Momenta Urges Justices To Clarify Drug Safe Harbor Rule

Law360, New York (June 5, 2013, 3:08 PM EDT) -- Momenta Pharmaceuticals Inc. and Sandoz Inc. urged the U.S. Supreme Court on Monday to review a Federal Circuit ruling allowing sales of competing generic versions of blood thinner Lovenox, which they claim wrongly expanded the Hatch-Waxman Act’s safe harbor provision.

Momenta and its exclusive licensee Sandoz urged the justices to clarify the scope of the safe harbor provision, which allows generics makers to use patented processes to prepare generic drugs before a patent expires in order to pursue approval from regulators like the U.S. Food and...
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