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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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`SAMSUNG BIOEPIS CO., LTD., CELLTRION INC,
`and BIOCON BIOLOGICS INC.
`Petitioner,
`
`v.
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`REGENERON PHARMACEUTICALS, INC.
`Patent Owner.
`
`Patent No. 11,253,572
`
`_______________
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`Inter Partes Review No. IPR2023-008841
`
`____________________________________________________________
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`PATENT OWNER’S OPPOSITION TO PETITIONER’S
`MOTION FOR DISCOVERY PURSUANT TO 37 C.F.R. § 42.51(b)
`
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`1 IPR2024-00260 and IPR2024-00298 are joined with this proceeding.
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`IPR2023-00884
`Patent No. 11,253,572
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`Regeneron challenged the prior art status of three references relied upon by
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`Samsung Bioepis in its Patent Owner Preliminary Response on August 25, 2023.
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`Regeneron further developed these arguments in its Response, filed February 23,
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`2024, with declarations from named inventor and Regeneron’s CSO George
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`Yancopoulos and Regeneron’s Global Program Head for Ophthalmology, Karen
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`Chu. Dr. Yancopoulos and Ms. Chu sat for deposition on April 11-12, 2024, and
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`answered all questions posed by Samsung’s counsel.
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`Now, apparently unhappy with the evidentiary record, Samsung requests
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`over 100 deposition and trial exhibits from parallel litigation between Mylan and
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`Regeneron, without articulating any specific reason the exhibits are relevant to the
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`subject matter of the declarations. Samsung argues that its Motion should be
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`granted because the District Court and PTAB proceedings both implicate the
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`patentability of the ’572 patent. But Dr. Yancopoulos and Ms. Chu’s declarations
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`do not address the district court’s bases for unpatentability. They provide factual
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`testimony regarding whether Exhibits 1006, 1007, and 1010 are prior art. The
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`District Court did not address that issue and found the claims obvious over
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`different references. Moreover, several exhibits post-date the priority date of the
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`’572 patent, so their relevance to declarations about antedation remains unclear.
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`The Board should not condone Samsung’s fishing expedition. Before filing
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`its Motion, Samsung never suggested that its request was routine discovery. It is
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`1
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`IPR2023-00884
`Patent No. 11,253,572
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`not, nor do the Garmin factors support Samsung’s request for additional discovery.
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`For the reasons set forth below, its Motion should be denied.
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`I.
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`PETITIONER’S REQUEST IS NOT ROUTINE DISCOVERY
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`Samsung never contended that its request for over 100 trial and deposition
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`exhibits was routine discovery, until the Board requested that the parties consider
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`that possibility on May 7. (Ex.3003; Ex.1070, 11-12.) Samsung now argues,
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`however, that its request is routine discovery under 37 C.F.R. § 42.51(b)(1)(iii)
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`because the District Court found two claims of the ’572 patent invalid. (See Mot.
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`3-4.) While that is true, Regeneron disagrees with the District Court’s
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`determination. And more importantly, there is no inconsistency in Regeneron’s
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`position. In both proceedings, Regeneron has vigorously defended the
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`patentability of the claims in the ’572 patent. Moreover, even after Samsung
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`obtained the public District Court transcripts of Dr. Yancopoulos and Ms. Chu’s
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`trial and deposition testimony, Samsung does not provide any basis for its assertion
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`that the requested exhibits would reveal inconsistencies with Regeneron’s positions
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`here. Routine discovery is “not broadly directed to any subject area in general
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`within which the requesting party hopes to discover such inconsistent
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`information.” Synaptive Med. Inc. v. Karl Storz Endoscopy-America, Inc.,
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`IPR2018-00462, Paper 14, at *3 (P.T.A.B. Oct. 11, 2017) (denying routine
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`discovery). Therefore, Samsung’s request is not for routine discovery.
