Case 1:23-cv-00089-TSK Document 99 Filed 02/14/24 Page 1 of 9 PageID #: 4082
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`CLARKSBURG DIVISION
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`REGENERON PHARMACEUTICALS, INC.,
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`Plaintiff,
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`v.
`CELLTRION, INC.,
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`Defendant.
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`REGENERON PHARMACEUTICALS, INC.,
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`Plaintiff,
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`v.
`SAMSUNG BIOEPIS CO., LTD.,
`Defendant.
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`REGENERON PHARMACEUTICALS, INC.,
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`Plaintiff,
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`v.
`FORMYCON AG,
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`Defendant.
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`REGENERON PHARMACEUTICALS, INC.,
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`Plaintiff,
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`v.
`SAMSUNG BIOEPIS CO., LTD.,
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`Defendant.
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`Civil Action No. 1:23-cv-00089-TSK
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`Civil Action No. 1:23-cv-00094-TSK
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`Civil Action No. 1:23-cv-00097-TSK
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`Civil Action No. 1:23-cv-00106-TSK
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`DEFENDANTS CELLTRION, INC., SAMSUNG BIOEPIS CO., LTD.,
`AND FORMYCON AG’S RESPONSE TO PLAINTIFF’S EMERGENCY
`MOTION FOR CLARIFICATION OF THE COURT’S JANUARY 9, 2024 ORDER
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`Case 1:23-cv-00089-TSK Document 99 Filed 02/14/24 Page 2 of 9 PageID #: 4083
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`Defendants Celltrion, Inc. (“Celltrion”), Samsung Bioepis Co., Ltd. (“SB”), and Formycon
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`AG (“Formycon”) (collectively, “PI Defendants”)1 jointly submit this response to Plaintiff Regen-
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`eron Pharmaceuticals, Inc.’s (“Regeneron”) Emergency Motion for Clarification of the Court’s
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`January 9, 2024 Order. (ECF No. 95 in Case No. 1:23-cv-89, ECF No. 96 in Case No. 1:23-cv-
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`94, ECF No. 80 in Case No. 1:23-cv-97, and ECF No. 77 in Case No. 1:23-cv-106 (“Mot.”).)2
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`This dispute arises from the Court’s January 9, 2024 Order Setting Briefing Schedule on
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`Motions to Dismiss and Setting Schedule for Preliminary Injunction Proceedings. (ECF No. 61 in
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`1:23-cv-89, ECF No. 69 in Case No. 1:23-cv-94, ECF No. 45 in Case No. 1:23-cv-97, and ECF
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`No. 40 in Case No. 1:23-cv-106 (“Scheduling Order”).) Under Regeneron’s proposed briefing
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`procedure, its omnibus brief in opposition to the PI Defendants’ motions to dismiss for lack of
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`personal jurisdiction will contain highly confidential information from each PI Defendant,
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`including information relating to their commercialization plans, in unredacted format subject to
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`inspection by each PI Defendant. But each PI Defendant closely guards this highly confidential
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`information, especially with respect to the other PI Defendants, all of whom are direct competitors
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`seeking to launch their own biosimilars of Eylea®. The Court should thus reject Regeneron’s
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`proposal and, instead, direct Regeneron to file its brief under seal for the Court’s review and serve
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`on each PI Defendant a redacted copy of its brief to protect highly confidential information. To
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`the extent Regeneron believes that redaction would frustrate the PI Defendants’ ability to respond,
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`then Regeneron should file separate briefs.
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`1 The PI Defendants’ counsel have appeared specially for the limited purpose of contesting
`jurisdiction and have already filed their respective motions to dismiss pursuant to Fed. R. Civ. P.
`12(b)(2). This brief, which is limited to procedural aspects of the case, is being submitted to
`facilitate early and prompt resolution of the PI Defendants’ jurisdictional challenge.
`2 In the interest of efficiency, the PI Defendants have filed this identical response in each of their
`respective actions.
