As of July 2017 there had been at least 363 inter partes review petitions filed against patents listed in the Food and Drug Administration's Orange Book and 74 filed against patents that have been identified as reading on Purple Book Centre for Drug Evaluation and Research-listed biologic drugs. Of these 437 inter partes reviews, 116 resulted in a final written decision. There are a number of lessons to be learned from these.
There has been some concern regarding the statistics periodically issued by the US Patent Trial and Appeal Board, owing to the fact that the reported numbers overlook multiple inter partes review challenges to the same patents and, potentially, different outcomes in those challenges. While certain drug patents have been challenged in multiple inter partes review petitions, concern as to different outcomes appears to be unfounded.
A divided en banc Federal Circuit recently issued several opinions addressing the burden of proof concerning a motion to amend claims in inter partes review proceedings. While none of the opinions garnered a full majority, the leading opinion placed the burden of persuasion with respect to the patentability of amended claims on the petitioner.
The verdict in a recent patent infringement case between two pharmaceutical companies is the first instance in which a patent owner has recovered significant infringement damages under the Biologics Price Competition and the Innovation Act. It is also the first time that a patent owner has recovered damages under the act for infringement that a competitor carried out before the commercial marketing of the competitor's biosimilar.
In a recent patent infringement case, a Federal Circuit panel rejected an Eastern District of Texas judge's proposed four-factor test for determining whether venue is proper over a defendant in a patent infringement action under the 'regular and established place of business' prong of the US patent venue statute. In its place, the Federal Circuit introduced its own three requirements to determine what constitutes a 'regular and established place of business'.