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.
Background
The rest of this article is locked for subscribers only. Please login to continue reading.
If you don't have a login, you will need to purchase a subscription to gain access to this article, including all our online content. Please use this link and follow the steps.
For multi-user price options, or to check if your company has an existing subscription to us that we can add you to for FREE, please email Atif Choudhury at achoudhury@worldipreview.com
USITC, pharmaceuticals, Gemcitabine, ANDA