UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`WEST-WARD PHARMACEUTICALS INTERNATIONAL LIMITED
`Petitioner
`
`v.
`
`
`
`NOVARTIS AG
`Patent Owner
`
`
`
`
`
`Case No. To Be Assigned
`Patent No. 9,006,224
`
`
`
`
`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
`
`WEST-WARD PHARMACEUTICALS INTERNATIONAL LIMITED
`Petitioner
`
`v.
`
`
`
`NOVARTIS AG
`Patent Owner
`
`
`
`
`
`Case No. To Be Assigned
`Patent No. 9,006,224
`
`
`
`
`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 ............................................... 2
`
`III.
`
`STATEMENT OF REASONS FOR RELIEF REQUESTED ............... 6
`
`A.
`
`B.
`
`Joinder Will Not Impact The Board’s Ability To Complete
`The Review In A Timely Manner ................................................ 7
`
`Joinder Will Promote Efficiency By Consolidating Issues
`And Preventing Inconsistencies ................................................... 9
`
`C. Without Joinder, West-Ward And The Public Would Be
`Prejudiced ................................................................................... 10
`
`D.
`
`Joinder Will Not Prejudice Patent Owner Or Par ...................... 11
`
`IV. CONCLUSION ..................................................................................... 11
`
`
`
`i
`
`
`
`
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`P.T.A.B. Decisions
`Dell, Inc. v. Network-1 Security Solutions, Inc.,
`Case IPR2013-00385 .................................................................................... 6, 8, 9
`
`Motorola Mobility LLC v. SoftView LLC,
`IPR2013-00256 ................................................................................................. 8, 9
`
`Oracle America, Inc. v. Realtime Data
`LLC, IPR2016-01672 ............................................................................................ 2
`
`Statutes
`
`35 U.S.C. § 103 .......................................................................................................... 4
`
`35 U.S.C. § 315(c) ................................................................................................. 1, 6
`
`35 U.S.C. § 316(a)(11) ............................................................................................... 7
`
`Leahy-Smith America Invents Act ............................................................................ 6
`
`Other Authorities
`
`37 C.F.R. § 42.22 ................................................................................................... 2, 9
`
`37 C.F.R. § 42.100(c) ................................................................................................. 7
`
`37 C.F.R. § 42.122(b) ........................................................................................ 1, 2, 9
`
`157 Cong. Rec. S1376 (daily ed. Mar. 8, 2011) ........................................................ 7
`
`
`
`ii
`
`
`
`
`
`I.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED
`
`Petitioner West-Ward Pharmaceuticals International Limited (“West-Ward”
`
`or “Petitioner”) respectfully requests joinder pursuant to 35 U.S.C. § 315(c) and
`
`37 C.F.R. § 42.122(b) of the petition for inter partes review submitted concurrently
`
`herewith (hereinafter “West-Ward IPR Petition”) with the pending inter partes
`
`review of claims 1-3 of U.S. Patent No. 9,006,224 (“the ’224 Patent”) in Par
`
`Pharmaceutical, Inc. v. Novartis AG, Case No. IPR2016-01479 (“Par IPR”), which
`
`was instituted on February 15, 2017. The West-Ward IPR Petition presents the
`
`same grounds of invalidity as set forth in the Par Pharmaceutical, Inc. (“Par”) IPR
`
`Petition. (IPR2016-01479, Paper 1).
`
`On July 19, 2016, Roxane Laboratories, Inc. (“Roxane”)1 filed a petition for
`
`inter partes review of claims 1-2 of the ’224 patent. (IPR2016-01461, Paper No. 2).
`
`The Board denied institution of Roxane’s Petition on February 13, 2017. (IPR2016-
`
`01461, Paper No. 9).
`
`Roxane and West-Ward respectfully submit that the Roxane IPR Petition
`
`established that each element of claim 1 and claim 2 of the ’224 patent is found in
`
`the prior art, and that there is a reasonable likelihood that at least claim 1 and claim
`
`
`1
`On January 11, 2017, the Mandatory Notices in IPR2016-01461 were
`
`updated to identify West-Ward as an additional real-party-in-interest. (IPR2016-
`
`01461, Paper No. 8).
