UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`GNOSIS S.P.A., GNOSIS BIORESEARCH S.A., AND GNOSIS U.S.A., INC.
`Petitioners
`
`V.
`
`SOUTH ALABAMA MEDICAL SCIENCE FOUNDATION
`
`Patent Owner
`
`Case IPR2013-00118
`
`U.S. Patent No. 6,673,381
`
`PATENT OWNER’S NOTICE OF FILING PETITION FOR WRIT OF
`
`CERTIORARI WITHIN THE TIME ALLOWED UNDER SUP. CT. R. 13
`
`

`
`Case IPR20l3-00118
`
`U.S. Patent 6,673,381
`
`Notice is hereby given that South Alabama Medical Science Foundation
`
`(“Patent Owner”) will file a petition for writ of certiorari before the Supreme Court
`
`of the United States, appealing from the Court of Appeals for the Federal Circuit’s
`
`decision in S. Ala. Med. Sci. Found. v. Gnosis S.p.A., 808 F.3d 823 (Fed. Cir. 2015)
`
`(“SAMSF I”), affirming the Final Written Decision of the Patent Trial and Appeal
`
`Board (“PTAB”) entered on June 20, 2014 (Paper 64). The time for appeal—that is,
`
`appeal to the Supreme Court—has not expired. Patent Owner’s petition for writ of
`
`certiorari will be filed before July 25, 2016 in accordance with Sup. Ct. R. 13.
`
`Patent Owner’s appeal arose from IPR No. 2013-00118. On December 17,
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`2015, a divided panel of the Federal Circuit issued a precedential decision upholding
`
`the PTAB’s Final Written Decision (Paper 64) finding all claims-at-issue invalid. A
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`2-1 majority upheld the PTAB’s invalidity rulings on the basis that the factual
`
`findings were supported by “substantial evidence.” The dissent indicated that the
`
`“clear error” standard should have been applied given the nature of inter partes
`
`review (“IPR”) proceedings, which were intended to be an alternative for district
`
`court proceedings. SAMSFI, 808 F.3d at 828 (Newman, J ., dissenting) (referring to
`
`her dissent in the companion case Merck & Cie v. Gnosis S.p.A., 808 F .3d 829, 839-
`
`40 (Fed. Cir. 2015) (“Merck 1”), where application of the “clear error” standard
`
`instead of the “substantial evidence” standard would have changed the outcome of
`
`the appeal).
`
`

`
`On January 19, 2016, Patent Owner petitioned the Federal Circuit for an en
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`banc rehearing arguing, inter alia, that the panel majority should have applied a
`
`“clear error” standard of review to the PTAB’s factual findings instead of the more
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`deferential “substantial evidence” standard. On April 26, 2016, the Federal Circuit
`
`denied Patent Owner’s petition for en banc rehearing. S. Ala. Med. Sci. Found. v.
`
`Gnosis S.p.A., No. 2014-1778, slip op. at 2 (Fed. Cir. Apr. 26, 2016) (“SAMSF 11”)
`
`(per curiam).‘ In rejecting Patent Owner’s petition, Judges O’Malley, Wallach, and
`
`Stoll concurred while observing that application of the “substantial evidence”
`
`standard of review is “seemingly inconsistent with the purpose and content of the
`
`[America Invents Act (‘AIA’)]” and that “a substantial evidence standard of review
`
`makes little sense in the context of an appeal from an IPR proceeding.”
`
`1d,,
`
`concurrence at 1 (O’Mal1ey, J ., et al., concurring) (concurring for the same reasons
`
`as stated in the denial of en banc rehearing in the companion case Merck & Cie v.
`
`Gnosis S.p.A., No. 2014-1779, concurrence at 2 (Fed. Cir. Apr. 26, 2016) (“Merck
`
`I1”) (O’Malley, J ., et al., concurring). However, according to the concurring
`
`opinion, the question regarding the appropriate standard of appellate review was
`
`more appropriately addressed by Congress or the Supreme Court, given the Supreme
`
`Court’s decision in Dickinson v. Zurko, 527 U.S. 150 (1999). Merck II, concurrence
`
`1 Slip opinion and mandate included as Attachment
`respectively.
`
`1
`
`and Attachment 2,
`
`

