Intellectual property rights (IPR) in pharmaceutical industry provide certain exclusive rights to the inventors or creators of their property, in order to enable them to get commercial benefits from their creative efforts or reputation. There are several types of intellectual property protection like patent, copyright, trademark, etc.


Patents and Exclusivity

Patents and exclusivity work in a similar fashion but are distinct from one another and governed by different statutes.

Patents are a property right granted by the United States Patent and Trademark Office anytime during the development of a drug and can encompass a wide range of claims “to exclude others from making, using, offering for sale, or selling the invention throughout the United States or importing the invention into the United States” for a limited time. Generally, the term of a new patent is 20 years from the date on which the application for the patent was filed in the United States.

 

Exclusivity refers to certain delays and prohibitions on approval of competitor drugs available under the statute that attach upon approval of a drug or of certain supplements. A new drug application (NDA) or abbreviated new drug application (ANDA) holder is eligible for exclusivity if statutory requirements are met. [See 21 C.F.R. 314.108, 316.31, 316.34 and sections 505A, 505E, and 505(j)(5)(B)(iv)] of the FD&C Act.


Exclusivity Periods

  • Orphan Drug Exclusivity (ODE) – 7 years
  • New Chemical Entity Exclusivity (NCE) – 5 years
  • Generating Antibiotic Incentives Now (GAIN) Exclusivity– 5 years added to certain exclusivities
  • New Clinical Investigation Exclusivity – 3 years
  • Pediatric Exclusivity (PED) – 6 months added to existing Patents/Exclusivity
  • Patent Challenge (PC) – 180 days (this exclusivity is for ANDAs only)
  • Competitive Generic Therapy (CGT) - 180 days (this exclusivity is for ANDAs only)


Submission of patent information upon and after approval

  • NDA number
  • The NDA applicant's name
  • Trade name (or proposed trade name) of new drug
  • Active ingredient(s) of new drug
  • Dosage Form(s)
  • Strength(s)
  • Route(s) of Administration
  • Type of Use
  • The patent owner's name, full address, phone number and, if available, fax number and email address
  • Information on whether the patent has been submitted previously for the NDA or supplement


Types of claims on patent

  • Active ingredient
  • Polymorph of active ingredient
  • Metabolite of the active ingredient
  • Intermediate
  • Method-of-use patent etc.


Patent number is varied depending on these claims and the expiration date is varied depending on the time of application and approval.


Source of Patent and Exclusivity Information 

By following below sequence you can find the patent and exclusivity information of any FDA approved drug product for US MARKET:


FDA Website (Home) > Drug > Drug Approvals and Databases > Orange Book > Search > Click on Application No. > Click on Patent and Exclusivity Information > Find the Patent No., Expiration Date, Submission Date, Exclusivity Code, Exclusivity Expiration etc. > Patent search on uspto.gov.


WTO TRIPS Agreement

The World Trade Organizations (WTO) operates the global system of trade rules and helps developing countries build their trade capacity. It also provides a forum for its members to negotiate trade agreements and to resolve the trade problems they face with each other. 


The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is the most comprehensive multilateral agreement on intellectual property (IP).


A developing or least-developed country (WTO Member) shall be waived to the extent necessary to enable a pharmaceutical product produced or imported under a compulsory license in that Member to be exported to the markets of those other developing or least developed country parties to the regional trade agreement that share the health problem in question.


References:

  • World Trade Organizations (WTO)
  • USFDA

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