Johnson & Johnson has successfully defended its patent for the blockbuster schizophrenia drug Invega Sustenna against appeals from generic drug manufacturers Teva and Viatris, preserving the company's market exclusivity until 2031. The US Court of Appeals for the Federal Circuit ruled Tuesday that the pharmaceutical giant's dosing regimen patent remains valid, blocking generic competition for nearly another decade.
Federal Circuit Upholds Patent Validity
The three-judge panel, led by Judge Richard Taranto, determined that Teva Pharmaceuticals USA Inc. and Viatris' Mylan Laboratories Ltd. subsidiary failed to demonstrate that the claimed dosing schedules in US Patent No. 9,439,906 would have been obvious to skilled researchers. This ruling reverses the generic manufacturers' attempts to invalidate the patent and bring competing versions of the antipsychotic medication to market.
The court specifically noted that "the presumption that overlapping dosing ranges are usually obvious didn't apply here," distinguishing this case from typical pharmaceutical patent challenges where dosing modifications are often considered routine adjustments.
Patent Challenge Details
During oral arguments, Federal Circuit Judge Sharon Prost had questioned J&J's Janssen Pharmaceuticals unit attorney about whether the dosing method represented genuine innovation or merely an obvious modification. Prost expressed surprise at the company's argument that a decrease in dosage amount wouldn't constitute a meaningful difference in the patent claim, suggesting the dosing change might actually be the patent's key innovation.
The generic manufacturers had argued that the dosing regimens covered by the patent were obvious variations of existing treatments, a common strategy in pharmaceutical patent litigation. However, the Federal Circuit panel found insufficient evidence to support this obviousness claim.
Market Impact and Exclusivity Extension
The ruling extends J&J's monopoly on Invega Sustenna, a long-acting injectable antipsychotic medication used to treat schizophrenia, until 2031. This decision blocks Teva and Viatris from launching generic versions that could significantly reduce treatment costs for patients and healthcare systems.
The patent protection covers specific dosing schedules rather than the drug's basic formulation, highlighting the pharmaceutical industry's strategy of securing extended market exclusivity through method-of-use patents. These secondary patents often prove crucial in maintaining competitive advantages beyond the expiration of primary drug patents.
Implications for Generic Competition
The Federal Circuit's decision represents a significant victory for J&J in maintaining its position in the lucrative antipsychotic drug market. For generic manufacturers, the ruling underscores the challenges of successfully challenging pharmaceutical patents, particularly those covering dosing regimens and administration methods.
The case demonstrates the ongoing tension between brand-name pharmaceutical companies seeking to maximize patent protection and generic manufacturers working to bring lower-cost alternatives to market. With patent protection now secured until 2031, J&J can continue to command premium pricing for Invega Sustenna without generic competition.
