`
`
`
`
`
`
`
`
`2001 M Street, NW, Suite 600
`Washington, DC 20036
`+1 202 682 7000 tel
`+1 202 857 0940 fax
`
`Brian E. Ferguson
`+1 (202) 682-7516
`brian.ferguson@weil.com
`
`November 20, 2020
`
`
`Elizabeth J. Holland
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
`Phone: (212) 813-8800
`Email: EHolland@goodwinlaw.com
`Email: DG-NovartisPFS@goodwinlaw.com
`
`Re:
`
`
`Dear Elizabeth:
`
`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 IPR2020-1318
`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.
`
`Specifically, the invalidity grounds in the two IPRs are as follows:
`
`IPR2020-01317 Grounds
`
`
`Certain Pre-Filled Syringes for Intravitreal Injection and Components Thereof,
`Inv. No. 337-TA-1207
`
`• Obviousness of claims 1-3, 5-9, 14-22, and 24 under 35 U.S.C. § 103 based on PCT Pat. Pub.
`WO 2011/006877 (“Sigg”) in view of PCT Pat. Pub. WO 2009/030976 (“Boulange”), and if
`necessary, U.S. Pharmacopeia, USP 789, Particulate Matter in Ophthalmic Solutions, USP 34
`NF 29 (2011) (“USP789”);
`
`• Obviousness of claims 4, 10 and 23 under 35 U.S.C § 103 based on Sigg in view of Boulange
`and Arno Fries, Drug Delivery of Sensitive Biopharmaceuticals With Prefilled Syringes, 9(5)
`DRUG DELIVERY TECH. 22 (2009) (“Fries”), and if necessary, USP789;
`
`• Obviousness of claims 11-13 under 35 U.S.C § 103 based on Sigg in view of Boulange, and PCT
`Pat. Pub. WO 2007/149334 (“Furfine”), and if necessary, USP789;
`
`• Obviousness of claim 25 under 35 U.S.C § 103 based on Sigg in view of Boulange, and the
`March 7, 2011 Record of Drugs.com, Macugen Prescribing Information, available
`
`Regeneron Exhibit 1067.001
`Regeneron v. Novartis
`IPR2020-01317
`
`
`
`Elizabeth J. Holland
`November 20, 2020
`Page 2
`
`athttps://web.archive.org/web/20110307065238/http://www.drugs.com:80/pro/macugen.html
`(“Macugen® Label”), and if necessary, USP789;
`
`• Obviousness of claim 26 under 35 U.S.C § 103 based on Sigg in view of Boulange, and 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 (“Dixon”), and
`if necessary, USP789.
`
`IPR2020-01318 Grounds
`
`• Claims 1-10 and 14-24 based on PCT Pat. Pub. WO 2008/077155 (“Lam”) in view of Certified
`English Translation of Bruno Reuter and Claudia Petersen, “Die Silikonisierung von Spritzen:
`Trends, Methoden, Analyseverfahren,” TechnoPharm 2, Nr. 4 (2012): 238-244 (“Reuter”), and if
`necessary, USP789;
`
`• Claim 11-13 based on Lam and Reuter in view of Furfine, and if necessary, USP789;
`
`• Claim 25 based on Lam and Reuter in view of Macugen® Label, and if necessary, USP789;
`
`• Claim 26 based on Lam and Reuter in view of Dixon, and if necessary, USP789.
`
`If the Board declines institution of IPR2020-01317 or IPR2020-1318, Regeneron reserves the right to
`pursue these non-instituted invalidity grounds in the ITC investigation.
`
`Further, as we indicated in our November 20, 2020 email to you, Regeneron intends to move to
`terminate IPR2020-01318. If that motion is granted but the Board declines to institute trial in IPR2020-
`01317, then Regeneron reserves the right to pursue the above-identified invalidity grounds in the ITC
`investigation. If, 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.
`
`Best regards,
`
`/s/ Brian E. Ferguson
`
`Brian E. Ferguson
`
`cc: Counsel of Record - via email
`
`Regeneron Exhibit 1067.002
`Regeneron v. Novartis
`IPR2020-01317
`
`
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