By: B. Jefferson Boggs, Esq.
`Matthew L. Fedowitz, Esq.
`Daniel R. Evans, Esq.
`MERCHANT & GOULD P.C.
`1900 Duke Street, Suite 600
`Alexandria, VA 22314
`Main Telephone: (703) 684-2500
`Main Facsimile: (703) 684-2501
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`
`BRECKENRIDGE PHARMACEUTICAL, INC.
`Petitioner
`
`
`
`v.
`
`
`
`NOVARTIS AG
`Patent Owner
`
`_____________________
`
`Case No. IPR2016-01103
`Patent No. 5,665,772
`_____________________
`
`
`
`REPLY TO PATENT OWNER NOVARTIS’S OPPOSITION TO
`PETITIONER BRECKENRIDGE’S MOTION FOR JOINDER OF ITS
`PETITION ON CLAIM 7
`
`
`Matthew L. Fedowitz, Esq.
`Daniel R. Evans, Esq.
`MERCHANT & GOULD P.C.
`1900 Duke Street, Suite 600
`Alexandria, VA 22314
`Main Telephone: (703) 684-2500
`Main Facsimile: (703) 684-2501
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`
`BRECKENRIDGE PHARMACEUTICAL, INC.
`Petitioner
`
`
`
`v.
`
`
`
`NOVARTIS AG
`Patent Owner
`
`_____________________
`
`Case No. IPR2016-01103
`Patent No. 5,665,772
`_____________________
`
`
`
`REPLY TO PATENT OWNER NOVARTIS’S OPPOSITION TO
`PETITIONER BRECKENRIDGE’S MOTION FOR JOINDER OF ITS
`PETITION ON CLAIM 7
`
`
`
`
`
`
`I.
`I.
`
`
`TABLE OF CONTENTS
`
`TABLE OF CONTENTS
`
` Breckenridge’s Petition Is Not Time-Barred .................................................... 1
`Breckenridge’s Petition Is Not Time-Barred .................................................. ..l
`
`II. Breckenridge Is Not Seeking or Obtaining a Strategic Advantage .................. 2
`II.
`Breckenridge Is Not Seeking or Obtaining a Strategic Advantage ................ ..2
`
`III. Claim 7 Is Patentably Indistinct ....................................................................... 4
`III. Claim 7 Is Patentably Indistinct ..................................................................... ..4
`
`IV.
`IV.
`
`Joinder Will Not Unreasonably Expand the Instituted Proceedings ................ 5
`Joinder Will Not Unreasonably Expand the Instituted Proceedings .............. ..5
`
`
`
`
`
`i
`
`
`
`
`
`
`STATUTES
`
`STATUTES
`
`TABLE OF AUTHORITIES
`
`TABLE OF AUTHORITIES
`
`35 U.S.C. § 315(b) ..................................................................................................... 1
`35 U.S.C. § 315(b) ................................................................................................... ..1
`
`35 U.S.C. § 315(c) ..................................................................................................... 1
`35 U.S.C. § 315(c) ................................................................................................... ..1
`
`OTHER AUTHORITIES
`
`37 C.F.R. § 42.122(b) ............................................................................................1, 3
`37 C.F.R. § 42.122(b) .......................................................................................... ..1, 3
`
`OTHER AUTHORITIES
`
`
`
`ii
`
`
`
`
`
`Petitioner Breckenridge Pharmaceutical, Inc. has agreed (and will agree) to
`
`any reasonable request to accommodate joinder of its challenge to claim 7.
`
`Novartis steadfastly opposes joining claim 7, going so far as to accuse
`
`Breckenridge of making a strategic decision to delay requesting inter parties
`
`review of claim 7—which is asserted in the district court litigation—in order to
`
`somehow improperly manipulate the IPR procedure and gain an unfair advantage.
`
`Instead, it is Novartis that seeks to leverage the situation to its strategic advantage
`
`and avoid consideration of its patentably-indistinct composition claim in the same
`
`proceeding as its compound and method of treatment claims.
`
`I.
