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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`_________________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_________________________
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`SAMSUNG BIOEPIS CO., LTD.,
`Petitioner,
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`v.
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`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`_________________________
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`Case IPR2023-00884
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`U.S. Patent No. 11,253,572
`_________________________
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`PETITIONER’S REPLY TO
`PATENT OWNER’S PRELIMINARY RESPONSE
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`TABLE OF EXHIBITS
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`1001-1064|Previously presented U.S. Patent App. No. 13/940,370 (July 12, 2013)
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`Pursuant to the Board’s authorization (Ex. 3001), Petitioner submits this
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`reply to Patent Owner’s Preliminary Response (“POPR”) (Paper 6). Patent
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`Owner’s attempt to antedate the 2010 Press Releases and ARVO Abstract fails for
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`three independent reasons. Because Patent Owner’s substantive arguments against
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`institution for Grounds II and III and portions of Grounds I and VI-VIII are
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`premised upon Patent Owner’s flawed attempts to antedate these references,
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`institution is appropriate as set out further below.
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`I.
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`Patent Owner’s Attempt to Antedate the Art Fails Because the ’572
`Patent is Subject to AIA 35 U.S.C. §§ 102 and 103
`Patent Owner contends (at 12) that a January 2011 provisional application
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`provides written description support for claim 25 and therefore pre-AIA Sections
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`102 and 103 apply to the ’572 patent. On that basis, Patent Owner alleges it can
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`swear behind certain prior art references relied on by Petitioner. But claim 25 has
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`an earliest effective filing date of, at best, July 12, 2013, and thus the ’572 patent
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`should be treated as a post-AIA patent and analyzed under post-AIA law. Patent
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`Owner’s attempt to antedate these references can be rejected for this reason alone.
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`“AIA 35 U.S.C. 102 and 103 apply to any patent application that contains or
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`contained at any time a claim to a claimed invention that has an effective filing
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`date that is on or after March 16, 2013.” MPEP 2159.02; Leahy–Smith America
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`Invents Act (“AIA”), Pub.L. No. 112–29, § 3(c), 125 Stat. 284 (2011). Patent
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`1
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`Owner has the burden of establishing an earlier effective filing date. See Rsch.
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`Corp. Techs. v. Microsoft Corp., 627 F.3d 859, 870 (Fed. Cir. 2010).
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`Claim 25 depends from claim 15 and requires the treatment of diabetic
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`macular edema through “sequentially administering to the patient a single initial
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`dose of 2 mg of aflibercept, followed by one or more secondary doses of 2 mg of
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`aflibercept [four weeks apart], followed by one or more tertiary doses of 2 mg of
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`aflibercept [eight weeks apart]” wherein “four secondary doses are administered to
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`the patient.” Ex. 1001. Thus, claim 25 requires five 2 mg injections of aflibercept
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`spaced four weeks apart, followed by further injections spaced eight weeks apart,
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`all for the treatment of DME. That dosing regimen was not described in any of the
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`priority applications until, at best, July 12, 2013. Specifically, on July 12, 2013,
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`U.S. Patent Application 13/940,370 (the “’370 application”) was filed, adding
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`Example 7. See Ex. 1065, ¶¶ 69-91. Example 7 provides a list of permutations on
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`dosing regimens, one of which recites five initial loading doses as in claim 25. Id.
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`Patent Owner contends (at 12-13) that paragraph 18 of the earlier January
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`2011 provisional application provided a “literal description of all elements of claim
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`25.” Paragraph 18 states that “[t]he methods of the invention may comprise
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`administering to a patient any number of secondary and/or tertiary doses of a
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`VEGF antagonist”—i.e. 2, 8, 20, 40, etc. Ex. 2025, ¶ 18. It singles out only the
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`use of only one secondary dose: “in certain embodiments, only a single secondary
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`2
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`dose is administered to the patient.” Id. It lists other secondary dose possibilities
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`in an unbounded series: “In other embodiments, two or more (e.g. 2, 3, 4, 5, 6, 7,
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`8, or more) secondary doses are administered to the patient.” Id. Accordingly, the
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`series of secondary doses alone could extend from months to years.
