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Patent Fights In Brief: AstraZeneca And Wyeth Face Challenges

Executive Summary

AstraZeneca blocks Apotex's generic Pulmicort Respules: A federal court granted AstraZeneca's request for a temporary restraining order to prevent Apotex from launching a generic version of its Pulmicort Respules (budesonide), the pediatric formulation of its asthma drug. The New Jersey district court will hold a hearing on April 27 to determine whether to continue the injunction. FDA approved Apotex's generic on March 30 and AstraZeneca then filed suit claiming Apotex infringed two of its patents covering methods for treating a respiratory disease. U.S. sales of Pulmicort totaled $982 million in 2008, 90 percent of which were for Respules. In November AstraZeneca settled a suit against Teva over the patents, which expire in 2019, granting Teva an exclusive license to begin selling its generic on Dec. 15. Under the agreement, AstraZeneca is to receive "a significant undisclosed royalty on sales of Teva's product, with a marked step down in payments if additional at-risk generic products enter the marketplace." Teva also is paying an undisclosed sum in damages for its unauthorized launch of a generic in November (1"The Pink Sheet," Dec. 1, 2008, In Brief). AstraZeneca filed suit against Breath Ltd. last year after it submitted an ANDA for budesonide

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Pulmicort generics on hold for a year

Teva walks away with minor bruises from its preliminary injunction hearing against AstraZeneca for sale of generic Pulmicort Respules (budesonide inhalation suspension). The firm agreed to pay AstraZeneca an undisclosed royalty and halt further shipments until Dec. 15, 2009, under an agreement signed in New Jersey Federal Court Nov. 25. The patent settlement lifts Teva's temporary restraining order, enabling an estimated three to four months of already shipped inventory to remain on the market for further distribution. "The sheer brilliance of the strategy is that on Dec. 15, 2009, we get to do it all over again and Teva can ship generic Pulmicort with exclusivity economics since the settlement surely precluded an authorized generic," Needham analyst Eliot Wilbur says in a note. While the deal appears to shave almost nine years off Pulimcort's patent life - the earliest list patent expires in 2018 - the timing gives AstraZeneca some breathing room, as well as Teva, in what had been an at-risk launch (1"The Pink Sheet," Nov. 24, 2008, p. 17). Par, which was distributing an authorized generic, may be the only party in the drama not to benefit from the settlement


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