Filed on behalf of: Roxane Laboratories, Inc.
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`Entered: November 10, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________
`
`ROXANE LABORATORIES, INC.
`Petitioner
`
`v.
`
`NOVARTIS AG
`Patent Owner
`_______________________
`
`
`
`Case IPR2016-01102
`U.S. Patent No. 5,665,772
`_______________________
`
`
`Before LORA M. GREEN, CHRISTOPHER L. CRUMBLEY, and ROBERT A.
`POLLOCK, Administrative Patent Judges.
`
`
`
`PETITIONER’S REQUEST FOR REHEARING OF
`THE BOARD’S DECISION DENYING JOINDER
`
`
`
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`Entered: November 10, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________
`
`ROXANE LABORATORIES, INC.
`Petitioner
`
`v.
`
`NOVARTIS AG
`Patent Owner
`_______________________
`
`
`
`Case IPR2016-01102
`U.S. Patent No. 5,665,772
`_______________________
`
`
`Before LORA M. GREEN, CHRISTOPHER L. CRUMBLEY, and ROBERT A.
`POLLOCK, Administrative Patent Judges.
`
`
`
`PETITIONER’S REQUEST FOR REHEARING OF
`THE BOARD’S DECISION DENYING JOINDER
`
`
`
`
`
`
`Case IPR2016-01102
`U.S. Patent No. 5,665,772
`
`
`TABLE OF CONTENTS
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`Table Of Authorities ................................................................................................. ii
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`I.
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`II.
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`Legal Standard ................................................................................................. 2
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`Argument ......................................................................................................... 3
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`A.
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`B.
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`C.
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`The Board Did Not Explain Why Roxane Should Be Prejudiced
`By Deficiencies In The Par I IPR Petition ............................................ 3
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`The Board Improperly Denied Roxane’s Joinder Motion Based
`On Scheduling Complications Beyond Roxane’s Control .................... 4
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`The Board Erred In Failing To Take Into Account The Public
`Interest ................................................................................................... 6
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`III. Conclusion ....................................................................................................... 7
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`
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`
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`i
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`Case IPR2016-01102
`U.S. Patent No. 5,665,772
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`
`TABLE OF AUTHORITIES
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` Page(s)
`
`Cases
`Consol. Bearings Co. v. United States,
`348 F.3d 997 (Fed. Cir. 2003) .............................................................................. 3
`
`Cuozzo Speed Techs. v. Lee,
`136 S.Ct. 2131 (2016) ........................................................................................... 6
`
`In re Gartside,
`203 F.3d 1305 (Fed. Cir. 2000) ............................................................................ 3
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`James V. Hurson Assoc., Inc. v. Glickman,
`229 F.3d 277 (D.C. Cir. 2000) .......................................................................... 6, 7
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`Statutes
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`35 U.S.C. § 316(a)(12) ............................................................................................... 4
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`35 U.S.C. § 316(a)(11) ............................................................................................... 5
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`Other Authorities
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`37 C.F.R. §42.71(c) .................................................................................................... 2
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`37 C.F.R. §42.71(d) ................................................................................................... 2
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`37 C.F.R. § 42.100(c) ................................................................................................. 5
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`37 C.F.R. § 42.122 (b) ............................................................................................... 4
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`77 Fed. Reg. 48680 ................................................................................................ 4, 5
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`Legislative History
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`157 Cong. Rec. S1376........................................................................................ 4, 5, 6
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`
`
`ii
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`Case IPR2016-01102
`U.S. Patent No. 5,665,772
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`Petitioner Roxane Laboratories, Inc. (“Roxane”) respectfully requests
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`rehearing of the Board’s Decision denying joinder, Paper 17 (Oct. 27, 2016)
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`(“Dec.”).
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`Roxane timely filed an IPR petition requesting review of claims 1-3 and 7-
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`10 of the ‘772 patent (the “Roxane Petition”) and a Motion for Joinder with Par
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`Pharmaceutical, Inc.’s (“Par’s”) IPR2015-00084 (the “Par I IPR”), instituted on
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`claims 1-3 and 8-10 of the ‘772 patent. The Board granted Roxane’s Motion for
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`Joinder with respect to claims 1-3 and 8-10, but denied it with respect to claim 7.
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`The Board also denied a second IPR petition submitted by Par, directed to claim 7
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`of the ‘772 patent (IPR2016-01059; the “Par II IPR”).
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`Roxane is aware that Par is concurrently filing a Request for Rehearing of
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`the Board’s Decision denying joinder in the Par II IPR. The subject of Par’s
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`Request for Rehearing is the same as that of the present Request for Rehearing. If
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`Par’s Request for Rehearing is granted, Roxane’s Request for Rehearing likewise
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`should be granted.
