BPCIA Patent Dance: Navigating the Biosimilar Litigation Landscape in 2020
Since the beginning of 2019, the number of biosimilar litigation - particularly those concerning the Biologics Price Competition and Innovation Act (BPCIA) “patent dance” - has drastically increased. One of the notable BCPIA cases that are being closely watched, is Amgen’s legal battle with Novartis’ Sandoz arm over the Enbrel patent, in which the former intends to hold commercial exclusivity for Enbrel until 2029. The legal precedents established in this dispute are expected to impact the biosimilar market as well as the pending and future biosimilar patent lawsuits.
With the changing biosimilar landscape and stiffer competition in the backdrop, counsel to drug companies should keep an eye out for these lawsuits and other legal developments to devise effective patent management and litigation strategies.
Listen to patent experts, Sean Sheridan (Charles River Associates) and Eberle Schultz (O'Melveny & Myers LLP) as they provide the audience with an in-depth analysis of the recent biosimilar litigation trends relating to the BPCIA patent dance. Speakers will also offer the best patent management and litigation practices in light of the recent developments.
This LIVE Webcast will discuss the following key provisions:
- The BPCIA Patent Dance – Statistics and Recent Trends
- Notable Cases and Court Decisions
- Best Patent Management Practices
- Effective Litigation Strategies
Sean Sheridan, Ph.D., Principal
Charles River Associates
- Overview of the Economics of the Biosimilar Market in the U.S., including:
- Similarities and Differences with the Generic Pharmaceutical Market
- Market Penetration and Pricing of Biosimilars
- Discussion of How the Economics of Biosimilars May Impact Litigation-related Issues, including:
- Evaluating Potential Damages Exposure and Whether to Launch at-risk
- Evaluating Irreparable Harm When Seeking a Preliminary Injunction
Eberle Schultz, Counsel
O'Melveny & Myers LLP
- Litigation Landscape in 2020
- Highlights of Litigation in 2019
- Cases Won and Lost
- Cases to Look to in 2020
Who Should Attend:
- Biotech and Pharmaceutical Companies
- Patent Lawyers and Consultants
- Patent Litigators
- In-house Counsel
- Top Level Management
Dr. Sheridan is a principal in the Intellectual Property Practice at Charles River Associates. He has addressed a broad range of financial and economic issues in the context of litigation, including lost profits, unjust enrichment, reasonable royalty, commercial success, irreparable harm, and the economic prong of the domestic industry requirement in Section 337 ITC matters. The engagements he has worked on span a wide range of industries, and include pharmaceuticals, biologics, diagnostics and medical devices. Previously, Dr. Sheridan was as an assistant director at the technology transfer office at the University of Chicago, where he worked for five years, focusing primarily on the commercialization of early stage technologies. Dr. Sheridan was named to the IAM Patent 1000: The World’s Leading Patent Professionals (economic experts) in 2019.
Dr. Sheridan is a principal in the Intellectual Property Practice at Charles River Associates. He has addressed a broad range …
Eberle Schultz is a Counsel at O’Melveny & Myers where she practices complex patent litigation within the biotechnology, pharmaceutical, and chemical industries. Eberle counsels life sciences clients in all aspects of patent litigation to help businesses achieve their strategic goals.
Eberle represents innovator pharmaceutical companies in patent ligation under the Hatch-Waxman Act and is experienced in innovator declaratory judgement actions, inter partes review proceedings before the Patent Trial and Appeal Board, Federal Circuit appeals, licensing disputes, and patent validity opinions. She has litigated a variety of technologies, including multiple anti-cancer therapies and biologics.
Eberle Schultz is a Counsel at O’Melveny & Myers where she practices complex patent litigation within the biotechnology, pharmaceutical, and …
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Method of Presentation:
General knowledge of biosimilar patent laws
NY Category of CLE Credit:
Areas of Professional Practice
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About Charles River Associates
Charles River Associates is a leading global consulting firm that offers economic, financial, and strategy expertise to major law firms, corporations, accounting firms, and governments around the world.
With proven skills in complex cases and exceptional strength in analytics, CRA consultants have provided astute guidance to clients in thousands of successful engagements. We offer litigation and regulatory support, business strategy and planning, market and demand forecasting, policy analysis, and risk management consulting.
Our success stems from the outstanding capabilities of our consultants, many of whom are recognized as experts in their respective fields; our close relationships with a select group of respected academic and industry experts; and from a corporate philosophy that stresses interdisciplinary collaboration and responsive service.
About O'Melveny & Myers LLP
It’s more than what you do: it’s how you do it. Across sectors and borders, in board rooms and courtrooms, we measure our success by yours. And in our interactions, we commit to making your O’Melveny experience as satisfying as the outcomes we help you achieve. Our greatest accomplishment is ensuring that you never have to choose between premier lawyering and exceptional service. So, tell us. What do you want to achieve? Visit us at omm.com.