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`2
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`II. ADDITIONAL DISCOVERY IS NOT WARRANTED UNDER THE
`GARMIN FACTORS
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`IPR2023-00884
`Patent No. 11,253,572
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`Factor 1. Samsung has not shown “more than a possibility or mere
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`allegation” of something useful in its requested materials. Garmin, IPR2012-
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`00001, Paper 26 at 6. Samsung has repeatedly failed to explain what would be
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`relevant, much less useful, in its requested materials. (See Mot.; Ex.1070.)
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`Samsung’s gesture toward the District Court finding claims 6 and 25 unpatentable
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`is irrelevant. (Mot., 3-4.) Dr. Yancopoulos and Ms. Chu’s IPR declarations are
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`limited in scope; they address actual reduction to practice of certain ’572 claims
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`(not claim 25) and whether Exhibits 1006, 1007, and 1010 are Dr. Yancopoulos’s
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`own work. (Ex.2063; Ex.2064.) The Mylan trial addressed neither reduction to
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`practice nor these three references. (Ex.2032, 21-30; Ex.2093, 236-311.)
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`In view of these facts, the Board’s decision in Amneal Pharms. LLC v.
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`Alemirall, LLC, IPR2019-00207, Paper 39 (P.T.A.B. Dec. 31, 2019) does not
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`support Samsung’s request. There, the movant requested a “limited production” of
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`only deposition testimony (not exhibits). Id. at 5. Because the nonmovant’s expert
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`relied on a patent office declaration showing unexpected results, additional
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`discovery was the only way for the movant to obtain cross examination testimony
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`of the declarant, the only person with personal knowledge of that subject matter.
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`Id. at 6. In stark contrast, Samsung has failed to tailor its request for information
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`relating to the subject matter of the two Regeneron employee declarations.
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`3
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`IPR2023-00884
`Patent No. 11,253,572
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`Factor 2. Samsung’s request for additional discovery is improper because
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`Samsung is requesting litigation positions (which are also largely irrelevant to
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`Dr. Yancopoulos and Ms. Chu’s testimony), despite its argument otherwise. (Mot.,
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`4.) Specifically, the exhibits requested by Samsung include Regeneron’s
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`interrogatory responses, Rule 26(a) disclosures, Rule 30(b)(6) deposition topics,
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`and a case narrowing stipulation. (See Ex.1073, 1654:10-13; Ex.1075, 17:15-23,
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`40:2-11, 43:5-19.)
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`Factor 3. Samsung is wrong that its requested materials are “not publicly
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`available.” (Mot., 4.) Not only are many of them public, but the public documents
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`that Samsung requests further illustrate Samsung’s untargeted approach. For
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`example, PTX 1 and PTX 3 are the ’572 patent and ’601 patent. (Ex.1071, 100:16-
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`101:21.) PTX 311 and DTX 8180 are scientific publications that Samsung already
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`filed in this proceeding as Exs.1038, 1039. (See Ex.1071, 150:2-17, 182:1-8,
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`255:2-8.) The public docket includes several more exhibits that Samsung contends
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`are important additional discovery, but that Samsung did not bother to pull before
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`filing its Motion. For example, DTX 913, 915, 5385, and 8190 are documents
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`filed as ECF Nos. 505-29, -24, -44, and -42, respectively. (See Ex.1071, 190:25-
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`191:5, 220:12-18; Ex.1073, 1606:2-24, 1629:7-15.) Samsung also had ample
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`opportunity to ask Ms. Chu and Dr. Yancopoulos about any relevant requested
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`information during their respective depositions. Having chosen not to do so, it
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`4
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`IPR2023-00884
`Patent No. 11,253,572
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`should not now be permitted to pursue litigation-style discovery requests,
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`particularly given its lack of diligence and justification.
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`Factor 5. Samsung argues that this factor favors additional discovery
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`because its request is allegedly “limited in scope and not overly burdensome.” But
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`as discussed above, Samsung’s request is overbroad. Additionally, some of the
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`requested materials are sensitive, requiring careful review for Regeneron’s
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`confidential information as well as entry of a new protective order for “outside
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`counsel’s eyes only” materials. (See Ex.1070, 7-8.) Even if the Board is willing to
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`enter such a protective order, the production of Regeneron materials implicating
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`proprietary, highly confidential, and competitively sensitive information in another
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`forum, to two new parties (Samsung and Celltrion) and more outside counsel,
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`increases the risk of inadvertent disclosure, without sufficient justification.