`
`Breckenridge’s Petition Is Not Time-Barred
`
`Despite Novartis’s allegation that Breckenridge’s petition is “time-barred”,
`
`Breckenridge’s petition accompanying its motion for joinder was timely filed. 35
`
`U.S.C. § 315(b) states the one year deadline for filing a petition does not apply to a
`
`request for joinder under § 315(c). Section 315(c) contemplates filing a motion for
`
`joinder in an already instituted IPR. Inter partes review in IPR2016-00084 was not
`
`instituted until April 29, 2016 and Breckenridge filed its petition regarding claim 7
`
`and motion to join on May 26, 2016, which is within one month of the institution
`
`date and in compliance with 37 C.F.R. § 42.122(b). IPR2016-00084, Paper 8;
`
`IPR2016-01103, Papers 1, 4, and 5.
`
`
`
`1
`
`
`
`
`
`
`
`Breckenridge separately filed its petition and motion for joinder of claim 7
`
`from its petition and joinder motion in IPR2016-01023 (claims 1-3 and 8-10) in
`
`order to mirror those petitions currently before the Board that it wished to join.
`
`II. Breckenridge Is Not Seeking or Obtaining a Strategic Advantage
`
`Novartis attempts to misdirect the Board and argue that Breckenridge not
`
`challenging claim 7 prior to institution of the Par IPR somehow provided it with a
`
`strategic advantage. Paper 10 at 7-9. Novartis’s post hoc reasoning—that the
`
`obviousness grounds for claim 7 are somehow in tension with those for the
`
`compound claims (1-3 and 10) and the treatment claims (8-9)—is merely an
`
`attempt to prop up claim 7 in view of prior art that would render it unpatentable.
`
`What is more, Novartis’s arguments are simply incorrect and inaccurately
`
`characterize both the claims and Breckenridge’s and Par’s petitions.
`
`There is no conflict between Breckenridge’s ground of unpatentability on
`
`claim 7 and the instituted grounds in IPR2016-00084. For claims 1-3 and 8-10, Par
`
`argued it would be obvious to modify rapamycin at the C40 position to make
`
`everolimus. For claim 7, Breckenridge still maintains it would be obvious to
`
`modify rapamycin at the C40 position to make everolimus and also asserts it would
`
`be obvious to formulate everolimus with a pharmaceutically acceptable carrier in
`
`view of the prior art. Novartis mischaracterizes Breckenridge’s position by
`
`repeating one of its old arguments suggesting “a POSA did not have to modify
`
`
`
`2
`
`
`
`
`
`rapamycin chemically to render it a useful immunosuppressant, but instead could
`
`have used formulation approaches to achieve that goal.” Paper 10 at 8; IPR2016-
`
`00084, Prelim Resp. 20-21. However, by instituting IPR2016-00084, the Board
`
`rejected Novartis’s argument.
`
`In addition, the timing of Breckenridge’s petitions followed the usual course
`
`after institution and nothing deceptive can be drawn from this. Procedurally, an
`
`institution decision on claims 1-3 and 8-10 in IPR2016-00084 opens a window for
`
`filing a petition and motion for joinder of claim 7 under 37 C.F.R. § 42.122(b).
`
`There is no bar prohibiting a party from following this course. Upon learning that
`
`the Board instituted inter parties review of claims 1-3 and 8-10 in the Par IPR,
`
`Breckenridge followed such an approach seeking to join IPR2016-00084 for
`
`claims 1-3 and 8-10 within one month of its institution. Breckenridge then
`
`mirrored its petition and accompanying motion for joinder involving claim 7 with
`
`that of Par in IPR2016-01059. All of this is in accordance with 37 C.F.R. §
`
`42.122(b).
`
`No matter the procedure pursued, claim 7 is obvious for the same reasons as
`
`claims 1-3 and 8-10 in the Par IPR and its patentability should be decided by the
`
`Board. Despite Novartis using its opposition to joinder as a second preliminary
`
`response, their paper ignores the fact that instituted claims 8 and 9 require
`
`
`
`3
`
`
`
`
`
`administering the compound of claim 1.1 Paper 10 at 7-8. This necessarily requires
`
`the compound to be in the form of a composition.
`
`Par already demonstrated claims 8 and 9 would have been obvious in
`
`IPR2016-00084. If there were any contradictions in Par’s successful arguments for
`
`instituting IPR of compound claim 1 and method claims 8 and 9, Novartis could
`
`have pointed them out in its preliminary response. Yet Novartis chose not to do so.
