May 10, 2019

Doug Robinson Authors Article on Secondary Considerations & Pharmaceutical Patents for IAM Magazine

Neptune Generics, LLC v. Eli Lilly & Company (case nos. 2018-1257 and 2018-1258) (April 26, 2019) is a relevant case for pharmaceutical patent litigation practitioners to keep in mind as they prepare for and proceed through the litigation process.  This case, a win for patentee Eli Lilly, is particularly informative on the role of skepticism of others in determining the patentability of an invention.

The Neptune case came to the Court of Appeals for the Federal Circuit from the Patent Office’s Patent Trial and Appeal Board.  This consolidated case involved various inter partes review challenges brought by Neptune and others concerning U.S. Patent No. 7,772,209, which is related to Lilly’s Alimta® (pemetrexed disodium) cancer treatment product.  The PTAB ruled that the petitioners did not show claims 1–22 of that patent to be invalid.  The Federal Circuit affirmed on two grounds.  First, it found the PTAB’s obviousness analysis was not flawed and its factual findings (important for this article) were supported by substantial evidence.  Second, it rejected a subject matter eligibility (i.e., § 101) argument because that type of argument is not allowed in IPR proceedings.

The Federal Circuit also placed weight on the FDA’s views during clinical trials of pemetrexed.  In response to fatalities during trial of pemetrexed, Lilly proposed supplementation with folic acid and vitamin B12.  The FDA responded that the “medical officer does not support adding vitamins” because that would be “risky.”  The PTAB found, and the Federal Circuit agreed, that this was sufficient to show “skepticism of others,” which is important to the obviousness analysis.  In doing so, the PTAB and Court rejected Neptune’s argument that such “skepticism” must be predicated on the belief that something is “technically infeasible,” “unworkable,” or “impossible.”  Rather, skepticism in the obviousness context is a looser concept, although varying degrees of skepticism may have different levels of persuasiveness.

Thus, while this case is a good reminder of the important role of objective evidence, including skepticism, in the obviousness analysis, it is also important to view this decision through the lens of the standard of review applied.  That is, this case should not be taken as an ironclad pronouncement by the Federal Circuit that, for example, skepticism by the FDA always supports nonobviousness, but rather that here the evidence of skepticism was substantial enough to support the Board’s factual finding.

Read full article.