(Reuters) - A high-stakes decision on whether to extend U.S. marketing exclusivity of Eli Lilly and Co's blockbuster Alimta lung cancer drug is not expected until next year, following a two-week trial in Indianapolis federal court.
Most industry analysts have long assumed the $2.6 billion-a-year drug will lose U.S. patent protection and face competition from cheaper generics in January 2017, with the lapse of the basic patent on the pill's chemical structure.
But Lilly argued during the trial before U.S. District Court Judge Tanya Walton Pratt that a separate "method-of-use" patent on the way Alimta is administered should protect the medicine from U.S. generics until 2022. The trial, which began August 19, ended late last week.
The so-called '209 patent covers administration of two nutrients - folic acid and vitamin B12 - to patients before they receive Alimta, to prevent side effects. Alimta's package insert label instructs doctors to administer the nutrients prior to and during use of the medicine.
The defendants in the case, Teva Pharmaceutical Industries Ltd and Fresenius SE & Co KGaA, challenged the validity of the '209 patent.
Plaintiff Lilly and the opposing generic drugmakers have requested permission to file a series of post-trial briefings that would extend past mid-December, according to an official of the Clerk of Court's office.
Pratt will then review them, along with evidence from the trial, before issuing a ruling, the official said.
Attorneys for Teva and Lilly declined to comment on the case.
(Reporting by Ransdell Pierson; Editing by David Gregorio)
- Pharmaceuticals & Drug Trials