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Washington Highlights

USPTO Releases New Interim Guidelines on Patenting Natural Products

December 19, 2014—The U.S. Patent and Trademark Office (USPTO) Dec. 16 published in the Federal Register new interim guidelines on patent subject matter eligibility. The guidelines are designed to help the agency’s own examiners distinguish naturally occurring products or processes from inventions incorporating natural principles in ways eligible for patenting. 

The interim guidelines would revise the agency’s March 2014 guidance to reflect recent U.S. Supreme Court decisions on patentable subject matter, including the 2013 Myriad decision that overturned patents on naturally occurring breast cancer genes. However, the USPTO’s March guidelines were widely criticized by the biotech and pharmaceutical industry as being too proscriptive, potentially excluding protection for products such as vaccines, and extending beyond the focus of court decisions.

In October, the AAMC joined with other higher education associations in urging the PTO to further revise its examiner guidelines and provide a lengthy opportunity for public input [see Washington Highlights, Oct. 17]. The new interim guidelines provide a much broader framework than previous guidelines for determining eligibility and also include case examples of patents involving natural products or processes. 

The agency is accepting public comment on the interim guidelines through March 16, 2015.


Stephen Heinig
Director, Science Policy
Telephone: 202-828-0488

Matthew Shick, JD
Director, Gov't Relations & Regulatory Affairs
Telephone: 202-862-6116


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Washington Highlights, a weekly electronic newsletter, features brief updates on the latest legislative and regulatory activities affecting medical schools and teaching hospitals.

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Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806