1. For HIV/AIDS, WHO-recommended combinations involve one or more constituents that are widely patented in some countries, including some least-developed countries. Formulation of these FDCs, and perhaps CBCs with these constituents, may require licensing agreements or other arrangements that would enable their legal production.
2. Most existing active ingredients for combination products for TB and malaria are not patented, although some important ones are, such as the antimalarial combination of artemether and lumefantrine known as Coartem/Riamet (Novartis). This situation may change over time as new chemical entities are developed. New FDCs and/or constituents in the pipeline may be patented and their IP will have to be properly managed to assure access.
3. Property holders may be reluctant to provide information about the number and nature of their IP portfolios. This lack of transparency as to the existence and scope of these IP rights creates uncertainty for potential competitors thereby decreasing the likelihood that such competition will occur. It is also often time consuming and difficult for procurement organizations to verify the existence and legal status of patents. Much of the relevant information should be available in the public domain, but in practice it can be difficult to obtain and/or it is just not accessible in a form which is easily understood by non-experts.
4. Various mechanisms exist that can be used to ensure that patents and other intellectual property rights do not prevent but rather facilitate the development, access and marketing of FDCs and CBCs. These mechanisms can include voluntary and non-voluntary licensing, cross licensing, pooled licensing, and other measures consistent with TRIPS safeguards (interpreted in conjunction with the Doha Declaration on the TRIPS Agreement and Public Health).
5. When specific needs and products are identified and collaborative negotiations are pursued, the IP problems may be overcome in a mutually acceptable fashion. Where collaborative negotiation does not lead to a voluntary solution however, it may be necessary to use public policy tools (including the TRIPS/Doha safeguards) to enable the necessary solution to the problem.
6. Post-2005, there will be a need to effectively manage access to certain future FDCs and constituents, including those using newly patented active ingredients, as the options for countries will have changed.
7. Least developed countries who are members of the WTO are under no obligation to enforce patents for any pharmaceutical products until at least 2016, as agreed by the World Trade Organization (WTO) Members in paragraph 7 of the Doha Declaration on the TRIPS Agreement and Public Health.
Some ways forward
1. Explore feasibility and mechanisms for public listing of licence, patent and registration status. This may involve more cooperation between countries, international organizations, national organizations (including patent offices) and companies.
2. Licensing and other IP arrangements for FDC and CBC would be facilitated by a clear identification of the priority products and formulations to be selected for licence negotiations.
3. The feasibility of expanded IP licensing arrangements should be explored with WHO and WIPO, including identification of (a) the IP needed, (b) potential licensors (IP holders), and potential licensees (other producers). Other mechanisms for technology transfer may also be possible.
4. Explore the possibility of consultations between individual industries and other stakeholders on specific IP issues for specific products.
5. If used, voluntary licensing, patent pools, and other IP sharing arrangements generally should be implemented in a manner that stimulates competition among various qualified producers. Such arrangements should include the necessary IP to manufacture specifically defined products.
6. Explore other mechanisms that would effectively address the multiple IP ownership issues of FDCs and promote innovation, which may include mechanisms for joint or collective management of IP rights.