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US court rules in favour of AstraZeneca in Symbicort patent litigation

A US district court for the Northern District of West Virginia has decided in favour of AstraZeneca in a patent litigation lawsuit against Mylan Pharmaceuticals, which is now part of Viatris, and Kindeva Drug Delivery.

The US district court ruled AstraZeneca’s patents protecting its asthma and COPD drug Symbicort were not invalid in the US.

According to a statement by AstraZeneca, the court ruled that its patents protecting asthma and chronic obstructive pulmonary disease (COPD) drug Symbicort (budesonide/formoterol) were not invalid in the US. In a statement, Viatris confirmed to Pharmaceutical Technology that the court ruled that the patents were not invalid “for obviousness”.

AstraZeneca’s biopharmaceuticals business unit executive vice-president Ruud Dobber said: “AstraZeneca is pleased with the Court’s decision, and we maintain full confidence in the strength of our intellectual property rights protecting Symbicort.”

“Viatris obviously disagrees with the district court decision and intends to file an appeal to continue vigorously to defend its position that the patents are invalid,” said Viatris in a statement shared with Pharmaceutical Technology.

The case has been ongoing since October 2018 when AstraZeneca filed a Hatch-Waxman Act suit accusing Mylan of infringing three patents for Symbicort in the US. The suit was originally filed at the US district court for Delaware, but it was quickly moved to the Northern District of West Virginia.

Initially, another defendant in the case was 3M, which had filed for an abbreviated new drug application in June 2018 to sell a generic version of Symbicort. According to Bloomberg Law, two months later 3M transferred said application to Mylan, which then notified AstraZeneca of its intent to market a generic version of Symbicort.

In July 2020, Kindeva Drug Delivery was added as a defendant and in October 3M was dismissed from the action.

The case was heard in September 2020. Mylan and Kindeva Drug Delivery argued that the three patent claims were invalid under US patent laws. Closing arguments were held in January 2021.

March 4th, 2021

https://www.pharmaceutical-technology.com/

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