Shire settles with Actavis/Watson over Intuniv; Lilly sues J&J

Ireland-headquartered Shire (LSE: SHP) says it has settled all pending litigation with Actavis (NYSE: ACT) and Watson Laboratories (which acquired Actavis and is now also trading under that name) for generic versions of Shire's Intuniv (guanfacine hydrochloride) for the treatment of attention deficit hyperactivity disorder.

The settlement provides Actavis with a license to make and market Actavis' generic versions of Intuniv in the USA on December 1, 2014, or earlier in certain limited circumstances. Such sales will require the payment of a royalty of 25% of gross profits to Shire during the 180 day period of Actavis' exclusivity. The settlement also provides Watson with a license to make and market Watson's generic versions of Intuniv in the USA 181 days after Actavis' launch of generic Intuniv, or earlier in certain limited circumstances. To date, the US Food and Drug Administration has granted final approval only to Actavis' Abbreviated New Drug Application for generic versions of Intuniv.

These litigations were patent infringement lawsuits relating to US patents 6,287,599. The law suit against Actavis proceeded to trial in the District Court of Delaware in September 2012 wherein Teva Pharmaceuticals USA was also a defendant. The Delaware court has not issued a decision. The law suit against Watson is scheduled for trial to begin on February 10, 2014 wherein Impax Laboratories is also a defendant.