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`2
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`Case 1:23-cv-00089-TSK Document 99 Filed 02/14/24 Page 3 of 9 PageID #: 4084
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`ARGUMENT
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`Regeneron “requests the Court’s guidance on how to effectuate its order to file an omnibus
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`response” to the PI Defendants’ motions to dismiss for lack of personal jurisdiction “while also
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`referencing Defendants’ confidential information.” (Mot. at 5.) Regeneron asserts that it
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`“proposed a reasonable compromise, which Defendants rejected outright and without providing a
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`counterproposal.” (Id.) Regeneron is incorrect on both points. Its proposal is not reasonable—in
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`fact, it would be a violation of the terms of the Protective Order that Regeneron and the PI
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`Defendants have nearly finalized and would unnecessarily expose some of the most commercially
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`sensitive confidential information of each defendant to the others. And the PI Defendants did
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`provide a counterproposal during last Friday’s meet and confer—that Regeneron serve a redacted
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`version of its omnibus response on counsel simultaneously with its under seal filing with this
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`Court. The PI Defendants’ counterproposal is the best way to proceed under the circumstances.
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`I.
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`Regeneron’s Proposal Would Expose Each PI Defendant’s Highly Confidential
`Business Information and Violate the Protective Orders That Are Nearly Finalized.
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`Given the highly confidential nature of this information, Regeneron’s proposal – that
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`outside counsel for each PI Defendant be allowed to view an unredacted omnibus opposition brief
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`– is not acceptable. As the PI Defendants explained to Regeneron during the parties’ February 9,
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`2024 meet and confer, knowing the commercialization strategy of another defendant would
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`potentially affect the other defendants’ litigation strategy and potentially provide a significant
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`business advantage. The PI Defendants further explained that allowing outside counsel for the PI
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`Defendants to view each other’s confidential or outside-counsel’s-eyes-only (“OCEO”)
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`3
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`Case 1:23-cv-00089-TSK Document 99 Filed 02/14/24 Page 4 of 9 PageID #: 4085
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`information would clearly violate the draft proposed protective orders in each of the PI Defendants’
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`respective actions, which the parties are nearly done negotiating. (E.g., Ex. A.3)
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`The draft protective orders provide that confidential and OCEO information in each action
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`may be disclosed by the receiving party (here, Regeneron) only to certain “Qualified Persons,”
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`which includes the receiving party’s own outside counsel of record. (Id. ¶¶ 9–10.) Unsurprisingly,
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`the draft protective orders do not allow Regeneron to disclose a PI Defendant’s confidential or
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`OCEO information to outside counsel for other PI Defendants in different cases. After all, this is
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`highly confidential information to each individual PI Defendant.
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`In fact, the draft protective order that Regeneron proposed to each individual defendant
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`specifically defines “Action” as limited to the action against that individual defendant – e.g.,
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`“Action” as to Formycon means only “the case captioned Regeneron Pharmaceuticals, Inc. v.
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`Formycon AG, Civil Action No. 1:23-cv-00097-TSK, which is currently pending in the Northern
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`District of West Virginia,” and not the actions pending against Celltrion or SB. (Id. ¶ 1(b).) The
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`draft protective orders further provide: “All Protected Material shall be used solely for this Action,
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`including any appeal(s) therefrom or any remands thereto. Protected Material may not be used
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`under any circumstances for a related, separate or foreign action or proceeding, prosecution of
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`any patent application, patent licensing or for any other purpose.” (Id. ¶ 6 (emphasis added).)
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`Despite these provisions, Regeneron proposed submitting each PI Defendant’s confidential
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`information in the other actions by filing its omnibus opposition brief and serving an unredacted
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`copy on all outside counsel. Thus, not only would Regeneron’s proposal inflict substantial harm
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`3 Solely for purposes of this response, the draft proposed protective order attached as Exhibit A,
`which relates to Case No. 1:23-cv-97, accepts all changes and deletes all comments in the latest
`draft provided by Regeneron. The PI Defendants understand that Regeneron sent substantively
`identical drafts to each of them during the most recent exchange of drafts.
