- A German appellate court has ruled in favor of Actavis in a patent case involving Eli Lilly's lung cancer drug, Alimta (pemetrexed), which is slated for patent expiry in December. The court, reversing a lower court's ruling, says that Actavis can prepare to market a generic version of the drug.
- The court found that Actavis could market pemetrexed as long as it marketed an alternative salt form of the drug, according to Reuters.
- Lilly contends that it should enjoy Alimta exclusivity until June 2021 because a vitamin regimen that is used with the drug is covered under patents. Alimta is used for the treatment of non-small cell lung cancer (NSCLC).
The German court isn't the first to rule that Eli Lilly's claim is untenable—an English court did so, too, last year. The upshot is that it is not patent infringement if another company comes in and offers a generic version of Alimta when the original patent expires. The addition of folic acid and vitamin B12 to the Alimta treatment regimen is intended to offset adverse events.
At face value, such a claim may seem like a bad attempt at a line extension, given that using vitamins to offset negative side effects or shore up health in general is commonly used in medical practice. Alimta was developed by Eli Lilly in 2004, and the company plans to appeal this decision to the German Supreme Court.
This is the latest blow to Lilly in recent weeks. Last month, the company was forced to delay regulatory filings for an in-development long-acting insulin over reports of adverse liver events.