MUMBAI: Israeli generic major Teva and Mumbai-based Glenmark Pharmaceuticals have settled a patent dispute over various generic versions of Coreg —
a drug used for treating congestive heart failure — out of court. Teva had filed a case against Glenmark Generics (Glenmark Pharma’s US subsidiary) over the latter’s process patent for preparing Carvedilol, the main pharmaceutical compound used in the generic version of Coreg. Glenmark had, in turn, filed a lawsuit challenging two of Teva’s patents related to the drug. When contacted about the out-of-court settlement, Vijay Soni, executive VP, Glenmark Generics, told ET: “We confirm the withdrawal of the lawsuit.” A stipulation of dismissal signed by Judge Garrett E. Brown Jr. of the US District Court of New Jersey has brought an end to the litigation. The settlement will in no way impact Glenmark’s product, Carvedilol, which is being currently sold in the US market, and is likely to be mutually beneficial to both parties, industry sources said. Carvedilol is a pharmaceutical compound, referred to in industry jargon as the active pharmaceutical ingredient (API), used in the product sold by GlaxoSmithKline (GSK) under the trade name Coreg. In 2006, just before it went off patent, Coreg had a turnover of 195 million pounds. It was GSK’s fifth best-selling drug in the second-quarter of 2007. Teva currently controls a majority share in this market, going neck-and-neck with GSK. Other manufacturers have a comparatively smaller share of the pie. According to IMS Health data, annual US sales of drugs using Carvedilol as API were about $1.7 billion for the 12 months ending June 2007, making this a significant market for either company. Teva, which filed its case in August 2008, claimed that Glenmark was not using a novel method to make the drug, and had instead infringed on a process which the Israeli firm had patented. Glenmark contended that it had an innovative process for manufacturing the drug. In December 2008, the Indian company filed a set of counter-claims calling Teva’s patents invalid and unenforceable due to misrepresentation to the US Patent and Trademark Office. It also accused Teva of engaging in “sham” litigation and violating federal antitrust laws. Glenmark is not the only company that Teva had filed a lawsuit regarding this product. The Israeli firm had filed lawsuits against seven Indian companies related to Carvedilol. Ranbaxy and Dr Reddy’s had already settled out of court with Teva. In 2007, the USFDA approved 14 generic versions of Coreg (Carvedilol), dealing a blow to GSK and its partner, the French firm, Flamel Technologies. Some of the other Indian firms, who received USFDA approval to market this drug, were Aurobindo Pharma, Caraco Pharma (the US subsidiary of Sun Pharma), Dr. Reddy’s Laboratories, Lupin, Ranbaxy and Zydus.