UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`LUPIN LTD. AND LUPIN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`
`HORIZON THERAPEUTICS, LLC,
`Patent Owner
`________________
`
`Case IPR 2016-00829
`Patent 9,095,559
`________________
`
`PATENT OWNER’S REQUEST FOR REHEARING OF THE
`DECISION TO INSTITUTE TRIAL
`37 C.F.R. 42.71(c)
`
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`LUPIN LTD. AND LUPIN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`
`HORIZON THERAPEUTICS, LLC,
`Patent Owner
`________________
`
`Case IPR 2016-00829
`Patent 9,095,559
`________________
`
`PATENT OWNER’S REQUEST FOR REHEARING OF THE
`DECISION TO INSTITUTE TRIAL
`37 C.F.R. 42.71(c)
`
`
`
`TABLE OF CONTENTS
`
`I.
`
`INTRODUCTION AND STATEMENT OF RELIEF REQUESTED ......... ..1
`
`II.
`
`LEGAL STANDARDS ................................................................................. ..1
`
`TABLE OF CONTENTS
`INTRODUCTION AND STATEMENT OF RELIEF REQUESTED ........... 1
`I.
`LEGAL STANDARDS ................................................................................... 1
`II.
`III. BASIS FOR RELIEF REQUESTED .............................................................. 2
`IV. ARGUMENT ................................................................................................... 2
`V.
`CONCLUSION ................................................................................................ 6
`
`
`III.
`
`BASIS FOR RELIEF REQUESTED ............................................................ ..2
`
`IV.
`
`ARGIHVIENT ................................................................................................. ..2
`
`V.
`
`CONCLUSION .............................................................................................. . .6
`
`IPR2016-00829
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`IPR2016-00829
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`i
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`TABLE OF AUTHORITIES
`
`Cases
`Arendi S.A.R.L. v. Appel Inc.,
`2016 WL 4205964 (Fed. Cir. Aug. 10, 2016) ........................................................ 4
`Atl. Research Mktg. Sys. v. Troy,
`659 F.3d 1345 (Fed. Cir. 2011) .............................................................................. 2
`Cisco Systems Inc. v. C-CATION Techs., Inc.,
`IPR2014-00454, Paper 12 (PTAB Aug. 29, 2014) ................................................ 4
`Eli Lilly & Co. v. Bd. Of Regents of the Univ. of Wash.,
`334 F.3d 1264 (Fed. Cir. 2003) .............................................................................. 2
`Stevens v. Tamai,
`366 F.3d 1325 (Fed. Cir. 2004) .............................................................................. 2
`United States v. Bradshaw,
`281 F.3d 278 (1st Cir. 2002) .................................................................................. 2
`Statutes
`35 U.S.C. § 325(d) ..................................................................................................... 5
`Regulations
`37 C.F.R. § 42.71 ....................................................................................................... 1
`37 C.F.R. § 42.71(c) ...............................................................................................1, 2
`37 C.F.R. § 42.71(d) .................................................................................................. 1
`
`IPR2016-00829
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`ii
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`I.
`
`INTRODUCTION AND STATEMENT OF RELIEF REQUESTED
`Pursuant to 37 C.F.R. § 42.71(c) Horizon Therapeutics, LLC (“Horizon” or
`“Patent Owner”) respectfully requests a rehearing in response to the Decision,
`Institution of Inter Partes Review of U.S. Patent No. 9,095,559 (“Decision”) (Paper
`No. 13).
`On September 30, 2016, the Board authorized the institution of this inter
`partes review (“IPR”) of claims 1-15 of U.S. Patent No. 9,095,559 (“the ’559
`patent”) on the two grounds presented in the petition: (1) obviousness of claims 1,
`2, 4, 5, 7-10, 12, and 13 over Blau, Simell and the ’859 Publication and (2)
`obviousness of claims 3, 6, 11, 14, and 15 of the ’559 patent over Blau, Simell, the
`’859 Publication and Brusilow ’84. See Decision at 18. Patent Owner respectfully
`requests reconsideration of the Board’s decision to institute on both grounds.
`This Request for Rehearing on behalf of the Patent Owner is filed within 14
`days of the Decision (Paper No. 13) and is timely under 37 C.F.R. § 42.71.
