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

Phase II Efficacy Trials, Phase III Clinical Trials, NDA Submission, Approval and Marketing

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


Conducted on Thursday, March 8, 2018

Recorded event now available

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Program Materials

This CLE webinar will provide guidance to 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 small molecules in Phase II efficacy trials and proceeding through large-scale randomized Phase III clinical trials, submission of the NDA, and subsequent approval and marketing.

Description

Congratulations, your small molecule drug has passed the hurdles of preclinical studies, “first-in-human” Phase I safety, Phase II efficacy, and large-scale randomized Phase III clinical trials. Maybe, the NDA is already approved. Along the way, patent counsel has worked to secure U.S. patents with claims directed to the drug substance, back up drug substances, drug products, and methods of treatment, among other novel and non-obvious inventions.

The return on the invested effort, time and multimillion dollar development costs now depends strongly on patent exclusivity, which generally runs longer than regulatory exclusivity. Patent exclusivity based on claims to a new chemical entity is common, but what about patent exclusivity for polymorphs, 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 ANDA litigation? You must give your portfolio a “health check” to answer these questions. What can be done to uncover sub-optimal protection and serious defects depends on how soon the issues are identified and solutions are implemented. This is not a course on due diligence, which is inter partes; health checks are ex parte.

Listen as our authoritative panel of patent attorneys discusses the essentials of patent exclusivity that are in critical need of checking. The panel will offer suggestions for strategies to improve U.S. patents that will be Orange Book listable and other U.S. patents that will not be listable, but may be challenged in PTAB proceedings or added to an ANDA litigation.

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Outline

  1. Are Orange Book listed patent claims definite under the current standards?
  2. Do Orange Book listed patent claims possess written description support under the current standards?
  3. Are Orange Book listed patent 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 impact, if any, did terminal disclaimers cause to patent term adjustment under Federal Circuit cases such as Gilead and its progeny?
  6. What is the situation with patent term extension?
  7. The critical time from first NDA approval to four years thereafter
  8. Are inventorship issues a problem?
  9. 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 ANDA litigation?
  10. Prosecution options through continuation applications or reissue practice

Benefits

The panel will review these and other key issues:

  • What can be done if sub-optimal protection or even serious defects are discovered during the “health check”?
  • Are Orange Book listed patent claims definite or enabled under the current standards?
  • Is there a need for supplemental examination to clear the path to enforceability?

Faculty

Irving, Thomas
Thomas L. Irving

Partner
Finnegan Henderson Farabow Garrett & Dunner

Mr. Irving has 35 years of experience in the field of IP law. His practice includes due diligence, patent prosecution,...  |  Read More

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

Partner
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.

Partner
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

Livingstone, John
John D. Livingstone

Partner
Finnegan Henderson Farabow Garrett & Dunner

Mr. Livingstone focuses on U.S. district court patent litigation involving the pharmaceutical, chemical, and...  |  Read More

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