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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`REGENERON PHARMACEUTICALS, INC.,
`Petitioner,
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`v.
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`NOVARTIS PHARMA AG, NOVARTIS TECHNOLOGY LLC,
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Patent Owner.
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`Inter Partes Review No. IPR2021-00816
`U.S. Patent No. 9,220,631 B2
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`PATENT OWNER’S NOTICE OF APPEAL
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`IPR2021-00816
`U.S. Patent No. 9,220,631 B2
`Patent Owner’s Notice of Appeal
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`Pursuant to 35 U.S.C. §§ 141-144 and 319 and 37 C.F.R. §§ 90.2 and 90.3,
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`notice is hereby given that Patent Owner Novartis Pharma AG, Novartis Technology
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`LLC, and Novartis Pharmaceuticals Corporation hereby appeal to the United States
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`Court of Appeals for the Federal Circuit from the Final Written Decision entered
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`October 25, 2022 in IPR2021-00816 (Paper 113), and from all prior and
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`interlocutory rulings related thereto or subsumed therein, to the extent they are
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`adverse to Patent Owner. The Final Written Decision remains under seal, and the
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`parties proposed redactions to the Board by email on November 18, 2022. See Paper
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`115. Because the Board has not yet approved or entered a redacted version, the Final
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`Written Decision is not being attached to the electronically filed Notice of Appeal,
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`but a paper copy is being served on the Director by mail.
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`In accordance with 37 C.F.R. § 90.2(a)(3)(ii), Patent Owner further indicates
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`that the issues on appeal include, but are not limited to:
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`(1) whether the Board erred in adopting Petitioner’s definition of, and
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`unique approach to identifying, a person of ordinary skill in the art, and
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`whether the Board properly conducted the obviousness analysis from the
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`perspective of the person of ordinary skill in the art it identified;
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`(2) whether the Board erred in concluding that Petitioner demonstrated
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`by a preponderance of the evidence that independent claim 1 of U.S. Patent
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`1
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`IPR2021-00816
`U.S. Patent No. 9,220,631 B2
`Patent Owner’s Notice of Appeal
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`No. 9,220,631 B2 would have been obvious to the person of ordinary skill in
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`the art based on the combination of Sigg, Boulange, and USP789, including,
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`but not limited to, whether the Board erred in concluding that:
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`(a) Boulange does not teach away from using Syringe C, and a
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`skilled artisan would have been motivated to use Boulange Syringe C,
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`in a pre-filled syringe for intravitreal administration of a VEGF
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`antagonist;
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`(b) USP789 would have motivated a skilled artisan to design an
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`ophthalmic solution with no more than 2 particles > 50 μm in diameter
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`per mL;
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`(c) Boulange’s pre-filled syringe would have been compatible
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`with Sigg’s terminal sterilization method, and a skilled artisan would
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`have reasonably expected the combination to work;
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`(d) Sigg is enabled for the portions of its disclosure upon which
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`Petitioner relied, and a skilled artisan would have been able to make
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`and use the claimed invention without undue experimentation;
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`(e) Patent Owner did not establish that the Lucentis PFS is
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`coextensive with the claims or that it embodies the claimed features;
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`2
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`IPR2021-00816
`U.S. Patent No. 9,220,631 B2
`Patent Owner’s Notice of Appeal
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`(f) Patent Owner did not persuasively show that the commercial
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`success of Lucentis PFS was due to a claimed feature that was not
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`already known in the art prior to the ’631 patent;
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`(g) the prior art would have taught a skilled artisan that the
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`Macugen PFS was terminally sterilized;
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`(h) the Genentech license provides insufficient evidence of non-
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`obviousness; and
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`(i) evidence of long-felt need, failure of others, and skepticism
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`were outweighed by evidence of obviousness;
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`(3) whether the Board erred in concluding that Petitioner demonstrated
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`by a preponderance of the evidence that dependent claim 14 of the ’631 patent,
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`including its additional limitations, would have been obvious to the person of
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`ordinary skill in the art based on the combination of Sigg, Boulange, and
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`USP789, including, but not limited to, whether the Board erred in concluding
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`that Petitioner established by a preponderance of the evidence that it would
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`have been a matter of routine optimization for a skilled artisan to achieve a
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`slide force of “less than about 5N”;
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`(4) whether the Board erred in concluding that Petitioner demonstrated
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`by a preponderance of the evidence that dependent claim 17 of the ’631 patent,
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`3
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`IPR2021-00816
`U.S. Patent No. 9,220,631 B2
`Patent Owner’s Notice of Appeal
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`including its additional limitations would have been obvious to the person of
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`ordinary skill in the art based on the combination of Sigg, Boulange, and
