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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ARGENTUM PHARMACEUTICALS LLC
`Petitioner
`v.
`
`ICOS CORPORATION,
`Patent Owner
`
`U.S. Patent No. 6,943,166 B1
`Inter Partes Review No. IPR2017-01762
`
`MOTION FOR JOINDER
`35 U.S.C. § 315(c) and 37 C.F.R. § 42.122(b)
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`
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`U.S. Patent No. 6,943,166
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`TABLE OF CONTENTS
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`
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`I.
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`STATEMENT OF PRECISE RELIEF REQUESTED ............................... 1
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`II. BACKGROUND ............................................................................................. 2
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`III. STATEMENT OF REASONS FOR RELIEF REQUESTED .................... 3
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`A. Joinder is Appropriate ................................................................................... 4
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`B. No New Grounds of Unpatentability Are Asserted ..................................... 4
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`C. Joinder Will Not Impact the Existing Schedule .......................................... 5
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`D. Discovery and Briefing Can Be Simplified................................................... 6
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`IV. CONCLUSION ............................................................................................... 7
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`-i-
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`U.S. Patent No. 6,943,166
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`I.
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`STATEMENT OF PRECISE RELIEF REQUESTED
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`Petitioner Argentum Pharmaceuticals LLC (“Argentum” or “Petitioner”)
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`respectfully requests joinder pursuant to 35 U.S.C. § 315(c) and 37 C.F.R.
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`§ 42.122(b) of the above-captioned inter partes review (“Argentum IPR”) with the
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`pending inter partes review involving the same patent and the same ground of
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`invalidity in Mylan Pharmaceuticals Inc. v. ICOS Corporation, IPR2017-00323
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`(“Mylan IPR”), which was instituted on June 12, 2017. Joinder is appropriate
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`because it will promote efficient and consistent resolution of the validity of a single
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`patent and will not prejudice any of the parties to the Mylan IPR.
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`Argentum notes that on July 7, 2017, Mylan and Patent Owner filed a Joint
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`Motion to Terminate the Mylan IPR. IPR2017-00323, Paper 18. Argentum is also
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`aware that Dr. Reddy’s Laboratories, Inc. (“Dr. Reddy’s”) moved for joinder of its
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`petition (“DRL IPR”) to the Mylan IPR on July 10, 2017. IPR2017-01757, Motion
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`for Joinder, Paper 3. Institution of the Argentum IPR and joinder with the Mylan
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`IPR will ensure that at least one petitioner remains to complete trial at the Board.
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`Joinder here would comport with the Board’s decisions in two IPRs where the
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`Board granted joinder of a second IPR just one day before the Board terminated the
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`petitioner of the first IPR: AT&T Services, Inc. v. Convergent Media Solutions, LLC,
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`Case IPR2017-01237, (PTAB May 10, 2017) (Paper 10) (granting joinder to second
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`IPR); Netflix, Inc. v. Convergent Media Solutions, LLC, Case IPR2016-01814,
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`(PTAB May 11, 2017) (Paper 15) (terminating only the petitioner of the first IPR).
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`-1-
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`U.S. Patent No. 6,943,166
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`Although a motion was filed to terminate the Mylan IPR on July 7th, joinder
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`of the Argentum IPR is still appropriate. First, the Board’s decision to grant joinder
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`in the Convergent IPRs is applicable here, as the Board has yet to grant Mylan’s and
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`Patent Owner’s Joint Motion to Terminate. Second, joinder promotes efficiency.
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`Should the Board deny Argentum’s Motion for Joinder and opt to institute
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`Argentum’s petition as a novel IPR, the Board must then restart the review process,
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`which would duplicate past efforts. By granting Argentum’s joinder to Mylan’s
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`pending IPR, the Board will ensure that time and resources will not be wasted by
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`redoing the review of the same ground and analysis. Finally, public policy weighs
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`in favor of joinder—restarting the process by instituting Argentum’s IPR as new
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`would only serve to delay the ultimate determination of the patentability of the
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`challenged claims.
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`This Motion for Joinder is timely under 37 C.F.R. §§ 42.22 and 42.122(b), as
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`it is submitted no later than one month after June 12, 2017, the date on which the
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`Mylan IPR was instituted.
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`II. BACKGROUND
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`On November 22, 2016, Mylan filed a Petition for inter partes review
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`challenging claims 1-12 of United States Patent No. 6,943,166 (the “’166 patent”),
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`which was assigned Case No. IPR2017-00323. On June 12, 2017, the Board
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`instituted review of claims 1-12 on the following ground:
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`(1) Claims 1-12 are unpatentable under 35 U.S.C. § 103 as obvious over
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`-2-
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`U.S. Patent No. 6,943,166
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`’675 PCT (Daugan) in view of the Sildenafil NDA and FDA Guideline.