`
`In opposing joinder, Novartis argues that the pharmaceutical composition of claim
`
`7 contradicts Par’s evidence that a person of ordinary skill in the art would modify
`
`rapamycin to, inter alia, improve solubility. In sum, Novartis attempts to present
`
`arguments that it failed to make in its preliminary response and overlooks the
`
`Board’s decision to institute with respect to method claims 8 and 9.
`
`III. Claim 7 Is Patentably Indistinct
`
`Breckenridge identified Federal Circuit precedent holding that formulation
`
`claims are patentably indistinct from claims to the underlying compounds and
`
`claims to methods of treatment using the compound. Paper 1 at 2-3. Novartis’s
`
`efforts to distinguish those cases are disingenuous. A person of ordinary skill in the
`
`art would understand that administering everolimus requires a pharmaceutical
`
`composition comprising a pharmaceutically acceptable carrier to administer
`
`1 Novartis did the same in opposing Par’s and Roxane’s joinder motions in
`
`IPR2016-01059 and IPR2016-01102.
`
`
`
`4
`
`
`
`
`
`everolimus. Thus, the composition of claim 7 is on all fours with the limitations of
`
`claim 1-3 and 8-10 and rises and falls with the instituted claims.
`
`IV. Joinder Will Not Unreasonably Expand the Instituted Proceedings
`
`Breckenridge remains flexible and accommodating and is willing to fully
`
`coordinate with Par on scheduling in the joined proceeding. Breckenridge is also
`
`willing to assume an understudy role, submit consolidated filings, coordinate on
`
`managing questioning at depositions and presentations at the hearing, and
`
`coordinate with Dr. Jorgensen. Ex. 1030, p. 17, ll. 4-15; Paper 4 at 11-12.
`
`Novartis’s allegations that it was not entitled to submit a preliminary
`
`response or depose Dr. Jorgensen form a contrived burden. Paper 10 at 9-10.
`
`Breckenridge never argued for such restrictions. Instead, Breckenridge merely
`
`stated that since the instituted claims are already before the Board, any arguably
`
`new subject matter (i.e. pharmaceutically acceptable carrier) is limited to the
`
`additional feature in claim 7 and would have been obvious to use when
`
`administering in claims 8 and 9. Therefore, because the declarations relied on are
`
`entirely the same between the two petitions, Breckenridge does not believe that two
`
`depositions are required.
`
`
`
`
`
`5
`
`
`
`Respectfully submitted,
`
`
` /Matthew L. Fedowitz/
`By:
`B. Jefferson Boggs, Esq., Reg. No. 32,344
`Matthew L. Fedowitz, Esq., Reg. No. 61,386
`Daniel R. Evans, Esq., Reg. No. 55,868
`Merchant & Gould P.C.
`1900 Duke Street, Suite 600
`Alexandria, VA 22314
`jboggs@merchantgould.com
`mfedowitz@merchantgould.com
`devans@merchantgould.com
`Main Telephone: (703) 684-2500
`Main Facsimile: (703) 684-2501
`
`Counsel for Petitioner
`
`
`
`
`
`
`
`
`
`
`Date: July 27, 2016
`
`
`
`6
`
`
`
`
`
`CERTIFICATION OF SERVICE
`
`Pursuant to 37 C.F.R. 42.6(e), I certify that on this 27th day of July, 2016, a
`
`true and correct copy of the foregoing REPLY TO PATENT OWNER
`
`NOVARTIS’S OPPOSITION TO PETITIONER BRECKENRIDGE’S
`
`MOTION FOR JOINDER OF ITS PETITION ON CLAIM 7 was served by
`
`electronic mail on Patent Owner’s lead and backup counsel at the following email
`
`address:
`
`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
`
`
`Respectfully submitted,
`
`
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`
` /Matthew L. Fedowitz/
`B. Jefferson Boggs, Esq., Reg. No. 32,344
`Matthew L. Fedowitz, Esq., Reg. No. 61,386
`Daniel R. Evans, Esq., Reg. No. 55,868
`MERCHANT & GOULD P.C.
`1900 Duke Street, Suite 600
`Alexandria, VA 22314
`jboggs@merchantgould.com
`mfedowitz@merchantgould.com
`devans@merchantgould.com
`Main Telephone: (703) 684-2500
`Main Facsimile: (703) 684-2501
`
`Counsel for Petitioner
`
`7
`
`
`July 27, 2016
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