Lilly betting B12 can protect blockbuster Alimta from generics

Alimta--courtesy of Eli Lilly.

Most people take vitamins to boost their energy or protect against colds. But Eli Lilly ($LLY) is hoping vitamin B12 will protect it from losing up to $3.5 billion in sales a year.

The Indianapolis-based company is fighting Teva Pharmaceutical Industries ($TEVA) over the patent for its blockbuster lung cancer drug Alimta, which expires in 2016. But the drug also has a so-called method-of-use patent which covers the use of folic acid and vitamin B12 for patients taking Alimta, Reuters reports. Its approved label even tells doctors to give patients the nutrients ahead of and during treatment with Alimta. If that separate patent stands up to legal challenges and generic makers cannot include the prescription of those on their own labels, then Lilly may get 5 more years of protection on the drug.

While many industry watchers, including some patent attorneys, believe Lilly's chances are slim, it would be an incredible turn of events for a drug that is forecast to hit peak sales of $3.5 million in 2016 and for a company that is being battered badly by patent losses. Lilly lost patent protection in 2011 on Zyprexa, at one time a $4.5 billion-a-year seller. It will lose protection late this year on another blockbuster, antidepressant Cymbalta, which generates $5 billion a year. Next year, Evista, another blockbuster, loses to generics. If the patent is upheld, the extra half decade of exclusivity would offer some breathing room while Lilly gets more products into the market. In guidance today, CEO John C. Lechleiter gave an upbeat outlook and pointed to the company's pipeline of drugs as offering support for its future, The Wall Street Journal reports.

Neither company would comment, but when the case goes to trial this summer, Teva is expected to argue that giving folic acid and vitamin B12 as part of the treatment is so obvious that there is no reason that it should be patent protected. Not everyone agrees. Patent attorney Patricia Carson with Kirkland & Ellis in New York tells Reuters that it looks like the researchers figured out that administering folic acid and vitamin B12 ahead of Alimta was needed and not a procedure that would commonly be used. "In development (of Alimta), they came up with this type of method."

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