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`Paper No. 3
` Filed July 10, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
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`DR. REDDY’S LABORATORIES, INC.
`Petitioner
`
`v.
`
`ICOS CORPORATION
`Patent Owner
`
`_____________________
`
`Case No. IPR2017-01757
`Patent No. 6,943,166 B1
`_____________________
`
`PETIONER’S MOTION FOR JOINDER TO RELATED INTER PARTES
`REVIEW OF U.S. PATENT NO. 6,943,166 (CASE NO. IPR2017-00323)
`PURSUANT TO 35 U.S.C. § 315(c) AND 37 C.F.R. § 42.122(b)
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`I.
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`STATEMENT OF THE PRECISE RELIEF REQUESTED
`Dr. Reddy’s Laboratories, Inc. (“DRL” or “Petitioner”) hereby moves the
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`Patent Trial and Appeal Board (“Board”) for joinder of its today-filed petition for
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`inter partes review (“DRL IPR”) with a previously instituted IPR, filed by Mylan,
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`on the same patent and the same ground of invalidity, Mylan Pharmaceuticals Inc.
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`v. ICOS Corporation, Case No. IPR2017-00323 (“Mylan IPR”). The DRL IPR
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`and the Mylan IPR are substantially identical. Resolving the two IPRs will
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`necessarily involve consideration of the same issues. Patent Owner (“ICOS”) will
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`not be prejudiced by joinder as no new grounds are raised by DRL.
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`DRL notes that on the previous business day to this Motion, Mylan and
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`Patent Owner filed a Joint Motion to Terminate the Mylan IPR. IPR2017-00323,
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`(Paper18) (July 7, 2017). Therefore, institution of the DRL IPR and joinder with
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`the Mylan IPR will ensure that a petitioner remains to complete Trial at the Board.
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`Joinder here would comport with the Board’s decision as to a set of two IPRs
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`where the Board granted joinder of a second IPR just one day before the Board
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`terminated the petitioner of the first IPR: AT&T Services, Inc. v. Convergent
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`Media Solutions, LLC, Case IPR2017-01237, (PTAB May 10, 2017) (Paper 10)
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`(granting joinder to second IPR); Netflix, Inc. v. Convergent Media Solutions, LLC,
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`Case IPR2016-01814, (PTAB May 11, 2017) (Paper 15) (terminating only the
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`petitioner of the first IPR).
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`1
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`Although a motion was filed to terminate the Mylan IPR on July 7th, joinder
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`of the DRL IPR is still appropriate, perhaps more so. As an initial matter, the
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`Board’s decision to grant joinder in the Convergent IPRs should control here, as
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`the Board has yet to grant Mylan’s and Patent Owner’s Joint Motion to Terminate.
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`Moreover, joinder makes sense as a matter of efficiency. Should the Board deny
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`DRL’s instant Motion for Joinder and opt to institute DRL’s application as a novel
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`IPR (substantially identical to that submitted by Mylan), the Board must then
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`restart the review process, thus duplicating its past efforts. Grant of DRL’s joinder
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`to Mylan’s pending IPR would be a more efficient use of Board time and resources
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`than setting the clock back to redo this review. Finally, public policy weighs in
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`favor of joinder – restarting the process by instituting DRL’s IPR as new would
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`only serve to delay the ultimate determination as to the patentability of the
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`challenged claims.
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`II. BACKGROUND
`Several months ago, on April 13, 2017, Patent Owner and Eli Lilly
`1.
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`and Co. (“Lilly”) filed a complaint accusing DRL and Dr. Reddy’s Laboratories,
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`Ltd., of infringing the ‘166 patent. Eli Lilly and Co., et al. v. Dr. Reddy’s
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`Laboratories, Inc., et al., Civil Action No. 17-cv-02541-KM-MAH (D.N.J.). Lilly
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`is a real party in interest to the Mylan IPR and Dr. Reddy’s Laboratories, Ltd. is a
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`real party in interest to the DRL IPR.
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`2
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`2.
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`Seven months earlier, on September 2, 2016, Mylan Pharmaceuticals
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`Inc. (“Mylan”) had been sued in the United States District Court for the Eastern
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`District of Virginia by Patent Owner and Lilly on the ‘166 patent. Eli Lilly & Co.
