June 15, 2005
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Companies can conduct research based on patents of rivals

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The U.S. Supreme Court ruled earlier this week a pharmaceutical company has the right to develop medications based on a rival’s patents provided the new therapy could not feasibly come to market before the initial patent expires, according to court documents.

In a decision that overturned a lower court’s ruling, the Supreme Court held Germany’s Merck KGaA could begin research and development on a string of peptides used to inhibit tumor growth. Integra LifeSciences Holdings currently has patents on those peptides and sued Merck for patent infringement after Merck set up animal trials for a cancer therapy, according to an Associated Press report. Merck argued it was entitled to begin the research under a Food and Drug Administration exemption that allows companies to use others patented compounds “for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use or sale of drugs.”

The U.S. Court of Appeals for the Federal Circuit ruled last year that the FDA exemption did not apply to preclinical research, but only to clinical trials. The Supreme Court disagreed and remanded the decision back to the lower court and vacated the damages decision.