Revived Patent Challenge: Teva and Viatris Poised to Shake Up Schizophrenia Drug Market

In a recent development, Teva Pharmaceutical Industries Ltd and Viatris Inc have successfully persuaded a U.S. appeals court to revive their challenges against a patent held by Johnson & Johnson (J&J) for a widely-used schizophrenia drug. This decision presents a new opportunity for Teva and Viatris to potentially introduce more affordable generic versions of the medication into the market.

According to a Reuters report, the U.S. Court of Appeals for the Federal Circuit ruled that the sole remaining patent owned by J&J, which covers its popular drug Invega Sustenna, could potentially be invalid. Consequently, the case has been remanded to a federal court in New Jersey for further examination.

Expressing satisfaction with the court’s decision, a spokesperson for Teva stated that the company looks forward to making this crucial medication available to patients at reduced costs as soon as possible. Meanwhile, representatives for J&J and Viatris have yet to comment on the ruling.

In the past year, J&J amassed over $4.1 billion in global sales from Invega Sustenna and related products, with nearly $2.9 billion generated from U.S. sales alone. Legal disputes arose when J&J initiated lawsuits against Teva and Mylan (now part of Viatris) for alleged patent infringement related to their proposed generic versions of the drug in 2018 and 2019, respectively.

Previously, U.S. District Judge Claire Cecchi ruled against Teva in 2021, finding its arguments insufficient to invalidate J&J’s patent covering a specific dosing regimen for Invega Sustenna. Viatris had agreed to be bound by Cecchi’s decision in its case as well.

However, a three-judge panel from the Federal Circuit overturned Cecchi’s ruling on Monday, citing the possibility that Teva could demonstrate the patent’s invalidity due to the dosing regimen being obvious to experts in the field.

This development signals a potential shift in the landscape of pharmaceutical patent disputes, with implications for both drug manufacturers and patients seeking access to more affordable treatment options.

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