Throughout these pages, and the wider debate, you will find references to various terms and agreements regarding intellectual property (IP), patents and transparency.  This glossary of terms helps to decipher and engage in the work to improve access to medicines.

GLOSSARY

Bolar Exemption
A legal exception that permits the use of a patented invention before the patent expires for the purposes of obtaining marketing approval of a generic product for a commercialisation once the patent expires[1].

Compulsory License/Government Use
A compulsory licence is an authorisation by a competent government authority to use a patented invention by a third party without the consent of the patent holder, against a payment of “adequate remuneration”. A “government use” is a particular form of compulsory licence issued by the government for its own use or for the use of a third party[2].

Data Exclusivity
Prohibition of use of pharmaceutical test data submitted to a regulatory agency by an originator company for the purpose of registering a generic drug. Generic companies rely on this test data to demonstrate the safety and efficacy of their bioequivalent drug. [3]

Evergreening
The practice of seeking secondary patents with the aim to extend market exclusivity beyond the patent term of the basic patent[4].

Most Favoured Nation (MFN) treatment
One of the founding principles of the World Trade Organization. MFN Treatment says that all trading partners must be given equal advantages as the “most favoured” trading partner. For example, a country may not grant tariff exemptions to only one trading partner unless it extends the same to all trading partners[5].

Parallel Importation
Parallel importation refers to the import and resale in a country, without the consent of the patent holder, of a patented product that has been legitimately put on the market of the exporting country. Parallel imports take place when there are significant price differences for the same good in different markets[6].

Supplementary Protection Certificate
Supplementary Protection Certificates (SPCs) constitute an example of additional monopoly rights, intended to expand monopoly protection for medicines beyond the twenty-year patent term[7].

TRIPS Flexibilities
A term used broadly to describe a set of norms, rules and standards that allow variations in the implementation of the TRIPS Agreement obligations, including limits on the excessive use of Intellectual Property Rights[8].

TRIPS+
These are measures that require more stringent intellectual property standards than those contained in TRIPS, or that limit flexibilities inherent in TRIPS. They are often contained in bilateral or regional trade agreements.

Voluntary Licence
A license granted by a patent holder to a third party to produce and/or market and distribute a patented product, usually in exchange for a royalty on net sales and certain other conditions (for example geographical restrictions on where the product can be sold).[9]

 

REFERENCES

[1] UNHLP Report of the United Nations Secretary General’s on Access to medicines. Promoting Innovation and access to health technologies. September 2016 pp. 5

[2] t’Hoen, E. Private patents and public health. Changing Intellectual Property rules for access to medicines Health Action International (HAI) 2016 pp. 146

[3] ibid

[4] ibid

[5] t’Hoen, E. Private Patents and Public Health. Changing Intellectual Property rules for access to medicines Health Action International (HAI) 2016 pp

[6] ibid

[7] MSF ACCESS CAMPAIGN Briefing note on supplementary protection certificates Threatening access to affordable medicines across the European Union September 2017. PP. 1 Accessible at https://www.msfaccess.org/content/briefing-note-supplementary-protection-certificates-spcs

[8] UNHLP Report of the United Nations Secretary General’s on Access to medicines. Promoting Innovation and access to health technologies. September 2016 pp.6

[9] ibid.

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