UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ROXANE LABORATORIES, INC.
`Petitioner
`
`v.
`
`
`
`NOVARTIS AG
`Patent Owner
`
`
`
`
`
`Case No. To Be Assigned
`Patent No. 5,665,772
`
`
`
`
`MOTION FOR JOINDER
`PURSUANT TO 35 U.S.C. § 315(c) AND 37 C.F.R. § 42.122(b)
`
`
`
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ROXANE LABORATORIES, INC.
`Petitioner
`
`v.
`
`
`
`NOVARTIS AG
`Patent Owner
`
`
`
`
`
`Case No. To Be Assigned
`Patent No. 5,665,772
`
`
`
`
`MOTION FOR JOINDER
`PURSUANT TO 35 U.S.C. § 315(c) AND 37 C.F.R. § 42.122(b)
`
`
`
`
`
`
`
`
`
`
`
`
`
`TABLE OF CONTENTS
`
`
`
`TABLE OF AUTHORITIES ............................................................................ ii
`
`I.
`
`II.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED ................. 1
`
`STATEMENT OF MATERIAL FACTS ............................................... 1
`
`III.
`
`STATEMENT OF REASONS FOR RELIEF REQUESTED ............... 4
`
`A.
`
`B.
`
`Joinder Will Not Impact The Board’s Ability To Complete
`The Review In A Timely Manner ................................................ 5
`
`Joinder Will Promote Efficiency By Consolidating Issues
`And Preventing Inconsistencies ................................................... 8
`
`C. Without Joinder, Roxane Would Be Prejudiced .......................... 9
`
`D.
`
`Joinder Will Not Prejudice Patent Owner Or Par ...................... 10
`
`IV. CONCLUSION ..................................................................................... 11
`
`
`
`i
`
`
`
`
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Aventis Pharma Deutschland GmbH v. Lupin, Ltd.,
`499 F.3d 1293 (Fed. Cir. 2007) ............................................................................ 6
`
`Statutes
`
`35 U.S.C. § 103 .......................................................................................................... 2
`
`35 U.S.C. § 315(c) ................................................................................................. 1, 4
`
`35 U.S.C. § 316(a)(1) ............................................................................................... 10
`
`35 U.S.C. § 316(a)(11) ............................................................................................... 5
`
`35 U.S.C. § 316(b) ..................................................................................................... 9
`
`Other Authorities
`
`37 C.F.R. § 42.1(b) .................................................................................................... 9
`
`37 C.F.R. § 42.22 ....................................................................................................... 1
`
`37 C.F.R. § 42.100(c) ........................................................................................... 5, 10
`
`37 C.F.R. § 42.122(b) ................................................................................................ 1
`
`Legislative History
`
`157 Cong. Rec. S1376................................................................................................ 5
`
`
`
`ii
`
`
`
`
`
`I.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED
`
`Petitioner Roxane Laboratories Inc. (“Roxane” or “Petitioner”) respectfully
`
`requests joinder pursuant to 35 U.S.C. § 315(c) and 37 C.F.R. § 42.122(b) of the
`
`inter partes review petition submitted concurrently herewith (hereinafter “Roxane
`
`IPR”) with the pending inter partes review concerning, for claims 1-3 and 8-10, the
`
`same two grounds of invalidity in Par Pharmaceutical, Inc. v. Novartis AG, Case
`
`No. IPR2016-00084 (“Par IPR”), which was instituted on April 29, 2016, and for
`
`claim 7, the same prior art, evidence and arguments in the grounds of invalidity in
`
`the Par IPR. Joinder is appropriate because it will promote efficient and consistent
`
`resolution of the validity of a single patent and will not prejudice any of the parties
`
`to the Par IPR.
`
`This Motion for Joinder is timely under 37 C.F.R. §§ 42.22 and 42.122(b), as
`
`it is submitted within one month of April 29, 2016, the date on which the Par IPR
`
`was instituted.
`
`II.
`
`STATEMENT OF MATERIAL FACTS
`1.
`
`Petitioner is not aware of any reexamination certificates or pending
`
`prosecution concerning U.S. Patent No. 5,665,772 (“the ’772 Patent”), which is the
`
`subject of both the Par IPR and the Roxane IPR.
`
`2.