`II. LEGAL STANDARDS
`Pursuant to 37 C.F.R. § 42.71(d), a request for rehearing “must specifically
`identify all matters the party believes the Board misapprehended or overlooked, and
`the place where each matter was previously addressed in a motion, an opposition, or
`a reply.”
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`1
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`IPR2016-00829
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`“When rehearing a decision on petition, a panel will review the decision for
`an abuse of discretion.” 37 C.F.R. § 42.71(c). “An abuse of discretion occurs where
`the decision (1) is clearly unreasonable, arbitrary, or fanciful; (2) is based on an
`erroneous conclusion of law; (3) rests on clearly erroneous fact findings; or (4)
`involves a record that contains no evidence on which the Board could rationally base
`its decision.” Stevens v. Tamai, 366 F.3d 1325, 1330 (Fed. Cir. 2004) (citing Eli
`Lilly & Co. v. Bd. Of Regents of the Univ. of Wash., 334 F.3d 1264, 1266-67 (Fed.
`Cir. 2003)). “A decision based on an erroneous view of the law . . . ‘invariably
`constitutes an abuse of discretion.’” Atl. Research Mktg. Sys. v. Troy, 659 F.3d 1345,
`1359 (Fed. Cir. 2011) (citing United States v. Bradshaw, 281 F.3d 278, 291 (1st Cir.
`2002).
`III. BASIS FOR RELIEF REQUESTED
`The Patent Owner requests reconsideration of both grounds of the Decision to
`institute IPR of claims 1-15 of the ’559 patent because the Board erred as a matter
`of law in instituting review in reliance on expert testimony in place of prior art.
`IV. ARGUMENT
`The Board committed an abuse of discretion in instituting IPR in this case
`because its obviousness analysis erroneously relies on the testimony of Petitioner’s
`expert, Dr. Vaux, to supply a claim element that is absent from the prior art.
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`IPR2016-00829
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`Representative independent claim 2 of the ’559 patent recites:
`2. A method of treating a subject with a urea cycle
`disorder who has previously been administered an initial
`dosage of glyceryl tri-[4-phenylbutyrate] and who has a
`fasting plasma ammonia level less than the upper limit of
`normal for plasma ammonia level, the method comprising:
`(a) measuring a fasting plasma ammonia level for the
`subject;
`(b) comparing the fasting plasma ammonia level to the
`upper limit of normal for plasma ammonia level; and
`(c) administering an adjusted dosage of glyceryl tri-[4-
`phenylbutyrate], that is greater than the initial dosage if
`the fasting plasma ammonia level is greater than half
`the upper limit of normal for plasma ammonia level.
`As explained in Patent Owner’s Preliminary Response, the Petition fails to
`identify support in the record for its assertion that a POSA would have known to
`increase the dosage or administer an initial dosage of glycerol phenylbutyrate to a
`urea cycle disorder (“UCD”) patient having a fasting plasma ammonia level less than
`the upper limit of normal (“ULN”) but greater than half the ULN as required by step
`(c) of the claims of the ’559 patent. Prelim. Resp. at 35-40 citing Pet. at 24-25, 28,
`29, 31, 42-44. Instead, the Petition hinges on the conclusory and unsupported
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`assertion of its expert that “a POSA would have been motivated to administer more
`drug to reduce ammonia levels in cases where the fasting plasma ammonia level was
`above half the ULN but below the ULN.” Pet. at 24 citing Ex. 1002 at ¶¶ 51, 55;
`see also Pet. at 28, 29, 31, 42-44.
`Like the Petition, the Board’s obviousness analysis improperly relies on the
`testimony of Petitioner’s expert to supply an element—step (c) of the challenged
`claims—that is missing from the prior art of record. Such analysis constitutes legal
`error because the knowledge of a POSA “cannot be used as a wholesale substitute
`for reasoned analysis and evidentiary support, especially when dealing with a
`limitation missing from the prior art references specified.” Arendi S.A.R.L. v. Appel
`Inc., 2016 WL 4205964 at *5, 8-9 (Fed. Cir. Aug. 10, 2016) (reversing the Board’s
`finding of unpatentability where there was nothing in the record to support the
`Board’s conclusion that supplying the missing limitation would be obvious to one
`of skill in the art); see also Cisco Systems Inc. v. C-CATION Techs., Inc., IPR2014-
`00454, Paper 12, at 10-13 (PTAB Aug. 29, 2014) (denying institution of IPR where
`the petition failed to “(1) specify sufficiently where each element of the claims is
`found in the applied references, and (2) include a detailed explanation of the
`significance of the quotations and citations from the applied references”).
