US judge dismisses attorney’s ‘opportunistic’ whistleblower suit
A Californian judge has thrown out an attorney’s whistleblower lawsuit alleging Bausch Health Companies fraudulently obtained a patent for its ulcerative colitis drug Apriso (mesalamine).
In an order to dismiss issued on Monday, May 11, Judge James Donato of the US District Court for the Northern District of California concluded that the attorney was a “far cry from the quintessential whistleblower” plaintiff contemplated by the False Claims Act (FCA).
Attorney Zachary Silbersher’s suit claimed that Salix Pharmaceuticals, a subsidiary of Valeant (now known as Bausch), had obtained a patent to block generic versions of Apriso, causing artificially high prices to be billed to Medicare and Medicaid.
In 2014, Bausch obtained a patent—US number 8,865,688—covering a method for administering certain granulated mesalamine formulations.
Generic makers subsequently sued to invalidate the patent, with lead plaintiff GeneriCo filing a petition for inter partes review.
The Patent Trial and Appeal Board (PTAB), in May 2017, concluded that claims 1 and 16 were unpatentable as obvious. Bausch appealed against the decision to the US Court of Appeals for the Federal Circuit, but the court affirmed the PTAB.
Silbersher served as a lead counsel for GeneriCo in the PTAB proceedings, and again in defending the decision before the Federal Circuit.
In his lawsuit, Silbersher claims that Bausch wrongfully obtained the ‘688 patent by deliberately omitting material prior art.
The heart of Silbersher’s case, said the court earlier this week, is that the defendants obtained the patent by “willful deceit”, as “confirmed” by the PTAB decision.
“In effect, Silbersher simply seized upon a favourable patent decision in a case he litigated and added the new punchline of a false claim. That is the quintessence of the opportunistic and ‘parasitic’ lawsuit Congress has always intended to bar,” added Donato.
According to the judge, the suit is barred under an FCA rule that precludes claims stemming from publicly disclosed information.
Silbersher may file an amended complaint consistent with this order by June 15, but no new claims or parties may be added without the court’s prior approval.
In a comment emailed to LSIPR, Silbersher said: “This is an important case revealing how abuse of the patent system results in gross overcharging for drugs. The district court’s decision is based on an unduly restrictive reading of the FCA, and we intend to appeal.” Did you enjoy reading this story? Sign up to our free daily newsletters and get stories sent like this straight to your inbox.
