Hatch-Waxman Act Updates in 2015
The implementation of the Hatch-Waxman Act three decades ago has created vast changes and implications on pharmaceutical industries. With this law, the public can easily access generic medicines in lower costs, which will provide them greater health and economic benefits. To date, generic industries continue to strive for innovations and developments that will make numerous adjustments to the Hatch-Waxman Act.
In this two-hour LIVE webcast, our panel of key thought leaders and practitioners will offer a discussion of the fundamentals as well as updates regarding the latest and significant issues surrounding this topic. This course also offers an overview of the latest trends and best practices in minimizing risks as well as developing enforcement strategies to ensure compliance with the Hatch-Waxman Act.
Key topics include:
- Hatch-Waxman Act – An Overview
- Recent Developments and their Implications on Generic Industries
- Key Trends and Challenges
- Patent Law Enforcement and Risk Mitigation Schemes
- Reasonable Fines and Penalties for Non-Compliance
- Up-to-the-Minute Regulatory Issues and Developments
Lucian C. Chen, Partner
Farney Daniels PC
- Introductory segment
- Jurisdictional issues
Nigamnarayan Acharya, Senior Counsel
Seyfarth Shaw LLP
- More recent IPR decisions
Arlene L. Chow, Partner
Hogan Lovells US LLP
- Assessment of recent IPR decisions by the PTAB involving pharmaceutical patents.
Gary E. Hood, Shareholder
- Personal jurisdiction – decision trends, factors to succeed, strategic considerations for generic considering whether to challenge
- IPR – strategic considerations for a generic considering an IPR challenge to patents, estoppel as between IPR and district court litigation, percentages for institution/success
Will Autz, Counsel
O'Melveny & Myers LLP
- Personal jurisdiction,
- Life sciences,
- Recent supreme court cases
Who Should Attend:
- Healthcare Law Attorneys
- FDA Attorneys
- Biotech/Pharma Industry Lawyers
- Patent Licensing Attorneys
- Drug Manufacturing Executives
- Health Industry Advisors
- Patent Litigators
- Other Related/Interested Professionals
Lucian Chen is a registered patent attorney and partner in Farney Daniels’ New York office. He practices a broad range of intellectual property and commercial law spanning multiple technology areas, with an emphasis on complex pharmaceutical and biotechnology patent litigation, particularly cases involving the Hatch-Waxman Act. Mr. Chen has broad experience representing clients in high-stakes patent litigation cases involving products as varied as computer software, antifungals, antibiotics, personal electronics, osteoporosis therapies, oral contraceptives, and cholinesterase inhibitors. His extensive involvement in all aspects of patent litigation spans counseling clients and initiating litigation, through to both bench and jury trials. Mr. Chen is the Editor-in-Chief of Biotechnology Law Report, the leading journal on law and government regulation of biotech. He holds a B.A. in biology from the Johns Hopkins University, an M.P.H. in health management from Columbia University and a J.D. from St. Johns University.
Lucian Chen is a registered patent attorney and partner in Farney Daniels’ New York office. He practices a broad range …
Nigamnarayan (Nigam) Acharya is senior counsel in Seyfarth Shaw LLP’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 senior counsel in Seyfarth Shaw LLP’s Atlanta office, where he is a member of the Intellectual …
Arlene Chow's practice focuses on intellectual property matters, with an emphasis on patent litigation in the pharmaceutical, biotechnological, and medical device industries. Arlene has served as lead trial counsel in Hatch-Waxman proceedings and has extensive experience in all aspects of patent litigation, including claim construction proceedings, through bench and jury trial and on appeal. Arlene is also acting as lead counsel in multiple inter partes review proceedings before the U.S. Patent and Trademark Office involving pharmaceutical patents. Arlene has a degree in in molecular biophysics and biochemistry and has litigated and/or counseled on numerous drugs, including but not limited to those for the treatment of hemophilia, pain, multiple sclerosis, hypertension, depression, ulcers, menopause, skin cancer, schizophrenia, asthma, and insomnia.
Arlene Chow's practice focuses on intellectual property matters, with an emphasis on patent litigation in the pharmaceutical, biotechnological, and medical …
Gary E. Hood is a skilled and successful trial attorney. A veteran of nearly 20 years of courtroom litigation throughout the United States, he has successfully led numerous trial teams in various types of lawsuits. Mr. Hood joined Polsinelli in 2011 to establish and lead the firm’s Hatch-Waxman pharmaceuticals practice. He continues to lead that practice, and is also the Vice-Chairman of the firm’s Intellectual Property and Technology Group. Gary regularly speaks on issues relating to patent and intellectual property litigation and specifically Hatch-Waxman litigation, and has been named an IP Star and Chicago Leading Lawyer the past several years. A former officer in the U.S. Navy, he developed and employs a unique case preparation method that identifies success strategies early, and enables him to allocate resources to optimize client results.
