Mark E. Waddell, Partner, Loeb & Loeb LLP to Speak at TKG's Hatch-Waxman Litigation: The Evolving Legal and Regulatory Framework LIVE Webcast

Top Quote This event is scheduled for September 26, 2017 from 12:00pm – 2:00pm (ET). End Quote
  • (1888PressRelease) September 06, 2017 - The Knowledge Group/The Knowledge Congress Live Webcast Series, the leading producer of regulatory focused webcasts, has announced today that Mark E. Waddell, Partner, Loeb & Loeb LLP will speak at the Knowledge Group’s webcast entitled: “Hatch-Waxman Litigation: The Evolving Legal and Regulatory Framework.”

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    About Mark E. Waddell
    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.

    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.

    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:

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