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US court rejects Dr Reddy's plea against Pfizer

Our Bureau

Pfizer did not file a lawsuit against the former within the 45-day period prescribed by the Hatch-Waxman Act.

Hyderabad, July 11

DR Reddy's Laboratories Ltd, the Hyderabad-based pharmaceutical giant listed on the New York Stock Exchange (NYSE), announced on Friday that the US District Court for the District of New Jersey dismissed the company's suit that sought a declaratory judgment that its Sertraline product did not infringe Pfizer's `699 patent.

In a press release, Dr Reddy's said the court declined to hear the case, stating that Dr Reddy's 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 Pfizer's `699 patent.

In this context, 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 Food and Drug Administration (USFDA) for Sertraline HCl tablets, equivalent to 25, 50 and 100 mg base, with a Paragraph-IV certification on four of the five patents listed on the Orange Book.

Subsequently, Dr Reddy's notified Pfizer of the filing. According to Dr Reddy's, Pfizer did not file a lawsuit against the former within the 45-day period prescribed by the Hatch-Waxman Act. In view of this, during February 2003, Dr Reddy's filed a lawsuit seeking declaratory judgment against Pfizer.Sertraline HCl is the generic version of Pfizer's Zoloft, which is indicated for use in the treatment of major depressive disorder, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder and premenstrual dysphoric disorder, the release said.

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