US District Court decision favours Symbicort in patent litigation – AstraZeneca

The US District Court for the Northern District of West Virginia has decided in favour of AstraZeneca in litigation against Mylan Pharmaceuticals Inc. (Mylan) and Kindeva Drug Delivery L.P. (Kindeva), determining that asserted claims in three of AstraZeneca’s patents protecting Symbicort (budesonide/formoterol) in the US are not invalid.

Symbicort US patent trial: In October 2018, AstraZeneca initiated litigation against Mylan and subsequently against 3M Company (3M) asserting infringement of various US patents covering Symbicort. In July 2020, Kindeva was added as a defendant in the action. 3M was voluntarily dismissed from the case. In September 2020, Mylan and Kindeva stipulated to
patent infringement to the extent that the asserted patent claims were found to be valid and enforceable, but reserved the right to seek a vacatur of the stipulation if the US Court of Appeals for the Federal Circuit reverses or modifies the District Court’s claim construction. At trial, Mylan and Kindeva contended that each asserted patent claim is invalid under the US patent laws.

Symbicort (budesonide/formoterol) is a combination formulation containing budesonide, an inhaled corticosteroid that treats underlying inflammation, and formoterol, a long-acting beta2-agonist bronchodilator with a fast onset of action, in a single inhaler. Symbicort was launched in 2000 and is approved in approximately 120 countries to treat asthma and/or chronic obstructive pulmonary disease (COPD) either as Symbicort Turbuhaler or Symbicort pressurised metered-dose inhaler (pMDI). In the US, Symbicort is only approved for use in a pMDI. In January 2020 AstraZeneca entered an agreement with Prasco, LLC to distribute an authorised-generic version of Symbicort in the US.