Proving Them Wrong: FDA Skepticism Helps Save Patent Claims

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 Alimta with vitamin B12. Faced with a clinical roadblock threatening to halt its clinical trials, Eli Lilly proposed introducing vitamin B12 to the ongoing trial.

During interactions between Eli Lilly and the FDA in connection with the ongoing clinical trial, FDA officials repeatedly expressed skepticism that the addition of vitamin B12 would be effective. Two letters from the FDA, in addition to meeting minutes between Eli Lilly and FDA officials, showed that the FDA was not convinced vitamin supplementation was warranted, and viewed addition of vitamins to the trial as “risky.”

The PTAB found that the FDA’s negative reaction to the addition of vitamin B12 sufficiently showed skepticism of others regarding the claim method. In reaching this conclusion, the PTAB repeatedly emphasized that this skepticism was by the FDA, the agency charged with evaluating such treatment methods. Aided by a deficiency in the prior art that the Board identified, the PTAB concluded that the challenged claims were not unpatentable.


When arguing for nonobviousness, search for skepticism of others wherever you can find it. A patent owner is in a strong position to defend its claims from obviousness challenges if the patented invention proved skeptics wrong. However, these IPRs further illustrate that with skepticism by others, what was said and who said it are both important. That the FDA in particular was skeptical of Eli Lilly’s patented method seemed to resonate with the PTAB.