Allergan urged a California federal judge to allow it to immediately appeal his ruling requiring the pharmaceutical giant to face a False Claims Act suit over dementia drugs, arguing that decisions expected from separate, ongoing litigation could potentially resolve the suit brought by a patent attorney against the drugmaker.
In a 20-page motion filed on Dec. 30., Allergan urged U.S. Magistrate Judge Joseph C. Spero to certify an interlocutory appeal order and stay the suit until the Ninth Circuit issues a decision in a suit against Valeant brought by Zachary Silbersher, the same patent attorney who sued Allergan, that answers questions related to the FCA's public disclosure bar.
Allergan argued that if the Ninth Circuit finds that the public disclosure bar is applicable in Silbersher's litigation against Valeant, it would also answer questions in his ongoing suit against Allergan.
"If the Ninth Circuit were to decide that the public disclosure bar applies, any discovery skirmishes and pre-trial work in the meantime would amount to no more than a waste of judicial resources," the motion said.
In his May 2018 suit, Silbersher said Allergan acquired patents for Namenda XR and Namzaric — extended-release medications to treat dementia and Alzheimer's disease — through fraudulent means in an effort to keep generic versions at bay.
But Allergan moved to toss the suit in June 2019 under the public disclosure bar, arguing that Silbersher's FCA claims are barred because they stem from information from "public patent prosecution files" that existed for several years. The FCA's public disclosure bar prohibits relators from bringing qui tam whistleblower lawsuits based on fraud that's already been disclosed through public channels.
Allergan also took aim at the patent attorney's FCA accusations, criticizing his purported failure to allege any inaccurate factual information in showing that the Alzheimer's drugs were defective or misrepresented.
But Silbersher fired back, arguing that Allergan either knowingly or recklessly used an invalid patent to edge out generic competitors from the marketplace "so that it could charge the government monopoly prices and remove the government's ability to purchase less expensive generics."
He also said that an amendment to the FCA narrowed the scope of the public disclosure bar and, therefore, his claims are valid.
Allergan's bid to dodge the FCA lawsuit in December was rejected after Judge Spero found that Silbersher sufficiently alleged that the pharmaceutical company fraudulently obtained the dementia drug patents.
But Allergan continues to argue that the public disclosure bar remains a "threshold barrier" to the suit since courts are required under the FCA to dismiss an action if the bar applies, according to the motion.
Allergan underlined in its argument that the Ninth Circuit's resolution to questions around the public disclosure bar, such as if information reported by the U.S. Patent and Trademark Office on its patent application retrieval website is considered a "federal report," could "pave the way" for dismissing the suit entirely.
Alternatively, Allergan requested the suit be stayed until the Ninth Circuit issues forthcoming decisions in the Valeant suit and in United States ex rel. Integra Medical Analytics LLC v. Providence Health & Services . The drugmaker argued that the Valeant and Integra suits could clarify both the scope and the meaning of the public disclosure bar and even "alter this court's analysis of the issues" from Allergan's motion to dismiss.
Furthermore, Allergan underlined that Silbersher's intent to seek "massive volumes" of information spanning a 15-year period may be in vain depending on the Ninth Circuit's outcome.
"Mr. Silbersher's initial requests for production demonstrate just how burdensome discovery will be for defendants and affected government agencies," the motion said. "An immediate appeal, on the other hand, could eliminate potential waste and inefficiency by narrowing the issues to be addressed in this action, if not resolving the case entirely."
Counsel for the parties and representatives of Allergan did not immediately respond to Law360's request for comment on Monday.
Silbersher is represented by Nicomedes Sy Herrera, Laura E. Seidl, Shawn Kennedy and Bret D. Hembd of Herrera Kennedy LLP, Tejinder Singh of Goldstein & Russell PC and Warren T. Burns, Christopher J. Cormier and C. Jacob Gower of Burns Charest LLP.
Allergan is represented by M. Sean Royall and Olivia Adendorff of Kirkland & Ellis LLP and John D.W. Partridge and Emma M. Strong of Gibson Dunn & Crutcher LLP.
The suit is Zachary Silbersher et al. v. Allergan Inc. et al., case number 3:18-cv-03018, in the U.S. District Court for the Northern District of California.