US senator backs 13.5-year shield for biotech drugs

WASHINGTON, July 8 | Wed Jul 8, 2009 4:45pm EDT

WASHINGTON, July 8 (Reuters) - A senior Democratic U.S. senator has proposed up to 13.5 years of protection from generic competition for brand-name biotechnology medicines as lawmakers work to craft legislation to overhaul the healthcare system.

The proposal from Sen. Edward Kennedy, chairman of the Senate health committee, likely will be amended "substantially, maybe even replaced," a committee aide said on Wednesday.

Brand-name companies are pushing for a 12-year-to-14-year period of exclusivity to protect themselves from cheaper rivals, saying they need that period of time to encourage investment in new medicines. Generic drugmakers support a proposal in the House of Representatives that provides up to five years of exclusivity.

The White House backs a seven-year exclusivity period.

Under Kennedy's plan, brand-name medicines could receive nine years of protection, plus up to four-and-a-half additional years for new uses or pediatric studies.

Biotech medicines, or biologics, are made from living things and are more complicated to produce than traditional, chemical-based drugs.

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* TAKE A LOOK-Congress tackles health reform[ID:N07323916] (Reporting by Lisa Richwine, editing by Leslie Gevirtz)

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