Zydus, Teva end patent disputes

MUMBAI: Ahmedabad-based ZydusCadila and Israeli generic major Teva have settled their patent disputes over active pharmaceutical ingredients (APIs)

used to make generic versions of GlaxoSmithKline’s heart drug and Johnson & Johnson’s anti-psychotic drug. Zydus will now be able to sell its generic versions of these products in the US without legal implications from Teva. Teva currently controls a majority market share in these products. When contacted about the settlement and the company’s product launch in the US, a Zydus Cadila spokesperson declined to comment. Judge Garrett E Brown Jr. of the US District Court of New Jersey signed a stipulation on May 14 of dismissal, bringing an end to the claims and counterclaims of patent infringement and federal antitrust law violations in a lawsuit over two of Teva’s patents related to blood pressure and congestive heart failure treatment Coreg.

GlaxoSmithKline makes the heart drug Coreg, while Johnson & Johnson makes the antipsychotic drug Risperdal. Teva had filed a case against Zydus over the patent that Teva had for preparing a chemical compound Carvedilol — a pharmaceutical compound used in the treatment of congestive heart failure. It is the API used in the product sold by GSK under the trade name Coreg. According to data from IMS Health, the annual sales of Carvedilol in the US were about $1.7 billion for the year ended June 2007, making this is significant market for both companies. Annual sales of Risperdal were approximately $2.6 billion in the US for the year ended March 31, 2008. In 2006, just before it went off-patent, Coreg grossed revenues of £195 million for GSK. Teva currently controls a majority share in this market, closely with GSK. According to data from IMS Health, the annual sales of Carvedilol in the US were about $1.7 billion for the year ended June 2007, making this is significant market for both companies. The dispute had centred on Zydus’s alleged infringement of Teva’s patents relating to Carvedilol, the active ingredient in Coreg. In its complaint, Teva said it attempted to obtain information on the composition and processes the company intended to use in May 2007, but Zydus declined to produce the samples, forcing it to file its lawsuit on October 12, 2007. In the case of Risperidone, Zydus had submitted a motion to transfer the case to the US District Court for the Eastern District of Virginia, which it later withdrew. Zydus had sued Teva in the court for violating antitrust laws and deceiving the Patent and Trademark Office in the US in obtaining the patents for preparation of Risperidone