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 Tuesday, January 22, 2019

Recorded event now available

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Program Materials

This CLE webinar 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, "[b]iological 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." Development of biologics has many unique facets.

For example, "[i]n 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
      1. 2018 FDA Biosimilar Action Plan: Balancing Innovation and Competition (July 2018)
      2. Federal Register Notice and Public Meeting on Facilitating Price Competition and Innovation in the Biological Products Marketplace (Sept. 2018)
      3. Recent FDA guidances 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 (PGRs) and inter partes reviews (IPRs) of biologic patents
      1. Status and trends in PGR and IPR proceedings
      2. Federal Circuit appeals from the Patent Trial and Appeal Board (PTAB)
    3. Biosimilar patent litigation
      1. Primary differences between biosimilar patent litigation and Hatch-Waxman litigation
      2. Status and trends in biosimilar patent litigations
      3. 2018 Amendment to Medicare Prescription Drug, Improvement and Modernization Act of 2003: FTC and DOJ review of biosimilar patent litigation settlements


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?


Cyr, Shana
Shana K. Cyr, Ph.D.

Finnegan Henderson Farabow Garrett & Dunner

Dr. Cyr represents clients in complex patent litigations, contentious proceedings before the USPTO, and appeals related...  |  Read More

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

Karst, Kurt
Kurt R. Karst

Hyman Phelps & McNamara

Mr. Karst provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug...  |  Read More

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