`
`On September 16, 2014, Novartis AG (“Novartis”) filed a complaint in
`
`the District of Delaware accusing Roxane of infringing the ’772 Patent. D.I.1,
`
`1
`
`
`
`
`
`1:14-cv-01196-RGA (D. Del.). Novartis asserts claims 1-3, 7 and 10 against
`
`Roxane. Claim 1 of the ’772 Patent is directed to a compound of Formula I.1
`
`Claims 2, 3 and 10 depend from claim 1. Claim 7 of the ’772 Patent recites a
`
`pharmaceutical composition comprising a compound of claim 1. Claims 8 and 9
`
`recite methods of using a compound of claim 1.
`
`3.
`
`Par Pharmaceuticals, Inc. (“Par”) filed a petition for inter partes
`
`review of claims 1-3 and 8-10 the ’772 Patent on October 26, 2015. (Par IPR,
`
`IPR2016-00084).
`
`4.
`
`The Par IPR included, inter alia, the following two grounds for
`
`challenging the validity of the ’772 Patent:
`
`Ground 1: Claims 1-3 and 10 are invalid under 35 U.S.C. § 103 on the
`
`ground that they are rendered obvious in view of Morris, Van Duyne,
`
`Rossmann, Lemke, and Yalkowsky; and
`
`Ground 2: Claims 8 and 9 are invalid under 35 U.S.C. § 103 on the
`
`ground that they are rendered obvious in view of Morris, Van Duyne,
`
`Rossmann, Lemke, Yalkowsky, and in further view of Hughes.
`
`(Par IPR, IPR 2016-0084, Petition at 38-54).
`
`5.
`
`The Board instituted the Par IPR on April 29, 2016 on Grounds 1 and
`
`
`1
`On February 9, 2016, the Patent Office entered a certificate of correction that
`
`corrects Claim 1. (Ex. 1030, ’772 Patent Certificate of Correction.)
`
`2
`
`
`
`
`
`2. (Par IPR, IPR 2016-0084, Paper 8 at 5-6, 17).
`
`6.
`
`On May 17, 2016, Par filed a petition for IPR of claim 7 of the ’772
`
`Patent and filed a motion to join the IPR on claim 7 with the previously instituted
`
`IPR2016-00084 on claims 1-3 and 8-10. In support of its petition and motion, Par
`
`asserts that it was sued by Novartis for infringement of claim 7 of the ’772 Patent,
`
`and that claim 7 is invalid on the same grounds as claims 1, 8 and 9 on which an
`
`IPR has already been instituted.
`
`7.
`
`The Petition filed in the present Roxane IPR (“Roxane’s IPR Petition”)
`
`requests that an IPR be instituted for claims 1-3 and 7-10 of the ’772 Patent based
`
`on the identical grounds underlying institution of the Par IPR.
`
`8. With respect to claims 1-3 and 8-10 of the ’772 Patent, Roxane’s IPR
`
`Petition presents the identical grounds for invalidity on which the Par IPR was
`
`instituted for those claims.
`
`9.
`
`Roxane’s IPR Petition, like Par’s IPR Petition for claim 7 of the ’772
`
`Patent, asserts that Roxane was sued by Novartis for infringement of, inter alia,
`
`claim 7 of the ’772 Patent, that claim 7 is invalid on the same grounds as claims 8
`
`and 9 of the ’772 Patent, on which an IPR has already been instituted, and that the
`
`validity of claim 7 of the ’772 Patent should rise or fall with the validity of the
`
`compound and method claims of the ’772 Patent.
`
`10. As of the date of the filing of this Motion, Roxane is involved in three
`
`3
`
`
`
`
`
`litigations involving the ’772 Patent in the District of Delaware. Par and/or
`
`Breckenridge Pharmaceutical, Inc. are involved in related counterpart litigations.2
`
`III. STATEMENT OF REASONS FOR RELIEF REQUESTED
`The Leahy-Smith America Invents Act (AIA) permits joinder of inter partes
`
`review proceedings. The statutory provision governing joinder of inter partes
`
`review proceedings is 35 U.S.C. § 315(c), which reads as follows:
`
`(c) JOINDER.--If the Director institutes an inter partes
`
`review, the Director, in his or her discretion, may join as a
`
`party to that inter partes review any person who properly
`
`files a petition under section 311 that the Director, after
`
`receiving a preliminary response under section 313 or the
`
`expiration of the time for filing such a response,
`
`determines warrants the institution of an inter partes
`
`review under section 314.
