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 Owners.
`
`
`
`
`
`
`
`Case IPR2021-00816
`Patent 9,220,631
`
`PETITIONER’S REPLY TO PATENT OWNER’S PRELIMINARY RESPONSE
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`REGENERON PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`NOVARTIS PHARMA AG,
`NOVARTIS TECHNOLOGY LLC,
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Patent Owners.
`
`
`
`
`
`
`
`Case IPR2021-00816
`Patent 9,220,631
`
`PETITIONER’S REPLY TO PATENT OWNER’S PRELIMINARY RESPONSE
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`I.
`
`II.
`
`TABLE OF CONTENTS
`The GENERAL PLASTIC FACTORS SUPPORT INSTITUTION ................ 1
`Factors 4 and 5 Support Institution Because Regeneron Could
`A.
`Only Raise the ITC Termination in the Current Petition ...................... 1
`Factors 1-3 Favor Institution ................................................................. 2
`B.
`THE FINTIV FACTORS SUPPORT INSTITUTION .................................... 5
`
`ii
`
`
`
`
`
`
`Ex.
`1001
`
`Ex.
`1002
`
`Ex.
`1003
`
`Ex.
`1004
`
`Ex.
`1005
`
`Ex.
`1006
`
`PETITIONER’S EXHIBIT LIST
`
`U.S. Patent No. 9,220,631 (“the ’631 Patent”)
`
`Prosecution File History of U.S. Patent No. 9,220,631
`
`Declaration of Horst Koller under 37 C.F.R. § 1.68.
`
`Curriculum Vitae of Horst Koller
`
`ITC Investigation No. 337-TA-1207, Staff’s Pre-Hearing Brief (public
`version)
`
`ITC Investigation No. 337-TA-1207, Complainant’s Unopposed
`Motion to Terminate
`
`Ex.
`1007 PCT Patent Publication No. WO 2011/006877 to Sigg et al. (“Sigg”)
`Ex.
`PCT Patent Publication No. WO 2009/030976 to Boulange et al.
`1008
`(“Boulange”)
`
`Ex.
`1009
`
`Ex.
`1010
`
`Ex.
`1011
`
`Ex.
`1012
`
`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 (“2008 Macugen Label”)
`
`ITC Investigation No. 337-TA-1207, Initial Determination Terminating
`the Investigation
`
`Bhavnesh D. Shah & Bhupendra G. Prajapati, Pre-Filled Syringes: A
`New Concept, PHARMA BIO WORLD 51 (2009) (“Shah”)
`
`Arno Fries, Drug Delivery of Sensitive Biopharmaceuticals With
`Prefilled Syringes, 9(5) DRUG DELIVERY TECH. 22 (2009) (“Fries”)
`
`iii
`
`
`
`
`
`
`
`
`Ex.
`1013
`
`Ex.
`1014
`
`Ex.
`1015
`
`Ex.
`1016
`
`Ex.
`1017
`
`Ex.
`1018
`
`Ex.
`1019
`
`Thomas Schoenknecht, Prefilled Syringes: Why New Developments Are
`Important In Injectable Delivery Today, in PREFILLED SYRINGES
`INNOVATIONS THAT MEET THE GROWING DEMAND (OnDrugDelivery
`2005) (“Schoenknecht”)
`
`U.S. Patent Publication No. 2012/0091026 to Chacornac et al.
`(“Chacornac”)
`
`Sandeep Nema & John D. Ludwig, Pharmaceutical Dosage Forms:
`Parenteral Medications, Volume 1: Formulation and Packaging (3rd
`ed. 2010) (“Nema Vol. 1”)
`
`Sandeep Nema & John D. Ludwig, Pharmaceutical Dosage Forms:
`Parenteral Medications, Volume 2: Facility Design, Sterilization and
`Processing (3rd ed. 2010) (“Nema Vol. 2”)
`
`PCT Patent Publication No. WO 2007/035621 to Scypinski et al.
`(“Scypinski”)
`
`U.S. Patent Publication No. 2003/0003014 to Metzner et al.
