The US District Court of New Jersey has dismissed the suit of Dr Reddy's Laboratories against US multinational giant Pfizer, seeking a declaratory judgement that its product Sertraline did not infringe Pfizer's 699 patent. Sertraline HCl is the generic version of Pfizer's Zoloft, indicated for use in the treatment of major depressive disorder, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder and pre-menstrual dysphoric disorder. Pfizer has five patents for Zoloft which will expire at different dates between June 2006 and February 2013. Zoloft has a worldwide sale of $ 2.4 billion.

In a press release in Hyderabad, Dr Reddy's said the court declined to hear the case stating that "The company had not demonstrated a reasonable apprehension of the suit by Pfizer and that in any event Pfizer needed more time to investigate whether Dr Reddy's Sertraline had infringed Pfizer's patent."

Dr Reddy's indicated that it intended to provide Pfizer with whatever information was needed, and if necessary, to renew its suit thereafter.

Earlier, Dr Reddy's had filed an abbreviated new drug application (ANDA) before the US FDA for Sertraline HCl tablets, equivalent to 25mg, 50mg, and 100mg base, with a Paragraph IV certification on four of the five patents listed on the Orange Book. The company, subsequently, notified Pfizer of the filing of the case. However, Dr Reddy's did not file the lawsuit against Pfizer within the 45-day period prescribed by the Hatch-Waxman Act, governing the generic business in US.

The company filed a lawsuit in February 2003 against Pfizer seeking declaratory judgement that the claims of certain Pfizer patents are invalid and/or not infringed.

The judgement comes even as Dr Reddy's is awaiting the US Appellate Court's verdict in the case against Pfizer relating to Dr Reddy's major product, Amlodipine Maleate. The hearing in the case was completed on July 9. The company is hopeful of winning this case.