Case 1:22-cv-00061-TSK-JPM Document 439 Filed 05/04/23 Page 1 of 8 PageID #: 29582
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`AT CLARKSBURG
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`REGENERON PHARMACEUTICALS, INC.,
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`Plaintiff,
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`v.
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`MYLAN PHARMACEUTICALS INC.,
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`Defendant.
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`Civil Action No. 1:22-cv-00061-TSK
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`DEFENDANT’S RULE 56(d) MOTION TO DEFER AND CONDUCT FURTHER
`DISCOVERY TO ADEQUATELY OPPOSE SUMMARY JUDGMENT
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`Regeneron Pharmaceuticals, Inc.’s (“Regeneron”) Motion for Summary Judgment (Dkt.
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`428) (“Regeneron’s Motion”) presents assumptions Regeneron wrongly characterized as
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`“undisputed facts” regarding the effective dates of U.S. Patent Nos. 8,110,546 (“Dix ‘546” or “the
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`’546 patent”), 10,406,226 (“Dix ‘226” or “the ’226 patent”) (collectively the “Dix Prior Art”) or
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`International Patent Application No. WO2006/088650 (“Wiegand”), on the one hand; and the
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`effective date for the asserted U.S. Patent No. 11,084,865 (“the ‘865 patent”), on the other hand.
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`(Dkt. 428-1, at 4-6). Because these theories and assumptions were untimely—presented for the
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`first time in the Motion—Mylan moves for appropriate relief pursuant to FED. R. CIV. P. 56(d). In
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`support of such relief, Mylan relies upon the facts set forth in the accompanying Affidavit of Heinz
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`J. Salmen in Support of Rule 56(d) Motion (“Salmen Affidavit”), filed as Exhibit 1 hereto.
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`I.
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`BACKGROUND.
`Over a year ago, in its Detailed Statement disclosures, Mylan Pharmaceuticals Inc.
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`(“Mylan”) disclosed to Regeneron the prior art it proposed using to challenge the validity of the
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`‘865 patent, including for obviousness under 35 U.S.C. § 103. (Mylan’s Detailed Statement for
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`Case 1:22-cv-00061-TSK-JPM Document 439 Filed 05/04/23 Page 2 of 8 PageID #: 29583
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`the 865 Patent, Ex. H to Mylan’s Memorandum in Opposition to Regeneron’s Motion for
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`Summary Judgment (“Mylan’s Response”)). Over five months ago, in discovery requests, Mylan
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`asked Regeneron for the factual basis for any challenge it would mount against Mylan’s prior art.
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`(Mylan’s Interrogatory No. 6, Ex. J to Mylan’s Response; see also Dkt. 237). Regeneron never
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`contended during discovery that Dix ‘546, Dix ‘226, or Wiegand cannot be used to show
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`obviousness under § 103, because they purportedly can only be classified as § 102(e) references.
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`Now, just six weeks before trial, Regeneron has introduced a new theory that it never
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`disclosed or substantiated during discovery, a theory for which Regeneron has the burden of
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`production. Mylan therefore was deprived the opportunity to take discovery it requires to present
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`facts to justify its opposition, including the opportunity to discover or explore at least the following
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`issues:
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`
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`
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`
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`
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`Documents concerning the roles of each individual named as an inventor on the
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`Dix Prior Art and Wiegand;
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`Documents concerning assignment of rights by each named inventor of the ’546,
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`’226, and ‘865 patents.
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`Documents concerning employment agreements for each inventor of the ’546, ’226,
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`and ‘865 patents.
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`Documents concerning priority dates, written description support, and joint activity
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`to support Regeneron’s arguments concerning which formulations were
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`purportedly invented by whom, and when; and what testing characteristics were
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`made by whom, and when, and to whom such information was communicated,
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`before or after any publication dates involving Dix ‘226; the Dix ‘546; and/or
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`Wiegand.
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`2
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`
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`Documents concerning written support for each asserted claim, not only in the June
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`16, 2006 provisional application, but in each of the ten (10) further filings in the
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`chain of applications that led to Patent Application No. 16/739,559 from which the
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`‘865 patent actually issued.
