Trials@uspto.gov
`571.272.7822
`
`
` Paper: 58
`Date: May 23, 2024
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`SAMSUNG BIOEPIS CO., LTD., CELLTRION, INC., and
`BIOCON BIOLOGICS INC.,
`Petitioners,
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`____________
`
`IPR2023-008841
`Patent 11,253,572 B2
`____________
`
`
`Before SUSAN L. C. MITCHELL, ROBERT A. POLLOCK, and
`RYAN H. FLAX, Administrative Patent Judges.
`
`FLAX, Administrative Patent Judge.
`
`
`
`ORDER
`Granting Petitioner’s Motion for Additional Discovery
`37 C.F.R. § 42.51(b)(2)
`
`
`
`
`
`
`1 IPR2024-00260 and IPR2024-00298 are joined with IPR2023-00884. See
`Papers 31 and 33.
`
`
`571.272.7822
`
`
` Paper: 58
`Date: May 23, 2024
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`SAMSUNG BIOEPIS CO., LTD., CELLTRION, INC., and
`BIOCON BIOLOGICS INC.,
`Petitioners,
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`____________
`
`IPR2023-008841
`Patent 11,253,572 B2
`____________
`
`
`Before SUSAN L. C. MITCHELL, ROBERT A. POLLOCK, and
`RYAN H. FLAX, Administrative Patent Judges.
`
`FLAX, Administrative Patent Judge.
`
`
`
`ORDER
`Granting Petitioner’s Motion for Additional Discovery
`37 C.F.R. § 42.51(b)(2)
`
`
`
`
`
`
`1 IPR2024-00260 and IPR2024-00298 are joined with IPR2023-00884. See
`Papers 31 and 33.
`
`
`
`IPR2023-00884
`Patent 11,253,572 B2
`
`
`INTRODUCTION
`I.
`On May 10, 2024, Petitioner, Samsung Bioepis Co., LTD
`(“Petitioner” or “Samsung”) filed an authorized Motion for (Additional)
`Discovery (Paper 56 (“Pet. Mot.”)), which is opposed (Paper 57 (“PO
`Opp.”)) by Patent Owner, Regeneron Pharmaceuticals, Inc. (“Patent Owner”
`or “Regeneron”). For the reasons discussed below, Petitioner’s Motion is
`granted.
`For context, Regeneron is the owner of U.S. Patent 11,253,572 B2
`(Ex. 1001, “the ’572 patent”). Paper 5, 1. On April 27, 2023, Samsung filed
`a Petition for inter partes review challenging the patentability of claims 1–
`30 (all claims) of the ’572 patent. Paper 2, 1 (“Pet.”). Trial was instituted
`on November 17, 2023. Paper 13. Subsequently, on December 14, 2023,
`Celltrion, Inc. in IPR2024-00260, and on December 18, 2023, Biocon
`Biologics Inc. in IPR2024-00298, each respectively filed a petition for inter
`partes review also challenging the patentability of claims 1–30 of the ’572
`patent, and filed motions for joinder with IPR2023-00884. Papers 31 and
`33. The trials were instituted and the motions were granted. Id. These
`joined petitioners each agreed to take a silent, subordinate role to Samsung
`in the joined proceeding. Paper 31, 12; Paper 33, 13.
`All parties identify Regeneron Pharmaceuticals, Inc. v. Mylan
`Pharmaceuticals Inc., No. 1:22-cv-00061-TSK (N.D. W.Va.) (the “related
`district court litigation”) as a related matter. See Papers 13, 31, 33. On
`April 29, 2024, the parties jointly updated the Board on this matter,
`explaining that the District Court had issued a decision, including a finding
`that claims 6 and 25 of the ’527 patent (the only claims of the patent
`remaining in the litigation after the others were stipulated to be invalid under
`
`2
`
`
`
`IPR2023-00884
`Patent 11,253,572 B2
`
`the Court’s claim construction (see Ex. 2031)) were invalid over, inter alia,
`prior art asserted in this proceeding (e.g., Dixon (Ex. 1009), Hecht
`(Ex. 1016), Regeneron’s 2009 Press Release (Ex. 1005)). Paper 55, n.2.
