Legal victory for Astra in US courts

Jul 3 2008 by Tony McDonough

SHARES in Cheshire pharmaceutical giant AstraZeneca were given a boost yesterday when the company announced it had won a key legal battle over cheaper unauthorised copies of its drugs.

The company sued two firms in the US for trying to market generic versions of Seroquel, a treatment for schizophrenia and bipolar depression.

The drug was the firm’s second best selling drug last year, generating revenues of £2bn.

Astra brought the case against Israel-based Teva Pharmaceutical Industries and US drugs firm Sandoz, which both specialise in making generic medicines.

They were both seeking to produce versions of Seroquel before a patent ran out in 2011, Astra said, but the US District Court for the District of New Jersey granted the company’s motion complaining its patent had been infringed.

The decision means Astra avoids a potentially costly and time-consuming trial scheduled to start next month.

The ruling comes three months after Astra settled with Indian pharmaceutical giant Ranbaxy over an attempt to make copies of Astra’s best-selling ulcer pill Nexium. Ranbaxy also wanted to market cheaper versions before the firm’s patent expired in 2014.

Teva and Sandoz had already conceded infringement and the validity of AstraZeneca's patent, so only the issue of inequitable conduct remained to be resolved.

“We are pleased with the court's decision to uphold our valid intellectual property. Seroquel remains an important part of our company's portfolio,” AstraZeneca chief executive David Brennan said in a statement.

Winning the patent action should underpin a part of the group's profits at a time when sales of top-seller Nexium, for ulcers and acid reflux, are slowing and new drugs are still several years from the market.

Astra’s profits fell 4% to £4.06bn in 2007, with the impact of cheaper drug copies cited as a reason.

The US patent on Seroquel is due to expire in September, 2011, although AstraZeneca is seeking a six-month extension for paediatric use, which would take it to March 2012.

By delaying the risk of generic competition until then, AstraZeneca gains valuable breathing-space to allow its new once-daily version of the medicine, Seroquel XR, to capture market share.

tonymcdonough