`
`1
`
`
`
`
`
`2 of the ’224 patent are invalid as obvious over the prior art cited therein.
`
`Nevertheless, the Board denied institution of Roxane’s IPR Petition. In view of the
`
`Board’s denial of institution of the Roxane IPR and institution of the Par IPR
`
`(IPR2016-01479), West-Ward respectfully requests joinder with the Par IPR.
`
`Joinder in similar circumstances was granted by the Board in Oracle America, Inc.
`
`v. Realtime Data LLC, IPR2016-01672, Paper No. 13, March 7, 2017.
`
`Joinder is appropriate because it will promote efficient and consistent
`
`resolution of the validity of a single patent, will not prejudice any of the parties to
`
`the Par IPR, and is timely under 37 C.F.R. §§ 42.22 and 42.122(b), as it is
`
`submitted within one month of February 15, 2017, the date on which the Board
`
`instituted the Par IPR.
`
`II.
`
`STATEMENT OF MATERIAL FACTS
`1.
`
`Petitioner is not aware of any reexamination certificates or pending
`
`prosecution concerning the ’224 Patent, which is the subject of the Par IPR and the
`
`West-Ward IPR Petition.
`
`2.
`
`On June 10, 2015, Novartis Pharmaceuticals Corporation and Novartis
`
`AG (“Novartis”) filed a complaint in the District of Delaware accusing Roxane,
`
`now West-Ward, of infringing the ’224 Patent. Novartis Pharm. Corp. et al. v.
`
`2
`
`
`
`
`
`Roxane Labs., Inc., No. 1:15-cv-474-RGA (D. Del.).2 In the District of Delaware
`
`litigation, Novartis asserts claims 1 and 2 against West-Ward based on the filing of
`
`an Abbreviated New Drug Application seeking approval to sell a generic version of
`
`Novartis’s AFFINITOR® everolimus product. Claim 1 of the ’224 Patent is
`
`directed to a method for treating pancreatic neuroendocrine tumors comprising
`
`administering a therapeutically effective amount of everolimus, wherein the tumors
`
`are advanced tumors after failure of cytotoxic chemotherapy. Claim 2 depends
`
`directly from claim 1 and specifies that the unit dose of everolimus is 10 mg/day.
`
`Claim 3, which was not asserted against Roxane in the District of Delaware
`
`litigation, but is at issue in the Par IPR, depends directly from claim 1 and specifies
`
`that the tumor is an islet cell tumor.
`
`3.
`
`On July 22, 2016, Par filed a petition for inter partes review of claims
`
`1-3 of the ’224 Patent. (IPR2016-01479, Paper No. 1). Prior to the July 22, 2016
`
`filing of the Par IPR Petition, neither Roxane nor West-Ward had any knowledge
`
`that Par was planning to file a Petition for inter partes review of claims 1-3 of the
`
`’224 Patent, or the bases or grounds of invalidity that Par would set forth in the Par
`
`IPR Petition.
`
`
`2
`On February 27, 2017, West-Ward was substituted as a party for Roxane in
`
`the District of Delaware litigation.
`
`3
`
`
`
`
`
`4.
`
`The Par IPR Petition included, inter alia, the following four grounds
`
`for challenging the validity of the claims of the ’224 Patent, each of which are
`
`different than the grounds in the Roxane IPR Petition:
`
`Ground 1: Claims 1-3 are invalid under 35 U.S.C. § 103 on the ground
`
`that they are rendered obvious in view of Oberg 2004, Boulay 2004 and
`
`O’Donnell;
`
`Ground 2: Claim 2 is invalid under 35 U.S.C. § 103 on the ground that
`
`it is rendered obvious in view of Oberg 2004, Boulay 2004 and O’Donnell, in
`
`further view of Tabernero;
`
`Ground 3: Claims 1-3 are invalid under 35 U.S.C. § 103 on the ground
`
`that they are rendered obvious in view of Boulay 2004, O’Donnell and
`
`Duran; and
`
`Ground 4: Claim 2 is invalid under 35 U.S.C. § 103 on the ground that
`
`it is rendered obvious in view of Boulay 2004, O’Donnell and Duran, in
`
`further view of Tabernero.