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`
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`
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`
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`Documents concerning claim-by-claim basis for common ownership by Regeneron
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`for each asserted claim in the ‘865 patent.
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`Documents concerning claim-by-claim basis for reduction to practice by
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`Regeneron for each asserted claim in the ‘865 patent.
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`A deposition of Regeneron and each named inventor to (1) inquire about the facts
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`contained in Regeneron’s Motion for Summary Judgment, dated April 20, 2023;
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`(2) authenticate and explain the documents newly produced and/or referenced in
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`Regeneron’s motion for summary judgment; (3) inquire about the discovery topics
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`outlined above; and (4) state the factual basis for why Regeneron withheld its
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`disclosure of the invalidity challenges set forth in its Motion until April 2023.
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`(Ex. 1, Salmen Affidavit at 9-10).
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`II.
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`LEGAL STANDARDS.
`Federal Rule 56(d) provides:
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`If a nonmovant shows by affidavit or declaration that, for specified reasons,
`it cannot present facts essential to justify its opposition, the court may:
`(1)
`defer considering the motion or deny it;
`(2)
`allow time to obtain affidavits or declarations or to take
`discovery; or
`issue any other appropriate order.
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`(3)
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`FED. R. CIV. P. 56(d).
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`The Fourth Circuit has interpreted the requirements of Rule 56(d) to require an affidavit
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`that “particularly specifies legitimate needs for further discovery” and identifies “which aspects of
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`3
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`discovery required more time to complete.” Nguyen v. CNA Corp., 44 F.3d 234, 242 (4th Cir.
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`1995). Indeed, the Fourth Circuit places “great weight on the [Rule 56(d)] affidavit” and, to that
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`end, “[a] party may not simply assert in its brief that discovery was necessary and thereby overturn
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`summary judgment when it failed to comply with the requirement of [Rule 56(d)] to set out reasons
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`for the need for discovery in an affidavit.” Evans v. Techs. Apps. & Serv. Co., 80 F.3d 954, 961
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`(4th Cir. 1996) (quoting Nguyen, 44 F.3d at 242 (internal citations omitted)).
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`Further, Rule 56(d) requires the district court to refuse to grant summary judgment when
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`the non-movant “has not had the opportunity to discover information that is essential to [its]
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`opposition.” Works v. Colvin, 519 F. App’x 176, 181–82 (4th Cir. 2013) (internal quotations
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`omitted). It is incumbent upon the nonmovant that it must show through affidavits that it cannot
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`yet properly oppose a motion for summary judgment. FED. R. CIV. P. 56(d); Evans, 80 F.3d at
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`961. “The purpose of the affidavit is to ensure that the nonmoving party is invoking the protections
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`of [Rule 56(d)] in good faith and to afford the trial court the showing necessary to assess the merits
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`of a party’s opposition.” Harrods Ltd. v. Sixty Internet Domain Names, 302 F.3d 214, 244 (4th
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`Cir. 2002) (quotation marks omitted). Importantly, because the rule “is intended as a safeguard
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`against a premature grant of summary judgment[,] [courts] should construe the rule liberally[.]”
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`Works, 519 F. App’x at 182 (internal quotations omitted); accord Harrods, 302 F.3d at 245 n. 18
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`(citing with approval sources applying the rule liberally).
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`III.
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`ARGUMENT
`As set forth in Mylan’s Response, and in view of the facts set forth in the Salmen Affidavit,
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`Mylan (the nonmovant) cannot present facts essential to justifying its opposition to Regeneron’s
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`Motion for Summary Judgment without first engaging in a period of discovery, because
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`Regeneron’s Motion presents a previously undisclosed theory in the case. See FED. R. CIV. P.
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`56(d). Further, the undisclosed theory rests on factual assumptions that Mylan contests. For
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`4
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`Case 1:22-cv-00061-TSK-JPM Document 439 Filed 05/04/23 Page 5 of 8 PageID #: 29586
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`example, Regeneron’s theory presumes that the ‘865 patent will secure a June 16, 2006 priority
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`date. (Dkt. 428-1, Regeneron Motion at 2). Regeneron has the burden of production to assert that
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`each asserted claim deserves the benefit of a June 2006 priority date so as to limit Dix ‘546, Dix
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`‘226, or Wiegand to § 102(e) prior art. Technology Licensing Corp. v. Videotek, Inc., 545 F.3d
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`1316, 1327 (2008). But Regeneron never disclosed, or tried to meet, that burden of production.
