Ethics Newsline®

WASHINGTON
The U.S. Federal Trade Commission is probing whether British-based pharmaceutical firm SmithKline Beecham acted illegally to keep competitors from releasing low-cost versions of the firm’s popular antidepressant, Paxil, according to press reports.

The investigation centers on allegations made by Canadian firm Apotex Corp., which has been struggling to release a generic version of Paxil in the United States since 1998, reported the New York Times.

SmithKline has sued Apotex for alleged patent infringement, charges that automatically force Apotex to wait at least 30 months before receiving Food and Drug Administration (FDA) approval and releasing its lower-cost product.

While Apotex fights the suit, company representatives say SmithKline Beecham has obtained eight additional Paxil patents, each of which also forces Apotex into another 30-month delay. Those patents, Apotex insists, are simply a fraudulent means of keeping the company from releasing its product.

In a February complaint to the FDA, Apotex charged that SmithKline had “systematically and unlawfully” abused U.S. “patent listing procedures to stifle generic competition.”

The FTC confirmed to the New York Times that the request it filed last week for documents from SmithKline is a “preliminary inquiry” into those charges.

A similar spate of patent filings by major drug companies with expiring patents has regulators concerned that larger companies may be using legal loopholes to stifle competition and delay the release of generic versions of their drugs, noted the Times.

SmithKline Beecham spokesman Brian Jones denied any wrongdoing, insisting that his company’s recent round of patent filings is simply a means of “lawfully and legitimately protecting our products.”