Updated: April 1, 2022 at 5:10 p.m.
The University is suing three pharmaceutical companies in New Jersey federal court in an effort to stop the development, import and sale of a septic shock treatment drug that allegedly infringes on University-owned patents.
In a 59-page complaint filed in the U.S. District Court for New Jersey Tuesday, officials allege Indian pharmaceutical company Gland Pharma Limited, Chinese pharmaceutical company Shanghai Fosun Pharmaceutical and its American subsidiary Fosun Pharma USA are seeking permission to manufacture and sell a drug that is currently protected under GW’s patents. The University argues that the court should bar the companies from selling the drug while the patents are active and grant the University damages if the companies sell the drugs in the United States.
Officials said the companies should also cover the University’s attorney fees for the suit, according to the complaint.
“Unless Defendants are permanently enjoined by this Court, the acts of infringement set forth above will cause Plaintiffs irreparable harm for which there is no adequate remedy at law,” the lawsuit states.
The patents in question are for a drug known as Giapreza, which is used to treat adults with shock – dangerously low blood pressure, according to the European Medicines Agency. In 2019, the University sold a portion of its rights to the sales of the drug, which the School of Medicine and Health Sciences first developed.
La Jolla Pharmaceutical Company, which currently owns the rights to manufacture Giapreza, joined GW in the lawsuit as a plaintiff.
In a statement issued in February, La Jolla CFO Michael Jearne said the company received a notice from Gland Pharma Limited that month, indicating that it applied for Food and Drug Administration approval to sell “a generic version of GIAPREZA.”
Jearne said the notice from Gland Pharma Limited states that its drug sales would not infringe on the patents, which are “invalid, unenforceable.” He said the FDA cannot approve Gland’s application anytime earlier than seven and a half years after Giapreza’s initial FDA approval if the district court rules that the company infringed on the patents.
“The Company intends to vigorously defend its intellectual property rights protecting GIAPREZA,” Jearne said.
University spokesperson Crystal Nosal did not return a request for comment. Spokespersons for Shanghai Fosun Pharmaceutical, Fosun Pharma USA and Gland Pharma Limited did not immediately return requests for comment.
This post was updated to include the following:
The post has been updated to include an earlier statement from Jearne.