`II. APPLICABLE LEGAL STANDARDS
`As described in our Trial Practice Guide, in trials before the Board,
`“[d]iscovery is a tool to develop a fair record and to aid the Board in
`assessing the credibility of witnesses” and “discovery before the Board is
`focused on what the parties reasonably need to respond to the grounds raised
`by an opponent.” See Consolidated Trial Practice Guide, 84 Fed. Reg.
`64,280, § I.F (Nov. 21, 2019) (“Trial Practice Guide”). By rule, such
`discovery is divided into routine and additional discovery, the former
`category requiring production of a party’s cited exhibits, cross-examination
`of witnesses, and if not previously served, evidence relevant to information
`inconsistent with a position advanced by the producing party during the
`proceeding. 37 C.F.R. § 42.51(b)(1)–(2). The latter category, additional
`discovery, is directed to non-routine discovery that should be allowed, in
`IPRs, in the interests of justice. Id. § 42.51(b)(2); see also 35 U.S.C.
`§ 316(a)(5).
`Regarding the authorization of additional discovery, the Board set
`forth, in Garmin Int’l, Inc. v. Cuozzo Speed Techs. LLC, IPR2012-00001,
`Paper 26 at 6–7 (PTAB Mar. 5, 2013) (precedential) (“Garmin”), the
`following factors for consideration:
`Factor 1: Whether there is more than a possibility and mere
`allegation that something useful will be found and whether the
`party requesting discovery is already in possession of evidence
`tending to show beyond speculation that something useful will
`be discovered;
`
`3
`
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`IPR2023-00884
`Patent 11,253,572 B2
`
`
`Factor 2: Whether the party requesting discovery is seeking its
`opponent’s litigation positions and underlying basis for those
`positions;
`Factor 3: Whether the party requesting discovery has the
`ability to generate equivalent information by other means;
`Factor 4: Whether the party requesting discovery has presented
`easily understandable instructions and questions; and
`Factor 5: Whether the request for discovery is overly
`burdensome to answer or sensible and reasonably tailored
`according to a genuine need.
`We address the facts presented and the parties’ arguments in view of
`these factors, below.
`
`III. DISCUSSION
`Petitioner seeks discovery of certain documents and “requests that
`Patent Owner produce transcripts and underlying exhibits of prior testimony
`from Karen Chu and George Yancopoulos and exhibits cited in the District
`Court’s decision invalidating the ’572 patent (collectively, ‘Requested
`Materials’ and more specifically listed in Ex. 3003 at 2).” Pet. Mot. 1.
`Petitioner identifies the Requested Materials as follows:
`1. The deposition transcript of Karen Chu from the Mylan
`Litigation and all exhibits thereto;
`2. The deposition transcript of George Yancopoulos from the
`Mylan Litigation and all exhibits thereto;
`3. The trial exhibits from the Mylan Litigation cited in the trial
`testimony of Karen Chu and/or George Yancopoulos[,] [which
`include PTX 0001, PTX 0003, PTX 0080, PTX 0188, PTX
`0304, PTX 0311, PTX 0491, PTX 0686, PTX 0932, PTX
`1028C, PTX 1170, PTX 3131, PTX 3133, PTX 3150, PTX
`3151, PTX 3167, PTX 3168, PTX 3187, PTX 3188, PTX 3216,
`PTX 3332, PTX 3333, PDX 1-1, PDX 1-2, PDX 3.001, PDX
`3.002, PDX 3.004, PDX 3-0311-B, PDX 932-C, DTX 0019,
`DTX 0212, DTX 0216, DTX 0227, DTX 0228, DTX 0902,
`
`4
`
`
`
`IPR2023-00884
`Patent 11,253,572 B2
`
`
`DTX 0913, DTX 0915, DTX 0916, DTX 2053, DTX 2053A,
`DTX 2730, DTX 2745, DTX 3196, DTX 4070, DTX 4957,
`DTX 5073, DTX 5082, DTX 5385, DTX 7001, DTX 7212,
`DTX 7272, DTX 8127, DTX 8180, DTX 8190, DTX 9002,
`DTX 9003, DTX 9005, DTX 9006];
`4. The following trial exhibits from the Mylan Litigation cited
`in the court’s Memorandum Opinion and Order Following
`Bench Trial (ECF No. 692 in the Mylan Litigation) related to
`Regeneron’s clinical development of aflibercept: DTX 0213,
`DTX 0220, DTX 0222, DTX 0226, DTX 0229, DTX 0230,
`DTX 0232, DTX 0234.
