By: Vivek Ganti (vg@hkw-law.com)
`Reg. No. 71368
`Sharad Bijanki (sb@hkw-law.com)
`Reg. No. 73400
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_________________
`
`COMPLEX INNOVATIONS LLC,
`Petitioner
`
`v.
`
`AMGEN INC.,
`Patent Owner
`_________________
`
`Case IPR2016-00085
`U.S. Patent No. 7,829,595 B2
`_________________
`
`PETITIONERS’ REQUEST FOR REHEARING
`
`
`
`
`
`
`
`Reg. No. 71368
`Sharad Bijanki (sb@hkw-law.com)
`Reg. No. 73400
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_________________
`
`COMPLEX INNOVATIONS LLC,
`Petitioner
`
`v.
`
`AMGEN INC.,
`Patent Owner
`_________________
`
`Case IPR2016-00085
`U.S. Patent No. 7,829,595 B2
`_________________
`
`PETITIONERS’ REQUEST FOR REHEARING
`
`
`
`
`
`
`
`
`TABLE OF AUTHORITIES
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` PAGE
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`CASE LAW
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`Federal Circuit Court of Appeals
`KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 398, 127 S.Ct. 1727, 1729, 167
`L.Ed.2d 705 (2007) ........................................................................................ 2, 4
`
`
`USPTO, Patent Trial and Appeal Board
`Amneal Pharmaceuticals, LLC v. Supernus Pharmaceuticals, Inc., IPR2013-
` 00368, Final Written Decision, Paper 94 ..................................................... 6
`Conopco, Inc. DBA Unilever v. the Procter & Gamble Co., IPR2013-
` 00505, 2014 WL 1253037 ............................................................................ 5, 6
`Endo Pharm., Inc., v. Depomed, Inc., IPR2014-00652, 2014 WL 4925712 .... 5
`
`FEDERAL REGULATIONS
`37 C.F.R. § 42.71(c) .......................................................................................... 2
`37 C.F.R. § 42.71(d) ......................................................................................... 1, 2
`37 C.F.R. § 42.105 ............................................................................................ 8
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`Pursuant to 37 C.F.R. § 42.71(d), Petitioners hereby request rehearing of the
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`Board’s Decision Denying Institution (Paper No. 8, April 13, 2016) which
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`challenges the validity of U.S. Patent No. 7,829,595 (Ex. 1001, referred to as the
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`“‘595 Patent”).
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`I.
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`INTRODUCTION AND STATEMENT OF RELIEF
`REQUESTED
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`The inter partes review process is a solemn and expensive process the
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`purpose of which is to determine whether patents should have been issued in view
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`of the state of the art at the time of filing. Here, Petitioners submitted an inter
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`partes review based on the prior art reference of U.S. 6,211,244 issued to Van
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`Wagenen et al. (submitted as Ex. 1003, referred to as “Van Wagenen”). The
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`relevant subject matter of the Van Wagenen reference unquestionably dates back to
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`the prior art, and establishes a reasonable likelihood that Petitioner would prevail
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`on at least one of the challenged claims of the ‘595 Patent. The Board denied
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`review, finding that Petitioner failed to identify where Van Wagenen discloses
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`cinacalcet, and determining that Petitioner failed to provide “sufficient evidence to
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`support the determination that a relevant skilled artisan would have combined
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`cinacalcet with the six recited excipients to arrive at the claimed composition.”
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`Decision Denying Institution, Paper No. 8, p. 10, 12, 14. Petitioners request that
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`the Board reconsider its decision to deny institution.
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`1
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`II. LEGAL STANDARD
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`A request for rehearing “must specifically identify all matters the party
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`believes the Board misapprehended or overlooked, and the place where each
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`matter was previously addressed in a motion, an opposition, or reply.” 37 C.F.R. §
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`42.71 (d). “When rehearing a decision on petition, a panel will review the decision
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`for an abuse of discretion.” 37 C.F.R. § 42.71(c).
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`III. BASIS FOR RELIEF REQUESTED
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`In arriving at its conclusion that Petitioner failed to provide a sufficient
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`motivation to combine, the Board abused its discretion by misapprehending or
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`overlooking the fact that cinacalcet is and was in the prior art of the ‘595 patent.
