By: B. Jefferson Boggs, Esq.
`
`Matthew L. Fedowitz, Esq.
`Daniel R. Evans, Esq.
`MERCHANT & GOULD P.C.
`1701 Duke Street, Suite 310
`Alexandria, VA 22314
`jboggs@merchantgould.com
`mfedowitz@merchantgould.com
`devans@merchantgould.com
`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. 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)
`
`
`
`
`Matthew L. Fedowitz, Esq.
`Daniel R. Evans, Esq.
`MERCHANT & GOULD P.C.
`1701 Duke Street, Suite 310
`Alexandria, VA 22314
`jboggs@merchantgould.com
`mfedowitz@merchantgould.com
`devans@merchantgould.com
`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. 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 CONTENTS
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED .............................. 1
`STATEMENT OF THE PRECISE RELIEF REQUESTED ............................ .. 1
`
`
`
`I.
`I.
`
`II. STATEMENT OF MATERIAL FACTS ............................................................. 1
`
`STATEMENT OF MATERIAL FACTS ........................................................... .. 1
`
`II.
`
`III. STATEMENT OF REASONS FOR RELIEF REQUESTED ............................ 3
`III. STATEMENT OF REASONS FOR RELIEF REQUESTED .......................... .. 3
`
`JOINDER WILL NOT II\/IPACT THE BOARD’S ABILITY TO
`
`JOINDER WILL NOT IMPACT THE BOARD’S ABILITY TO
`COMPLETE THE REVIEW IN A TIMELY MANNER ...................... 4
`
`COMPLETE THE REVIEW IN A TIMELY MANNER .................... .. 4
`
`A.
`
`A.
`
`B.
`
`B.
`
`JOINDER VVILL PROMOTE EFFICIENCY BY
`
`CONSOLIDATING ISSUES AND PREVENTING
`
`JOINDER WILL PROMOTE EFFICIENCY BY
`CONSOLIDATING ISSUES AND PREVENTING
`INCONSISTENCIES ............................................................................... 8
`
`INCONSISTENCIES ............................................................................. .. 8
`
`C. WITHOUT JOINDER, BRECKENRIDGE MAY BE
`C. WITHOUT JOINDER, BRECKENRIDGE MAY BE
`PREJUDICED .......................................................................................... 8
`PREJUDICED ........................................................................................ .. 8
`
`D.
`
`D.
`
`JOINDER WILL NOT PREJUDICE PATENT OWNER OR
`
`JOINDER WILL NOT PREJUDICE PATENT OWNER OR
`PAR ........................................................................................................... 8
`
`PAR ......................................................................................................... .. 8
`
`IV. CONCLUSION ..................................................................................................... 8
`
`IV. CONCLUSION ................................................................................................... .. 8
`
`
`
`
`
`i
`
`
`
`I.
`
`
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED
`Petitioner Breckenridge Pharmaceutical, Inc. (“Breckenridge” or the
`
`“Petitioner”) respectfully requests joinder pursuant to 35 U.S.C. § 315(c) and 37
`
`C.F.R. § 42.122(b) of the above-captioned inter partes review (hereinafter
`
`“Breckenridge IPR”) with the pending inter partes review concerning the same
`
`patent and 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. 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 of
`
`institution of the Par IPR.
`
`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 Breckenridge IPR.
`
`2.
`
`On August 13, 2014, Novartis Pharmaceuticals Corporation and
`
`Novartis AG (“Novartis”) filed a complaint accusing Breckenridge of infringing
`
`the ’772 patent. On August 27, 2014, the waiver of service of summons was
`
`
`
`1
`
`
`
`filed. Novartis Pharmaceuticals Corporation and Novartis AG. v.
`
`Breckenridge Pharmaceutical, Inc., C.A. No. 1:14-CV-01043-RJA (D. Del.).
`
`3.
`
`Par Pharmaceutical, Inc. (“Par”) filed its petition for inter partes
`
`review of the ’772 patent on October 26, 2015. (Par IPR, IPR2016-00084).
`
`4.
