Filed on behalf of: Par Pharmaceutical, Inc.
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`Entered: May 17, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________
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`PAR PHARMACEUTICAL, INC.
`Petitioner
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`v.
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`NOVARTIS AG
`Patent Owner
`_______________________
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`Case IPR2016-01059
`U.S. Patent No. 5,665,772
`_______________________
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`PETITIONER’S MOTION FOR JOINDER
`PURSUANT TO 37 C.F.R. § 42.122(B)
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`Entered: May 17, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________
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`PAR PHARMACEUTICAL, INC.
`Petitioner
`
`v.
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`NOVARTIS AG
`Patent Owner
`_______________________
`
`Case IPR2016-01059
`U.S. Patent No. 5,665,772
`_______________________
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`PETITIONER’S MOTION FOR JOINDER
`PURSUANT TO 37 C.F.R. § 42.122(B)
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`Case IPR2015-01059
`U.S. Patent No. 5,665,772
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`TABLE OF CONTENTS
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`I.
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`II.
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`Introduction ...................................................................................................... 1
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`Relief Requested .............................................................................................. 3
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`III. Material Facts .................................................................................................. 3
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`IV.
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`Joinder Is Appropriate in this Case ................................................................. 5
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`A. Governing Law ...................................................................................... 5
`B.
`Dependent Claim 7 Is Unpatentable on the Same Grounds as
`Claims 1, 8, and 9 .................................................................................. 7
`Joinder Will Resolve the Disputes Between the Parties,
`Benefitting the Public Interest Without Prejudicing Novartis .............. 9
`Joinder Will Not Impact the Oral Argument Date Already Set
`for IPR2016-00084 .............................................................................. 12
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`D.
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`C.
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`V.
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`Conclusion ..................................................................................................... 15
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`TABLE OF AUTHORITIES
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`CASES
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`Page(s)
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`Aventis Pharma Deutschland GmbH v. Lupin, Ltd.,
`499 F.3d 1293 (Fed. Cir. 2007) .................................................................... 1, 8, 10
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`Geneva Pharm., Inc. v. Glaxosmithkline PLC,
`189 F. Supp. 2d 377 (E. D. Va. 2002),
`aff’d 349 F.3d 1373 (Fed. Cir. 2003) ............................................................... 9, 10
`
`In re Metoprolol Succinate Patent Litig.,
`494 F.3d 1011 (Fed. Cir. 2007) ............................................................................. 11
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`STATUTES
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`35 U.S.C. § 315(b) ..................................................................................................... 6
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`35 U.S.C. § 315(c) .................................................................................................3, 5
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`35 U.S.C. § 316(b) ................................................................................................... 11
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`P.T.A.B. DECISIONS
`Ariosa Diagnostics, Inc. v. Isis Innovation Ltd.,
`No. IPR2013-00250 (P.T.A.B. Sept. 3, 2013), Paper 24 ....................................6, 7
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`Dell Inc. v. Network-1 Sec. Sols., Inc.,
`No. IPR2013-00385 (P.T.A.B. July 29, 2013), Paper 17 ....................................... 5
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`Enzymotec Ltd. v. Neptune Tech. & Biores., Inc.,
`No. IPR2014-00556 (P.T.A.B. July 9, 2014), Paper 19 .................................. 7, 14
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`Kyocera Corp. v. Softview LLC,
`No. IPR2013-00004 (P.T.A.B. Apr. 24, 2013), Paper 15 ....................................... 6
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`Par Pharm., Inc. v. Novartis AG,
`No. IPR2016-00084 (P.T.A.B. Apr. 29, 2016), Paper 8 .....................................3, 9
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`Samsung Elecs. Co. v. Va. Innovation Scis., Inc.,
`No. IPR2014-00557 (P.T.A.B. June 13, 2014), Paper 10 ............................. passim
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`Target Corp. v. Destination Maternity Corp.,
`No. IPR2014-00508 (P.T.A.B. Feb. 12, 2015), Paper 28 ....................................... 6
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`Zhongshan Broad Ocean Motor Co. v. Nidec Motor Corp.,
`No. IPR2015-00762 (P.T.A.B. Oct. 5, 2015), Paper 16 ................................ 11, 12
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`REGULATIONS
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`37 C.F.R. § 42.1(b) ............................................................................................. 2, 11
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`37 C.F.R. § 42.122(b) ....................................................................................... 3, 5, 6
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`37 C.F.R. § 42.22 ....................................................................................................... 3
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`37 C.F.R. § 42.5(c)(1) .............................................................................................. 13
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`37 C.F.R. § 42.53(d)(5) .............................................................................................. 2
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`Petitioner Par Pharmaceutical, Inc. (“Par”) respectfully requests joinder of
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`the petition for inter partes review of claim 7 of U.S. Patent No. 5,665,772
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`(“the ’772 Patent”), filed concurrently with this motion, with the instituted inter
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`partes review in Par Pharmaceutical, Inc. v. Novartis AG, No. IPR2016-00084.
