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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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`ARGENTUM PHARMACEUTICALS LLC,
`Petitioner,
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`v.
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`COSMO TECHNOLOGIES LIMITED,
`Patent Owner.
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`___________________
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`Case IPR2018-00080
`U.S. Patent No. 9,320,716
`___________________
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`PATENT OWNER’S OPPOSITION TO ARGENTUM
`PHARMACEUTICALS LLC’S MOTION FOR JOINDER
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`Mail Stop: PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`IPR2018-00080
`Patent No. 9,320,716
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`Patent Owner Cosmo Technologies Limited (“Cosmo”) submits this
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`opposition to Argentum Pharmaceuticals LLC’s (“Argentum”) motion for joinder of
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`IPR2018-00080 (the “Argentum IPR”) with IPR2017-01035 (the “Mylan IPR”).
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`In the Mylan IPR, Petitioner Mylan Pharmaceuticals Inc. (“Mylan”) and Patent
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`Owner have settled their dispute and filed a joint motion for termination. See IPR2017-
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`01035, Paper 23. Pursuant to the settlement, Mylan has agreed that neither it nor its
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`expert, Dr. Anthony Palmieri, will participate in an IPR proceeding challenging the
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`patent at issue. Id. at 4 (“Petitioner represents that it will no longer participate in this
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`inter partes review and will file no further papers. Petitioner has also agreed not to
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`permit its expert witness, Dr. Anthony Palmieri, to assist Argentum or any other
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`Petitioner in an IPR proceeding challenging the patent at issue.”).
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`For reasons discussed in the joint motion for termination, the Board should
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`terminate the Mylan IPR. Termination saves the parties litigation costs and the Board
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`administrative resources thereby furthering the AIA’s purpose of providing an efficient
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`and less costly alternative forum for adjudicating patent disputes and encouraging
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`settlement. If the Mylan IPR is terminated, then Argentum’s joinder request should be
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`denied as moot. See Ubisoft, Inc. v. Uniloc USA, Inc., IPR2016-00414, Paper 16 at 5
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`(June 2, 2016) (“Because [the first IPR] is no longer pending, it cannot serve as a
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`proceeding to which another proceeding may be joined. We, therefore, must deny
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`Petitioner’s Motion for Joinder.”).
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`There is no prejudice to Argentum if joinder is denied. Patent Owner has never
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`brought a patent infringement lawsuit against Argentum and is unlikely to do so
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`because Argentum has never made any drug products related to the challenged patent.
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`See Ex. 2001. Argentum is not subject to any statutory bar under 35 U.S.C. § 315(b),
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`and joinder is unnecessary for the Board to evaluate fully Argentum’s new petition and
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`supporting evidence.
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`Joinder should also be denied because, in the event the Mylan IPR has not yet
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`been terminated, joinder would prejudicially complicate the schedule in the Mylan IPR,
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`and in fact, cannot work under the current schedule. An institution decision on
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`Argentum’s IPR petition will not be issued until after January 31, 2018—the deadline
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`for Patent Owner to file a preliminary response, see 35 U.S.C. § 314(b) (institution
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`decision is “after” a preliminary response or the last date on which such response may
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`be filed), 37 C.F.R. § 42.107(b) (“The preliminary response must be filed no later than
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`three months after the date of a notice….”)—and will most likely be issued
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`approximately three months later in late April 2018. In contrast, Patent Owner’s
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`Response in the Mylan IPR is due several months before then, on December 20, 2017,
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`and oral argument is scheduled for June 15, 2018. See IPR2017-01035, Paper 18 at 7
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`(Due Dates 1 and 7 in Scheduling Order). Joining the Argentum IPR would prejudice
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`Patent Owner by injecting critical new evidence, e.g., unpatentability testimony from a
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`different expert witness, late in the Mylan IPR proceeding without giving Patent Owner
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`an adequate opportunity to respond. See ZTE Corp. v. Adaptix Inc., IPR2015-01184,
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`Paper 10 at 5 (July 24, 2015) (denying joinder because a different expert declarant
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`raises “new issues…[that] would adversely impact the IPR [] trial”).
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`Argentum’s motion for joinder states that if Mylan’s expert will not participate
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`in the IPR, then Argentum’s expert, Dr. Hartmut Derendorf, and his accompanying
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`declaration must be substituted in. See Paper 3 at 7. And as discussed above, Mylan
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`has agreed in the settlement agreement that its expert will not assist Argentum or
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`participate in the IPR. Joinder would, therefore, introduce a different expert witness in
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`the Mylan IPR. While Argentum’s expert makes statements in his declaration similar
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`to those made by Mylan’s expert, there are notable differences, including his
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`educational background (Ex. 1006 ¶ 8), his academic work experience (id. ¶¶ 9, 11), his
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`research interests (id. ¶ 10), his consulting work for industry (id. ¶¶ 12-13), and his
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`membership in professional organizations and journals (id. ¶ 15, 17). Importantly,
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`Dr. Derendorf’s prior statements and publications (more than 460 scientific
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`publications and over 880 presentations in total) concerning targeted-drug-release
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`pharmaceutical formulations will be critical to the issues in dispute (id. ¶ 16, Ex. 1007).
