PTO too broad in guidance on natural products: PhRMA, BIO

The Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organization said the U.S. Patent and Trademark Office exceeded the bounds of two recent Supreme Court rulings in updated guidance on the patentability of products involving natural phenomena and natural products. The 2012 and 2013 rulings covered the patentability of isolated DNA, cDNA and process claims on the use of biomarkers in determining treatment. In its March guidance, PTO extended the scope of the decisions to all natural products and noted that product claims involving natural phenomena and natural products are patent eligible only if "significantly different" from what exists in nature.

In comments to PTO, PhRMA argued the guidance ignored limitations of the rulings and instead "improperly elevates and expands" the court's statements. The group said PTO improperly combined language from the rulings to create its "significantly different" test. PhRMA also said the guidance would add "unnecessary cost and burden" to both industry and PTO, since patent examiners must now determine subject matter eligibility for many life sciences applications that previously would not have required such scrutiny (see BioCentury Extra, March 6). ...