In brief: Pfizer vs Teva; Allergan; Johnson & Johnson

By Staff Writers
Monday, 24 January, 2005

An appeals court has ruled against Teva Pharmaceuticals Industries in its bid to keep 180 days of exclusivity for its generic version of Pfizer's popular Zoloft antidepressant.

The US Court of Appeals for the Federal Circuit rejected Teva's bid to overturn a lower court ruling over whether the company can seek a court ruling that it does not infringe on Pfizer's brand-name patent before it releases its generic version.

In a 2-1 opinion the three-judge appeals panel disagreed with Teva and antitrust authorities at the Federal Trade Commission, concluding that there were no grounds for Teva's lawsuit because it faced no imminent threat of a patent lawsuit from Pfizer.

"We are not persuaded by Teva's and the FTC's arguments," two of the judges said in their opinion.

Teva had sued Pfizer after the drug giant made a deal with Ivax Pharmaceuticals, a subsidiary of Ivax, to sell a different generic version of the drug, whose chemical name is sertraline.

Teva contended that Pfizer was using the deal as a way of "parking" its patent and holding back competition with Zoloft.

J&J says deaths in Alzheimer drug trial spur review

Johnson & Johnson said health authorities are reviewing data from two clinical trials in which more patients taking its Reminyl Alzheimer's treatment died than patients taking a placebo.

The drug is currently approved for patients with mild to moderate dementia caused by Alzheimer's disease. The pair of two-year trials, involving 2,000 patients in 16 countries, were studying whether the medicine could also help patients with mild cognitive impairment.

J&J said 20 deaths were seen in the studies - with 15 among those taking Reminyl and five occurring in patients receiving placebos. The company said the review was sparked by its report concerning the "imbalance of mortality" to health authorities last summer.

Allergan fails in bid to get antibiotic reclassified

Allergan said a federal court has dismissed the company's lawsuit against the US Food and Drug Administration, a suit that sought to get the agency to reclassify one of its drugs as a non-antibiotic.

Allergan brought its lawsuit against the FDA in October 2003 in an effort to get the FDA to reclassify its eye antibiotic Restasis a non-antibiotic to obtain a certain three-year period of marketing exclusivity.

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