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`I.
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`INTRODUCTION
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`In instituting the -00084 proceeding, the Board already found that Par has
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`demonstrated a reasonable likelihood of proving claims 1, 8, and 9 obvious.
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`Independent claim 1 recites a genus of rapamycin derivatives. Claims 8 and 9
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`recite methods of using those rapamycin derivatives for therapeutic effect.
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`Par now seeks to join dependent claim 7, which recites a composition
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`comprising a compound of claim 1 and a pharmaceutically acceptable carrier.
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`When the prior art describes using a class of compounds with pharmaceutical
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`excipients—as it does here—the validity of pharmaceutical composition claims, as
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`claimed in claim 7, “rise[s] or fall[s] with the validity of” the compound claim.
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`Aventis Pharma Deutschland GmbH v. Lupin, Ltd., 499 F.3d 1293, 1303 (Fed. Cir.
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`2007) (finding a dependent pharmaceutical composition claim obvious because the
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`independent compound claim was obvious and the prior art taught using ACE
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`inhibitors with pharmaceutical excipients). The prior art explicitly taught using
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`therapeutic amounts of rapamycin and its derivatives with pharmaceutically
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`acceptable carriers. Thus, dependent claim 7 is unpatentable over the exact same
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`1
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`prior art and evidence as already-instituted claims 1, 8, and 9. To be clear, Par has
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`re-filed the same references, expert declaration, and other evidence that the Board
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`has already found show a reasonable likelihood that Par will prevail with respect to
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`independent claim 1 and dependent claims 8 and 9.
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`Because there are no substantive differences between the instituted claims
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`and claim 7 and Par relies on the exact same art and evidence, joinder will not
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`disrupt the schedule for -00084 proceeding, thus ensuring “the just, speedy, and
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`inexpensive resolution” of both proceedings. 37 C.F.R. § 42.1(b). First, the
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`briefing schedule in this proceeding may be accelerated to minimize or eliminate
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`any impact on the -00084 proceeding. Novartis’s Preliminary Response in the -
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`00084 proceeding already addressed the substantive issues raised in this joinder
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`petition. Even if Novartis is given an entire month to draft its Preliminary
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`Response addressing the patentably indistinct differences between the instituted
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`claims and claim 7, an institution decision should issue no later than mid-
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`September, well before the October 31, 2016, Due Date 2 in the -00084
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`proceeding. This would allow the proceeding to be synchronized no later than
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`Par’s reply brief.
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`Further, because cross-examination is limited to the scope of the expert
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`declaration, 37 C.F.R. § 42.53(d)(5), the current petition does not add any
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`additional discovery because it uses the exact same expert declaration as the
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`instituted petition. Novartis may cross-examine Par’s expert on the entire scope of
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`his testimony in a single deposition, which could be taken before the Board
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`institutes this proceeding.
