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Diana L. Courson

Supreme Court Rules for Generic Companies in Unanimous Decision ‎Advocated by Brief Filed by Zuckerman Spaeder LLP Partner Carlos Angulo ‎

April 18, 2012

Zuckerman Spaeder LLP is pleased to announce that yesterday’s unanimous ‎decision by the U.S. Supreme Court in Caraco v. Novo Nordisk upheld the principle of access to ‎affordable generic drugs, as advocated by an amicus brief filed in the case by partner Carlos Angulo. ‎The brief, filed pro bono on behalf of Rep. Henry Waxman (D-CA), urged the court to reverse the ‎decision of the U.S. Court of Appeals for the Federal Circuit that enabled brand name drug companies ‎to thwart generic competition by closing off access to a key generic approval pathway, known as the ‎‎“section viii” process. This process enables the FDA to immediately approve a generic product for ‎non-patented uses and allow the generic to “carve out” of its labeling information regarding patented ‎uses. The Federal Circuit ruled that counterclaim provisions added to the Hatch-Waxman generic drug ‎approval law in 2003 did not allow a generic company to sue brand companies for submitting general ‎and overbroad descriptions of its patent coverage to FDA—descriptions that would prevent FDA and ‎generic companies from identifying when a section viii approval for non-patented uses would be ‎appropriate.‎

The Supreme Court reversed the Federal Circuit decision in a unanimous opinion, written by Justice ‎Elena Kagan, with Justice Sonia Sotomayor also filing a concurring opinion. The court’s opinion ‎emphasizes many of the points made in the brief filed on behalf of Congressman Waxman—in ‎particular, that the Federal Circuit’s reading of the counterclaim provisions significantly undermined ‎Congress’ goal in enacting those provisions of strengthening the section viii approval pathway and of ‎ensuring patients’ access to safe, affordable generic drugs.‎

‎“The Supreme Court’s unanimous decision affirms the right of generic companies to challenge brand ‎companies’ overbroad descriptions of their patent coverage, in addition to preserving a key generic ‎approval pathway that the Federal Circuit’s decision had jeopardized,” said Mr. Angulo. “The court’s ‎decision will have a major impact on the generic industry’s continuing efforts to provide consumers ‎with access to affordable, safe, and effective drugs, and it is fully consistent with Congress’ intent in ‎enacting the Hatch-Waxman counterclaim provisions.” ‎

Mr. Angulo focuses his practice on food and drug law, including litigation, administrative practice ‎before the FDA, and legislative policy matters. He has represented generic drug manufacturers and ‎the generic drug trade association in multiple matters before the FDA and in federal trial and appellate ‎courts. He has extensive experience in matters arising under the Hatch-Waxman generic drug ‎approval law. He also represents anti-smoking groups, medical device distributors, and other clients in ‎the food and drug field. He also has litigated complex commercial cases, including ‎securities and ‎consumer class actions, and antitrust cases. His legislative and policy practice emphasizes civil rights ‎and health-related issues, and he has extensive experience on corporate compliance matters under ‎the Foreign Agents Registration Act and Lobbying Disclosure Act.‎