DALLAS — The nationally recognized litigation firm of Burns Charest LLP has been retained to represent patent attorney Zachary Silbersher in two federal lawsuits alleging that pharmaceutical companies Valeant and Allergan violated the False Claims Act by fraudulently obtaining patents for Apriso and Namenda XR / Namzaric. 

The lawsuits allege that the defendants improperly sought the patents to block cheaper generics from reaching the market and to unlawfully charge federal and state governments inflated prices for the drugs.

Warren T. Burns and Christopher J. Cormier of Burns Charest LLP are leading the firm’s efforts.  They join Nicomedes Sy Herrera, Andrew Purdy, and Laura Seidl of Herrera Purdy LLP and Tejinder Singh of Goldstein & Russell, P.C.

“The exclusion of generic competition allows brand pharmaceutical manufacturers to charge monopoly prices for drugs,” said Mr. Herrera. “Even if an invalid patent is later challenged, the drug manufacturers can extend their drug monopolies and reap tremendous profits for years while validity is litigated.” 

According to the lawsuits, when drug companies extend their monopolies through patents obtained through fraud or misrepresentation, any governmental payments based on the inflated prices are considered false claims. If these lawsuits succeed, the federal government could recover three times what it was charged for every false claim, resulting in billions of dollars in damages and statutory fines.

“We believe that the False Claims Act, which was amended and strengthened in 2010 as part of the Affordable Care Act, paves the way for lawsuits like these to deter fraudulent and monopolistic conduct and to seek recovery for governmental entities that had no choice but to overpay for drugs as a result of the alleged misconduct,” said Mr. Cormier.

Apriso, prescribed for ulcerative colitis, costs approximately $600 per month and generates more than $200 million in annual revenue for the defendants. Namenda XR and Namzaric are prescribed for the treatment of dementia and Alzheimer’s. A one-month supply of each drug costs about $450.  Medicare Part D and Medicaid alone paid a total of $3.122 billion from mid-2014 through 2017 (the last date data is available) for Namenda XR and Namzaric. This does not include direct purchases from other government programs, such as the Veterans Health Administration and the Department of Defense’s TRICARE program.

“There are numerous ways that drug companies engage in anticompetitive behavior, many of which are based on asserting invalid patents,” said Mr. Burns. “These important lawsuits should lead to enormous changes in how pharmaceutical companies seek to protect their brands after the initial patent periods expire.”

“If we find success, I would expect that manufacturers will be much more careful in patent proceedings, and we would hope that it would lead to lower drug prices through the introduction of competition earlier via generic versions,” Mr. Singh said. 

A hearing on the Apriso suit, titled U.S. ex rel. Silbersher v. Valeant Pharms. Int’l, Inc., No. 3:18-cv-01496-JD (N.D. Cal.), is scheduled for August 8, 2019, before U.S. District Judge James Donato. 

The Namenda XR/Namzaric suit, titled U.S. ex rel. Silbersher v. Allergan PLC, et al., No. 3:18-cv-03018-JS (N.D. Cal.), is pending before U.S. Magistrate Judge Joseph Spero.

Burns Charest represents clients in general commercial litigation matters; large, complex class actions; antitrust cases; oil and gas royalty disputes; environmental pollution cases; mass torts; and asbestos exposure claims. The firm has offices in Dallas, Denver, and New Orleans. To learn more, visit http://www.burnscharest.com.

Herrera Purdy LLP represents clients in complex class actions, including antitrust, unfair competition, and consumer cases. The firm also represents select corporate clients in high-stakes commercial litigation matters. The firm has offices in the San Francisco Bay Area and Newport Beach, California. To learn more, visit: http://www.HerreraPurdy.com.

Goldstein & Russell, P.C. has a unique focus on practice before the Supreme Court of the United States. Although the firm principally practices before the Supreme Court, it also represents clients in a small number of important matters in the lower courts. The firm’s partners also run the Supreme Court Litigation Clinic at Harvard Law School. To learn more, visit http://www.goldsteinrussell.com.