Cited Statutory Sections: 101 and 103

This appeal concerned 10 inter partes reviews (IPRs) filed by petitioners Neptune Generics, Fresenius Kabi USA and Mylan Laboratories against all of the claims of U.S. Patent No. 7,772,209, which is owned by Eli Lilly & Co. The ’209 patent concerns methods of administering pemetrexed disodium, an antifolate chemotherapeutic agent, in combination with folic acid and a methylmalonic acid (MMA) lowering agent, such as vitamin B12. The co-administration of the folic acid and the MMA lowering agent was represented as reducing the toxicity of the antifolate chemotherapy.

The petitioners relied on references concerning the actions and toxicities of antifolate chemotherapeutic agents, the metabolism of vitamins, and the role of folic acid in modulating toxicity of antifolates. The Patent Trial and Appeal Board concluded that, although the use of folic acid to reduce toxicity of antifolates was known in the prior art, there was no reason provided by the prior art to also administer vitamin B12. Accordingly, the Board determined that a prima facie case of obviousness was not established by the petitioners. The Board also determined that skepticism from FDA officials regarding the administering of vitamins supported a determination of non-obviousness. More specifically, certain FDA officials warned against the administration of vitamins during antifolate chemotherapy and considered it “risky.” The Federal Circuit affirmed the Board’s determination of non-obviousness.

Skepticism by the field is often referred to as a “secondary consideration” or “objective indicia” of non-obviousness. The Board traditionally has been reluctant to allow secondary considerations to overcome a prima facie case of obviousness. Here, however, the secondary consideration of skepticism supported the Board’s determination that a prima facie case of obviousness had not been established by the petitioners.

The petitioners also argued that the claims were not patent eligible under 35 U.S.C. § 101. The Federal Circuit stated that IPRs are limited to 35 U.S.C. §§ 102 and 103, and therefore the court could not address the patent eligibility issue in an appeal of an IPR.