Judge Upholds Validity of Eli Lilly Patent

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.

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