HomeWebcastHatch-Waxman Litigation: Legal and Regulatory Updates in 2018
Online CLE Hatch-Waxman CLE

Hatch-Waxman Litigation: Legal and Regulatory Updates in 2018

Live Webcast Date: Wednesday, May 30, 2018 from 3:00 pm to 4:00 pm (ET)
Litigation (CLE)Pharmaceutical & Life Sciences CLE & CPERecording

Online CLE Hatch-Waxman

Join us for this Knowledge Group Online CLE Hatch-Waxman Webinar. Following the Supreme Court's decision in TC Heartland, LLC v. Kraft Foods Group Brands LLC and the U.S. Food and Drug Administration's (FDA) issuance of the Final Rule for the implementation of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, new and existing issues in the Hatch-Waxman litigation landscape are given increased attention. Counsel for Hatch-Waxman cases must understand these issues to best serve the interest of their clients.

In this Webcast, a panel of key thought leaders and professionals assembled by The Knowledge Group will discuss in-depth the legal and regulatory developments impacting the Hatch-Waxman litigation landscape. They will also provide the audience with practical strategies in bringing out the best in these lawsuits amidst these developments.

Key topics include:

  • Hatch-Waxman Act: An Overview
  • Impact of FDA Rule Changes
  • TC Heartland's Impact on Hatch-Waxman
  • Venue and Jurisdiction in personam
  • Other Legal and Regulatory Updates

Agenda

SEGMENT 1:
Bella S. SatraAttorney
Barclay Damon, LLP

Relatively recent regulatory changes affecting Orange Book listings, exclusivities and use codes.

SEGMENT 2:
Jason LiefSpecial Counsel
Cooley LLP

Recent developments in Hatch-Waxman cases regarding venue after the TC Heartland decision

Who Should Attend

  • FDA Attorneys   
  • Biotech/Pharma Industry Lawyers
  • Patent Litigators
  • In-house Counsel
  • Drug Manufacturing Executives
  • Health Industry Advisors
  • Other Related/Interested Professionals

Online CLE Hatch-Waxman

SEGMENT 1:
Bella S. SatraAttorney
Barclay Damon, LLP

Relatively recent regulatory changes affecting Orange Book listings, exclusivities and use codes.

SEGMENT 2:
Jason LiefSpecial Counsel
Cooley LLP

Recent developments in Hatch-Waxman cases regarding venue after the TC Heartland decision

Online CLE Hatch-Waxman

Online CLE Hatch-Waxman

Jason LiefSpecial CounselCooley LLP

Jason Lief is a patent litigator who focuses on pharmaceutical and Hatch-Waxman litigation.  For more than two decades Jason has represented some of the world’s most renowned innovators in dozens of cases often involving billion-dollar products, establishing a winning track record and a reputation for courtroom excellence.  Jason has litigated and tried dozens of Hatch-Waxman and other pharmaceutical patent cases before federal courts throughout the US, including cases involving Zantac®; Wellbutrin®; Wellbutrin SR®; Wellbutrin XL®; Ceftin®; Intuniv®; Vyvanse®; Oxtellar XR®; Angiomax® and Lialda®.  In addition, Jason has litigated biotech, chemical and consumer products patent cases, as well as copyright, trademark and trade secret cases.  He has argued before the US Court of Appeals for the Federal Circuit and also made appearances in foreign courts pursuant to the Hague Convention.

Online CLE Hatch-Waxman

Bella S. SatraAttorneyBarclay Damon, LLP

Bella S. Satra is a senior associate in the Intellectual Property Litigation and Commercial Litigation Practice Areas at Barclay Damon LLP. Bella focuses her practice in patent and complex commercial litigation and has represented clients in various areas and industries, including pharmaceuticals, medical devices, broadband and telecommunications, and electric power generation, transmission and distribution systems. Prior to joining Barclay Damon, she practiced at a large international law firm in San Francisco, handling matters that involved intellectual property, antitrust and unfair competition, bankruptcy, and contract disputes. Bella is also experienced in appellate litigation and has briefed or argued matters before the Second Circuit, Ninth Circuit, Federal Circuit and the New York Appellate Division.


Click Here to Read Additional Material

Online CLE Hatch-Waxman

Course Level:
   Intermediate

Advance Preparation:
   Print and review course materials

Method Of Presentation:
   On-demand Webcast

Prerequisite:
   Basic Knowledge in Hatch-Waxman Act

Course Code:
   147144

NY Category of CLE Credit:
   Areas of Professional Practice

Total Credit:
    1.0 CLE

No Access

You are not logged in. Please or register to the event to gain access to the materials and login instructions.

About the Knowledge Group

The Knowledge Group

The Knowledge Group has been a leading global provider of Continuing Education (CLE, CPE) for over 13 Years. We produce over 450 LIVE webcasts annually and have a catalog of over 4,000 on-demand courses.

About the Knowledge Group

The Knowledge Group

The Knowledge Group has been a leading global provider of Continuing Education (CLE, CPE) for over 13 Years. We produce over 450 LIVE webcasts annually and have a catalog of over 4,000 on-demand courses.

Cooley has 900 lawyers across 12 offices in the United States, China and Europe. Clients partner with Cooley on transformative deals, complex IP and regulatory matters, and high-stakes litigation, where innovation meets the law. We have a fully integrated IP litigation, counseling and prosecution practice and are called on to litigate IP disputes involving core technologies, products and brands. Visit us as: www.cooley.com.

Website: https://www.cooley.com/

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 Albany, Boston, Buffalo, Newark, New York City, Syracuse, Toronto, and Washington, D.C.  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 as well as healthcare law.  Barclay Damon’s IP attorneys are regularly called upon to 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, and licensing negotiations, as well as Hatch-Waxman and medical device litigation.

Website: https://barclaydamon.com/

Jason Lief is a patent litigator who focuses on pharmaceutical and Hatch-Waxman litigation.  For more than two decades Jason has represented some of the world’s most renowned innovators in dozens of cases often involving billion-dollar products, establishing a winning track record and a reputation for courtroom excellence.  Jason has litigated and tried dozens of Hatch-Waxman and other pharmaceutical patent cases before federal courts throughout the US, including cases involving Zantac®; Wellbutrin®; Wellbutrin SR®; Wellbutrin XL®; Ceftin®; Intuniv®; Vyvanse®; Oxtellar XR®; Angiomax® and Lialda®.  In addition, Jason has litigated biotech, chemical and consumer products patent cases, as well as copyright, trademark and trade secret cases.  He has argued before the US Court of Appeals for the Federal Circuit and also made appearances in foreign courts pursuant to the Hague Convention.

Bella S. Satra is a senior associate in the Intellectual Property Litigation and Commercial Litigation Practice Areas at Barclay Damon LLP. Bella focuses her practice in patent and complex commercial litigation and has represented clients in various areas and industries, including pharmaceuticals, medical devices, broadband and telecommunications, and electric power generation, transmission and distribution systems. Prior to joining Barclay Damon, she practiced at a large international law firm in San Francisco, handling matters that involved intellectual property, antitrust and unfair competition, bankruptcy, and contract disputes. Bella is also experienced in appellate litigation and has briefed or argued matters before the Second Circuit, Ninth Circuit, Federal Circuit and the New York Appellate Division.

Ultimate Value Annual Program

Bring a colleague for only $149, a savings of $50 per additional attendee.

  • Unlimited Access to Live & Recorded Webcasts
  • Instant Access to Course Materials
  • And More!

$199