`(“Metzner”)
`
`U.S. Pharmacopeia, USP 789, Particulate Matter in Ophthalmic
`Solutions, USP 34 NF 29 (2011)
`
`Ex.
`1020 U.S. Patent Publication No. 2011/276005 to Hioki et al. (“Hioki”)
`Ex.
`PCT Patent Publication No. WO 2007/149334 to Furfine et al.
`1021
`(“Furfine”)
`
`Ex.
`1022
`
`Ex.
`1023
`
`Ex.
`1024
`
`Michael W. Stewart et al., Fresh From the Pipeline Aflibercept, 11
`NAT. REV. DRUG DISCOV. 269 (2012) (“Stewart”)
`U.S. Patent No. 7,060,269 to Baca et al. (“Baca”)
`
`Gerald McDonnel and Denver Russell, Antiseptics and Disinfectants:
`Activities, Action, and Resistance, Clinical Microbiology Review, (Jan.
`1999) (“McDonnel”).
`
`iv
`
`
`
`
`
`
`
`
`Ex.
`1025
`
`Ex.
`1026
`
`Ex.
`1027
`
`Ex.
`1028
`
`Lu Liu et al., Silicone Oil Microdroplets and Protein Aggregates in
`Repackaged Bevacizumab and Ranibizumab: Effects of Long-term
`Storage and Product Mishandling, 52(2) INVESTIGATIVE
`OPHTHALMOLOGY & VISUAL SCIENCE 1023 (2011) (“Liu”)
`
`U.S. Patent No. 7,404,278 to Wittland et al. (“Wittland”)
`
`U.S. Food and Drug Administration, Lucentis® Highlights of the
`Prescribing Information, (June 2010) (“Lucentis Label”)
`
`International Organization for Standardization, ISO 11040-4 Prefilled
`Syringes – Part 4: Glass Barrels for Injectables (2nd ed. 2007) (“ISO
`11040-4”)
`
`Ex.
`1029 PCT Patent Publication No. WO 2008/077155 to Lam et al. (“Lam”)
`Ex.
`James A. Dixon, et al. "VEGF Trap-Eye for the treatment of
`1030
`neovascular age-related macular degeneration." Expert opinion on
`investigational drugs 18.10 (2009): 1573-1580. (“Dixon”)
`
`Ex.
`1031
`
`Ex.
`1032
`
`Ex.
`1033
`
`Ex.
`1034
`
`Ex.
`1035
`
`Ex.
`1036
`
`Declaration of Dr. Szilard Kiss under 37 C.F.R. § 1.68.
`
`Curriculum Vitae of Dr. Szilard Kiss
`
`Declaration of James L. Mullins, Ph.D.
`
`Dow Corning® 365 35% Dimethicone NF Emulsion – Frequently
`Asked Questions (2002) (“DC365 FAQ”)
`
`European Patent Application No. 12174860 to Novartis AG
`
`U.S. Food and Drug Administration, Guidance for Industry: Sterile
`Drug Products Produced by Aseptic Processing—Current Good
`Manufacturing Practice (September 2004)
`
`v
`
`
`
`Ex.
`1037
`
`Ex.
`1038
`
`Ex.
`1039
`
`Ex.
`1040
`
`Ex.
`1041
`
`Ex.
`1042
`
`Ex.
`1043
`
`Ex.
`1044
`
`Ex.
`1045
`
`Ex.
`1046
`
`Ex.
