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Exceptions and Limitations to Patent Rights

The granting of exclusive patent rights is considered as an incentive for investment in innovative activities and the production of knowledge.  However, allowing the enforcement of the full scope of the exclusive rights in all circumstances may not always meet the ultimate goal of the patent system to enhance the public welfare.  Therefore, in order to strike the right balance between the interests of the right holders, third parties and the public, the scope of the enforceable patent rights is, under national patent laws, calibrated by certain exceptions and limitations. The policy choice to introduce or maintain such exceptions or limitations under national law is reserved for decision by individual countries, subject to their commitments under international law.

Since the socio-economic conditions and priorities of a country influence this balancing of interests, provisions in patent laws on exceptions and limitations vary from one country to another. 

The Standing Committee on the Law of Patents (SCP) has identified that the legislation of many countries provides some or all of the following exceptions and limitations to patent rights:

  • private and/or non-commercial use;
  • experimental use and/or scientific research;
  • extemporaneous preparation of medicines;
  • prior use;
  • use of articles on foreign vessels, aircrafts and land vehicles;
  • acts for obtaining regulatory approval from authorities;
  • exhaustion of patent rights;
  • compulsory licensing and/or government use; and
  • certain use of patented inventions by farmers and breeders.

For information on how countries implemented these exceptions and limitations to patent rights, see the Questionnaire (last updated on October 2015), the Reponses to the Questionnaire, the Documents prepared by the Secretariat and Expert studies and seminars. In addition, the web page on certain aspects of national and regional laws (Annex II of document SCP/12/3 Rev.2) provides a summary of exceptions and limitations provided in the applicable national/regional laws.

SCP activities on the topic

During recent years, a number of documents prepared by the SCP Secretariat and external experts as well as proposals made by Member States have been subjects of discussion and deliberation at the sessions of the SCP.

Documents prepared by the Secretariat

Draft reference documents on:

Preliminary studies on nine most commonly found exceptions and limitations to patent rights

  • Compulsory Licenses and/or Government Use (Part I) (SCP/21/4 Rev. (2014))
  • Compulsory Licenses and/or Government Use (Part II) (SCP/21/5 Rev. (2014))
  • Exhaustion of Patent Rights (SCP/21/7 (2014))
  • Acts for obtaining Regulatory Approval from Authorities (SCP/21/3 (2014))
  • Farmers’ and/or Breeders’ Use of Patented Inventions (SCP/21/6 (2014))
  • Experimental Use and/or Scientific Research (SCP/20/4 (2013))
  • Private and/or Non Commercial Use (SCP/20/3 (2013))
  • Prior Use (SCP/20/6 (2013))
  • Use of Articles on Foreign Vessels, Aircrafts and Land Vehicles (SCP/20/7 (2013))
  • Extemporaneous Preparation of Medicines (SCP/20/5 (2013))

Member States’ experiences and case studies 

  • Practical Experiences on the Effectiveness of, and Challenges Associated to, Exceptions and Limitations (SCP/25/3 and SCP/25/3 ADD. (2016))
  • Member States’ Experiences and Case Studies on the Effectiveness of Exceptions and Limitations (SCP/23/3 (2015))

General documents on exceptions and limitations to patent rights

Proposals by Member States

Proposal by the Delegation of Brazil regarding exceptions and limitations to patent rights (SCP/19/6 (2013) and SCP/14/7 (2010))

Questionnaire & responses

  • Questionnaire on exceptions and limitations (Table)
  • Overview of Responses to the Questionnaire on Exceptions and Limitations to Patent Rights (SCP/18/3 (2012))
  • Responses to the Questionnaire on Exceptions and Limitations to Patent Rights (SCP/17/3 and SCP/17/3 Add. (2011))
  • Draft Questionnaire on Exceptions and Limitations to Patent Rights (SCP/16/3 Rev. (2011))

Expert studies and seminars

  • Seminar on Exceptions and Limitations to Patent Rights (SCP/21/INF/2 (2014))
    • Presentations are available at SCP/21 under "Other Related Documents"
  • Seminar on Exceptions and Limitations (SCP/20/INF/2 (2014))
    • Presentations are available at SCP/20 under "Other Related Documents"
  • Experts’ Study on Exclusions from Patentable Subject Matter and Exceptions and Limitations to the Rights (SCP/15/3 (2010))