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GPhA Praises Supreme Court Decision Allowing Swifter Resolution of Patent Disputes - Court Upholds Declaratory Judgments

ARLINGTON, VA, January 9, 2007-- The Generic Pharmaceutical Association (GPhA) today said the U.S. Supreme Court’s decision in MedImmune v. Genentech is a win for consumers, enabling affordable medicines to reach the market in a timely manner. GPhA had filed a “friend of the court” brief in support of MedImmune, arguing that without declaratory judgments, the launch of affordable generic drugs would be unduly delayed, to the detriment of consumers.

“Today’s decision is a victory for consumers and the entire healthcare system in the fight to reduce healthcare costs while improving care,” said GPhA President and CEO Kathleen Jaeger. “By striking down the Federal Circuit’s ‘reasonable apprehension’ test, the Supreme Court has ruled in favor of American consumers by making it harder for brand companies to delay generics from coming to market.”

Jaeger pointed out that generics provide the same medicine and the same results as brands, yet at a significantly lower cost -- as much as 80% less. In fact, generics save consumers and taxpayers billions of dollars each year in prescription drug costs.

The 1984 Hatch-Waxman Act sought to permit the resolution of patent disputes before the expiration of patents to accelerate consumer access to affordable medicines. In 2003, Congress recognized that some brand drug companies had sought to delay this infringement litigation, forcing generic companies to decide between launching a product with the risk of being sued and foregoing launching the product at all. In response, Congress expressly provided generic companies with the ability to bring declaratory judgment actions to promptly resolve patent disputes. Today’s Supreme Court decision means that generic companies will now be able to use those provisions to benefit consumers with expedited market entry.

GPhA's friend of the court brief is available online.

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic drug industry. Generics represent 56% of the total prescriptions dispensed in the United States, but only 13% of all dollars spent on prescription drugs.

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