Hatch-Waxman Litigation: The Evolving Legal and Regulatory Framework
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
Eric H. Yecies, Partner
Holland & Knight
Mark E. Waddell, Partner
Loeb & Loeb LLP
Laura A. Vogel, Partner
Barclay Damon, LLP
Thomas Hedemann, Counsel
Axinn, Veltrop & Harkrider LLP
Who Should Attend:
- Healthcare Law Attorneys
- FDA Attorneys
- In-house Counsel
- Biotech/Pharma Industry Lawyers
- Drug Manufacturing Executives
- Health Industry Advisors
Eric H. Yecies is an attorney in Holland & Knight’s New York office, serving as a partner in the firm’s Intellectual Property Group and sitting on the Hiring Committee. Mr. Yecies’ practice focuses on intellectual property, with an emphasis on litigating and counseling in the pharmaceutical, chemical, biotechnology and medical device areas. He has first chair trial experience in federal district courts and an active, complex appellate litigation practice before the U.S. Courts of Appeals.
Mr. Yecies litigates patent, design patent, trade secret, trademark, false advertising, anti-competitive, counterfeiting and licensing cases across technical disciplines, including controlled-release pharmaceuticals, fixed-dose combinations, nanoparticles, immuno-therapies, endocrine and hormone products, transdermal delivery, genetic engineering, oncogenetics, medical diagnostic agents, consumer products, crop science, and oncologic and neurologic treatments. He counsels on patent validity and infringement, licenses, commercial collaboration, patent prosecution, corporate due diligence and regulatory disputes.
Eric H. Yecies is an attorney in Holland & Knight’s New York office, serving as a partner in the firm’s …
Mark Waddell practices in the areas of life sciences and intellectual property, with a particular focus on representing branded drug companies in Hatch-Waxman matters and biosimilars, as well as providing strategic analyses concerning their patent and exclusivity protection. In addition to acting as lead counsel in district court, Patent Trial and Appeal Board (“PTAB”), and appellate matters in the Federal Circuit and U.S. Supreme Court, Mr. Waddell has represented branded pharma clients in REMS/ETASU negotiations, a variety of contract disputes, and antitrust analyses. Mr. Waddell has a strong background in pharmaceutical R&D, having practiced in-house at Hoffmann-La Roche Inc. early in his career, working on regulations implementing the Hatch-Waxman Act, interfacing with the U.S. Trade Representative in securing pharmaceutical patent rights abroad, and assisting with pharma industry lobbying efforts concerning process patent protection.
Mark Waddell practices in the areas of life sciences and intellectual property, with a particular focus on representing branded drug companies …
Laura Vogel is a partner in the Boston office of Barclay Damon LLP, where she advises clients in the pharmaceutical and biotechnologies 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-deterrant 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.
Laura Vogel is a partner in the Boston office of Barclay Damon LLP, where she advises clients in the pharmaceutical …
Thomas practices intellectual property litigation with a focus on pharmaceutical (Hatch-Waxman) and medical device patent litigation. He also represents clients in trademark and copyright litigation. His experience ranges across all aspects of litigation from pre-litigation counseling and strategy through fact and expert discovery, dispositive motions and trial. Thomas also has significant appellate experience before the Federal and Second Circuit Courts of Appeals, and is an adjunct professor at the University of Connecticut School of Law. Thomas earned his J.D. from Yale Law School and served as a law clerk to the Honorable Alfred V. Covello of the United States District Court for the District of Connecticut.
Thomas practices intellectual property litigation with a focus on pharmaceutical (Hatch-Waxman) and medical device patent litigation. He also represents clients …
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Method of Presentation:
Basic Knowledge in Hatch-Waxman Act
NASBA Field of Study:
Production - Non-Technical
NY Category of CLE Credit:
Areas of Professional Practice
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About Holland & Knight
Holland & Knight is a global law firm with more than 1,250 lawyers and other professionals in 27 offices throughout the world. Among the nation's largest law firms, Holland & Knight provides representation in litigation, business, real estate and governmental law. Interdisciplinary practice groups and industry-based teams provide clients with access to attorneys throughout the firm, regardless of location.
To address your needs as effectively and efficiently as possible, we work collaboratively, drawing upon our depth and breadth of legal experience and industry knowledge. Our "one firm" structure positions us to support the most complex matters at all levels, with comprehensive and value-added service.
The firm is organized into four practice sections – Litigation, Government, Business and Real Estate. Through integrated practice groups and industry-based teams, we can provide efficient and responsive legal representation anywhere in the world.
About Loeb & Loeb LLP
Loeb & Loeb is a multiservice law firm with approximately 350 attorneys and offices across the U.S. and Asia. The firm provides a full range of patent prosecution, licensing, litigation and strategic counseling services to clients from around the world in every technology field. With a principal focus on trial and litigation capability, they represent clients in all manner of patent disputes and have served as lead trial counsel in more than 100 patent, trade secret and other technology-related litigations. Loeb’s patent litigators have extensive experience with interpreting and applying the Hatch-Waxman Act, including litigating infringement, validity and enforceability of patents on behalf of branded pharmaceutical companies, as well as successful representation of clients in multidistrict Hatch-Waxman cases. They also provide sophisticated advice on related issues such as FDA exclusivity policies, FTC oversight of settlements and orphan drug rules.
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.
About Axinn, Veltrop & Harkrider LLP
Axinn is a different kind of law firm. It combines the skills, experience and dedication of the world’s largest firms with the focus, responsiveness, efficiency and attention to client needs of the best boutiques. Axinn was established in the late 1990s by lawyers from premier Wall Street firms with a common vision, and has been joined by lawyers from the best firms and law schools who share that vision. Axinn is devoted to providing the highest conceivable quality of service in three practice areas: antitrust, intellectual property and high-stakes litigation. Axinn achieves that goal with world-class skills and deep trial experience. Time and again, major companies have turned to Axinn for their biggest deals and cases, often on the eve of trial.