US Supreme Court Refines Pharmaceutical Patent Law in Merck KGaA v Integra Case

In what may ultimately be a significant victory for consumers, the US Supreme Court ruled that pharmaceutical companies are entitled to the benefit of the research "safe harbour" exemption from patent infringement earlier than previously thought permissible. The decision sets aside a holding by the US Court of Appeals for the Federal District and sends the case back to the lower court for reconsideration in light of the Supreme Court's determination. Integra LifeSciences Holdings Corp (Integra) had sued Merck KGaA (Merck) for allegedly infringing its US patent on a specific amino acid sequence in the course of Merck's early-stage research into a new cancer therapy. Merck had argued that it was entitled to the "safe harbour" exemption which was acknowledged to apply to later-stage human trials, typically involving generic drugs. Although the lower courts disagreed, the US Supreme Court accepted Merck's argument, ruling that Congress intended drug companies to have more flexibility in investigating new drugs, not just generics. Merck had further submitted that potential treatments for many diseases would be delayed for as long as a decade due to the lengthy FDA approval process, if drug companies had to sit idly by while the patents expire. Said Justice Antonin Scalia: "The use of patented compounds in preclinical studies is protected as long as there is a reasonable basis for believing that the experiments will produce the types of information that are relevant" to a future drug. For an Associated Press news story, visit: http://makeashorterlink.com/?K3B621D4B Summary by: Nyall Engfield