`Sent:
`To:
`Cc:
`
`Subject:
`
`Follow Up Flag:
`Flag Status:
`
`Your Honors,
`
`Malik, Jitty <jitty.malik@katten.com>
`Tuesday, February 25, 2020 1:55 PM
`Trials
`Fisher, Stanley; Genderson, Bruce; Berniker, Jessamyn; Mahaffy, Shaun; Pacchioli, Alissa
`M.; Sheh, Anthony; West, Christopher W.; Radeke, Heike Simone
`IPR2020-00040
`
`Follow up
`Flagged
`
`I am lead counsel for Petitioner Mylan Pharmaceuticals Inc. (“Mylan” or “Petitioner”) in IPR2020‐00040. Mylan would
`like to request a conference call with the Panel respectfully seeking its permission to submit a 15 page Reply to the
`issues raised in Patent Owner’s Preliminary Response (“POPR”). Patent Owner Merck Sharp & Dohme Corp. (“Merck” or
`“Patent Owner”) objects to the breadth of Mylan’s request and is amenable to the Board’s granting Mylan a 5‐page
`Reply and Merck a 5‐page Surreply, both limited to the issue of whether WO ‘498 is available as prior art as asserted in
`Mylan’s obviousness Grounds 3 and 4. The parties have met and conferred regarding Petitioner’s request, but have
`been unable to reach an agreement.
`
`Petitioner requests two weeks to file its Reply after the Board grants permission (should the Board be inclined to do
`so). Patent Owner requests two weeks thereafter to file its Surreply.
`
`Patent Owner’s and Petitioner’s counsel are generally available any time next week for a conference with the Panel
`except Monday (March 2nd) and Friday (March 6th). Counsel for both parties are generally available any time the week of
`March 9th.
`
`The parties’ respective positions are set forth below:
`
`Petitioner (Mylan):
`The issues in the 54 page POPR include alleged antedating evidence (with four separate declarations), 325(d) arguments,
`314(a) arguments, and anticipation‐related arguments. Petitioner’s requested 15 pages represent a near 75% decrease
`in page count when compared to the 54 page POPR.
`
`In the cases cited in Merck’s POPR dealing with antedating evidence (Associated British Foods plc v. Cornell Research
`Foundation, Inc.; FreeBit AS v. Bose Corp.; LG Elecs. Inc. v. Wi‐LAN Inc (POPR at 45)), those petitioners were granted 4‐5
`pages to respond to that issue only. Furthermore, when a patent owner raises only 325(d) and 314(a) arguments in a
`POPR, the PTAB has previously granted 10 pages to address those issues (even if the petitioner was able to devote some
`space in its original petition to 325(d) and 314(a) issues). IPR2019‐00400, Order (Paper 12), Petition at 64‐66 (Paper 3);
`IPR2019‐00207, Decision at 1 (Paper 13), Petitioner’s Reply (Paper 10), Petition at 63‐64 (Paper 3).
`
`Patent Owner (Merck):
`Mylan has no reply as a matter of right and “[a]ny such request must make a showing of good cause.” 37 C.F.R. §
`42.108. Merck objects to Mylan’s request insofar as no good cause supports Mylan’s request for a reply concerning the
`Board’s discretion under 35 U.S.C. §§ 325(d) and 314(a)—or any other merits issues aside from the availability of WO
`’498 as prior art for obviousness. Many of the issues raised in Merck’s POPR were reasonably foreseeable, and the
`arguments that Mylan seeks to raise in reply should have been set forth in the Petition.
`IPR2020-00040
`Ex. 3001 p. 1 of 2
`
`1
`
`
`
`Relevant to § 325(d), and as Mylan has acknowledged, see Pet. at 2–3, WO ’498 is discussed at the very beginning of the
`challenged patent, and Mylan is party to the parallel litigation underlying the POPR’s discussion of the Board’s § 314(a)
`discretion. See Instrumentation Lab. Co. v. Hemosonics LLC, IPR2018‐00264, Paper 7 at 3–4 (P.T.A.B. Mar. 9,
`2017). Moreover, Mylan has already addressed the Board’s discretion under both statutory provisions, see Pet. at 66–
`69, without exhausting the Petition’s 14,000 word limit. See Mylan Pharms. Inc. v. Sanofi‐Aventis Deutschland GmbH,
`IPR2017‐01526, Paper 8 at 4 (P.T.A.B. Oct. 6, 2017). In short, Mylan is not entitled to a reply to address arguments with
`respect to both the Board’s discretion and the merits that could and should have been raised in the Petition itself.
`
`Petitioner (Mylan) Position’s on Patent Owner’s Requested Sur‐Reply:
`
`Mylan appreciates that Merck is “amenable to the Board’s granting Mylan a 5‐page Reply,” however, Mylan objects to
`Patent Owner’s 5 page Surreply. Put simply, Patent Owner has already addressed the alleged antedating evidence
`(including submitting no less than four declarations), see POPR. at 32–44, without exhausting the POPR’s 14,000 word
`limit, and all of its alleged arguments should have been raised in its POPR. For that matter, no automatic right (or good
`cause) exists to a Surreply to a Reply that has not even been submitted, including whether 5 pages for such a Surreply
`without any corresponding page reduction is excessive.
`
`Counsel for Patent Owner has been copied on this email.
`
`Respectfully,
`
`Jitendra Malik
`
`Jitendra (“Jitty”) Malik Ph.D.
`Partner
`Katten
`Katten Muchin Rosenman LLP
`550 S. Tryon Street, Suite 2900 | Charlotte, NC 28202-4213
`direct +1.704.344.3185
`jitty.malik@katten.com | katten.com
`
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`IPR2020-00040
`Ex. 3001 p. 2 of 2
`
`2
`
`