`Ex. 3003, 2; see also Ex. 1070, 12 (identifying the “trial exhibits” referenced
`under above List No. 3).2 Petitioner argues that Karen Chu and George
`Yancopoulos are witnesses having prepared declaration testimony in this
`proceeding, and also testified in the related district court litigation, on “the
`same or similar subject matter relating to the patentability of the ’572
`patent.” Pet. Mot. 1 (citing Ex. 1071, 87–250, Ex. 1072, 3–44, Ex. 1073,
`44–130, Ex. 1074, Ex. 1075). For example, Petitioner argues this “similar
`subject matter” covers topics such as the history of the claimed drug’s
`development, clinical trials, objective indicia of non-obviousness, and
`reduction to practice of the claimed invention. Id. at 1–2.
`Petitioner first argues that the above-identified Requested Materials
`constitute routine discovery under 37 C.F.R. § 42.51(b)(1)(iii). Id. at 3–4.
`As support for this proposition, Petitioner asserts only that the documents
`
`
`2 Petitioner expressly identified the listed documents set forth in Exhibit
`3003, at 2, as its “Requested Materials.” This list differs from a similar list
`of materials in Exhibit 1070, which further includes list numbers 5 and 6,
`which refer to collaboration agreements by Bayer and Regeneron and
`corrected copies of Exhibits 2007 and 2011, respectively. We take this
`omission by Petitioner to be intentional.
`
`5
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`IPR2023-00884
`Patent 11,253,572 B2
`
`were part of the evidence of record before the District Court, which found
`the evidence “did not support a finding of patentability.” Id. at 3–4. As an
`initial matter, we find Petitioner has not shown that the sought discovery is
`routine under our rules. It is not established or even asserted by Petitioner
`that the documents sought have been cited in any paper or testimony in this
`proceeding, and Petitioner has not sufficiently identified why any sought
`information is “inconsistent with a position advanced by” Patent Owner in
`this proceeding. 37 C.F.R. § 42.51(b)(1); In re Pearson, 494 F.2d 1399,
`1405 (CCPA 1974) (“Attorney’s argument in a brief cannot take the place of
`evidence.”).
`Petitioner also argues that the above-identified Requested Materials
`should be produced as compelled additional discovery per 37 C.F.R.
`§§ 42.51(b)(2) and 42.52, under the guidance of Garmin. Petitioner argues
`that Garmin Factors 2, 3, and 4 “undisputedly support the request, that
`Garmin Factor 1 favors Petitioner because the request is not merely
`speculative, and that Garmin Factor 5 favors Petitioner because the request
`is limited in scope and not overly burdensome. Id. at 4–5.
`Patent Owner opposes the sought additional discovery. PO Opp. 1.
`Patent Owner argues that Garmin Factors 1–5 all favor denial of Petitioner’s
`Motion. PO Opp. 3–4.
`A. GARMIN FACTOR 1–MORE THAN A POSSIBILITY AND MERE
`ALLEGATION; BEYOND SPECULATION
`Garmin Factor 1 seeks to prevent mere speculative grabs for evidence
`of unknown usefulness. Garmin, at 7. Under this factor, the movant should
`have a “threshold amount of evidence or reasoning tending to show beyond
`speculation that something useful will be uncovered,” meaning something
`favorable in substantive value to the movant’s contentions. Id.
`
`6
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`IPR2023-00884
`Patent 11,253,572 B2
`
`
`Petitioner argues that the information sought here in the specific
`documents requested includes information on the validity of the claims of
`the ’572 patent, generally, but more specifically on matters covered by the
`testimony of Ms. Chu and Dr. Yancopoulos in this proceeding and in the
`related district court litigation, such as the development of the patented
`invention. Pet. Mot. 4–5. Implicit in Petitioner’s argument is that the
`credibility of these witnesses might also be illuminated by the sought
`information.