Gary E. Hood is a skilled and successful trial attorney. A veteran of nearly 20 years of courtroom litigation throughout …
Will Autz is a counsel at O’Melveny & Myers, LLP where he focuses his practice on complex patent litigation, particularly within the biotechnology, pharmaceutical and chemical industries. Will represents brand pharmaceutical companies in patent litigation under the Hatch-Waxman Act and is experienced in international arbitration and enforcement proceedings, USPTO interference proceedings, validity opinions, and intellectual property due diligence. Will’s technical experience includes anti-cancer therapies; antivirals; drugs for treating attention deficit disorder; and enlarged prostate glands; biologics for regulating the immune system and for treating macular degeneration; eukaryotic protein expression technology; and oral contraceptives.
Will Autz is a counsel at O’Melveny & Myers, LLP where he focuses his practice on complex patent litigation, particularly …
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NASBA Field of Study:
Specialized Knowledge and Applications
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Areas of Professional Practice
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About Farney Daniels PC
An impressive array of prominent corporations, innovative start-ups, and pioneering individual innovators trusts the lawyers at Farney Daniels to handle a wide range of complex, high-stakes intellectual property cases. This diverse collection of clients appreciates that our attorneys combine decades of large firm experience with the nimbleness and creativity of a small, entrepreneurial law firm. In large part because we offer cutting-edge work set in the congenial collegiality of a litigation boutique, we attract the top notch legal talent required to deliver consistently the skill, insight, attention to detail, and value our clients expect from their counsel.
Our attorneys have successfully handled myriad matters involving huge potential damages and possibly-crippling injunctions in federal district and appellate courts across the nation, and before the International Trade Commission, as well as the Federal Trade Commission. Nonetheless, we recognize that every matter is important to our clients; thus we bring the same level of care and effort to each endeavor entrusted to the firm, regardless of size.
About Seyfarth Shaw LLP
At Seyfarth Shaw, we are leading the way to deliver legal services more effectively, more efficiently, more transparently.
Seyfarth Shaw provides thoughtful, strategic, practical legal counsel to client companies and legal teams of all sizes. With more than 800 attorneys in the U.S., London, Shanghai, Melbourne and Sydney, we offer a national platform and an international gateway to serve your changing business and legal needs in litigation, employment, corporate, real estate and employee benefits.
We have gained acclaim for our innovative SeyfarthLean client service model, which incorporates the core principles of Lean Six Sigma to the delivery of legal services, and we continue to develop new reporting and project management tools for greater transparency and collaboration with our clients.
Our efforts have contributed to our recognition among in-house counsel as ‘Best of the Best’ for client service among the 2013 BTI Consulting Group’s Client Service A-Team and being named among the Top 10 in the Financial Times U.S. Innovative Lawyers Report in 2012.
About Hogan Lovells US LLP
Hogan Lovells is a global legal practice that helps corporations, financial institutions, and governmental entities across the spectrum of critical business and legal issues globally and locally. We have over 2,500 lawyers operating out of more than 40 offices in Africa, Asia, Europe, Latin America, the Middle East, and the United States. Hogan Lovells offers an exceptional, high quality transatlantic capability, with extensive reach into the world’s commercial and financial centers; distinctive strengths in the areas of intellectual property, litigation and arbitration, corporate, finance, and government regulatory; and access to a depth of knowledge and resource in many major industry sectors. Our practice breadth, geographical reach, and industry knowledge provide us with insights into the issues that affect our clients most deeply and enable us to provide high quality business-oriented legal advice to assist them in achieving their commercial goals.
Polsinelli, a national law firm ranked among the Am Law 100 with over 740 attorneys located in 20 offices, deliberately seeks constant improvement in all that we do. At its inception more than forty years ago, the firm established a culture of openness and entrepreneurship that still pervades today. As the fastest growing U.S. law firm for the past six years as ranked by The American Lawyer*, the firm’s growth has been fueled by the recruitment of like-minded attorneys from top law firms across the country.
Polsinelli attorneys successfully build enduring client relationships by providing practical legal counsel infused with business insight, and with a passion for assisting General Counsel and CEOs in achieving their objectives. The firm focuses on healthcare, financial services, real estate, life sciences and technology, and energy and business litigation, and has depth of experience in 100 service areas and 70 industries.
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.