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`Filed: February 22, 2019
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`____________________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`____________________________
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`MYLAN PHARMACEUTICALS INC.
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`and
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`DR. REDDY’S LABORATORIES, INC.,
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`Petitioners
`
`v.
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`HORIZON PHARMA USA, INC. and NUVO PHARMACEUTICALS
`(IRELAND) DESIGNATED ACTIVITY COMPANY,
`Patent Owners.
`____________________________
`
`Case No. IPR2017-019951
`U.S. Patent No. 9,220,698
`____________________________
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`RESPONSE TO PATENT OWNERS’ MOTION TO TERMINATE
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`1 Petitioner Dr. Reddy’s Laboratories, Inc. (“DRL”), from IPR2018-00894, has
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`been joined as a Petitioner to this proceeding.
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`TABLE OF CONTENTS
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`Page
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`BACKGROUND ...................................................................................................... 1
`I.
`The District Court Litigation and Summary Judgment ........................ 2
`II.
`The ’698 and ’208 Inter Partes Reviews ............................................. 3
`ARGUMENT ............................................................................................................ 5
`I.
`The Board Has Already Construed the Claims and Applied the
`Prior Art ................................................................................................ 5
`A.
`The Board Has Already Construed the Claims .......................... 6
`B. One Can Apply the Relied-Upon Art to the Challenged
`Claims ........................................................................................ 8
`Efficiency Does Not Weigh in Favor of Terminating the IPRs ........... 9
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`II.
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`-i-
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`PAGE
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`TABLE OF AUTHORITIES
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`CASES
`Apple Inc. v. Evolutionary Intelligence, LLC,
`No. IPR2014-00086, Paper 8 (PTAB Apr. 25, 2014)........................................... 8
`Blackberry Corp. v. MobileMedia Ideas, LLC,
`IPR2013-00036, Paper 65 (PTAB Mar. 7, 2014) ................................................. 9
`Comtech Mobile Datacom Corp. v. Vehicle IP, LLC,
`Case IPR2018-00531, Paper 9 (PTAB July 20, 2018) ....................................... 10
`Enzo Biochem, Inc. v. Applera Corp.,
`599 F.3d 1325 (Fed. Cir. 2010) ............................................................................ 6
`Ex Parte Miyazaki,
`89 U.SP.Q.2d 1207 (B.P.A.I. Nov. 19, 2008) ...................................................... 7
`Ex Parte Saceman,
`27 U.S.P.Q.2d 1472 (B.P.A.I. 1993) .................................................................... 8
`In re Alpert,
`2013 WL 3805709 (PTAB July 15, 2013) ........................................................... 8
`In re Keller,
`2013 WL 6212689 (PTAB Nov. 26, 2013) .......................................................... 8
`In re Packard,
`751 F.3d 1307 (Fed. Cir. 2014) ............................................................................ 7
`In re Siraky,
`2014 WL 869351 (PTAB Feb. 28, 2014) ............................................................. 8
`In re Steele,
`305 F.2d 859 (CCPA 1962) .................................................................................. 7
`Microsoft Corp. v. IpLearn-Focus, LLC,
`IPR2015-00097, Paper 11 (PTAB Mar. 26, 2015) ............................................... 9
`Power Integrations, Inc. v. Lee,
`797 F.3d 1318 (Fed. Cir. 2015) ............................................................................ 7
`
`
`
`ii
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`
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`United Carbon Co. v. Binney & Smith Co.,
`317 U.S. 228 (1942) .............................................................................................. 7
`Vibrant Media, Inc.. v. Gen. Elec. Co.,
`No. IPR-2013-00172, Paper 50 (PTAB July 28, 2014) ........................................ 9
`OTHER AUTHORITIES
`37 C.F.R. § 42.5(a) ................................................................................................... 10
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`iii
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`Patent Owners’ motion to terminate (’698 IPR Paper 66) rests on the district
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`court’s indefiniteness finding—a finding they are appealing—and a supposed
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`resultant inability of Mylan and Dr. Reddy’s Laboratories (“Petitioners”) to now
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`prove unpatentability. Patent Owners have waived that position. Their argument
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`should be rejected for that reason as well as their misapprehension of the law, their
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`own patents, and the prior art. Although the patents fail to provide clear
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`boundaries, unpatentability can still be found because the prior art does not fall
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`near these undefined edges; it falls dead-center in the claims.