`
`at 2, 6-7 (O’Malley, J ., et al., concurring). In a dissenting opinion, Judge Newman
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`likewise recognized the inapplicability of the “substantial evidence” standard of
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`review for appeals from IPR proceedings. SAMSF II, dissent at 1-2 (Newman, J .,
`
`dissenting).
`
`Further, three other judges of the Federal Circuit (Chief Judge Prost and
`
`Judges Moore and Reyna) previously have agreed with the premise underlying the
`
`issue to be presented by Patent Owner, namely, that IPRs are a surrogate for district
`
`court proceedings and should be treated as such. In re Cuozzo Speed Techs., LLC,
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`793 F.3d 1297, 1300 (Fed. Cir. 2015) (Prost, C.J., et al., dissenting), cert. granted,
`
`Cuozzo Speed Techs., LLC v. Lee, 2016 U.S. LEXIS 632 (U.S. Jan. 15, 2016) (No.
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`15-446).
`
`The issues to be raised by Patent Owner’s certiorari petition will include
`
`whether the Federal Circuit should apply a “clear error” standard of review to the
`
`PTAB’s factual findings in IPRs rather than the “substantial evidence” standard
`
`given the purpose of the AIA. The petition will present a substantial question that
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`has a reasonable likelihood of being granted because: (1) there is a split within the
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`Federal Circuit over whether the “substantial evidence” standard should apply to
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`IPR reviews given the purpose and content of the AIA; (2) it will address an issue
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`that is predicated on a topic presently before the Supreme Court in Cuozzo Speed
`
`Techs, LLC v. Lee—namely, whether IPR proceedings were intended to function as
`
`

`
`surrogates for district court litigation; and (3) it will have implications for virtually
`
`all appeals to the Federal Circuit from IPR final decisions.
`
`

`
`Dated: May 9, 2016
`
`
`
`_ ResJ;eefij_1l-I Submitted by:
`
` '
`
`'. Esq., Reg. No.: 42,062
`Counsel for Patent Owner
`
`Alston & Bird LLP
`
`90 Park Avenue, 12th Floor
`
`New York, New York 10016-1387
`Telephone: (212) 210-9529
`Facsimile: (212) 922-3975
`E-mail: thomas.parker@alston.com
`
`Jitendra Malik, Ph.D, Esq., Reg. No.: 55,823
`Counsel for Patent Owner
`
`Alston & Bird LLP
`
`4721 Emperor Boulevard, Ste. 400
`Durham, North Carolina 27703-8580
`
`Telephone: (919) 862-2210
`Facsimile: (919) 862-2260
`E-mail: jitty.malik@a1ston.com
`
`Peter Rogalskyj, Esq., Reg. No.: 38,601
`Counsel for Patent Owner
`
`The Law Office of Peter Rogalskyj
`P.O. Box 44
`
`63 Big Tree Street
`Livonia, NY 14487
`Telephone: (585) 346-1004
`Facsimile: (585) 346-1001
`E-mail: pr@prpatent.com
`
`

`
`ATTACHMENT 1
`
`ATTACHMENT 1
`
`

`
`Case: 14-1778 Document: 62 Page: 1 Filed: 04/26/2016
`
`United States Court of Appeals
`for the Federal Circuit
`______________________
`
`SOUTH ALABAMA MEDICAL SCIENCE
`FOUNDATION,
`Appellant
`
`v.
`
`GNOSIS S.P.A., GNOSIS BIORESEARCH S.A.,
`GNOSIS U.S.A., INC.,
`Appellees
`______________________
`
`2014-1778, 2014-1780, 2014-1781
`______________________
`
`Appeals from the United States Patent and Trade-
`mark Office, Patent Trial and Appeal Board, in Nos.
`IPR2013-00116, IPR2013-00118, IPR2013-00119.
`______________________
`
`ON PETITION FOR REHEARING EN BANC
`______________________
`
`THOMAS J. PARKER, Alston & Bird LLP, New York,
`NY,
`for appellant. Also
`represented by DEEPRO
`MUKERJEE, YI WEN WU; JITENDRA MALIK, Durham, NC;
`KIRK T. BRADLEY, Charlotte, NC; PETER ROGALSKYJ, Law
`Office of Peter Rogalskyj, Livonia, NY.
`
`JOSEPH CWIK, Amin Talati & Upadhye, LLC,
`Chicago, IL, for appellees. Also represented by JONATHAN
`JACOB KRIT.
`
`______________________
`
`

