Diagnosis for the Biomedical Industry
The Mayo decision has the potential to affect thousands of existing patents directed to personalized medicine and other practical applications that may be construed as being impermissibly drawn to a natural law.
Unfortunately, the Court’s opinion may have upset the careful balance between industry and academic research that has helped stimulate the development and commercialization of numerous medical innovations through 30 years of Bayh-Dole sponsored technology transfer. This decision could discourage private investment in and funding of innovations in biotechnology, particularly in the field of diagnostic medicine, due to the uncertainty surrounding the availability of patent protection.
The Court recognized, however, that too broad an application of its exclusionary principle could eviscerate all patents, for all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas.
On its face, the Court’s conclusion would seem to mean that the application of a discovery is only patentable if the application is itself novel and not obvious, altogether apart from the novelty of the discovery. Fortunately, the Court did specifically acknowledge that the exclusionary rule ought not to be interpreted to cover newly discovered first or subsequent medical indications for a known substance.
The U.S. Patent and Trademark Office issued a memorandum providing preliminary guidance to patent examiners on the subject matter eligibility standard set forth in Mayo. The Patent Office will likely wait for the Federal Circuit’s decision in AMP v. Myriad, which the Supreme Court remanded in view of Mayo, to issue more detailed examination guidelines on determining subject matter eligibility.
At issue in Myriad is the patent eligibility of not only diagnostic methods but also genes and gene fragments. The Federal Circuit previously found the isolated genes covered by Myriad’s patent claims to be directed to patentable subject matter, but will have to reconsider whether this too is unpatentable naturally occurring subject matter.
Until the effects of the Court’s decision become manifest, patent applicants, owners, and licensees should consider pursuing re-issues of narrower method claims, while applicants of pending patent applications should consider whether any claim amendments can be made to add “additional features” sufficient to transform the claims into a patentable application of a natural law.
Unfortunately, the Court’s test for patentability expressed as “doing significantly more” or “adding enough” beyond the recitation of a natural law is merely a matter of degree rather than of kind, and therefore fails to provide reliable guidance for the industry. Companies also should consider whether the Court’s decision provides another weapon to defend against or invalidate potentially troublesome patents of their competitors.