Determining the intellectual property and patent status of medical products is a complex task that may require support from UNDP HQ or external resources. While Global Fund policies allow grant funds to be used to contract an intellectual property consultant, if needed, for non-Global Fund engagement, such as procurement services to governments and/or other parties, please consult with the UNDP Global Fund/Health Implementation Support Team.
A patent is an exclusive right granted for an invention, a product (i.e. a drug, an active ingredient) or a process (i.e. manufacturing) that provides a new way of doing something or offers a new technical solution to a problem. A patent provides its owner with protection for the invention for a limited period—generally 20 years. Each country (or region, where applicable) has its own patent laws, and a product that is patented in one country may not be patented in another. For example, a patent may exist in an exporting country but not in the importing country or vice versa. The national or regional patent situation will directly affect what products can be procured from which suppliers and what scope there will be for negotiation on prices.
A country may also be subject to regional patent laws. For example, 17 countries in Western and Central Africa are members of the African Organization of Intellectual Property (OAPI), which has issued patents for many antiretroviral products that are enforceable in its Member States. Nine former Soviet Union countries are parties to the Eurasian Patent Convention and recognize Eurasian patents issued by the Eurasian Patent Organization, including those issued for pharmaceuticals.
To initiate a patent search, the enquirer must know the international nonproprietary name (INN), the name of the patent owner (i.e. originator, inventor, university) or the name of the license-holder and the exporting and importing country/countries in question.
The basic steps for resolving the patent status of medical products are as follows:
- Determine if the country has patent laws providing for the enforcement of patents for pharmaceutical products. Under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement of the World Trade Organization (WTO), all Member States, except least developed countries (LDCs), were obligated to enforce the patenting of pharmaceutical products by 1 January 2005.
LDCs have been granted an extension of the waiver on pharmaceutical products until 1 January 2033, further to the previous extension until 1 January 2016. However, almost all LDCs have begun to allow the patenting of pharmaceutical products, so it should not be assumed that there is no patent problem simply because the pharmaceuticals being bought are for an LDC. If an LDC has a patent system, it must publicly elect not to enforce those laws in order to comply with the TRIPS Agreement invoking non-recognition and non-enforceability of patents and data protection. LDCs should complete a declaration that affirms that they are utilizing the transition period for implementing the minimum requirements of the TRIPS Agreement for pharmaceutical patents.
If it is determined in step 1 that there is no patent law for the patenting of pharmaceutical products, then there is no in-country obstacle to purchasing generic medicines, whether imported or procured locally.
Tools that are available in the public domain to assist in patent searches include the Medicines Patent Pool database. Currently, however, they are limited to antiretrovirals and selected hepatitis drugs.
- If it is determined in step 1 that the country provides patent protection to pharmaceutical products, then the enquirer must determine if any products on its procurement list are patented or receive patent protection. To determine which products are patented, COs should request that the patent office conduct a patent search. Information on whether a product is patented or not should be public; however, if the patent office is unable to provide a conclusive answer, then the CO should consult the UNDP Global Fund/Health Implementation Support Team and consider contracting a patent lawyer or a patent representative to conduct the search.
- If it is determined in step 1 that there is no patent law for the patenting of pharmaceutical products, then there is no in-country obstacle to purchasing generic medicines, whether imported or procured locally.
- If it is determined in step 2 that some of the products on the list are, in fact, patented, it must then be determined whether the patents are valid. To be valid, patents must comply with national law and the patent-holder must comply with national administrative requirements for maintaining the patent. The latter usually requires the patent-holder to pay a maintenance fee (generally on an annual basis). Failure to pay this fee in a timely manner could result in the patent lapsing.
- If there are valid patents on any of the products on the procurement list, determine if the country can utilize any of the flexibilities in the TRIPS Agreement (commonly referred to as ‘the TRIPS public health flexibilities’) to legally purchase generic versions of the product. The most common TRIPS flexibilities are voluntary licences, compulsory licences, government use orders, and parallel imports. Use of these flexibilities is consistent with international laws and allows the recipient country to legally purchase generic versions of patented pharmaceutical products. However, it is imperative that the flexibilities be correctly invoked by the relevant responsible governmental authorities to allow for their legal use.
- If there are valid patents on any of the products on the procurement list, and no flexibilities in the TRIPS Agreement or other measures to legally purchase generic versions of the product are found, the COs should procure the product from the patent-holder.
A detailed description of how to utilize the public health TRIPS flexibilities to reduce the cost of medicines is provided in Good Practice Guide: Improving Access to Treatment by Utilizing Public Health Flexibilities in the WTO TRIPS Agreement.