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
`
`
`
`
`
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`
`
`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
`_____________________
`
`
`
`PETITIONER’S REQUEST FOR REHEARING
`PURSUANT TO 37 C.F.R. § 42.71
`
`
`1
`
`
`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
`_____________________
`
`
`
`PETITIONER’S REQUEST FOR REHEARING
`PURSUANT TO 37 C.F.R. § 42.71
`
`
`1
`
`
`
`I.
`
`Introduction
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`Breckenridge Pharmaceutical, Inc. (“Petitioner” or “Breckenridge”) hereby
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`respectfully requests rehearing of the October 27, 2016 Decision (“Decision”)
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`Granting, Granting-In-Part, and Denying Motions for Joinder 35 U.S.C. § 315(c);
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`37 C.F.R. § 42.122(b). In particular, Petitioner requests rehearing of the Board’s
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`decision not to grant joinder with regard to claim 7 in U.S. Patent No. 5,665,772 to
`
`IPR2016-00084.
`
`Breckenridge is aware that Par Pharmaceutical, Inc. (“Par”) is concurrently
`
`filing its “Petitioner’s Request for Rehearing of The Board’s Decision Denying
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`Joinder” in IPR2016-01059 on November 10, 2016. The subject of Par’s Request
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`for Rehearing is the same as that of the present Request for Rehearing.
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`Breckenridge requests that to the extent Par’s Request for Rehearing is granted, so
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`too should the present Request for Rehearing be granted.
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`Breckenridge’s Request for Rehearing should also be granted on two
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`separate, additional grounds. These include: (1) the Board misapprehending the
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`different nature of Breckenridge’s procedural posture when compared to that of
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`Par; and (2) the Board overlooking the fact that it specifically stated that it would
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`issue a decision on the schedules for the five cases involving joinder within a week
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`of June 17, 2016.
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`
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`
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`2
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`
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`II. Applicable Rules
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`37 C.F.R. § 42.71(d) states:
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`(d) Rehearing. A party dissatisfied with a decision may file a single
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`request for rehearing without prior authorization from the Board. The
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`burden of showing a decision should be modified lies with the party
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`challenging the decision. The request must specifically identify all
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`matters the party believes the Board misapprehended or overlooked,
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`and the place where each matter was previously addressed in a
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`motion, an opposition, or a reply. A request for rehearing does not toll
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`times for taking action. Any request must be filed:
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`(1) Within 14 days of the entry of a non-final decision or a decision to
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`institute a trial as to at least one ground of unpatentability asserted in
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`the petition; or
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`(2) Within 30 days of the entry of a final decision or a decision not to
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`institute a trial.
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`In accordance with 37 C.F.R. § 42.71(d)(1), this Request is being filed
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`within 14 days of the entry of the October 27, 2016 Decision Denying
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`Breckenridge’s Motions for Joinder.
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`
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`3
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`
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`III. Requested Relief
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`Breckenridge respectfully requests reconsideration of the Board’s decision
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`not to grant joinder with regard to claim 7 in U.S. Patent No. 5,665,772 to
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`IPR2016-00084. Petitioner submits that the Board recognized that “[i]nstitution of
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`trial as to claim 7 on the Par II, Breckenridge II, and Roxane Petitions is
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`warranted.” (IPR2016-01103, October 27, 2016 Decision (Paper 18) at 12.)
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`However, the Board denied joinder on bases germane to Par and not Breckenridge
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`and despite telling Breckenridge that it would issue a schedule within one week of
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`the June 17, 2016 teleconference with the Board that would have reduced any
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`potential complication with the existing proceeding.
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`IV. Argument
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`In its Decision, the Board stated that “[t]hough we recognize the arguments
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`in favor of joining the claim 7 ground to the pending inter partes review, two
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`factors weigh strongly against such joinder.” Id. at 15. The first factor the Board
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`identified was “that no explanation has been given for why claim 7 – the validity of
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`which, according to the Petitioners, is so closely related to claim 1, 8, and 9 – was
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`not raised in the Par I Petition.” Id. (emphasis added) The second factor identified
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`was that the Board “consider[ed] the effect joinder would have on the already-
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`instituted trial.” Id. at 17. Stating that “[t]hough the statute provides that the one-
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`year deadline for rendering a final decision may be adjusted in the case of
`
`
`
`4
`
`
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`joinder…, we are hesitant to do so in cases where joinder will unduly complicate
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`the existing proceeding…” Id.
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`For the Board to base its decision to deny joinder to Breckenridge on these
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`two factors demonstrates that it misapprehended and overlooked two critical
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`issues. These errors unfairly prejudice Breckenridge.
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`Regarding the first factor, Breckenridge should not be prejudiced for Par
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`failing to provide an explanation why claim 7 was not raised in the “Par I Petition.”
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`Breckenridge is neither related to nor a real party-in-interest of Par so there is no
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`need for Breckenridge to provide any explanation regarding the Par I Petition. In
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`fact, Breckenridge could never resolve the issue as to claim 7 because at no time
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`did it have the opportunity to include it in an original petition addressing the
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`patentability of the claims in the ‘772 patent. As a result, this issue is strictly
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`unique to Par. Breckenridge’s motion for joinder should be considered separately.
