LONDON (dpa-AFX) - Anglo-Swedish drug maker AstraZeneca Plc (AZN, AZN.L) announced that the United States District Court for the District of New Jersey ruled that AstraZeneca's US Patent, protecting Pulmicort Respules in the US, is invalid.
The court also ruled that the generic defendants involved in the litigation do not infringe AstraZeneca's second patent, US Patent No. 7,524,834.
'AstraZeneca strongly disagrees with the Court's decision. AstraZeneca has full confidence in the strength of its intellectual property rights protecting PULMICORT RESPULES. AstraZeneca is considering next steps, including an appeal of the Court's decision,' said Paul Hudson, Executive Vice President, North America.
The company said that the Court's ruling will not change its revenue guidance for 2013, which is that the company anticipates a mid to high-single digit decline in revenue on a constant currency basis.
Subject to additional generics entering the market, guidance for Core Other Income in 2013 is now that it could be significantly below $600 million. The company still expects Core earnings per share to decline significantly more than revenue in 2013.
The patents protecting Pulmicort Respules expire in 2018, with paediatric exclusivity extending into 2019.
AstraZeneca filed patent infringement lawsuits against Apotex Inc.; Apotex Corp.; Watson Laboratories and Breath Limited; and Sandoz, Inc., for infringement of US patents directed to methods of use and formulation and form of active ingredient (budesonide) for Pulmicort Respules.
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