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, Marketing
Course Details
- smart_display Format
On-Demand
- signal_cellular_alt Difficulty Level
- work Practice Area
Patent
- event Date
Thursday, July 21, 2022
- schedule Time
1:00 p.m. ET./10:00 a.m. PT
- timer Program Length
90 minutes
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This 90-minute webinar is eligible in most states for 1.5 CLE credits.
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This CLE course 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 proceedings through large-scale randomized Phase III clinical trials, submission of the NDA, and subsequent approval and marketing.
Dr. Feldstein focuses on U.S. district court litigation, primarily concerning the enforcement of U.S. patent rights and trade secret issues, and post-grant trial proceedings at the USPTO, including inter partes review (IPR) and post grant review (PGR). He maintains an active patent prosecution practice, preparing and prosecuting U.S. patent applications on behalf of domestic and foreign clients. He also provides opinions and strategic guidance to clients on infringement, validity, enforceability, and clearance matters. His practice encompasses a range of technologies, including pharmaceuticals, biochemistry, polymers, small molecule chemistry, optics, and medical and analytic devices.
Mr. Irving has 47 years of experience in the field of IP law. His practice includes due diligence, patent prosecution, reissue and reexamination, patent interferences, and counseling, including prelitigation, Orange Book listings of patents covering FDA-approved drugs, and infringement and validity analysis in the chemical fields, as well as litigation. He has served as lead counsel in many patent interferences.
Dr. MacAlpine practices patent procurement, due diligence investigations, opinion work, and client counseling, primarily in the chemical and pharmaceutical areas. She has extensive experience in handling patent matters before the U.S. Patent and Trademark Office (USPTO), including post-grant proceedings specifically IPRs, appeals, and oral hearings at the PTAB; drafting and prosecution of patent applications; reissue and reexamination proceedings; and interferences.
Dr. Weingarten has a diverse intellectual property practice focusing on patent litigation before U.S. district courts and the U.S. International Trade Commission (ITC), post-grant trial proceedings at the U.S. Patent and Trademark Office (USPTO), prosecution, and strategic portfolio management. He also drafts opinions on patent infringement, validity, and enforceability, and prepares intellectual property agreements, such as those relating to license and supply. In addition, he prepares and prosecutes U.S. patent applications on behalf of domestic and foreign clients.
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, backup 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 secure 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. How can counsel efficiently identify and address sub-optimal protection and severe defects? Unlike 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.
- Are Orange Book listed patent claims definite under the current standards?
- Do Orange Book listed patent claims possess written description support under the current standards?
- Are Orange Book listed patent claims enabled under the current standards?
- Is there a need for a supplemental examination to clear the path to enforceability?
- 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?
- What is the situation with a patent term extension?
- The critical time from first NDA approval to four years after
- Are inventorship issues a problem?
- 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?
- Prosecution options through continuation applications or reissue practice
The panel will review these and other key issues:
- What are the alternatives if the "health check" reveals sub-optimal protection or severe defects?
- Are Orange Book listed patent claims definite or enabled under the current standards?
- Is there a need for a supplemental examination to clear the path to enforceability?
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