On April 26, 2019, the Federal Circuit affirmed three final
written decisions of the Patent and Trial Appeal Board
("Board") in related inter partes reviews
("IPRs") in which the Board upheld the patentability of
all the claims of U.S. Patent 7,772,209 ("the '209
patent") over obviousness challenges.1 Neptune
Generics, LLC v. Eli Lilly & Co., — F.3d –,
No. 2018-1257, 2019 WL 1868289 (Fed. Cir. Apr. 26, 2019). This
decision provides insightful guidance on the proper use of evidence
relating to FDA regulatory review—such as communications with
the FDA and the skepticism of FDA medical officers—in
determining obviousness.
The '209 patent is listed in the FDA Orange Book for
ALIMTA® (pemetrexed disodium), an antifolate drug marketed by
Lilly and approved for treating certain types of lung cancer and
mesothelioma. The claims of the '209 patent are directed to a
method of administering pemetrexed by pretreating patients with
both folic acid and a methylmalonic acid
