Suven Life sued for Ovide patent violation by Taro

US-based Taro Pharmaceuticals North America has sued Hyderabad-based custom research and manufacturing services major Suven Life Sciences alleging an infringement of patent involving its head lice killer lotion Ovide. Taro sought the court’s intervention in stopping Suven from marketing the generic version of Ovide. The drug had a market of about $30 million in the US in 2010.

Taro Pharmaceuticals North America is a subsidiary of Taro Pharmaceutical Industries, now controlled by India’s largest drug-maker Sun Pharmaceutical Industries.

Suven was sued on its abbreviated new drug application (ANDA) 091559 in New Jersey district court. According to Suven, the ANDA was submitted to the US Food and Drug Administration (USFDA) for approval under the Federal Food, Drug and Cosmetic Act. The application contained data from bio-availability or bio-equivalence studies to obtain approval to engage in the commercial manufacture and use of sale of malathion lotion 0.5% (the Suven ANDA product).

“The Suven ANDA identifies Ovide malathion lotion 0.5% of Taro Pharma as the reference listed drug and includes a certification with respect to the US patent 445, which is listed in the FDA’s Electronic Orange Book,” the company said.

The 445 patent of Taro is listed as having an expiry date of February 1, 2027.

According to Suven, no valid and enforceable claim of the 445 patent will infringed upon by the manufacture, use or sale of the Suven ANDA product. “A detailed statement of the factual and legal bases upon which Suven based its Paragraph IV certification has been submitted and the same has been informed to Taro Pharma. This information is supplied for the sole purpose of complying with the referenced statutes,” the company said.

Based on this para IV certification, Taro has filed a complaint against Suven claiming that Suven’s proposed Malathion produce will infringe one or more claims of 445 patent.    

Suven Life CEO Venkat Jasti said his company had filed its ANDA with the USFDA in May 2009. But during March this year, Suven filed Paragraph IV certification and served notices to Taro.

If a generic company files an ANDA with a Paragraph IV certification, then the branded company is notified as per norms. After the notice, the branded company has 45 days to file a patent infringement action against the generic company. Taro Pharmaceuticals has done just that by suing Suven.

Jasti said the company hopes to win the case against Taro and obtain market exclusivity for the product, which has a niche space in the US.