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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`
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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. IPR2016-01023
`Patent No. 5,665,772
`_____________________
`
`
`
`REPLY TO PATENT OWNER NOVARTIS’S OPPOSITION TO
`PETITIONER BRECKENRIDGE’S MOTION FOR JOINDER
`
`

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`TABLE OF CONTENTS
`
`TABLE OF CONTENTS
`
`
`Introduction .......................................................................................................... 1 
`Introduction ........................................................................................................ .. 1
`
`I. 
`
`I.
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`II.  Breckenridge’s Motion for Joinder Is Not Time-Barred .................................. 1 
`II.
`Breckenridge’s Motion for Joinder Is Not Time-Barred ................................ ..1
`
`III. 
`III.
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`Joinder Does Not Prejudice Novartis, Par, or the Board .................................. 2 
`Joinder Does Not Prejudice Novartis, Par, or the Board ................................ ..2
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`IV.  Denying Joinder Will Prejudice Breckenridge ................................................. 5 
`IV. Denying Joinder Will Prejudice Breckenridge ............................................... ..5
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`
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`
`
`i
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`

`
`
`CASES
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Dell Inc. v. Elecs. and Telecomms. Research, Inst.
`IPR2015-00549 ..................................................................................................... 5
`
`Dell, Inc. v. Network-1 Security Solutions, Inc.,
`IPR2013-00385 ..................................................................................................... 1
`
`Lupin Ltd. v. Senju Pharm. Co. Ltd.,
`IPR2015-01871 ..................................................................................................... 3
`
`Motorola Mobility LLC v. SoftView LLC,
`IPR2013-00256 ..................................................................................................... 1
`
`Samsung Elecs. Co., Ltd. v. Arendi S.A.R.L.
`IPR2014-00142 ..................................................................................................... 4
`
`Snap-On Inc. v. Milwaukee Electric Tool Corp.,
`IPR2016-00345 ..................................................................................................... 3
`
`ZTE Corp. v. Adaptix Inc.
`IPR2015-01184 ..................................................................................................... 5
`
`STATUTES
`
`35 U.S.C. § 102(b) ................................................................................................. 1, 4
`
`35 U.S.C. § 315(b) ..................................................................................................... 2
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`35 U.S.C. § 315(c) ................................................................................................. 2, 3
`
`35 U.S.C. § 363 .......................................................................................................... 4
`
`OTHER AUTHORITIES
`
`37 C.F.R. § 42.122(b) ................................................................................................ 2
`
`MPEP § 1893.03(b).................................................................................................... 4
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`MPEP § 706.02 .......................................................................................................... 4
`
`
`
`ii
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`

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`I.
`
`Introduction
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`In its opposition, Novartis raises two primary arguments. First, Novartis
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`alleges that Breckenridge’s petition and motion for joinder were “late-filed.”
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`Second, Novartis alleges that granting Breckenridge’s motion for joinder will
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`prejudice Novartis based on its inclusion of Dr. Baldwin’s declaration and
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`identifying prior art under 35 U.S.C. § 102(b); as well as a contrived theory that
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`Breckenridge will raise further new exhibits or arguments in reply to Patent
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`Owner’s response. These arguments do not withstand scrutiny.
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`Novartis implicitly acknowledges the weakness in its arguments by
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`conceding that it will not oppose joinder if Breckenridge agrees to procedures
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`similar to those already proposed in Breckenridge’s motion for joinder. Paper 5 at
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`5-6. For example, Breckenridge proposed that the Board may adopt procedures
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`analogous to those in Dell, Inc. v. Network-1 Security Solutions, Inc., IPR2013-
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`00385 (Paper 17 at 8-9) and Motorola Mobility LLC v. SoftView LLC, IPR2013-
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`00256 (Paper 10 at 8-10). Breckenridge also stated that it seeks to join the Par IPR
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`in an understudy role without any active participation separate from Par unless
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`authorized by the Board and pertaining to an issue unique to Breckenridge.
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`II. Breckenridge’s Motion for Joinder Is Not Time-Barred
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`Novartis refers to Breckenridge’s petition as “late-filed.” Paper 12 at 1, 4, 6.
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`This is disingenuous. Breckenridge’s petition and accompanying motion for
`
`
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`1
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`

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`joinder to IPR2016-00084 were timely filed and are ripe for joinder.
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`37 C.F.R. § 42.122(b) provides that joinder may be requested no later than
`
`one month after the institution date of any inter partes review for which joinder is
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`requested. See also 35 U.S.C. § 315(b) and (c). Inter partes review in IPR2016-
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`00084 was instituted on April 29, 2016. IPR2016-00084, Paper 8. Breckenridge
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`filed its petition and motion to join on May 10, 2016 within one month of the
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`institution date in accordance with 37 C.F.R. § 42.122(b). IPR2016-01023, Papers
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`4-6. On this basis, Breckenridge’s petition and motion are timely.
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`III. Joinder Does Not Prejudice Novartis, Par, or the Board
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`Novartis alleges prejudice because of Breckenridge’s reliance on the
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`declaration of Dr. Baldwin. Paper 12 at 4-5. Novartis’s argument, however,
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`disregards Breckenridge’s motion for joinder and its representations to the Board
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`regarding Dr. Baldwin’s declaration.1
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`Breckenridge repeatedly stated it will adopt Dr. Jorgensen’s declaration
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`should Par agree. In its motion for joinder, Breckenridge stated “Breckenridge will
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`rely on the same expert as Par, should Par permit it.” Paper 5 at 6. Breckenridge’s
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`1 Novartis alleges that Breckenridge’s petition does not cite to Dr. Jorgensen’s
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`declaration (Ex. 1003). However, Breckenridge’s petition cites Dr. Baldwin’s
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`declaration (Ex. 1030), which repeatedly refers to Dr. Jorgensen’s declaration. See
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`Ex. 1030, ¶¶ 17, 40, 44, 49, 50, 69, 118, 133, 177.
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`2
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`

