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Storer v. Clark

United States Court of Appeals, Federal Circuit

June 21, 2017

RICHARD STORER, GILLES GOSSELIN, JEAN-PIERRE SOMMADOSSI, PAOLA LACOLLA, Appellants
v.
JEREMY CLARK, Appellee UNITED STATES, Intervenor

         Appeal from the United States Patent and Trademark Office, Patent Trial and Appeal Board in No. 105, 981.

          Gregory A. Castanias, Jones Day, Washington, DC, argued for appellants. Also represented by Jennifer Loraine Swize; Anthony M. Insogna, John David Kinton, San Diego, CA; Thomas Eugene Friebel, New York, NY; Calvin Griffith, Cleveland, OH.

          Frank Scherkenbach, Fish & Richardson PC, Boston, MA argued for appellee. Also represented by Jonathan Elliot Singer, Craig E. Countryman, W. Chad Shear, San Diego, CA.

          Joseph Forrest Busa, Appellate Staff, Civil Division, United States Department of Justice, Washington, DC, argued for intervenor. Also represented BY Mark R. Freeman, Benjamin C. Mizer; Thomas W. Krause, Office of the Solicitor, United States Patent and Trademark Office, Alexandria, VA.

          Before Prost, Chief Judge, NEWMAN, and Dyk, Circuit Judges.

          Newman, Circuit Judge.

         This patent interference contest involves methods of treating hepatitis C by administering compounds having a specific chemical and stereochemical structure, based on the following foundation formula of a five-membered ring having the fluorine substituent in the 2'(down) position:

         (IMAGE OMITTED)

         Storer Br. at 8. The priority decision was based on enablement of this product. The interference was declared between an issued patent (Storer et al.) and a pending application (Clark), both of which were filed before the effective date of the America Invents Act, the statute that abolished the first-to-invent interference rule in favor of a first-to-file rule. By the terms of the Act, § 3(n)(2), the prior, first-to-invent, law applies to this interference.

         To establish priority, Storer relied on the disclosure in the provisional specification from which priority was claimed for conception and constructive reduction to practice. In its joint decision on Clark's motion to deny Storer the benefit of the provisional application and on Clark's motion to invalidate Storer's claims on the grounds of lack of enablement and written description, [1]the Patent Trial and Appeal Board (PTAB or "Board") held that Storer's provisional application was not enabling for the count of the interference, and on that ground the PTAB entered judgment granting priority to Clark.[2]Storer appeals that judgment and the underlying decision on Clark's motions.

         We take note that Storer initially filed in the District of Delaware, seeking review of the Board's decision under 35 U.S.C. § 146. The district court dismissed the case, Idenix Pharmaceuticals. LLC v. Gilead Pharmasset LLC, 2016 WL 6804915, at *1 (D. Del. Nov. 16, 2016), based on this court's ruling in Biogen MA, Inc. v. Japanese Foundation for Cancer Research, 785 F.3d 648 (Fed. Cir. 2015), that the America Invents Act eliminated the option of district court review under Section 146 for interferences declared after September 15, 2012. Although Storer says that Biogen was incorrectly decided, that decision is binding on this panel. Storer's appeal of the district court's dismissal has been stayed pending the outcome of this appeal. Order, Idenix Pharm. LLC v. Gilead Phar-masset LLC, No. 17-1369 (Fed. Cir. Feb. 16, 2017).

         Background

         Inventors Richard Storer et al. were issued U.S. Patent No. 7, 608, 600 ("the '600 Patent"), on a final application filed on June 27, 2003. The patent is assigned to Idenix Pharmaceuticals. In the interference proceeding, Storer was initially declared the senior party based on the June 28, 2002 filing date of provisional application No. 60/392, 350 (called "the S1 application" by the Board). Clark's Application No. 11/854, 218, assigned to Gilead Pharmasset, was filed September 12, 2007, with priority claimed to a provisional application filed on May 30, 2003.

         Clark moved to deny Storer the priority date of the S1 application and to invalidate Storer's claims, arguing that the S1 application did not enable compounds having the 2´F(down) substituent. Storer argued that these compounds were generically disclosed in the S1 application, and were readily obtained based on the disclosure in the S1 provisional and the prior art. The Board did not agree, and by withdrawing entitlement to the provisional's filing date, the Board awarded priority to Clark. Storer now appeals that decision.

         Discussion

         The Interfering Claims

         Storer and Clark were investigating the treatment of hepatitis C using modified nucleoside compounds, including certain heterocyclic compounds having a fluorine substituent in the 2´ position. The PTAB identified the interfering subject matter, and selected claims for purposes of determining priority. From the Storer patent, the Board selected claim 1:

1. A method for the treatment of a host infected with a hepatitis C virus, comprising administering to the host infected with a hepatitis C virus an effective amount of a compound having the formula:

         (IMAGE OMITTED)

or a pharmaceutically acceptable salt thereof, wherein:
R1 is H; mono-, di- or triphosphate; acyl; an amino acid ester; a carbohydrate; a peptide;
or a pharmaceutically acceptable leaving group which when administered in vivo provides a compound wherein R1 is H or phosphate;
R2 is H; acyl; an amino acid ester; a carbohydrate; a peptide; or a pharmaceutically acceptable leaving group which when administered in vivo provides a compound wherein R2 is H;
Base* is selected from the group consisting of adenine, N6-alkylpurine, N6-acylpurine, N6-benzylpurine, N6-halopurine, N6-vinylpurine, N6-acetylenic purine, N6-acyl purine, N6-hydroxyalkylpurine, N6-alkylamino-purine, N6-thioalkyl purine, R2-alkylp urine, R2-alkyl-6-thiopurine, thymine, cytosine, 5-fluorocytosine, 5-methylcytosine, 6-azapyrimidine, 6-azacytosine, 2-and/or 4-mercaptopyrimidine, uracil, 5-halouracil, 5-fLuorouracil, C5-alkylpyrimidine, C5-benzylpyrimidine, C5-halopyrimidine, C5- vinylpyrimidine, C5-acetylenic pyrimidine, C5-acyl pyrimidine, C5-hydroxyalkyl purine, C5-amidopyrimidine, C5-cyanopyrimidine, C5-iodopyrimidine, C6-iodo-pyrimidine, C5-Br-vinyl pyrimidine, C6-Br-vinylpyrimidine, C5- nitropyrimidine, C6-amino-pyrimidine, N2-alkylpurine, N2-alkyl-6-thiopurine, 5-azacytidinyl, 5-azauracilyl, triazolopyridinyl, imidazolopyridi-nyl, pyrrolopyrimidinyl, pyrazolopyrimidinyl, guanine, hypoxanthine, 2, 6-diaminopurine, and 6-choropurine;
R12 is C(Y3)3; and
Y3 is independently H or F.

         From the Clark application, the Board selected claim 164:

164. A method for the treatment of hepatitis C infection, which comprises:
administering to a mammal in need thereof an an-tivirally effective amount of a (2'R)-2'-deoxy-2-fluoro-2'-C-methyl nucleoside (β-D or β-L) or its pharmaceutically acceptable salt of the structure:

         (IMAGE OMITTED)

wherein R1 and R7 are independently H, a monophosphate, a diphosphate, a triphosphate, a H-phosphonate, an alkyl, an alkyl sulfonyl, or an ar-ylalkyl sulfonyl; and R4 is NH2 or OH.

         The parties agree that the only question focuses on whether the Storer S1 provisional together with the prior art enabled ...


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