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
`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.
`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
`
`
`
`
`
`
`
`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
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED .............................. 1
`
`
`
`I.
`
`II. STATEMENT OF MATERIAL FACTS ............................................................. 2
`
`III. STATEMENT OF REASONS FOR RELIEF REQUESTED ............................ 4
`
`A. Dependent Claim 7 is Unpatentable on the Same Grounds as
`Claims 1, 8, and 9. .................................................................................... 7
`
`B.
`
`C.
`
`Joinder will not impact the Board’s ability to complete the
`review in a timely manner ........................................................................ 9
`
`Joinder will promote efficiency by consolidating issues and
`preventing inconsistencies ..................................................................... 13
`
`D. Without joinder, Breckenridge may be prejudiced ............................... 13
`
`E.
`
`Joinder will not prejudice Patent Owner or Par and Will Benefit
`the Interests of the Public ....................................................................... 14
`
`IV. CONCLUSION ................................................................................................... 15
`
`
`
`
`
`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 directed to Claim 7
`
`of U.S. Patent No. 5,665,772 (hereinafter “Breckenridge CLAIM 7 IPR”) with the
`
`pending inter partes review concerning the same patent and the same grounds of
`
`invalidity in Par Pharmaceutical, Inc. v. Novartis AG, Case No. IPR2016-00084
`
`(“Par IPR”), which was instituted on April 29, 2016 (Paper No. 8).
`
`The instant Motion for Joinder on behalf of Breckenridge is consistent with the
`
`substance of Motion for Joinder of claim 7 of U.S. Patent No 5,665,772 filed on
`
`behalf of Par Pharmaceutical, Inc. in IPR2016-01059, Paper No. 3 (“Par CLAIM 7
`
`IPR”). To the extent the Motion for Joinder (Paper No. 3) filed on behalf of Par
`
`Pharmaceutical, Inc. in IPR2016-01059 is granted, Breckenridge requests this Motion
`
`for Joinder of Claim 7 also be granted as the arguments and substance are essentially
`
`the same. 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 instituted Par IPR (IPR2016-00084) or the pending Par Claim 7 IPR
`
`(IPR2016-01059). 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. (IPR2016-00084).
`
`
`
`1
`
`
`
`
`
`II.
`
`STATEMENT OF MATERIAL FACTS
`
`1.
`
`Breckenridge is not aware of any reexamination certificates or
`
`pending prosecution concerning the ‘772 patent, which is the subject of the Par IPR
`
`(IPR2016-00084), the Breckenridge IPR (IPR2016-01023), the Par Claim 7 IPR
`
`(IPR2016-01059), and the present Breckenridge Claim 7 IPR petition.
`
`2.
`
`On August 13, 2014, Novartis Pharmaceuticals Corporation and
`
`Novartis AG (collectively “Novartis”) filed a complaint accusing Breckenridge of
`
`infringing the ’772 patent. On August 27, 2014, the waiver of service of summons
`
`was filed. Novartis Pharmaceuticals Corp. and Novartis AG. v.Breckenridge
`
`Pharmaceutical, Inc., C.A. No. 1:14-CV-01043-RJA (D. Del.).
`
`3.
`
`Par filed its petition for inter partes review of the ’772 patent on
`
`October 26, 2015. (Par IPR, IPR2016-00084).
`
`4.
`
`The Par IPR petition (IPR2016-00084) included 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;
`
`
`
`2
`
`
`
`
`
`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, Paper No. 2 at p. 38-54).
`
`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.
`
`On May 10, 2016, Breckenridge filed its motion for joinder and its
`
`petition seeking inter partes review on identical grounds on which the Par IPR was
`
`instituted - those being Grounds 1 and 2 of the Par IPR. (Breckenridge IPR,
`
`IPR2016-01023).
`
`7.
`
`On May 17, 2016, Par filed its motion for joinder and its petition
`
`seeking inter partes review of claim 7, which depends directly from claim 1, on the
`
`same grounds, the same prior art, expert testimony, and other evidence relied on by
`
`the Board in instituting review of claims 1, 8, and 9 in IPR2016-00084. (Par Claim 7
`
`IPR, IPR2016-01059, Paper No. 3).
