Case Title: AstraZeneca AB v. Mylan Pharmaceuticals Inc, U.S. District Court for the Northern District of West Virginia
Mylan Pharmaceuticals Inc, a subsidiary of Viatris, cleared a hurdle Wednesday in its attempt to launch a generic version of AstraZeneca AB's blockbuster asthma drug Symbicort, convincing a West Virginia federal court to declare an AstraZeneca patent invalid.
Following a bench trial, U.S. District Judge Irene Keeley stated that the relevant parts of AstraZeneca's only patent still at issue in the case were "extraordinarily broad" and did not adequately describe the drug's composition.
According to an AstraZeneca report, Symbicort sales totaled more than $2.7 billion last year.
In March, the US Food and Drug Administration granted preliminary approval to Viatris' Breyna, the first generic version of Symbicort. The generic was developed in collaboration with 3M Co spinoff Kindeva Drug Delivery LP, which is also a defendant in the case.
According to an AstraZeneca spokesperson, the company is disappointed with the decision but "fully confident in the strength of its intellectual property rights protecting Symbicort" and is considering an appeal.
In a press release issued Thursday, Viatris president Rajiv Malik stated that the decision "clears away yet another of AstraZeneca's invalid patents, which have only served to block generic versions and delay access to this important product for American patients."
According to Viatris, the parties agreed in May that their generic would not infringe on three other AstraZeneca patents. On December 13, another bench trial in a separate AstraZeneca patent case against Mylan and Kindeva over the generic drug is set to begin in West Virginia.
AstraZeneca, based in the United Kingdom, filed the case against Mylan and Kindeva in 2018. Last year, the United States Court of Appeals for the Federal Circuit overturned parts of a ruling in AstraZeneca's favour and remanded the case to the West Virginia court.