Eli Lilly bids to stop generics cutting Alimta exclusivity

Eli Lilly has begun its defence of a patent covering lung cancer drug Alimta against generic companies including Teva, Barr Laboratories and APP Pharmaceuticals.

Alimta is an injectable drug for the treatment of nonsquamous non-small cell lung cancer. It is made with the active ingredient pemetrexed.

Eli Lilly’s US patent ‘209 covers a way of administering the drug with two nutrients – folic acid and vitamin B12 – which protect against Alimta’s side effects.

In 2010, Eli Lilly brought the case against the generic drug makers at the US District Court for the Southern District of Indiana after they filed Abbreviated New Drug Applications to market their own versions of Alimta. The ‘209 patent, which covers “antifolate combination therapies” expires in 2022.

Lilly’s basic patent covering Alimta’s composition of matter expires in 2017. If it wins its case against the generics, which started on August 19, the company will ensure that it keeps its market exclusivity for Alimta until 2022. An extra five years’ exclusivity is worth an estimated about $14 billion to the company, based on Alimta’s sales of $669 million in the second quarter of 2013.

A spokesperson for Eli Lilly told LSIPR: “We believe this patent is valid and enforceable and we are prepared to defend our intellectual property. The significant scientific research that Lilly performed in support of the vitamin dosage regimen patent deserves intellectual property protection.”

The defendants are expected to argue that the administration of Alimta with the nutrients is obvious.

Kevin Noonan, a partner at McDonnell Boehnen Hulbert & Berghoff LLP in Chicago, said that while some have reported the case as unusual, lawsuits concerning method of use patents are fairly common.

“Taking these two vitamins with Alimta will give a better response, and so the question is: is that something someone would know? If the answer is no, and if its results are sufficiently better, you can get a patent on that, which [Eli Lilly] did,” he said.

He added that once the patent expires, if another company wanted to make a version of Alimta to be administered without the two nutrients, it shouldn’t be infringing.

However: “If the FDA required [the drug] to be made in this way, that would be an interesting question,” he said.