AstraZeneca says Mylan, Kindeva infringe another Symbicort patent
AstraZeneca filed a patent infringement lawsuit against Mylan Pharmaceuticals and Kindeva Drug Delivery on Tuesday, claiming that their generic asthma Symbicort (budesonide/formoterol) infringes a brand-new patent that was issued the same day.
Continuing a years-long patent dispute between AstraZeneca and Mylan, this recent lawsuit alleges that Mylan and its manufacturing partner Kindeva’s generic infringes a brand new patent covering the treatment which was issued on Tuesday, April 26.
On the same day the new patent was issued, AstraZeneca filed a complaint alleging infringement was filed in the US District Court for the Northern District of West Virginia.
AstraZeneca is seeking injunctive relief barring the companies from marketing or selling the drug prior to the expiration of the newly-obtained US patent 11,311,558.
According to the complaint, Mylan’s ANDA was approved by the US Food and Drug Administration on March 16, 2022.
Mylan had previously notified AstraZeneca in 2018 that it was intending to seek approval to market the generic, claiming that its ANDA would not infringe three prior patents related to Symbicort—US patent 7,759,328, 8,143,239, and 8,575,137.
It also sent a follow-up letter in 2019 claiming that a fourth patent, US patent 10,166,247, was either invalid or not infringed by its ANDA.
The patents describe and claim a suspension composition in a pressurised metered-dose inhaler for the treatment of asthma and other respiratory diseases.
This prompted AstraZeneca to sue Mylan and 3M Company asserting infringement of the three patents. Kindeva was added as a defendant in July 2020 while 3M was voluntarily dismissed from the case.
Litigation proceeded in October 2020. But prior to the trial, Mylan stipulated infringement of the first three patents but challenged their validity. The court upheld the validity of the three patents, entering a judgement of nonobviousness for each asserted claim.
Mylan appealed the decision to the US Court of Appeals for the Federal Circuit.
In a split decision handed down in March 2021, the Federal Circuit disagreed with the lower court’s interpretation of the term “0.0001%” in relation to the concentration of Polyethylene Glycol found in Symbicort and vacated the case for further proceedings.
While the proceedings were taking place, AstraZeneca was working to secure the ‘558 patent. It sent a letter to Mylan in March 2022, notifying the company that the then-pending claims of the patent application were infringed by Mylan’s generic.
AstraZeneca now seeks a declaratory judgement that Mylan’s ANDA infringes the ‘558 patent, as well as a permanent injunction barring the two defendants from releasing the Symbicort generic prior to the expiration of the ‘558 patent.
AstraZeneca has disclosed that Symbicort generated about $2.7 billion in revenue for the company in 2020, second only to Tagrisso, a medication used in the treatment of non-small-cell lung carcinomas.
Did you enjoy reading this story? Sign up to our free daily newsletters and get stories sent like this straight to your inbox.
