US Appeals Court revives Teva and Viatris case against J&J schizophrenia drug patent

Way for low-cost alternative: Teva Pharmaceutical and Viatris have secured a victory in a US appeals court on Monday, reigniting their efforts to contest a patent covering Johnson & Johnson's blockbuster schizophrenia drug. 

This decision offers them a renewed opportunity to pave the way for the launch of more affordable generic versions of the medication.

The US Court of Appeals for the Federal Circuit ruled that the last remaining J&J patent related to its Invega Sustenna drug might be invalid, prompting the case to be remanded to a New Jersey federal court for reassessment.

A spokesperson for Teva expressed satisfaction with the ruling, stressing on the company's eagerness to make this crucial low-cost medication available to patients as soon as possible. Representatives for J&J and Viatris have yet to comment on the decision.

Last year, J&J recorded over $4.1 billion in global sales of Invega Sustenna and its related products, with nearly $2.9 billion generated from U.S. sales alone, according to company data. 

Legal disputes arose when J&J sued Teva and Mylan, now part of Viatris, for patent infringement concerning their proposed generic versions of the drug in 2018 and 2019, respectively.

In a ruling from 2021, US District Judge Claire Cecchi found Teva unable to demonstrate the invalidity of J&J's patent, which covers a dosing regimen for Invega Sustenna. 

Viatris consented to abide by Cecchi's decision in its case.

However, a three-judge panel at the Federal Circuit overturned Cecchi's ruling on Monday, sending the case back to the New Jersey court. 

The appeals court indicated that Teva might have the opportunity to establish the patent's invalidity, citing that the dosing regimen could have been deemed obvious to an ordinary person in the field.

(With Reuters Inputs)