Abbreviated New Drug Application (ANDA) with Paragraph IV Certification: Critical Insights in 2015
Overview:
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
Agenda:
SEGMENT 1:
Hassen A. Sayeed, M.D., Partner
Ropes & Gray LLP
Challenges To Personal Jurisdiction In Hatch-Waxman Litigation
- Overview of personal jurisdiction after Daimler AG v. Bauman
- Generic challenges to personal jurisdiction in Hatch-Waxman cases
- Strategic considerations and takeaways
SEGMENT 2:
Alyson Wooten, PharmD, Attorney
Kilpatrick Townsend & Stockton LLP
The Use of Inter Partes Review Petitions in Generic Drug Litigation
- Review of the competing statutes: Hatch-Waxman vs. AIA
- Strategies for use of IPR in the pharmaceutical context
- Special issues with concurrent ANDA litigation
SEGMENT 3:
Margaret O'Boyle, Counsel
O'Melveny & Myers LLP
The Impact Of Pending Patent Reform Legislation On Hatch-Waxman Litigation
- Overview of pending legislation, including the Innovation Act (H.R. 9), PATENT Act (S. 1137), and STRONG Patents Act (D. 632)
- Potential impact of pending legislation on Hatch-Waxman litigation and IPR proceedings in the pharmaceutical context
- Pharmaceutical industry’s response to pending legislation
- What happens next?
Who Should Attend:
- Patent Attorneys
- Patent Consultants
- Patent Licensing Attorneys
- Patent Litigators
- Pharma Industry Lawyers
- Pharmaceutical Company Executives
- Professionals coming from Biotech and Pharmaceutical Firms
- Professionals coming from Food and Drug Industries
- FDA Attorneys
- Drug Manufacturing Executives
- Other Related/Interested Professionals
Hassen A. Sayeed, M.D. is a partner in Ropes & Gray’s New York office. Hassen counsels life sciences clients in …
Margaret O'Boyle is a Counsel at O’Melveny & Myers, LLP where she focuses her practice on complex patent litigation, particularly …
Dr. Alyson Wooten focuses her practice on patent litigation with emphasis in the area of health and life sciences. Registered …
Course Level:
Intermediate
Advance Preparation:
Print and review course materials
Method of Presentation:
On-demand Webcast (CLE)
Prerequisite:
NONE
Course Code:
144939
NASBA Field of Study:
Specialized Knowledge and Applications
NY Category of CLE Credit:
Areas of Professional Practice
Total Credits:
2.0 CLE
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SPEAKERS' FIRMS:
About Ropes & Gray LLP
Ropes & Gray is one of the world’s premier law firms, with more than 1,100 lawyers and legal professionals serving clients in major centers of business, finance, technology and government. The firm has offices in New York, Washington, D.C., Boston, Chicago, San Francisco, Silicon Valley, London, Hong Kong, Shanghai, Tokyo and Seoul, and has consistently been recognized for its leading practices in many areas, including private equity, M&A, life sciences, health care, finance, investment management, hedge funds, tax, intellectual property, litigation, securities litigation, government enforcement, and privacy & data security.
Website: https://www.ropesgray.com/
About O'Melveny & Myers LLP
With approximately 700 lawyers in 15 offices worldwide, O’Melveny & Myers LLP helps industry leaders across a broad array of sectors manage the complex challenges of succeeding in the global economy. O’Melveny is a values-driven law firm, guided by the principles of excellence, leadership, and citizenship. Its commitment to these values is reflected in the firm’s dedication to improving access to justice through pro bono work and championing initiatives that increase the diversity of the legal profession. For more information, please visit www.omm.com .
Website: https://www.omm.com/
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.
Website: https://www.kilpatricktownsend.com/
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