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`The Board agreed that the Roxane Petition established that claim 7 of the
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`‘772 patent is likely obvious. Dec. at 12. The only difference between claim 7 and
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`claim 1 is that claim 7 recites a composition comprising a therapeutically effective
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`amount of the compound of claim 1 and an acceptable carrier, without any further
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`specificity. Nevertheless, the Board did not institute review. Accordingly, if the
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`1
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`Case IPR2016-01102
`U.S. Patent No. 5,665,772
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`Board finds that claims 1-3 and 8-10 are unpatentable, claim 7 will block the
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`public from using an obvious compound, for its obvious methods of use.
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`The Board identified two reasons for denying Roxane’s joinder motion as to
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`claim 7. Dec. at 15. First, according to the Board, Par’s inadvertent omission of
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`claim 7 in the Par I IPR petition is not a “sufficient justification for the grant of
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`joinder.” Id. at 15. Second, according to the Board, the joinder of claim 7 would
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`“unduly complicate” and cause “undue delays” in the Par I IPR proceeding, to
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`which Roxane has been joined. Id. at 17.
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`In denying joinder, the Board misapprehended or overlooked at least the
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`following matters. First, the Board did not explain why Roxane should be
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`prejudiced by Par’s failure to include claim 7 in the Par I IPR. Second, the Board
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`abused its discretion when it found that joining claim 7 would cause undue delays
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`and unduly complicate the Par I IPR. Third, the Board failed to adequately
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`account for the public interest.
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`I.
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`Legal Standard
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`A party seeking rehearing must identify the matters that the Board
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`misapprehended or overlooked. 37 C.F.R. §42.71(d). The Board reviews its
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`decision for an abuse of discretion, 37 C.F.R. §42.71(c), which occurs when the
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`“decision represents an unreasonable judgment in weighing relevant factors” or
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`“the agency offers insufficient reasons for treating similar situations differently.”
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`2
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`Case IPR2016-01102
`U.S. Patent No. 5,665,772
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`In re Gartside, 203 F.3d 1305, 1315-16 (Fed. Cir. 2000); Consol. Bearings Co. v.
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`United States, 348 F.3d 997 (Fed. Cir. 2003).
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`II. Argument
`A. The Board Did Not Explain Why Roxane Should Be Prejudiced
`By Deficiencies In The Par I IPR Petition
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`The Board’s decision turned on Par’s failure to establish any reason except
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`inadvertence for failing to include claim 7. Dec. at 17 (inadvertent omission is not
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`a “sufficient justification for the grant of joinder”). Roxane’s petition and motion
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`for joinder, in contrast, were timely filed within a month of institution of the Par I
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`IPR and included claim 7, which had been asserted in litigation against Roxane.
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`The Board did not explain why Roxane should be prejudiced by Par’s inadvertent
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`omission of claim 7 in the Par I IPR Petition when claim 7 was not omitted from
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`Roxane’s timely filed petition. Roxane is neither related to Par nor a real party-in-
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`interest in the Par I IPR, so Roxane should not be prejudiced by Par’s failure to
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`explain its inadvertent omission of claim 7 in the Par I IPR petition.
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`The Board has consistently disfavored “second bites at the apple, which use
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`[the Board’s] prior decision as a roadmap to remedy [the] prior, deficient
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`challenge.” Butamax Advanced Biofuels v. Gevo, IPR2014-00581, Paper 8 at 12-
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`13 (October 14, 2014) (Crumbley, joined by Elluru and Begley); Conopco v. The
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`Procter & Gamble Co., IPR2014-00628, Paper 23 at 3-5 (Mar. 20, 2015) (cited by
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`3
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`U.S. Patent No. 5,665,772
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`Board). Roxane, however, did not take a “second bite” for claim 7. Roxane filed
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`its Petition and Motion for Joinder for claims 1-3 and 7-10 at the appropriate time
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`and it did not gain a strategic advantage by doing so. Moreover, the addition of
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`claim 7 would not introduce complications because, as to claim 7, the Roxane
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`Petition seeks to add only a single dependent claim to those instituted in the Par I
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`IPR and seeks to do so based on the same art and evidence in instituted Ground 2.
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`B.
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`The Board Improperly Denied Roxane’s Joinder Motion Based
`On Scheduling Complications Beyond Roxane’s Control
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`As demonstrated in the previous section, Roxane’s joinder motion would
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`have introduced only minor substantive complications to the Par I IPR. The Board
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`overlooked this fact and erred by denying joinder based on scheduling
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`complications that resulted despite Roxane’s timely filing and that were beyond
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`Roxane’s control.
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`Congress directed the Office to “set a time period for requesting joinder” to
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`ensure that joinder petitions do not unduly impact the first case. 35 U.S.C.
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`§ 316(a)(12). The Office made clear to Congress “that it intends to use this
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`authority to encourage early requests for joinder and to discourage late requests.”