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`Furthermore, Samsung’s request for more than 100 exhibits is not “responsibly
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`tailored according to a genuine need.” Garmin, IPR2012-00001, Paper 26 at 7.
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`The list includes documents far post-dating the last events discussed in Dr.
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`Yancopoulos’s and Ms. Chu’s declarations (e.g., Ex.1074, 55:2-5), and documents
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`clearly unrelated to the facts of whether Dr. Yancopoulos reduced certain
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`challenged claims to practice (e.g., Ex.1073, 1624:2-6 (addressing diabetic
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`retinopathy indication)).
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`5
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`IPR2023-00884
`Patent No. 11,253,572
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`Date: 5/17/2024
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`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
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`6
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`IPR2023-00884
`Patent No. 11,253,572
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`Certificate of Service (37 C.F.R. § 42.6(e)(4))
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`I hereby certify that the attached “PATENT OWNER’S OPPOSITION TO
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`PETITIONER’S MOTION FOR DISCOVERY PURSUANT TO 37 C.F.R. §
`
`42.51(b)” was served on the below date on the Petitioner via e-mail (by consent) to
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`the following counsel of record:
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`Raymond N. Nimrod (Reg. No. 31,987)
`Richard W. Erwine (Reg. No 41,737)
`Matthew A. Traupman (Reg. No. 50,832)
`Laura Fairneny (pro hac vice to be applied for)
`Elliot Choi (pro hac vice granted)
`Zachariah Summers (pro hac vice granted)
`Sarah Cork (pro hac vice to be applied for)
`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
`Email: raynimrod@quinnemanuel.com
`Email: richarderwine@quinnemanuel.com
`Email: matthewtraupman@quinnemanuel.com
`Email: laurafairneny@quinnemanuel.com
`Email: elliotchoi@quinnemanuel.com
`Email: zachsummers@quinnemanuel.com
`Email: landonsmith@quinnemanuel.com
`Email: qe-samsungbioepis@quinnemanuel.com
`
`Paul J. Molino (Reg. No. 45,350)
`William A. Rakoczy (pro hac vice to be filed)
`Deanne M. Mazzochi (Reg. No. 50,158)
`Heinz J. Salmen (pro hac vice to be filed)
`Eric R. Hunt (pro hac vice to be filed)
`
`7
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`
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`IPR2023-00884
`Patent No. 11,253,572
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`Neil B. McLaughlin (Reg. No. 70,810)
`Lauren M. Lesko (pro hac vice to be filed)
`L. Scott Beall (Reg. No. 52,601)
`Thomas H. Ehrich (Reg. No. 67,122)
`Steven J. Birkos (Reg. No. 65,300)
`Jake R. Ritthamel (pro hac vice to be filed)
`Rakoczy Molino Mazzochi Siwik LLP
`6 West Hubbard Street
`Chicago, IL 60654
`Telephone: (312) 527-2157
`Facsimile: (312) 843-6260
`MYL_REG_IPR@rmmslegal.com
`
`Lora Green (Reg. No. 43,541)
`Yahn-Lin Chu (Reg. No. 75,946)
`Robert Cerwinski (to be admitted pro hac vice, pending)
`Aviv Zalcenstein (to be admitted pro hac vice, pending)
`Brigid Morris (to be admitted pro hac vice, pending)
`Gemini Law LLP
`40 W 24th Street, Suite 6N
`New York, NY 10010
`Tel.: 917-915-8832
`Email: lgreen@geminilaw.com
`Email: fchu@geminilaw.com
`Email: rcerwinski@geminilaw.com
`Email: azalcenstein@geminilaw.com
`Email: bmorris@geminilaw.com
`
`
`
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`Dated: 5/17/2024
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`/Adam R. Brausa/
`Adam R. Brausa, Reg. No. 60,287
`
`8
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