Filed on behalf of: Par Pharmaceutical, Inc.
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`Entered: June 30, 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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`Before PATRICK E. BAKER, Trial Paralegal
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`PETITIONER’S REPLY BRIEF IN SUPPORT OF ITS MOTION FOR
`JOINDER PURSUANT TO 37 C.F.R. § 42.122(B)
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`Entered: June 30, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________
`
`PAR PHARMACEUTICAL, INC.
`Petitioner
`
`v.
`
`NOVARTIS AG
`Patent Owner
`_______________________
`
`Case IPR2016-01059
`U.S. Patent No. 5,665,772
`_______________________
`
`
`Before PATRICK E. BAKER, Trial Paralegal
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`PETITIONER’S REPLY BRIEF IN SUPPORT OF ITS MOTION FOR
`JOINDER PURSUANT TO 37 C.F.R. § 42.122(B)
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`Case IPR2016-01059
`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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`Par Does Not Seek a Second Bite Of The Apple ............................................ 1
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`Par Did Not Seek Nor Obtain A Strategic Advantage .................................... 3
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`III. Claim 7 Is Patentably Indistinct From The Instituted Claims ......................... 4
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`IV.
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`Joinder Will Not Unreasonably Expand The Instituted Proceedings .............. 5
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`V.
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`Conclusion ....................................................................................................... 5
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`Case IPR2016-01059
`U.S. Patent No. 5,665,772
`TABLE OF AUTHORITIES
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`CASES
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`Page(s)
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`Medtronic, Inc. v. Norred,
`No. IPR2014-00823, Paper 12 (P.T.A.B. Dec. 8, 2014) ......................................... 2
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`Micro Motion, Inc. v. Invensys Sys., Inc.,
`No. IPR2014-01409, Paper 14 (P.T.A.B. Feb. 18, 2015) ....................................... 2
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`Reloaded Games, Inc. v. Parallel Networks LLC,
`No. IPR2014-00950, Paper 12 (P.T.A.B. Oct. 22, 2014) ....................................... 2
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`Samsung Elecs. Co. v. Affinity Labs of Tx., Ltd.,
`No. IPR2015-00820, Paper 12 (P.T.A.B. May 15, 2015) ....................................... 2
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`Samsung Elecs. Co. v. Va. Innovation Scis.,
`No. IPR2014-00557, Paper 10 (P.T.A.B. June 13, 2014) ....................................... 2
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`Zhongshan Broad Ocean Motor Co. v. Nidec Motor Corp.,
`No. IPR2015-00762, Paper 16 (P.T.A.B. Oct. 5, 2015) ......................................... 1
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`ii
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`Case IPR2016-01059
`U.S. Patent No. 5,665,772
`The facts of this case justify joinder. As is evident from the calls with the
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`Board, Petitioner Par has agreed (and will agree) to any reasonable request to
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`accommodate joinder and regrets its inadvertent omission of claim 7. For its part,
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`Patent Owner Novartis steadfastly opposes joining claim 7, going so far as to
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`accuse Par of making a strategic decision to omit claim 7—which is asserted in the
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`district court litigation—in order to somehow abuse the IPR procedure to its
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`advantage. In fact, it is Novartis that seeks to leverage the situation to its strategic
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`advantage and avoid consideration of its patentably-indistinct composition claim in
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`the same proceedings as its compound and method of treatment claims.
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`I.
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`PAR DOES NOT SEEK A SECOND BITE OF THE APPLE
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`Novartis first argues that joinder should be denied because Par is seeking a
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`“second bite of the apple.” (Opp. 4-9.) Not so. This is not a situation where Par
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`has added substantive arguments to try and remedy substantive shortcomings in
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`the -00084 petition. Rather, Par seeks to join the inadvertently omitted claim 7.
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`Contrary to Novartis’s allegations, Par is not attempting to cure a
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`“deficiency on the merits” because Par is not a “seek[ing] to introduce additional
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`grounds based on additional prior art through a second petition.” Zhongshan
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`Broad Ocean Motor Co. v. Nidec Motor Corp., No. IPR2015-00762, Paper 16 at 8
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`(P.T.A.B. Oct. 5, 2015) (emphases added). Par relies on the same grounds and the
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`same prior art that are already instituted for claims 8 and 9. Par does not seek to
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`Case IPR2016-01059
`U.S. Patent No. 5,665,772
`cure a “deficiency” but rather to include “similar sets of claimed subject matter and
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`prior art” so that the Board can arrive at a consistent result for the ’772 patent and
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`resolve the entire dispute between the parties. Samsung Elecs. Co. v. Va.
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`Innovation Scis., No. IPR2014-00557, Paper 10 at 18 (P.T.A.B. June 13, 2014).
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`None of Novartis’s cited cases presents facts as found here. (Opp. 7-8, 11-
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`12.) In Micro Motion and Reloaded Games, the petitioners sought to add new
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`grounds and/or references to challenge claims the Board previously declined to
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`institute, using the institution decision as a guide to remedy deficiencies in the
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`earlier filed petition. Micro Motion, Inc. v. Invensys Sys., Inc., No. IPR2014-
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`01409, Paper 14 at 14 (P.T.A.B. Feb. 18, 2015); Reloaded Games, Inc. v. Parallel
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`Networks LLC, No. IPR2014-00950, Paper 12 at 4-5 (P.T.A.B. Oct. 22, 2014). In
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`Samsung Elecs. Co. v. Affinity Labs of Tx., Ltd., challenges to the claims in the new
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`petition were already under review in multiple proceedings, and the Board found
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`that the additional burden, costs, and use of judicial resources was not justified.
