Margaret O’Boyle, Counsel, O’Melveny & Myers LLP to Speak at KC’s Event

NEW YORK - Aug. 5, 2015 - PRLog -- The Knowledge Group/The Knowledge Congress Live Webcast Series, the leading producer of regulatory focused webcasts, has announced today that Margaret O’Boyle, Counsel, O’Melveny & Myers LLP will speak at the Knowledge Congress’ webcast entitled: “Abbreviated New Drug Application (ANDA) with Paragraph IV Certification: Critical Insights in 2015”.  This event is scheduled for August 25, 2015 from 3:00 pm – 5:00 pm (ET).

For further details, please visit:

http://theknowledgegroup.org/event_name/abbreviated-new-drug-application-anda-with-paragraph-iv-certification-critical-insights-in-2015-live-webcast/

About Margaret O’Boyle

Margaret O’Boyle is a Counsel at O’Melveny & Myers, LLP where she focuses her practice on complex patent litigation, particularly within the biotechnology, pharmaceutical, and chemical industries.

Margaret represents innovator pharmaceutical companies in patent litigation under the Hatch-Waxman Act and is experienced in USPTO inter parties review proceedings, and patent validity opinions.

Margaret’s technical experience includes anti-cancer therapies; antivirals; drugs for treating high cholesterol; and biologics.

About O’Melveny & Myers LLP

With approximately 700 lawyers in 15 offices worldwide, O’Melveny & Myers LLP helps industry leaders across a broad array of sectors manage the complex challenges of succeeding in the global economy. O’Melveny is a values-driven law firm, guided by the principles of excellence, leadership, and citizenship. Its commitment to these values is reflected in the firm’s dedication to improving access to justice through pro bono work and championing initiatives that increase the diversity of the legal profession. For more information, please visit www.omm.com

Event Synopsis:

When a pharmaceutical company wants to sell a generic version of a branded product, it usually files an Abbreviated New Drug Application (“ANDA“) with the FDA showing that its generic product will meet certain bioequivalence standards as compared to the branded drug.

As part of its ANDA, a generic drug maker may certify that one or more patents covering the branded drug are invalid, not infringed or unenforceable (a “Paragraph IV Certification”).  The Drug Price Competition and Patent Term Restoration Act (the “Hatch-Waxman Act”) governs the patent litigation that follows. The Hatch-Waxman Act is designed to encourage a balance between incentives promoting technological innovation and market competition. If the patent owner sues within 45 days of receiving notice of a Paragraph IV Certification, the FDA will delay approving the ANDA at issue for 30 months in order to resolve the patent dispute.  At the same time, the first successful filer of a Paragraph IV Certification receives generic marketing exclusivity from FDA for 180 days.

The basic framework of Hatch-Waxman litigation has been made more complicated by recent changes to the Patent Act, pending legislation in Congress, and recent case law.  The Knowledge Group has assembled a panel of key thought leaders to provide the audience with a review and in-depth analysis of these “hot topics” affecting Hatch-Waxman litigation strategy.

Key issues include that will be covered in this two-hour CLE course are:

An Overview Of Hatch-Waxman Litigation
Challenges To Personal Jurisdiction In Hatch-Waxman Litigation
The Use Of IPRs And Post-Grant Review Strategy In Hatch-Waxman Litigation
The Impact Of Pending Patent Reform Legislation On Hatch-Waxman Litigation

About The Knowledge Group, LLC/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 to an event, please visit: http://theknowledgegroup.org