Biosimilar Litigation: Navigating Patent Dance Trends and Developments
With the emergence of biosimilars, the patent dance landscape has shifted drastically. Along with its prevalence is the notable rise in biosimilar applications. In the recent U.S. Supreme Court and the U.S. Court of Appeals decision for the Federal Circuit, biosimilar applicants can now have the control to eliminate the patent dance and “collapse the two litigation phases into one single action,” thus, creating speedy application process and accelerating the potential for market launch.
As this trend profoundly altered the biosimilar litigation landscape, companies and practitioners must be in the loop for further developments for them to be properly guided when filing for biosimilar application.
Join a panel of key thought leaders and professionals assembled by The Knowledge Group as they provide the audience with an in-depth analysis of the emerging patent dance trends and developments. Speakers will also discuss risk issues and best compliance practices to avoid pitfalls.
This LIVE Webcast will discuss the following key provisions:
- Patent Dance: An Overview
- Emerging Trends and Developments
- Notable Cases and Court Decisions
- Risk Issues and Challenges
- Best Compliance Practices
- 2019 Outlook
- New Dance Moves: How Recent Case Law Has Reshaped
the BPCIA Patent Dance
- The Dancers
- The Dance
- The Dance + Afterparty
- Sandoz v. Amgen, 137 S. Ct. 1664 (Jun. 12, 2017)
- New Move 1: All About the Afterparty
- New Move 2: Crashing the Afterparty
- Amgen v. Apotex, 827 F.3d 1052 (Fed. Cir. 2016)
- New Move 3: Canceling the Afterparty
- Amgen v. Hospira, 15-cv-839 (D. Del. Sept. 22, 2017)
- New Move 4: Putting the Shoe on the Other Foot
- New Move 5: Racing While Dancing
- Amgen v. Genentech, 17-cv-7349, D.I. 56 (C.D. Cal. Feb. 2, 2018)
- Celltrion v. Genentech, 18-cv-274, D.I. 78 (N.D. Cal. May 9, 2018)
- Regulatory framework and economic incentives impacting IP litigation for biologics
- Brand and biosimilar strategic decisions in biologic IP litigation
- Factors potentially impacting future biosimilar IP litigation
Christopher Loh practices complex patent litigation in the areas of pharmaceuticals, biotechnology and chemistry. Over the past fifteen years, he has litigated patent cases involving oncology therapies, anti-HIV therapies, anti-hepatitis drugs, antidepressants and statins, including as lead counsel. He has experience arguing before the United States Court of Appeals for the Federal Circuit, and has won on behalf of patent owners in inter partes review proceedings before the Patent Trial and Appeal Board. In addition to his litigation work, Christopher also counsels clients on transactional and patent prosecution issues concerning both small-molecule drugs and biological products such as recombinant antibodies, and advises clients on a range of intellectual property matters including inventorship, trade secrets, and licensing.
Christopher is a frequent author and commentator on intellectual property issues, and has twice won the Burton Award for Legal Achievement in recognition of his exceptional writing. His publications have appeared in Lexology, the National Law Journal, the New York Law Journal, Bloomberg IP and Managing Intellectual Property. He has presented at the BIO IPCC Counsels conference, the New Jersey Intellectual Property Law Association Pharmaceutical/Chemical Patent Practice Update, and has taught for Lawline.
Christopher Loh practices complex patent litigation in the areas of pharmaceuticals, biotechnology and chemistry. Over the past fifteen years, he …
Dr. Richard A. Mortimer, a Managing Principal in Analysis Group’s Boston office, specializes in health economics, industrial organization, microeconomic theory, and econometrics. He has provided economic analyses in numerous antitrust matters involving questions of market power, pricing, and market exclusion and foreclosure in a variety of industries, with a focus on healthcare. Dr. Mortimer has also provided analyses and expert testimony on behalf of clients in the healthcare industry on litigation and government investigations involving allegations of improper promotion and kickback payments. His experience includes leading analyses of large data sets to assess questions of market definition, class certification, liability, and damages. In addition to work in litigation, Dr. Mortimer has undertaken research in the area of health care policy, and has coauthored several public policy studies. These studies have addressed a number of topics, including the potential cost savings from passage of legislation developing an accelerated pathway for biosimilar entry; the impact of authorized generic entry on incentives for generics to challenge patents and on long-run generic prices, and the appropriate data exclusivity periods for biologics. Dr. Mortimer’s research has been published in leading peer-reviewed journals, including Health Affairs, Nature Reviews Drug Discovery, The Journal of Industrial Economics, and the Journal of Medical Economics.
Dr. Richard A. Mortimer, a Managing Principal in Analysis Group’s Boston office, specializes in health economics, industrial organization, microeconomic theory, …
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Method Of Presentation:
General knowledge of biosimilar litigation
NY Category of CLE Credit:
Areas of Professional Practice
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