How big is your boat? The 'experimental use' safe harbour


Mark Nuell

How big is your boat? The 'experimental use' safe harbour

A recent US court decision has added to debate about the extent of an ‘experimental use’ safe harbour for using patented pharmaceutical products, as Mark Nuell explains.

Momenta Pharmaceuticals Inc v Amphastar Pharmaceuticals Inc (Federal Circuit, August 3, 2012) is the latest decision examining the scope of the ‘experimental use’ exception to infringement afforded by 35 USC §271(e)(1).

The Court of Appeals for the Federal Circuit (CAFC) panel of Judges Rader, Dyk and Moore found that the statute exempted from infringement acts that occurred after approval by the Food and Drug Administration (FDA) for marketing of a ‘biosimilar’ drug that were required to be performed to comply with FDA regulations relating to documenting the composition of the drug. There is a split among the judges as to whether the safe harbour established by 35 USC §271(e)(1) encompasses acts occurring after FDA approval for marketing is obtained, so this case seems destined to go to the Supreme Court.

Momenta Pharmaceuticals is preceded by two Supreme Court decisions and one other CAFC decision that map the shores of the safe harbour. Eli Lilly & Co v Medtronic Inc (1990) held that the safe harbour provision extended beyond drug compounds to medical devices. Merck KGaA v Integra Lifesciences I Ltd (2005) held that the safe harbour extended back in time to shelter activities relating to pre-clinical studies and the use of a patented compound other than for therapeutic study for clinical approval.

pharmaceuticals, safe harbour, Momenta, Classen, experimental use