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`USP789, including, but not limited to, whether the Board erred in concluding
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`that Sigg would have provided motivation and a reasonable expectation of
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`success with respect to “a blister pack comprising a pre-filled syringe
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`according to claim 1, wherein the syringe has been sterilized using H2O2 or
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`EtO”;
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`(5) whether the Board erred in concluding that Petitioner demonstrated
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`by a preponderance of the evidence that dependent claim 21 of the ’631 patent,
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`including its additional limitations would have been obvious to the person of
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`ordinary skill in the art based on the combination of Sigg, Boulange, and
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`USP789, including, but not limited to, whether the Board erred in concluding
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`that the claimed “pre-filled syringe . . . wherein the syringe has been sterilized
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`using EtO or H2O2 with a Sterility Assurance Level of at least 10−6” would
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`have been obvious, without addressing whether a person of ordinary skill in
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`the art would have been motivated to achieve the claimed Sterility Assurance
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`Level or had a reasonable expectation of success in doing so;
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`(6) whether the Board erred in concluding that Petitioner demonstrated
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`by a preponderance of the evidence that dependent claim 22 of the ’631 patent,
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`4
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`IPR2021-00816
`U.S. Patent No. 9,220,631 B2
`Patent Owner’s Notice of Appeal
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`including its additional limitations, would have been obvious to the person of
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`ordinary skill in the art based on the combination of Sigg, Boulange, and
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`USP789, including, but not limited to, whether the Board erred in concluding
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`that the objective indicia of non-obviousness, including Vetter’s skepticism,
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`were insufficient to demonstrate non-obviousness;
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`(7) whether the Board erred in concluding that Petitioner demonstrated
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`by a preponderance of the evidence that dependent claim 24 of the ’631 patent,
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`including its additional limitations, would have been obvious to the person of
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`ordinary skill in the art based on the combination of Sigg, Boulange, and
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`USP789, including, but not limited to, whether the Board erred in concluding
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`that Petitioner demonstrated by a preponderance of the evidence that a skilled
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`artisan would have been motivated to combine Sigg and Boulange to make a
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`pre-filled syringe within claim 1 and administer an ophthalmic solution using
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`that syringe to treat a patient with those ocular diseases, and whether the
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`skilled artisan would have reasonably expected success in doing so;
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`(8) whether the Board erred in concluding that Petitioner demonstrated
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`by a preponderance of the evidence that claims 2, 3, 5-9, 15, 16, and 18-20 of
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`the ’631 patent would have been obvious to the person of ordinary skill in the
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`art based on the combination of Sigg, Boulange, and USP789;
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`5
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`IPR2021-00816
`U.S. Patent No. 9,220,631 B2
`Patent Owner’s Notice of Appeal
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`(9) whether the Board erred in concluding that Petitioner demonstrated
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`by a preponderance of the evidence that claims 4, 10, and 23 of the ’631 patent
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`would have been obvious to the person of ordinary skill in the art over the
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`combined teachings of Sigg, Boulange, USP789, and Fries;
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`(10) whether the Board erred in concluding
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`that Petitioner
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`demonstrated by a preponderance of the evidence that claims 11-13 of the
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`’631 patent would have been obvious to the person of ordinary skill in the art
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`over the combined teachings of Sigg, Boulange, USP789, and Furfine;
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`(11) whether the Board erred in concluding
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`that Petitioner
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`demonstrated by a preponderance of the evidence that claim 25 of the ’631
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`patent would have been obvious to the person of ordinary skill in the art over
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`the combined teachings of Sigg, Boulange, USP789, and 2008 Macugen
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`Label;
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`(12) whether the Board erred in concluding
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`that Petitioner
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`demonstrated by a preponderance of the evidence that claim 26 of the ’631
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`patent would have been obvious to the person of ordinary skill in the art over
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`the combined teachings of Sigg, Boulange, USP789, and Dixon;
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`(13) whether, in arriving at its decision, the Board erred by failing to
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`consider the prior art as a whole;
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`6
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`IPR2021-00816
`U.S. Patent No. 9,220,631 B2
`Patent Owner’s Notice of Appeal
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`(14) whether, in arriving at its decision, the Board acted in a manner
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`that was arbitrary, capricious, an abuse of discretion, or otherwise not in
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`accordance with law, or based on factual findings unsupported by substantial
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`evidence; and
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`(15) whether the Board erred in any finding or determination supporting
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`or related to those issues, as well as all other issues decided adversely to Patent
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`Owner in any orders, decisions, rulings, and opinions.
