UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_______________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________________________
`
`LUPIN LTD. and LUPIN PHARMACEUTICALS INC.
`Petitioners
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.
`Patent Owner
`
`____________________
`
`U.S. Patent No. 8,129,431 to Sawa et al.
`Issue Date: March 6, 2012
`Title: Aqueous Liquid Preparation Containing 2-Amino-3-(4-
`bromobenzoyl) Phenylacetic Acid
`____________________
`
`Inter Partes Review No.: Unassigned
`____________________
`
`
`
`MOTION FOR JOINDER
`PURSUANT TO 35 U.S.C. § 315(c) AND 37 C.F.R. § 42.122(b)
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`
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`_______________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________________________
`
`LUPIN LTD. and LUPIN PHARMACEUTICALS INC.
`Petitioners
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.
`Patent Owner
`
`____________________
`
`U.S. Patent No. 8,129,431 to Sawa et al.
`Issue Date: March 6, 2012
`Title: Aqueous Liquid Preparation Containing 2-Amino-3-(4-
`bromobenzoyl) Phenylacetic Acid
`____________________
`
`Inter Partes Review No.: Unassigned
`____________________
`
`
`
`MOTION FOR JOINDER
`PURSUANT TO 35 U.S.C. § 315(c) AND 37 C.F.R. § 42.122(b)
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`Table of Contents
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`STATEMENT OF THE PRECISE RELIEF REQUESTED ................... 1
`I.
`STATEMENT OF MATERIAL FACTS ................................................... 1
`II.
`III. STATEMENT OF REASONS FOR RELIEF REQUESTED ................. 4
`A.
`Joinder will not impact the Board’s ability to complete the
`review in a timely manner ................................................................. 5
`Joinder will promote efficiency by consolidating issues and
`preventing inconsistencies ................................................................. 8
`C. Without joinder, Lupin may be prejudiced ..................................... 8
`D.
`Joinder will not prejudice Patent Owners or InnoPharma ........... 9
`IV. CONCLUSION ............................................................................................. 9
`
`B.
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`
`
`i
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`I.
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`STATEMENT OF THE PRECISE RELIEF REQUESTED
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`Petitioners Lupin Ltd. and Lupin Pharmaceuticals Inc. (collectively, “Lupin”
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`or the “Petitioners”) respectfully request joinder pursuant to 35 U.S.C. § 315(c)
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`and 37 C.F.R. § 42.122(b) of the above-captioned inter partes review (hereinafter
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`“Lupin IPR”) with the pending inter partes review concerning the same patent and
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`the same two grounds of invalidity in InnoPharma Licensing, Inc., et al. v. Senju
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`Pharmaceutical Co., Ltd., et al., Case No. IPR2015-00903 (“InnoPharma IPR”),
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`which was instituted on August 7, 2015. Joinder is appropriate because it will
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`promote efficient and consistent resolution of the validity of a single patent and
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`will not prejudice any of the parties to the InnoPharma IPR.
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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 August 7, 2015, the date on which the
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`InnoPharma IPR was instituted.
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`II.
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`STATEMENT OF MATERIAL FACTS
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`1.
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`Petitioners are not aware of any reexamination certificates or pending
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`prosecution concerning U.S. Patent No. 8,129,431 (“the ’431 patent”), which is the
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`subject of both the InnoPharma IPR and the Lupin IPR.
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`2.
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`On January 31, 2014, Senju Pharmaceutical Co., Ltd., et al (“Senju”)
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`filed a complaint accusing Lupin of infringing the ’431 patent. On February 21,
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`2014, the waiver of service of summons was filed. Senju Pharmaceutical Co.,
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`
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`1
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`
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`
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`Ltd., Bausch & Lomb, Inc., and Bausch & Lomb Pharma Holdings Corp. v. Lupin,
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`Ltd. and Lupin Pharmaceuticals, Inc., C.A. No. 1:14-CV-00667-MAS-LHG
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`(D.N.J.).
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`3. Metrics Inc. (“Metrics”) filed a petition for inter partes review on
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`June 26, 2014. (Metrics IPR, IPR2014-01041). The Board instituted the Metrics
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`IPR on February 19, 2015. InnoPharma filed a motion to join on March 19, 2015.
