1 January 2011PatentsDaniel Yonan and Mark Fox Evens

Big pharma and Section 337: the next frontier

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

To preserve its market share after Hospira, Inc launched a generic version of gemcitabine (Gemzar®), complainant Eli Lilly and Company filed a complaint at the commission under Section 337, naming Hospira and three others as respondents. The ensuing fast-track investigation is based upon a non-Orange Book listed process patent.

The complaint alleges that the four named respondents manufacture, import and subsequently sell a generic version of gemcitabine through Hospira that infringes the patent. Lilly hopes that the commission will find that the respondents have violated the patent and issue an order excluding the continued importation of generic gemcitabine into the US. The investigation is scheduled for a hearing in January 2012.

Pharmaceutical patent litigation under Section 337

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