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`Pursuant to 37 C.F.R. §90.3, this Notice of Appeal is timely, having been filed
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`within 63 days after the date of the Final Written Decision.
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`Pursuant to 35 U.S.C. §142 and 37 C.F.R. §90.2(a), a copy of this Notice of
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`Appeal is being filed simultaneously with the Patent Trial and Appeal Board, the
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`Clerk’s Office for the United States Court of Appeals for the Federal Circuit, and
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`the Director of the Patent and Trademark Office.
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`7
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`December 23, 2022
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`IPR2021-00816
`U.S. Patent No. 9,220,631 B2
`Patent Owner’s Notice of Appeal
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`Respectfully submitted.
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`
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`/Elizabeth J. Holland/
`Elizabeth J. Holland (Reg. No. 47,657)
`ALLEN & OVERY LLP
`1221 Avenue of the Americas
`New York, NY 10020
` (212) 610-6300
`elizabeth.holland@allenovery.com
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`Counsel for Patent Owner
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`8
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`IPR2021-00816
`U.S. Patent No. 9,220,631 B2
`Patent Owner’s Notice of Appeal
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`CERTIFICATE OF FILING AND SERVICE
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`Pursuant to 37 C.F.R. §§90.2(a)(1) and 104.2(a), I hereby certify that, in
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`addition to being filed electronically through the Patent Trial and Appeal Board’s P-
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`TACTS system, a true and correct original version of the foregoing PATENT
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`OWNER’S NOTICE OF APPEAL is being filed by Express Mail on December 23,
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`2022, with the Director of the United States Patent and Trademark Office, at the
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`following address:
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`Director of the United States Patent and Trademark Office
`c/o Office of the Solicitor
`United States Patent and Trademark Office
`Mail Stop 8, P.O. Box 1450
`Alexandria, VA 22313-1450
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`Pursuant to 37 C.F.R. §90.2(a)(2) and Federal Circuit Rules 15(a)(1), 52(a),
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`and 52(e), I hereby certify that a true and correct copy of the foregoing PATENT
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`OWNER’S NOTICE OF APPEAL is being filed in the United States Court of
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`Appeals for the Federal Circuit on December 23, 2022, and that the filing fee is being
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`paid electronically using pay.gov.
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`I further certify that the foregoing PATENT OWNER’S NOTICE OF
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`APPEAL was served electronically via e-mail, as agreed to by counsel, on December
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`23, 2022, on the following counsel for Petitioner:
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`9
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`IPR2021-00816
`U.S. Patent No. 9,220,631 B2
`Patent Owner’s Notice of Appeal
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`WEIL, GOTSHAL & MANGES LLP
`Elizabeth Stotland Weiswasser (elizabeth.weiswasser@weil.com)
`Anish R. Desai (anish.desai@weil.com)
`Natalie Kennedy (natalie.kennedy@weil.com)
`Andrew Gesior (andrew.gesior@weil.com)
`Christopher M. Pepe (christopher.pepe@weil.com)
`Matthew D. Sieger (matthew.sieger@weil.com)
`Priyata Y. Patel (priyata.patel@weil.com)
`Regeneron.IPR.Service@weil.com
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`REGENERON PHARMACEUTICALS, INC.
`Petra Scamborova (petra.scamborova@regeneron.com)
`James T. Evans (james.evans@regeneron.com)
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`/Elizabeth J. Holland/
`Elizabeth J. Holland (Reg. No. 47,657)
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`10
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