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`Because the current petition offers no new substantive arguments, evidence,
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`references, or testimony, does not disrupt the schedule for the instituted
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`proceedings, and does not add additional discovery, joinder of this petition with the
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`instituted petition is appropriate.
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`II. RELIEF REQUESTED
`Pursuant to 35 U.S.C. § 315(c) and 37 C.F.R. § 42.122(b), Par respectfully
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`requests joinder of the petition for inter partes review of claim 7 of the ’772 Patent
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`filed concurrently with this motion, with the instituted inter partes review in Par
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`Pharmaceutical, Inc. v. Novartis AG, No. IPR2016-00084.
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`This motion is timely under 37 C.F.R. §§ 42.22 and 42.122(b) because it is
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`well within one month of the Board’s decision instituting review of claims 1-3 and
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`8-10 of the ’772 Patent. Par Pharm., Inc. v. Novartis AG, No. IPR2016-00084
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`(P.T.A.B. Apr. 29, 2016), Paper 8.
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`III. MATERIAL FACTS
`1.
`On October 26, 2015, Par filed a Petition for inter partes review
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`requesting review of claims 1-3 and 8-10 of the ’772 Patent.
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`2.
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`On April 29, 2016, the Board instituted trial on claims 1-3 and 8-10 in
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`IPR2016-00084.
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`3.
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`On May 17, 2016, Par filed this motion and its petition seeking inter
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`partes review of claim 7, which depends directly from claim 1. The instant petition
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`presents the same grounds—the exact same prior art, expert testimony, and other
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`evidence—relied on by the Board in instituting review of claims 1, 8, and 9 in
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`IPR2016-00084.
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`4.
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`Specifically,
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`the
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`instant petition demonstrates
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`that
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`the same
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`combination of Morris (Ex. 1005), Van Duyne (Ex. 1006), Rossmann (Ex. 1024),
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`Yalkowsky (Ex. 1007), Lemke (Ex. 1008), and Hughes (Ex. 1009) that renders
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`claims 8 and 9 obvious renders claim 7 obvious.
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`5.
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`Claim 7 of the ’772 Patent is directed to a pharmaceutical composition
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`comprising a therapeutically effective amount of a compound of claim 1 and a
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`pharmaceutically acceptable carrier. Claim 8 is directed to a method of
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`administering an immunosuppressant effective amount of a compound of claim 1
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`to induce an immunosuppressant effect. Claim 9 is similar to claim 8 but is
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`directed to a method of preventing allograft rejection.
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`6.
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`Novartis has asserted that Par will infringe claim 7 of the ’772 Patent
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`in the pending litigations captioned Novartis AG v. Par Pharmaceutical, Inc., Nos.
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`1:14-cv-1289-RGA (D. Del.), 1:14-cv-1494-RGA (D. Del.), 1:15-cv-78-RGA (D.
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`Del.), 1:15-cv-475-RGA (D. Del.). For this reason, Par seeks to join claim 7 to the
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`-00084 instituted petition to resolve its disputes with Novartis regarding the ’772
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`Patent.
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`IV. JOINDER IS APPROPRIATE IN THIS CASE
`Joinder is appropriate because (1) the references, expert declaration, and
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`arguments in the current petition are essentially identical to those in the -00084
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`instituted petition; (2) there is little burden to Novartis and any minimal burden is
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`far outweighed by the public interest and efficiency of resolving the disputes
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`between the Parties concerning the ’772 Patent; and (3) joinder of the current
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`petition with the -00084 instituted petition will not impact the schedule of
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`the -00084 proceeding.