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`Paragraph 18 fails to disclose multiple elements of claim 25. It makes no
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`mention of claim 25’s recited interval for initial and secondary doses (4 weeks),
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`the recited dosage amount (2.0 mg), the recited indication (DME), or that the
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`tertiary doses are given at 8 week intervals. Nor is there any indication (in
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`paragraph 18 or elsewhere) of what combination of those variables should be
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`selected: the possibilities are effectively infinite based on the number of secondary
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`doses or intervals between doses alone, let alone the other recited variables.
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`At best, paragraph 18 discloses a classic “laundry list” of the number of
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`secondary and tertiary doses—“(e.g. 2, 3, 4, 5, 6, 7, 8, or more)”—nothing more.
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`“[L]aundry list disclosures are insufficient to satisfy the written description
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`requirement when there is no further guidance (‘blazemarks’) provided about
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`which species or combination of species included as part of the list may be selected
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`to arrive at the claimed invention.” Collegium Pharm., Inc. v. Purdue Pharma L.P.,
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`PGR2018-00048, Paper 18, 16 (Oct. 4, 2018). There are no blazemarks.
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`Accordingly, the ’572 patent should be treated as a post-AIA patent. Patent
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`Owner’s attempt to antedate the prior art can be rejected on that ground alone.
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`3
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`II.
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`Institution Is Necessary Because Patent Owner’s Evidence Is
`Unreliable, Disputed, and Raises Substantial Questions of Fact
`Patent Owner cites (at 22-28) several exhibits purporting to show that certain
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`prior art references reflect Dr. Yancopoulos’s sole work and, separately, that he
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`conceived of the claimed inventions before these references were published. As
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`set out below in Section III, however, this evidence demonstrates that in fact Patent
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`Owner cannot antedate the art, and at a minimum, that there are substantial factual
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`disputes that would be premature to resolve on these papers. In similar situations,
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`the Board has instructed that institution is necessary to allow cross-examination,
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`further discovery, briefing, and development.
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`In particular, the Board routinely finds that “[i]t is premature at the
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`institution stage to address the merits of Patent Owner’s antedating contention”
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`where the antedating evidence “has neither been developed nor tested on this
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`record.” See, e.g., Mylan Pharm. Inc. v. Boehringer Ingelheim Int’l GmbH,
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`IPR2016-01565, Paper 15, 4; id., Paper 17, 13; Medtronic Inc. v. Teleflex
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`Innovations S.A.R.L., IPR2020-00132, Paper 22 at 10-11; Associated British
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`Foods, plc v. Cornell Rsch. Found., Inc., IPR2019-00577, Paper 25 at 31. Indeed,
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`permitting full development of the record is particularly important because for
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`several grounds, Patent Owner’s substantive arguments are premised upon its
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`attempt to antedate the art.
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`4
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`Section III below explains why Patent Owner’s assertions are not supported
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`by the evidence.
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` The Board should decline Patent Owner’s
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`invitation to simply accept its factual assertions before institution.
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`III. Patent Owner’s Attempt to Antedate the Prior Art Fails
`Finally, Patent Owner’s response on Grounds II and III and portions of
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`Grounds I and VI-VIII is dependent on its arguments that it can allegedly antedate
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`certain prior art. As shown below, however, its antedating arguments fail, and thus
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`institution is appropriate on this third independent basis as well.
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`A.
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`Patent Owner Has Not Shown Dr. Yancopoulos Is the Sole
`Inventor of the Disclosures in the Prior Art
`Patent Owner argues that the 2010 Press Releases and ARVO Abstract are
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`not prior art under pre-AIA Section 102(a) because they are allegedly Dr.
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`5
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`Yancopoulos’s “own work.” 1 The cherry-picked evidence that Patent Owner
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`submitted, however, shows that the clinical trial designs and results disclosed in
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`the 2010 Press Releases and ARVO Abstract were not solely his work. In
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`particular, Dr. Yancopoulos appears to have had no involvement as to the visual
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`acuity limitations. As Patent Owner (at 25) concedes, the exception on which it
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`relies applies only if Dr. Yancopoulos is the “‘sole inventor of what is disclosed in
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`the printed publication.” (emphasis added); see also EmeraChem Holdings, LLC v.
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`Volkswagen Grp. of Am., Inc., 859 F.3d 1341, 1345-48 (Fed. Cir. 2017). Thus the
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`references do not fall under the relevant exception.
