The blood thinner Lovenox®—active ingredient enoxaparin sodium injection—has been prescribed more than 2.3 billion times worldwide, often to treat deep vein thrombosis (DVT). Complications from DVT kill more Americans annually than AIDS and breast cancer combined.

When Momenta Pharmaceuticals and its business partner Sandoz, Inc. were ready to pursue FDA approval on a generic version of Lovenox®, they turned to Zuckerman Spaeder for assistance.

Punch and counterpunch

In 2010, Lovenox® manufacturer Sanofi-Aventis sued for a preliminary injunction to block FDA approval of the Sandoz/Momenta generic version of Lovenox®. A district court denied the injunction request.

Sanofi-Aventis subsequently moved for summary judgment against the FDA, which cross-moved for summary judgment. Sandoz, represented by Zuckerman Spaeder, intervened as a defendant at the preliminary injunction stage and also cross-moved for summary judgment after Sanofi’s injunction request was denied.

Cleared for market

In February 2012, in Sanofi-Aventis v. Food and Drug Administration et al., the U.S. District Court for the District of Columbia upheld FDA’s approval of the Sandoz/Momenta generic product, ruling that the FDA acted within its authority to approve the generic drug.

The District Court granted FDA’s and Sandoz’s cross-motions for summary judgment, dismissing the Sanofi lawsuit and clearing the way for the Sandoz/Momenta product to go to market.

On behalf of Momenta, Zuckerman Spaeder partners Bill Schultz and Carlos Angulo advised Sandoz with food and drug and administrative law matters related to the briefs and oral arguments at both the preliminary injunction and summary judgment stages.