AstraZeneca to contest US court ruling over asthma medicine

Drugmaker AstraZeneca announced Tuesday that a US court ruled that its patent protecting its medicine Pulmicort Respules in the nation is invalid.

Drugmaker AstraZeneca announced Tuesday that a US court ruled that its patent protecting its medicine Pulmicort Respules in the nation is invalid.

The company said it strongly disagreed with the District Court of New Jersey's decision over the drug, which is used for the treatment of asthma.

"AstraZeneca has full confidence in the strength of its intellectual property rights protecting Pulmicort Respules," said Executive Vice President Paul Hudson.

"AstraZeneca is considering next steps, including an appeal of the court's decision."

The decision comes after AstraZeneca filed infringement lawsuits against Apotex, Watson Laboratories, Breath Limited and Sandoz for infringement of US patents directed to methods of use, formulation and form of active ingredient budesonide for Pulmicort Respules.

At the trial, the company said that the defendants' generic budesonide inhalation suspension products would infringe the claims of the two AstraZeneca patents.

The defendants denied the claims and asserted that each patent was invalid.

The firm stressed that the court's decision was limited to the US and has no impact on the validity of patents elsewhere.

It will also have no effect on the group's revenue guidance for 2013 which is for a mid to high-single digit decline in revenue on a constant currency basis, AstraZeneca insisted.

However, if additional generics enter the market it would materially impact royalties received on sales of Pulmicort Respules.

Royalties represented an annualised value of approximately $260m in 2012 under the core other income line in the company's annual report.

Subject to additional generics entering the market, guidance for core other income in 2013 is estimated to be significantly below $600m. The company expects core earnings per share to fall more than revenue in 2013.

RD

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