`
`(IPR 2016-01479, Paper No. 1 at 37-55).
`
`5.
`
`The Board instituted the Par IPR on February 15, 2017 on Grounds 1-
`
`4. (IPR 2016-01479, Paper No. 8 at 18).
`
`4
`
`
`
`
`
`6.
`
`The West-Ward IPR Petition filed in conjunction with this Motion for
`
`Joinder requests that the Board institute an IPR for claims 1-3 of the ’224 Patent
`
`based on the identical grounds underlying institution of the Par IPR.
`
`7.
`
`On March 10, 2017 Argentum Pharm. LLC (“Argentum”) filed a
`
`petition for inter partes review of the ’224 patent and motion for joinder to the Par
`
`IPR. (See IPR2017-01063).
`
`8.
`
`As of the date of the filing of this Motion, West-Ward is involved in
`
`litigation involving the ’224 Patent in the District of Delaware. Par and Argentum
`
`are not parties to that litigation and West-Ward has not found any evidence that Par
`
`or Argentum is involved in any District Court litigation in which Novartis has
`
`asserted the ’224 Patent.3
`
`
`
`
`3
`On June 10, 2015, Novartis sued Par for infringement of the ’224 patent.
`
`Novartis Pharm. Corp. et al. v. Par Pharm., Inc., No. 1:15-cv-475-RGA (D. Del.).
`
`An amended complaint was filed on June 19, 2015. On October 15, 2015, a
`
`Stipulation and Order dismissing the proceeding, without prejudice, was filed. The
`
`Stipulation and Order states, inter alia, that Par “has withdrawn its Paragraph IV
`
`certification with respect to U.S. Patent No. 9,006,224.”
`
`5
`
`
`
`
`
`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, and other factors, while being
`
`“mindful that patent trial regulations, including the rules for joinder, must be
`
`construed to secure the just, speedy, and inexpensive 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
`
`6
`
`
`
`
`
`or delay an existing proceeding.” Id. at 10. Under this framework, joinder of the
`
`West-Ward 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 factors 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 one-year
`
`of the institution of the Par IPR because the grounds asserted in the West-Ward IPR
`
`Petition are identical to the grounds upon which the Par IPR was instituted. Indeed,
`
`in circumstances such as these, the PTO anticipated that joinder would be granted
`
`as a matter of right. See 157 CONG. 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
`
`7
`
`
`
`
`
`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).
`
`In addition, West-Ward 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. As explained
`
`below, West-Ward will assume an “understudy” role if it is joined to the Par IPR.
`
`West-Ward will only assume an active role in the event that Par settles with
`
`Novartis.
`
`In challenging claims 1-3 of the ’224 Patent, West-Ward will rely on the
`
`same grounds, evidence, and expert support that was relied on in the now instituted
`
`Par IPR. West-Ward proposes that if joined with the Par IPR, Par and West-Ward
`
`will make consolidated filings, for which Par will be responsible, and no additional
`
`pages will be allowed for West-Ward. In addition, West-Ward will coordinate with
`
`Par on all discovery and trial, with Par being responsible for questioning of
`
`witnesses and defense of witnesses at depositions, and Par being responsible for the
`
`presentation at the oral hearing. This procedure would minimize any complication
`
`or delay caused by joinder, and would create less complication than previously
`
`allowed by the Board. See Dell, IPR2013-00385, Paper 17 at 8-9 and Motorola
`
`Mobility LLC v. SoftView LLC, IPR2013-00256, Paper 10 at 8-10 (where the Board
`
`ordered the petitioners to make consolidated filings, for which the first petitioner
`
`8
`
`
`
`
`
`was responsible, and allowed the new petitioner to file seven additional pages with
`
`corresponding additional responsive pages allowed to the Patent Owner, and where
`
`the Board permitted the petitioners to manage the questioning at depositions and
`
`presentations at the hearing to avoid redundancy).
