Princeton, New Jersey
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Regulatory Exclusivity - U.S.

How exclusivity is a parallel market protection to patents.
  • Level:  Core Course
  • Duration:  30 minutes
  • Instructor: 
    Matthew Holley, JD, M.Ed

You will learn:

  • Drug Application Types
  • Drug Clinical Investigation
  • Biologic Reference Product
  • Orphan
  • Antibiotic - GAIN/QIDP
  • Generic drug  exclusivities
  • Interchangeable Biologics
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PowerPoint: 
Instructor

Matthew Holley

Matt has served as General Counsel for two different pharmaceutical companies.   In those roles he has managed the patent and trademark portfolios, including developing patent strategies.   He has particularly worked with Business Development and internal development teams to develop patents for in-licensed product, internally developed products and life-cycle innovations.  He has taught internal company teams on patent development and dynamics with outside counsel.    

Course Resources and References

Drug Application Types
United States Code 
Regulation
Agency Guidance
Best Explanation of Drug Application Types
505B1 NDA: Complete FDA New Drug Approval Guide - Registrar Corp
505B2 NDA: Accelerated FDA Drug Approval Explained - Registrar Corp
505(b)(2) Development Articles And Insights | Premier Consulting
New Chemical Entity
Academy Cheat Sheet on Drug Exclusivity
United States Code
21 CFR Part 314 -- Applications for FDA Approval to Market a New Drug  21 CFR 314.108
New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products | FDA
The Scope of New Chemical Entity Exclusivity and FDA’s “Umbrella” Exclusivity Policy
New Clinical Investigation
Orphan Product Exclusivity
FDA guidance document: “21 C.F.R Part 316 - Orphan
Drugs.”
www.fda.gov/RegulatoryInformation/Legislation/
FederalFoodDrugandCosmeticActFDCAct/
SignificantAmendmentstotheFDCAct/OrphanDrugAct/
default.htm
2 FDA guidance docume

Antibiotic - GAIN/QIDP
21 U.S.C. 355f Generating Antibiotic Incentives Now Act of 2011 ("GAIN"); 505E of the FD&C Act.
21 C.F.R. § 317.2
Qualified Infectious Disease Product Designation Questions and Answers Guidance for Industry download
Time to GAIN: Are Your FDA Marketing Exclusivities Eligible for Extension? | Articles | Finnegan | Leading IP+ Law Firm
Opinion:  2018 U.S. Department of Health and Human Services report  GENERATING ANTIBIOTIC INCENTIVES NOW
Opinion:  The Wrong Cure: Financial Incentives for Unimpressive New Antibiotics - PORTAL: Program on Regulation, Therapeutics, and Law

Pediatric Exclusivity
Cheat Sheet on Pediatric Exclusivity
FDA guidance document: “Guidance for Industry, Qualifying
for Pediatric Exclusivity Under Section 505A of the Federal
Food, Drug, and Cosmetic Act.”
www.fda.gov/downloads/drugs/developmentapprovalprocess/
developmentresources/ucm049924.pdf
180-day First Generic Challenger
Cheat Sheet on First Generic Challenger Exclusivity
Guidance for Industry 180-Day Exclusivity: Questions and Answers
Competitive Generic Therapy
Guidance for Industry:  Competitive Generic Therapies https://www.fda.gov/media/136063/download 

List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic | FDA
Competitive Generic Therapy Approvals | FDA

.Characteristics and Outcomes of Products Seeking Competitive Generic Therapy Designation and Exclusivity - PMC
Biologic Reference Product
Cheat Sheet on Biologic Reference Product Exclusivity
Microsoft PowerPoint - Webinar - FDA Lifecycle Management Webinar Regulatory Exclusivity for Novel Drugs and Biologics.PPTX
First Interchangeable Biologic
Cheat Sheet on First Interchangeable Biologic Exclusivity
download  Exclusivity Which one is for me?  Rinku Patel, PharmD  FDA

Peng, B., & Tomas, M. C. (2014). A Cheat Sheet to Navigate the Complex Maze of Exclusivities in the United States. Pharmaceutical Patent Analyst, 3(4), 339–343. https://doi.org/10.4155/ppa.14.30

How to think of categories of patents.
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