`
`In exercising its discretion to grant joinder, the Board considers the impact of
`
`substantive and procedural issues on the proceedings, as well as other
`
`considerations, while being “mindful that patent trial regulations, including the
`
`rules for joinder, must be construed to secure the just, speedy, and inexpensive
`
`
`2
`For a list of related litigations involving the ’772 Patent, see Roxane’s
`
`Petition for inter partes review, pages 15-16, submitted concurrently herewith.
`
`4
`
`
`
`
`
`resolution of every proceeding.” See Dell, Inc. v. Network-1 Security Solutions,
`
`Inc., Case IPR2013-00385, Paper No. 17 (July 29, 2013) at 3. The Board should
`
`consider “the policy preference for joining a party that does not present new issues
`
`that might complicate or delay an existing proceeding.” Id. at 10. Under this
`
`framework, joinder of the present Roxane IPR with the Par IPR is appropriate.
`
`“A motion for joinder should: (1) set forth the reasons why joinder is
`
`appropriate; (2) identify any new grounds of unpatentability asserted in the petition;
`
`(3) explain what impact (if any) joinder would have on the trial schedule for the
`
`existing review; and (4) address specifically how briefing and discovery may be
`
`simplified.” Id. at 4. Petitioner fully addresses each of these below.
`
`A.
`
`Joinder Will Not Impact The Board’s Ability To Complete The
`Review In A Timely Manner
`
`Joinder in this case will not impact the Board’s ability to complete its review
`
`in a timely manner. 35 U.S.C. § 316(a)(11) and associated rule 37 C.F.R.
`
`§ 42.100(c) provide that inter partes review proceedings should be completed and
`
`the Board’s final decision issued within one year of institution of the review. In
`
`this case, joinder will not affect the Board’s ability to issue the decision within this
`
`required one-year timeframe because the grounds asserted in Roxane’s IPR Petition
`
`are identical to the grounds upon which the Par IPR was instituted as to claims 1-3
`
`and 8-10 of the ’772 Patent. Indeed, in circumstances such as these, the PTO
`
`anticipated that joinder would be granted as a matter of right. See 157 CONG.
`
`5
`
`
`
`
`
`REC. S1376 (daily ed. Mar. 8, 2011) (statement of Sen. Kyl) (“The Office
`
`anticipates that joinder will be allowed as of right – if an inter partes review is
`
`instituted on the basis of a petition, for example, a party that files an identical
`
`petition will be joined to that proceeding, and thus allowed to file its own briefs and
`
`make its own arguments.”) (emphasis added).
`
`Joinder is also appropriate as to claim 7 of the ’772 Patent, which recites a
`
`composition comprising a therapeutically effective amount of a compound of claim
`
`1 and a pharmaceutically acceptable carrier, because claim 7 is invalid as obvious in
`
`view of the same arguments, combinations of prior art, and expert testimony that the
`
`Board already considered before instituting review of claims 8 and 9 of the ’772
`
`Patent. Specifically, Roxane’s petition demonstrates that the same combination of
`
`Morris, Van Duyne, Rossmann, Lemke, Yalkowsky, and Hughes that renders
`
`claims 8 and 9 obvious also renders claim 7 obvious.
`
`Moreover, the Federal Circuit has explained that the validity of claim to a
`
`pharmaceutical composition comprising a compound – like claim 7 – “rise[s] or
`
`fall[s] with the validity of” the compound claim when the prior art describes using
`
`compounds of the same class with pharmaceutical excipients—as the prior art does
`
`here. Aventis Pharma Deutschland GmbH v. Lupin, Ltd., 499 F.3d 1293, 1303 (Fed.
`
`Cir. 2007). In particular, in this case, the compound of claim 1 is a rapamycin
`
`derivative, and the prior art explicitly taught using therapeutic amounts of
`
`6
`
`
`
`
`
`rapamycin and its derivatives with pharmaceutically acceptable carriers. Thus,
`
`claim 7, a pharmaceutical composition comprising a rapamycin derivative, is
`
`obvious for the same reasons that claims 1-3 and 8-10, for which the Par IPR has
`
`been instituted, are obvious.
`
`In addition, Roxane respectfully proposes procedures to simplify any further
`
`briefing and discovery, which will minimize any potential impact on the schedule
`
`or the volume of materials to be submitted to the Board. Given that Par and
`
`Roxane will rely on the same arguments and combinations of prior art to challenge
`
`claims 1-3 and 8-10, for which an IPR has already been instituted, and claim 7,
`
`which Roxane and Par contend is obvious for the same grounds as claims 1-3 and
`
`8-10, the Board may adopt procedures similar to those adopted in Dell, Inc. v.