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`4
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`Case 1:23-cv-00089-TSK Document 99 Filed 02/14/24 Page 5 of 9 PageID #: 4086
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`on the PI Defendants’ business interests by needlessly exposing highly confidential business
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`information, it would also violate the protective orders that Regeneron has nearly finished
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`negotiating. The Court should reject Regeneron’s proposal on those grounds.
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`II.
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`The Court Should Adopt the PI Defendants’ Counterproposal for Handling Their
`Highly Confidential Business Information in Regeneron’s Omnibus Opposition.
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`After explaining to Regeneron that its proposal failed to address concerns over
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`confidentiality, in an effort to compromise, the PI Defendants made a simple, easy-to-implement
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`counterproposal for purposes of the PI Defendants’ motions to dismiss: that Regeneron serve on
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`each PI Defendant a copy of its omnibus opposition brief redacting confidential and OCEO
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`information from the other PI Defendants simultaneously with Regeneron’s filing of its omnibus
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`opposition brief under seal. This proposal respects the PI Defendants’ confidentiality interests and
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`the draft proposed protective orders by ensuring that outside counsel for the PI Defendants are not
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`exposed to each other’s confidential or OCEO information.
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`Regeneron should be capable of determining what information to redact from each PI
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`Defendant. Much of that information has already been designated as confidential or OCEO by
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`each of the individual PI Defendants. If Regeneron is unsure whether to redact certain information
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`from a PI Defendant, it can ask each Defendant now whether it considers the information to be
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`confidential and redact it accordingly. Or Regeneron could simply redact all information from a
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`given PI Defendant from the versions of the omnibus opposition brief provided to the other PI
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`Defendants (so long as Regeneron does not discuss each PI Defendants’ confidential information
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`in a manner that cannot be separated, as discussed further below). Regeneron also has ample time
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`to make these redactions before the February 19, 2024 deadline for its opposition and to provide a
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`redacted copy with its filing. Indeed, this is often done in other jurisdictions.
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`5
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`Case 1:23-cv-00089-TSK Document 99 Filed 02/14/24 Page 6 of 9 PageID #: 4087
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`The PI Defendants believe their proposal is workable as to the omnibus opposition brief
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`because they expect that, in the context of that motion, Regeneron’s discussion of their confidential
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`information should be separable, and they should not be prejudiced in their response by being
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`unable to see the specific confidential information of the other PI Defendants. In other words, the
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`facts specific to each of them should be discussed separately in the opposition. There is no reason,
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`for instance, for Regeneron to discuss Formycon’s confidential information in addressing whether
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`the Court has jurisdiction over SB—and vice versa.
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`If, however, Regeneron believes that it must discuss each PI Defendant’s confidential
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`information in a manner that would deprive the PI Defendants of the opportunity to respond if that
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`information was redacted, there is an even easier solution: Regeneron can simply file separate
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`motions in each case addressing only each individual PI Defendant. The PI Defendants would
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`prefer this solution, but recognize that the Court has already ordered an omnibus opposition brief
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`and do not seek modification given their reasonable proposed compromise.
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`Finally, the PI Defendants note that, while their proposed procedure is appropriate for
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`Regeneron’s omnibus response to their motions to dismiss, it would not be workable in the context
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`of Regeneron’s requested omnibus motion for preliminary injunction and memorandum. As set
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`out above, confidentiality issues with the omnibus opposition can be managed through immediate
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`redaction, without prejudicing their ability to respond, because Regeneron’s discussion of each of
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`their individual facts should be separate, and each PI Defendant should be able to understand
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`Regeneron’s opposition without seeing the facts regarding the other PI Defendants (again, if
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`Regeneron cannot represent that this is the case, it should agree to file separate motions instead).
