According to Viatris, the US District Court for the Northern District of West Virginia has determined that US Patent No. 10,166,247, which covers AstraZeneca’s Symbicort budesonide / formoterol MDI, is invalid. In March 2021, the same court upheld claims in three other patents protecting Symbicort. An appeals court reversed the March 2021 decision in December 2021 and returned the case to the lower court. AstraZeneca later stipulated that the Mylan product did not infringe the three patents in question (7,759,328, 8,143,239, and 8,575,137).
AstraZeneca had sued Mylan (now part of Viatris) for patent infringement in 2018 after Mylan filed an ANDA for a generic version of Symbicort, and the company later added 3M (now Kindeva Drug Delivery) to the suit. The FDA tentatively approved the Mylan ANDA in March 2021 and announced its final approval of the ANDA in March 2022. The Mylan generic version of the MDI is called Breyna.
The Viatris announcement notes that AstraZeneca has now also asserted infringement of an additional Symbicort patent (11,311,558), and the court is set to hear that case on December 13, 2022. The expiration date for that patent is January 29, 2023, and pediatric exclusivity expires on July 29, 2023.
Viatris President Rajiv Malik commented, “We are extremely pleased with the court’s decision as it 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. This affirms Viatris’ continuing efforts to break down barriers to patient access for important medicines. We already have FDA approval for our generic Symbicort product, and we look forward to the opportunity to bring our more affordable product to market.”
Read the Viatris press release.