`
`West-Ward’s IPR Petition and Par’s IPR Petition rely on testimony from the
`
`same experts, Dr. Ratain and Dr. Bennett. Par has consented to West-Ward’s
`
`joinder, and Par and West-Ward have agreed to work together with respect to
`
`Dr. Ratain and Dr. Bennett; therefore this aspect of the IPR will present no
`
`additional burden on the Patent Owner. Further, West-Ward will cooperate with
`
`Par to simplify briefing and discovery wherever possible. All of these procedures
`
`are consistent with precedent. See, e.g., Dell, IPR2013-00385, Paper 17; Motorola,
`
`IPR2013-00256, Paper 10.
`
`Furthermore, West-Ward diligently and timely filed its petition and motion
`
`for joinder within the time set by statute. 37 C.F.R. §§ 42.22 and 42.122(b).
`
`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.
`
`9
`
`
`
`
`
`C. Without Joinder, West-Ward And The Public Would Be
`Prejudiced
`
`West-Ward would be prejudiced if it is not permitted to join and to
`
`participate in the Par IPR, as a decision in the Par IPR could impact the issues in
`
`West-Ward’s underlying District Court litigation (Novartis Pharm. Corp. et al. v.
`
`Roxane Labs., Inc., No. 1:15-cv-474-RGA (D. Del.)).
`
`Further, the public interest may be harmed if West-Ward is not joined to the
`
`Par IPR. As mentioned above, while Novartis has sued West-Ward in Delaware
`
`District Court for infringement of the ’224 patent (and had sued Par for
`
`infringement of the ’224 patent), West-Ward has not found any evidence that Par or
`
`Argentum is currently involved in District Court litigation related to the ’224 patent.
`
`See supra, n.3. If West-Ward is not joined to the Par IPR, settlement with Novartis
`
`prior to a written decision is more likely. This increases the likelihood that a
`
`proceeding to establish the unpatentability of the invalid claims of the ’224 patent,
`
`claims that Novartis asserts cover its commercial AFFINITOR® drug product, will
`
`be terminated. This is not in the public interest because it increases the likelihood
`
`that an invalid patent will delay commercial sale of a generic AFFINITOR® drug
`
`product. For this reason, failure to join West-Ward to the Par IPR prejudices the
`
`public interest.
`
`10
`
`
`
`
`
`Joinder Will Not Prejudice Patent Owner Or Par
`
`D.
`Permitting joinder will not prejudice Novartis or Par. West-Ward’s proposed
`
`grounds for instituting an IPR for claims 1-3 of the ’224 Patent are identical to the
`
`four grounds on which the Decision of Institution was based in the Par IPR (Case
`
`No. IPR2016-01479), and relies on the same evidence and expert support.
`
`Moreover, Par does not object to joinder of West-Ward.
`
`For all of the foregoing reasons, joinder will not affect the timing of the Par
`
`IPR.
`
`IV. CONCLUSION
`For the foregoing reasons, West-Ward respectfully requests that the Board
`
`grant West-Ward’s Petition for inter partes review of claims 1-3 of the ’224 Patent
`
`and join that inter partes review proceeding with Par Pharmaceutical, Inc. v.
`
`Novartis AG, Case No. IPR2016-01479.
`
`
`
`March 13, 2017
`
`
`
`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 West-Ward
`Pharmaceuticals International Limited
`
`11
`
`
`
`
`
`
`
`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 13th day of March, 2017 on the Patent Owner by serving via
`
`overnight delivery to the correspondence address of record for U.S. Patent
`
`No. 9,006,224 shown in PAIR and Novartis Pharmaceuticals Corporation’s current
`
`litigation counsel in Novartis Pharm. Corp. et al. v. Roxane Labs., Inc., No. 1:15-cv-
`
`474-RGA (D. Del.):
`
`Novartis Pharmaceuticals 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 Federal Express
`
`
`
`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 Pharmaceutical,
`
`Inc. v. Novartis AG, IPR2016-01479 as follows:
`
`Par Pharmaceutical, Inc.
`
`Daniel Brown
`Latham & Watkins LLP
`885 Third Avenue
`New York, NY 10022-4834
`
`
`
`
`
`Jonathan M. Strang
`Latham & Watkins LLP
`555 Eleventh Street, NW, Ste. 1000
`Washington, DC 20004-1304
`
`
`
`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
`
`
`
`
`March 13, 2017
`
`
`
`
`
`
`
`
`
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