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`Before the Board decided on the joinder, the Metrics IPR was terminated.
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`(IPR2014-01041, Paper 39, page 4)
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`4.
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`InnoPharma Licensing, Inc., et al. (“InnoPharma”) filed its petition
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`for inter partes review of the ’431 patent on March 19, 2015. (InnoPharma IPR,
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`IPR2015-00903).
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`5.
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`The InnoPharma IPR included the following two grounds for
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`challenging the validity of the ‘431 patent:
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`Ground 1: Claims 1-5, 7-14, and 18-19 as obvious over Ogawa and
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`Sallmann under 35 U.S.C. § 103; and
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`Ground 2: Claims 6, 15-17, and 20-22 as obvious over Ogawa,
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`Sallmann, and Fu under 35 U.S.C. § 103. (IPR2015-00903, Paper 19,
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`page 20).
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`6.
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`The Board instituted the InnoPharma IPR on August 7, 2015 on
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`Grounds 1 and 2.
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`
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`2
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`
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`7.
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`The Petition filed in the present Lupin IPR presents only the identical
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`grounds on which the InnoPharma IPR was instituted.
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`8.
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`Up until March 19, 2015, the deadline for filing a Motion to Join the
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`Metrics IPR, there were eight different litigations involving the ‘431 patent
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`(involving 5 different defendants in multiple jurisdictions).1 At the time of the
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`deadline to seek joinder to the Metrics IPR (March 19, 2015), all eight litigations
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`were still pending. However, as of August 2015, all but two of these litigations
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`have settled, leaving the litigations involving Lupin and InnoPharma as
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`defendants.2
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`
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`1 For a list of related litigations involving the ‘431 patent, see Lupin’s
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`Petition for Inter Partes review, pages 12-14, submitted concurrently herewith.
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`2 Petitioners note that two additional litigations were filed subsequent to the
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`deadline to seek joinder to the Metrics IPR and involving the ‘431 patent, one also
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`involving InnoPharma, and one involving Watson Laboratories, Inc. (Senju v.
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`InnoPharma, C.A. No. 1:15-cv-03240-JBS-KMW (D.N.J. filed May 8, 2015); and
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`Senju v. Watson Laboratories, Inc., C.A. No. 1:15-cv-05591-JBS-KMW (D.N.J.
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`filed July 16, 2015); full case cites can be found in Lupin’s Petition for IPR on
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`pages 13-14).
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`
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`3
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`
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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 partes
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`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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`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, Paper No. 17 (July 29, 2013) at 3. The Board should
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`consider “the policy preference for joining a party that does not present new issues
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`that might complicate or delay an existing proceeding.” Id. at 10. Under this
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`framework, joinder of the present Lupin IPR with the InnoPharma IPR is
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`appropriate.
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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
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`4
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`
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`petition; (3) explain what impact (if any) joinder would have on the trial schedule
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`for the existing review; and (4) address specifically how briefing and discovery
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`may be simplified.” Id. at 4. Each of these is addressed fully below.
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`A.
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`Joinder will not impact the Board’s ability to complete the review
`in a timely manner
`
`Joinder in this case will not impact the Board’s ability to complete its review
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`in a timely manner. 35 U.S.C. § 316(a)(11) and associated rule 37 C.F.R. §
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`42.100(c) provide that inter partes review proceedings should be completed and
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`the Board’s final decision issued within one year of institution of the review. In
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`this case, joinder will not affect the Board’s ability to issue the decision within this
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`required one-year timeframe because the Petition filed in the present Lupin IPR is
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`identical to the InnoPharma IPR. Indeed, in circumstances such as these, the PTO
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`anticipated that joinder would be granted as a matter of right. See 157 CONG.