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`et al. v. Mylan et al., No. 1:16-cv-01122 (E.D.V.A).
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`3.
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`Mylan filed its petition for inter partes review of the ‘166 patent on
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`November 22, 2016. Mylan IPR, IPR2017-00323 (Paper 2).
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`4.
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`The Mylan IPR included the following ground for challenging the
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`validity of the ‘166 patent:
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`Ground 1: Claims 1-12 are Obvious under 35 U.S.C. § 103 over the ‘675
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`PCT in view of the Sildenifil NDA and FDA Guideline. Mylan IPR, IPR2017-
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`00323 (Petition, Paper 2 at 30-46).
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`5.
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`The Board instituted the Mylan IPR on June 12, 2017. Mylan IPR,
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`IPR2017-00323 (Paper 12 at 4, 17).
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`6.
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`The Petition filed in the DRL IPR presents the identical ground on
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`which the Mylan IPR was instituted.
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`7.
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`DRL is one of several defendants involved in pending litigations
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`regarding the ‘166 patent in the District of New Jersey or the Eastern District of
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`3
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`Virginia.1
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`8.
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`The District Court action in the Eastern District of Virginia between
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`Mylan, Patent Owner and Lilly was dismissed in a Consent Judgment entered July
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`6, 2016.
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`III. LEGAL STANDARD
`The Leahy-Smith America Invents Act (AIA) permits joinder of inter partes
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`review proceedings. The statutory provision governing joinder of inter partes
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`review proceedings, 35 U.S.C. § 315(c), gives the Board the discretion to grant
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`joinder of a properly filed petition for inter partes review.
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`In exercising its discretion to grant joinder, the Board considers the impact
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`of 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
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`rules for joinder, must be construed to secure the just, speedy, and inexpensive
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`resolution of every proceeding.” See Dell, Inc. v. Network-1 Security Solutions,
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`Inc., Case IPR2013-00385, (PTAB July 29, 2013) (Paper No. 17 at 3). In deciding
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`whether to grant joinder, the Board should consider “the policy preference for
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`joining a party that does not present new issues that might complicate or delay an
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`1 A list of pending litigations involving the ‘166 patent is at DRL’s Petition for
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`Inter Partes review, page 26, submitted earlier today.
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`4
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`existing proceeding.” Id. at 10.
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`The Board also considers four enumerated factors. “A motion for joinder
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`should: (1) set forth the reasons why joinder is appropriate; (2) identify any new
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`grounds of unpatentability asserted in the petition; (3) explain what impact (if any)
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`joinder would have on the trial schedule for the existing review; and (4) address
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`specifically how briefing and discovery may be simplified.” Id. at 4.
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`IV. ANALYSIS
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`A. This Joinder Motion is Timely
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`This Motion for Joinder is timely under 37 C.F.R. §§ 42.22 and 42.122(b),
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`as it is submitted within one month of June 12, 2017, the date the Mylan IPR was
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`instituted. DRL cannot be accused of sitting on its rights: the DRL IPR was filed
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`only several months after DRL and the other real party interest to the DRL IPR
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`were sued in District Court for infringement of the ‘166 patent.
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`B. The Factors Weigh In Favor of Joinder
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`1.
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`Joinder Is Appropriate
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`DRL seeks to join the Mylan IPR proceeding in order to ensure that an
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`accused infringer with an active interest in the proceeding remains a party to the
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`instituted Trial, especially under the assumption that Mylan will be terminated
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`from the Mylan IPR. Accordingly, joining the two IPRs is the most practical way
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`to secure the just, speedy, and inexpensive resolution of the challenge to the ‘166
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`5
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`patent. See 37 C.F.R. § 42.1(b). As discussed above, joinder also represents the
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`most efficient use of Board resources, as the Board could then avoid de novo
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`review of the complete IPR DRL filed today.
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`2.
