ANDAs and The Hatch-Waxman Act: Cases, Trends and Developments to Watch For in 2017
As the growth rate for Abbreviated New Drug Application (ANDA) filings remain steadier than filing rates for other patent litigation, the pharmaceutical companies and their counsel need to keep themselves abreast of the latest issues hounding the industry. In the face of Hatch-Waxman Act and ANDA applications, the industry should be well-equipped in protecting and maximizing the value of pharmaceutical patents.
The Knowledge Group has assembled a panel of key thought leaders and practitioners to provide an opportunity to discuss the various issues surrounding the Hatch-Waxman Act and the Abbreviated New Drug Application (ANDA), which the pharmaceutical industry should watch out for in 2017. The panel of speakers will provide an in-depth discussion of the notable cases, trends, and developments. Speakers will also offer best practices in avoiding and mitigating future litigation risks.
Key topics include:
- Emerging Trends and Developments
- Recent Cases
- Potential Litigation Risks and Remedies
- Critical Issues and Implications
- Best Practices
Mark Deming, Attorney
- Inter-play between litigation and post-grant review proceedings (IPR, PGR, CBM)
- Jurisdiction and venue in Hatch-Waxman cases
- Analysis of time-to-disposition in most popular districts
- FDA January 2017 Draft Guidance re: 180-Day Exclusivity
Carolyn S. Wall , Attorney
O'Melveny & Myers
- Jurisdiction in light of Acorda and TC Heartland
- 2016 FDA revisions to ANDA regulations
- Exclusivity after Benicar
- Interaction between district court litigation and post-grant proceedings (and effects of Trump administration)
Dr. David Blackburn, Director
NERA Economic Consulting
- Proving Commercial Success in ANDA Cases
- Understanding the Legal Standard
- Lessons from Economics
- Lessons from Recent Decisions
- At-Risk Entry and Irreparable Harm
Who Should Attend:
- FDA Attorneys
- Biotech/Pharma Industry Lawyers
- Patent Licensing Attorneys
- Pharmaceutical Company Executives
- Patent Litigators
- Bio/Pharma Industries
- Other Related/Interested Professionals
Mark Deming is an intellectual property attorney who regularly advises large and small companies throughout the country. Mark’s practice consists of patent, trademark, and trade dress matters, and he maintains a particular focus of Hatch-Waxman Act Paragraph IV litigation, assisting with the representation of both brand and generic pharmaceutical companies. Mark is involved in all aspects of case developments, from initial assessment to discovery, motions practice, claim construction, expert witnesses, trial and appeal. Mark is also a registered patent attorney.
Prior to joining Polsinelli, Mark clerked for two years with District Judge Michael Schneider and Magistrate Judge John Love in the United States District Court for the Eastern District of Texas, one of the nation’s busiest patent dockets. As a clerk, he developed broad experience with including patent litigation and assisted the court with conducting jury and bench trials, entering findings of fact and conclusions of law, holding Markman hearings, ruling on dispositive motions, evaluating the sufficiency of contention disclosures, resolving discovery disputes, and interpreting local rules.
Mark has a Bachelor of Science degree in Computer Engineering from the University of Illinois Department of Electrical and Computer Engineering.
Mark Deming is an intellectual property attorney who regularly advises large and small companies throughout the country. Mark’s practice consists …
Dr. Blackburn's areas of expertise include intellectual property (IP), antitrust and competition policy, and econometric analysis. He conducts analyses related to the issues of commercial success and preliminary and permanent injunctions in both Inter Partes Review and Abbreviated New Drug Application (ANDA) proceedings pursuant to the Hatch-Waxman Act. Additionally, he conducts research and prepares expert reports for patent, trademark, and copyright infringement disputes, and false and misleading advertising cases.
Dr. Blackburn has represented clients in a variety of industries, including medical devices, pharmaceuticals, computer software, natural resources, industrial goods and chemicals, consumer products, entertainment, and financial services. Before joining NERA, Dr. Blackburn received his PhD in economics from Harvard University and his ScB in applied mathematics and economics, with honors, from Brown University.
Dr. Blackburn's areas of expertise include intellectual property (IP), antitrust and competition policy, and econometric analysis. He conducts analyses related …
Carolyn S. Wall is an intellectual property litigator specializing in ANDA/Hatch-Waxman and other patent litigation. Her clients include pharmaceutical and biotechnology companies, financial institutions, and other companies with deep R&D investments.
Carolyn’s background is in molecular biology. She has many years of research experience in both academic and institutional settings, directed to antibody engineering, stem cell biology, and cell signaling. Carolyn’s extensive technical experience allows her to understand the complexities and demands associated with her clients’ research and development projects, and to truly appreciate the value of their intellectual property.
In addition to her commercial work, Carolyn provides pro bono services to various clients, including criminal appeals and copyright and trademark matters.
Carolyn S. Wall is an intellectual property litigator specializing in ANDA/Hatch-Waxman and other patent litigation. Her clients include pharmaceutical and …
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About Polsinelli PC
Polsinelli is an Am Law 100 firm with more than 800 attorneys in 19 offices, serving corporations, institutions, and entrepreneurs nationally. Ranked in the top five percent of law firms for client service*, 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, financial services, real estate, intellectual property, mid-market corporate, and business litigation. Polsinelli attorneys have depth of experience in 100 service areas and 70 industries. The firm can be found online at www.polsinelli.com. Polsinelli PC. In California, Polsinelli LLP.
About NERA Economic Consulting
NERA Economic Consulting is a global firm of experts dedicated to applying economic, finance, and quantitative principles to complex business and legal challenges. NERA's economists create strategies, studies, reports, expert testimony, and policy recommendations for government authorities and the world’s leading law firms and corporations. NERA’s clients value our ability to apply and communicate rigorous approaches clearly and convincingly, our commitment to deliver unbiased findings, and our reputation for quality and independence. Our clients rely on the integrity and skills of our unparalleled team of economists and other experts backed by the resources and reliability of one of the world’s largest economic consultancies. With its main office in New York City, NERA serves clients from more than 25 offices across North America, Europe, and Asia Pacific.
About O'Melveny & Myers
O’Melveny is home to some of the nation’s preeminent practitioners in Hatch-Waxman and biologics litigation. Offering the technical depth of an intellectual property boutique, coupled with the resources of an elite global litigation powerhouse, our team provides unparalleled service to innovator companies. As scientists, and litigators, we know the pharmaceutical industry. We know chemistry. We know biotechnology. We know formulation technology. We know the law. And we know the regulatory environment. Our team has handled dozens of significant cases for drug manufacturers whose patents were threatened by generic challengers, and protected billions in sales revenue.