10 May 2013Big Pharma

AstraZeneca loses Seroquel appeal

The UK Court of Appeal has upheld the High Court’s decision that AstraZeneca’s patent for a sustained release formulation of anti-psychotic drug quetiapine is invalid.

AstraZeneca markets quetiapine under the name Seroquel XL, which is used in the treatment of schizophrenia, bipolar disorder and major depressive disorder.

The ruling means that companies may start marketing generic versions of Seroquel in the UK.

AstraZeneca received a patent to protect the Seroquel formulation, which uses a gelling agent for stable release.

Six companies, including Teva UK, Hexal and Sandoz, filed to revoke AstraZeneca’s patent on the grounds of obviousness. In March 2012, the High Court found in the companies’ favour and invalidated the patent.

In its appeal, AstraZeneca contended that the patent is inventive as there was no approved dosage form of quetiapine on the market at the priority date, nor any perceived advantage or motivation to formulate the drug as a sustained release dosage form.

On April 30, after a five day trial, Justice Arnold agreed the patent has no inventive step, as a skilled person would find a once-a-day formulation desirable, and that a sustained release formulation or higher dose or an immediate release formulation are both “obvious possibilities” to achieve this.

A spokesperson for the claimants Intas Pharmaceuticals and Accord Healthcare said: “The decision to fight this action is vindicated by the court’s judgment and means that the over 5 million patients in the UK with serious mental illnesses such as schizophrenia and bipolar disorder now have better access to a more convenient and effective medicine.”

Simon Cohen, a partner at Taylor Wessing that led the team advising a number of companies challenging the patent, said: “The UK Court of Appeal has confirmed once again that High Court decisions on obviousness will generally not be disturbed on appeal, reflecting the fact that the High Court Judge is the judge of fact and the Court of Appeal merely has to decide whether the decision was wrong on the evidence and arguments made at first instance.

“Unlike in other European jurisdictions (and the EPO), the appeal is not a de novo hearing.”

Kristina Cornish, partner at Kilburn & Strode LLP in London, said that while the ruling will improve some patients’ access to cheaper drugs, it may keep AstraZeneca from investing in a particular area of research that could help other patents.

“It’s not as simple as being a victory for patients,” she said.

“I think we may be seeing the beginning of a trend for these dosage or sustained release claims,” she continued. As UK courts are seen to be considering these claims in a consistent manner, some larger pharmaceutical companies will be more cautious about filing and “bank less” on the outcome, she said.

Cornish noted that this particular case has been fought in countries outside the UK. In the Netherlands AstraZeneca’s patent was found to be valid, raising questions about what the introduction of the Unified Patent Court means for big pharma.

In light of cases such as these, larger drug companies may be consider opting out of the UPC for the maximum term of seven years, she said.

“We might gather a real understanding about whether some of these big pharmaceutical companies will be opting out for as much time as possible,” she said.

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