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.
IPRs are often filed to challenge important patents – the same patents likely to be tested in litigation. In such circumstances, parties should pay careful attention when asserting arguments in the IPR that were addressed in the litigation. Several generic drug makers faced this circumstance in relation to obviousness arguments made in a series of IPRs against Eli Lilly & Co. (IPR2016-00318, IPR2016-00237 and IPR2016-00240), in which similar arguments made in a co-pending appeal before the Federal Circuit were found to be lacking. While the PTAB is not required to agree with courts on all issues, particularly in view of the fact that the standards of review between the two venues are different, these IPRs illustrate that petitioners and patent owners would be wise to carefully address what courts have said about the arguments at issue.
Prodrugs are inactive compounds designed to be converted into pharmaceutically active metabolites following delivery to a patient. Prodrugs have important pharmacokinetic advantages over traditional compounds, and a recent PTAB decision, Lupin Limited v. Vertex Pharmaceuticals Inc. (IPR2016-00558), illustrates how prodrugs can possess patent advantages as well. In its analysis of obviousness, the PTAB focuses on unpredictable results and whether a person of ordinary skill in the art has a reasonable expectation of success in view of the available art, as outlined in Procter & Gamble Co. v. Teva Pharm. USA, Inc., 566 F.3d 989 (Fed. Cir. 2009), frequently applied in pharmaceutical cases.
IPR is a common way to challenge patents covering pharmaceutical compounds, often on grounds of obviousness. As illustrated in the recent decision in in Mylan Pharmaceuticals Inc. v. AstraZeneca (IPR2015-01340), such IPRs may rely on a “lead compound analysis” involving a two-prong inquiry that asks: (i) whether a structurally similar prior art compound would have been selected as a “lead compound” and (ii) whether there was motivation to modify that compound to arrive at the claimed compound.