Word Definition
Antiretroviral (ARV) Antiretroviral medicines (ARVs) are used for the treatment of HIV/AIDS. An ARV regimen usually consists of three medicines, which are sometimes combined in to one pill, a ‘fixed-dose combination’ or FDC.
Compulsory licence Compulsory licence can be granted by a government to an entity other than a patent holder to produce a given product that is patented, in exchange for ‘adequate remuneration. In the case of medicines, compulsory licences have been granted when patents have formed a barrier to public health. The ability of governments to issue compulsory licences is one of several flexibilities enshrined in the World Trade Organization’s TRIPS Agreement (Trade-Related Aspects of Intellectual Property Rights) and reiterated in the 2001 Doha Declaration on TRIPS and Public Health
Doha Declaration on TRIPS and Public Health The Doha Declaration was issued at the World Trade Organization ministerial meeting in Doha, Qatar, in 2001. It crucially stated that “…the [TRIPS] Agreement can and should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all.”
Drug resistance Drug resistance occurs after a patient has been taking antiretrovirals for a certain period, and leads to treatment no longer being effective, meaning the virus is no longer adequately suppressed in a patient. This, in turn, results in patients again becoming ill because of weakened immune systems, and being susceptible to opportunistic infections such as tuberculosis (TB), the number one killer of people living with HIV/AIDS.
First-line ARV A first-line ARV combination is the first set of medicines a patient who is being initiated on antiretroviral treatment takes. If they become resistant to one or more of the drugs in this regimen, they need to be switched to a ‘second-line’ regimen, consisting of other ARVs.
Fixed-dose combination (FDC) A fixed-dose combination, or FDC, contains two or more medicines combined into one pill, greatly simplifying treatment for patients and medical staff alike. They also help patients better adhere to their treatment, reduce the risk of resistance, and simplify supply chains. FDCs for AIDS were largely pioneered by Indian generic manufacturers, and have played a key role in helping scale up treatment to millions of people living with HIV/AIDS in developing countries. While FDCs for older generations of HIV medicines exist, combinations containing newer HIV medicines are desperately needed, as are those for children. The Medicines Patent Pool could help facilitate the development of newer FDCs.
Generic medicine A generic medicine refers to a drug that is therapeutically equivalent to an originator product, but is produced by an entity that does not hold the patent for the medicine in question.
Licence A licence is an agreement in which a patent holder allows another party to make, use, and/or sell the invention.
Licensor The patent-holder that grants the licence (for example, a pharmaceutical company, university, or public research institution).
Licensee The entity that receives a licence to use a patent (for example, the MPP, a generic drug manufacturer or drug developer).
Sub-license A sub-licence is an agreement in which a licensee (for example, the MPP) grants licensed rights to an eligible third party (for example, a generic drug manufacturer or drug developer).
Non-exclusive licence A non-exclusive licence is a licence that can be granted to more than one entity. For example, a patent-holder can grant non-exclusive licences to multiple generic drug manufacturers.
Voluntary licence A voluntary licence is a voluntary agreement reached between the patent-holder (licensor and the licensee). Terms and conditions of such a licence are agreed between the patent holder and licensee, and can specify in which countries a medicine can be sold and what the royalty will be. The Medicines Patent Pool is a mechanism that manages voluntary licences between multiple licensors and licensees.
Originator medicine An originator medicine refers to one that is produced by the patent-holder on the medicine in question.
Paediatric formulations Paediatric formulations refer to versions of medicines that have been developed specifically for children. Paediatric HIV/AIDS remains a major problem in developing countries, with nearly half a million children newly infected in 2008. However, because paediatric HIV/AIDS is virtually no longer a problem in wealthy countries, there is insufficient market incentive for the pharmaceutical industry to develop these formulations for children. Therefore, paediatric formulations of HIV medicines are often lacking or are difficult to use. The Medicines Patent Pool could help facilitate the development of appropriate paediatric formulations of HIV medicines.
Patent A patent is the right to prevent anyone else from making, using or selling the patented invention. It is granted by a government or regional authority. A patent term typically lasts for 20 years, which means that during that period of time, the patent holder has a monopoly on the invention (e.g. a medicine) and can charge the highest price the market will bear.
Patent holder The entity that holds the patent rights (e.g. an individual, pharmaceutical company, university, or public research institution)
Royalty A royalty is compensation paid to a patent holder in exchange for use of the patented invention.
Second-line ARV A second-line antiretroviral regimen is needed for patients who have developed drug resistance to their first set of medications – their first line. Second-line HIV medicines typically contain newer generation medicines that are significantly more expensive than first-line medicines.
TRIPS Agreement The 1994 World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) sets minimum standards for the protection of intellectual property, such as patents, in all WTO Members (153 countries as of 2010). All members of the WTO must comply with the standards set by the TRIPS Agreement. TRIPS required many developing countries to begin granting patents on medicines. For example, India introduced pharmaceutical product patents in 2005 to comply with (TRIPS).
TRIPS Flexibilities As expressly recognised in the Doha Declaration, the TRIPS Agreement contains several flexibilities that countries may use in order to, among other things, safeguard public health, for instance through the issuance of compulsory licences.
UNITAID UNITAID – the innovative financing mechanism dedicated to scaling-up the treatment of AIDS, tuberculosis and malaria – was established in 2006 by the governments of Brazil, Chile, France, Norway and the United Kingdom to provide additional funding for the fight against these three pandemic diseases. Roughly 70% of UNITAID’s funds come from a solidarity levy on airline tickets. Today, UNITAID is supported by 29 countries and the Bill and Melinda Gates Foundation. UNITAID decided to explore the possibility of establishing a patent pool for medicines in July 2008 and confirmed in December 2009 that it would create and fund a patent pool for medicines. The Medicines Patent Pool was thus established in July 2010, and is being funded by UNITAID under a five-year Memorandum of Understanding.

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