The biotechnology company United Therapeutics Corp. has confirmed earilier this month that it has filed a lawsuit against Sandoz, Novartis AG’s generic unit, for patent infringement.
Sandoz reportedly filed approached the U.S. Food and Drug Administration (FDA) last January with a marketing application for a new pulmonary hypertension drug. The drug Sandoz wants to sell is understood to be a copycat version of a product, Remodulin, currently marketed by United Therapeutics.
In the lawsuit, which was filed in the District Court for New Jersey in the US, United Therapeutics alleges that no less than three of its patents on the Remodulin will be infringed by Sandoz’s new generic version of the product.
As the company has responded within the required 45 days of receiving notice from Sandoz, approval for the generic version of the drug will be automatically stayed by the FDA. Under the Hatch-Waxman Act, this could last for as long as 30 months.
The exact terms of the lawsuit have not yet been made public, but it is likely that United Therapeutics Corp will be seeking to block the sale of Sandoz’s generic version of its drug indefinitely. The company could also seek significant damages from the Swiss-based Novartis AG, which being such a large corporation is likely to have professional indemnity insurance in order to cover patent infringement related cases of this kind.