Evidence of skepticism of others in an IPR can be used to
support the patentability of claims in response to obviousness
challenges—skepticism is a standard "objective
indicia" or secondary consideration of nonobviousness. In a
recent series of IPRs filed by several generic drug makers against
Eli Lilly & Co. (IPR2016-00318, IPR2016-00237 and IPR2016-00240), Eli Lilly bolstered its case
for nonobviousness by pointing to the skepticism of the U.S. Food
& Drug Administration (FDA) concerning its patented method. The
PTAB's decision illustrates that while skepticism by some may
be helpful to patent owners, skepticism by the right people may be
critical.
The challenged
claims in Eli Lilly's U.S. Patent No. 7,772,209 are directed to
a method for co-administering the antifolate pemetrexed disodium
(Alimta®) with a combination of folic acid and vitamin B12 for
the treatment of cancer. During clinical trials supervised by the
FDA, Eli Lilly initially had not supplemented
