JD Supra

SCOTUS won’t hear Teva v. GSK: Where does that leave us on FDA labeling carve-outs?

To promote generic competition, the Hatch-Waxman Act established a pathway through which the U.S. Food and Drug Administration (FDA) may approve an abbreviated new drug application (ANDA) for a ...
JD Supra

Patents and the FDA: Four Critical Considerations Medical Device Companies Must Know to Successfully Introduce New Products into the Market

The intersection of patent strategy and FDA regulatory strategy is a critical consideration for medical device companies. A well-integrated approach can create powerful barriers to entry, strengthen ...

High Court Should Hear Skinny Label Drug Patent Case, US Says

The federal government urged the US Supreme Court to hear an appeal from Hikma Pharmaceuticals USA Inc. challenging an ...