Chief Judge Gregory M. Sleet of the U.S. District Court for the District of Delaware ruled last week that generic drug manufacturers, such as Teva Pharmaceuticals, had infringed on Pfizer’s Lyrica patents.  Lyrica, also known as Pregabalin (U.S. Pat. 6,197, 819), is used to treat chronic pain disorders like fibromyalgia and other neuropathic pain disorders.

Pfizer registered its patents with the USPTO, secured FDA approval in 2004, and sold its first batches of the drug in the fall of 2005.  Lyrica was also one of the drugs involved in the recent fraudulent marketing case brought against Pfizer, which resulted in Pfizer shelling out $2.3 billion to resolve civil and criminal healthcare liability issues ($48 million of the settlement can be specifically attributed to Lyrica).

Several generic drug manufacturers such as Teva, Mylan, and Watson Pharmaceuticals, challenged the validity of the Lyrica patents and applied for FDA approval for generic versions of the drug.   Pfizer subsequently filed a lawsuit in April 2009, seeking injunctive relief to prevent competitors from launching competing generic versions prior to the patent expiration date.

The patents at issue (U.S. Pat. 5,563,175; U.S. Pat. 6,001,876; U.S. Pat. 6,197, 819) cover various elements of the Lyrica drug and also have different patent expiration dates.  Two of these patents, the ones pertaining to Pregabalin and methods for using it to treat pain, will expire in December 2018.  On the other hand, the remaining patent, which covers the method for using Pregabalin to treat seizure disorders, will expire in October 2013.

However, because the court determined that the generic manufacturers must wait until the expiration of patents covering the drug, Pfizer will likely be able to continue its exclusive sale and manufacture of Lyrica until 2018 barring an appeal decision indicating otherwise.

Share