A federal judge upheld the validity of a key U.S. patent for Eli
Lilly & Co.'s blockbuster lung-cancer drug Alimta, a big legal
victory that could relieve sales pressure for the drug maker later
this decade.
The decision, issued Monday by a U.S. District Judge in
Indianapolis, would preserve the product's protection from generic
competition until 2022. That could change if generic drug companies
appeal the ruling.
Lilly's sales have been hurt by generic competition for other
drugs while its research labs have failed to produce enough newer
therapies to replace lost sales. Alimta had $2.7 billion in sales
last year, making it the company's No. 2 product behind
antidepressant Cymbalta.
If the ruling had gone against Lilly, the Indianapolis company
would have lost about five years of exclusivity for Alimta,
exposing it to generic competition in 2017, when a different patent
covering the drug's chemical composition expires.
Lilly said in a written statement it is confident the Alimta
patent is valid and enforceable, and the company conducted
"significant scientific research" in support of the patent. A
spokeswoman for Teva Pharmaceutical Industries Ltd., which had
challenged the validity of the Alimta patent, couldn't immediately
be reached.
The patent in question the one due to expire in 2022--covers the
method of administering Alimta with folic acid and vitamin B12,
which have been shown to reduce the incidence of side effects of
Alimta, such as low counts of white blood cells.
The drug's prescribing label, approved by the U.S. Food and Drug
Administration, instructs doctors to start providing the
supplements about one week before the first dose of Alimta, and to
continue them during treatment.
Several generic-drug makers, including Teva and Fresenius Kabi
SE & Co.'s APP Pharmaceuticals unit, have sought to sell
generic versions of Alimta before the vitamin-dosage-regimen patent
expires.
The generic-drug companies argued in court papers that the
patent was invalid because previous research would have led a
person of ordinary skill in oncology or nutrition to conclude
Alimta should be given with folic acid and B12. Under patent law, a
court can deem a patent invalid if its claims are "obvious" and
anticipated by previous research.
Lilly filed a patent-infringement lawsuit against the companies
in 2010, shortly after the vitamin-dosage-regimen patent was
issued. The suit sought a judgment that the generic companies have
infringed the patent, and that they be barred from selling copies
of Alimta until the patent expires.
Lilly argued the patent was valid because the method of
administering vitamins with the drug was an unexpected finding that
essentially saved Alimta's development, which had been in doubt
because of side effects.
In a 33-page ruling issued Monday, U.S. District Judge Tanya
Walton Pratt said the generic drug companies failed to show that
the patent's claims were invalid for obviousness. She wrote that
the method of administering B12 with folic acid wouldn't have been
obvious to a person skilled in oncology or nutrition.
Write to Peter Loftus at peter.loftus@wsj.com
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