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`REC. S1376 (daily ed. Mar. 8, 2011) (statement of Sen. Kyl) (“The Office
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`anticipates that joinder will be allowed as of right – if an inter partes review is
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`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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`In addition, Lupin respectfully proposes procedures to simplify any further
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`briefing and discovery, which will minimize any potential impact on the schedule
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`or the volume of materials to be submitted to the Board. Given that the petitioners
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`5
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`will be addressing the identical ground for challenging the claims at issue, the
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`Board may adopt procedures similar to those adopted in Dell, Inc. v. Network-1
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`Security Solutions, Inc., IPR2013-00385 and Motorola Mobility LLC v. SoftView
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`LLC, IPR2013-00256. In those cases, the Board ordered the petitioners to file
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`consolidated filings, for which the first petitioner was responsible, and allowed the
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`new petitioner to file seven additional pages with corresponding additional
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`responsive pages allowed to the Patent Owner. IPR2013-00385, Paper 17 at 8;
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`IPR2013-00256, Paper 10 at 8-9. This procedure would minimize any
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`complication or delay caused by joinder, as the Board recognized in those cases.
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`As in Cases IPR2013-00385 and IPR2013-00256, the petitioners in this case can
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`work together to manage the questioning at depositions and presentations at the
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`hearing to avoid redundancy. IPR2013-00385, Paper 17 at 9; IPR2013-00256,
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`Paper 10 at 9-10. Additionally, while the Petitioners in the Lupin IPR and the
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`Petitioner in the InnoPharma IPR have relied upon testimony from separate experts
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`in their respective petitions, the conclusions and underlying reasoning of the
`
`experts are identical, and therefore present no additional burden on the part of the
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`Patent Owners to address. All of these concessions offered by Lupin are consistent
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`with precedent and are consistent with concessions offered by InnoPharma when it
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`sought to join the Metrics IPR. Dell, Inc. v. Network-1 Security Solutions, Inc.,
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`
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`6
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`
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`IPR2013-00385; Motorola Mobility LLC v. SoftView LLC, IPR2013- 00256; and
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`InnoPharma IPR, IPR2015-00903, Motion to Join, pages 5-6.
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`Furthermore, in order to further simplify the proceeding, Lupin will rely on
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`the same expert as InnoPharma, should InnoPharma permit it. If InnoPharma
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`allows Lupin to retain the same expert, then Lupin will withdraw its expert
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`declaration of Dr. Lawrence and rely solely on the declaration and testimony of
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`InnoPharma’s expert, Dr. Laskar. The Board has previously acknowledged that
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`such concessions on the part of a party seeking to join are sufficient to minimize
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`the impact on the original proceeding (see SAP America Inc. v. Clouding IP, LLC,
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`IPR2014-00306, Paper 13, page 4).
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`Even if, through no fault of its own, Lupin were required to proceed with its
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`own expert, there would be no impact on the Board’s ability to complete its review
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`in a timely manner. Moreover, there would be only a modest impact on the Patent
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`Owners, given that little additional preparation would be needed for the deposition
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`of Lupin’s expert beyond that required for the deposition of InnoPharma’s expert.
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`Indeed, InnoPharma itself argued when seeking joinder to the Metrics IPR, that
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`“while InnoPharma and Metrics have relied upon testimony from separate experts
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`in their respective petitions, the conclusions and underlying reasoning of the
`
`experts are congruent, and therefore present no additional burden on the part of the
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`Patent Owners to address.” IPR2015-00903, Motion to Join, page 6. InnoPharma
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`
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`7
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`
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`
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`further argued that it “diligently and timely filed its petition and motion for joinder
`
`within the time set by statute” and that the requested extension was “within the
`
`amount prescribed by statute.” IPR2015-00903, Paper 14, page 4. Thus,
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`InnoPharma concluded that “[i]t would be axiomatic that a petition, motion for
`
`joinder, and extension that complies with all the rules does not cause undue delay.
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`IPR2015-00903, Paper 14, page 4.
`
`Although Lupin believes it is very unlikely, in the event that InnoPharma
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`does not agree to allow Lupin to retain its expert, and the Board determines it
`
`would not be able to complete these proceedings within the one-year timeframe as
`
`a result of having to provide the Patent Owners with the opportunity to additionally
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`depose Dr. Lawrence, Lupin would in that case agree to withdraw Dr. Lawrence’s
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`declaration and instead rely solely on the declaration of InnoPharma’s expert, Dr.
`
`Laskar.
`
`B.
`
`Joinder will promote efficiency by consolidating issues and
`preventing inconsistencies
`
`Proceeding with a consolidated inter partes review as outlined above would
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`avoid inefficiency and prevent inconsistencies and would result in a final written
`
`decision without any delay.
