Big pharma and Section 337: the next frontier


Daniel Yonan and Mark Fox Evens

A recent US International Trade Commission investigation may open a new avenue for enforcing certain pharmaceutical patents, say Daniel Yonan and Mark Fox Evens.

With its March 16, 2011 vote to institute Investigation No. 337-TA-766, entitled Certain Gemcitabine and Products Containing Same, the United States International Trade Commission (commission) quite possibly opened a new frontier for enforcing non-Orange Book listed patents.

Investigations under 19 U.S.C. § 1337 (Section 337) are traditionally used by patent holders in the electrical and mechanical industries. As a result of the commission’s decision, however, innovators may now begin using the Section 337 process to frustrate post-Orange Book patent certainty by adding additional barriers, significant risk and expense to generic drug entry into the US.


USITC, pharmaceuticals, Gemcitabine, ANDA