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`The accompanying Petition filed by Argentum presents only the identical
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`ground on which the Mylan IPR was instituted.
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`III. STATEMENT OF REASONS FOR RELIEF REQUESTED
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`The Leahy-Smith America Invents Act (“AIA”) permits joinder of inter
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`partes review proceedings. The statutory provision governing joinder of inter partes
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`review proceedings is 35 U.S.C. § 315(c), which reads as follows:
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`(c) JOINDER.—If the Director institutes an inter partes
`review, the Director, in his or her discretion, may join as
`a party to that inter partes review any person who
`properly files a petition under section 311 that the
`Director, after receiving a preliminary response under
`section 313 or the expiration of the time for filing such a
`response, determines warrants the institution of an inter
`partes review under section 314.
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`
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`In exercising its discretion to grant joinder, the Board considers the impact of
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`substantive and procedural issues on the proceedings, as well as other
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`considerations, while being “mindful that patent trial regulations, including the rules
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`for joinder, must be construed to secure the just, speedy, and inexpensive resolution
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`of every proceeding.” Dell, Inc. v. Network-1 Security Solutions, Inc., IPR2013-
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`00385, Paper No. 17 (July 29, 2013) at 3. The Board should consider “the policy
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`preference for joining a party that does not present new issues that might complicate
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`or delay an existing proceeding.” Id. at 10. Under this framework, joinder of the
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`present Argentum IPR with the Mylan IPR is appropriate.
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`-3-
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`U.S. Patent No. 6,943,166
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`“A motion for joinder should: (1) set forth the reasons why joinder is
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`appropriate; (2) identify any new grounds of unpatentability asserted in the petition;
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`(3) explain what impact (if any) joinder would have on the trial schedule for the
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`existing review; and (4) address specifically how briefing and discovery may be
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`simplified.” Id. at 4. Each of these factors is addressed fully below.
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`A.
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`Joinder is Appropriate
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`
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`Joinder with the Mylan IPR is appropriate here because the Argentum IPR is
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`limited to the same ground instituted in the Mylan IPR and relies on the same prior
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`art analysis and expert testimony submitted by Mylan. The Argentum IPR is
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`identical with respect to the ground raised in the Mylan IPR, and does not include
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`any grounds not raised in that proceeding.
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`Joinder is also appropriate because it will promote the just, speedy, and
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`inexpensive resolution of patentability issues, including the determination of
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`validity of the challenged claims of the ’166 patent. For example, a final written
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`decision on the validity of the ’166 patent has the potential to minimize issues and
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`potentially resolve any litigation with respect to the ’166 patent. As discussed
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`above, joinder also represents the most efficient use of Board resources, as the
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`Board could then avoid de novo review of the same IPR.
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`B. No New Grounds of Unpatentability Are Asserted
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`
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`The Argentum IPR does not present any new grounds of unpatentability. As
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`mentioned above, the Argentum IPR presents only the instituted ground from the
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`-4-
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`U.S. Patent No. 6,943,166
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`Mylan IPR. Additionally, the Argentum IPR is based on the same prior art analysis
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`and expert testimony submitted by Mylan.
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`C.
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`Joinder Will Not Impact the Existing Schedule
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`
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`Joinder in this case will not impact the Board’s ability to complete its review
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`in a timely manner. In this case, joinder will not affect the Board’s ability to issue a
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`final written decision within the one-year timeframe because Argentum agrees to
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`adhere to all deadlines set forth in the Mylan IPR Scheduling Order. IPR2017-
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`00323, Paper 13. Argentum is introducing no additional prior art and the expert
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`declarations of Argentum’s experts are substantially identical to the declaration of
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`Mylan’s experts. Therefore, the trial schedule for the Mylan IPR should not be
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`adversely impacted by Argentum’s joinder. Argentum is seeking Mylan’s consent
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`to retain Mylan’s experts, Dr. George Grass, Pharm.D., Ph.D. and Dr. Muta M. Issa,
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`M.D., M.B.A., but no consent has been given. Argentum’s retained experts agree
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`with, and have adopted the opinions of Mylan’s experts. Additionally, in the event
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`that Dr. Reddy's allows Argentum to rely directly on the testimony of their experts,
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`and make them available for depositions with respect to the Argentum IPR then
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`Argentum would agree not to make Dr. Culley C. Carson III, M.D. and Dr. Jackie
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`Corbin, Ph.D. available for deposition such that their testimony is not considered in
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`the Argentum IPR.
