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Overview:

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
  • Outlook

Credit:

Course Level:

Intermediate

 

Advance Preparation:

Print and review course materials

 

Method of Presentation:

On-demand Webcast (CLE)

 

Prerequisite:

General knowledge of biosimilar patent laws

 

Course Code:

147359

 

NY Category of CLE Credit:

Areas of Professional Practice

 

Total Credit:

1.0 CLE


CLE State Requirements:

https://knowledgewebcasts.com/cle-state-requirements/

Speaker Panel:

Sean Sheridan, Ph.D., Principal
Charles River Associates

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.

Eberle Schultz, Counsel
O'Melveny & Myers LLP

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.

Agenda:

SEGMENT 1:

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

SEGMENT 2:

Eberle SchultzCounsel

O'Melveny & Myers LLP

  • Litigation Landscape in 2020
  • Highlights of Litigation in 2019
  • Cases Won and Lost
  • Cases to Look to in 2020

Date & Time:

Thursday, February 06, 2020

3:00 pm to 4:00 pm (ET)

Materials:

Download Course Materials

Who Should Attend:

  • Biotech and Pharmaceutical Companies
  • Patent Lawyers and Consultants
  • Patent Litigators
  • In-house Counsel
  • Top Level Management
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SPEAKERS

Sean Sheridan, Ph.D.Principal
Charles River Associates
Eberle SchultzCounsel
O'Melveny & Myers LLP

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