Teva Pharmaceutical (TEVA.TA) and Viatris (VTRS.O) successfully persuaded a U.S. appeals court on Monday to revive their challenges to a patent regarding a popular Johnson & Johnson (JNJ.N) schizophrenia drug.
This ruling offers them a renewed opportunity to pave the way for launching more affordable generic versions of the medication.
The U.S. Court of Appeals for the Federal Circuit ruled that a key J&J patent covering its Invega Sustenna might be invalid, prompting a reconsideration by a New Jersey federal court.
Expressing satisfaction with the decision, a Teva spokesperson stated the company’s eagerness to swiftly provide this crucial, cost-effective medication to patients.
There was no immediate response from representatives of J&J and Viatris regarding the court’s decision.
According to company data, J&J recorded over $4.1 billion in sales of Invega Sustenna and related drugs globally last year, with almost $2.9 billion generated from U.S. sales alone.
In 2018 and 2019, respectively, J&J sued Teva and Mylan (now part of Viatris) for patent infringement over their proposed generic versions of the drug.
In 2021, U.S. District Judge Claire Cecchi ruled against Teva, stating it had failed to demonstrate the invalidity of J&J’s patent covering a dosing regimen for Invega Sustenna. Viatris agreed to abide by Cecchi’s decision in its case.
However, a three-judge Federal Circuit panel overturned Cecchi’s ruling on Monday, sending the case back to the New Jersey court.
The appeals court suggested that Teva might be able to establish the patent’s invalidity because the dosing regimen would have been apparent to an ordinary person in the field.
