New York, NY, April 29, 2016 --(PR.com
)-- The Knowledge Group/The Knowledge Congress Live Webcast Series, the leading producer of regulatory focused webcasts, has announced today that Michal A. Malkiewicz, Director, Epsilon Economics will speak at the Knowledge Group’s webcast entitled: “Tips and Strategies in Winning Paragraph IV Disputes in 2016 & Beyond.” This event is scheduled for August 23, 2016 from 12:00pm to 2:00pm (ET).
For further details, please visit: https://theknowledgegroup.org/event-homepage/?event_id=1963
About Michal A. Malkiewicz
Michal A. Malkiewicz is a Director at Epsilon Economics, where he specializes in the application of economics to intellectual property and complex commercial disputes. Mr. Malkiewicz has been involved in a variety of health care and life sciences disputes before U.S. and foreign courts and before U.S. and international arbitration organizations. He has previously presented on economic issues in Paragraph IV disputes.
About Epsilon Economics
Epsilon Economics is a firm of economists and financial analysts specializing in economic analysis, analytics, and strategy. Epsilon Economics has extensive experience in providing life sciences clients with the full range of economic analysis, high-end analytics, and strategy consulting, both in and out of litigation.
Under the 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 will help generic and brand pharmaceutical companies understand the fundamental as well as complex aspects of this significant topic. They will also offer best tips and strategies in winning Paragraph IV Disputes.
Key topics include:
• ANDA with Paragraph IV Certification – Overview
• Current Trends
• Notable Cases
• Implications to the Market
• Best Litigation Tips and Strategies
About The Knowledge Group/The Knowledge Congress Live Webcast Series
The Knowledge Group was established with the mission to produce unbiased, objective, and educational live webinars that examine industry trends and regulatory changes from a variety of different perspectives. The goal is to deliver a unique multilevel analysis of an important issue affecting business in a highly focused format. To contact or register for an event, please visit: http://theknowledgegroup.org /