`1047
`
`
`
`
`
`
`Affidavit of Internet Archive Office Manager
`
`Internet Archive WayBack Machine, March 8, 2011 Record of
`Drugs.com, Welcome to Drugs.com, available at
`https://web.archive.org/web/20110308203650/http://www.drugs.com:
`80/
`
`Internet Archive WayBack Machine, February 25, 2011 Record of
`Drugs.com, FDA Professional Drug Information, available at
`https://web.archive.org/web/20110225193929/http://www.drugs.com:
`80/pro/
`
`U.S. Food and Drug Administration, Eylea® Highlights of the
`Prescribing Information, (November 2011) (“Eylea label”)
`
`U.S. Food and Drug Administration, Guidance for Industry: Container
`Closure Systems for Packaging Human and Biologics – Chemistry,
`Manufacturing, and Controls Documentation (May 1999), available at
`https://www.fda.gov/downloads/drugs/guidances/ucm070551.pdf
`International Standard ISO-7864, Sterile hypodermic needles for single
`use, ISO 7864:1993(E) (“ISO-7864”)
`
`International Standard ISO-9626, Stainless steel needle tubing for the
`manufacture of medical devices – Amendment 1, ISO
`9626:1991/Amd.1:2001(E) (“ISO-9626”)
`Advait Badkar, et al. Development of Biotechnology Products in Pre-
`filled Syringes: Technical Considerations and Approaches, American
`Association of Pharmaceutical Sciences, June 2011, 12(2): 564-572
`(“Badkar”)
`William Leventon, “Medical Device Sterilization: What Manufacturers
`Need to Know” (MDDI online, Sept. 1, 2002), available at
`https://www.mddionline.com/medical-device-sterilization-what-
`manufacturers-need-know (“Leventon”)
`Pamela Carter, et al. The lowdown on low temperature sterilization for
`packaged devices, Healthcare Purchasing News, July 2008, 42-45.
`(“Carter”)
`U.S. Patent Publication No. 2005/0182370 to Hato (“Hato”)
`
`vi
`
`
`
`
`
`
`
`
`Ex.
`1048
`
`Ex.
`1049
`
`Ex.
`1050
`
`Ex.
`1051
`
`Ex.
`1052
`
`Ex.
`1053
`
`Ex.
`1054
`
`Ex.
`1055
`
`Ex.
`1056
`
`Ex.
`1057
`
`U.S. Department of Labor, Occupational Safety & Health
`Administration, Ethylene Oxide (EtO): Understanding OSHA’s
`Exposure monitoring Requirements, 2007 OSHA3325-01N (2007),
`available at https://www.osha.gov/Publications/ethylene_oxide.html
`(“OSHA Guidelines”)
`Bryon Lambert, et al. Radiation and Ethylene Oxide Terminal
`Sterilization Experiences with Drug Eluting Stent Products, American
`Association of Pharmaceutical Sciences, December 2011, 12(4):1116-
`1126 (“Lambert”)
`IPR2020-1317, Paper No. 10, Patent Owner’s Preliminary Response
`
`IPR2020-1317, Paper No. 14, Patent Owner’s Sur-Reply
`
`
`John R. Gillis & Gregg Mosley, Validation of Pharmaceutical
`Processes, Chapter 16 – Validation of Ethylene Oxide Sterilization
`Processes (2011), pp.241-262 (“Gillis”)
`FDA Pesticide Analytical Manual Vol. 1, Chapter 6 - HPLC, available
`at
`https://www.fda.gov/downloads/Food/FoodScienceResearch/
`ucm113651.pdf
`Kim, Leo & D’Amore, Patricia, ASIP Centennial Commentary – A
`Brief History of Anti-VEGF for the Treatment of Ocular Angiogenesis,
`The American Journal of Pathology, August 2012 182(2):376-379,
`available at (note: published online July 2, 2012
`https://ajp.amjpathol.org/article/S0002-9440(12)00442-7/fulltext )
`J.S. Penn, et al. Vascular Endothelial Growth Factor in Eye Disease,
`Prog. Retin Eye Res., July 2008, 27(4):331-371. (“Penn2008”)
`
`U.S. Food and Drug Administration, Trivaris ® Highlights of the
`Prescribing Information, (May 2008) (“Trivaris label”)
`
`Internet Archive WayBack Machine, May 17, 2011 Record of U.S.
`Pharmacopeia, Understanding USP–NF, available at
`https://web.archive.org/web/20110517215303/http://www.usp.org/
`USPNF/understandingUSPNF.html
`
`vii
`
`
`
`Ex.
`1058
`
`Ex.
