UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC.,
`Petitioners
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`v.
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`JANSSEN ONCOLOGY, INC.,
`Patent Owner
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`Inter Partes Review No. IPR2016-01332
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`U.S. Patent No. 8,822,438
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`MOTION FOR JOINDER PURSUANT TO
`35 U.S.C. § 315(c) AND 37 C.F.R. § 42.122(b)
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC.,
`Petitioners
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`v.
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`JANSSEN ONCOLOGY, INC.,
`Patent Owner
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`Inter Partes Review No. IPR2016-01332
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`U.S. Patent No. 8,822,438
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`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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`I.
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`II.
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`STATEMENT OF THE PRECISE RELIEF REQUESTED .......................... 1
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`STATEMENT OF MATERIAL FACTS ........................................................ 1
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`III. STATEMENT OF REASONS FOR RELIEF REQUESTED ........................ 3
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`B.
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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 ........................................................................................ 4
`Joinder will promote efficiency by consolidating issues, avoiding
`duplicate efforts, and preventing inconsistencies ................................. 6
`Joinder will not prejudice Patent Owners or Amerigen ........................ 6
`C.
`IV. CONCLUSION ................................................................................................ 7
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`i
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`TABLE OF AUTHORITIES
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`CASES
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`Amerigen Pharm. Ltd. v. Janssen Oncology, Inc.,
`Case IPR2016-00286 ................................................................................ 1, 2, 3, 6
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`Dell, Inc. v. Network-1 Security Solns., Inc.,
`Case IPR2013-00385 ........................................................................................ 3, 5
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`Motorola Mobility LLC v. SoftView LLC,
`Case IPR2013-00256 ............................................................................................ 5
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`STATUTES
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`35 U.S.C. § 315(c) ................................................................................................. 1, 3
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`35 U.S.C. § 316(a)(1) ................................................................................................. 6
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`35 U.S.C. § 316(a)(11) ............................................................................................... 4
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`OTHER AUTHORITIES
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`37 C.F.R. § 42.22 ....................................................................................................... 1
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`37 C.F.R. § 42.100(c) ............................................................................................. 4, 6
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`37 C.F.R. § 42.122(b) ................................................................................................ 1
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`U.S. Patent 8,822,438 .................................................................................... 1, 2, 6, 7
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`ii
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`I.
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`STATEMENT OF THE PRECISE RELIEF REQUESTED
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`Petitioners Mylan Pharmaceuticals Inc. (“Mylan,” or “Petitioner”)
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`respectfully request 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 (hereinafter “Mylan IPR”)
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`with the pending inter partes review concerning the same patent and the same
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`grounds of invalidity in Amerigen Pharmaceuticals Limited v. Janssen Oncology,
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`Inc., Case No. IPR2016-00286 (“Amerigen IPR”), which was instituted on May
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`31, 2016. Joinder is appropriate because it will promote efficient and consistent
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`resolution of the validity of a single patent and will not prejudice any of the parties
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`to the Amerigen 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 May 31, 2016, the date on which the Board
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`instituted the Amerigen IPR.
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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. 8,822,438(“the ’438 patent”), which is the
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`subject of both the Amerigen IPR and the Mylan IPR. The following litigations or
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`inter partes reviews relate to the ’438 patent are pending:
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`Amerigen Pharms. Ltd. v. Janssen Oncology, Inc., IPR2016-00286
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`(P.T.A.B.);
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`1
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`Argentum Pharms. LLC v. Janssen Oncology, Inc., IPR2016-01317
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`(P.T.A.B.);
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`BTG Int’l Ltd. v. Actavis Labs. FL, Inc., No. 15-cv-5909-KM-JBC
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`(D.N.J.);
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`BTG Int’l Ltd. v. Amerigen Pharms., Inc., No. 16-cv-02449-KM-JBC
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`(D.N.J.);
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`Janssen Biotech, Inc. v. Mylan Pharms. Inc., No. 15-cv-00130-IMK
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`(N.D.W. Va.); and
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`BTG Int’l Ltd. v. Glenmark Pharms. Inc., USA, No. 16-cv-03743-KM-
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`JBC (D.N.J.).
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`2.
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`Amerigen Pharmaceuticals Limited (“Amerigen”) filed its petition for
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`inter partes review of the ’438 patent on December 4, 2015. IPR2016-00286,
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`Paper 1.
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`3.
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`The Amerigen IPR included the following two grounds for
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`challenging the validity of the ’438 patent:
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`Ground 1: Claims 1-20 were unpatentable as obvious over O’Donnell in
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`view of Gerber; and
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`Ground 2: Claims 1-4 and 6-11 were unpatentable as obvious over U.S.
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`Patent No. 5,604,213 in view of Gerber.
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`See IPR2016-00286, Paper 1.
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`2
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`4.
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`The Board instituted the Amerigen IPR on May 31, 2016, on both
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`grounds. See IPR2016-00286, Paper 14.
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`5.
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`The Petition filed in the present Mylan IPR includes only the two
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`grounds on which the Amerigen IPR was instituted.
