LSIPR Newsletter 02:13
US appeals court upholds AstraZeneca’s Seroquel XR patent formulations. The judge rejected this claim and found in favour of AstraZeneca.
washington DC, US
The US Court of Appeals for the Federal Circuit has affirmed a 2012 ruling that AstraZeneca’s patent for ‘blockbuster’ antipsychotic drug Seroquel XR is valid and has been infringed by companies selling competing generics. In a one-line judgment published on February 14, the court upheld a ruling delivered by the District Court of New Jersey on March 29 last year, which found pharmaceutical companies Mylan, Torrent and Osmotica liable for infringement for selling generic versions of Seroquel XR in the US before the patent for the drug expired on May 28, 2017. The New Jersey court also granted an injunction blocking the companies from producing competing generics in the US before this date. In a statement issued following Thursday’s judgment, AstraZeneca said it was pleased with the court’s decision. Mylan, Torrent and Osmotica did not immediately respond to requests for comment. Seroquel XR is used to treat depression, bipolar disorder and schizophrenia and is an extended release version of Seroquel.
AstraZeneca has also been defending its Seroquel XR patent in Europe and was successful in Spain and the Netherlands, but unsuccessful in the UK and Germany.
The Federal Circuit.
AstraZeneca’s patent for the original Seroquel expired in 2012 but its follow-up was granted protection from the US Patent and Trademark Office in 1999. Mylan, Torrent, Osmotica and Anchen Pharmaceuticals (which later paid an outof-court settlement) tried to invalidate the Seroquel XR patent after AstraZeneca sued them for applying to release generic versions of the drug in 2010. The companies argued that the method of using a gelling agent to create a slow release tablet was obvious to anyone with experience of working in the field of sustained release pharmaceutical
Ira Levy, partner at Goodwin Procter LLP in New York, said the appeal court’s decision is no great surprise given the detailed nature of the district court ruling last year, but added: “It is slightly unusual that the court issued a one-line affirmance rather than addressing the merits of the decision. “This decision will keep the US market for Seroquel XR closed until at least late 2016, when at least one company, Intellipharmaceutics International, may enter through settlement. But the rulings in Germany and the UK may allow generics companies to move their inventory to markets where they can sell,” he said. Levy also said that the divergence in opinion between EU courts is unusual given the similar patent standards applied across Europe. “If this continues, it could lead to calls for greater harmonisation in courts’ approaches to similar or related global patents,” he added. n
Teva faces $2 billion damages for selling generic Protonix In December 2007—more than three years before the patent’s expiry date—Teva launched its generic in what is known as an ‘at risk’ launch (a launch during continuing patent litigation), expecting Nycomed and Pfizer’s patent to be invalidated.
patau tikva, israel
Israeli company Teva Pharmaceuticals could be forced to pay more than $2 billion in damages for selling a generic version of Nycomed’s and Pfizer’s heartburn reliever pantoprazole (sold as Protonix) before the drug’s patent exclusivity expired in the US.
A jury upheld the pantoprazole patent’s validity in April 2010, however, and found Teva liable for infringement. The decision was upheld by a judge in New Jersey, and a jury trial to determine the damages that should be awarded to Nycomed and Pfizer is scheduled for July this year.
Teva announced last year that it expected to pay around $670 million in damages for infringing the pantoprazole patent, which is owned by European pharmaceutical company Nycomed and licensed to US drugs maker Pfizer. But in an annual report filed in the US on February 12, the company said that “ultimate resolution of this matter could result in a further loss of up to $1.4 billion in excess of the amount accrued”. Teva asked the US Food and Drug Administration (FDA) to approve its generic version of pantoprazole in 2004. Nycomed
and Pfizer sued Teva for patent infringement, attempting to block its generic from being released; Teva claimed the pantoprazole patent is obvious and attempted to have the patent invalidated.
Life Sciences IP Review
Howard Hogan, a partner at Gibson, Dunn & Crutcher LLP in Washington, DC, said that $2 billion would not be an unusually large settlement for a case concerning a blockbuster drug, but added: “This should serve as a warning to generics companies about the dangers of at risk launches.” n