Mahima
The US Court for the Northern District of West Virginia held that claims contended in three of AstraZeneca’s patents protecting Symbicort in the US are valid, thus deciding in favor of AstraZeneca against Mylan Pharmaceutical Inc (Mylan) and Kindeva Drug Delivery L.P (Kindeva).
AstraZeneca is a British-Swedish multinational biopharmaceutical company. Its headquarters are in Cambridge and England. It primarily focuses on pioneering, developing, and commercializing prescription medicines in predominantly three therapy areas – cardiovascular, oncology, renal and metabolism, and respiratory and immunology.
Symbicort (budesonide/formoterol) is a combination formulation containing budesonide and formoterol. The former is an inhaled corticosteroid that helps in treating underlying inflammation while the latter is a long-acting beta2-agonist bronchodilator. It has been approved in around 120 countries for the treatment of asthma and/or chronic obstructive pulmonary disease (COPD). In the US, Symbicort’s application is approved only in the form of a pressurized metered-dose inhaler (pMDI).
AstraZeneca initiated litigation against Mylan and later against 3M Company proclaiming infringement of various US patents covering Symbicort. Kindeva became a defendant while 3M Company was voluntarily dismissed from the case.
The stipulation to patent infringement by Mylan and Kindeva was to such a limit that the arguable patent claims were found to be valid and enforceable. However, the right to seek a vacatur of such requirement was reserved if the US Court of Appeals for the Federal Circuit converses or amends the District Court’s claim construction.
Executive Vice President of BioPharmaceuticals Business Unit, Ruud Dobber, expressed his satisfaction with the judgment, “AstraZeneca is pleased with the Court’s decision and we maintain full confidence in the strength of our intellectual property rights protecting Symbicort.”