The Patent Trial and Appeal Board (PTAB) issued its first final written decisions June 20, 2014, in four inter partes reviews (IPR) of pharmaceutical-related patents. The four decisions effectively invalidated all 58 of the challenged patent claims spread across four patents owned by Merck & Cie and South Alabama Medical Science Foundation (SAMSF) who previously accused Husch Blackwell client Gnosis SpA of infringement.
SAMSF owns three of the patents, which are licensed to Merck & Cie who also owns the fourth patent relating to natural folates in combination with other ingredients. The patents are licensed for use in several prescription medical foods by Pamlab LLC.
In response to alleged patent infringement claims asserted in 2012, Gnosis brought the four IPR proceedings under the new American Invents Act (AIA) legislation challenging the patents and staying related litigation in the Eastern District of Texas in 2013. The cases are Gnosis SpA et al. v. South Alabama Medical Science Foundation, case numbers IPR2013-00116, IPR2013-00118, and IPR2013-00119; and Gnosis SpA et al. v. Merck & Cie, case number IPR2013-00117.
In its decisions, the PTAB found that many claims of the patents challenged by Gnosis were rendered unpatentable as anticipated or obvious by several prior art references, including an earlier European patent application and U.S. patent. Other patent claims were canceled at the request of Merck & Cie or SAMSF.
The patents at issue were U.S. Patent Numbers 5,997,915; 6,011,040; 6,673,381; and 7,172,778.
The patents generally related to combinations of a natural folate and other ingredients that can be used to treat folate deficiencies or conditions associated therewith. As a defense, the patent owners brought several arguments against the obviousness of many of the claims that were not canceled, including arguments that the patents were licensed, had commercial success, and that the disclosed natural folate was previously believed to have poor substrate activity and low bioavailability.
Despite these arguments, the PTAB ruled that such factors were unpersuasive and insufficient to overcome Gnosis’ “strong showing” of obviousness. In one decision, the PTAB stated “[t]he causal relationship between the claimed subject matter and the objective evidence [of secondary considerations] is tenuous, at best.”
According to the United States Patent and Trademark Office (USPTO), roughly 6 percent of AIA petitions filed to date have been related to pharmaceutical inventions, while 86 percent challenge electrical, computer, and mechanical inventions. Recently, however, several petitions by generic drug companies have surfaced challenging the validity of patents owned by the brand drug companies.
Other pharmaceutical companies will now look very closely at the PTAB’s final decisions issued in the Gnosis case. They likely establish a blueprint for how the PTAB will approach pharmaceutical patents in the AIA’s IPR process.