Under Hatch-Waxman Act, a generic challenger seeking abbreviated new drug application (ANDA) approval is required to file a certification regarding each relevant Orange Book patent. One of the certifications an ANDA applicant may file is the Paragraph IV certification which states that the branded drug’s “patent is invalid, unenforceable or would not be infringed by marketing of the ANDA product.” Considered as a technical act of patent infringement, a Paragraph IV filing gives the brand pharmaceutical company the right to initiate a patent infringement lawsuit.
With the increasing number of Paragraph IV filings and the vulnerability of every product as a generic target, both generic and brand companies should therefore expect Paragraph IV litigation and be prepared with its coming.
In this two-hour LIVE Webcast, a panel of distinguished professionals and thought leaders assembled by The Knowledge Group helped generic and brand pharmaceutical companies understand the fundamental as well as complex aspects of this significant topic. They also offered best tips and strategies in winning Paragraph IV Disputes.
Key topics include:
ANDA with Paragraph IV Certification – Overview
Implications to the Market
Best Litigation Tips and Strategies