Actavis and Zydus settle Asacol patent dispute

Irish-based drug manufacturer Actavis has settled its patent dispute with Zydus Pharmaceuticals.

The two companies have finalised a licensing agreement that will grant Zydus the right to market a generic version of Asacol (mesalamine), with Zydus paying royalties to Warner Chilcott.

Warner Chilcott is the owner of the patent and a subsidiary of Actavis.

Confirmation of the deal had been expected after the two companies announced a tentative agreement in December 2013 to settle the dispute.

The row began in May 2013, after Warner Chilcott filed an opposition to Zydus’s abbreviated new drug application for an equivalent generic drug, alleging patent infringement.

Mesalamine is an anti-inflammatory drug used to treat ulcerative colitis and Crohn’s disease. The patent ’662 covered the method by which the drug reached the colon, using additional layers on the 800mg tablet to protect the drug from dissolving.

Both parties disputed the interpretations of the claims 1, 2, 5, 7, 11, 14 and 16 of the patent. These claims centred on the substances that made up the inner and outer layers of the tablet, and whether there was an official distinction made in the claim.

Zydus argued the claim limited the type of substances that composed the inner and outer layers of the tablet, stating that the claims in the patent only covered a select group of polymers.

Warner Chilcott disagreed, arguing that the claim allowed for different substances to be used in the composition of the inner and outer layers of the tablet.

Under the terms of the agreement, Zydus will be granted an exclusive licence to market the generic-equivalent drug after November 15, 2015, subject to approval by the US Food and Drug Administration.

If it does not gain approval it will be allowed to launch its own generic-equivalent of the product from July 1, 2016.

Neither Actavis nor Zydus responded to requests for comment.