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South Alabama Medical Science Foundation v. Gnosis S.P.A.

United States Court of Appeals, Federal Circuit

December 17, 2015

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, Patent Trial and Appeal Board in No. IPR2013-00116.

THOMAS J. PARKER, Alston & Bird LLP, New York, N.Y. argued for appellant. Also represented by 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 argued for appellees. Also represented by JONATHAN JACOB KRIT, Amin Talati, LLC, Chicago, IL.

Before NEWMAN, PLAGER, and HUGHES, Circuit Judges. OPINION filed by Circuit Judge HUGHES. Dissenting opinion filed by Circuit Judge NEWMAN.

OPINION

Page 824

Hughes, Circuit Judge.

This is a companion case to Merck & Cie v. Gnosis S.p.A., No. 14-1779, 808 F.3d 829, (Fed. Cir. Dec. 17, 2015) ( Gnosis I ), also decided today. As Merck argued in that case, South Alabama Medical Science Foundation argues here that the prior art taught away from its claimed use of a reduced folate to treat folate deficiency, and that objective indicia of non-obviousness further demonstrate the validity of its patents. Although the Patent Trial and Appeal Board erred in its assessment of the evidence of licensing, the Board's other factual findings are supported

Page 825

by substantial evidence. Because we agree with the Board's ultimate conclusion of obviousness in light of those findings, we affirm.

I

South Alabama Medical Science Foundation (SAMSF) owns U.S. Patent Nos. 5,997,915 ('915 patent), 6,673,381 ('381 patent), and 7,172,778 ('778 patent). At the request of Gnosis S.p.A., Gnosis Bioresearch S.A., and Gnosis U.S.A. (collectively, Gnosis) and after granting SAMSF's motion to cancel certain claims, the Board instituted review of claims 37, 94-97, 99-100, and 110-111 of the '915 patent; claim 32 of the '381 patent; and claim 15 of the '778 patent.

All three patents relate to administering the " natural" stereoisomer of 5-methyl-tetrahydrofolic acid (L-5-MTHF) and other vitamins to treat symptoms associated with folate deficiency. We explained the background for this technology in Gnosis I, at **2-3. In brief, 5-MTHF is a reduced folate that is a critical component of certain metabolic cycles. A deficiency of folate causes a variety of health issues, including cardiovascular disease, neurological disorders, birth defects, and skeletal disorders.

Claim 37 of the '915 patent recites " a method of increasing a human subject's dietary intake of folate comprising administering . . . one or more natural isomers of reduced folate selected from [a group including L-5-MTHF]" and " an essential nutrient preparation . . . comprising a vitamin other than ascorbic acid . . . in an amount equal to or greater than 25% of the daily requirement for the vitamin." '915 patent, col. 23 ll. 16-31. Claims 94-97, 99-100, and 110-111 ultimately depend from claim 37, and specifically require that " the one or more natural isomers of reduced folate is substantially chirally pure [5-MTHF] or a polyglutamyl derivative thereof." '915 patent, reexamination certificate, col. 4 ll. 34-50, 55-62; col. 6 ll. 26-31.

Claim 32 of the '381 patent similarly recites a method of treating vascular disease using a composition including one or more substantially chirally pure natural isomers of reduced folate (e.g. L-5-MTHF) and an essential nutrient preparation comprising ...


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