Doll v. Bilski, a controversial Federal Circuit decision that addresses the patent eligibility doctrine, is currently on petition to the Supreme Court for a writ of certiorari. The decision clearly has significant ramifications for the patentability of many life science inventions, particularly in the areas of diagnostics and personalized medicine, as discussed in previous posts, and has already been used to summarily invalidate claims reciting a method for providing an improved vaccination protocol in Classen v. Biogen. The patent eligibility doctrine, as it is currently being applied by the courts, has raised significant concerns on the part of many in the biotechnology and pharmaceutica industries, as evidenced by the number of amicus briefs filed in the case of Prometheus v. Mayo, a patent eligibility case arising out of the life sciences. In view of the importance of the issue to the biotechnology and pharmaceutical industries, and the widely expressed fear that Bilski could preclude the effective patenting of many important biotechnology innovations, one might have thought that the industry would have sided with Bilski in his attempt to overturn the Federal Circuit decision.
In fact, however, a review of the Supreme Court docket conducted March 11, 2009, reveals that only one of the nine amicus curiae briefs that have been filed in support of the petition has come out of the life sciences industry. Notably absent are the major biotechnology and pharmaceutical companies that weighed in to support Prometheus, and representatives of the industry such as the Biotechnology Industry Organization (BIO) and the Pharmaceutical Researchers and Manufacturers of America (PhRMA).
The only biotechnology amicus brief was filed by Medistem (http://www.medisteminc.com/), a publicly traded US biotechnology company whose business focuses on the development of adult stem cell-based medicines, and methods of treatment combining the use of diagnostics and with their medicines, i.e., personalized medicine. In its brief, Medistem argues that the restrictive approach to the patentability of process inventions set forth in Bilski casts a cloud of uncertainty as to whether companies such as Medistem will be able to effectively protect diagnostic and personalized medicine inventions with patents. They point to Judge Rader’s dissent in Bilski, in which he opined that the majority's opinion will “undermine and discourage future research for diagnostic tools," and stress that the unintended consequence of Bilski could be a significant drop-off in investment for the discovery of new diagnostics and clinically relevant biological correlations. Their brief repeatedly references w dire predictions of Judge Rader, such as his view that the majority's ruling in Bilski "inadvertently advises investors that they should divert their unprotectable investments away from the discovery of ‘scientific relationships’ within the body to diagnose breast cancer or Lou Gehrig's disease or Parkinson's or whatever.”
In view of the apparent threat to biotechnology innovation, one might question why it is that other representatives of biotechnology have not supported Bilski's petition. I think it can be explained by a view among many in biotechnology that even though the Federal Circuit decided to Bilski wrongly, and if applied literally the decision could prove detrimental to future life sciences innovation, the hope is that the situation can be rectified at the Federal Circuit level in subsequent panel decision. Their is a fear that the Supreme Court might very well conclude that Bilski's “business method” claims are patent ineligible, and might do so in a manner that creates unintended negative consequences for the patenting of biotechnology inventions. Should the Supreme Court decide to grant certiorari, I believe the biotechnology industry will have to weigh in heavily and attempt to persuade the Supreme Court to decide the case in a manner that clarifies that the machine-transformation test articulated in Bilski is not the only test for patent eligibility of processes, particularly fundamentally biological processes, and that a more flexible and lenient test is more appropriate.
Nonetheless, Medistem apparently feels that the problems created for biotechnology by Bilski need to be addressed as soon as possible. Or perhaps the company has no confidence that the Federal Circuit will develop an appropriate patent eligibility doctrine for biotechnology inventions on its own. Because Bilski is an en banc decision, Medistem fears that the machine-transformation test established by the majority will be the de facto final word on patent eligibility for all processes. Clearly, the Federal Circuit's recent decision in Classen v. Biogen did not inspire much confidence, but we are hopeful that the court will perform better when it decides Prometheus.