The United States District Court of New Jersey has dismissed Dr Reddy's Laboratories' suit seeking a declaratory judgement that its Sertraline HCL generic product did not infringe Pfizer's 5,248,699 (`699) patent.
The development comes at a time with the pharma major awaiting the US appellate court's judgement in the case of Pfizer's another product, Amlodipine Maleate, after conclusion of the court hearing on July 9.
Pfizer's five patents on Sertraline HCL will expire at different dates starting from June 30, 2006 to February 13, 2013. The product is used in the treatment of major depressive disorder, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder and pre-menstrual dysphoric disorder.
The district court declined to hear Dr Reddy's case stating that the company had not demonstrated a reasonable apprehension of suit by Pfizer and that in any event Pfizer needed more time to investigate whether Dr Reddy's Sertraline product infringed its 699 patent.
Dr Reddy's told the court that it intended to provide Pfizer with whatever information it needed and, if necessary, to renew the suit thereafter.
Dr Reddy's filed the lawsuit in February this year seeking declaratory judgement with regard to its abbreviated new drug application for Sertraline HCL, the generic version of Pfizer's $2.4 billion wide-range anti-disorder drug Zoloft.
Dr Reddy's had filed the ANDA with US Food and Drug Administration for Sertraline HCL tablets, equivalent to 25 mg, 50 mg and 100 mg base, with Para IV certification on four of the five patents listed on the Orange book.
While Dr Reddy's notified Pfizer of the filing, which is a mandatory requirement, Pfizer did not file a lawsuit against Dr Reddy's within the 45-day period prescribed by the Hatch-Waxman Act governing the generics business in US.
It prompted Dr Reddy's to file a lawsuit on its own, which seeks the declaratory judgement that the claims of certain Pfizer patents pertaining to Sertraline HCL are invalid and/or not infringed.