`
`8.
`
`As with the Par Claim 7 IPR (IPR2016-01059), the concurrently filed
`
`petition relies on the same grounds, the same prior art, expert testimony, and other
`
`
`
`3
`
`
`
`
`
`evidence relied on by the Board in instituting review of claims 1, 8, and 9 in
`
`IPR2016-00084. (Par Claim 7 IPR, IPR2016-01059, Paper No. 1).
`
`9.
`
`Claim 7 of the ’772 Patent is directed to a pharmaceutical
`
`composition comprising a therapeutically effective amount of a compound of
`
`claim 1 and a pharmaceutically acceptable carrier. Claim 8 is directed to a
`
`method of administering an immunosuppressant effective amount of a compound
`
`of claim 1 to induce an immunosuppressant effect. Claim 9 is similar to
`
`claim 8 but is directed to a method of preventing allograft rejection.
`
`10.
`
`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. (Roxane) 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
`
`1 For a list of related litigations involving the ‘772 patent, see Breckenridge’s
`
`Petition for Inter Partes review, section II.B, submitted concurrently herewith.
`
`
`
`4
`
`
`
`
`
`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.
`
`Joinder of inter partes review proceedings is permitted up to one month after
`
`the institution decision. 37 C.F.R. § 42.122(b).
`
`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., IPR2013-00385, Paper No. 17, at 3 (PTAB July 29, 2013). 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. Furthermore, the
`
`Board takes into account “the particular facts of each case, substantive and
`
`procedural issues, and other considerations,” while remaining “mindful that patent
`
`trial regulations, including the rules for joinder, must be construed to secure
`
`the just, speedy, and inexpensive resolution of every proceeding.” Id. at 3.
`
`
`
`5
`
`
`
`
`
`Joinder allows a petitioner to join new issues to an existing proceeding even
`
`if the petitioner was served with a complaint alleging infringement of the patent
`
`over one year ago. 35 U.S.C. § 315(b) (the time limit “shall not apply” to a request
`
`for joinder); 37 C.F.R. § 42.122(b) (same); Ariosa Diagnostics, Inc. v. Isis
`
`Innovation Ltd., IPR2013-00250, Paper No. 24 (PTAB Sept. 3, 2013)(joining
`
`dependent claims to a proceeding); see also Target Corp. v. Destination Maternity
`
`Corp., No. IPR2014-00508, Paper No. 28 (PTAB Feb. 12, 2015) (seven-judge
`
`panel granting rehearing for joining a new ground with new prior art); Samsung
`
`Elecs. Co. v. Va. Innovation Scis., Inc., No. IPR2014-00557, Paper No. 28
`
`(PTAB June 13, 2014) (joining additional claims).
`
`“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.” See Dell, IPR2013-00385, Paper No. 17, at 4 (July 29, 2013).
`
`Joinder is justified when, as here, the second petition involves the same
`
`patent, the same references, the same expert declaration, and essentially
`
`identical patent scope as the instituted petition. “[T]he possibility of broadening
`
`the scope of issues” is not “an adequate reason for denying joinder” particularly
`
`where the joined petition “is based on the prior art already of record” and “the
`
`
`
`6
`
`
`
`
`
`impact of joinder on the previous proceeding will be minimal from both a
`
`procedural and substantive view point.” Enzymotec Ltd. v. Neptune Tech. &
`
`Biores., Inc., IPR2014-00556, Paper No. 19, at 5 (PTAB. July 9, 2014).
`
`Under this framework, joinder of the instant Breckenridge Claim 7 IPR with
`
`the Par IPR (IPR2016-00084) is appropriate to the extent the Par Claim 7 IPR
`
`(IPR2016-01059) Motion for Joinder is also granted.
`
`A. Dependent Claim 7 is Unpatentable on the Same Grounds as
`Claims 1, 8, and 9.
