In 2012, Merck & Cie (Merck), South Alabama Medical Science Foundation (SAMSF) and Pamlab filed suit against Gnosis and others in the Eastern District of Texas. The lawsuit accused Gnosis of manufacturing prescription vitamin supplements that infringed three SAMSF patents relating to dietary folate supplementation and a Merck patent relating to the use of tetrahydrofolates in pharmaceutical production. The litigation was stayed pending a decision on Gnosis’ request for inter partes review of these patents under the America Invents Act. Based on obviousness findings and the cancellation of 32 claims by SAMSF and six claims by Merck, Gnosis prevailed on all of the 58 claims it challenged. Regarding the obviousness findings, the PTO was unpersuaded by SAMSF’s and Merck’s attempts to use evidence of “commercial success” (net sales, growth in sale, licensing arrangements, copying by others and fulfillment of long-felt but unmet need) as objective indicia of nonobviousness. The PTO said that, “In relation to commercial success, the evidence must show ‘both that there is commercial success and that the thing (product or method) that is commercially successful is the invention disclosed and claimed in the patent.’” (Emphasis supplied.)  Here, given the existence and availability of “strong” prior art, SAMSF and Merck failed to meet the second prong of this analysis. Thus, the PTO gave the evidence of commercial success provided by SAMSF and Merck little to no weight in evaluating obviousness.

According to Ryan Davis’s Law360 article, "Merck Supplement Patents Nixed in 1st Pharma AIA Reviews," “only about 6 percent of the AIA petitions filed to date have challenged pharmaceutical patents,” making this possibly the “first inter partes review involving pharmaceutical-related patents.”

Gnosis S.P.A. v. South Alabama Medical Science Foundation, IPR2013-00116, IPR2013-00118 & IPR2013-00119 (PTAB June 20, 2014) [Kamholz (opinion); Bonilla; Snedden]; Gnosis, S.P.A. v. Merck & CIE, IPR2013-0017 (PTAB June 20, 2014) [Kamholz (opinion); Bonilla; Snedden].