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`The Board further abused its discretion by misapprehending or overlooking the
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`principles of the Supreme Court’s standard of obviousness in light of the
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`statements in the Declaration of Walter G. Chambliss, Ph.D. Ex. 1021; KSR Int’l
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`Co. v. Teleflex Inc., 550 U.S. 398, 398, 127 S.Ct. 1727, 1729, 167 L.Ed.2d 705
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`(2007). The proffered evidence demonstrates a reasonable likelihood that the
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`challenged patent is merely a routine formulation based on known substances
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`literally present in a textbook.
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`As an initial matter, there is no doubt that all of the elements of the claimed
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`invention were known in the prior art, and the Board abused its discretion by not
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`recognizing this fact. First, the ‘595 Patent admits on its face that the chemical
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`2
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`
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`cinacalcet is within the prior art. Petition at 3, 14. Moreover, neither the Board nor
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`the Patent Owner ever disputed that cinacalcet was within the prior art for the ‘595
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`Patent, or ever disputed that the ‘595 patent itself admitted that. See generally
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`Decision Denying Institution of Inter Partes Review, paper 8; Patent Owner’s
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`Preliminary Response, Paper 7 at 12-13. In essence, the Board only disputed
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`Petitioner’s citations without actually disputing the facts. This was all the more
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`improper for the Board to do because Petitioner did in fact disclose that cinacalcet
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`was in the prior art by identifying it in the Van Wagenen reference. See Petition at
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`3, 14. The Patent Owner actually helps to clarify any misunderstanding on this
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`point by noting that the generic name “cinacalcet” was approved in the calendar
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`year after the Van Wagenen reference issued. See Patent Owner’s Preliminary
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`Response at 13 n.1. Finally, there is no doubt that the claimed excipients are all
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`listed, along with their desirable properties, in the Handbook of Pharmaceutical
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`Excipients. Again, neither the Board nor the Patent Owner disputes this fact.
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`The Board’s other abuse of discretion is based on the misapplication of KSR.
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`In denying the Petition, the Board misapprehended or overlooked the standards for
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`obviousness, and therefore misapplied the Supreme Court’s test. According to the
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`Supreme Court in KSR, when there are “a finite number of identified, predictable
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`solutions, a person of ordinary skill has good reason to pursue the known options
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`within his or her technical grasp.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
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`3
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`421, 127 S. Ct. 1727, 1742, 167 L. Ed. 2d 705 (2007). If this pursuit “leads to the
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`anticipated success,” then “it is likely the product not of innovation but of ordinary
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`skill and common sense.” Id. (emphasis added).
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`Here, a POSITA seeking a cinacalcet formulation would be motivated to
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`select each individual excipient based on its prior art properties listed in the
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`Handbook of Pharmaceutical Excipients (“HPE”), i.e., KSR’s “finite number of
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`identified, predictable solutions.” See, e.g., Ex. 1021 at ¶¶ 8-12, 19-28, 32, 38, 42,
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`46; KSR Int’l Co., 550 U.S. at 421, 127 S. Ct. at 1742. After selection of the
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`known excipients for combination with cinacalcet, a POSITA would have arrived
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`at the ‘595’s claimed composition through routine formulation or experimentation,
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`which is explained as commonly used by a POSITA in the pharmaceutical arts.
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`See, e.g., Ex. 1021 at ¶¶ 73, 76-96. Accordingly, a POSITA would have been
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`sufficiently motivated to combine, through selection and routine experimentation,
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`the prior art substances as claimed by the ‘595 Patent. KSR Int’l Co., 550 U.S. at
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`421, 127 S. Ct. at 1742 (rejecting the Federal Circuit’s “constricted analysis” and
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`erroneous conclusion that a patent claim “cannot be proved obvious merely by
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`showing that the combination of elements was ‘[o]bvious to try’”) (internal citation
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`omitted).
