Lilly defends blockbuster Alimta with unusual ammo

Mon Aug 19, 2013 2:01pm EDT
 
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By Ransdell Pierson

(Reuters) - Eli Lilly and Co, now facing one of the worst patent cliffs in its history, could find $15 billion in sorely needed relief if it beats the odds and wins a closely watched patent battle with generic drugmaker Teva Pharmaceutical Industries.

While a Lilly victory is not widely expected, a number of patent attorneys and industry analysts say the patent being challenged by Teva, beginning Monday in Indianapolis federal court, will pass legal muster.

The U.S. Court of Appeals in Washington last summer upheld the validity of the basic patent on the chemical structure of Alimta, protecting Lilly's $2.6 billion-a-year lung cancer drug from generics until January 2017.

The Indianapolis court will weigh the merits of a separate "method-of-use" patent on the way Alimta is administered. If the court upholds the patent, Lilly would be able to fend off generic alternatives to Alimta until 2022.

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 of the drug. Alimta's package insert 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 language of the branded drug's label, Ben Hsing, a partner in the law firm of Kaye Scholer in New York, said in a recent interview.

But generics could have a hard time doing so because of Lilly's patented descriptions of the need to take the nutrients and how to do so, said Hsing, who last year successfully defended Roche Holding AG's Tarceva lung cancer drug from patent challenges by generic drugmaker Mylan Inc.

"This is the first time I've heard of a company going down this route to defend a patent, by adding nutrients" to a drug regimen, said Les Funtleyder, a healthcare strategist at investment firm Poliwogg. "So the likely outcome of this case is not clear cut."   Continued...