Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products

The Hon. Michelle K. Lee
Deputy Under Secretary of Commerce
Acting Director
United States Patent and Trademark Office

Via email to [email protected]

Re: March 4, 2014, Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products

July 31, 2014

Dear Acting Director Lee,

The undersigned national and regional biotechnology industry associations appreciate this opportunity to comment on the USPTO’s March 4 guidance for the determination of subject matter eligibility of claims relating to products and processes derived from natural sources or materials (the “Guidance”). We write to express our concern over the recent judicial and administrative expansion of nonstatutory patent law governing the patent-eligibility of certain classes of biotechnology inventions in the United States, as manifested in the PTO’s March 4 Guidance.

Together, our associations represent thousands of biotech businesses, academic and nonprofit research centers, technology transfer organizations and other entities dedicated to biotechnological innovation throughout the world. Our increasingly global industry provides breakthrough products and technologies that combat debilitating and rare diseases, reduce our environmental footprint, provide food security, use less and cleaner energy, and drive economic growth.

Internationally harmonized, science-based regulatory and legal frameworks are important for competitiveness and innovation to ensure faster and more equitable access to new biotech products and processes for patients, farmers and consumers around the world. It is in this context that we note with concern the significant departure from internationally accepted norms of patentability that would be established by the Guidance, particularly with regard to industrial, agricultural, and pharmaceutical preparations of naturally-derived substances, compositions, and processes...