Immunotherapy at the Crossroads: Will Shifting Patent and Regulatory Trends Help or Hurt?

The new USPTO director has embraced a recent Federal Circuit decision (Vanda v. Westward) that supports eligibility of patient-tailored therapies, pointing to a new pathway around the Supreme Court’s decision in Mayo v. Prometheus. This favorable trend in eligibility coincides with the approval of two new immunotherapies by the FDA, which raises groundbreaking questions about the appropriate business models.

Join attorneys from Foley & Lardner LLP alongside seasoned corporate counsel as they discuss the future of biopharma method patents, options for business strategies, and how to align patent claim strategy for immunotherapy products with FDA labeling information. Topics include:

• Has the U.S. Reached a Turning Point in the Protection of Tailored Immunotherapies?
  
  
  
  • How the Federal Circuit distinguished the Supreme Court’s Mayo v. Prometheus decision on eligibility of a method claim
  
  
  • How infringement was found by one company even though the claim had both a diagnostic and a treatment step
  
  
  • Lessons for U.S. prosecution and protection strategy of immunotherapy
  
  
  • How to draft patent claims properly


• Panel Discussion: Corporate Counsels Speak on Challenges and Strategies in Commercializing Immunotherapy


• How Labeling Decisions May Affect FDA Approval of Products
  
  
  
  • Recent FDA approvals on immunotherapy products
  
  
  • Aligning patent claim language with labeling requirements

Featured Corporate Counsel Speakers Include:

• Danielle Pasqualone, Vice President, Intellectual Property, Five Prime Therapeutics, Inc.


• Yu-Ming Dammann, Lead Intellectual Property Counsel, Kite Pharma


• Hans Sauer, Deputy General Counsel for Intellectual Property, BIO

Foley Speakers Include:

• Nate Beaver, Partner, Government Solutions and FDA Practice


• Steve Maebius, Partner, Chemical, Biotechnology & Pharmaceutical Practice


• Kristel Schorr, Partner and Chair, Chemical, Biotechnology & Pharmaceutical Practice

CLE Information

Foley & Lardner LLP will apply for CLE credit after the program, wherever applicable. Foley & Lardner LLP certifies that this activity has been approved for California MCLE credits by the State Bar of California in the amount of 1.0 General credit. Foley & Lardner LLP is a State Bar of California MCLE approved provider. Please note that participants must be in attendance on the date of the event; credit may not be obtained by viewing and/or listening to a program recording after the event. Certificates of attendance will be distributed to eligible participants approximately eight weeks after the program via email.

Important Information for New York Attorneys: This program is appropriate for experienced attorneys only.