The Biotechnology Industry Organization (BIO) and the Pharmaceutical Research and Manufacturers of America (PhRMA) have jointly filed an amici brief curiae brief urging the Federal Circuit to grant en banc rehearing of Ariosa v. Sequenom. The brief is available here. I am the counsel of record.
BIO and PhRMA are concerned that the development and commercialization of a range of biotechnology and pharmaceutical innovations will be impeded if the Federal Circuit does not address the mounting uncertainty currently afflicting patentable subject matter jurisprudence. The brief points out the critical importance of effective patent protection for biotechnology and pharmaceutical innovators, and the current unprecedented level of uncertainty with respect to the scope of patent eligible subject matter. This uncertainty is affecting both the patent user community and the PTO, which has responded with an ongoing stream of revised and re-revised non-final and interim guidance documents. With each new PTO Guidance, BIO members have observed an increasing rate of claim rejections, affecting a diverse range of biotechnology, including novel antibiotic molecules, industrial enzymes, diagnostic processes, and crop production products.
The unsettled state of the law has also created doubt as to whether issued patents will be able to withstand challenge. The brief points out that the vast majority of judicial decisions addressing patent eligibility under the recently articulated standards have resulted in a determination of ineligibility. For example, Appendix 3 of the recent PTO “July 2015 Update: Subject Matter Eligibility,” identifies 24 post-Mayo subject matter eligibility cases decided by the Federal Circuit, of which 22 held all of the challenged claims to be patent ineligible.
The brief urges the court to clarify the contours of both Step I and Step II of the Mayo two-step test for patent eligibility. It posits that the Supreme Court would not have articulated a two-step test if it did not intend the first step to serve some meaningful gatekeeping function, but that under the standard applied by the panel it is difficult to see how any analytical or detection method would ever not satisfy Step I, so long as that method is designed to detect something that occurs naturally. With regard to Step II, the brief asks for clarification with regard to the proper application of the “inventive concept” and “preemption” standards of patent eligibility. As an example, the brief discusses the practical challenges facing the inventor of a new diagnostic test under the new patent eligibility jurisprudence.
In its recent decisions the Supreme Court apparently assumed the existence of limiting principles that would maintain patent eligibility for truly meritorious inventions (this was Judge Linn’s characterization of Sequenom’s claimed invention in his concurring opinion), even if that invention can be deconstructed into a combination of natural phenomena and conventional technology. The brief argues that en banc reconsideration would allow the Federal Circuit to address the nature of these limiting principles suggested in Mayo. Alternatively, if the court finds that Supreme Court precedent does not provide for limiting principles that provide a meaningful opportunity for patenting important biotechnology innovations, that would suggest a need for the Supreme Court to readdress the contours of patent eligibility in the context of biotechnology. Ariosa v. Sequenom would be an appropriate vehicle for alerting the Supreme Court to the urgent need for this clarification.