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`A. Governing Law
`Joinder of inter partes review proceedings is permitted up to one month after
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`the institution decision. 35 U.S.C. § 315(c); 37 C.F.R. § 42.122(b). In deciding
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`whether to allow joinder, the Board takes into account “the particular facts of each
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`case, substantive and procedural issues, and other considerations,” while remaining
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`“mindful that patent trial regulations, including the rules for joinder, must be
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`construed to secure the just, speedy, and inexpensive resolution of every
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`proceeding.” See Dell Inc. v. Network-1 Sec. Sols., Inc., No. IPR2013-00385
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`(P.T.A.B. July 29, 2013), Paper 17 at 3.
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`Joinder allows a petitioner to join new issues to an existing proceeding even
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`if the petitioner was served with a complaint alleging infringement of the patent
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`over one year ago. 35 U.S.C. § 315(b) (the time limit “shall not apply” to a request
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`for joinder); 37 C.F.R. § 42.122(b) (same); Ariosa Diagnostics, Inc. v. Isis
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`Innovation Ltd., No. IPR2013-00250 (P.T.A.B. Sept. 3, 2013), Paper 24 (joining
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`dependent claims to a proceeding); see also Target Corp. v. Destination Maternity
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`Corp., No. IPR2014-00508 (P.T.A.B. Feb. 12, 2015), Paper 28 (seven-judge panel
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`joining a new ground with new prior art); Samsung Elecs. Co. v. Va. Innovation
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`Scis., Inc., No. IPR2014-00557 (P.T.A.B. June 13, 2014), Paper 10 (joining
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`additional claims).
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`A motion for joinder should (1) provide the reasons why joinder is
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`appropriate; (2) identify any new grounds of unpatentability being raised in the
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`subsequent petition; (3) explain what impact (if any) there will be on the trial
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`schedule for the existing review; and (4) address how briefing and/or discovery
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`may be simplified to minimize schedule impact. Kyocera Corp. v. Softview LLC,
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`No. IPR2013-00004 (P.T.A.B. Apr. 24, 2013), Paper 15 at 4.
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`Joinder is justified when, as here, the second petition involves the same
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`parties, the same patent, the same references, the same expert declaration, and
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`essentially identical patent scope as the instituted petition. “[T]he possibility of
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`broadening the scope of issues” is not “an adequate reason for denying joinder”
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`particularly where the joined petition “is based on the prior art already of record”
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`and “the impact of joinder on the previous proceeding will be minimal from both a
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`procedural and substantive view point.” Enzymotec Ltd. v. Neptune Tech. &
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`Biores., Inc., No. IPR2014-00556 (P.T.A.B. July 9, 2014), Paper 19 at 5.
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`B. Dependent Claim 7 Is Unpatentable on the Same Grounds as
`Claims 1, 8, and 9
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`Joinder
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`is appropriate here because, as Par demonstrates
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`in
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`the
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`accompanying petition, dependent claim 7 is unpatentable using the same prior art,
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`expert declaration, and other submitted evidence already considered with respect to
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`the instituted claims 1, 8, and 9.
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`For example, the Board held joinder is appropriate to add challenges to
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`claims that are dependent on claims under review in the instituted petition, even
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`when citing additional prior art to address the limitations of the dependent claims.
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`Ariosa, No. IPR2013-00250, Paper 25 at 2-3 (adding new dependent claims and a
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`new ground of invalidity for dependent claim 9); see also Enzymotec, No.
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`IPR2014-00556, Paper 19 at 5-6 (allowing joinder of additional claims in part
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`because the grounds were based on prior art already of record). Here, the case for
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`joinder is even stronger than in Ariosa or Enzymotec because no new art,
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`testimony, or other evidence is required to assess the patentability of claim 7.
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`The Board held joinder is appropriate to allow challenges to claims
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`originally denied institution even where the new grounds use the same art in a new
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`7
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`combination. Samsung, No. IPR2014-00557, Paper 10 at 14-18 (granting
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`institution of claims 58 and 63, which were denied institution in the original
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`petition (Paper 3 at 2, 17)). Thus, even in the face of allowing a petitioner to
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`reargue the unpatentability of non-instituted claims, the Board joined a petition to
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`add dependent claims that added minimal new subject matter described in a prior
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`art reference already of record. Id. at 17. The case for joinder is stronger here
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`because Par relies on the same combination already applied against instituted
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`claims 8 and 9, and the Board has not already addressed and declined institution on
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`claim 7. In these circumstances, joinder is appropriate.