`
`The Par IPR included the following four 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;
`
`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;
`
`Ground 3: Claims 1-3 and 10 of the ’772 Patent Would Have Been
`
`Obvious Over Routine Use of Computer-Aided Drug Design Software In View of
`
`Morris, Van Duyne, Lemke, and Yalkowsky; and,
`
`Ground 4: Claims 8 and 9 are Invalid under 35 U.S.C. § 103 on the
`
`Ground That They Are Rendered Obvious Over Routine Use of Computer-Aided
`
`Drug Design Software In View of Morris, Van Duyne, Lemke, and Yalkowsky,
`
`and in further view of Hughes.
`
`(Par IPR, IPR2016-00084, Petition at p. 38-54).
`
`
`
`2
`
`
`
`5.
`
`The Board instituted the Par IPR on April 29, 2016 on Grounds 1
`
`and 2. (Par IPR, IPR2016-00084, Paper 8 at 5-6, 17).
`
`6.
`
`The Petition filed in the Breckenridge IPR presents only the
`
`identical grounds on which the Par IPR was instituted. Those being Grounds 1
`
`and 2 of the Par IPR.
`
`7.
`
`To date, Par and Breckenridge represent two of the three defendants
`
`involved in pending litigation regarding the ‘772 patent in the District of
`
`Delaware. Roxane Laboratories, Inc. is the third defendant involved in pending
`
`litigation regarding the ‘772 patent also in the District of Delaware.1
`
`
`
`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 states:
`
`(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
`
`1 For a list of related litigations involving the ‘772 patent, see Breckenridge’s
`
`Petition for Inter Partes review, page 7, submitted concurrently herewith.
`
`
`
`3
`
`
`
`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
`
`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 Breckenridge 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 addresses each of these fully 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.
`4
`
`
`
`
`
`
`
`§ 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 time frame because the grounds asserted in the
`
`Breckenridge IPR petition are identical to the grounds on 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 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, Breckenridge 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 Breckenridge will be addressing identical grounds for challenging the
`
`claims at issue, 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
`
`
`
`5
`
`
`
`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 to avoid redundancy. IPR2013-
`
`00385, Paper 17 at 9; IPR2013-00256, Paper 10 at 9-10. Additionally, while the
`
`Petitioner in the Breckenridge IPR and the Petitioner in the Par IPR have relied
`
`upon testimony from separate experts in their respective petitions, the
`
`conclusions and underlying reasoning of the experts are essentially identical, and
`
`therefore present no additional burden on the Patent Owner. All of these
`
`concessions offered by Breckenridge are consistent with precedent. Lupin Ltd.
`
`and Lupin Pharmaceuticals Inc. v. Senju Pjharmaceutical Co. Ltd., IPR2015-
`
`01871, Paper 13; and, Dell, Inc. v. Network-1 Security Solutions, Inc., IPR2013-
`
`00385; Motorola Mobility LLC v. SoftView LLC, IPR2013- 00256.
`
`Furthermore, in order to further simplify the proceeding, Breckenridge
`
`will rely on the same expert as Par, should Par permit it. If Par allows
`
`Breckenridge to retain the same expert, then Breckenridge will withdraw its
`
`expert declaration of Dr. Baldwin and rely solely on the declaration and
`
`
`
`6
`
`
`
`testimony of Par’s expert, Dr. Jorgensen. The Board has previously
`
`acknowledged that such concessions on the part of a party seeking to join are
`
`sufficient to minimize the impact on the original proceeding (see Lupin Ltd. and
`
`Lupin Pharmaceuticals Inc. v. Sunju Pjharmaceutical Co. Ltd., IPR2015-
`
`01871, Paper 13, pages 2-7; and, SAP America Inc. v. Clouding IP, LLC,
`
`IPR2014-00306, Paper 13, page 4).
`
`Even if, through no fault of its own, Breckenridge were required to
`
`proceed with its own expert, there would be no impact on the Board’s ability to
`
`complete its review in a timely manner. Moreover, there would be only a modest
`
`impact on the Patent Owner, given that little additional preparation would be
`
`needed for the deposition of Breckenridge’s expert beyond that required for the
`
`deposition of Par’s expert as the conclusions and underlying reasoning of the
`
`experts are consistent.