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`First, the 2010 Press Releases and ARVO Abstract do not provide any
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`indication that Dr. Yancopoulos was the sole contributor to the DA VINCI and
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`VIEW clinical trials these reference describe. To the contrary, the November 2010
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`Press Release quotes the VIEW 2 Principal Investigator, Dr. Ursula Schmidt-
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`Erfurth, regarding the results, as well as Dr. Jeffery Heier, the Chair of the Steering
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`Committee for the VIEW 1 trial. Dr. Yancopoulos is not named or credited.
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`1 Patent Owner also suggests (at 25 n.9) that the 2010 Press Releases and
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`ARVO Abstract are not prior art under AIA Section 102(b)(1)(A) and states that
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`the same standard applies to both AIA and pre-AIA patents for an inventor’s
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`alleged “own work.” On that basis, Petitioner addresses both arguments together,
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`and its response is equally applicable if the ’572 patent is an AIA patent.
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`6
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`Similarly, in the December 2010 Press Release, Dr. Yancopoulos is quoted as to a
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`separate study, Copernicus, but he is not named or credited as to the Phase 2 DME
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`Results on which Patent Owner relies. As to the 2010 ARVO Abstract, it lists two
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`authors, but nowhere credits Dr. Yancopoulos.
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`Second, Patent Owner did not submit a declaration from Dr. Yancopoulos
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`stating that the relevant disclosures of the 2010 Press Releases and ARVO Abstract
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`are his sole work.
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` And Patent Owner’s other evidence regarding Dr.
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`Yancopoulos’s role in these studies is deficient. Patent Owner quotes (at 27)
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`uncorroborated trial testimony stating that Dr. Yancopoulos “played a major role
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`in designing and carrying out the VIEW trial” described in the 2010 Press
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`Releases—not that he was the sole designer. Similarly, Patent Owner states (at 26)
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`Dr. Yancopoulos merely “was involved” in choosing the dosing regimen for the
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`DA VINCI trial—not that it was his sole work.
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`Third, the documents Patent Owner cites in support of even these equivocal
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`statements underscore, among other things, that others contributed to the
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`determination of critical elements of the claims. 2 For instance, Exhibit 2009,
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`which Patent Owner (at 26) alleges shows the DA VINCI trial is “Dr.
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`Yancopoulos’s own work” because Patent Owner allegedly takes a “top down
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`7
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`approach” to clinical trial design, actually quotes Dr. Yancopoulos stating that
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`“[h]ere at REGN, we like a top-down approach, in which major decisions are made
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`by our Senior Management Team,” not by Dr. Yancopoulos alone. Ex. 2009, 2.
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`(emphasis added). Dr. Yancopoulos then notes as to the 8-week dosing regimen
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`that the “dose [is] somewhat still undecided” and that “we are a bit still struggling
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`with the high dose to be used for the q8w interval.” Id. (emphasis added). Thus,
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`on a key point—the dosing amount disclosed in the 2010 Press Releases—Dr.
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`Yancopoulus was not, as Patent Owner contends, the “‘sole inventor’ of what is
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`disclosed in the printed publication,” but made the decision with others.
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`Finally, Patent Owner’s evidence regarding the visual acuity results
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`disclosed in the 2010 Press Releases and ARVO Abstract is even weaker.3 Patent
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`Owner (at 23) is reduced to claiming merely that the results were “sent to the sole
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`inventor, Dr. Yancopoulos.” Patent Owner does not claim Dr. Yancopoulos had
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`any role in running the trials, interpreting the data, or determining the visual acuity
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`results.
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`3 Similarly, for claims 6 and 12, which recite an isotonic formulation,
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`Patent Owner argues (at 42-43) Dr. Yancopoulos “made the final decision” as to
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`the formulation. But Exhibit 2009 discloses that others contributed to the decision
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`about which formulation to use, which was open question. Ex. 2009, 2.
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`8
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`Dr. Yancopoulos admitted
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`that a team of experts was responsible for coming up with the clinical trial
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`parameters. See, e.g., Ex. 2003, 141:14-17, 143:15-145:15, and 212:25-214:3.
