FTC Questions Patent Listings on Brand-Name Rx Drugs
The Federal Trade Commission has launched an investigation into at least four cases in which brand-name drug makers may have "inappropriately listed" patents in the FDA Orange Book, a summary of drugs and patents, to prevent lower-cost generic drugs from reaching the market, USA Today reports. An Orange Book listing protects brand-name drug makers from losing exclusive marketing rights to generic rivals, and the FTC has questioned whether some companies "are claiming that certain patents apply to their drugs when they don't." The cases include:
- Whether Bristol-Myers Squibb Co. may have "misrepresented" the patent on the company's anti-anxiety drug BuSpar to the FDA or the U.S. Patent and Trademark Office.
Biovail Corp.'s patent for the heart drug Tiazac, which the FDA said should not have appeared in the Orange Book.
- An effort by Bristol-Myers to "protect its market" for the company's breast cancer drug Taxol, which lost patent protection last year.
- Whether GlaxoSmithKline may have listed a patent for the company's antidepressant drug Paxil that "didn't apply to the drug as approved by the FDA."
In most cases, the FDA lists new patents in the Orange Book "without researching their validity." The Patent and Trademark Office approves patents, but drug companies must "certify that they are properly listed" in the Orange Book. The FTC has begun to investigate the allegations of improper listing as part of an "ongoing crackdown on practices that thwart generic competition" among drug companies. "The people who depend on (generic drugs) the most are sick and often disadvantaged," Joe Simons, head of the FTC antitrust division, said, adding, "It's particularly appropriate to intervene when those people are getting hurt" (O'Donnell/Appleby, USA Today, 1/8).
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