AstraZeneca wins US court ruling on Symbicort patent claims

pharmafile | March 3, 2021 | News story | Research and Development AstraZeneca, Symbicort, law 

A US district court has ruled in favour of AstraZeneca in litigation against Mylan Pharmaceuticals and Kindeva Drug Delivery, AstraZeneca announced in a statement.

The court determined that asserted claims in three of AstraZeneca’s patents protecting the company’s respiratory drug Symbicort (budesonide/formoterol) in the US are not invalid.

In October 2018, AstraZeneca took legal action against generics specialist Mylan and subsequently against 3M Company, asserting infringement of various US patents covering Symbicort. Then, in July 2020, CDMO Kindeva was added as a defendant in the action, and 3M was voluntarily dismissed from the case.

In September last year, 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, both Mylan and Kindeva contended that each asserted patent claim for Symbicort is invalid under the US patent laws.

The recent court ruling asserts that AstraZeneca’s US patent claims for their drug stand.

Ruud Dobber, Executive Vice President of AstraZeneca’s BioPharmaceuticals Business Unit, said: “AstraZeneca is pleased with the court’s decision, and we maintain full confidence in the strength of our intellectual property rights protecting Symbicort.”

Symbicort, launched in 2000, 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. The drug is approved in approximately 120 countries to treat asthma and chronic obstructive pulmonary disease 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 to distribute an authorised-generic version of Symbicort in the US.

Darcy Jimenez

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