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`The motions for preliminary injunction, however, are very different. The Court has not
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`ordered an omnibus motion—it has ordered “motion(s)” and “memoranda”—and the PI
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`6
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`Case 1:23-cv-00089-TSK Document 99 Filed 02/14/24 Page 7 of 9 PageID #: 4088
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`Defendants are concerned that Regeneron intends to collate their confidential commercial
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`information—particularly as to the irreparable harm analysis—in a manner that would prevent
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`each PI Defendant from understanding and responding to the full basis of Regeneron’s argument
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`because each PI Defendant cannot see the confidential information of the other. For instance, if
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`Regeneron submits Formycon’s confidential commercialization information into Celltrion’s case
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`(and vice versa), Formycon’s counsel would not have access to Celltrion’s information and could
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`not share it with their client to formulate a response. That would deprive each PI Defendant of the
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`ability to understand the case against it. And, under the terms of the latest draft proposed protective
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`orders, as to which the parties are near agreement, submitting confidential or OCEO information
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`disclosed in one “Action” in another would constitute an obvious violation. There is no need for
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`Regeneron to do this, and the issue would be resolved if Regeneron would agree to merely follow
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`the procedure set out in the Court’s Order, and file “motions” for PI and supporting “memoranda.”
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`So far, Regeneron has proven unwilling to do so.
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`The PI Defendant have proposed a commonsense solution to the problem of filing an
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`omnibus opposition to the motions to dismiss without compromising their confidential
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`information. Regeneron has not identified—and cannot identify—any reason why it cannot
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`comply with their counterproposal.
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`CONCLUSION
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`For the foregoing reasons, the PI Defendants respectfully request that the Court clarify its
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`January 9, 2024 Scheduling Order by ordering Regeneron to serve redacted copies of its omnibus
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`brief in opposition to the PI Defendants’ motions to dismiss on each PI Defendant, redacting
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`confidential and OCEO information from the other PI Defendants, at the same time that Regeneron
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`files its omnibus brief under seal.
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`7
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`Case 1:23-cv-00089-TSK Document 99 Filed 02/14/24 Page 8 of 9 PageID #: 4089
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`Dated: February 14, 2024
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`/s/ Max C. Gottlieb
`Max C. Gottlieb (WVSB #13201)
`Michael B. Hissam (WVSB #11526)
`Andrew C. Robey (WVSB #12806)
`Carl W. Shaffer (WVSB #13260)
`HISSAM FORMAN DONOVAN RITCHIE PLLC
`P.O. Box 3983
`Charleston, WV 25339
`681-265-3802 office
`304-982-8056 fax
`mhissam@hfdrlaw.com
`mgottlieb@hfdrlaw.com
`arobey@hfdrlaw.com
`cshaffer@hfdrlaw.com
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`Attorney for Defendant Celltrion, Inc. appearing for
`the limited purpose of contesting jurisdiction
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`/s/ Sandra K. Law
`Sandra K. Law (WVSB No. 6071)
`SCHRADER COMPANION, DUFF & LAW, PLLC
`401 Main Street
`Wheeling, West Virginia 26003
`(304) 233-3390 (phone)
`(304) 233-2769 (fax)
`skl@schraderlaw.com
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`Attorney for Defendant Samsung Bioepis Co., Ltd.
`appearing for the limited purpose of contesting
`jurisdiction
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`/s/ M. David Griffith, Jr.
`M. David Griffith, Jr. (WVSB No. 7720)
`THOMAS COMBS & SPANN PLLC
`300 Summers Street, Suite 1380
`Charleston, West Virginia 25301
`(304) 414-1800 (phone)
`(304) 414-1801 (fax)
`dgriffith@tcspllc.com
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`Attorney for Defendant Formycon AG appearing for
`the limited purpose of contesting jurisdiction
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`8
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`Case 1:23-cv-00089-TSK Document 99 Filed 02/14/24 Page 9 of 9 PageID #: 4090
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`CERTIFICATE OF SERVICE
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`I hereby certify that on February 14, 2024, I electronically filed the foregoing with the
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`Clerk of the Court by using the Court’s CM/ECF system. Counsel of record for all parties will be
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`served by the Court’s CM/ECF system.
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`/s/ Max C. Gottlieb
`Max C. Gottlieb (WVSB #13201)
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`9
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