Love It AND List It—What’s New with the Orange Book and Hatch-Waxman Litigation

The FDA’s Orange Book plays a critical role in pharmaceutical patent litigation under the Hatch-Waxman Act. The Orange Book lists approved drug products, as well as patents and regulatory exclusivities relating to those products. When a drug company files a 505(b)(2) application or abbreviated new drug application (ANDA) seeking approval for a proposed drug product, it must certify as to each patent listed in the Orange Book for the reference listed drug. If the company files a paragraph IV certification, alleging that a listed patent is invalid or will not be infringed by the proposed drug product, the patent owner can sue the company for patent infringement. Filing suit within 45 days of a paragraph IV notice generally entitles the patent owner to a regulatory stay, where the 505(b)(2) or ANDA cannot be approved for a period of 30 months while the patent infringement litigation plays out.

As the law continues to develop through Hatch-Waxman litigations, the FDA is taking steps to “enhance” the “important resource” that is the Orange Book.

Please join us as we discuss recent developments relating to Hatch-Waxman litigation and the FDA’s Orange Book, including:

• Recent Hatch-Waxman decisions;
• Recent guidance from the FDA related to Hatch-Waxman litigations and the Orange Book; and
• FDA-solicited public comments about the Orange Book.

Recorded: View On-Demand

Speakers:
Shana K. Cyr, Ph.D.
Mark J. Feldstein
Ryan P. O’Quinn, Ph.D.

Moderator:
Drew D. Christie

Date:
Wednesday, October 16, 2019

Time:
10:00 a.m. PDT
1:00 p.m. EDT
7:00 p.m. CEST

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