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.

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.

Symbicort was first approved in the US for adults with asthma in 2006. Its US label was then expanded in 2009 and 2017 to include COPD and childhood asthma respectively. According to AstraZeneca’s 2020 annual report, the company still holds US patents on Symbicort until 2022 and 2029.

This is not the first time AstraZeneca has had legal issues regarding Symbicort patents. In 2014, AstraZeneca filed several lawsuits against Teva’s attempt to launch a generic version of Symbicort in Europe. In September 2014, Teva announced that the UK high court ruled in favour of Teva’s case against the validity of AstraZeneca’s patents for Symbicort. Earlier that year, Teva also successfully revoked AstraZeneca patents covering Symbicort before the European Patent Office and a Norwegian Court.

Despite the ongoing pandemic, AstraZeneca reported in its full year 2020 results that global sales of Symbicort grew by 9% to $2.7bn. The product’s strength was largely due to sales growth in the US, which total $1bn, while Symbicort struggled in Europe and Japan because of generic competition.

In the financial report, AstraZeneca also noted that the company’s collaborator Prasco launched an authorised generic version of the product in the US in January 2020.