`
`Case: 14-1778 Document: 62 Page: 2 Filed: 04/26/2016
`
`
`
` 2
`
` SOUTH ALABAMA MEDICAL SCIENCE v. GNOSIS S.P.A.
`
`
`Before PROST, Chief Judge, NEWMAN, LOURIE, DYK,
`MOORE, O’MALLEY, REYNA, WALLACH, TARANTO, CHEN,
`HUGHES, and STOLL, Circuit Judges.
`O’MALLEY, Circuit Judge, with whom WALLACH and
`STOLL, Circuit Judges, join, concur in the denial of the
`petition for rehearing en banc.
`NEWMAN, Circuit Judge, dissents from the denial of the
`petition for rehearing en banc.
`
`PER CURIAM.
`
`
`
`
`
`
`
`
`
`
`
`
`
`FOR THE COURT
`
`/s/ Daniel E. O’Toole
`
` Daniel E. O’Toole
`
`Clerk of Court
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`O R D E R
`Appellant South Alabama Medical Science Founda-
`
`tion filed a petition for rehearing en banc. A response to
`the petition was invited by the court and filed by the
`appellees Gnosis S.p.A., Gnosis Bioresearch S.A., and
`Gnosis U.S.A., Inc.
`The petition was referred to the panel that heard the
`appeal, and thereafter the petition and response were
`referred to the circuit judges who are in regular active
`service. A poll was requested, taken, and failed.
`Upon consideration thereof,
`IT IS ORDERED THAT:
`The petition for rehearing en banc is denied.
`The mandate of the court will issue on May 3, 2016.
`
`
`
`
`
`
`
`
`
` April 26, 2016
`
` Date
`
`
`
`
`
`
`
`
`

`
`Case: 14-1778 Document: 62 Page: 3 Filed: 04/26/2016
`
`United States Court of Appeals
`for the Federal Circuit
`______________________
`
`SOUTH ALABAMA MEDICAL SCIENCE
`FOUNDATION,
`Appellant
`
`v.
`
`GNOSIS S.P.A., GNOSIS BIORESEARCH S.A.,
`GNOSIS U.S.A., INC.,
`Appellees
`______________________
`
`2014-1778, 2014-1780, 2014-1781
`______________________
`
`Appeals from the United States Patent and Trade-
`mark Office, Patent Trial and Appeal Board, in Nos.
`IPR2013-00116, IPR2013-00118, IPR2013-00119.
`______________________
`O’MALLEY, Circuit Judge, with whom WALLACH and
`STOLL, Circuit Judges, join, concurring in the denial of the
`petition for rehearing en banc.
`This is a companion appeal to Merck & Cie v. Gnosis
`S.p.A., No. 2014-1779 (Fed. Cir. Dec. 17, 2015). Petitioner
`South Alabama Medical Science Foundation “seeks en
`banc rehearing for the same reasons addressed” by Merck
`& Cie in its petition for rehearing. Pet. for Reh’g 3. I
`therefore concur in the denial of rehearing en banc for the
`same reasons stated in my concurrence in the companion
`appeal. See Merck & Cie v. Gnosis S.p.A., No. 2014-1779
`(Fed. Cir. 2016 Apr. 26, 2016) (O’Malley, J., concurring in
`denial of rehearing en banc).
`
`