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`157 Cong. Rec. S1376 (Sen. Kyl); 37 C.F.R. § 42.122 (b); Final Rules for IPR, 77
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`Fed. Reg. 48680, 48707 (one-month time period set in response to a comment
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`seeking “clarification of the timing for requesting joinder”). Accordingly, the
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`4
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`U.S. Patent No. 5,665,772
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`Office established the one-month joinder period to ensure the just, speedy, and
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`inexpensive resolution of the proceedings. Enzymotec Ltd. v. Neptune Techs. &
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`Bioresources, Inc., IPR2014-00556, Paper 19 at 4 (July 4, 2015). Roxane could
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`not file a motion for joinder before the Par I IPR was instituted because it would
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`have been denied as premature. Linear Tech. Corp. v. In-Depth Test, IPR2015-
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`01994, Paper 7 (Oct. 20, 2015).
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`Congress and the Office did not promulgate this one-month period with the
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`notion it would disqualify petitioners based on circumstances beyond their control.
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`Rather, the Office told Congress that it “anticipates that joinder will be allowed as
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`of right.” 157 Cong. Rec. S1376 (Sen. Kyl). To address inevitable scheduling
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`complications, Congress authorized the Office to extend the first proceeding’s
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`schedule in case of joinder which “allow[s] [it] to manage the more complex
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`[joinder] cases.” 77 Fed. Reg. at 48707; 35 U.S.C § 316(a)(11); 37 C.F.R.
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`§ 42.100(c).
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`Here, Roxane’s joinder motion was timely and joinder of claim 7 would add
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`only a single dependent claim beyond those instituted in the Par I IPR based on the
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`same art and evidence relied on in instituted Ground 2. Any scheduling
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`complications due to joinder result from delays beyond Roxane’s control.
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`Accordingly, the Board abused its discretion in finding that joinder would cause
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`undue scheduling complications.
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`5
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`Case IPR2016-01102
`U.S. Patent No. 5,665,772
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`C. The Board Erred In Failing To Take Into Account The Public
`Interest
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`In passing the AIA, Congress sought to “improve patent quality and restore
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`confidence in the presumption of validity” by giving the Office the “significant
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`power to revisit and revise earlier patent grants” to “screen[] out bad patents while
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`bolstering valid ones.” Cuozzo Speed Techs. v. Lee, 136 S.Ct. 2131, 2140 (2016)
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`(citations omitted). The Office told Congress that “joinder will be allowed as of
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`right,” but retained the discretion to deny joinder as a “safety valve … to avoid
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`being overwhelmed” by “a deluge of joinder petitions in a particular case.” 157
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`Cong. Rec. S1376 (Sen. Kyl); Enzymotec, Paper 19 at 6 n.1 (quoting Sen. Kyl);
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`Target, Paper 28 at 10 (“liberal joinder of reviews, including those having new
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`arguments”).
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`Here, the Board denied joinder despite correctly finding that institution on
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`claim 7 “is warranted” based on the art and evidence in the Roxane Petition. Dec.
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`at 12. Finding the other challenged claims (i.e., claims 1-3 and 8-10) unpatentable
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`would confirm that claim 7 should never have issued. In that case, the public will
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`be prevented from using the composition of claim 7 even though the compound
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`used in that composition, and methods of using that compound, are obvious. The
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`Board did not consider this harm to the public. The Board’s denial of Roxane’s
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`motion to join claim 7 was therefore an abuse of discretion. James V. Hurson
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`6
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`Case IPR2016-01102
`U.S. Patent No. 5,665,772
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`Assoc., Inc. v. Glickman, 229 F.3d 277, 284 (D.C. Cir. 2000) (abuse of discretion
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`to fail to consider relevant factors).
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`III. Conclusion
`For the above reasons, Petitioner respectfully requests a rehearing of the
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`joinder decision.
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`Dated: November 10, 2016
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`Respectfully submitted,
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`By: /Keith A. Zullow/
`Keith A. Zullow (Reg. No. 37,975)
`Counsel for Petitioner Roxane
`Laboratories, Inc.
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`7
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`Case IPR2016-01102
`U.S. Patent No. 5,665,772
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e), I certify that on this 10th day of November,
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`2016, a true and correct copy of the foregoing PETITIONER’S REQUEST FOR
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`REHEARING OF THE BOARD’S DECISION DENYING JOINDER was
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`served by electronic mail on Patent Owner’s lead and backup counsel at the
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`following email address:
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`Nicholas N. Kallas (Reg. No. 31,530)
`Raymond R. Mandra (Reg. No. 34,382)
`Christina Schwarz (pro hac vice)
`Fitzpatrick, Cella, Harper & Scinto
`1290 Avenue of the Americas
`New York, NY 10104-3800
`ZortressAfinitorIPR@fchs.com
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`By: /Keith A. Zullow/
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`Keith A. Zullow (Reg. No. 37,975)
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
`212-813-8846; 646-558-4226 (fax)
`kzullow@goodwinlaw.com
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`Counsel for Petitioner Roxane
`Laboratories, Inc.
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