Eli Lilly & Co may have a $15 billion wild card up its sleeve as it waits for desperately needed new drugs to bear fruit. Should an obscure patent on Lilly lung cancer drug Alimta survive a court challenge this year, the company would be able to wring more than five additional years of peak sales out of the fast-growing product that it would otherwise lose to cheaper generics. Annual sales of Alimta are expected by Wall Street to climb to $3.5 billion by 2016, when its basic patent lapses. Once faced with generic competition, branded drugs typically lose more than 80 percent of sales within a year. While the likelihood of a Lilly victory is not a widely held view, a growing number of patent attorneys and industry analysts believe the particular patent being challenged will pass legal muster. Alimta may keep its marketing exclusivity until 2022, thanks to protection from a separate so-called method-of-use patent on the way the drug is administered that many investors and Wall Street watchers are not aware of or have failed to appreciate. Historically, method-of-use patents have had a much tougher time holding up in court than basic chemical patents on medicines. They are often viewed as manipulative, blatant efforts to extend the sales life of products. But this one could be different because of specific safety language in the Alimta label that could provide a road block to cheaper generics. The so-called ‘209 patent covers the administration of two nutrients - folic acid and vitamin B12 - to patients before they receive Alimta, to protect against toxic side effects of the cancer drug. Alimta’s approved label instructs doctors to administer the nutrients prior to and during use of the medicine. “For a generic to win approval, it usually has to copy the branded drug’s label,” said patent attorney Ben Hsing, a partner in the law firm of Kaye Scholer in New York.