`1059
`
`Ex.
`1060
`
`Ex.
`1061
`
`Ex.
`1062
`
`Ex.
`1063
`
`Ex.
`1064
`
`Ex.
`1065
`
`Ex.
`1066
`
`Ex.
`1067
`
`Ex.
`1068
`
`
`
`
`
`
`Christine I. Falkner-Radler, et al. Needle Size in Intravitreal Injections-
`Preliminary Results of a Randomized Clinical Trial, AVRO Annual
`Meeting Abstract, March 2012, 54(884), available at
`https://iovs.arvojournals.org/article.aspx?articleid=2350271 (“ARVO
`abstract”)
`Carsten H. Meyer, et al. Steps for a Safe Intravitreal Injection
`Technique – A look at how European and American approaches
`compare, Retinal Physician (July 1, 2009), available at
`https://www.retinalphysician.com/issues/2009/july-aug/steps-for-a-
`safe-intravitreal-injection-technique (“Meyer”)
`Curriculum Vitae of James L. Mullins, Ph.D.
`
`DUPONT™ TYVEK® COMPLIANCE TO ISO 11607-1:2006 (2011)
`
`Center for Drug Evaluation and Research, Application Number: 21-
`756, Approved Labeling, Macugen® (pegaptanib sodium injection)
`(December 17, 2004) (“2004 Macugen Label”)
`Evangelos S. Gragoudas, et al. Pegaptanib for Neovascular Age-
`Related Macular Degeneration, New England Journal of Medicine
`2004; 351:2805-16, with Supplementary Appendix.
`IPR2020-1317, Paper No. 15, Institution Decision
`
`Anita M. Leys, et al. Neovascular Growth Following Photodynamic
`Therapy for Choroidal Hemangioma and Neovascular Regression after
`Intravitreous Injection of Triamcinolone, Retina 2006; 26(6):693-7,
`available at https://pubmed.ncbi.nlm.nih.gov/16829815/ (“Leys”)
`Australian Government, Department of Health and Ageing, Australian
`Public Assessment Report for Aflibercept, (July 2012)
`
`Sophie J. Bakri and Noha S. Ekdawi, Intravitreal Silicone Oil Droplets
`after Intravitreal Drug Injections, Retina 2008; 20:996-1001, available
`at https://pubmed.ncbi.nlm.nih.gov/18698303/ (“Bakri”)
`Jared S. Bee, et al. Effects of Surfaces and Leachables on the Stability
`of Biopharmaceuticals, Journal of Pharmaceutical Science (Oct. 2011),
`available at https://pubmed.ncbi.nlm.nih.gov/21523787/ (“Bee”)
`
`viii
`
`
`
`Ex.
`1069
`
`Ex.
`1070
`
`Ex.
`1071
`
`Ex.
`1072
`
`Ex.
`1073
`
`Ex.
`1074
`
`Ex.
`1075
`
`Ex.
`1076
`
`Ex.
`1077
`
`Ex.
`1078
`
`Ex.
`1079
`
`Ex.
`1080
`
`
`
`
`
`
`Michael Colucciello, Prefilled Syringe Delivery of Intravitreal Anti-
`VEGF Medications: Advantages for Patients and Physicians, Retinal
`Physician (Mar. 1, 2019), available at
`https://www.retinalphysician.com/issues/2019/march-2019/prefilled-
`syringe-delivery-of-intravitreal-anti-ve (“Colucciello”)
`Declaration of Juergen Sigg (“Sigg Declaration”)
`
`Department of Health & Human Services, Macugen Approval Letter
`(Dec. 18, 2004)
`
`Lonny Wolgemuth, Challenges with Prefilled Syringes: The Parylene
`Solution, ONdrugDelivery (Oct. 2012), available at
`https://ondrugdelivery.com/wp-content/uploads/2018/11/Oct2012.pdf
`Therese M. Sassalos, Prefilled Syringes for Intravitreal Drug Delivery,
`Clinical Ophthalmology 2019:13 701-706, available at
`https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6485318/
`SCS Coating Systems, SCS Parylene Properties (2007), available at
`https://www.physics.rutgers.edu/~podzorov/parylene%20properties.pdf
`(“SCS”)
`Lonny Wolgemuth, Assessing the Effects of Sterilization Methods on
`Parylene Coating, Medical Device & Diagnostic Industry, (Aug. 2002)
`
`David E. Overcashier, et al. Technical Considerations in the
`Development of Pre-filled Syringes for Protein Products, Am. Pharm.
