UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`SAMSUNG BIOEPIS CO., LTD.,
`Petitioner,
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`Patent No. 11,253,572
`
`Inter Partes Review No. IPR2023-00884
`
`PATENT OWNER’S SUR-REPLY TO PETITIONER’S REPLY TO
`PATENT OWNER’S PRELIMINARY RESPONSE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`SAMSUNG BIOEPIS CO., LTD.,
`Petitioner,
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`Patent No. 11,253,572
`
`Inter Partes Review No. IPR2023-00884
`
`PATENT OWNER’S SUR-REPLY TO PETITIONER’S REPLY TO
`PATENT OWNER’S PRELIMINARY RESPONSE
`
`
`
`IPR2023-00884
`
`Petitioner still has not met its burden to show “a reasonable likelihood that
`
`[it] would prevail with respect to at least 1 of the claims challenged.” 35 U.S.C.
`
`§ 314(a). For several grounds, Petitioner chose to rely on Patent Owner’s
`
`disclosures of its own clinical trial results—the same results that support the ’572
`
`patent. See POPR 8. The disclosures were published less than a year before the
`
`priority date and can only be prior art if they (1) predate Regeneron’s invention of
`
`the ’572 claims; and (2) do not disclose the work of the inventor, Dr. Yancopoulos.
`
`Petitioner argues that Dr. Yancopoulos was not shown to be the sole “inventor” of
`
`the “prior art,” but Petitioner does not challenge inventorship of the ’572 claims.
`
`Common sense dictates that any intersection of the claims and Regeneron’s
`
`disclosures would stem from the same source—the inventor—and would be
`
`published after conception. Beyond that common-sense point (which Petitioner
`
`does not address), record evidence of the Eylea® clinical development timeline
`
`supports Patent Owner’s arguments that the references are not prior art. Petitioner
`
`has no reasonable likelihood of prevailing with Regeneron’s 2010 disclosures.
`
`Institution should be denied.
`
`I.
`
`Pre-AIA 35 U.S.C. § 102 Applies
`
`Claim 25 is the sole basis for Petitioner’s assertion that AIA § 102 applies.
`
`The Petition did not dispute that the other challenged claims find adequate written
`
`description support in Regeneron’s January 21, 2011 provisional application and
`
`1
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`
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`IPR2023-00884
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`would therefore be subject to pre-AIA § 102, absent claim 25. Pet. 14 n.1; see
`
`POPR 12 n.5. Claim 25 does not change the analysis because it adds only one
`
`limitation: four secondary doses. Paragraph 18 of the provisional expressly
`
`discloses four secondary doses as a suitable option. Patent Owner never contended
`
`that paragraph 18 alone supplies every limitation of claim 25, as Petitioner
`
`suggests. Reply 2. The remaining limitations, which claim 25 shares with each of
`
`claims 15–24, find support throughout the provisional. Most clearly, Example 5
`
`describes the DA VINCI trial, in which “patients with clinically significant
`
`DME . . . received three initial doses of 2 mg VEGFT once every four weeks”
`
`followed by “once every 8 weeks dosing.” Ex.2025 ¶ 61. See also id. ¶¶ 16–17,
`
`19, 42 (4 weeks between secondary doses; 8 weeks between tertiary doses); ¶ 24,
`
`claim 6 (treating DME); ¶¶ 28, 42, claim 20 (2 mg). Because all its limitations are
`
`disclosed in the provisional, claim 25, like the other challenged claims, is entitled
`
`to a priority date no later than January 21, 2011, and pre-AIA § 102 applies.1
`
`II.
`
`Petitioner Has Not Demonstrated a Reasonable Likelihood that the 2010
`References Are Prior Art
`
`A.
`
`The Board May Resolve Prior Art Status at the Institution Stage
`
`The Board often decides the prior art status of a reference at the institution
`
`1 In any event, this issue is not dispositive. Petitioner’s references are not prior art
`
`under AIA § 102. POPR 13, 25 n.9, 27 n.10, 41 n.15.
`
`2
`
`
`
`IPR2023-00884
`
`stage. E.g., Dong Guan Leafy Windoware Co. Ltd. v. Anli Spring Co., Ltd.,
`
`PGR2020-00001, Paper 7 at 53 (PTAB Apr. 20, 2020) (finding based on patent
`
`owner’s evidence at institution that a reference is not prior art because AIA
`
`§ 102(b)(1)(A) applies); Microsoft Corp. v. Throughputer, Inc., IPR2022-01566,
`
`Paper 13 at 16–17 (PTAB May 31, 2023) (denying institution based on a finding
`
`that Petitioner’s reference did not qualify as a prior art printed publication).
`
`The decisions Petitioner cites, Reply 4, are all distinguishable. First,
`
`Petitioner’s references are Regeneron’s own disclosures, so the Board need only
`
`evaluate the order of events in Regeneron’s own timeline, which the references
`
`themselves help elucidate. None of Petitioner’s cases involved an allegation that
`
`the patent owner’s own disclosures were prior art. In addition, the testimony here
`
`has been tested in the district court trial on the ’572 patent. See Ex.2003 (trial
`
`transcript); Reply 9 (citing Yancopoulos cross-examination). Finally, each
`
`proceeding Petitioner cites was subject to the presumption against a patent owner
`
`on testimonial evidence, which no longer applies. 85 Fed. Reg. 79120, 79122
`
`(Dec. 9, 2020); see Medtronic Inc. v. Teleflex Innovations S.A.R.L., IPR2020-
`
`00132, Paper 22 at 11 (PTAB June 8, 2020) (expressly noting the presumption).