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`(Dkt. 428-1).
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`As fully set forth in the Salmen Affidavit, Mylan’s Response, and Mylan’s FED. R. CIV. P.
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`56(c) and LR Civ P 7.02 Statement of Contested Facts in Opposition to Regeneron’s Motion for
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`Summary Judgment in order to adequately defend against Regeneron’s previously undisclosed
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`contentions, Mylan requires discovery on numerous issues and the allegations of fact upon which
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`such arguments are premised, that Regeneron has advanced as grounds for summary judgment
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`regarding at least the following issues:
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`
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`
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`
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`
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`
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`What is the “inventive entity” of the Dix ‘226, Dix ‘546, and ’865 patents?
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`Did each inventor of the “inventive entity” of the Dix ‘226, Dix ‘546, and ’865
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`patents sign over their rights to Regeneron?
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`When did each inventor of the “inventive entity” of the Dix ‘226, Dix ‘546, and
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`‘865 patents sign over their rights to Regeneron?
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`Was signing over of their rights of the Dix ‘226, Dix ‘546, and ‘865 patents to
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`Regeneron part of any valid employment agreement?
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`What are the priority dates, where is the written description support, and was there
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`any joint activity that supports Regeneron’s arguments concerning which
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`formulations were purportedly invented by whom, and when?
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`5
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`Case 1:22-cv-00061-TSK-JPM Document 439 Filed 05/04/23 Page 6 of 8 PageID #: 29587
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`
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`What is the written support for each asserted claim, not only in the June 16, 2006
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`provisional application, but in each of the ten (10) further filings in the chain of
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`applications that led to the application filed in 2020 from which the ‘865 patent
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`actually issued?
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`
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`
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`What is the claim-by-claim basis for common ownership by Regeneron for each
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`asserted claim in the ‘865 patent?
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`What is the claim-by-claim basis for reduction to practice by Regeneron for each
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`asserted claim in the ‘865 patent?
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`Thus, Mylan respectfully requests that this Court order a period of discovery regarding the
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`above issues or refuse to grant summary judgment.
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`6
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`Case 1:22-cv-00061-TSK-JPM Document 439 Filed 05/04/23 Page 7 of 8 PageID #: 29588
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`Date: May 4, 2023
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`STEPTOE & JOHNSON PLLC
`
`
`/s/ William J. O’Brien
`Gordon H. Copland (WVSB #828)
`William J. O’Brien (WVSB #10549)
`400 White Oaks Boulevard
`Bridgeport, WV 26330
`(304) 933-8162
`gordon.copland@steptoe-johnson.com
`william.obrien@steptoe-johnson.com
`
`Of Counsel (admitted pro hac vice):
`William A. Rakoczy
`Deanne M. Mazzochi
`Heinz J. Salmen
`Eric R. Hunt
`Neil B. McLaughlin
`Lauren M. Lesko
`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`6 W. Hubbard St., Suite 500
`Chicago, IL 60654
`(312) 527-2157
`wrakoczy@rmmslegal.com
`dmmazzochi@rmmslegal.com
`hsalmen@rmmslegal.com
`ehunt@rmmslegal.com
`nmclaughlin@rmmslegal.com
`llesko@rmmslegal.com
`
`Attorneys for Defendant Mylan Pharmaceuticals Inc.
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`7
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`Case 1:22-cv-00061-TSK-JPM Document 439 Filed 05/04/23 Page 8 of 8 PageID #: 29589
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`CERTIFICATE OF SERVICE
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`I certify that on the 4th day of May 2023, I filed the foregoing “Defendant’s Rule 56(d)
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`Motion to Defer and Conduct Further Discovery to Adequately Oppose Summary Judgment” using
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`the Court’s CM/ECF system, which will send notice of the same to all counsel of record.
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` /s/ William J. O’Brien
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`8
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