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`Joinder is more justified here than in Ariosa, Enzymotec, or Samsung. The
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`unpatentability of claim 7 is precisely the same as for the instituted claims 1, 8, and
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`9. Claim 7 recites pharmaceutical compositions comprising a compound of claim
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`1, and the validity of this claim “rise[s] or fall[s] with the validity of” the
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`compound claim. Aventis, 499 F.3d at 1303 (finding a dependent pharmaceutical
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`composition claim obvious because the independent compound claim was obvious
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`and the prior art disclosed combining ACE inhibitors with pharmaceutical
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`excipients). Indeed, the specification of the ’772 Patent acknowledges that the
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`compounds can be administered via any “conventional” route, including standard
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`compositions and carriers in tablets, capsules, solutions, and suspensions. (Ex.
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`1001, ’772 Patent at 5:4-8.)
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`8
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`Further, claims
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`to a pharmaceutical composition comprising a
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`therapeutically effective amount of a compound
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`in combination with a
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`pharmaceutical carrier are not patentably distinct from claims to methods of
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`administering that compound in an amount to effect its therapeutic purpose.
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`Geneva Pharm., Inc. v. Glaxosmithkline PLC, 189 F. Supp. 2d 377, 384-85 (E. D.
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`Va. 2002), aff’d 349 F.3d 1373 (Fed. Cir. 2003). The patentably indistinct claims
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`analyzed in Geneva mirror claim 7 and claims 8 and 9 nearly exactly. Id. Indeed,
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`the Board’s analysis of claim 8, which requires administering an effective amount
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`of the compound of claim 1 to induce an immunosuppressant effect, essentially
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`acknowledges
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`that
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`the compound would be
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`included
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`in pharmaceutical
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`compositions in “therapeutically effective amounts” with an acceptable carrier. Par
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`Pharm., No. IPR2016-00084, Paper 8 at 15-16. Given this identity of analysis,
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`joinder is appropriate to consider the patentability of claim 7 consistently with
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`claims 1, 8, and 9.
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`C.
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`Joinder Will Resolve the Disputes Between the Parties, Benefit-
`ting the Public Interest Without Prejudicing Novartis
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`Any minimal additional burden to Novartis is vastly outweighed by the
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`interest in resolving the disputes between the parties with respect to the claims of
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`the ’772 Patent and the public’s interest in a consistent analysis of these patentably
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`indistinct claims. Samsung, No. IPR2014-00557, Paper 10 at 18.
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`Because of the identity in references, argument, and expert testimony,
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`Novartis will not be prejudiced by the addition of claim 7 to the instituted -00084
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`proceeding. As discussed above, claim 7 rises and falls with the instituted claims
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`and there is no difference in the art or evidence in this petition. And because there
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`is only one expert declaration, Novartis need only cross-examine Par’s expert in a
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`single deposition. In addressing the instituted claims, Novartis will have already
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`responded to the patentability arguments presented in this new petition. Thus,
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`responding to the instant petition will not require significant effort by Novartis, as
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`Novartis is already aware of the substantive arguments related to the same
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`references and expert testimony.
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`Any additional minimal burden stemming from addressing claim 7 is
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`“strongly outweighed by the public interest in having consistency of outcome
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`concerning similar sets of claimed subject matter and prior art.” Samsung, No.
