Pfizer Claims Generic-Drug Makers Infringe Lyrica Patent

January 29, 2013, by Mandour & Associates, APC

Orange County – Pfizer Inc. and Northwestern University filed a lawsuit in Delaware against Wockhardt Ltd. requesting a judgment that Wockhardt is infringing the Lyrica patent and seeking an injunction prohibiting the generic-drug maker from producing a generic form of the drug.

Lyrica is designated as a medication to treat nerve pain caused by shingles and diabetes.  The drug was also approved for management of nerve issues such as fibromyalgia and certain seizures.  Lyrica is Pfizer’s second biggest moneymaker after Lipitor, generating more than $3.7 billion in revenues in 2007.

Mumbai-based Wockhardt filed an abbreviated new drug application with the U.S. Food and Drug Administration in order to obtain permission to produce a generic version of the pregabalin oral solution.  The company claimed that Northwestern’s patent for the drug is invalid or that, if the patent is valid, it would not be infringed by the generic form of the drug Wockhardt plans to manufacture.

Northwestern’s patent for Lyrica was granted in March 2001 and the university licenses the patent exclusively to Pfizer.  The patent expires in 2018.

In the complaint, Pfizer and Northwestern say that Wockhardt informed the company and the university on December 14th that it had filed the abbreviated new drug application for a 20-milligram-per-milliliter pregabalin oral solution.

Pfizer and Northwestern actively defend the patent for Lyrica and have filed lawsuits against several generic-drug manufacturers as abbreviated new drug applications are filed with the FDA.

In October 2011, Judge Gregory M. Sleet ruled that several generic-drug manufacturers, including Wockhardt, would infringe the patent under the doctrine of equivalents.  The manufacturers asked the Federal Circuit to review the trial judge’s ruling, claiming that he had adopted Pfizer’s position without even looking at the generic-drug manufacturers’ side.

The generics manufacturers claimed that there is no sign Judge Sleet “weighed, considered or comprehended” the arguments they made claiming that the patent is invalid due to obviousness.  The companies claimed that his decision was a “wholesale adoption” of Pfizer’s positions.

The generic’s makers, which included Wockhardt, Mylan Pharmaceuticals Inc., Lupin Ltd., Cobalt Laboratories Inc. and others, claimed in their brief to the court that Pfizer should not have been allowed to argue infringement under the doctrine of equivalents because the claims of the patent were narrowed during prosecution.  They also claimed that the trial judge interpreted the claims of the patent too broadly.