Alyson Wooten, PharmD, Attorney, Kilpatrick Townsend & Stockton 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 Alyson Wooten, PharmD, Attorney, Kilpatrick Townsend & Stockton 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 Alyson Wooten, PharmD

Dr. Alyson Wooten focuses her practice on patent litigation with emphasis in the area of health and life sciences.  Registered as a patent attorney and pharmacist, Dr. Wooten has broad experience in the pharmaceutical industry, including medical services, regulatory, marketing and clinical trial analysis.

Dr. Wooten has represented several big medical and research facilities in a number of federal courts. She has participated in all aspects of patent litigation, including invalidity and infringement investigations, claim construction, preparation of expert reports and settlement negotiations.

While attending law school, Dr. Wooten worked as a patent agent for a leading pharmaceutical company focusing on Paragraph IV litigation and patent prosecution for new chemical entities.

Dr. Wooten was recognized in 2015 and the four years immediately preceding as a Georgia “Rising Star” in the area of Intellectual Property Litigation by Super Lawyers magazine.

About Kilpatrick Townsend & Stockton LLP

Kilpatrick Townsend is a full-service, international law firm with more than 620 lawyers in 17 offices worldwide. We have deep experience in the areas of intellectual property, litigation and corporate transactions. A close collaboration between the firm’s practice areas ensures that we are well-positioned to serve all of our clients’ needs. Kilpatrick Townsend focuses on delivering excellent work for our clients and serving the communities in which we work. Kilpatrick Townsend is one of the few general practice firms with a core commitment to intellectual property law. With 300 attorneys devoted to IP law, Kilpatrick Townsend offers clients specialization that exceeds even the most well-known boutique firms. For more information, please visit: www.kilpatricktownsend.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

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Tags:Patent, Legal, Anda, Paragraph Iv
Industry:Legal
Location:New York City - New York - United States
Subject:Events
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