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`BACKGROUND
`The ʼ698 and ʼ208 patents (“patents”) claim methods of administering a drug
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`formulation combining naproxen with esomeprazole. The patent claims recite steps
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`for administering that formulation and the intended pharmacokinetic (“PK”) and
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`pharmacodynamic (“PD”) results. The patents claim a particular PK/PD profile,
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`reciting a range of PK/PD values “±20%.” The claimed formulations, however,
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`need not produce any particular results. Importantly, the claims require only that
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`the ranges are “target[ed].” Thus, while a formulation actually producing the
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`recited values may “target” the recited range, the claims also envision one merely
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`“target[ing]” that range, even if one does not achieve the claimed results.
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`1
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`I.
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`
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`The District Court Litigation and Summary Judgment
`In 2016, Patent Owners filed suit in the District of New Jersey alleging that
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`Petitioners infringed the patents. Discovery ensued, followed by Markman, where
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`the parties contested the meaning of the term “target.” Patent Owners contended
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`that “target” means to “produce.” Ex. No. 2073 at 8. Petitioners contended that the
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`ordinary meaning of “target” is “with the goal of obtaining.” Id. at 11. The district
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`court agreed with Petitioners, construing “target” as “set as a goal.” Id.
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`On August 10, 2018, Petitioners moved for summary judgment that the
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`patents were indefinite. Petitioners argued that, given the district court’s
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`construction of “target” as “set as a goal,” the “patents provide no guidance
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`regarding how often, if ever, the recited ranges must be met or how close one must
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`come to those ranges to infringe the asserted claims.” Ex. 2074 at 15.
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`The district court agreed. In light of the aspirational nature of “target,” one
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`would have no means of knowing where the limits of the claimed aspirational
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`ranges ended. Id. at 18. Put differently, “the claim provides no discernable standard
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`for how far a particular formulation administered to any given patient or group of
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`patients can stray from the stated goals and still infringe the claims.” Ex. 2075 at
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`15 (quotations omitted). Moreover, a pill itself cannot “set a goal,” and the claims
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`fail to specify who “targets” these ill-defined PK/PD parameters. Id. Patent Owners
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`have appealed this decision. See Ex. 1056-58.
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`2
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`II. The ’698 and ’208 Inter Partes Reviews
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`In 2017, Mylan petitioned for inter partes review. DRL was joined to
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`the ’698 IPR and its request for joinder to the ’208 IPR is pending. Petitioners
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`pressed that the patents were either anticipated by prior art U.S. Patent No.
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`8,557,285 (“’285 patent”)—which covers the same formulation—or obvious over
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`the ’285 patent in combination with the EC-Naprosyn® label and an article,
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`Howden 2005. Paper 2.
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`Petitioners again argued that “target” means “with the goal of obtaining.” Id.
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`at 15-18. Petitioners expressly noted that the district court had construed “target”
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`as “set a goal” and that Petitioners intended to press indefiniteness to the district
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`court. Id. at 16 n.3; ’208 IPR, Paper 2 at 14-15 n.3. With respect to the PK/PD
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`ranges recited in the claims, Petitioners explained that their contentions with
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`respect to at least the ’285 patent were not contingent on any particular
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`construction of “target.” Paper 2 at 36 n.8. Given that the ’285 patent claimed the
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`same drug formulation as the patents, the PK/PD profile of that formulation—
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`regardless of how broad—would be inherent to that formulation and coextensive
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`with the claims. Id. at 36-40. Petitioners contended in the alternative that the EC-
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`Naprosyn label and Howden 2005 disclosed overlapping PK/PD ranges with the
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`patents for the drug’s two components, naproxen and esomeprazole, respectively.2
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`2 Esomeprazole is the S-enantiomer of omeprazole, the subject of Howden 2005.