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`Argentum’s expert will also inevitably provide new evidence when giving testimony in
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`deposition. Introducing this new evidence via joinder and substituting in Argentum’s
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`expert as the primary unpatentability expert would simply not be feasible under the
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`Mylan IPR schedule. Indeed, because an institution decision in the Argentum IPR will
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`not be issued until after January 31, 2018, Patent Owner is in the situation of filing its
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`Patent Owner Response in the Mylan IPR (assuming it has not yet been terminated),
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`due on December 20, 2017, even before deposing Argentum’s expert. Such an
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`outcome would unfairly prejudice Patent Owner.
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`Argentum’s joinder motion remarkably does not propose any modification to the
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`schedule in the event that Mylan and its expert do not participate in the IPR (which has
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`turned out to be the situation here), and, therefore, Argentum has failed to meet its
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`burden of proof in establishing that joinder is appropriate under 37 C.F.R. § 42.20(d).
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`See Sierra Wireless Am., Inc. v. M2M Sols. LLC, IPR2016-00853, Paper 16 (Sept. 20,
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`2016) (denying joinder because “Petitioner does not explain specific modifications to
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`the schedule that would be necessary to account for the additional issues, grounds, and
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`prior art raised in the Petition”). Argentum should not be allowed to propose any
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`schedule modifications in its reply brief as that would be improper new argument. See
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`Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1366 (Fed. Cir.
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`2016) (affirming the Board’s decision to reject a reply brief that was “presenting a new
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`argument for the first time”), citing 37 C.F.R. § 42.23(b) (“All arguments for the relief
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`requested in a motion must be made in the motion.”).
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`If trial is instituted in the Argentum IPR, then it should proceed on its own
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`schedule. A separate trial for the Argentum IPR, if instituted, would not require
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`additional Board resources because the Mylan IPR should be terminated. Therefore,
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`even if joinder is denied, only one IPR proceeding on the patent at issue will remain.
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`It will not prejudice Argentum for this Board to consider Argentum’s new IPR
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`petition and supporting evidence on its own schedule. Argentum will be afforded full
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`consideration of the arguments and evidence cited by its Petition, and the same
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`patentability standards will apply.1 Argentum chose when to file its IPR petition and
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`cannot now argue that its own decision has caused prejudice because the final decision
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`will be issued later than it wanted because of non-joinder. Joinder to an earlier
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`proceeding is discretionary, not a matter of right. See ZTE Corp., IPR2015-01184,
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`Paper 10 at 5 (“The decision to grant joinder is discretionary, with Petitioner, as the
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`moving party, bearing the burden to show that joinder is appropriate.”), citing 35
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`U.S.C. § 315(c). Argentum knew that by waiting until late October 2017 to file its IPR
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`petition, the soonest an institution decision could be rendered was late January 2018—
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`after Patent Owner’s Response in the Mylan IPR would have been filed. It knew that
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`unless Mylan desired to proceed as the primary petitioner, joinder would have been
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`impossible under the Mylan IPR schedule.
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`1 If instituted, Argentum’s IPR proceeding will still conclude with a final
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`decision prior to expiration of the patent at issue (June 9, 2020), and therefore the
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`claim construction standard remains the “broadest reasonable interpretation”
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`standard. See In re CSB-Sys. Int'l, Inc., 832 F.3d 1335, 1340 (Fed. Cir. 2016)
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`(“During reexamination proceedings of unexpired patents, however, the Board uses
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`the ‘broadest reasonable interpretation consistent with the specification’ standard, or
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`BRI.”). Argentum has not argued otherwise or raised concerns about claim
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`construction.
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`There is no prejudice to Argentum if joinder is denied because its Petition,
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`including its new testimony evidence, will be fully considered by the Board in the
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`ordinary course. If Argentum had wanted a final written decision sooner, then it should
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`have filed an IPR petition sooner. Petitioner Argentum’s motion for joinder should be
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`denied.
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`Dated: November 20, 2017
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`Respectfully submitted,
`/s/ Gary N. Frischling
`Gary N. Frischling
`Reg. No. 35,515
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`Irell & Manella LLP
`1800 Avenue of the Stars, Suite 900
`Los Angeles, CA 90067-4276
`Telephone: (310) 277-1010
`Fax: (310) 203-7199
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`Attorney for Patent Owner
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`IPR2018-00080
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. 42.6, the undersigned certifies that on November 20,
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`2017, a copy of the foregoing document was served by electronic mail upon the
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`following:
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`Tyler C. Liu
`Reg. No. 72,126
`Argentum Pharmaceuticals LLC
`202-749-8605
`TLiu@agpharm.com
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`Michael Houston
`Reg. No. 58,486
`FOLEY & LARDNER LLP
`321 North Clark Street, Suite 2800
`Chicago, Illinois 60654
`312-832-4500
`mhouston@foley.com
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`Joseph P. Meara
`Reg. No. 44,932
`James McParland, Ph.D.
`Reg. 69,440
`FOLEY & LARDNER LLP
`150 East Gilman St.
`Madison, WI 53703-1482
`608-258-4303
`jmeara@foley.com
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`Kevin Laurence
`Reg. No. 38,219
`LAURENCE & PHILLIPS IP
`LAW LLP
`klaurence@lpiplaw.com;
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`Matthew Phillips
`Reg. No. 43,403
`LAURENCE & PHILLIPS IP
`LAW LLP
`mphillips@lpiplaw.com
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`/s/ Susan Langworthy
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