Last week, in what appeared to be one of the first pharmaceutical based cases brought to a decision under the IPR regime, the Patent Trial and Appeals Board (PTAB) of the US Patent and Trademark Office held that the majority of claims in a series of vitamin supplement patents were invalid. This decision turns the welcoming lights on for the generic drug industry to utilize the inter partes review (IPR) procedures under the America Invents Act to challenge proprietary pharmaceutical patents. In this matter, the challenger Gnosis, a defendant in an infringement action brought by Merck & Cie, South Alabama Medical Science Foundation and Parmlab, which was stayed pending the IPR decision, successfully defended against the four patents in issue: United States Patent Nos. 5,997,915, 6,011,040, 6,673,381 and 7,172,778 which are directed to compositions and methods of use involving chiral reduced natural folate compounds used as food supplements to prevent or treat folate deficiency diseases.
The successful defense was based on an obvious attack on the patentability of the claims in issue based on US and foreign patent prior art. An attempt to overcome the obviousness challenge by asserting secondary considerations of nonobviousness, such as commercial success of the patentee’s licensing program, was denied by the PTAB as having an insufficient nexus to the claimed invention.