Big Molecule Watch
June 18, 2019

Bill Introduced to Limit Patent “Evergreening”

On June 11, Representatives Hakeem Jeffries (D-New York) and Doug Collins (R-Georgia) introduced a bipartisan bill with the stated purpose of addressing the rising cost of prescription drugs. According to the press release, the “Terminating the Extension of Rights Misappropriated (TERM) Act of 2019,” H.R. 3199, would “significantly limit[] the process known as ‘evergreening,’ whereby pharmaceutical companies make minor changes to a drug and file for a new patent on those trivial changes in order to extend their exclusivity.” The press release further states that under current law, a generic drug manufacturer “must prove why a new patent should not be granted” to the brand name manufacturer if they intend to enter the market before the patent expires. The TERM Act would shift the burden of proof to the brand name manufacturer, which would be presumed to have “disclaimed the patent term for each of the listed patents after the date on which the term of the first patent expires” unless it demonstrates that the later patents cover patentably distinct inventions.

The bill is co-sponsored by Representatives Ben Cline (R-Florida) and Debbie Mucarsel-Powell (D-Florida).

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