`Patent Owner argues that the testimony of these witnesses in this
`proceeding does not relate to the District Court’s bases for unpatentability,
`but provides factual testimony on actual reduction to practice and whether
`certain exhibits here are prior art (i.e., Regeneron’s Dec. 2010 Press Release
`(Ex. 1006), Regeneron’s Nov. 2010 Press Release (Ex. 1007), and an ARVO
`2010 Abstract (Ex. 1010)). PO Opp. 3. Patent Owner calls Petitioner’s
`request a “fishing expedition.” Id. at 1.
`Regardless of whether Patent Owner’s position is correct that the
`District Court did not base its finding of invalidity of the ’572 patent’s
`claims on the subject matter to which Ms. Chu and Dr. Yancopoulos testify
`in this proceeding, a brief review of their testimony in the related district
`court litigation shows that these witnesses did address relevant topics like
`inventorship, clinical trials, and development of the drug covered by the
`challenged claims in partnership with third parties. See, e.g., Ex. 1071, 112–
`113, 124, 133, 142, 151, 160; Ex. 1072, 1230–231, 1238, 1242–243, 1256,
`1259. Thus, we find that the sought discovery has some relation to subjects
`at issue in this proceeding.
`
`7
`
`
`
`IPR2023-00884
`Patent 11,253,572 B2
`
`
`We agree with Petitioner that its requests for discovery outlined above
`are not merely speculative, but are tailored, based on Petitioner’s knowledge
`and reasoning gleaned from the exhibits of record in this proceeding, to
`obtain the limited production of relevant evidence in the form of specific
`identified documents that were cited in the related district court litigation as
`relating to subject matter and witness credibility at issue in this proceeding.
`Therefore, we conclude Petitioner is in possession of a threshold amount of
`evidence or reasoning tending to show beyond mere speculation that
`something useful will be uncovered in the requested specific documents.
`Garmin, at 7.
`B. GARMIN FACTOR 2–LITIGATION POSITIONS
`Petitioner argues that the sought discovery “requests are targeted at
`Patent Owner’s witness testimony and underlying exhibits and not seeking
`to unearth any litigation positions.” Pet. Mot. 4. Patent Owner disagrees
`and argues that “the exhibits requested by Samsung include Regeneron’s
`interrogatory responses, Rule 26(a) disclosures, Rule 30(b)(6) deposition
`topics, and a case narrowing stipulation.” PO Opp. 4.
`Petitioner’s sought discovery is tailored and relates to the testimony of
`witnesses and bases for witnesses’ positions in this proceeding. Moreover,
`the related litigation at issue has concluded, but for any appeal. It is not
`apparent that any of the requested discovery would inappropriately reveal
`any litigation position of Patent Owner.
`We find this factor weighs in favor granting the Motion.
`
`8
`
`
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`IPR2023-00884
`Patent 11,253,572 B2
`
`C. GARMIN FACTOR 3–ABILITY TO GENERATE EQUIVALENT
`INFORMATION BY OTHER MEANS
`Petitioner argues that “[b]ecause the Requested Materials are not
`publicly available, Petitioner has no other methods available to ascertain this
`information.” Pet. Mot. 4.
`Patent Owner argues that this is incorrect and that “many” of the
`Requested Materials are publicly available. PO Opp. 4. Patent Owner lists,
`as examples of publicly available documents, the ’572 patent, U.S. Patent
`10,888,601, certain scientific publications, and other papers from the public
`docket of the related district court litigation. Id.
`Although it appears that some of the Requested Materials may be
`publicly available, most appear not to be (at least, it is not alleged
`otherwise); however, we find that all of them are, essentially, at Patent
`Owner’s fingertips and can be readily produced, having just been the subject
`of or at issue in the recently concluded related district court litigation. Thus,
`we find this factor weighs in favor of granting the Motion.
`D. GARMIN FACTOR 4: EASILY UNDERSTANDABLE REQUESTS
`Petitioner argues its request for discovery is easily understood because
`it “provided a tailored list of specific materials and exhibits from” the related
`district court litigation. Pet. Mot. 4. Patent Owner does not contest this.
`We agree with Petitioner that its discovery requests are
`understandable. They are specific as to the documents desired. See
`Ex. 3002. We find this factor weighs in favor of granting the Motion.