`
`Joinder is appropriate here because, as demonstrated in the accompanying
`
`petition, dependent claim 7 is unpatentable using the same prior art, expert
`
`declaration, and other submitted evidence already considered with respect to the
`
`instituted claims 1, 8, and 9 in the Par IPR (IPR2016-00084).
`
`The Board has held joinder is appropriate to add challenges to claims
`
`that are dependent on claims under review in an instituted petition, even when
`
`citing additional prior art to address the limitations of the dependent claims.
`
`Ariosa, IPR2013-00250, Paper 25 at 2-3 (adding new dependent claims and new
`
`ground of invalidity for dependent claim 9); see also Enzymotec, IPR2014-
`
`00556, Paper 19 at 5-6 (allowing joinder of additional claims in part as the
`
`grounds were based on prior art already of record). The rationale for joinder here
`
`is even stronger than in Ariosa or Enzymotec because no new art, testimony, or
`
`other evidence is required to assess the patentability of claim 7.
`7
`
`
`
`
`
`
`
`The Board held that joinder is appropriate to allow challenges to claims
`
`originally denied institution even where the new grounds use the same art in a new
`
`combination. Samsung, IPR2014-00557, Paper 10 at 14-18 (granting institution
`
`of claims 58 and 63, which were denied institution in the original petition
`
`(Paper 3 at 2, 17)). Thus, even in the face of allowing a petitioner to reargue
`
`the unpatentability of non-instituted claims, the Board joined a petition to add
`
`dependent claims that added minimal new subject matter described in a prior art
`
`reference already of record. Id. at 17. Again, the case for joinder is stronger
`
`here because Breckenridge relies on the same combination already applied
`
`against instituted claims 8 and 9, and the Board has not already addressed and
`
`declined institution on claim 7. In these circumstances, joinder is appropriate.
`
`Indeed, joinder is more justified here than in Ariosa, Enzymotec, or
`
`Samsung. The unpatentability of claim 7 is the same as for the instituted claims 1,
`
`8, and 9. Claim 7 recites pharmaceutical compositions comprising a compound of
`
`claim 1, and the validity of this claim “rise[s] or fall[s] with the validity of” the
`
`compound claim. Aventis Pharma Deutschland GmbH v. Lupin, Ltd., 499 F.3d
`
`1293, 1303 (Fed. Cir. 2007) (finding a dependent pharmaceutical composition
`
`claim obvious because the independent compound claim was obvious and the
`
`prior art disclosed combining ACE inhibitors with pharmaceutical excipients).
`
`Indeed, the specification of the ’772 Patent acknowledges that the compounds
`
`
`
`8
`
`
`
`
`
`can be administered via any “conventional” route, including standard
`
`compositions and carriers in tablets, capsules, solutions, and suspensions. (Ex.
`
`1001, ’772 Patent at 5:4-8.)
`
`Further, claims to a pharmaceutical composition comprising a
`
`therapeutically effective amount of a compound in combination with a
`
`pharmaceutical carrier are not patentably distinct from claims to methods of
`
`administering that compound in an amount to affect its therapeutic purpose.
`
`Geneva Pharm., Inc. v. Glaxosmithkline PLC, 189 F. Supp. 2d 377, 384-85 (E.D.
`
`Va. 2002), aff’d 349 F.3d 1373 (Fed. Cir. 2003). The patentably indistinct claims
`
`analyzed in Geneva closely mirror claim 7 and claims 8 and 9. Id. Indeed, the
`
`Board’s analysis of claim 8, which requires administering an effective amount of
`
`the compound of claim 1 to induce an immunosuppressant effect, essentially
`
`acknowledges that the compound would be included in pharmaceutical
`
`compositions in “therapeutically effective amounts” with an acceptable carrier. Par
`
`Pharm., IPR2016-00084, Paper 8 at 15-16. Given this identity of analysis,
`
`joinder is appropriate to consider the patentability of claim 7 consistently with
`
`claims 1, 8, and 9.
`
`B.
