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Patent & Regulatory Exclusivity Analysis

Intellectual property rights are among the most vital economic assets for any research or corporate organization. Traditionally, IP has focused on patents, trademarks, copyrights, and trade secrets. These IP protections convey exclusive rights and advantages that provide incentives for investments needed for research and development. For pharmaceutical and biotechnology products, these traditional rights are enhanced by significant regulatory rights that provide data and market exclusivity and other market advantages.

Patents Versus Regulatory Exclusivity

Pharmaceutical patents and FDA regulatory exclusivity accomplish similar objectives but differ significantly in various ways. A drug or medical device patent grants the owner intellectual property rights over that product via the United States Patent and Trademark Office, preventing others from making, using, or selling patented inventions. Regulatory exclusivity bars the filing or approval of applications and varies in scope and duration. Although related, most regulatory exclusivity periods and patents operate in parallel.

Drug and device patent owners are currently protected by a 20-year patent term (from the application filing date). Patent terms are not affected by drug or device FDA approval status. The 20-year patent term may be extended in some scenarios, such as when products, methods of use, or manufacturing methods require pre-marketing approval.

Exclusivity periods differ depending on the type of exclusivity granted:

  • New Chemical Entity (NCE) Exclusivity: up to 5 years
  • New Clinical Investigation Exclusivity: 3 years
  • Reference Product Exclusivity: 12 years
  • Orphan Drug Exclusivity: 7 years
  • Pediatric Exclusivity: adds 6 months to some patents/exclusivities
  • Patent Challenge Exclusivity (for ANDAs): 180 days
  • Generating Antibiotic Incentives Now (GAIN) Exclusivity: adds 5 years to products receiving Qualified Infectious Disease Product designation
  • Competitive Generic Therapy (CGT) Exclusivity (for ANDAs): 180 days

Pharmaceutical Patent & Regulatory Exclusivity Analysis

Detailed analysis of existing patents and market exclusivities should be undertaken to optimize life cycle management.

A regulatory IP strategy should take into account:

  • The scientific characteristics of the product
  • The regulatory status of the product
  • Clinical information regarding the safety and efficacy of the product
  • The competitive environment
  • Pricing
  • Consumer preference, and
  • Timing with respect to product development, exclusivity expiration, patent protection, competitor product introduction, and other market developments.

Pharma Patent and Exclusivity Expertise

Gregory Glover MD JD is a leading authority on the complex interaction of FDA regulation and intellectual property. Dr. Glover advises U.S. research biotechnology companies, medical device developers, and biological and small molecule pharmaceutical sponsors and manufacturers on preparing patent and exclusivity applications, filing extension requests, and analyzing validity in complex pharmaceutical IP portfolios.

Dr. Glover’s knowledge of the ever-shifting regulatory landscape involving new drugs, generics, biologics, biosimilars, cell therapies, and medical devices offers drug developers and manufacturers a competitive advantage. His decades of expertise in pharmaceutical patents and regulatory exclusivity help drug sponsors maximize and defend their market positions.

To Connect with Gregory Glover, MD JD, and Pharmaceutical Law Group

202.589.1780 or [hidden email]