In the courtroom fracas over the patents on AstraZeneca’s multibillion-dollar inhaler Symbicort, Viatris and Kindeva Drug Delivery have toppled yet another intellectual property pillar. Still, AstraZeneca is fighting tooth and nail to keep its asthma and chronic obstructive pulmonary disease (COPD) franchise standing.
Thursday, Viatris and Kindeva declared victory over a fourth patent on AZ’s drug-device combo, which brought home (PDF) more than $2.7 billion in sales for the British pharma last year.
A U.S. federal court in West Virginia found that AZ’s so-called '247 Symbicort patent is invalid for lack of written description and enablement, Viatris said in a press release. In a statement, Viatris President Rajiv Malik accused AstraZeneca of using its Symbicort patents to “block generic versions and delay access to this important product for American patients.”
The victory marks the fourth Symbicort patent deemed invalid or not infringed in court, Viatris and Kindeva pointed out.
Still, the fight’s not yet over.
AstraZeneca recently cried infringement on a fifth patent that it secured April 26. The case over that IP dispute with Viatris and Kindeva is set to go to trial Dec. 13.
The patent involved in that case, known as '558, relates to the formulation of formoterol and budesonide, the active ingredients in Symbicort. The patent is currently set to expire Jan. 29, 2023, with pediatric exclusivity lapsing July 29.
In light of the latest victory, meanwhile, it’s unclear whether Viatris and Kindeva aim to launch their Symbicort generic in 2023. The companies did not immediately respond to Fierce Pharma’s request for comment.
Symbicort won its orignal asthma approval back in 2006. The drug-inhaler combo picked up its nod in COPD three years later in 2009.
Meanwhile, Viatris and Kindeva won a tentative approval for their Symbicort generic last March, making the partners’ budesonide/formoterol fumarate product the first FDA-christened copycat to AZ’s drug. AstraZeneca, for its part, launched an authorized generic of the medicine in Jan. 2020.
Authorized generics are brand-name drugs sold cheaper without the brand name on the label.
Viatris' generic, dubbed Breyna, bagged a full approval earlier this year.
If launched, Viatris and Kindeva’s inhaler would represent the first bout of external conflict to AZ’s med. Further, as the first to debut on the generics scene, the partners would score a coveted 180 days of marketing exclusivity.