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`Notably, Patent Owner does not state that Dr. Yancopoulos even reviewed
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`the clinical trial results, let alone analyzed them and determined which of the
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`various reported visual acuity results should be claimed as part of any alleged
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`invention or reported in the 2010 Press Releases or ARVO Abstract. The only
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`conclusion from the evidence Patent Owner cites, in fact, is that he had no such
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`role, precluding any finding that it reflects his sole work.
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`Because, even based on Patent Owner’s limited, self-selected evidence, it is
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`clear that multiple individuals contributed to the subject matter described in the
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`2010 Press Releases and ARVO Abstract, Patent Owner’s argument that these
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`references are not prior art because they reflect Dr. Yancopoulos’s sole work fails.
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`B.
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`Patent Owner Has Not Shown Dr. Yancopoulos Conceived and
`Reduced to Practice the Invention Before Any of the Prior Art
`Patent Owner likewise cannot establish that Dr. Yancopoulos conceived and
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`reduced to practice the claimed subject matter before the date of the 2010 Press
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`Releases and ARVO Abstract. First, as noted above, Patent Owner adduced no
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`evidence that Dr. Yancopoulos conceived multiple aspects of the invention,
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`including at least the dosing amount and the visual acuity limitations. For instance,
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`the mere fact that clinical trial results were allegedly communicated to Dr.
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`9
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`Yancopoulos is insufficient to establish conception. Rather, conception requires a
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`showing that “the inventor disclosed to others his ‘complete thought expressed in
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`such clear terms as to enable those skilled in the art’ to make the invention.” Kridl
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`v. McCormick, 105 F.3d 1446, 1449-50, (Fed. Cir. 1997) (emphasis added).
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`Nothing in the record shows that Dr. Yancopoulos arrived at the complete idea
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`recited in the ’572 patent claims—notably its precise dosing intervals, dosing
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`amounts, indications, in combination with the visual acuity limitations reciting
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`specific results—let alone disclosed that idea to others as a complete thought.
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`Patent Owner also “does not explain in sufficient detail how the proffered
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`testimony and documents disclose every feature of the subject matter challenged.”
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`NRG Energy, Inc. v. Midwest Energy Emissions Corp., IPR2020-00926, Paper 19
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`at 33 (PTAB Dec. 2, 2020). At most, Patent Owner provides a general citation to
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`trial testimony and other evidence, and asks Petitioner and the Board to decipher
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`the alleged conception of each and every limitation of the ’572 patent. Because the
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`conception of “every feature” is not shown as required, Patent Owner’s attempt to
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`antedate its 2010 Press Releases and ARVO Abstract fails.
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`IV. Conclusion
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`Accordingly, for the reasons set forth in its Petition and above, Petitioner
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`respectfully requests the Board grant inter partes review of the ’572 patent.
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`10
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`DATED: September 18, 2023
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`Respectfully submitted,
`By /Raymond N. Nimrod/
`Raymond N. Nimrod (Reg. No. 31,987)
`raynimrod@quinnemanuel.com
`QUINN EMANUEL URQUHART
`& SULLIVAN LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`Tel:
`(212) 849-7000
`Fax: (212) 849-7100
`
`
`Attorneys for Petitioner Samsung Bioepis
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`11
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`CERTIFICATE OF SERVICE
`In accordance with 37 C.F.R. § 42.6(e), I hereby certify that on September
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`18, 2023, true and correct copies of Petitioner’s Reply to Patent Owner’s
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`Preliminary Response and Exhibit 1065 were served via electronic mail to Patent
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`Owner at the following email addresses of record:
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`Brausa, Adam R. ABrausa@mofo.com
`Davis, Kira A KiraDavis@mofo.com
`Weires, Rebecca RWeires@mofo.com
`Durie, Daralyn J. DDurie@mofo.com
`Regeneron-MoFo-IPR Regeneron-MoFo-IPR@mofo.com
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`DATED: September 18, 2023
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`Respectfully submitted,
`By /Raymond N. Nimrod/
`Raymond N. Nimrod (Reg. No. 31,987)
`raynimrod@quinnemanuel.com
`QUINN EMANUEL URQUHART
` & SULLIVAN, LLP
`51 Madison Ave., 22nd Floor
`New York, NY 10010
`Tel: (212) 849-7000
`Fax: (212) 849-7100
`
`
`12
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