`
`B.
`
`The Relied-Upon Portions of the 2010 References Are the
`Inventor’s Own Work
`
`Although Petitioner does not contest Dr. Yancopoulos’s status as inventor of
`
`the ’572 claims, it challenges whether the allegedly same subject matter disclosed
`
`3
`
`
`
`IPR2023-00884
`
`by Regeneron in 2010 is Dr. Yancopoulos’ own work. That argument makes no
`
`sense. As Patent Owner emphasized in its preliminary response, Dr. Yancopoulos
`
`is the inventor of the ’572 Patent, which discloses the VIEW and DA VINCI trials
`
`and includes claims drawn to the dosing regimens and results of these trials. The
`
`patent enjoys a presumption of correct inventorship. Incyte Corp. v. Concert
`
`Pharms., Inc., PGR2021-00006 Paper 68 at 34 (PTAB May 11, 2022) (applying
`
`the presumption to resolve whether a reference fell under the exceptions of AIA
`
`§ 102(b)(1)); see also Ex.2003, 137:3–6; Ex.1014, 55.
`
`The collaboration Petitioner points to between Dr. Yancopoulos and others
`
`does not preclude a finding that Petitioner’s references disclose the inventor’s own
`
`work. In Katz, the court determined that the patent owner showed that a reference
`
`coauthored by students working at the inventor’s direction was the inventor’s own
`
`work. In re Katz, 687 F.2d 450, 455–56 (C.C.P.A. 1982). In Incyte, the Board
`
`found that a reference fell within the exception of AIA § 102(b)(1) even though the
`
`data therein was generated by a co-inventor’s staff member, not the co-inventor
`
`herself. PGR2021-00006, Paper 68 at 20–21, 42. Dr. Yancopoulos, co-founder
`
`and chief scientist at Regeneron, was the “initiator and the driver” of the claimed
`
`dosing regimen. Ex.2003, 97:7–13, 137:3–6. Regeneron took a “top-down
`
`approach” to clinical trial design, Ex.2009, and naturally, many other individuals at
`
`Regeneron worked on the clinical trial to test the dosing regimen.
`
`4
`
`
`
`IPR2023-00884
`
`C.
`
`Regeneron Invented the Challenged Claims Before It Published
`the 2010 References
`
`Patent Owner provided corroborating evidence, in the form of internal
`
`presentations and reports, to show that it reduced to practice the invention of
`
`the ’572 claims no later than when it obtained the VIEW and DA VINCI results.
`
`POPR 22–24, 26–27 (citing, inter alia, Ex.2024; Ex.2015; Ex.2010; Ex.2011). To
`
`the extent it is has shown actual reduction to practice, Patent Owner need not
`
`corroborate conception. Purdue Pharma L.P. v. Boehringer Ingelheim GMBH,
`
`237 F.3d 1359, 1365 (Fed. Cir. 2001) (“To antedate . . . a party must show either
`
`an earlier reduction to practice, or an earlier conception followed by a diligent
`
`reduction to practice.”); see also Mylan Pharms. Inc. v. Merck Sharp & Dohme
`
`Corp., IPR2020-00040, Paper 91 at 52 (PTAB May 7, 2021) (finding a patent
`
`owner antedated a reference based on Merck’s actual reduction to practice alone),
`
`aff’d, 50 F.4th 147 (Fed. Cir. 2022).
`
`Patent Owner has provided testimony and documents showing Regeneron’s
`
`clinical development timeline. “There is no final single formula that must be
`
`followed in proving corroboration.” Kridl v. McCormick, 105 F.3d 1446, 1450
`
`(Fed. Cir. 1997). In view of this standard, Patent Owner’s evidence shows that
`
`Petitioner has not demonstrated a reasonable likelihood of showing that
`
`Regeneron’s own clinical trial disclosures, made less than one year before the
`
`priority date of the references, are prior art.
`
`5
`
`
`
`IPR2023-00884
`
`Dated: September 28, 2023
`
`Respectfully submitted,
`
`By: /Adam R. Brausa/
`Adam R. Brausa, Reg. No. 60,287
`MORRISON & FOERSTER LLP
`425 Market Street
`San Francisco, California 94105
`Tel: (415) 268-6053
`ABrausa@mofo.com
`
`Counsel for Patent Owner
`
`6
`
`
`
`IPR2023-00884
`
`Certificate of Service (37 C.F.R. § 42.6(e)(4))
`
`I hereby certify that the attached PATENT OWNER’S SUR-REPLY TO
`
`PETITIONER’S REPLY TO PATENT OWNER’S PRELIMINARY RESPONSE
`
`was served on the below date on the Petitioner via e-mail (by agreement) to the
`
`following counsel of record:
`
`Raymond N. Nimrod (Reg. No. 31,987)
`Matthew A. Traupman (Reg. No. 50,832)
`Landon Andrew Smith (Reg. No. 79,248)
`QUINN EMANUEL URQUHART
`& SULLIVAN, LLP
`51 Madison Ave., 22nd Floor
`New York, NY 10010
`General Tel: (212) 849-7000
`Direct Tel: (212) 849-7322
`Fax: (212) 849-7100
`raynimrod@quinnemanuel.com
`matthewtraupman@quinnemanuel.com
`landonsmith@quinnemanuel.com
`qe-samsungbioepis@quinnemanuel.com
`
`Dated: September 28, 2023
`
`By /Adam R. Brausa/
`Adam R. Brausa, Reg. No. 60,287
`
`7
`
`
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