Sept 4 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 Aug. 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