`
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`IPR2016-00829
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`In its decision to institute review with respect to claims 1 and 2, the Board
`“credit[s] the testimony of Dr. Vaux that the goal of maintaining a patient at normal
`ammonia levels would have lead one of ordinary skill in the art to increase drug
`doses when fasting ammonia levels approach the upper limit of normal. . .” Decision
`at 10 (emphasis added). With respect to claim 3, the Board also adopts the testimony
`of Dr. Vaux that “those of skill in the art would have increased the dose of a nitrogen
`scavenging drug in a patient with a fasting plasma ammonia level approaching the
`upper limit of normal.” Id. at 14-15 citing Ex. 1002 ¶93. Further, in rejecting Patent
`Owner’s argument that the Petition should be denied under 35 U.S.C. § 325(d)
`because the Patent Office already considered and rejected the same prior art
`references during prosecution, the Board holds that “Petitioner has presented new
`evidence, such as Dr. Vaux’s testimony . . .” Decision at 17 (emphasis added).
`Further, the prior art of record fails to support Dr. Vaux’s testimony. The
`Decision states that “Dr. Vaux’s testimony is also supported by the evidence he cites
`for example, that plasma ammonia levels vary a [sic] different times of the day (Ex.
`1012) or after eating (Ex. 1006, 268 (Table 11.5) and Ex. 1017) . . .” Decision at 11.
`This assertion is incorrect because none of the prior art references cited by Dr. Vaux
`teach or suggest increasing the dosage or administering an initial dosage of a
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`IPR2016-00829
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`nitrogen scavenging drug to a patient having a fasting ammonia level below the
`ULN. See Prelim. Resp. at 23, 35-40. On the contrary, as admitted in the Petition,
`Yajima (Ex. 1012) teaches diurnal fluctuation of blood ammonia levels. Pet. at 19-
`20, 24, 29. Likewise, Levin (Ex. 1017) teaches that plasma ammonia levels may rise
`after ingestion of protein in a patient with a UCD. Id. at 20, 24, 29. Blau (Ex. 1006)
`similarly indicates that plasma ammonia levels can be 30-60 µmol/L higher post-
`prandially. Id. at 43-44. Furthermore, Yajima, Levin and Blau do not provide
`recommendations for dosing of nitrogen scavenging drugs, let alone suggest that a
`POSA should increase the dose of drug if a subject’s fasting plasma ammonia level
`is below the ULN. Prelim. Resp. at 23, 35-40.
`Thus, in its Decision, the Board commits legal error by relying on expert
`testimony to supply an element—step (c) of the challenged claims—that is absent
`from the prior art. Accordingly, the Board’s institution of IPR in this case constitutes
`an abuse of discretion, warranting rehearing.
`V. CONCLUSION
`Because the Board’s decision to institute IPR of the challenged claims is based
`on an error of law and absent such error, the Board would have had no basis for
`institution of IPR, Patent Owner respectfully requests that the Board grant its request
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`IPR2016-00829
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`for rehearing and decline to institute inter partes review of the ’559 patent on
`Grounds 1 and 2 of the Petition.
`Date: October 14, 2016
`
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`
`
`Respectfully submitted,
`By: / Robert F. Green /
`Robert F. Green
`Reg. No. 27,555
`Lead Counsel for Patent Owner
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`IPR2016-00829
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`CERTIFICATE OF SERVICE
`I hereby certify that on October 14, 2016, a copy of the foregoing PATENT
`OWNER HORIZON THERAPEUTICS, LLC’S REQUEST FOR
`REHEARING was served was served via electronic mail, as agreed to by counsel,
`upon the following counsel for the Petitioners:
`Elizabeth J. Holland: eholland@goodwinproctor.com
`Cynthia Lambert Hardman: chardman@goodwinprocter.com
`/ Robert F. Green /
`Robert F. Green
`Reg. No. 27,555
`Lead Counsel for Patent Owner
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`IPR2016-00829
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