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`The Board here abused its discretion by misapprehending or overlooking the
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`principles set forth in KSR by failing to consider that in certain chemical arts a
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`4
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`POSITA’s practice of selection and routine formulation or experimentation is
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`sufficient for an obviousness determination. This abuse of discretion is highlighted
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`because in previous decisions, the Board has properly determined that such
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`selection and routine formulation or experimentation was sufficient for
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`obviousness. In particular, in Conopco, Inc. DBA Unilever v. the Procter &
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`Gamble Co., IPR2013-00505, 2014 WL 1253037 (Patent Tr. & App. Bd. Feb. 12,
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`2014) the Board decided to institute an inter partes review because it was
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`“persuaded that a skilled artisan would have been led to conduct routine
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`experiments to optimize for those desirable properties—and, thereby, the values of
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`the indices—in the shampoo composition.” Id. at *6. Such “desirable properties”
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`included “anti-dandruff efficacy (i.e. bioavailability and coverage)” and anti-
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`microbial activity. Id. The Board further stated that “[i]t is sufficient that at least
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`one test for optimizing the beneficial property associated with each specified index
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`was available at the relevant time.” Id. at *7. Accordingly, the Board was again
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`“persuaded that a skilled artisan would have had the ability and the desire to
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`optimize for those properties using available techniques and assays.” Id. (citing
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`KSR for the proposition that “[a] skilled artisan possesses ordinary creativity and is
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`not an automaton”); see also Endo Pharm., Inc., v. Depomed, Inc., IPR2014-
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`00652, 2014 WL 4925712, at *10 (Patent Tr. & App. Bd. Sept. 29, 2014) (finding
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`that “a person of ordinary skill in the art would have been had been led to the
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`5
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`
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`claimed invention, and able to make and use the invention, without anything more
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`than routine experimentation”); Amneal Pharmaceuticals, LLC v. Supernus
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`Pharmaceuticals, Inc., IPR2013-00368, Final Written Decision, Paper 94, at 14
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`(“Without evidence that the claimed IR:DR ratio was known or could have been
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`reached through routine experimentation, Amneal’s challenge fails.”). Instead of
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`addressing the substance of this issue (or rectifying its decision with any of the
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`Board’s prior decisions on the issue), the Board merely labeled paragraph 94 of Dr.
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`Chambliss’ Declaration “improperly conclusory,” thereby dismissing Dr.
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`Chambliss’ explanation of the pharmaceutical industry’s practice of routine
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`formulation through selection and testing to derive compositions of prior art API’s
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`and excipients. See Decision Denying Institution of Inter Partes Review, Paper
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`No. 8, at 15.
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`In sum, the ‘595 Patent describes nothing more than applying the prior art
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`API, cinacalcet, to textbook formulation as taught in HPE. This is no different
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`than the fact pattern in Conopco, Inc. DBA Unilever v. the Procter & Gamble Co.
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`regarding shampoo formulation, where the Board decided to institute, and is a
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`perfectly acceptable ground to prove obviousness recognized in KSR by the
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`Supreme Court of the United States. By rejecting Dr. Chambliss’s conclusion that
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`“it would be obvious to include excipients in the claimed composition” (Ex. 1021,
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`¶94), the Board creates a virtually impossible evidentiary standard of proving that
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`6
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`formation of such a composition is routine and known to a POSITA. Petitioner
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`urges the Board to give the testimony of Dr. Chambliss, who has over 38 years in
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`pharmaceutical drug development, the evidentiary weight it deserves.
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`IV. CONCLUSION
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`For the foregoing reasons, Petitioners request that the Board institute review
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`HILL, KERTSCHER & WHARTON, LLP
`
`/Vivek Ganti/
`
`
`Vivek Ganti (Registration No. 71,368)
`Lead Counsel for Petitioners
`3350 Riverwood Pkwy, Suite 800
`Atlanta, GA 30339
`(770) 953-0995
`
`7
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`on the instant petition.
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`Respectfully submitted,
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`
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`Date: May 13, 2016
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`CERTIFICATION OF SERVICE
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`The undersigned hereby certifies that the foregoing paper was served via
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`electronic mail on May 13, 2016, as agreed to by the parties pursuant to 37 C.F.R.
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`§ 42.105, in its entirety on the following:
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`
`John D. Murnane
`jmurnane@fchs.com
`Alicia A. Russo
`arusso@fchs.com
`Justin J. Oliver
`joliver@fchs.com
`FITZPATRICK, CELLA, HARPER & SCINTO
`Amgen595IPR@fchs.com
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`
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`Date: May 13, 2016
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`Respectfully submitted,
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`HILL, KERTSCHER & WHARTON,
`LLP
`
`
`/Vivek Ganti/
`
`
`
`Vivek Ganti (Reg. No. 71,368)
`Lead Counsel for Petitioners
`
`3350 Riverwood Pkwy, Suite 800
`Atlanta, GA 30339
`(770) 953-0995
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