Patent Term Adjustment After In re Cellect**

Patent Term Adjustment After In re Cellect**

View Session Speakers

Patents are often filed on drug candidates long before the innovator receives FDA approval. As a result, the terminal portion of the patent’s life is the most valuable and important to ensure the innovator can see a return on their investment. Extra years, months, or even days of patent term can result in millions of dollars of revenue. Thus, the application of the ever-changing Patent Term Adjustment (PTA) rules is particularly important to the pharmaceutical industry.

Patent Term Adjustment for USPTO delay is guaranteed by statute (35 U.S.C. 154) and the calculation of how many additional days of patent term should be rewarded is a fact-intensive inquiry that relies on a complicated landscape of rules and case law. Recent judicial holdings (e.g., In re Cellect) have significantly weakened PTA and have in some cases created “traps” that subvert congressional intent. For example, companies can lose PTA for simply filing an Information Disclosure Statement (e.g., Supernus Pharmaceuticals, Inc. v. Iancu). On the other hand, actions that would normally be discouraged (such as filing a Request for Continued Examination) have become important tools to protect PTA.

This panel will discuss the policy implications of this ever-evolving framework of rules and cases.

Materials

Amicus, USPTO Urge Denial of Cellect SCOTUS Petition

PTAs, PTEs and Terminal Disclaimer Practice under In re Cellect

CAFC Issues Precedential Ruling on Proper Analysis for Patent Term Adjustment in Double Patenting Cases

Let’s Do Something About the Unauthorized Doctrine of Non-Statutory Judicially Created Obviousness-Type Double Patenting

Double Patenting Slide

Survey

https://www.surveymonkey.com/r/Patent-Term-Adjustment-After-In-re-Cellect