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`No New Grounds of Unpatentability
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`The ground asserted in the DRL IPR petition is identical to the ground on
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`which the Mylan IPR was instituted. Purposefully, the cited art is the same and the
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`expert declarations submitted with the DRL IPR are substantially identical to the
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`expert declarations submitted in the Mylan IPR. Indeed, in circumstances such as
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`these, the PTO anticipated that joinder would be granted as a matter of right. See
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`157 CONG. REC. S1376 (daily ed. Mar. 8, 2011) (statement of Sen. Kyl) (“The
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`Office anticipates that joinder will be allowed as of right – if an inter partes review
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`is instituted on the basis of a petition, for example, a party that files an identical
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`petition will be joined to that proceeding, and thus allowed to file its own briefs
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`and make its own arguments.”) (emphasis added).
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`3.
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`No Impact on IPR Trial Schedule
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`This motion is being filed within one month of institution of the Mylan IPR,
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`and Petitioner agrees to adhere to all applicable deadlines set forth in the Mylan
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`IPR Scheduling Order. DRL is introducing no additional prior art and the expert
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`declarations of DRL’s experts are substantially identical to the declarations of
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`Mylan’s experts. Accordingly, the trial schedule for the Mylan IPR should not be
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`6
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`adversely impacted by DRL’s joinder. DRL notes that it sought Mylan’s consent
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`to retain Mylan’s experts for the purpose of the DRL IPR, but no consent was
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`given. DRL’s retained experts agree with, and therefore intend to adopt the
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`opinions of Mylan’s experts.
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`4.
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`Discovery and Briefing Can Be Simplified
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`Assuming that Mylan will be terminated, the need to depose two sets of
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`experts will be avoided. Moreover, the deposition of DRL’s experts should be no
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`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 DRL
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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
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`Qualcomm Inc., v. Bandspeed, Inc., Case IPR2014-00556, (PTAB Nov. 16, 2015)
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`(Paper 21 at 5) (granting joinder in the face of a Motion to Terminate a first IPR).
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`5.
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`Joinder Will Not Prejudice Patent Owner
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`DRL’s joinder will not result in any prejudice to Patent Owner or Mylan. No
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`additional grounds, art, arguments or expert opinions are being introduced, no new
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`evidence or issues are being added, and no additional briefing should be necessary
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`7
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`as a result of DRL’s joinder. Assuming Mylan is terminated, Mylan cannot be
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`prejudiced.
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`V. CONCLUSION
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`For the foregoing reasons, DRL respectfully requests that the Board grant its
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`Petition for inter partes review of the ‘166 patent and join the inter partes review
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`proceeding with Mylan Pharmaceuticals Inc. v. ICOS Corporation, Case No.
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`IPR2017-00323.
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`Date: July 10, 2017
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`Respectfully submitted,
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`
`/ Louis H. Weinstein /
`Louis H. Weinstein (Reg. No. 45,205)
`Alan H. Pollack (Reg. No. 39,802)
`BUDD LARNER, P.C.
`150 John F. Kennedy Parkway
`Short Hills, NJ 07078
`lweinstein@buddlarner.com
`apollack@buddlarner.com
`Telephone: (973) 379-4800
`Facsimile: (973) 379-7734
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`8
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing PETIONER’S
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`
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`MOTION FOR JOINDER TO RELATED INTER PARTES REVIEW OF U.S.
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`PATENT NO. 6,943,166 (CASE NO. IPR2017-00323) PURSUANT TO 35 U.S.C.
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`§ 315(c) AND 37 C.F.R. § 42.122(b) was served on July 10, 2017 via overnight
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`delivery on the patent owner at the correspondence address of record as follows:
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`[Via U.S.P.S. Priority Mail]
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`ICOS CORPORATION
`ELI LILLY AND COMPANY
`P.O. Box 6288
`Patent Division
`Indianapolis, IN 46206-6288
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`MARSHALL, GERSTEIN & BORUN LLP [Via Federal Express]
`233 South Wacker Drive
`6300 Willis Tower
`Chicago IL, 60606-6357
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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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`[Via Federal Express]
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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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`9
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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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`Dated:
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`[Via Federal Express]
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`[Via Federal Express]
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` By: / Louis H. Weinstein /
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` Louis H. Weinstein
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` Reg. No. 45,205
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`ICOS Corporation
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`July 10, 2017
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`1131157
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`10
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