AstraZeneca says Pulmicort Respules patent ruled invalid

AstraZeneca (AZN) announced that the United States District Court for the District of New Jersey ruled that AstraZeneca's Patent No. 6,598,603, protecting Pulmicort Respules in the U.S., is invalid. The court further ruled that the generic defendants involved in the litigation do not infringe AstraZeneca’s second patent, No. 7,524,834. The decision will not change AstraZeneca’s revenue guidance for 2013, which is that the company anticipates a mid to high-single digit decline in revenue on a constant currency basis. In the event that additional generics enter the market, this would materially impact royalties received on sales of Teva’s (TEVA) generic version of Pulmicort Respules, AstraZeneca said. The royalties represented an annualized value of approximately $260M in 2012. Subject to additional generics entering the market, AstraZeneca said its guidance for Core Other Income in 2013 could be significantly below $600M. The company still expects Core EPS to decline significantly more than revenue in 2013. AstraZeneca added that it is considering next steps, including an appeal of the court’s decision.

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