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`6.
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`The grounds proposed in the present Mylan IPR are, therefore, the
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`same grounds of invalidity on which the Board instituted the Amerigen IPR.
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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 Solns., Inc.,
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`3
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`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 Mylan IPR with the Amerigen 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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`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
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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. 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 Mylan IPR
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`contains the identical grounds on which the Amerigen IPR was instituted.
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`In addition, Mylan 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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`4
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`or the volume of materials to be submitted to the Board. Given that both of the
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`petitioners—Mylan and Amerigen— will be addressing the identical grounds for
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`challenging the claims at issue, the Board may adopt procedures similar to those
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`adopted in Dell, Inc. v. Network-1 Security Solns., Inc., IPR2013-00385 and
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`Motorola Mobility LLC v. SoftView LLC, IPR2013-00256. In those cases, the
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`Board ordered the petitioners to file consolidated filings, for which the first
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`petitioner was responsible, and allowed the new petitioner to file seven additional
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`pages with corresponding additional responsive pages allowed to the Patent
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`Owner. IPR2013-00385, Paper 17 at 8; IPR2013-00256, Paper 10 at 8-9. This
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`procedure would minimize any complication or delay caused by joinder, as the
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`Board recognized in those cases. As in Cases IPR2013-00385 and IPR2013-
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`00256, the Petitioners in this case can work together to manage the questioning at
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`depositions and presentations at the hearing to avoid redundancy. IPR2013-00385,
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`Paper 17 at 9; IPR2013-00256, Paper 10 at 9-10. Additionally, while the Petitioner
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`in the Mylan IPR and the Petitioner in the Amerigen IPR have relied upon
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`testimony from separate experts in their respective petitions, the conclusions and
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`underlying reasoning of the experts are congruent, and therefore present no
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`additional burden on the part of the Patent Owners to address.
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`5
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`B.
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`Joinder will promote efficiency by consolidating issues, avoiding
`duplicate efforts, and preventing inconsistencies
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`It is noted that Mylan would not be time barred from filing the present
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`Petition without a corresponding motion for joinder. However, determining the
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`same validity questions concerning the ’438 patent in separate concurrent
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`proceedings would duplicate efforts, and create a risk of inconsistent results and
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`piecemeal review. Proceeding with a consolidated inter partes review would avoid
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`inefficiency and potential inconsistency and would result in a final written decision
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`without any delay.
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`C.
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`Joinder will not prejudice Patent Owners or Amerigen
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`Permitting joinder will not prejudice the Patent Owner or Amerigen. As
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`noted above, the proposed grounds for instituting inter partes review in the Mylan
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`IPR are identical to the ones on which the Amerigen IPR was instituted.
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`Moreover, joinder will not affect the timing of the Amerigen IPR, and any
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`extension to the schedule that may be required is permitted by law and the
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`applicable rules. 35 U.S.C. § 316(a)(1); 37 C.F.R. § 42.100(c). In fact, joinder is
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`likely more convenient and efficient for the Patent Owners by providing a single
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`trial on the ’438 patent. By allowing all grounds of invalidity to be addressed in a
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`single proceeding, the interests of all parties and the Board will be well served.
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`6
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`IV. CONCLUSION
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`For the foregoing reasons, Mylan respectfully requests that its Petition for
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`inter partes review of U.S. Patent No. 8,822,438 be instituted and that the
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`proceeding be joined with Amerigen Pharmaceuticals Limited v. Janssen
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`Oncology, Inc., Case No. IPR2016-00286.
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`June 30, 2016
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`Respectfully submitted,
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`/Brandon M. White/
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`Brandon M. White, Esq.
`Reg. No. 52,354
`Perkins Coie LLP
`700 Thirteenth Street, N.W.
`Suite 600
`Washington, DC 20005-3960
`bmwhite@perkinscoie.com
`Tel: 202-654-6206
`Fax: 202-654-9681
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`Counsel for Petitioner
`Mylan Pharmaceuticals Inc.
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`7
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e), I certify that I caused to be served a true and
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`correct copy of the foregoing: MOTION FOR JOINDER PURSUANT TO 35
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`U.S.C. § 315(c) AND 37 C.F.R. § 42.122(b) by Federal Express Next Business
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`Day Delivery on this day on the Patent Owner’s correspondence address of record
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`for the subject patent as follows:
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`Janssen Oncology, Inc.
`10990 Wilshire Blvd., Suite 1200
`Los Angeles, CA 90024
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`Johnson & Johnson,
`Attn: Joseph F. Shirtz
`One Johnson & Johnson Plaza
`New Brunswick, NJ 08933-7003
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`and by email to the service addresses for Patent Owner listed in Paper No. 13 in
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`IPR2016-00286:
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`JANS-ZYTIGA@akingump.com and
`ZytigaIPRTeam@sidley.com
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`Dated: June 30, 2016
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`/Brandon M. White/
`Brandon M. White
`Reg. No. 52,354
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`
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`Counsel for Petitioner Mylan Pharmaceuticals Inc.
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