Supreme Court Protects R&D

OCTOBER 01, 2005

The nation's top court handed the generic pharmaceutical industry an important legal victory by ordering the US Court of Appeals to reconsider its controversial decision in Merck KGaA v Integra Life Sciences, a ruling that critics say violates the concept of the Bolar provision of the 1984 Hatch-Waxman Act. Under the Bolar standard, pharmaceutical manufacturers are allowed to begin research on the development of lower-cost generic equivalents before the patent has expired on the reference product.

The federal appeals court decision would have prevented generic pharmaceutical companies from beginning exploratory research on potential medicines for months and, in some cases, years. Although the Supreme Court's action does not close the door on the legal wrangling over Bolar, generic drug industry officials view this ruling as a significant step toward preserving what they consider a critical tool for promoting competition in the pharmaceutical marketplace.

Kathleen Jaeger, president and chief executive officer of the Generic Pharmaceutical Association, said, "By allowing exploratory research prior to patent expiration for the sole purpose of supporting FDA review of potential new drug products, the decision reaffirms the importance of the Bolar provision to facilitate access to pharmaceutical products."


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