`
`In the event that Par does not agree to allow Breckenridge to retain Par’s
`
`expert, and the Board determines it would not be able to complete these
`
`proceedings within the one-year time frame as a result of having to provide the
`
`Patent Owner with the opportunity to additionally depose Dr. Baldwin,
`
`Breckenridge would, in that case, agree to withdraw Dr. Baldwin’s declaration
`
`and instead rely solely on the declaration of Par’s expert, Dr. Jorgensen.
`
`
`
`7
`
`
`
`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.
`
`C. Without joinder, Breckenridge may be prejudiced
`Breckenridge would be prejudiced if it is not permitted to join and
`
`participate in the Par IPR, which will affect not only Breckenridge’s inter partes
`
`review Petition, but also the underlying litigation (Novartis Pharmaceuticals
`
`Corporation and Novartis AG. v. Breckenridge Pharmaceutical, Inc., C.A. No.
`
`1:14-CV-01043-RJA (D.Del.)). This is because the decision in the Par IPR will
`
`likely impact the issues in the underlying litigation.
`
`Joinder will not prejudice Patent Owner or Par
`
`D.
`Permitting joinder will not prejudice Novartis or Par. Breckenridge’s
`
`proposed grounds for instituting an IPR are identical to the two grounds on which
`
`the Decision of Institution was based in the Par IPR (Case No. IPR2016-00084).
`
`Joinder will not affect the timing of the Par IPR, and any extension to the
`
`schedule that may be required is permitted by law and the applicable rules. 35
`
`U.S.C. § 316(a)(1); 37 C.F.R. § 42.100(c).
`
`IV. CONCLUSION
`For the foregoing reasons, Breckenridge respectfully requests that the
`
`8
`
`
`
`
`
`
`
`
`
`
`
`
`
`Board grant its Petition for inter partes review of the ’772 patent and join the
`
`inter partes review proceeding with Par Pharmaceutical, Inc. v. Novartis AG,
`
`Case No. IPR2016-00084.
`
`
`
`May 10, 2016
`
` Respectfully submitted,
`
`
`/Mattthew 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.
`1701 Duke Street, Suite 310
`Alexandria, VA 22314
`jboggs@merchantgould.com
`mfedowitz@merchantgould.com
`devans@merchantgould.com
`Main Telephone: (703) 684-2500
`Main Facsimile: (703) 684-2501
`
`
`
`9
`
`
`
`CERTIFICATION 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 this 10th day of May, 2016 on the Patent Owner by serving via
`
`overnight delivery the correspondence address of record for the ’772 Patent and
`
`counsel for Novartis AG and via FedEx International Priority Novartis AG:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`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
`
`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 email on the counsel
`
`of record for the Petitioner and Patent Owner in Par Pharmaceutical, Inc. v.
`
`Novartis AG, Case No. IPR2016-00084 as follows:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Par Pharmaceutical, Inc.
`
`
`Daniel Brown
`Latham & Watkins, LLP.
`885 Third Avenue
`New York, NY 10022
`daniel.brown@lw.com
`
`Robert Steinberg
`Latham & Watkins, LLP.
`355 South Grand Avenue
`Los Angeles, CA 90071-1560
`bob.steinberg@lw.com
`
`
`Novartis AG
`
`
`Nicholas Kallas
`Fitzpatrick, Cella, Harper & Scinto
`1290 Avenue of the Americas
`New York, NY 10104-3800
`nkallas@fchs.com
`
`
`
`May 10, 2016
`
`
`
`
`
`
`Respectfully submitted,
`
`
`/Mattthew 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.
`1701 Duke Street, Suite 310
`Alexandria, VA 22314
`jboggs@merchantgould.com
`mfedowitz@merchantgould.com
`devans@merchantgould.com
`Main Telephone: (703) 684-2500
`Main Facsimile: (703) 684-2501
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
