Caraco Won Summary Judgment on Generic Ultracet (Tramadol and Acetaminophen)

Caraco announced that the United States District Court of New Jersey has granted Caraco's motion for summary judgment and held that the claims of Ortho-McNeil ‘s reissue patent USRE39221- which covers a pharmaceutical composition comprising a tramadol material and acetaminophen, wherein the ratio of the tramadol material to acetaminophen is a weight ratio from about 1:1 to about 1:1600 are invalid as obvious.
Caraco's Tramadol with Acetaminophen product is a generic version of Ortho-McNeil's Ultracet.
The District court concluded that Caraco has demonstrated by clear and convincing evidence that the combination of Tramadol with Acetaminophen in a weight ratio of 1:5 and 1: 1600 are obvious to person having ordinary skill in the art. The judge also observed that the patent application of USRE39221 was initially rejected by the USPTO in 1991 on the grounds of obviousness w.r.t prior patent application by Frankus et al. However, some claims were granted in 1994 and in reissue patent in 2006. The Company commenced shipment of Tramadol with Acetaminophen following the USFDA's approval on December 19, 2005, and it has remained on the market since that time.