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`3
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`In other words, administering the formulations disclosed in the EC-Naprosyn label
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`and Howden 2005 did not merely target the same PK and PD values, but stray
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`beyond the recited ranges into undefined territory; it both targeted and resulted in
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`PK/PD values squarely in the recited ranges. Id. at 54-55, 57-58. It thus would
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`have been obvious for a POSA to “target” these known, effective PK/PD profiles
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`regardless of the additional unknown breadth of the patents’ claims. Id. at 54-55,
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`57-58.
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`In their preliminary responses, Patent Owners side-stepped this issue—
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`including the construction of “target.” Patent Owners instead argued (incorrectly),
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`e.g., that § 315’s time bar applied and that the ’285 patent was not prior art. Paper
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`10; ’208 IPR, Paper 7. Notably, Patent Owners did not dispute the meaning of
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`“target,” offer a contrary construction, or even dispute whether the prior art
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`disclosed the PK/PD ranges recited in the patents. Paper 10.
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`The Board instituted both IPRs. The Board first adopted Petitioners’ and the
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`district court’s view that “target” means “have or set the goal of obtaining.” Paper
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`18 at 11-12 In so finding, the Board noted that “Patent Owner does not address
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`Petitioner’s proposed construction.” Id. at 11 The remainder of the Board’s
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`institution decision, however, did not center on “targeted” PK/PD values. Rather,
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`as to the ’285 patent grounds, the Board noted that the ’285 patent disclosed an
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`identical formulation, which would therefore inherently produce an identical
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`4
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`PK/PD profile. Paper 18 at 21-22. As to the EC-Naprosyn label and Howden 2005,
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`the Board noted that Petitioners’ art “directly” disclosed the same PK and PD
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`values for naproxen and esomeprazole. Id. at 9, 23-27; ’208 IPR, Paper 9 at 18-22.
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`Regarding the “target” limitation, the Board noted Petitioners’ argument that, “to
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`ensure efficacy, it would have been obvious to target the PK/PD values of prior art
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`drugs known to be effective.” Paper 18 at 27.
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`Both IPRs moved forward, and Patent Owners filed their response in
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`the ’698 IPR. Paper 37 at 39-40. Again, Patent Owners did not address the
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`construction of “target” or whether the prior art actually achieved the targeted
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`profiles, as pressed by Petitioners. Id. at 39-45.
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`In 2018, the proceedings were stayed in light of Patent Owner’s bankruptcy.
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`Currently, in the ’698 IPR, Petitioner must file its reply, and the Board must hear
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`the parties’ arguments and issue its decision (Paper 67); in the ’208 IPR, Patent
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`Owners must file their response, Petitioner its reply, and the Board must hear oral
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`argument and issue a decision (’208 IPR, Paper 27).
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`ARGUMENT
`I. The Board Has Already Construed the Claims and Applied the Prior Art
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`The district court found the claims indefinite because they set no boundary
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`allowing the accused infringer to determine the borders of the claims. Ex. 2075 at
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`15. But the unpatentability of the patent claims does not depend on identifying the
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`5
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`outer boundaries of the claims: the prior art falls squarely within the “target[ed]”
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`ranges recited in the claims. Patent Owners nonetheless hope to evade review by
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`arguing that Petitioners cannot prove that the patents are unpatentable because the
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`district court found that they are indefinite. See Paper 66 at 4-8. Patent Owners’
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`motion is little more than a motion for reconsideration in disguise, and one that
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`points to no error in the Board’s institution decision. That alone is fatal to Patent
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`Owners’ motion.