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`Indeed, the Board recognized that institution of trial as to claim 7 was warranted
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`based on Breckenridge’ Petition. Id. at 12; IPR2016-01103, Petition, Paper 1.
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`Because of this and in keeping with the Office’s anticipation that “joinder will be
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`allowed as of right,” the second step in the analysis would include joining
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`Breckenridge’s claim 7 petition to that of IPR2016-00084. 157 Cong. Rec. S1376
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`(Sen. Kyl). The Board, however, erred by applying its basis for denying Par’s
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`
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`5
`
`
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`joinder motion to Breckenridge. This represents a clear misapprehension of
`
`Breckenridge’s distinct and different procedural posture compared to that of Par.
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`
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`Furthermore, the Board’s statement that Breckenridge requests joinder “[t]o
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`the extent the Motion for Joinder…filed on behalf of Par [Par II] is granted,”
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`signals a misunderstanding of the intent of Breckenridge’s statement. (IPR2016-
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`01103, October 27, 2016 Decision (Paper 18) at 15.) Breckenridge did not intend
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`to agree that its motion should stand or fall with Par’s. Rather, the statement
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`merely conveyed the notion that Breckenridge’s motion should be granted for any
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`or all the same substantive reasons as Par’s. Reasons for denial not applicable to
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`Breckenridge would obviously not be included. Indeed, the full sentence reads
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`“[t]o the extent the Motion for Joinder filed on behalf of Par [Par II]…is granted,
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`Breckenridge requests this Motion for Joinder of Claim 7 also be granted as the
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`arguments and substance are essentially the same.” (IPR2016-01103, Paper 4 at
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`page 1, emphasis added.) Against this backdrop, it is clear that the partially quoted
`
`sentence does not indicate that Breckenridge agreed to be penalized for the faults
`
`of Par and cannot be a reasonable basis to deny joinder.
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`Regarding the second factor, Breckenridge should not be unfairly prejudiced
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`for the Board’s delay in issuing a decision on the Motions for Joinder with regard
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`to claim 7 of U.S 5,665,772. Any complications that may exist now were not due
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`to the actions of Breckenridge. Breckenridge filed its Petition and Motion for
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`
`
`6
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`
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`Joinder on May 26, 2016, which was timely under 37 C.F.R. §42.122(b), as it was
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`submitted within one month of April 29, 2016, the date on which the Par IPR was
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`instituted. IPR2016-00084, Paper 8. The Board issued its decision denying
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`Breckenridge’s claim 7 Motion for Joinder on October 27, 2016. This decision is
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`five months after Breckenridge timely filed its motion and, at least, four months
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`after several teleconferences with the Board discussing harmonizing the schedules
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`between the petitions to be joined with IPR2016-00084. See IPR2016-01103, Exs.
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`1030 and 1031. Breckenridge fulfilled every procedural requirement, paid the
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`required filing fees, and made every effort to comply with the Board’s request that
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`the parties work together to coordinate a schedule harmonizing the proceedings.
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`Accordingly, Breckenridge should not be unfairly prejudiced by the Board’s delay.
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`What is more, Breckenridge relied on the Board stating that within a week, it
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`would issue an Order on the schedules for the five cases involving joinder relating
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`to U.S. 5,665, 772. See IPR2016-01103, Ex. 1031 at page 26, lines 20-23 and page
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`27, lines 19-21 (“And in the next, I'm going to say week or so, we will be able to
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`get an order out on the sort of more global issue of the schedule in all of the five
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`cases” and “[w]atch next week for the revised schedule or some sort of order on
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`the schedule”). It is unreasonable and prejudicial to deny Breckenridge’s Motion
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`for Joinder of claim 7 when the Board represented that they would provide a
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`schedule within a week or so of the June 17, 2016 teleconference and then wait
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`
`
`7
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`
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`until October 27, 2016 to change directions and state the reasoning for denying
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`joinder was because scheduling concerns, which may complicate the existing
`
`proceeding.
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`In view of this, the Decision denying joinder of claim 7 misapprehended the
`
`differing nature of Breckenridge’s procedural posture when compared to that of
`
`Par. The Board also overlooked the fact that it specifically stated that it would
`
`issue a decision on the schedules for the five cases seeking joinder within a week
`
`of its June 17, 2016 teleconference with the parties. For both of these reasons,
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`Breckenridge has been unfairly prejudiced. Breckenridge, therefore, respectfully
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`requests that the Board reconsider its Decision denying its Motion for Joinder of
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`claim 7.
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`V. Conclusion
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`For the forgoing reasons, Breckenridge respectfully requests rehearing of the
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`joinder decision.
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`
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`8
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`
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`Respectfully submitted,
`
`
`By: /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
`
`
`9
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`
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`Date: November 10, 2016
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`CERTIFICATION OF SERVICE
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`Pursuant to 37 C.F.R. 42.6(e), I certify that on this 10th day of November,
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`2016, true and correct copies of the foregoing PETITIONER’S REQUEST
`
`FOR REHEARING PURSUANT TO 37 C.F.R. § 42.71 were served by
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`electronic mail on Patent Owner’s lead and backup counsel at the following
`
`email address:
`
`Nicholas N. Kallas (Reg. No. 32,530)
`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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`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
`
`10
`
`
`November 10, 2016
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