Biologics and Biosimilars: FDA Initiatives and Guidance, Approvals and Exclusivity, Patent Prosecution, Litigation

Recording of a 90-minute premium CLE webinar with Q&A

Conducted on Thursday, February 13, 2020

Recorded event now available

or call 1-800-926-7926
Course Materials

This CLE course will provide essential updates on FDA practice and patent law relating to biologics and biosimilars. The panel will discuss the current state of and recent changes to FDA initiatives, approvals, and exclusivities, as well as patent prosecution, post-grant proceedings, and litigation.


As recognized by the FDA, "Biological products often represent the cutting edge of biomedical research and, in time, may offer the most effective means to treat a variety of medical illnesses and conditions that presently have no other treatments available." The development of biologics has many unique facets.

For example, "In contrast to most drugs that are chemically synthesized and their structure is known, most biologics are complex mixtures that are not easily identified or characterized." Reflecting this complexity, the regulatory and legal landscapes for biologics are still evolving. FDA and intellectual property strategies for biologics must be coordinated and track these changing requirements and trends.

Listen as our authoritative panel provides information about recent FDA and patent developments for biologics, including FDA initiatives, approvals, and exclusivities, as well as patent prosecution, post-grant proceedings, and litigation.



  1. FDA updates
    1. FDA initiatives for biologics and biosimilars
    2. Biologic and biosimilar approvals and exclusivity
      1. Critical differences between biologic and biosimilar approvals and exclusivities vs. small molecule approvals and exclusivities
      2. Prosecution considerations and FDA guidelines
      3. Status of biologic and biosimilar approvals and exclusivities
  2. Patent updates
    1. Prosecution of biologic patents
      1. Section 101 patent eligibility guidelines
      2. Section 103 obviousness trends
    2. Post-grant reviews and inter partes reviews of biologics patents
      1. Status and trends in PGR and IPR proceedings
      2. Federal Circuit appeals from the Patent Trial and Appeal Board
    3. Biosimilar patent litigation
      1. Primary differences between biosimilar patent litigation and Hatch-Waxman litigation
      2. Status and trends in biosimilar patent litigations


The panel will review these and other critical issues:

  • What can we learn from FDA's recent guidance on biologics and biosimilars?
  • How does FDA's recent guidance impact patent strategy?
  • Should your patent strategy for biologics differ from your approach for small molecule drugs?


Feldstein, Mark
Mark J. Feldstein, Ph.D.

Finnegan Henderson Farabow Garrett & Dunner

Dr. Feldstein focuses on U.S. district court litigation, primarily concerning the enforcement of U.S. patent rights and...  |  Read More

Koblitz, Sara
Sara W. Koblitz

Hyman Phelps & McNamara

Ms. Koblitz advises FDA-regulated clients on a range of issues with a particular focus on Hatch-Waxman patent and...  |  Read More

Weingarten, M. David
M. David Weingarten, Ph.D.

Finnegan Henderson Farabow Garrett & Dunner

Dr. Weingarten has a diverse intellectual property practice focusing on patent litigation before U.S. district courts...  |  Read More

Access Anytime, Anywhere

Strafford will process CLE credit for one person on each recording. All formats include course handouts.

To find out which recorded format will provide the best CLE option, select your state:

CLE On-Demand Video