Extent of Drug Patents With Terminal Disclaimers and Obviousness-Type Double Patenting Rejections

Author:

Tu S. Sean1,Kesselheim Aaron S.2,Chao Bernard3

Affiliation:

1. West Virginia University College of Law, Morgantown

2. Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital, Boston, Massachusetts

3. University of Denver Sturm College of Law, Denver, Colorado

Abstract

This study evaluates the frequency of terminal disclaimers filed by drug patent holders to obviate obviousness-type double patenting rejections associated with drug patent thickets.

Publisher

American Medical Association (AMA)

Reference6 articles.

1. Polymorphs and prodrugs and salts (oh my!): an empirical analysis of “secondary” pharmaceutical patents.;Kapczynski;PLoS One,2012

2. Biologic patent thickets and terminal disclaimers.;Tu;JAMA,2024

3. Patent and Trademark Office. Terminal Disclaimer Practice to Obviate Nonstatutory Double Patenting: Notice of Proposed Rulemaking. Federal Register. May 10, 2024. Accessed June 29, 2024. https://www.federalregister.gov/documents/2024/05/10/2024-10166/terminal-disclaimer-practice-to-obviate-nonstatutory-double-patenting

4. Welch, Braun, and Klobuchar introduce bipartisan legislation to streamline drug patent litigation, lower cost of prescription drugs. Senator Peter Welch website. January 12, 2024. Accessed June 29, 2024. https://www.welch.senate.gov/welch-braun-and-klobuchar-introduce-bipartisan-legislation-to-streamline-drug-patent-litigation-lower-cost-of-prescription-drugs/

5. US Patent and Trademark Office. PatentsView. Updated April 22, 2024. Accessed June 29, 2024. https://patentsview.org/

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