Patent Exclusivity Health Checks for Biologics: Are Your U.S. Patents Ready to Maximize ROI?

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

Conducted on Thursday, September 23, 2021

Recorded event now available

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Course Materials

This CLE course will guide patent counsel on the essentials of patent exclusivity that are in critical need of independent checking. The panel will discuss crucial health checks on U.S. patent exclusivity for biologics in Phase II efficacy trials and proceedings through large scale randomized Phase III clinical trials, submission of the BLA, and subsequent approval and marketing.


Congratulations! Your biologic has passed the hurdles of preclinical studies, "first-in-human" Phase I safety, Phase II efficacy, and large scale randomized Phase III clinical trials. And maybe the BLA is even already approved. Along the way, patent counsel has worked to secure U.S. patents with claims directed to the biologic itself, structurally-related biologics, formulations containing the biologic, and treatment methods, among other related novel and nonobvious inventions.

The return on the invested effort, time, and multimillion-dollar development costs will be enhanced by patent exclusivity extending beyond the regulatory exclusivity afforded under the Biologics Price Competition and Innovation Act (BPCIA). Patent exclusivity based on claims to a novel biologic is common, but what about patent exclusivity for formulations, combination therapies, and clinical trial results?

How strong and enforceable are your U.S. patents? Will they stand up in post-grant proceedings? In BPCIA litigation? Do you have at least one patent claim that is rock solid, enforceable, valid, and infringed by a biosimilar's label? It is critical to give your portfolio a "health check" to answer these questions. What can be done if the health checkers, generally a firm not involved in the preparation and prosecution of the patents, uncover sub-optimal protection or even serious defects depends on how soon the issues are uncovered and the implementation of creative solutions.

Listen as our authoritative panel of patent attorneys discusses the essentials of patent exclusivity that are in critical need of independent checking. The panel will offer suggestions for improving U.S. patents that may be subject to litigation under the BPCIA. The panel will also address current PTAB challenges of patents directed to innovative biologics products and lessons learned from those proceedings. Finally, the panel will present current developments gleaned from recent biosimilars litigation to help counsel prepare to fend off challenges that could reduce ROI.



  1. Are U.S. patent claims subject to litigation under the BPCIA (hereafter, BPCIA claims) definite under the current standards?
  2. Do the BPCIA claims possess written description support under the current standards?
  3. Are the BPCIA claims enabled under the current standards?
  4. Is there a need for Supplemental Examination to clear the path to enforceability?
  5. Were terminal disclaimers needed and, if so, filed, and what effect, if any, did terminal disclaimers cause to Patent Term Adjustment under Federal Circuit cases such as Gilead and its progeny?
  6. Patent infringement issues relevant to BPCIA claims
  7. What is the situation with Patent Term Extension?
  8. The critical times for challenge by a biosimilar under the BPCIA
  9. Are inventorship issues a problem?
  10. Is ownership settled to determine a real party in interest in AIA Post Grant Proceedings and to determine necessary part(y)ies for purposes of bringing the BPCIA litigation?
  11. Prosecution options through continuation applications or reissue practice
    1. Consider including several claims with varying claim scope to minimize the necessity of amendment in an AIA Post Grant Proceeding and provide a written description, enablement, novelty, and nonobviousness back-ups before PTAB and/or the district court
    2. Are continuation applications pending?
    3. If reissue may be appropriate, consider reissue recapture and issues under In re Tanaka
  12. Looking for additional BPCIA patents on inventions beyond the biologic itself
    1. Patent claims tracking the results of clinical trials that will be included in the generic manufacturer's label
    2. Biologic combination therapy patents
    3. New indications that are novel and nonobvious over the indications disclosed in the original biologics patent(s)
    4. Improved formulations patents, particularly for those formulations designed for large scale randomized Phase III clinical trials
  13. Preparing for challenges at the PTAB and district court
    1. Have you secured experts?
    2. What is your strategy if the biosimilar applicant discloses its BLA?
    3. What is your strategy if the biosimilar applicant is unwilling to disclose its BLA?


The panel will review these and other critical issues:

  • How should counsel respond if a health check uncovers sub-optimal protection or defects in a patent claim?
  • Are the BCPIA claims definite or enabled under the current standards?
  • Is there a need for supplemental examination to clear the path to enforceability?


Barker, M. Paul
M. Paul Barker

Finnegan Henderson Farabow Garrett & Dunner

Mr. Barker has a diverse practice, including interferences, post-grant proceedings, patent prosecution, arbitration,...  |  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

Murphy, Amanda
Amanda K. Murphy, Ph.D.

Finnegan Henderson Farabow Garrett & Dunner

Dr. Murphy focuses her practice on client counseling and patent prosecution for a range of clients. She prepares new...  |  Read More

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