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`No. IPR2015-00820, Paper 12 at 2, 5 (P.T.A.B. May 15, 2015). And in Medtronic,
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`Inc. v. Norred, the Board denied joinder because the petitioner sought review of
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`the decision denying institution through joinder rather than rehearing. No.
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`IPR2014-00823, Paper 12 at 5 (P.T.A.B. Dec. 8, 2014). Here, Par does not present
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`any arguments for claim 7 that were previously rejected by the Board.
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`2
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`Case IPR2016-01059
`U.S. Patent No. 5,665,772
`II.
`PAR DID NOT SEEK NOR OBTAIN A STRATEGIC ADVANTAGE
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`Novartis next argues that separating claim 7 from the -00084 petition
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`somehow provided Par a strategic advantage. (Opp. 9-11.) Novartis’s reasoning—
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`that the obviousness grounds for claim 7 are somehow in tension with those for the
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`compound claims (claims 1-3 and 10) and the treatment claims (claims 8-9)—is
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`incorrect and inaccurately characterizes both the claims and Par’s petitions.
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`Novartis’s scurrilous implication that Par’s counsel was dishonest to the
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`Board in stating that the omission of claim 7 was inadvertent is unfounded, and
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`even Novartis admits that it was “surprise[d]” by the omission. (Opp. 1, 4, 7, 10.)
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`Par can think of no strategic reason to seek review of claims 1-3 and 8-10, wait to
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`file a second petition on claim 7 based on the same references and grounds, and
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`request the Board grant joinder. Novartis’s attempt to articulate any reason fails.
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`Further, whether claim 7 is obvious for the same reasons as the instituted
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`claims goes to the merits and should be decided based on the -01059 petition and
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`preliminary response.1 But Novartis unfairly uses its opposition as a second
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`preliminary response. (Opp. 10.) Novartis’s argument is confusing and ignores
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`instituted claims 8 and 9, which require administering the compound of claim 1.
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`Specifically, Par demonstrated in the -00084 petition that claims 8 and 9
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`1 Novartis has done the same in its oppositions to Breckenridge’s and Roxane’s
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`motions for joinder. (Nos. IPR2016-01102, IPR2016-01103.)
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`3
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`Case IPR2016-01059
`U.S. Patent No. 5,665,772
`would have been obvious. Were there any contradictions in Par’s (successful)
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`arguments for instituting review of compound claim 1 and method claims 8 and 9,
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`Novartis could have pointed them out in its preliminary response. It did not.
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`Instead, Novartis argued that a POSA would not have been motivated to
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`chemically modify rapamycin but instead to create pharmaceutical compositions to
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`improve its solubility. (Prelim. Resp. 20-21.) That argument was correctly
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`rejected by the Board. Now, in opposing joinder, Novartis appears to argue that
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`claim 7—because it recites a pharmaceutical composition—contradicts Par’s
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`evidence that a POSA would modify rapamycin to, inter alia, improve solubility.
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`Novartis appears to conflate specific pharmaceutical compositions that increase
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`solubility of a compound—an argument it already made to the Board—with the
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`pharmaceutical compositions recited in claim 7, which require only an unspecified
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`pharmaceutically acceptable carrier with no indication of any impact on solubility.
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`Regardless of its possible merits, Novartis will have the opportunity to present any
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`such argument to the Board in its preliminary response.
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`III. CLAIM 7 IS PATENTABLY INDISTINCT FROM THE INSTITUTED
`CLAIMS
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`In its petition, Par identified Federal Circuit precedent holding that
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`formulation claims are patentably indistinct from claims to the underlying
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`compounds and claims to methods of treatment using the compound. (E.g., Pet. 2-
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`3.) Novartis’s efforts to distinguish those cases fail. As explained in § II, a POSA
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`U.S. Patent No. 5,665,772
`would understand to use a pharmaceutical composition of everolimus comprising a
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`pharmaceutically acceptable carrier to administer everolimus. Therefore, claim 7
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`rises and falls with the instituted claims.
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`IV. JOINDER WILL NOT UNREASONABLY EXPAND THE
`INSTITUTED PROCEEDINGS
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`Given Par’s inadvertent error in omitting claim 7 from the -00084 petition, it
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`has strived to be flexible and will continue to be accommodating throughout the
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`joinder process. And to be clear, Par never argued that Novartis was not entitled to
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`submit a preliminary response to the -01059 petition or to depose Par’s expert, as
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`Novartis alleges. (Opp. 11-12.) Par merely stated that, because the instituted
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`claims are already before the Board, any arguably new subject matter in the -01059
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`petition is limited to the additional feature in claim 7—the pharmaceutically
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`acceptable carrier, which would have been obvious to use when administering
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`according to claims 8 and 9. And because the declaration is entirely the same
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`between the two petitions, Par does not believe that two depositions are required.
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`V. CONCLUSION
`Par respectfully asks the Board to join this proceeding with IPR2016-00084
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`for the reasons in its motion for joinder as further explained above.
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`Dated: June 30, 2016
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`Respectfully submitted,
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`/Daniel G. Brown/
`By:
`Daniel G. Brown (Reg. No. 54,005)
`Counsel for Petitioner
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`5
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`Case IPR2016-01059
`U.S. Patent No. 5,665,772
`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e), I certify that on this 30th day of June, 2016,
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`a true and correct copy of the foregoing PETITIONER’S REPLY IN SUPPORT
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`OF ITS MOTION FOR JOINDER PURSUANT TO 37 C.F.R. § 42.122(B)
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`was served by electronic mail on Patent Owner’s lead and backup counsel at the
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`following email address:
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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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`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)
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`Counsel for Petitioner
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