Pharmaceutical Claims Found Unpatentable

Pharmaceutical Claims Found Unpatentable

 by Michael K. Levy

On June 20, 2014, the Patent Trial and Appeal Board (PTAB) issued the first inter partes review (IPR) decisions reaching pharmaceutically-related subject matter, which in this case constituted dietary supplement and vitamin products. Four separate final written decisions, addressing four respective patents claiming related subject matter, held claims unpatentable directed to pharmaceutical compositions and methods of treatment using such compositions.

The twenty claims among the four patents ultimately reviewed by the PTAB were generally directed to treating particular indications by administering compositions containing a natural isomer of a reduced folate (e.g., 5-methyl-(6S)-THF), as an alternative to folic acid, which some individuals reportedly do not absorb easily. Petitioner essentially relied upon one prior art reference disclosing preparations for the use of folate or an undefined suitable active metabolite, and another disclosing the natural folate metabolite 5-methyl-(6S)-THF for treating folate deficiency. Despite Patent Owners’ reliance on nearly a dozen experts and other declarants’ testimony rebutting the combination, the PTAB found all challenged claims either anticipated or rendered obvious by the prior art. Notably, the PTAB carefully assessed the proffered objective evidence of nonobviousness (“secondary considerations”), finding in all cases that Patent Owners had failed to establish a nexus linking the evidence of commercial success, unexpected results, long-felt need, licensing and copying to any novel element in the claims. During the IPR proceedings, Patent Owners canceled a number of claims among the four patents, leaving only 30 for the PTAB to consider.

The four decisions were issued in Case Nos. IPR 2013-00116 (U.S. 5,997,915), IPR 2013-00117 (U.S. 6,011,040), IPR 2013-00118 (U.S. 6,673,381) and IPR 2013-00119 (U.S. 7,172,778).

Petitioners in all four cases were Gnosis SpA, Gnosis Bioresearch S.A., and Gnosis U.S.A., Inc. Patent Owners were South Alabama Medical Science Foundation (-00116, -00118 and -00119) and Merck & Cie (-00117).

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