Abbreviated New Drug Application (ANDA) with Paragraph IV Certification: Critical Insights in 2015
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
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
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
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 all aspects of complex patent litigation to help businesses achieve their strategic goals. Dr. Sayeed has litigated a diverse variety of technologies, including pharmaceuticals, biotechnology, and medical devices. He also has extensive experience with cases arising under the Hatch-Waxman Act on behalf of pioneer pharmaceutical companies.
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 within the biotechnology, pharmaceutical, and chemical industries.
Margaret represents innovator pharmaceutical companies in patent litigation under the Hatch-Waxman Act and is experienced in USPTO inter parties review proceedings, and patent validity opinions.
Margaret’s technical experience includes anti-cancer therapies; antivirals; drugs for treating high cholesterol; and biologics.
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 as a patent attorney and pharmacist, Dr. Wooten has broad experience in the pharmaceutical industry, including medical services, regulatory, marketing and clinical trial analysis.
Dr. Wooten has represented several big medical and research facilities in a number of federal courts. She has participated in all aspects of patent litigation, including invalidity and infringement investigations, claim construction, preparation of expert reports and settlement negotiations.
While attending law school, Dr. Wooten worked as a patent agent for a leading pharmaceutical company focusing on Paragraph IV litigation and patent prosecution for new chemical entities.
Dr. Wooten was recognized in 2015 and the four years immediately preceding as a Georgia "Rising Star" in the area of Intellectual Property Litigation by Super Lawyers magazine.
Dr. Alyson Wooten focuses her practice on patent litigation with emphasis in the area of health and life sciences. Registered …
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Method of Presentation:
NASBA Field of Study:
Specialized Knowledge and Applications
NY Category of CLE Credit:
Areas of Professional Practice
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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.
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 .
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.