USPTO Extends Deadline to Comment on Subject Matter Eligibility Analysis

26 June 2014 Personalized Medicine Bulletin Blog

Yesterday at BIO’s session entitled “Patent-Eligibility from the Trenches: Practical Implications of the Supreme Court’s Prometheus (Mayo) and Myriad Decisions” a panel of experts and an engaged audience discussed the controversial USPTO “Guidance for Determining Subject Matter Eligibility of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products” (2014 Guidance) and its implications for the biotechnology and pharmaceutical industries. The USPTO’s Former Acting Director Terry Stanek Rea announced that based on information gleaned from a prior BIO panel, the USPTO is open to revising its 2014 Guidance that called into question the patent-eligibility of many biotechnology and pharmaceutical inventions and is accepting public comments until July 31, 2014.

A Panel of Experts

Joining Terry Rea, now a partner with Crowell & Moring, LLP, was Dianna DeVore, Senior Vice President, IP and Legal Affairs, Ariosa Diagnostics Inc., Katherine Neville, Partner of Marshall, Gerstein & Borun, Matthew McFarland, a Principal with Miller & Ciresi, LLP and moderator W. Randy Kubetin, Managing Editor of Bloomberg BNA.

Terry Rea started the discussion with her overview of the 2014 Guidance and explained its application in the examination of claims that could be interpreted to encompass a natural product, a product derived from nature or laws of nature. She voiced a view, shared by many in the biotech industry, that the patent-eligibility inquiry should be a course filter to draw a fine line between the patent-eligible and ineligible. As a result of the 2014 Guidance, patent examiners are refusing many patent claims on the ground that they fail doctrines set forth in Myriad and/or Mayo, as interpreted by the 2014 Guidance. To garner additional public comment, the USPTO will be issuing sample claims and requesting the public’s additional input on whether, under U.S. Supreme Court precedent, the proposed claimed subject matter is patent-eligible.

Dianne DeVore picked up with discussion explaining the holdings of Mayo and Myriad and how the USPTO’s 2014 Guidance has placed into the public domain diagnostic technologies that previously had been patent-protected. As a result, she explained, innovators may choose to keep all or key supporting technologies as trade secrets. Terry Rea noted that a strong patent system discourages the use of trade secrets as patents are intended to place technology into the hands of the public upon expiration of the patent. Ultimately technology progresses to the benefit of the public as innovation can build upon the formerly patented technologies.

Katherine Neville provided interesting statistics on the number and type of therapeutics now on the market and benefiting patients that would fail under the 2014 Guidance. Matthew McFarlane announced the release of a review of his firm’s and BNA’s review and analysis of recently allowed biopharma patent claims entitled “Stopped at the Threshold: The Practical Impact of the Supreme Court’s Mayo and Myriad Decisions on Biotechnology Patent Practices.”

A Call to Action

The extended comment period and proposed draft claims provide interested stakeholders additional time to join and guide this important discussion. With the public’ assistance and upon further reflection, the USPTO will likely provide a refined Guidance to assist examiners and the public apply the principles of Mayo and Myriad to today’s discoveries.

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