Court denied summary judgement to Dr. Reddys against Teva's Coreg patent

A district judge has allowed Teva Pharmaceutical Industries Ltd. to proceed with its lawsuit to bar Dr. Reddy's Laboratories Inc. from marketing a generic version of GlaxoSmithKline Inc.'s congestive heart failure drug Coreg.

Dr. Reddy's had asked the U.S. District Court for the District of New Jersey in October for a partial summary judgment that the first two claims of one of the patents at issue, known as the '008 patent, were invalid because they were anticipated by prior art.

Teva, an Israel-based generic drug company, responded that it was not even asserting the first claim, making the motion moot, and disputed the plaintiff's interpretation of the second claim.
In his opinion handed down on Tuesday, Judge Garrett E. Brown, Jr. sided with Teva.

“The court will deny DRL’s summary judgment motion to the extent it concerns claim 1 of the ‘008 patent because there is no case or controversy as to that claim,” the judge wrote. As for the second claim, he said, summary judgment would be “premature” until the court could decide in claim construction whether the plaintiff's reading was correct.

An attorney for Dr. Reddy's declined to comment on the ruling.

Hyderabad, India-based Dr. Reddy's Taro is one of more than a dozen pharmaceutical companies being sued by Teva over their plans to market copycat versions of GlaxoSmithKline's drug Coreg.

The lawsuits concern U.S. Patent Numbers 6,699,997; 6,710,184; 7,056,942 and 7,126,008 – all of which are owned by Teva. The patents cover carvedilol, the active ingredient in Coreg.

GSK was granted six months of pediatric exclusivity for Coreg after its patent for the drug expired on March 5, 2007. But Teva says in its lawsuits that the generic companies' plans to manufacture and sell Coreg's active pharmaceutical ingredient to third parties constitute an imminent threat of infringement.

The U.S. Food and Drug Administration approved 14 Abbreviated New Drug Applications for carvedilol in September – including Dr. Reddy's – after Glaxo's exclusivity period ended. Taro's ANDA sought to market generic versions of Coreg in four different dosages.

Many of the suits accuse the generic drug makers of not providing Teva information to determine whether the generic tablets would fall under the patent claims.

The importation, manufacture and sale of carvedilol will infringe one or more claims of the four Teva patents, or contribute to or induce such infringement, Teva claims in its complaints.
Teva has asked the court to declare that its patents are valid and enforceable and enjoin the generic manufacturers from infringing the four patents.

Coreg is a beta blocker used to treat high blood pressure. From late 2006 to late 2007, Glaxo's total sales of the drug (Coreg and Coreg CR) exceeded $1 billion.

Dr. Reddy's is represented in the case by Budd Larner PC. Teva is represented by Lite DePalma Greenberg & Rivas LLC.

The case is Teva Pharmaceutical Industries Ltd. et al. v. Dr. Reddy's Laboratories Ltd., case number 3:07-cv-02894, in the U.S. District Court for the District of New Jersey.