US court ruling helps AstraZeneca stave off Teva, Sandoz from 4$-billion Seroquel

The New Jersey District Court has upheld upheld Anglo-Swedish pharmaceutical group AstraZeneca's patent rights to the schizophrenia and bipolar blockbuster Seroquel, which yields it over $4 billion a year.

The court awarded a summary judgement on favour of AstraZeneca ruling against claims by Israeli generics drug maker Teva, and Novartis generic pharma firm, Sandoz,  who said that AstraZeneca's assertions of its its patent had been inequitable.

AstraZeneca had sued Teva Pharmaceutical Industries Ltd. and Sandoz, Inc. alleging infringement of its patent throught their filings an abbreviated new drug applications to market generic versions of Seroquel (quetiapine fumarate) tablets in the US before its patent expires in 2011.

Teva and Sandoz conceded infringing the patent, but wanted to move the proceedings to a full trial that was scheduled to start on 11 August and could have lasted for a year. Since the court granted AstraZeneca's motion for summary judgment of 'no inequitable conduct' in its entirety, the trial is unnecessary. 

The ruling establishes AstraZeneca's exclusive right to manufacture the drug till the expiry of patent in 2011 in the US, the biggest market for the drug. AstraZeneca' is also applying for a six-month patent extension for paediatric use.

"We are pleased with the Court's decision to uphold our valid intellectual property. SEROQUEL remains an important part of our company's portfolio benefiting patients and physicians throughout the world," said David Brennan, CEO of AstraZeneca in a statement.

Analysts say the decision would come as a relief for the group, especially as a full trial The judgement confirms AstraZeneca's exclusive right to produce the drug until the patent expires in the US, the treatment's biggest market, in 2011. The group is also applying for a six month patent extension for use in paediatric patients.

The first quarter sales of Seroquel recorded $1.05 billion, up from $923 million in 2007.

While Teva has said that it would appeal the decision, Sandoz has yet to make a statement on its stand on the ruling.

Global pharma majors have been facing increasing pressure from generic firms that seek approvals to make generic versions of drugs protected by patents till 2011.

AstraZeneca's anti-cholesterol drug Crestor is also expected to face patent challenges in the next 18 months, which the drug maker intends to defend.

In April, the group settled out of court a long running dispute with Indian generics drug maker Ranbaxy over its biggest medicine, Nexium, an ulcer treatment that generates sales of $5.22bn a year. Under the terms of the settlement Ranbaxy will be able to produce the drug from May 2014, which is when the first patents held by AstraZeneca expire. A spokesman for AstraZeneca confirmed at the time that no damages had been paid by Ranbaxy, but that the Indian firm did accept AstraZeneca's patents.

However, there are still outstanding challenges over Nexium. Both Teva and another Indian group, Dr Reddy's have lodged proposals to manufacture their own versions of the drug.