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`A. The Board Has Already Construed the Claims
`Cognizant of both Petitioners’ indefiniteness argument and the district
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`court’s construction (Paper 2 at 16-18; ’208 IPR, Paper 2 at 14-17), the Board
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`construed “target” to mean “have or set the goal of obtaining.” Paper 18 at 10-
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`12; ’208 IPR, Paper 9 at 8-10. Patent Owners failed to oppose this construction in
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`their preliminary response in either IPR and, in the ’698 IPR, in their motion for
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`rehearing after institution and in their Patent Owner Response. Papers 10, 24,
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`37; ’208 IPR, Paper 7. For this reason alone, Patent Owners have waived this
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`argument at least with respect to the ’698 patent. Paper 19 at 3 (“The patent owner
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`is cautioned that any arguments for patentability not raised in the response will be
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`deemed waived.”).3
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`3 Given that the Board has construed “target,” the authority cited by Patent Owners
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`(at 5) is distinguishable. Enzo Biochem, Inc. v. Applera Corp., 599 F.3d 1325, 1332
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`6
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`And Patent Owners likewise repeatedly failed to argue in both IPRs that,
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`under the Board’s or any construction, a POSA cannot determine whether the
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`specific prior art identified here falls within the express PK/PD ranges recited in
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`the claims. Even now, Patent Owners do not concede that the claims are indefinite
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`under the district court’s construction—they are appealing the district court’s
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`judgment. Moreover, Patent Owners fail to argue, let alone establish, that the
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`claims are indefinite under the Board’s construction and its different indefiniteness
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`standards. In re Packard, 751 F.3d 1307, 1322 (Fed. Cir. 2014); Ex Parte
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`Miyazaki, 89 U.SP.Q.2d 1207, 1211 (B.P.A.I. Nov. 19, 2008). And importantly, in
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`light of the different standards used by each tribunal, the Board is not bound by a
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`district court’s determinations. Power Integrations, Inc. v. Lee, 797 F.3d 1318,
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`1326 (Fed. Cir. 2015). For the Patent Owners nonetheless to argue before the
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`Board that it cannot review patentability because the district court found the claims
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`(Fed. Cir. 2010) (in dicta, a claim that “cannot be construed” cannot be
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`anticipated); In re Steele, 305 F.2d 859, 862-63 (CCPA 1962) (same); United
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`Carbon Co. v. Binney & Smith Co., 317 U.S. 228, 236-37 (1942) (same). The
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`problem with Patent Owners’ claims is not that they cannot be construed—they
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`have been construed twice—but instead that the claims lack any clear endpoints.
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`7
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`indefinite, and before the Federal Circuit that the district court’s determination is
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`wrong, smacks of gamesmanship and misapplies the law.
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`B. One Can Apply the Relied-Upon Art to the Challenged Claims
`The patents’ indefiniteness does not prevent a finding of unpatentability; the
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`two are easily reconciled. The district court held that a POSA cannot tell how close
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`one needs to fall to the “target[ed]” profile to infringe, or how far from that profile
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`one can stray to avoid infringement. But regardless of the extent of the boundaries
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`of the claims, the prior art here falls squarely within the “target[ed]” PK/PD range.
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`Paper 2 at 36-40, 54-55, 57-58; Paper 18 at 9, 21-27. The prior art ’285 patent
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`discloses the same formulation—and thus inherently discloses the same profile—as
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`claimed in the patents. And the EC-Naprosyn label and Howden 2005 directly
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`overlap with the recited ranges. Under such circumstances, the Board has affirmed
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`anticipation rejections, instituted IPR proceedings, refused to terminate IPR
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`proceedings, and ultimately found claims unpatentable as, e.g., obvious. In re
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`Alpert, 2013 WL 3805709, at *5 n.1 (PTAB July 15, 2013) (affirming anticipation
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`and obviousness rejections even where a portion of the claim was indefinite); In re
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`Keller, 2013 WL 6212689, at *3-4 (PTAB Nov. 26, 2013) (affirming anticipation
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`of claims that were indefinite); In re Siraky, 2014 WL 869351, at *3 (PTAB Feb.
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`28, 2014) (same); Ex Parte Saceman, 27 U.S.P.Q.2d 1472 (B.P.A.I. 1993)
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`(affirming obviousness of claims that were indefinite); Apple Inc. v. Evolutionary
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`8
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`
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`Intelligence, LLC, No. IPR2014-00086, Paper 8 at 15 (PTAB Apr. 25, 2014)
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`(instituting IPR despite indefinite claims); Vibrant Media, Inc.. v. Gen. Elec. Co.,
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`No. IPR-2013-00172, Paper 50 at 9-11 (PTAB July 28, 2014) (finding that
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`Petitioner met its burden in proving claims unpatentable as obvious despite
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`indefiniteness). Thus, the rationale of the district court does not foreclose
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`anticipation or obviousness where, as here, the prior actually produces the claimed
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`profiles—not merely “target[s]” them.4
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`The decisions relied on by Patent Owners (at 4-7) are thus inapposite.
