The following is excerpted from an email alert from H. Keeto Sabharwal and Daniel E. Yonan of Sterne, Kessler, Goldstein & Fox regarding the above investigation over the non-Orange Book process patent for Gemcitabine:
Investigation No. 337-TA-766 entitled Certain Gemcitabine and Products Containing Same included a complainant not frequently before the Commission -- innovator pharmaceutical company Eli Lilly and Company. Lilly, through its complaint, requested the exclusion of generic versions of its popular anti-cancer drug Gemzar©. Specifically, Lilly alleged that a number of respondents, including SKGF client Intas Pharmaceuticals Ltd., manufactured abroad, and subsequently imported and sold within the United States, generic versions of Gemzar© that were allegedly made by using Lilly’s patented process technology.
Lilly filed its complaint at the Commission after its Orange Book listed patents on Gemzar© had expired or were declared invalid by the Court of Appeals for the Federal Circuit. Despite a lengthy pre-institution process where the Commission questioned whether Lilly’s allegations were pled with particularity, the Commission instituted the investigation in March 2011. The Administrative Law Judge established a 16-month target date, and the parties underwent extensive fact discovery. Before the fact discovery was completed, however, the parties motioned to terminate the investigation on the basis of a settlement agreement. Administrative Law Judge Rodgers ordered the termination of the investigation on August 16, 2011.
Although the terms of the settlement remain confidential, 337-TA-766 represents one of the few attempts by an innovator to use the Commission to protect revenue streams on key pharmaceutical drugs experiencing generic drug competition after litigation on the Orange Book listed patents has ended. Unlike the wave of smartphone and mechanical-based technology proceedings currently before the Commission, innovator pharmaceutical-based Section 337 investigations have only constituted about 2.5% of all investigations instituted since 1976. Further development of this trend could lead to new investigations with a new technology discipline requiring generic drug manufactures [sic] to more closely evaluate innovator non-Orange Book patent portfolios.
For a more detailed look at the issues behind this matter, read "Big Pharma and Section 337: The Next Frontier for Enforcement of Non-Orange Book Listed Pharmaceutical Drug Patents," published in BNA's Pharmaceutical Law and Industry Report.