Tips and Strategies in Winning Paragraph IV Disputes in 2016 & Beyond
Under Hatch-Waxman Act, a generic challenger seeking abbreviated new drug application (ANDA) approval is required to file a certification regarding each relevant Orange Book patent. One of the certifications an ANDA applicant may file is the Paragraph IV certification which states that the branded drug’s “patent is invalid, unenforceable or would not be infringed by marketing of the ANDA product.” Considered as a technical act of patent infringement, a Paragraph IV filing gives the brand pharmaceutical company the right to initiate a patent infringement lawsuit.
With the increasing number of Paragraph IV filings and the vulnerability of every product as a generic target, both generic and brand companies should therefore expect Paragraph IV litigation and be prepared with its coming.
In this two-hour LIVE Webcast, a panel of distinguished professionals and thought leaders assembled by The Knowledge Group will help generic and brand pharmaceutical companies understand the fundamental as well as complex aspects of this significant topic. They will also offer best tips and strategies in winning Paragraph IV Disputes.
Key topics include:
- ANDA with Paragraph IV Certification – Overview
- Current Trends
- Notable Cases
- Implications to the Market
- Best Litigation Tips and Strategies
Nigamnarayan Acharya, Shareholder
- Claim construction & Cuozzo decision
Gary E. Hood, Shareholder
- The issue of stays in District Court proceedings and parallel IPR proceedings
Pablo D. Hendler, Partner
- Personal jurisdiction issue
Dean L. Fanelli, Ph.D., Founding Partner
Fanelli Haag PLLC
- Issues Related to Divided and Induced Infringement
Michal A. Malkiewicz, Director
- Damages in Paragraph IV Litigation and the True Cost of an At-Risk Launch
Who Should Attend:
- Patent Attorneys
- Pharma Industry Lawyers
- Patent Licensing Attorneys
- FDA Attorneys
- Patent Litigators
- Patent Consultants
- Pharmaceutical Company Executives
- Professionals coming from Biotech and Pharmaceutical Firms
- Professionals coming from Food and Drug Industries
- Drug Manufacturing Executives
- Other Related/Interested Professionals
Michal A. Malkiewicz is a Director at Epsilon Economics, where he specializes in the application of economics to intellectual property and complex commercial disputes. Mr. Malkiewicz has been involved in a variety of health care and life sciences disputes before U.S. and foreign courts and before U.S. and international arbitration organizations. He has previously presented on economic issues in Paragraph IV disputes.
Michal A. Malkiewicz is a Director at Epsilon Economics, where he specializes in the application of economics to intellectual property …
Dean L. Fanelli, Ph.D. is a Founding Partner of the Fanelli Haag PLLC whose practice focuses on issues facing the biotechnology, pharmaceutical, and chemical industries. Dr. Fanelli’s expertise lies in patent portfolio creation and management, counseling, technology transactions, due diligence, and opinion work, including drafting novelty, freedom-to-operate, and invalidity opinions. Dr. Fanelli also has significant experience with the interplay between patent and FDA laws under the Hatch-Waxman Act, and he regularly handles IP issues attendant to mergers, acquisitions, and financing for life sciences companies as well as pre-litigation ANDA analyses associated with Hatch-Waxman paragraph IV litigation. Dr. Fanelli also has expertise with medical products, chemical compounds, polymer compositions, food additives and cosmetic compositions. Dr. Fanelli gained additional experience in strategic patent management and licensing while working in-house with an international pharmaceutical drug-delivery company and while working with a major consumer product company.
Dean L. Fanelli, Ph.D. is a Founding Partner of the Fanelli Haag PLLC whose practice focuses on issues facing the …
Gary E. Hood is a shareholder in the Chicago office of Polsinelli PC. He is the Vice-Chair of the Intellectual Property & Technology Litigation Group, and leads the firm’s Hatch-Waxman & Biosimilars practice. Gary’s 20 years of courtroom experience trying cases involving a range of legal issues have given him perspective and insight on judge and jury persuasion for which clients seek him out. This has led him to develop a unique case preparation method that identifies strategic direction early, and avoids the conventional "no stone unturned" approach that often drives fees.
Gary has experience in a broad array of civil and criminal matters. He now focuses his practice on intellectual property litigation including Hatch-Waxman matters, and regularly appears in courtrooms throughout the United States litigating a variety of pharmaceutical patent cases. Gary has been named a Chicago Leading Lawyer in various areas of intellectual property law since 2013. He was named in Intellectual Asset Management IAM Patent 1000 as recommended for patent litigation in Illinois in 2014 and 2015, and honored by Managing Intellectual Property magazine as an IP Star each year since 2013. He writes and speaks frequently at various conferences and seminars on topics related to intellectual property, including in the pharmaceuticals and biotech industries. Gary graduated magna cum laude from Gonzaga University School of Law, where he served as Editor-in-Chief of the Gonzaga Law Review and on the regional champion and national qualifying National Moot Court Team. Gary earned his bachelor of science degree in electrical engineering from the University of Southern California. He is a former United States Naval Officer and the recipient of a number of military medals and awards.