`
`Network-1 Security Solutions, Inc., IPR2013-00385 and Motorola Mobility LLC v.
`
`SoftView LLC, IPR2013-00256. In those cases, the Board ordered the petitioners to
`
`file consolidated filings, for which the first petitioner was responsible, and allowed
`
`the new petitioner to file seven additional pages with corresponding additional
`
`responsive pages allowed to the Patent Owner. IPR2013-00385, Paper 17 at 8;
`
`IPR2013-00256, Paper 10 at 8-9. This procedure would minimize any
`
`complication or delay caused by joinder, as the Board recognized in those cases.
`
`As in IPR2013-00385 and IPR2013-00256, the petitioners in this case can work
`
`together to manage the questioning at depositions and presentations at the hearing
`
`7
`
`
`
`
`
`to avoid redundancy. IPR2013-00385, Paper 17 at 9; IPR2013-00256, Paper 10 at
`
`9-10.
`
`Roxane’s and Par’s IPR petitions rely on testimony from the same expert,
`
`Dr. Jorgensen. Par has consented to Roxane’s joinder, and Par and Roxane have
`
`agreed to work together with respect to Dr. Jorgensen; therefore this aspect of the
`
`IPR will present no additional burden on the Patent Owner. Further, Roxane will
`
`cooperate with Par to simplify briefing and discovery wherever possible. All of
`
`these concessions offered by Roxane are consistent with precedent. See, e.g., Dell,
`
`Inc. v. Network-1 Security Solutions, Inc., IPR2013-00385, Paper 17; Motorola
`
`Mobility LLC v. SoftView LLC, IPR2013-00256, Paper 10.
`
`Furthermore, Roxane diligently and timely filed its petition and motion for
`
`joinder within the time set by statute.
`
`B.
`
`Joinder Will Promote Efficiency By Consolidating Issues And
`Preventing Inconsistencies
`Proceeding with a consolidated inter partes review as outlined above would
`
`avoid inefficiency and prevent inconsistencies and would result in a final written
`
`decision without any delay.
`
`Moreover, any additional minimal burden stemming from addressing claim 7
`
`of the ’772 Patent is “strongly outweighed by the public interest in having
`
`consistency of outcome concerning similar sets of claimed subject matter and prior
`
`art.” Samsung Elecs. Co. v. Va. Innovation Scis., Inc., No. IPR2014-00557, Paper
`
`8
`
`
`
`
`
`10 at 18. Because of the lack of any patentable distinction between claim 7 and
`
`claims 1, 8 and 9, the public would be disadvantaged if claims 1, 8 and 9 were
`
`canceled and yet claim 7 remained in force. In particular, claim 7, which is directed
`
`to a pharmaceutical composition comprising a compound of Formula I, would
`
`essentially prevent the public from practicing claims 1, 8 and 9, which are directed
`
`to the compound itself or methods of administering the compound. Such a result
`
`would undermine an impetus for the inter partes review procedure to ensure the
`
`quality and integrity of the patent system. See 35 U.S.C. § 316(b). Therefore, in the
`
`event that an IPR was not instituted for claim 7, Roxane would need to seek Ex
`
`Parte Reexamination of that claim to achieve consistency, which would
`
`unnecessarily burden Roxane, the Patent Office, and the Board (if an appeal of the
`
`reexamination decision is filed).
`
`Additionally, Novartis has asserted claims 1-3, 7 and 10 against Roxane in the
`
`related district court litigation. Joining claim 7 to the instituted proceedings
`
`therefore allows for resolution of the disputes between the Parties concerning the
`
`’772 Patent and meets the stated goal of allowing for the “just, speedy, and
`
`inexpensive resolution” of the entire dispute. See 37 C.F.R. § 42.1(b).
`
`C. Without Joinder, Roxane Would Be Prejudiced
`Roxane would be prejudiced if it is not permitted to join and to participate in
`
`the Par IPR, as any decision in the Par IPR will likely impact the issues in Roxane’s
`
`9
`
`
`
`
`
`underlying litigations (Novartis Pharm. Corp. et al. v. Roxane Labs., Inc., No. 1:14-
`
`cv-1196-RGA (D. Del.); Novartis Pharm. Corp. et al. v. Roxane Labs., Inc., No.
