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