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`IPR2014-00557, Paper 10 at 18. The public interest in the integrity of the patent
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`system is identical for claim 7 as it is for claims 1, 8, and 9 and warrants its joinder
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`to the instituted petition. Because of the lack of any patentable distinction between
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`claim 7 and claims 1, 8, and 9, Aventis, 499 F.3d at 1303; Geneva, 189 F. Supp. 2d
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`at 384-85, the public would be disadvantaged if claims 1, 8, and 9 were canceled
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`and yet claim 7 remained in force, preventing the public from practicing the
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`canceled claims. Cf. In re Metoprolol Succinate Patent Litig., 494 F.3d 1011,
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`1017-18 (Fed. Cir. 2007). Such a result would undermine an impetus for the inter
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`partes review procedure to ensure the quality and integrity of the patent system.
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`See 35 U.S.C. § 316(b).
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`Additionally, joining claim 7 to the instituted proceedings allows for
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`resolution of the disputes between the Parties concerning the ’772 Patent because
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`Novartis has asserted claim 7 against Par in the related district court litigation.
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`Joinder in this instance meets the stated goal to allow for the “just, speedy, and
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`inexpensive resolution” of the entire dispute. See 37 C.F.R. § 42.1(b).
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`Joinder is appropriate even to add issues and evidence that could have been
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`presented in the original petition. In Ariosa, the Board allowed petitioner to add an
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`additional new ground of invalidity for claim 8 that was not included in the
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`original petition. Ariosa, No. IPR2013-000250, Paper 25 at 2-3, granting Paper 4 at
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`4-5. Further, an expanded five Judge panel granted a motion for joinder to add a
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`ground of unpatentability that was previously denied for failing to include an
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`attesting affidavit with the translation of a reference. Zhongshan Broad Ocean
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`Motor Co. v. Nidec Motor Corp., No. IPR2015-00762 (P.T.A.B. Oct. 5, 2015),
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`Paper 16 at 7-9. In Zhongshan, the Board found that (1) the public interest is better
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`served by considering the merits of the requested ground and (2) the patent owner
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`had been aware of the substantive reference and substantive arguments and thus
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`there was no prejudice to the patent owner that would weigh against joinder. Id. at
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`8. The same reasoning finding joinder appropriate applies in this case. Here, the
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`references and substantive arguments with respect to claim 7 are identical to those
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`presented in the instituted -00084 proceeding. Novartis will not be prejudiced in
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`responding to the ground presented in the instant petition. And, similar to the
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`holding in Zhongshan, considering the merits of the ground of unpatentability in
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`the instant petition will better serve the public interest, particularly in view of the
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`absence of any patentable distinction between claim 7 and the instituted claims. Id.
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`In view of the strong public interest for having consistent outcomes for
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`similar claimed subject matter, the efficiency of resolving the disputes between the
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`Parties on the ’772 Patent, and the minimal burden on Novartis, joinder is
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`particularly appropriate here. Samsung, No. IPR2014-00557, Paper 10 at 18.
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`D.
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`Joinder Will Not Impact the Oral Argument Date Already Set for
`IPR2016-00084
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`Joinder will not delay the proceedings of the instituted petition or otherwise
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`prejudice Novartis in any discernable way. Par acted promptly to file the instant
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`petition concurrently with this motion for joinder well before the thirty-day
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`deadline after the decision instituting the petition in the -00084 proceeding,
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`limiting the impact on the current schedule. Par informed Novartis that this filing
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`was forthcoming and will continue to coordinate with Novartis and the Board to
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`ensure minimal impact to the schedule.
