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Washington Highlights

Associations Ask USPTO to Seek More Public Input on Natural Product Guidelines

October 17, 2014—The AAMC joined five higher education associations on an Oct. 17 letter  to the U.S. Patent and Trademark Office (USPTO) requesting an additional opportunity for the community to provide input on the agency’s recent guidelines on patent claims involving naturally occurring products. 

In March, the USPTO issued new guidelines to its patent examiners for determining the patentability of claims involving naturally occurring products, phenomena, or laws of nature. The guidelines had been changed to reflect recent U.S. Supreme Court decisions that determined naturally occurring sequences of the BRCA breast cancer genes are not eligible for patent protection. However, the Court did find that complementary DNA, or cDNA, being synthetically derived from the naturally occurring sequence is eligible for patenting.

The USPTO’s guidelines attempt to interpret and extend the Court’s reasoning to inventions across the life sciences to aid patent examiners in establishing whether a given life science application is even eligible for patent protection. The USPTO concludes that simply extracting a naturally occurring compound apart from its naturally occurring context does not make that compound eligible for patent protection. However, the biotechnology sector and many in academia have expressed concern that the guidelines are too prescriptive, potentially denying proprietary protection for compounds such as vaccines.

The associations’ letter states, “We understand that USPTO officials have suggested during recent public events that elements of the March Guidance will be revised and included in the final Guidance. Because it appears that the revisions may include substantive changes to the previous version, we are writing this letter to request the USPTO to re-issue the revised Guidance in draft form to allow the patent community and the public to comment on any significant proposed changes to the criteria used to determine patent eligibility or to the patent prosecution process. Any revised Guidance will have a profound impact on the life sciences community in the United States, including universities and their licensees, and the university mission to translate important discoveries into products that treat or cure diseases.” 

The AAMC, Association of American Universities, Association of Public and Land-grant Universities, Council on Governmental Relations, Association of University Technology Managers, and the American Council on Education signed the letter.

Contact:

Stephen Heinig
Director, Science Policy
Telephone: 202-828-0488
Email: sheinig@aamc.org

Heather Pierce, JD, MPH
Sr. Director, Science Policy & Regulatory Counsel
Telephone: 202-478-9926
Email: hpierce@aamc.org

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Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806
Email: jkleinman@aamc.org