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Back To Vidyya Federal Inquiry In The Works For Paxil Maker

Britain's SmithKline Beecham PLC Facing Investigation Into Whether It Violated Antitrust Laws

Britain's SmithKline Beecham PLC, the maker of the popular anti-depressant Paxil, is facing a federal investigation into whether it violated antitrust laws by preventing or impeding the marketing of generic equivalents.

The investigation was revealed this week in court documents filed in federal court in Chicago by Apotex Corp., which is trying to market a generic version of Paxil.

SmithKline officials said they are cooperating with the probe. The company ``has been requested to supply documents voluntarily in connection with our listing of patents for Paxil,'' said Brian Jones, a company spokesman.

``We believe we are acting lawfully to legitimately protect our products on which we hold valid patents,'' he said Thursday.

The Federal Trade Commission confirmed it is investigating SmithKline but declined to provide details.

SmithKline, which has its U.S. headquarters in Philadelphia, sold $2.11 billion worth of Paxil last year and has registered sharp increases this year. It is the company's No. 1 drug and has been approved by the Food and Drug Administration to treat depression, panic attacks and social anxiety.

In 1998, SmithKline filed a lawsuit against Apotex accusing it of infringing on its patent for Paxil. Apotex denies that and said SmithKline is using the lawsuit as a delaying tactic to prevent sales of a Paxil generic.

In the court documents filed Tuesday, Apotex requested the public disclosure of documents that ``disclose and document a conscious and considered plan by SmithKline to erect barriers to the entry of generic competition for Paxil.''

Under the federal Food, Drug and Cosmetic Act, the filing of the lawsuit automatically delayed FDA approval of Apotex's generic drug for 30 months, said Tim Gilbert, a lawyer for Apotex.

A resolution of the 1998 case is expected shortly, but SmithKline has obtained eight additional patents since then and has filed more lawsuits, producing additional 30-month delays in the FDA's approval of Apotex's generic drug, Apotex spokeswoman Michelle T. Slattery said.

``It is a serial abuse of the FDA regulations,'' Gilbert said.

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