Bayer HealthCare Pharmaceuticals Inc. and Teva Pharmaceuticals USA have agreed to pause their patent infringement case over Bayer's Nexavar cancer drug until a similar case can be resolved in Delaware federal court.
On Wednesday, both parties asked U.S. District Chief Judge Leonard P. Stark of the District of Delaware to stay the 6-month-old case in favor of Bayer's first-filed, consolidated litigation against Mylan Pharmaceuticals Inc. In both cases, Bayer is seeking to stop the companies from developing generic versions of Nexavar, which is used to treat kidney, liver and thyroid cancer.
"Resolution of the first-filer litigation is likely to substantially resolve many of the issues in the instant case, or at the least substantially inform the parties with respect to the issues in the instant case, and as such stands to streamline and expedite the ultimate resolution of this case," Bayer and Teva said in a joint motion to stay.
"Accordingly, judicial economy and efficiency would be best served by a stay of this case pending resolution, through decision of this court or by settlement, of the first-filer litigation."
Bayer sued Teva in December, after the Israel-based drugmaker notified the company a month earlier that it had submitted to the U.S. Food and Drug Administration an abbreviated new drug application to make and sell the generic.
In its Jan. 16 complaint, Bayer said it would suffer irreparable injury if Teva's generic were allowed to continue to the market and asked that the effective date for any FDA approval for the allegedly infringing drug be delayed until after its patent expires in December 2027.
"Teva has made, and will continue to make, substantial preparation in the United States to manufacture, use, sell, offer to sell and or import Teva's ANDA product with its proposed labeling prior to the expiration," Bayer said.
Teva has asked for a declaration of noninfringement, saying that Teva's patent was invalid as obvious and anticipated by prior art.
However, the case has progressed little in comparison to the nearly identical case Bayer initiated against Mylan almost a year earlier. In that case, Mylan has accused Bayer of drafting fraudulent patent applications to improperly obtain patent protection in order to extend its monopoly on the drug.
Bayer has denied those allegations and asked Stark to deny any additional discovery. Trial in the Mylan case is currently slated for November.
As of Thursday afternoon, Stark had not yet responded to the motion from Mylan and Teva.