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.
To continue reading, you need a subscription to WIPR. Start a subscription to WIPR for £455.
In-house feature articles, the archive and expert comment require a paid subscription. Subscribe now.
Want to give it a try? We are offering a two week free trial to the WIPR website – register and select “Free Trial” to begin access to the full WIPR archive and read the latest news, features and expert comment. Begin your free trial here.
Is your 2 week free trial about to end? Upgrade to a 12 month subscription for £455 now.
If you have already subscribed please login.
If you have any technical issues please email tech support.
USITC, pharmaceuticals, Gemcitabine, ANDA