Viatris and Kindeva Drug Delivery announced that they have won a significant court decision in which the U.S. District Court for the Northern District of West Virginia found that AstraZeneca's Symbicort patent, U.S. Patent No. 10,166,247, is invalid. The district court determined that the patent is invalid on two separate grounds – lack of written description and lack of enablement, the company said.
"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,” said Viatris president Rajiv Malik. “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."
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Today's decision marks the fourth Symbicort patent to be found either not infringed or invalid. In May, after Viatris and Kindeva won an appeal, AstraZeneca stipulated that the company's budesonide/formoterol fumarate dihydrate products would not infringe U.S. Patent Nos. 7,759,328, 8,143,239, and 8,575,137.
Viatris and Kindeva previously announced that Mylan, a Viatris subsidiary, received approval from the FDA for its Abbreviated New Drug Application for Breyna (budesonide and formoterol fumarate dihydrate inhalation aerosol), the first approved generic version of AstraZeneca's Symbicort. Breyna, a drug-device combination product, is indicated for certain patients with asthma or chronic obstructive pulmonary disease and will be available in 160 mcg/4.5 mcg and 80 mcg/4.5 mcg dosage strengths.
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AstraZeneca recently filed a new complaint asserting infringement of a fifth Symbicort patent, which was issued April 26, 2022, and shares the same specification and named inventors as the '247, '328, '239 and '137 patents. A trial on U.S. Patent No. 11,311,558 is currently scheduled for Dec. 13, 2022. The '558 patent expires on Jan. 29, 2023, with pediatric exclusivity expiring on July 29, 2023.