In a remarkable shift in the landscape of False Claims Act (FCA) jurisprudence, the Ninth Circuit’s ruling in Silbersher v. Valeant has paved the way for potential future FCA suits based on patent validity. The ruling marks a significant development, creating new channels for litigation and possibly escalating the stakes for patent applicants looking to transact with the government.
In the case, a generic-drug manufacturer challenged Valeant Pharmaceuticals International Inc.’s patent validity before the Patent Trial and Appeal Board. The challenge was successful, exposing that Valeant had obtained the patent by intentionally misleading the patent examiner.
Legal experts Joshua Robbins and Rick Taché denote the impact of this verdict as enormous, given it opens up a vista for FCA suits centred upon patent deceit. The ramifications of such a move may push patent applicants, who harbour intentions of governmental business transactions, to approach disclosures with increased caution and transparency.