`Rev. 2006;9(7): 77-83 (“Overcashier”)
`SDNY 20-5502 Docket
`
`Federal Court Statistics
`
`Novartis Letter to NDNY Court
`
`Mehmet S. Kocabora, et al. Intravitreal Silicone Oil Droplets
`Following Pegaptanib Injection, Acta Ophthalmologica 2010, available
`at https://onlinelibrary.wiley.com/doi/full/10.1111/j.1755-
`3768.2008.01336.x (“Kocabora”)
`
`ix
`
`
`
`
`
`
`
`
`Ex.
`1081
`
`Ex.
`1082
`
`Ex.
`1083
`
`Ex.
`1084
`
`Ex.
`1085
`
`Ex.
`1086
`
`Macugen Label (2008)
`
`U.S. Pharmacopeia, USP 789, Particulate Matter in Ophthalmic
`Solutions, USP 32 NF 27 (2009)
`
`Novartis NDNY Complaint
`
`Novartis Letter to SDNY Court
`
`ITC Investigation No. 337-TA-1207, Statement on the Public Interest
`by Proposed Respondent Regeneron Pharmaceuticals, Inc.
`
`ITC Investigation No. 337-TA-1207, Statement on the Public Interest
`by Szilard Kiss
`
`Ex.
`1087
`
`Nitin Rathore, et al. Variability in Syringe Components and its Impact
`on Functionality of Delivery Systems, PDA Journal of Pharmaceutical
`Science and Technology 2011, 65 468-480 (“Rathore”)
`Ex.
`1088 PCT Patent Publication No. WO 2007/084765 to Deschatelets et al.
`Ex.
`PCT Patent Publication No. WO 97/44068 to Tack et al.
`1089
`
`Ex.
`1090
`
`Text Minute Entry re Rule 16 Conference held on August 18, 2021,
`Novartis Pharma AG et al v. Regeneron Pharma., Inc., No. 1:20-cv-
`00690 (N.D.N.Y. Aug. 18, 2021)
`
`x
`
`
`
`
`
`
`The Board should reject Novartis’s request to deny institution under §
`
`314(a), and instead evaluate the merits of the Petition. Novartis avoided institution
`
`of Regeneron’s original IPR by representing that the ITC would decide the validity
`
`of the 631 Patent before a FWD. Petition 4-6, 8-9. 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.
`
`Novartis’s Fintiv argument should also be rejected. There is no basis for
`
`Novartis’s representation that a trial in the NDNY will occur anytime near the
`
`October 2022 FWD deadline. At the Rule 16 conference, the NDNY—consistent
`
`with local patent rules—adopted a schedule without setting a trial date. In fact, the
`
`NDNY has now twice rejected Novartis’s request to schedule a trial before
`
`October 2022. As such, Fintiv cannot support denial.
`
`I.
`
`The GENERAL PLASTIC FACTORS SUPPORT INSTITUTION
`Factors 4 and 5 Support Institution Because Regeneron Could
`A.
`Only Raise the ITC Termination in the Current Petition
`Novartis asserts that Regeneron chose a “serial petition strategy” instead of
`
`raising the ITC termination in a rehearing request. POPR at 8, 14-15. But
`
`1
`
`
`
`
`
`
`Regeneron had no choice. Due to Novartis’s gamesmanship, filing the present
`
`petition was the only means by which Regeneron could ensure that Novartis’s
`
`termination of the ITC Investigation would be fully considered by the Board.