`
`Case: 14-1778 Document: 62 Page: 4 Filed: 04/26/2016
`
`United States Court of Appeals
`for the Federal Circuit
`______________________
`
`SOUTH ALABAMA MEDICAL SCIENCE
`FOUNDATION,
`Appellant
`
`v.
`
`GNOSIS S.P.A., GNOSIS BIORESEARCH S.A.,
`GNOSIS U.S.A., INC.,
`Appellees
`______________________
`
`2014-1778, 2014-1780, 2014-1781
`______________________
`
`Appeals from the United States Patent and Trade-
`mark Office, Patent Trial and Appeal Board, in Nos.
`IPR2013-00116, IPR2013-00118, IPR2013-00119.
`______________________
`NEWMAN, Circuit Judge, dissenting from denial of the
`petition for rehearing en banc.
`This is the companion to Merck & Cie v. Gnosis S.p.A.,
`No. 14-1777 (Gnosis I), decided concurrently. As in Gno-
`sis I, the panel majority applied the deferential “substan-
`tial evidence” standard of review and, in doing so, adopted
`the factual findings of the PTAB and affirmed the PTAB’s
`cancellation of U.S. Patent Nos. 5,997,915, 6,673,381, and
`7,172,778. For the reasons discussed in my dissent to the
`denial of en banc rehearing in Gnosis I, I believe en banc
`consideration is necessary to realign the appellate stand-
`ard of review of these inter partes proceedings with the
`statutory purpose of the America Invents Act.
`
`

`
`Case: 14-1778 Document: 62 Page: 5 Filed: 04/26/2016
`
`
`
` 2
`
` SOUTH ALABAMA MEDICAL SCIENCE v. GNOSIS S.P.A.
`
`This case illustrates the pitfalls of the deferential
`“substantial evidence” standard. Despite concluding that
`the PTAB erred in assessing South Alabama Medical
`Science Foundation’s (SAMSF) licensing evidence, the
`panel majority affirmed the PTAB’s obviousness determi-
`nation, on the ground that it was supported by substan-
`tial evidence.
`There was extensive evidence of licensing, sublicens-
`ing, and relicensing of the SASMF patents. More than
`twelve companies have taken sublicenses to the SAMSF
`patents, and manufacture or sell products practicing the
`patents. The royalty stream for the SAMSF patents
`produces millions of dollars in annual revenue. The
`PTAB did not mention these as objective indicia of non-
`obviousness. Instead, the PTAB dismissed all of SAMSF’s
`objective evidence for lack of “nexus.” This was legal
`error, as the panel majority held. The majority nonethe-
`less affirmed because “that evidence is not enough to
`overcome the strong evidence of obviousness . . . relied
`upon by the Board to reach its conclusion of obviousness.”
`Gnosis II at 8. This too was legal error, for all of the
`evidence must be considered together in evaluating obvi-
`ousness. Graham v. John Deere Co., 383 U.S. 1, 17
`(1966); Leo Pharm. Products, Ltd. v. Rea, 726 F.3d 1346,
`1357 (Fed. Cir. 2013) (“Whether before the Board or a
`court, this court has emphasized that consideration of the
`objective indicia is part of the whole obviousness analysis,
`not just an afterthought.”)
`This is a crowded field of science, with conflicting ex-
`perimental results, from which it was not reasonably
`predictable that the compositions that were eventually
`developed would be biologically effective and commercial-
`ly successful. Objective indicia such as commercial suc-
`cess “may often be the most probative and cogent evidence
`[of non-obviousness] in the record,” Procter & Gamble Co.
`v. Teva Pharm. USA, Inc., 566 F.3d 989, 998 (Fed. Cir.
`2009) (modification in original) (quoting Stratoflex, Inc. v.
`
`

`
`Case: 14-1778 Document: 62 Page: 6 Filed: 04/26/2016
`
`SOUTH ALABAMA MEDICAL SCIENCE v. GNOSIS S.P.A.
`
`3
`
`Aeroquip Corp., 713 F.2d 1530, 1538 (Fed. Cir. 1983)).
`Considerations of biological effect and commercial and
`public response are a balance to judicial hindsight. In re
`Cyclobenzaprine Hydrochloride Extended-Release Capsule
`Patent Litigation, 676 F.3d 1063, 1075-76 (Fed. Cir. 2012)
`(“The objective considerations, when considered with the
`balance of the obviousness evidence in the record, guard
`as a check against hindsight bias.”).
`Precedent requires that the objective evidence be con-
`sidered together with the other evidence relating to the
`question of obviousness. In turn, my colleagues also err
`in law, for our appellate role includes assuring that the
`correct law is applied by the PTAB. Although the panel
`majority finds substantial evidence to support the PTAB’s
`conclusion, less than all of the evidence was analyzed and
`weighed by the PTAB. On the entirety of the record,
`including the objective considerations, the petitioner has
`not established invalidity by a preponderance of the
`evidence, as required by statute.
`Thus I respectfully dissent from the court’s refusal to
`reconsider this case en banc.
`
`

