AstraZeneca gets relief from the Court for its drug Symbicort

AstraZeneca gets relief from the Court for its drug Symbicort

The case was based on the contention that the patent was not valid in the US for being obvious. The court ruled in favour of AstraZeneca observing that the drug was not invalid for obviousness.

The US District Court for the Northern District of West Virginia (District Court) affirmed its decision in favour of AstraZeneca in a lawsuit filed against Mylan Pharmaceuticals. The lawsuit dealt with the AstraZeneca patent Symbicort.

AstraZeneca's Patent Symbicort protects Asthma and Chronic obstructive disease (COPD). The case was based on the contention that the patent was not valid in the US for being obvious. The court ruled in favour of AstraZeneca observing that the drug was not invalid for obviousness.

AstraZeneca in October 2018 filed a lawsuit against Mylan Pharmaceuticals for infringing its patent for Symbicort in the US. Mylan Pharmaceuticals is now part of Viatris and Kindeva Drug Delivery. This Hatch-Waxman suit was filed in the US District Court of Delaware and moved to the Northern District of West Virginia. Symbicort drug contains budesonide and formoterol. The former is an inhaled corticosteroid that treats inflammation and formoterol, a beta2-agonist bronchodilator.

Previously, another defendant was 3M Pharmaceuticals filing an abbreviated new drug application for selling a generic version of Symbicort. But the said application was transferred to Mylan and it was notified to AstraZeneca for marketing the generic version after which the 3M application was dismissed.

The defendant in the case, Mylan Pharmaceuticals contended that the patent Symbicort was invalid for obviousness. This drug was approved in 2006 for asthma treatment and was expanded in 2009 covering COPD and expanded in 2017 for covering childhood asthma. These two expansions helped in increasing the stake and sales in the US. The plaintiff combined the drug provided by Propeller Health which provides an app for building a care plan for patients. Even in the pandemic, the global sales grew to $2.7bn where maximum growth was in the US which totals to $1bn.

The plaintiff had also faced legal issues concerning Symbicort patents earlier as well. Teva launched a generic version of the Symbicort in Europe against which AstraZeneca files several lawsuits. In 2014, the UK High Court ruled in favour of Teva against the validity of AstraZeneca. Similarly, the AstraZeneca patent was successfully revoked before the European Patent Office and Norwegian Court. AstraZeneca struggles in the European Market due to the generic competition.

AstraZeneca's spokesperson said that they are pleased with the Court's decision while Viatris proves his dissatisfaction with the Court's decision and intends to file an appeal.