Laura A. Vogel with Barclay Damon, LLP to Speak at TKG’s Hatch-Waxman Litigation Webinar
09/02/2017

Laura A. Vogel, Partner, Barclay Damon, LLP will speak at TKG’s Hatch-Waxman Litigation Webinar scheduled for September 26, 2017 from 12:00pm ET

Online PR News – 02-September-2017 – New York – The Knowledge Group/The Knowledge Congress Live Webcast Series, the leading producer of regulatory focused webcasts, has announced today that Laura A. Vogel, Partner, Barclay Damon, LLP will speak at the Knowledge Group’s webcast entitled: “Hatch-Waxman Litigation: The Evolving Legal and Regulatory Framework.” This event is scheduled for September 26, 2017 from 12:00pm – 2:00pm (ET).

For further details, please visit: https://theknowledgegroup.org/event-homepage/?event_id=2930

About Laura A. Vogel
Laura Vogel is a partner in the Boston office of Barclay Damon LLP, where she advises clients in the pharmaceutical and biotechnology industries on patent related matters, including litigation, particularly Hatch-Waxman litigation; patent prosecution and portfolio development; due diligence investigations; freedom-to-operate, patentability, infringement, validity and inequitable conduct opinions. She has 15 years of experience in pharmaceutical patent practice and has been involved in more than 20 Abbreviated New Drug Application (ANDA) litigations as counsel or co-counsel relating to all types of dosage forms, including oral (tablets, capsules, ODTs, solutions), intravenous, intramuscular, ophthalmic formulations, transdermal patches, and abuse-deterrent dosage forms. Her practice regularly involves analysis of citizen petitions and regulatory issues, such as patent-based and FDA-granted exclusivities. Laura has represented clients in Interferences before the U.S. Board of Patent Appeals and Interferences, now the U.S. Patent Trial and Appeal Board (PTAB), where she has served as lead counsel in multiple Inter Partes Reviews (IPRs). She has also prepared and prosecuted U.S. and foreign patent applications in the areas of biotechnology, pharmaceuticals, food science, molecular and cellular biology, recombinant DNA technology, therapeutic proteins, diagnostic assays, gene therapy, vaccines and tissue sealant technology. Prior to joining Barclay Damon, Laura represented pharmaceutical and biotechnology companies in opinion, litigation and prosecution matters and played a vital role in establishing a Hatch-Waxman (ANDA) litigation practice at a previous law firm.

About Barclay Damon, LLP
Barclay Damon, LLP, listed as a “Top 250 Firm” by The National Law Journal, is a full-service, 275-attorney law firm with offices throughout the major cities of New York, in Toronto, Boston, Washington, D.C. and Newark. Barclay Damon provides comprehensive legal and business counsel to a diverse client base in 33 practice areas, including pharmaceutical and life sciences counseling and litigation. Barclay Damon’s IP attorneys are regularly called upon the counsel pharmaceutical and biotechnology manufacturers regarding intellectual property matters including freedom-to-operate analyses, due diligence investigations, infringement/validity/enforceability analyses, enforcement, regulatory (FDA) issues, licensing negotiations, as well as Hatch-Waxman and medical device litigation.

Event Synopsis:
Congress enacted the Hatch-Waxman Act ,formally known as the Drug Price Competition and Patent Term Restoration Act of 1984, P.L. 98-417, to expedite and streamline both generic drug approvals and patent litigation relating to generic drugs.. Prior to the adoption of the Act, no streamlined Food and Drug Administration (FDA) approval process existed for generic drugs. Instead, companies seeking to market generic drugs were required to conduct the same kinds of expensive, lengthy clinical trials that drug companies conducted for new brand-named drugs. Additionally, the Act provided a safe harbor to allow generic drug companies to investigate and patent new drugs in order to get FDA approval without the risk of patent infringement liability. See Roche Prods., Inc. v. Bolar Pharm. Co., 733 F.2d 858 (Fed. Cir. 1984).

Although the Hatch-Waxman Act has been amended multiple times since its enactment, the underlying structure remains the same, and the number of generic drugs successfully reaching the market has increased dramatically. However, along with the remarkable upsurge in approvals, the ever changing landscape of Hatch-Waxman litigation creates new risks and challenges for both brand drug sponsor companies and generic companies every day.

Join a panel of key thought leaders and professionals assembled by The Knowledge Group in a LIVE Webcast as they bring the audience to a road beyond the basics of bringing or defending against Hatch-Waxman Litigation and as they delve into the in-depth analysis of the current trends and recent court rulings surrounding this significant topic. Speakers will also provide the audience with practical strategies in bringing out the best in these lawsuits in a rapidly evolving legal climate.

Key topics include:
• Hatch-Waxman Act: Fundamentals
• Litigation Trends and Pitfalls
• Recent Court Decisions
• Scope, Privileges and Limitations
• Trends, Developments and What Lies Ahead in 2018

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/