Recently, Warner Chilcott received some encouraging news regarding its acne drug Doryx from a US district court.
The court, while passing a verdict on Warner Chilcott’s patent dispute with generic player Mylan Pharmaceuticals (MYL - Analyst Report) regarding Doryx, ruled in favor of a preliminary injunction thus preventing Mylan from launching a generic version of the drug (150 mg). The court came to the conclusion that Mylan infringed Warner Chilcott's patent (161) engulfing Doryx products. Mylan cannot launch the generic equivalent until the district court makes a final decision regarding the disputed patent. However, the court has not assigned any date for the trial.
We remind investors that Warner Chilcott received a paragraph IV patent certification notice from Mylan in March 2009. The notice informed Warner Chilcott that Mylan had filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to manufacture and market a generic version of Doryx, 150 mg. The paragraph IV certification implies that the filer believes the relevant patent to be invalid or will not be infringed by the generic version of the drug. Warner Chilcott challenged the application in May 2009.
Warner Chilcott is entangled in dispute regarding the Doryx products with other companies also such as Novartis (NVS - Analyst Report) and Impax Laboratories (IPXL - Analyst Report) . We note that Doryx, 150 mg, accounts for bulk of the revenues generated from the Doryx line of products at Warner Chilcott. Consequently, the relief provided by the court verdict is very much welcome for Warner Chilcott.
We currently have a Neutral recommendation on Warner Chilcott in the long-run. The stock carries a Zacks #3 Rank (Hold rating) in the short run. Although the company is facing patent expirations for many of its key drugs, we believe Warner Chilcott’s diversified product base will help withstand the generic threat.