`
`1:14-cv-1508-RGA (D. Del.); Novartis Pharm. Corp. et al. v. Roxane Labs., Inc.,
`
`No. 1:15-cv-128-RGA (D. Del.)).
`
`Joinder Will Not Prejudice Patent Owner Or Par
`
`D.
`Permitting joinder will not prejudice Novartis or Par. Roxane’s proposed
`
`grounds for instituting an IPR for claims 1-3 and 8-10 of the ’772 Patent are
`
`identical to the two grounds on which the Decision of Institution was based in the
`
`Par IPR (Case No. IPR2016-00084) for the same claims.
`
`Because Roxane contends that claim 7 of the ’772 Patent, and the claims of
`
`the ’772 Patent for which an IPR was already instituted, are obvious in view of the
`
`same arguments and combinations of prior art and rely on the same expert
`
`testimony, Novartis will not be prejudiced by the addition of claim 7. As discussed
`
`above, claim 7 rises and falls with the instituted claims and there is no difference in
`
`the art or evidence in Roxane’s IPR petition.
`
`For all of the foregoing reasons, joinder will not affect the timing of the Par
`
`IPR. Moreover, to the extent that an extension to the schedule may be required, it
`
`is permitted by law and the applicable rules. 35 U.S.C. § 316(a)(1); 37 C.F.R.
`
`§ 42.100(c).
`
`
`
`10
`
`
`
`
`
`IV. CONCLUSION
`For the foregoing reasons, Roxane respectfully requests that the Board grant
`
`Roxane’s Petition for inter partes review of claims 1-3 and 7-10 of the ’772 Patent
`
`and join that inter partes review proceeding with Par Pharmaceuticals, Inc. v.
`
`Novartis AG, Case No. IPR2016-00084.
`
`Respectfully submitted,
`
`
`
` /Keith A. Zullow/
`Keith A. Zullow (Reg. No. 37,975)
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
`Tel: 212-813-8846
`Fax: 646-558-4226
`kzullow@goodwinprocter.com
`
`
`
`Counsel for Petitioner Roxane
`Laboratories, Inc.
`
`
`11
`
`
`
`
`
`
`May 26, 2016
`
`
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that this “MOTION FOR JOINDER
`
`PURSUANT TO 35 U.S.C. § 315(c) AND 37 C.F.R. § 42.122(b)” was served in its
`
`entirety on this 26th day of May, 2016 on the Patent Owner by serving via
`
`overnight delivery to the correspondence address of record for the ’772 Patent:
`
`Novartis Pharmaceutical Corporation
`Intellectual Property Department
`Attn: Peter J. Waibel, Esq. (Head of Patent Litigation)
`One Health Plaza 433/2
`East Hanover, NJ 07936-1080
`
`
`
`Nicholas Kallas
`Fitzpatrick, Cella, Harper & Scinto
`1290 Avenue of the Americas
`New York, NY 10104-3800
`
`In addition, counsel for Novartis AG was served via FedEx International
`
`
`
`Priority at the following address:
`
`Novartis International AG
`Novartis Campus
`Attn: Alisa A. Harbin, Esq. (Head, Group Litigation and
`Intellectual property)
`Forum 1-1.20
`Basel, CH-4002
`Switzerland
`
`Courtesy copies of the foregoing were also served via overnight delivery on
`
`the counsel of record for the Petitioner and Patent Owner in Par Pharmaceuticals,
`
`Inc. v. Novartis AG, IPR2016-00084 as follows:
`
`
`
`
`
`Par Pharmaceutical, Inc.
`
`Daniel Brown
`Latham & Watkins LLP
`885 Third Avenue
`New York, NY 10022
`
`Robert Steinberg (Reg. No. 33,144)
`Latham & Watkins LLP
`355 South Grand Avenue
`Los Angeles, CA 90071-1560
`
`
`
`Novartis AG
`
`
`Nicholas N. Kallas
`Fitzpatrick, Cella, Harper & Scinto
`1290 Avenue of the Americas
`New York, NY 10104-3800
`
`
` /Keith A. Zullow/
`Keith A. Zullow
`Reg. No. 37,975
`
`
`
`
`
`
`
`
`
`
`May 26, 2016
`
`
`
`
`
`
`
`
`
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