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`C. Without joinder, Lupin may be prejudiced
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`Lupin would be prejudiced if it is not permitted to join and to participate in
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`the InnoPharma IPR, which will affect not only Lupin’s pending inter partes
`
`
`
`8
`
`
`
`
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`review Petition, but also the underlying litigation (Senju Pharmaceutical Co., Ltd.
`
`et al. v. Lupin, Ltd. et al., C.A. No. 1:14-CV-00667-MAS-LHG (D.N.J.)). The
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`decision in the InnoPharma IPR will likely simplify, or even resolve, the issues in
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`the underlying litigation.
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`D.
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` Joinder will not prejudice Patent Owners or InnoPharma
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`Permitting joinder will not prejudice Senju or InnoPharma. Lupin’s
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`proposed grounds for instituting an IPR are identical to those proposed by
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`InnoPharma in its petition. Joinder will not affect the timing of the InnoPharma
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`IPR, and any extension to the schedule that may be required is permitted by law
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`and the applicable rules. 35 U.S.C. § 316(a)(1); 37 C.F.R. § 42.100(c).
`
`IV. CONCLUSION
`
`For the foregoing reasons, Lupin respectfully requests that its Petition for
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`inter partes review of U.S. Patent No. 8,129,431 be instituted and that the
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`proceeding be joined with InnoPharma Licensing, Inc., et al. v. Senju
`
`Pharmaceutical Co., Ltd., et al., Case No. IPR2015-00903
`
`Although no additional fee is believed to be required for this Motion, the
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`Commissioner is hereby authorized to charge any additional fees which may be
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`required for this Motion to Deposit Acct. No. 05-1323 (Ref. No.
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`106745.0000006).
`
`
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`9
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`
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`September 4, 2015
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`
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`Respectfully submitted,
`
`
`
` /Deborah Yellin/
`Deborah H. Yellin
`Reg. No. 45,904
`CROWELL & MORING LLP
`Intellectual Property Group
`P.O. Box 14300
`Washington, DC 20044-4300
`
`
`
`10
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`
`
`
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`CERTIFICATION OF SERVICE
`
`
`
`The undersigned hereby certifies that this “MOTION FOR JOINDER
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`PURSUANT TO 35 U.S.C. § 315(c) AND 37 C.F.R. § 42.122(b)” was served in
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`its entirety this 4th day of September, 2015 on the Patent Owner by serving the
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`correspondence address of record for the ’431 Patent:
`
`WENDEROTH, LIND & PONACK, L.L.P.
`1030 15th Street, N.W.,
`Suite 400 East
`Washington DC 20005-1503
`
`Courtesy copies of the foregoing were also served via email on the counsel
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`of record for the Petitioner and Patent Owner in InnoPharma Licensing, Inc. v.
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`Senju Pharmaceutical Co., Ltd., IPR2015-00903 as follows:
`
`InnoPharma Licensing, Inc., et al.
`
`Lance Soderstrom
`ALSTON & BIRD LLP
`90 Park Avenue, 15th Floor
`New York, NY 10016-1387
`lance.soderstrom@alston.com
`
`
`
`
`
`
`Jitendra Malik, Ph.D.
`ALSTON & BIRD LLP
`4721 Emperor Blvd., Suite 400
`Durham, NC 27703-8580
`jitty.malik@alston.com
`
`Bryan Skelton, Ph.D.
`ALSTON & BIRD LLP 4721
`Emperor Blvd., Suite 400 Durham,
`NC 27703-8580
`bryan.skelton@alston.com
`
`
`
`
`
`
`
`Senju Pharmaceutical Co., Ltd., et al.
`
`
`
`Bryan C. Diner
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`Bryan.Diner@finnegan.com
`
`M. Andrew Holtman
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`Andy.Holtman@finnegan.com
`
`
`
`
`
`September 4, 2015
`
`
`
`Justin J. Hasford
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`Justin.Hasford@finnegan.com
`
`Joshua L. Goldberg
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`Joshua.Goldberg@finnegan.com
`
`
`Respectfully submitted,
`
`
`
` /Deborah Yellin/
`Deborah H. Yellin
`Reg. No. 45,904
`CROWELL & MORING LLP
`Intellectual Property Group
`P.O. Box 14300
`Washington, DC 20044-4300
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