`
`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. §
`9
`
`
`
`
`
`
`
`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 instant petition
`
`are identical to the grounds – the same prior art, expert testimony, and other
`
`evidence – relied on by the Board in instituting review of claims 1, 8, and 9 in the
`
`Par IPR (IPR2016-00084).
`
`In addition, the grounds asserted in the instant petition are essentially identical
`
`to those in the Par Claim 7 (IPR2016-01059).
`
`The narrow issue presented in the current petition as compared to the
`
`instituted petition in the Par IPR (IPR2016-00084) makes it particularly amenable
`
`to accelerated briefing under the Board’s discretionary authority under
`
`37 C.F.R. § 42.5(c)(1). In instituting the Par IPR (IPR2016-00084), the Board
`
`already determined that Petitioner demonstrated a reasonable likelihood of success
`
`in proving claims 1, 8, and 9 invalid. Thus, the only issue raised by the instant
`
`petition is the additional limitation included in claim 7.
`
`Preparing a Preliminary Response limited to claim 7 should not present a
`
`significant additional burden to Novartis as it is already aware of the substantive
`
`arguments from the references and expert declaration. Determining whether
`
`including a compound of claim 1 in a pharmaceutical composition is obvious
`
`
`
`10
`
`
`
`
`
`should require no significant additional analysis over that for claims 1, 8, and 9,
`
`addressed in the instituted petition. The same can be said with regard to Novartis
`
`needing to only take one deposition to cross-examine Dr. Jorgenson regarding his
`
`single declaration.
`
`Breckenridge is amenable to 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. Breckenridge is willing to coordinate in
`
`an understudy role with Par regarding their respective IPRs relating to the ‘772
`
`patent and Breckenridge is also agreeable to the proposed timing and schedule
`
`contemplated in the Par Claim 7 IPR (IPR2016-01059, Paper No. 3). By
`
`coordinating between the parties, harmonizing the remaining dates between the
`
`petitions filed by Breckenridge and Par will be simplified.
`
`In addition to or as an alternative, 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
`
`
`
`11
`
`
`
`
`
`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.
`
`Moreover, the Petitioner in the instant Breckenridge Claim 7 IPR and the
`
`Petitioner in the pending Par Claim 7 IPR can coordinate with the same expert, Dr.
`
`Jorgenson, as the Petitioner’s reliance upon testimony from the same expert and the
`
`conclusions and underlying reasoning is identical. Because of this, there is 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 Pharmaceutical Co. Ltd., IPR2015-01871, Paper 13
`
`(PTAB January 25, 2016); and, Dell, Inc. v. Network-1 Security Solutions, Inc.,
`
`IPR2013-00385; Motorola Mobility LLC v. SoftView LLC, IPR2013-00256.
`
`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. Senju
`
`Pharmaceutical Co. Ltd., IPR2015-01871, Paper 13, at 2-7; and, SAP America
`
`Inc. v. Clouding IP, LLC, IPR2014-00306, Paper 13, at 4).
`
`
`
`12
`
`
`
`
`
`Because the current petition may be joined to the instituted petition
`
`without any additional discovery, without disturbing the current schedule, and
`
`with no discernible prejudice to Novartis, joinder is appropriate.
`
`C.
`
`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.
`
`Because the current petition offers no new substantive arguments, evidence,
`
`references, or testimony, does not disrupt the schedule for the instituted
`
`proceedings, and does not add additional discovery, joinder of this petition with the
`
`instituted petition is appropriate.
`
`D. Without joinder, Breckenridge may be prejudiced
`
`Breckenridge would be prejudiced if it is not permitted to join and participate
`
`in the Par IPR (IPR2016-00084) in a similar manner as requested the motion for
`
`joinder filed in the Par Claim 7 IPR (IPR2016-01059). Further, not only
`
`Breckenridge’s inter partes review Petition will be affected, 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.)). A
`
`decision in IPR2016-00084 and IPR2016-01059 will likely impact the underlying
`
`litigation.
`
`
`
`13
`
`
`
`
`
`E.
