ZYDUS, TEVA SETTLE PATENT ROW

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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 antipsychotic drug.

Zydus will now be able to sell its generic versions of these products in the US without legal implications from Teva. Teva controls a majority market share in these products. When contacted about the settlement and when the company was looking to launch its product 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. Carvedilol is 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 ending 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 ending March 31, 2008, based on IMS sales data.

In 2006, just before it went offpatent, Coreg grossed revenues of GBP 195 million for GSK. It was GSK’s fifth best-selling drug in the secondquarter of 2007. 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 ending 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 Virginia court for violating antitrust laws and deceiving the Patent and Trademark Office in the US in obtaining the patents related to the preparation of Risperidone, the active ingredient in J&J’s antipsychotic drug, Risperdal.

Zydus had also sought to market a generic version of Risperdal. In a letter dated September 15, 2008, Teva demanded that Zydus refrain from marketing its generic version of the drug until Teva could analyse the product and the processes used to make it.

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