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`Blackberry Corp. v. MobileMedia Ideas, LLC, IPR2013-00036, Paper 65 at 7-15
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`(PTAB Mar. 7, 2014) (could not determine the anticipation of a mean-plus-
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`function claim where the limitation lacked any corresponding structure); Microsoft
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`Corp. v. IpLearn-Focus, LLC, IPR2015-00097, Paper 11 (PTAB Mar. 26, 2015)
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`(cannot analyze anticipation of a limitation with more than one possible meaning).
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`II. Efficiency Does Not Weigh in Favor of Terminating the IPRs
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`Finally, Patent Owners argue (at 8) that it would “not be an efficient” use of
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`the Board’s resources to proceed because the Federal Circuit will address
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`“construction of the term ‘target’ and the scope of the PK and PD elements of the
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`claims, which are precisely the issues that are dispositive of this review.” For
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`Patent Owners to urge for the first time now—eighteen months after the first
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`4 Notably, “produce” is the construction Patent Owners pressed in the district court.
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`9
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`petition was filed—that the construction of “target” is somehow dispositive of
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`these proceedings is disingenuous. In any event, until now, Patent Owners have not
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`here challenged the meaning of “target,” let alone made it the centerpiece of these
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`proceedings.5 And significant resources have already been expended—the ’698
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`IPR is almost complete and little (if any) additional discovery is required in
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`the ’208 IPR. Terminating the IPRs now would squander the significant resources
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`that have already been spent.
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`Should the Board be inclined to entertain Patent Owners’ request, however,
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`to avoid prejudice, Petitioners respectfully request the Board stay these
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`proceedings pursuant to the Board’s authority under 37 C.F.R. § 42.5(a), pending
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`the Federal Circuit appeal. See 37 C.F.R. § 42.5(a) (“The Board may determine a
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`proper course of conduct in a proceeding for any situation not specifically covered
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`by this part and may enter non-final orders to administer the proceeding.”).
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`5 Comtech Mobile Datacom Corp. v. Vehicle IP, LLC, Case IPR2018-00531, Paper
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`9 (PTAB July 20, 2018) (cited at 8), is thus distinguishable. In Comtech, the issue
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`on appeal was “dispositive,” the patent was expired, and no infringement suit had
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`even been filed to trigger §315(b)’s statutory bar. None of this is true here.
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`10
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`Dated: February 22, 2019
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`
`
`/Brandon M. White/
`Brandon M. White
`Reg. No. 52,354
`
`PERKINS COIE LLP
`700 13th Street, NW, Suite 600
`Washington, D.C. 20005
`Telephone: (202) 654-6206
`Facsimile: (202) 654-6211
`Email: bmwhite@perkinscoie.com
`
`Attorney for Mylan Pharmaceuticals Inc.
`
`
`11
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`CERTIFICATE OF SERVICE
`The undersigned hereby certifies that the foregoing Response to Patent
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`Owners’ Motion to Terminate was served electronically via email as follows:
`
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`Patent Owners:
`
`Thomas A. Blinka
`Jonathan G. Graves
`Ellen Scordino
`Cooley LLP
`zIPR2017-01995@cooley.com
`
`Margaret J. Sampson
`Stephen M. Hash
`Jeffrey S. Gritton
`Baker Botts LLP
`nuvo-
`vimovoBB@bakerbotts.com
`Petitioner Dr. Reddy’s:
`
`Alan H. Pollack
`Dmitry V. Shelhoff
`Stuart D. Sender
`Louis H. Weinstein
`apollack@buddlarner.com
`dshelhoff@buddlarner.com
`ssender@buddlarner.com
`lweinstein@buddlarner.com
`
`
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`12
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`Dated: February 22, 2019
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`/Brandon M. White/
`Brandon M. White
`
`Attorney for Mylan Pharmaceuticals Inc.
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`
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`13
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`
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