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`counsel said the same during the June 1, 2016 teleconference with the Board. Ex.
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`1033, p. 35, ll. 7-14. In response, Par’s counsel also indicated he did not oppose
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`Breckenridge using or relying on Dr. Jorgensen’s testimony. Id. at p. 35, l. 20-p.
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`36, l. 9. The Board recognized this agreement during the teleconference. Id. at p.
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`36, ll. 10-13. As a result, Novartis has no basis to allege any prejudice based on Dr.
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`Baldwin’s declaration being a new exhibit or presenting new arguments.
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`Novartis takes issue that Breckenridge has not withdrawn Dr. Baldwin’s
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`declaration despite its agreement to adopt Dr. Jorgensen’s declaration. Paper 12 at
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`4, fn. 1. Novartis’s argument fails to recognize proper procedure before the Board
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`as set forth, inter alia, in Lupin Ltd. v. Senju Pharm. Co. Ltd., IPR2015-01871,
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`Paper 13 at 2 (Jan. 25, 2016) where the Board stated “[w]e first address whether [a]
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`petition warrants review; only then do we address whether joinder is appropriate.
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`See 35 U.S.C. § 315(c).” See also Snap-On Inc. v. Milwaukee Electric Tool Corp.,
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`IPR2016-00345, Paper 12 at 2 (April 25, 2016). In view of this, Novartis’s request
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`lacks procedural foundation. A petition and its exhibits must stay intact for the
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`Board to examine the petition’s sufficiency prior to any decision on joinder.
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`Novartis cannot now disturb the record in an attempt to create a post-filing
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`deficiency in the petition and a scenario where the petition and associated evidence
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`are not supported by a declarant. Furthermore, Novartis’s arguments are
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`questionable procedurally given that any burden rests with it to file a motion to
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`3
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`

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`exclude evidence which would be due at a later “to be determined” Due Date 4.
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`Based on these procedural requirements, Novartis’s request should be disregarded.
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`Novartis also alleges that granting Breckenridge’s motion for joinder will
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`prejudice Novartis because the petition identifies Morris 1992 (Ex. 1005) as pre-
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`AIA § 102(b) prior art. This is not a new argument. Rather, it is a fact that Morris
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`1992 qualifies as prior art under § 102(b). A printed publication published “more
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`than one year prior to the date of the application for patent in the United States” is
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`prior art under pre-AIA § 102(b). Morris 1992 qualifies as such because it
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`published in January 1992, which is more than one year prior to the U.S. filing date
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`for the ’772 patent of September 24, 1993. The foreign priority date for GB
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`9221220 is not the date from which § 102(b) is calculated. 35 U.S.C. §§ 102(b),
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`363; MPEP §§ 706.02, 1893.03(b). Indeed, Novartis has never alleged that Morris
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`1992 is not prior art under § 102(b) or that it can be antedated and removed as prior
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`art. Novartis has been aware of Morris 1992 since at least the filing date of the Par
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`IPR. It cannot now argue that Breckenridge’s reliance on Morris 1992 as § 102(b)
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`prior art is a new argument or exhibit prejudicial to Novartis.
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`The cases Novartis points to where joinder was denied are distinguishable
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`from the facts and posture of this IPR. In Samsung Elecs. Co., Ltd. v. Arendi
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`S.A.R.L., the petitioner submitted a declaration from a different expert “to present
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`non-redundant rationale further supporting the instituted ground.” IPR2014-00142,
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`4
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`

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`Paper 11 at 6. Dr. Baldwin does not offer “non-redundant rationale”; his opinions
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`are the same as those of Dr. Jorgensen. In ZTE Corp. v. Adaptix Inc., the petitioner
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`stated it would rely on the existing expert in the instituted proceeding, but the
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`deposition of that expert had already occurred. IPR2015-01184, Paper 10 at 4-5.
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`Here, Dr. Jorgensen has not yet been deposed. In Dell Inc. v. Elecs. and
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`Telecomms. Research, Inst., the Board declined to add a third petitioner for a small
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`subset of claims at issue in an instituted trial. IPR2015-00549, Paper 10 at 8. In the
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`instant matter, Breckenridge seeks to join the Par IPR with respect to all of the
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`claims at issue in that IPR, not a small subset of claims at issue.
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`IV. Denying Joinder Will Prejudice Breckenridge
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`Novartis brushes aside the prejudice Breckenridge will face should joinder
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`be denied. Novartis alleges that a decision in the Par IPR will be the same whether
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`or not Breckenridge joins that IPR. Novartis’s argument fails to recognize the
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`consequences to Breckenridge if Par settles the Par IPR. Without joinder,
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`Breckenridge would no longer be able to step into the shoes of Par and pursue the
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`instituted IPR proceedings challenging the patentability of the claims at issue in the
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`’772 patent. In addition, any decision in the Par IPR will likely impact the
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`Delaware litigation involving Breckenridge, Par and Roxane.
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`5
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`

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`Respectfully submitted,
`
`
` /Matthew L. Fedowitz/
`By:
`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
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`Date: July 11, 2016
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`6
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`

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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 11th day of July, 2016,
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`a true and correct copy of the foregoing REPLY TO PATENT OWNER
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`NOVARTIS’S OPPOSITION TO PETITIONER BRECKENRIDGE’S
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`MOTION FOR JOINDER was served by electronic mail on Patent Owner’s
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`lead and backup counsel at the following email address:
`
`Nicholas N. Kallas (Reg. No. 31,530)
`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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`July 11, 2016
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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
`
`7