`
`Joinder will not prejudice Patent Owner or Par and Will Benefit
`the Interests of the Public
`
`Permitting joinder will not prejudice Novartis or Par. Breckenridge’s
`
`proposed grounds for instituting an IPR are essentially the same as the grounds, the
`
`exact same prior art, expert testimony, and other evidence relied on by the Board in
`
`instituting review of claims 1, 8, and 9 in the Par IPR (IPR2016-00084) and by Par
`
`in the Par Claim 7 IPR (IPR2016-01059).
`
`To the extent there exists a minimal burden stemming from addressing
`
`claim 7, it is “strongly outweighed by the public interest in having consistency
`
`of outcome concerning similar sets of claimed subject matter and prior art.”
`
`Samsung, IPR2014-00557, Paper 10, at 18. The public interest in the integrity of
`
`the patent system is identical for claim 7 as it is for claims 1, 8, and 9 and warrants
`
`its joinder to the instituted petition. Because of the lack of any patentable
`
`distinction between claim 7 and claims 1, 8, and 9, Aventis Pharma, 499 F.3d at
`
`1303; Geneva, 189 F. Supp. 2d at 384-85, the public would be disadvantaged if
`
`claims 1, 8, and 9 were canceled and yet claim 7 remained in force,
`
`preventing the public from practicing the canceled claims. Cf. In re
`
`Metoprolol Succinate Patent Litig., 494 F.3d 1011, 1017-18 (Fed. Cir. 2007).
`
`Additionally, joining claim 7 to the instituted proceedings allows for
`
`resolution of the disputes between the Parties concerning the ’772 patent because
`
`Novartis has asserted claim 7 against Breckenridge in the related district court
`14
`
`
`
`
`
`
`
`litigation. Joinder in this instance meets the stated goal to allow for the “just,
`
`speedy, and inexpensive resolution” of the entire dispute. See 37 C.F.R. § 42.1(b).
`
`In view of the strong public interest and the minimal burden on Novartis,
`
`joinder is particularly appropriate here. Samsung, IPR2014-00557, Paper 10 at 18.
`
`IV. CONCLUSION
`
`For the foregoing reasons, Breckenridge respectfully requests that the
`
`Board grant the instant Petition for inter partes review of the ’772 patent and join
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`the inter partes review proceeding with Par Pharmaceutical, Inc. v. Novartis AG,
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`Case No. IPR2016-00084.
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`May 26, 2016
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`Respectfully submitted,
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`/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.
`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
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`15
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`CERTIFICATION OF SERVICE
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`The undersigned hereby certifies that this “MOTION FOR JOINDER
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`PURSUANT TO 35 U.S.C. § 315(c) AND 37 C.F.R. § 42.122(b)” was served in
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`its entirety this 10th day of May, 2016 on the Patent Owner by serving via
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`overnight delivery the correspondence address of record for the ’772 Patent and
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`counsel for Novartis AG and via FedEx International Priority Novartis AG:
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`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
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`Novartis International AG
`Novartis Campus
`Attn: Alisa A. Harbin, Esq. (Head, Group Litigation and
`Intellectual Property)
`Forum 1-1.20
`Basel, CH-4002
`SWITZERLAND
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`Courtesy copies of the foregoing were also served via email on the counsel
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`of record for the Petitioner and Patent Owner in Par Pharmaceutical, Inc. v.
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`Novartis AG, Case No. IPR2016-00084 as follows:
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`Par Pharmaceutical, Inc.
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`Daniel Brown
`Latham & Watkins, LLP.
`885 Third Avenue
`New York, NY 10022
`daniel.brown@lw.com
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`Robert Steinberg
`Latham & Watkins, LLP.
`355 South Grand Avenue
`Los Angeles, CA 90071-1560
`bob.steinberg@lw.com
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`Novartis AG
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`Nicholas Kallas
`Fitzpatrick, Cella, Harper & Scinto
`1290 Avenue of the Americas
`New York, NY 10104-3800
`nkallas@fchs.com
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`May 26, 2016
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`Respectfully submitted,
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`
`/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.
`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
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