Shire settles Intuniv patent infringement law suit against Teva concerning

Ireland-headquartered drugmaker Shire (LSE: SHP) has settled its litigation against the US subsidiary of Israel’s Teva Pharmaceutical Industries (NYSE: TEVA) in connection with Teva’s Abbreviated New Drug Application for a generic version of Shire’s Intuniv (guanfacine) extended release Tablets for the treatment of attention-deficit hyperactivity disorder (ADHD).

The settlement provides Teva with a license to market in the USA either its own generic versions of Intuniv or authorized generic versions of the drug supplied by Shire. The license takes effect after the expiration of the 180 day exclusivity period granted to Actavis, as the first ANDA filer (The Pharma Letter April 26). Actavis is licensed by Shire to market generic product beginning on December 1, 2014. At the time of that patent settlement with Shire, Paul Bisaro, president and chief executive of Actavis, noted that Intuniv had US sales of around $475 million for the 12 month period ending January 31, 2013, according to IMS Health.

The litigation involves a patent infringement lawsuit relating to US patents 6,287,599 (the ‘599 Patent), and 6,811,794 (the ‘794 Patent). A bench trial against Actavis and Teva was held in September 2012. As Shire has previously settled with Actavis, and has now settled with Teva, the court will not be issuing a decision on the trial. As part of the settlement, Teva has confirmed that its proposed generic products infringe Shire’s ’599 and ’794 Patents and that the two patents are valid and enforceable with respect to those proposed generic products.