`
`ATTACHMENT 2
`
`ATTACHMENT 2
`
`

`
`Case: 14-1778 Document: 65 Page: 1 Filed: 05/05/2016
`UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT
`
`
`
`14-1778, 14-1780, 14-1781
`
`SOUTH ALABAMA MEDICAL SCIENCE FOUNDATION,
`Appellant
`
`
`
`
`
`
`
`v.
`
`GNOSIS S.P.A., GNOSIS BIORESEARCH S.A., GNOSIS U.S.A., INC.,
`Appellees
`
`Appeals from the United States Patent and Trademark Office in case no. IPR2013-00116, IPR2013-
`00118, IPR2013-00119
`
`MANDATE
`
` In accordance with the judgment of this Court, entered December 17, 2015, and pursuant to Rule 41(a)
`of the Federal Rules of Appellate Procedure, the formal mandate is hereby issued.
`
` Costs in the amount of $265.00 were determined and taxed against the appellant.
`
`
`
`
`
`
`
`
`FOR THE COURT
`
`/s/ Peter R. Marksteiner
`Peter R. Marksteiner
`Clerk of Court
`
`
`
`
`
`
`
`
`
`
`
`
`

`
`CERTIFICATE OF SERVICE
`
`I hereby certify that on May 9, 2016, in addition to being filed electronically
`
`through the Patent Review Processing System, the foregoing Patent Owner’s Notice
`
`of Filing Petition for Writ of Certiorari Within the Time Allowed Under Sup. Ct. R.
`
`13 was caused to be served by overnight mail to the following recipients:
`
`Director of the United States Patent and Trademark Office
`
`United States Patent and Trademark Office
`
`P.O. Box 1450
`
`Alexandria, Virginia
`22313-1450
`
`Office of the General Counsel
`
`United States Patent and Trademark Office
`
`P.O. Box 1450
`
`Alexandria, Virginia
`22313-1450
`
`/
`
`Dated: May 9, 2016
`
`3/
`
`
`
`"
`/
`Thomas Parkei, Esq., Reg. No.: 42,062
`Counsel for Patent Owner
`
`Alston & Bird LLP
`
`90 Park Avenue, 12th Floor
`New York, New York 10016-1387
`
`Telephone: (212) 210-9529
`Facsimile: (212) 922-3975
`E—mail: thomas.parker@alston.com
`
`

`
`CERTIFICATE OF SERVICE
`
`I hereby certify that on May 9, 2016, the Patent Owner’s Notice of Filing
`
`Petition for Writ of Certiorari Within the Time Allowed Under Sup. Ct. R. 13 was
`
`served by electronic mail, as consented to by the parties, upon the Petitioners’
`
`counsel of record upon the following:
`
`Jonathan J. Krit
`
`Joseph E. Cwik
`Amin Talati & Upadhye, LLC
`100 S. Wacker Drive, Suite 2000
`Chicago, Illinois 60606
`jonathan@amintalati.com
`joe@amintalati.com
`
`Erik B. Flom, Ph.D.
`Husch Blackwell LLP
`
`120 South Riverside Plaza, Suite 2200
`Chicago, Illinois 60606
`erik.flom@huschblackwe1l.com
`
`Dated: May 9, 2016
`
`/,
`
`(
`
`
`sq., Reg. No.2 42,062
`Thomas Parke ,
`Counsel for Patent Owner
`
`Alston & Bird LLP
`
`90 Park Avenue, 12th Floor
`
`New York, New York 10016-1387
`
`Telephone: (212) 210-9529
`Facsimile: (212) 922-3975
`E-mail: thomas.parker@alston.com