`
`Under 47 C.F.R. § 42.71(d), a party may “file a single request for
`
`rehearing,” but only within “30 days of the entry of a final decision.” The Board
`
`denied institution of Regeneron’s original IPR based on § 314(a) on January 15,
`
`2021, so Regeneron’s deadline was February 15, 2021. Ex. 1064. By delaying
`
`until April 8, 2021 to terminate the ITC Investigation, Novartis prevented
`
`Regeneron from raising the ITC termination in its rehearing request before the
`
`deadline. Moreover, no rule provides petitioners a clear right to file a second
`
`rehearing request or supplement an original request, and Novartis failed to explain
`
`how Regeneron could have done so. Instead, Regeneron’s only choice was to file
`
`this petition, which Regeneron did within two weeks of the ITC termination. Thus,
`
`Factors 4 and 5 favor institution because Regeneron did not delay at all.
`
`Factors 1-3 Favor Institution
`B.
`Although Regeneron previously filed two IPRs against the 631 Patent,
`
`Factors 1 and 2 favor institution because Regeneron is asserting the same prior art
`
`references from the original IPRs, which were never addressed on the merits. And
`
`as explained below, Factor 3 also favors institution because Regeneron did not
`
`utilize the previous IPRs as a roadmap to “shift[] . . . the prior art asserted and the
`
`
`
`2
`
`
`
`
`
`
`related arguments.” Gen. Plastic Indus. Co., Ltd. v. Kaisha, No. IPR2016-01357,
`
`2017 WL 3917706, at *7 (PTAB Sept. 6, 2017).
`
`Contrary to Novartis’s assertion, Regeneron gained no advantage by
`
`receiving the Board’s institution decision from the original IPR because the Board
`
`never addressed the merits. Likewise, Novartis’s assertions concerning discovery
`
`conducted in the ITC are wholly irrelevant because Factor 3 is limited to unfairness
`
`associated with utilizing materials from previous IPRs. Id. In Samsung, which
`
`Novartis cites extensively (e.g., POPR at 11), the Board only addressed unfairness
`
`associated with using materials from related IPR proceedings (not co-pending
`
`litigation). Samsung Elecs. Co. v. Elm 3DS Innovations, LLC, IPR2017-01305,
`
`Paper 11 at 19 (PTAB Oct. 17, 2017); see also Kashiv Biosciences, LLC v. Amgen
`
`Inc., IPR2019-00791, Paper 15 at 30-31 (PTAB Sept. 22, 2019) (rejecting
`
`argument that co-pending litigation is relevant under General Plastic).
`
`In addition, the “new combinations and arguments” identified by Novartis
`
`are of minimal relevance under Factor 3 because they do not reflect shifts in prior
`
`art arguments. POPR at 13. First, the absence of Reuter is irrelevant because
`
`Regeneron voluntarily withdrew Reuter by terminating IPR2020-01318 to
`
`conserve the Board’s resources. Second, the 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
`
`
`
`3
`
`
`
`
`
`
`merits. Third, the Sigg/Boulange ground was also presented in the original IPR,
`
`and was likewise not addressed on the merits. Moreover, it is not unfair that the
`
`Petition explains why Novartis’s Parylene C argument concerning Boulange is
`
`irrelevant because Regeneron would have had the opportunity to address that
`
`argument after institution if the original IPR had been decided on the merits.
`
`Fourth, Regeneron could not have addressed secondary considerations evidence in
`
`the original IPR because it did not learn of the purported evidence until after filing
`
`the original IPR. In any event, addressing secondary considerations is not a shift in
`
`prior art and is not unfair because Regeneron would have been entitled to address
`
`any such evidence after institution of the original IPR.
`
`Even if Regeneron gained some advantage from receiving Novartis’s POPR
`
`and ITC arguments—which it did not—there is no unfair advantage because this is
`
`all the result of Novartis’s attempt to forum shop its validity arguments.1 Novartis
`
`represented that the PTAB need not decide the merits of Regeneron’s original IPR
`
`because the ITC would do so first. After the ITC Staff concluded that there was
`
`clear and convincing evidence that the 631 Patent is invalid as obvious, Novartis
`
`terminated that case in the hopes of finding a more favorable forum in the NDNY.