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`The narrow issue presented in the current petition as compared to the
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`instituted petition makes it particularly amenable to accelerated briefing under the
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`Board’s discretionary authority under 37 C.F.R. § 42.5(c)(1). In instituting
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`the -00084 proceeding,
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`the Board has already determined
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`that Par has
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`demonstrated a reasonable likelihood of success in proving claims 1, 8, and 9
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`invalid. Thus, the only issue raised by the instant petition is the additional
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`limitation included in claim 7. Preparing a Preliminary Response limited to claim 7
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`should not present a significant additional burden to Novartis as Novartis is already
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`aware of the substantive arguments from the references and expert declaration. Par
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`proposes that the Preliminary Response be due 30 days from the filing of the
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`current petition, which would allow for an institution decision by mid-September
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`2016.1 As discussed above, determining whether including a compound of claim 1
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`in a pharmaceutical composition is obvious should require no significant additional
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`analysis over that for claims 1, 8, and 9, addressed in the instituted petition, and
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`1 Par reached out last week to Novartis to discuss coordinating the schedule with
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`the instituted proceeding. The parties were unable to schedule a call until later this
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`week. Par did not want to delay filing and will continue its efforts to coordinate
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`with Novartis.
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`U.S. Patent No. 5,665,772
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`Novartis need only take one deposition to cross-examine Par’s expert regarding his
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`single declaration.
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`The schedule for the current petition may be readily coordinated with the
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`schedule in the instituted proceedings. Because of the limited issue presented in the
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`current petition, if instituted, Novartis’s Response related to claim 7 could be filed
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`within a month of the institution decision. Enzymotec, No. IPR2014-00556, Paper
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`19 at 7 (setting deadline for response to the limited additional joined claims a
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`month after institution decision); Samsung, No. IPR2014-00557, Paper 10 at 18
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`(setting deadline for response at three weeks after institution decision for joined
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`petition). Such a schedule would allow for Novartis’s Response to the current
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`petition to be filed before Par’s Reply is due in the -00084 proceeding. See Par
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`Pharm., No. IPR2016-00084, Paper 9 at 6 (setting DUE DATE 2 as October 31,
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`2016). Par would then be able to incorporate a reply to claim 7 with the reply in the
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`-00084 proceeding, harmonizing the remaining dates between the two petitions.
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`As laid out above, no adjustments are necessary to the current schedule in
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`the instituted IPR proceeding and Novartis need only take one deposition of Par’s
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`single expert related to his sole declaration. Because the current petition may be
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`joined to the instituted petition without any additional discovery, without
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`perturbing the current schedule, and with no discernible prejudice to Novartis,
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`joinder is appropriate.
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`14
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`Case IPR2015-01059
`U.S. Patent No. 5,665,772
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`V. CONCLUSION
`For the reasons above and in the accompanying petition, Par respectfully
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`asks the Board to institute this proceeding and join it with IPR2016-00084.
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`Dated: May 17, 2016
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`Respectfully submitted,
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`By:
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`/Daniel G. Brown/
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`Daniel G. Brown (Reg. No. 54,005)
`Latham & Watkins LLP
`885 Third Avenue
`New York, NY 10022-4834
`212-906-1200; 212-751-4864 (Fax)
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`Counsel for Petitioner
`Par Pharmaceutical, Inc.
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`15
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`U.S. Patent No. 5,665,772
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`CERTIFICATE OF SERVICE
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`The undersigned certifies that a complete copy of this PETITIONER’S
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`MOTION FOR JOINDER PURSUANT TO 37 C.F.R. § 42.122(B) was
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`served on Novartis AG’s counsel:
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`Novartis Pharmaceutical Corporation
`Intellectual Property Department
`One Health Plaza 433/2
`East Hanover, NJ 07936-1080
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`Nicholas N. Kallas (Reg. No. 31,530)
`Raymond R. Mandra (Reg. No. 34,382)
`Fitzpatrick, Cella, Harper & Scinto
`1290 Avenue of the Americas
`New York, NY 10104-3800
`ZortressAfinitorIPR@fchs.com
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`via FEDERAL EXPRESS overnight delivery, on May 17, 2016
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`By: /Daniel G. Brown/
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`Daniel G. Brown (Reg. No. 54,005)
`Latham & Watkins LLP
`885 Third Avenue
`New York, NY 10022-4834
`212-906-1200; 212-751-4864 (Fax)
`
`Counsel for Petitioner
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