
`
`irrelevant to most of the claims,” such that:
`
`It wou
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