Stay Versus Stay: How Litigation Stays Pending IPRs Impact the 30-Month Regulatory Stay in Hatch-Waxman Litigation

WilmerHale
Contact

Upon initiation of a patent infringement action between branded and generic pharmaceutical companies, the Hatch-Waxman Act (21 U.S.C. § 355(j)) provides for an automatic 30-month stay of Food and Drug Administration approval of the Abbreviated New Drug Application (ANDA) for the proposed generic pharmaceutical product. As the legislative history of the Act makes clear, the purpose of the 30-month stay is to permit resolution of the underlying patent dispute before the generic product may enter the market.

Originally published in Bloomberg BNA's Patent, Trademark & Copyright Journal - March 25, 2016.

Please see full publication below for more information.

LOADING PDF: If there are any problems, click here to download the file.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© WilmerHale | Attorney Advertising

Written by:

WilmerHale
Contact
more
less

WilmerHale on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide
- hide