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ARTICLE · 24 JUNE 2019

"Statutory" Obviousness-Type Double Patenting for Pharma Patents?

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In short, the bill presumes obviousness-type double patenting of any subsequent orange book listed patent and shifts the burden to the patentee to demonstrate otherwise.

United StatesIntellectual Property
Daniel J. Pereira
Daniel J. Pereira
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As all patent practitioners know, obviousness-type double patenting is a judicially created doctrine to prevent the unjust extension of patent term of follow on patents that are simply obvious variants of earlier patents. The doctrine is applied during prosecution with the USPTO and can be used to challenge the validity of issued patents in contested matters. 35 USC 121 also speaks to this issue in certain circumstances.

On June 12, 2019, Representatives Hakeen Jeffreies and Doug Collins issued a press release touting their new proposed bill "Terminating the Extension of Rights Misappropriated" (TERM) Act of 2019. The bill purports to "address the rising cost of prescription drugs by significantly limiting 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 and maintain high prices." See, https://jeffries.house.gov/media-center/press-re

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