March 31 Eli Lilly was successful in a crucial legal battle on Monday when a U.S. District Judge in Indianapolis upheld the validity of its U.S. patent for the drugmaker' s blockbuster lung-cancer drug, Alimta.
The court said the defendants, Teva Pharmaceutical Industries Ltd, APP Pharmaceutical, now known as Fresenius Kabi USA LLC, Barr Laboratories Inc and Pliva Hrvatska D.O.O., failed to show by clear evidence that the asserted claims of the '209 Patent are invalid.
However, the decision that would preserve the $2.6 billion-a-year drug from generic competition until 2022, could change if generic drug companies appeal the ruling.
Lilly had earlier argued during the trial that began on Aug. 19 that a separate "method-of-use" patent on the way Alimta is administered should protect the medicine.
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 case no. 10-cv-01376 in the United States District Court for the Southern District of Indiana. (Reporting by Shubhankar Chakravorty in Bangalore; Editing by Eric Walsh)