`E. GARMIN FACTOR 5–OVERLY BURDENSOME, OR SENSIBLE AND
`REASONABLY TAILORED
`Petitioner argues its sought discovery is limited in scope and not
`overly burdensome. Pet. Mot. 5. Petitioner states that it
`
`9
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`IPR2023-00884
`Patent 11,253,572 B2
`
`
`seeks only the deposition testimony, and related exhibits, of two
`witnesses in the Mylan Litigation as well as the exhibits cited in
`relevant portions of the district court decision. These materials
`are readily available to Patent Owner from the ongoing Mylan
`Litigation. Further, there is no additional burden based on the
`timing of Petitioner’s request. Petitioner’s reply is not due until
`June 10, leaving several weeks for Patent Owner to complete
`what should be a straightforward production of a small set of
`specifically enumerated items.
`
`Id.
`
`Patent Owner argues that the request is overbroad and seeks sensitive
`material that should be subject to the protective order, which it argues will
`have to be amended to cover the production of material for “outside
`counsel’s eyes only.” PO Opp. 5. Patent Owner argues that Petitioner seeks
`“more than 100 exhibits,” and its request is not tailored to any genuine need.
`Id.
`
`We find this factor weighs in favor of granting the Motion. As noted
`above, the Requested Materials are expected to be immediately available to
`Patent Owner and in form for production. We find there is little if any
`burden on Patent Owner in producing the documents requested, which
`should be produced no later than May 31, 2024. We would entertain a
`request for an appropriate amendment to the protective order to maintain
`confidentiality of sensitive material.
`IV. CONCLUSION
`We find that the Garmin factors favor granting Petitioner’s requested
`discovery, as set forth above, and Petitioner has made a sufficient showing
`to justify its requested additional discovery. We authorize Petitioner’s
`tailored requests for document production and set the deadline for producing
`the Requested Materials (as defined above) at May 31, 2024.
`
`10
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`IPR2023-00884
`Patent 11,253,572 B2
`
`
`We remind the parties that if any confidential information is produced
`as discovery, a modified protective order may be requested, if necessary.
`See 37 C.F.R. §§ 42.14 and 42.54.
`
`For the foregoing reasons, it is
`ORDERED that Petitioner’s Motion for Additional Discovery is
`granted;
`FUTHER ORDERED that the discovery sought and identified above
`as the “Requested Materials” (see Ex. 3003) shall be produced to Petitioner
`by Patent Owner; and
`FURTHER ORDERED that the above-ordered discovery shall be
`completed by May 31, 2024.
`
`
`
`11
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`
`IPR2023-00884
`Patent 11,253,572 B2
`
`
`
`For PETITIONER SAMSUNG BIOEPIS CO., LTD.:
`
`Raymond N. Nimrod
`Matthew A. Traupman
`Landon Andrew Smith
`QUINN EMANUEL URQUHART & SULLIVAN LLP
`raynimrod@quinnemanuel.com
`matthewtraupman@quinnemanuel.com
`landonsmith@quinnemanuel.com
`qe-samsungbioepis@quinnemanuel.com.
`
`
`For PETITOINER CELLTRION, INC.:
`
`Lora Green
`Yahn Lin Chu
`GEMINI LAW LLP
`lgreen@geminilaw.com
`fchu@geminilaw.com
`
`
`For PETITIONER BIOCON BIOLOGICS INC.:
`
`Paul Molino
`Jeffrey Marx
`Neil McLaughlin
`Steven Birkos
`Deanne Mazzochi
`Thomas Ehrich
`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`paul@rmmslegal.com
`jmarx@rmmslegal.com
`nmclaughlin@rmmslegal.com
`sbirkos@rmmslegal.com
`dmazzochi@rmmslegal.com
`tehrich@rmmslegal.com
`
`
`12
`
`
`
`IPR2023-00884
`Patent 11,253,572 B2
`
`
`For PATENT OWNER:
`
`Adam R. Brausa
`Rebecca Weires
`Kira Davis
`Daralyn Durie
`MORRISON & FOERSTER LLP
`ABrausa@mofo.com
`RWeires@mofo.com
`kiradavis@mofo.com
`ddurie@mofo.com
`
`
`
`13
`
`
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