is a partner with McDonnell Boehnen Hulbert & Berghoff LLP. Dr. Williams has over a decade of experience in all areas of intellectual property law, with particular emphasis on patent litigation, prosecution and opinion work in the biotechnology, pharmaceuticals and chemistry sectors. Dr. Williams is a frequent speaker and author on a variety of intellectual property law topics and is also a regular contributor on patent related issues to the Patent Docs blog.
The Supreme Court will hear oral arguments in the Cuozzo Speed Technologies, LLC v. Lee on April 25, 2016, with a decision expected sometime before the end of June… [S]ome of the Federal Circuit judges have shown signs that their position on these questions are not as rigid as previously thought. This is not unprecedented – for example, when the Supreme Court was on the verge of considering the patent fee-shifting statute of 35 U.S.C. § 285 in the Octane Fitness case, Judge Rader was seen criticizing the Federal Circuit’s established test in a concurrence to the Kilopass Tech. Inc. v. Sidense Corp. case. The current Federal Circuit may also be recognizing that the present understanding of PTAB jurisprudence may be soon changing.
This statute tried to mirror the Hatch-Waxman statute for small molecules, including both an abbreviated drug approval process and a mechanism to address any patent claims during drug approval. However, because of the differences between these two types of drugs, stemming from the increased complexity in manufacturing and patent protection, unique provisions were included in the BPCIA. Unfortunately, as Judge Lourie of the Federal Circuit put it, the BPCIA could win a “Pulitzer prize for complexity or uncertainty.” And, it is these new provisions that could prove the downfall of the BPCIA, at least as it currently exists.