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`If the Board were to join both the DRL IPR and the Argentum IPR to the
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`Mylan IPR, Argentum anticipates participating in the proceeding in a limited
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`-5-
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`U.S. Patent No. 6,943,166
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`capacity as an understudy, absent termination of Dr. Reddy’s as a party.
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`Accordingly, Argentum does not believe that any extension of the trial schedule will
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`be required as a result of joinder.
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`D. Discovery and Briefing Can Be Simplified
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`
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`Assuming that the Mylan IPR will be terminated, the need to depose two sets
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`of experts will be avoided. Moreover, the deposition of Argentum’s experts should
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`be no more complicated than the deposition of Mylan’s experts because the analysis,
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`materials relied on, and conclusions are essentially the same. Because the Argentum
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`IPR is identical to the Mylan IPR with respect to grounds of unpatentability raised
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`and instituted in the Mylan IPR, briefing in a joined IPR, especially with Mylan
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`terminated, will not be more complicated. Moreover, because Mylan and Patent
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`Owner have settled, and assuming that Mylan will be terminated, “there will no
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`longer be issues of cooperation and duplication among petitioners.” See Qualcomm
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`Inc., v. Bandspeed, Inc., Case IPR2014-00556, (PTAB Nov. 16, 2015) (Paper 21 at
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`5) (granting joinder in the face of a Motion to Terminate a first IPR).
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`In the case where the only remaining parties to the Mylan IPR are Dr.
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`Reddy’s and Argentum, the Board may order petitioners to consolidate filings and to
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`limit Argentum to no additional filings in its understudy role. As long as Dr.
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`Reddy’s remains a party, Argentum will not submit any separate filings unless it
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`disagrees with Dr. Reddy’s position, and in the event of such disagreement it will
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`submit a short separate filing directed only to the points of disagreement. The Board
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`-6-
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`U.S. Patent No. 6,943,166
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`may allow the Patent Owner a corresponding number of pages to respond to any
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`separate filings. See Dell Inc. v. Network-1 Solutions, Inc., IPR2013-00385, Paper
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`17, at 8-9. Moreover, as long as Dr. Reddy’s allows Argentum to retain the same
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`experts, then Argentum agrees not to receive any separate cross-examination or re-
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`direct examination time and that all cross-examinations will occur within the
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`timeframe normally allotted by the rules to one party.
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`IV. CONCLUSION
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`For the foregoing reasons, Argentum respectfully requests that the
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`Argentum IPR be instituted and joined with the Mylan IPR.
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`Dated: July 12, 2017
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`Respectfully submitted,
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`/Kevin B. Laurence/
`Kevin B. Laurence
`Registration No. 38,219
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`Matthew C. Phillips
`Registration No. 43,403
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`Tyler Liu
`Registration No. 72,126
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`-7-
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`U.S. Patent No. 6,943,166
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. §§ 42.6(e) and 42.105, the undersigned certifies that on
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`July 12, 2017, a complete copy of the foregoing Motion for Joinder was served via
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`overnight delivery on the Patent Owner by serving the correspondence address of
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`record for the ʼ166 Patent:
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`MARSHALL, GERSTEIN & BORUN LLP
`233 South Wacker Drive
`6300 Willis Tower
`Chicago IL, 60606-6357
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`ICOS CORPORATION
`ELI LILLY AND COMPANY
`P.O. Box 6288
`Patent Division
`Indianapolis, IN 46206-6288
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`
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`Courtesy copies of the foregoing were also served via overnight delivery on the
`counsel of record for the Petitioner and Patent Owner in Mylan Pharmaceuticals
`Inc. v. ICOS Corporation, Case No. IPR2017-00323 as follows:
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`Mylan Pharmaceuticals Inc.
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`Steven W. Parmelee
`Michael T. Rosato
`Jad A. Mills
`WILSON SONSINI GOODRICH & ROSATI
`701 Fifth Avenue, Suite 5100
`Seattle, WA 98104-7036
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`-8-
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`U.S. Patent No. 6,943,166
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`ICOS Corporation
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`Mark J. Feldstein
`Joshua L. Goldberg
`Yieyie Yang
`Maureen D. Queler
`FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
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`Mark J. Stewart
`Dan L. Wood
`Gerald P. Keleher
`Eli Lilly and Company
`Lilly Corporate Center
`Indianapolis, IN 46285
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`/Kevin B. Laurence/
`Kevin B. Laurence
`Registration No. 38,219
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` Counsel for Petitioner
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`-9-
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