The US Supreme Court issues a decision addressing the pharmaceutical “use codes” and their impact on generic drugs approval process (Caraco)

New U.S. Supreme Court Decision Addresses Pharmaceutical “Use Codes”* The U.S. Supreme Court recently issued a decision that provides generic pharmaceutical manufacturers with the ability to challenge the “use codes” listed by brand name manufacturers in filings made with the U.S. Food and Drug Administration (“FDA”). The decision in Caraco v. Novo Nordisk illustrates the impact that these “use codes” can have on the generic drug approval process, and will likely open up a new area of litigation between brand name and generic manufacturers in the U.S. Specifically, a dispute can arise where a brand name manufacturer has a “method of use” or similar patent protecting its drug, and a generic manufacturer – in an attempt to avoid those patents – seeks to bring its generic drug to market for

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  • Gibson Dunn (New York)

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Eric Stock, The US Supreme Court issues a decision addressing the pharmaceutical “use codes” and their impact on generic drugs approval process (Caraco), 17 April 2012, e-Competitions Bulletin US Supreme Court, Art. N° 47238

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