"Crisis of patent law and medical innovation" in the US?

Can life science inventions be patent protected in the US? Up until June 2013, the answer would have been a resounding “yes”.  However, Mayo v. Prometheus, a now notorious decision of the U.S. Supreme Court, has clouded the issue in uncertainty and controversy, as explained here.  In particular, diagnostic methods risk being deemed to be directed to nothing more than a natural phenomena and therefore not patent-eligible.  A high profile example is Ariosa v Sequenom. Sequenom Inc. have now filed a petition to the U.S. Supreme Court and it is hoped that the court will take this opportunity to assess and perhaps rein back the impact of the Mayo v. Prometheus decision. 

As explained here, a non-invasive prenatal diagnostic test was held to be patent-ineligible by the US Federal Circuit in Ariosa v Sequenom.  The court held that the claimed method of detecting paternally inherited nucleic acids is unpatentable, finding that the method is merely directed to a law of nature.  Sequenom asked for reconsideration of this case by the Federal Circuit en banc.  Even though this request that was supported by twelve amici briefs, it was denied.

In March 2016, Sequenom filed a request (a Petition for Writ of Certiorari) for some of the issues that are at the core of this case to be reviewed by the US Supreme Court.  In the Petition, Sequenom has referred to the current practice in the US as a “crisis of patent law and medical innovation” and asked the Supreme Court to consider the following:

“Whether a novel method is patent-eligible where: (1) a researcher is the first to discover a natural phenomenon; (2) that unique knowledge motivates him to apply a new combination of known techniques to that discovery; and (3) he thereby achieves a previously impossible result without preempting other uses of the discovery?”

The US Supreme Court is not obliged to take on this case, but it has been urged to do so by high-profile industry representatives: over 20 amici briefs were filed.  For example, the UK BioIndustry Association has argued that the US courts’ application of intellectual property law is inconsistent with rulings on equivalent issues by courts and patent offices around the world, and so hinders international efforts to harmonise approaches to this important area of law. 

CIPA (the Chartered Institute of Patent Attorneys) has argued that the framework for assessing whether an invention is eligible for patentability, which was introduced as a result of the Mayo v. Prometheus decision, needs reconsideration.  In particular, CIPA believes that the right of a person who has made a breakthrough invention to receive commensurate protection was overlooked. CIPA also submitted that the Federal Court’s reasoning is irreconcilable with the obligations of the US under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

It is very much hoped that the US Supreme Court will allow the petition. The current interpretation of the law governing patent-eligibility has created a great deal of uncertainty for patent applicants, as well as for owners of patents that granted prior to the issue of the Mayo decision.  The petition would give the US Supreme Court the opportunity to review the Mayo framework for assessing whether an invention is patent-eligible, and to formulate a revised framework that ensures that life science innovation is not deprived of patent protection.

As always, we will keep you informed of further developments.  

19 May 2016