`
`
`1 Institution is particularly warranted here to ensure that future parties do not
`
`engage in similar forum shopping.
`
`
`
`4
`
`
`
`
`
`
`Having twice avoided a validity determination on the merits, it would be grossly
`
`unfair to Regeneron if Novartis could invoke General Plastic to do so again. Gen.
`
`Plastic, Paper No. 19 at 18 (explaining that multiple petitions may be permitted to
`
`ensure “the fundamental fairness of the process for all parties”).2
`
`II. THE FINTIV FACTORS SUPPORT INSTITUTION
`Novartis’s Fintiv argument has no merit. At the Rule 16 conference on
`
`August 18, 2021, the NDNY, consistent with local patent rules, adopted a schedule
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`without setting a trial date.3 The NDNY has twice rejected Novartis’s request to
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`schedule a trial before October 2022, and squarely rejected Novartis’s argument to
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`expedite the case by eliminating claim construction. Claim construction briefing
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`will begin on December 24, 2021, while fact and expert discovery deadlines will
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`not be set until after the Court issues a Markman Order. As such, the parties will
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`have invested little in the NDNY case by the institution deadline. Moreover, the
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`status of the SDNY case is irrelevant because it focuses on antitrust and
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`unenforceability issues, not the merits of Regeneron’s IPR grounds, and there is
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`also no trial date yet.
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`Accordingly, Fintiv cannot support denial of institution.
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`2 Factors 6 and 7 also favor institution because the Board never addressed the
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`merits of Regeneron’s original IPR and will do so here before the NDNY.
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`3 The parties will file a transcript and scheduling order once available. Ex. 1090.
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`5
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`Dated: August 20, 2021
`
`
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`Respectfully submitted,
`
`/Elizabeth 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
`
`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
`
`
`6
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`
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`CERTIFICATE OF COMPLIANCE
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`The undersigned certifies that this brief complies with the type-volume
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`limitations of 37 CFR § 42.24(a)(1)(i). This brief contains no more than 5 pages, as
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`permitted by the Board’s email authorization dated August 12, 2021.
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`
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`The undersigned further certifies that this brief complies with the typeface
`
`requirements of 37 CFR § 42.6(a)(2)(ii) and typestyle requirements of 37 CFR §
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`42.6(a)(2)(iii). This brief has been prepared in a proportionally spaced typeface
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`using Microsoft Word 2010 in Times New Roman 14 point font.
`
`
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`Dated: August 20, 2021
`
`
`
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`Respectfully submitted,
`
`/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
`E: Regeneron.IPR.Service@weil.com
`
`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
`E: Regeneron.IPR.Service@weil.com
`
`
`
`
`
`
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`
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`CERTIFICATE OF SERVICE
`
`I hereby certify that on August 20, 2021, copies of the foregoing
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`PETITIONER’S REPLY TO PATENT OWNER’S PRELIMINARY
`
`RESPONSE was served via electronic mail, upon the following:
`
`Elizabeth J. Holland
`Linnea Cipriano
`Goodwin Procter LLP
`620 Eighth Avenue
`New York, NY 10018
`EHolland@goodwinlaw.com
`LCipriano@goodwinlaw.com
`
`William G. James
`Goodwin Procter LLP
`1900 N Street, N.W.
`Washington, D.C. 20036
`WJames@goodwinlaw.com
`
`Joshua Weinger
`Goodwin Procter LLP
`100 Northern Avenue
`Boston, MA 02210
`JWeinger@goodwinlaw.com
`
`DG-NovartisPFS@goodwinlaw.com
`
`
`
`/Lauren McDuffie/
`Lauren McDuffie
`IP Paralegal
`Weil, Gotshal & Manges LLP
`2001 M Street N.W., Suite 600
`Washington, D.C. 20036
`202-682-7000
`lauren.mcduffie@weil.com
`
`
`
`
`
`
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