As per the terms of the settlement agreement, AstraZeneca has granted Teva a license to enter the US market with its generic version of oral Budesonide on February 15, 2012, subject to regulatory approval, or earlier in certain circumstances.
Further, Teva has conceded that both patents-in-suit in Teva’s US Entocort patent litigation are valid and enforceable. Teva has also conceded that both Entocort patents-in-suit would be infringed by the manufacture or sale of Teva’s generic version of oral Budesonide.
The US District Court for the District of Delaware is expected to enter a Consent Judgment and the corresponding patent litigation will be dismissed.
Reportedly, Merck Sharp & Dohme (formerly Merck & Co) through KBI and KBI-E, and under the terms of Merck’s restructured partnership with AstraZeneca, announced in 1998, also entered into the settlement agreement.