Tuesday, February 15, 2005

Jury deliberation begins in Zoloft "defense" murder trial

On February 14, 2005, jurors in Charleston, SC began deliberation in the murder trial of a 15-year-old boy who claims the antidepressant Zoloft drove him to kill his grandparents three years ago.

Zoloft is the most widely prescribed antidepressant in the United States with 32.7 million prescriptions written in 2003. In October 2004, the Food and Drug Administration [FDA] ordered Zoloft and other antidepressants to carry "black box" warnings — the government's strongest warning short of a ban — about an increased risk of suicidal behavior in children.

One recalls Pfizer recently won a litigation against Teva over a patent concerning Zoloft (sertraline hydrochloride). Therein, there was an issue of what it takes to file a declaratory judgment [DJ] action in the context of the Hatch-Waxman Act.

The US 4,356,518 patent on the composition of matter expires June 30, 2006, and the 5,248,699 patent on a polymorph expires in 2010. Pfizer lists both patents in the FDA's Orange Book (formally titled Approved Drug Products With Therapeutic Equivalence Evaluations).

In an earlier Hatch-Waxman case, Pfizer sued Ivax for patent infringement but Ivax and Pfizer settled the patent litigation between them over Zoloft in 2002, agreeing that Ivax would receive a license to the '699 patent and could begin marketing generic setraline hydrochloride by June 30, 2006.


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