FDA Rule Changes: The Impact on Hatch-Waxman Litigation
Webinar Series: The Evolving IP Landscape in the United States: Challenges & Opportunities

The U.S. Food and Drug Administration (FDA) recently issued a Final Rule implementing provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, also known as the Medicare Modernization Act (MMA). According to the FDA, provisions of the Final Rule also serve “to clarify and update [FDA] regulations based on recent court decisions and [the FDA’s] practical experience.”

This new rule is expected to impact multiple players in the pharmaceutical industry leading up to and during Hatch-Waxman litigation between innovators and generic companies.

This webinar will provide an overview of the new rule and will focus on key aspects of the rule and assess their potential impact on Hatch-Waxman litigants. Topics will include:

• How the new regulations relating to pharmaceutical use codes may impact enforcement of method of use patents
• How reissue patents may now be more valuable in light of this new rule
• How the new rule may force generic companies to provide more notice to brand companies with respect to amendments to their ANDAs

This webinar is the third and final segment of Finnegan’s Winter 2017 series, “The Evolving IP Landscape in the United States: Challenges & Opportunities.”

Moderator: 

Ningling Wang

Speakers: 
Paul W. Browning, Ph.D. 
Denise Main, Ph.D.

Date:

Wednesday, March 8, 2017

Time:

7:30 - 8:30 a.m. India
10:00 - 11:00 a.m. China/Taiwan
11:00 a.m. - 12:00 p.m. Japan/Korea

Scheduling Conflict?

Finnegan records all hosted webinars. To view the recorded program, simply register for the webinar and you will receive an access link shortly after the live program is complete.