Gary E. Hood is a shareholder in the Chicago office of Polsinelli PC. He is the Vice-Chair of the Intellectual …
Pablo Hendler recently joined Jones Day bringing with him extensive experience in all aspects of litigation, involving a broad range of technologies, particularly life science patent litigation. He has a unique combination of skills as a research chemical engineer, inventor, and attorney with more than 20 years of experience in patent infringement litigation, of which more than 15 years is primarily focused on pharmaceutical (e.g., Hatch-Waxman), biotechnology, and medical device litigation. Pablo's litigation experience includes serving as lead counsel and ranges from prediscovery diligence to preliminary injunction proceedings, trial, and appeals involving patents, false advertising, trademark, trade secret misappropriation, and breach of contract.
Pablo has successfully represented clients in numerous pharmaceutical patent cases involving: ANDAs (abbreviated new drug applications) concerning inhalation medication for the treatment of asthma, improved oxycodene formulations, controlled release opioid analgesics, antifungul agents, and a niacin cholesterol-lowering drug; genetically modified mice; plasmid vectors; nutraceuticals; and autonomous medical imaging, infusion pumps, spinal fusion implants, corn herbicides, purge and trap concentrators for gas chromatography, and machine vision and bar code technologies.
Pablo Hendler recently joined Jones Day bringing with him extensive experience in all aspects of litigation, involving a broad range …
Nigamnarayan (Nigam) Acharya is Shareholder in Baker Donelson’s Atlanta office, where he is a member of the Intellectual Property practice group. For more than 11 years, he has focused his practice on patent matters, including patent prosecution, patent litigation, strategic counseling and opinions, and patent-related due diligence. From experience with pharmaceutical and biotechnology clients, he has developed an understanding of the scientific, business, and legal issues.
Mr. Acharya has helped companies use intellectual property portfolios to enhance equity investments and has provided litigation support and counseled on Hatch-Waxman matters, including work in relation to Abbreviated New Drug Applications (ANDAs) on compounds such as ondansetron (Zofran®), sertraline (Zoloft®), and ciprofloxacin (Cipro®). He regularly analyzes the patent landscape relating to new product proposals and works closely with scientists at an early stage to advise on design-around strategies for ANDA filings.
Nigamnarayan (Nigam) Acharya is Shareholder in Baker Donelson’s Atlanta office, where he is a member of the Intellectual Property practice …
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About Epsilon Economics
Epsilon Economics is a firm of economists and financial analysts specializing in economic analysis, analytics, and strategy. Epsilon Economics has extensive experience in providing life sciences clients with the full range of economic analysis, high-end analytics, and strategy consulting, both in and out of litigation.
About Fanelli Haag PLLC
FANELLI Haag PLLC focuses on intellectual property and provides our clients with the highest caliber of legal representation together with the responsiveness, dedication, efficiency and versatility that only a smaller firm can offer. Our approach is a strategic one. We are uniquely positioned to provide solutions that not only meet, but anticipate, the needs of our clients. Our seamlessly integrated team of attorneys is able to efficiently partner with our clients to craft comprehensive rationally-designed intellectual property strategies. Strong scientific backgrounds, as well as years of legal experience working with the United States Patent and Trademark Office, top-tier international law firms and as venture capitalists and in-house counsel, allow our lawyers to work closely with our clients to understand their technical, business, and legal goals. The Firm provides a range of intellectual property services relating to patent prosecution, pre-investment due diligence investigations, freedom-to-operate analyses, opinion work and IP-sales/licensing transactions.
About Polsinelli PC
Polsinelli is an Am Law 100 firm with more than 800 attorneys in 19 offices, serving corporations, institutions, entrepreneurs and individuals nationally. Ranked in the top five percent of law firms for client service in 2016 by the BTI Client Service A-Team Report, the firm has risen more than 100 spots in Am Law's annual firm ranking over the past six years. Polsinelli attorneys provide practical legal counsel infused with business insight, and focus on health care and life sciences, financial services, real estate, technology and biotech, mid-market corporate, and business litigation. Polsinelli attorneys have depth of experience in 100 service areas and 70 industries.
About Jones Day
Jones Day is a global law firm with 43 offices in major centers of business and finance throughout the world. Its unique governance system fosters an unparalleled level of integration and contributes to its perennial ranking as among the best in the world in client service. Jones Day provides significant legal representation for almost half of the Fortune 500, Fortune Global 500, and FT Global 500.
About Baker Donelson
Baker Donelson gives clients access to a team of more than 650 attorneys and public policy advisors representing more than 30 practice areas to serve a wide range of legal needs. Clients receive knowledgeable guidance from experienced, multi-disciplined industry and client service teams. Ranked as the 64th largest law firm in the U.S., Baker Donelson is recognized by FORTUNE magazine as one of the "100 Best Companies to Work For."