Teva Pharmaceuticals, the Israel based generic major, has reportedly settled its patent litigation with the Ahmedabad-based Cadila Healthcare and its US-based subsidiary Zydus Pharmaceuticals Inc concerning the process of making carvedilol, the key ingredient in Coreg, a beta blocker used to treat high blood pressure. Carvedilol is the active pharmaceutical ingredient in GlaxoSmithKline's (GSK's) cardiac drug, Coreg.
According to reports, the companies have entered into a settlement and based on this, the US District Court of New Jersey signed off the suit on May 13, 2009. The litigation was against alleged infringement of four US patents, patent nos 7,056,942, 6,710,184, 6,699,997, and 7,126,008 assigned to Teva.
Teva has entered into a patent suit settlement with Mumbai-based Glenmark Pharmaceuticals in April, this year, for the same product apart from settling similar suits with Ranbaxy Laboratories, Dr Reddy's Laboratories and USV Ltd for carvedilol earlier.
Zydus filed a new drug master file to the US FDA on a new process for manufacturing carvedilol. Teva had provided Zydus with a covenant not to sue regarding the two patents, '184 and '942, earlier after withdrawing these patent claims from the law suit following review of the FDA filings of the latter. However, the Cadila officials were not available for comment and the details of the settlement are still not disclosed.
Settling the patent suits on the product obviously seems to be a strategy to reduce the cost incurred for litigations by companies, according to patent experts. "Globally, both the innovator and generic companies seems to be interested to settle their patent suits in the wake of the economic crisis. Also, the US market is not as luring at present as it was expected to be due to severe competition," said the Mumbai-based patent expert Dr Gopakumar G Nair.
In June 21 and 22, 2007, Teva has filed patent suits against more than a dozen companies against infringement of the four patent claims. The suits were against seven Indian firms, Lupin Ltd, Orchid Chemicals & Pharmaceuticals Ltd, Wanbury Ltd, USV Ltd, Cadila Pharma, Ranbaxy Lab and Dr Reddy's Laboratories even as other companies sued includes Mylan Pharmaceuticals, Taro Pharmaceuticals and Moehs Iberica SL.
The patent protection for Coreg expired in September 2007, following which the US FDA issued approval for generic versions of Coreg to various generic companies including the Indian majors, Aurobindo Pharma, Dr Reddy's Laboratories, Glenmark Pharmaceuticals, Lupin Ltd, Ranbaxy Laboratories and Zydus Pharmaceuticals.
GlaxoSmithKline, foreseeing the generic competition, employed 'life-cycle management techniques' by launching Coreg CR, a once-a-day oral medication for heart failure based on the original product in March 2007. In 2007, the carvedilol market was reported at USD 1.7 billion.