(2003; 40 pages)
4. How to read and use the patent table
The patent table compiled by MSF in Annex A only provides data regarding a selected number of drugs and countries. The drugs chosen are essential medicines for which patents already constitute a barrier to access or might do so in the coming years. The countries selected are countries where MSF has field projects, or is planning to open them, i.e. in which human resources were made available to obtain patent information.
It should be stressed that the patents mentioned in the table are mostly patents protecting the basic molecule of a given medicine (usually including a manufacturing process) or in the case of old molecules, the target therapeutic use of this medicine, such as the prevention or treatment of HIV/AIDS. We selected these particular patents not only because we couldn't search for all patents protecting a medicine (there may be a significant number in each country), but also because the patent related to the active ingredient of a medicine is generally the first applied for and therefore the first one to expire. This doesn't mean that no additional patent may have been granted later on to protect a different manufacturing process, or an improved formulation with fewer side-effects, or a new combination, and so forth. We would like to insist that the lack or expiry of a patent in a given country as provided in the table doesn't necessarily mean that you can import or manufacture generic versions of the medicine without a risk of being sued by a potential patent holder.
Thai activists filing a second case at the Thai Central Intellectual Property and International Trade Court in October 2002, after winning the fist case (see previous page). This time the activists aim at the withdrawal of the BMS ddI patent in Thailand.
Photo: © MSF
To help people make patent searches in countries that are not mentioned in the table, we have included the main priority date and number of the priority patent application for each medicine, as well as the number of the related international patent application, when it exists, and, for the sake of illustration, the number of the equivalent European patent. As explained in detail above, the priority date is key in determining the novelty of the invention, which may then give right to a patent. If your country is not included in the document, you could initiate a patent search by providing the priority details (date and number) of the patents related to the drug you are interested in to your patent office. You can also use the number of the international patent application to ask the patent office whether a patent has been granted in your country.
It is also advisable to first ask the patent office or WIPO from which date patents on medicines have been available in your country: if your country, like Guatemala or Peru, did not allow patenting of pharmaceuticals before a certain date, it is likely that patents with an earlier priority date will not be valid there. There would then be no need to initiate a patent search on these medicines in the local patent office.
The patent data in the table was obtained from and cross-checked between a variety of sources including local patent offices and a number of free Web sites, based on search by generic name, chemical formula and/or priority dates. Patent searches can be difficult for many reasons. We came across the following difficulties:
• Because patents protect inventions, a patent document or a patent application only describes the subject matter of the invention (i.e. the chemical formula of a molecule, a manufacturing process, a specific dosage form, a therapeutic use, etc) but seldom refers to the chemical name (INN) or brand name of a medicine because it may not have been known at the time of the patent application. Patent searches on medicines therefore require technical skills in chemistry to ensure you find out exactly which patents protect which medicines. In developing countries' patent offices, we were sometimes told that no patent protected a medicine but found out later from other sources that a patent had indeed been granted. Other times a patent was found but a thorough chemical analysis revealed that the patent was related to another medicine.
• The legal information we received from ARIPO, OAPI and WIPO was sometimes not consistent: for example, the information we got from ARIPO regarding the term of ARIPO patents conflicted with what WIPO said. Patents granted by ARIPO (numbered AP...) are subject to the national patent legislation of each ARIPO Member State. This explains why the expiry dates of ARIPO patents in Kenya, Malawi, Uganda, Zambia and Zimbabwe are different. There were also inconsistencies (which later turned out to be mistakes) regarding filing dates in some OAPI patents; the dates are necessary to calculate the estimated expiry date.
• Some countries such as Guatemala, Peru and Thailand are not included in international patent databases. Local patent offices were thus the only available sources to obtain patent data, and doublechecking was not possible.
• Some patent offices are not equipped with computers or do not have a local database containing all patent applications and granted patents, which made it very difficult to undertake a precise patent search.
• In Thailand and Ukraine we had to have patent documents translated locally. The translations may not have been 100% reliable given the complexity and technicality of patent documents.
• Requests for patent searches in patent offices are seldom free, and can be very expensive depending on the country.
Due to the above reasons, we insist that the reliability of the data provided in the table cannot be 100% guaranteed.
There have of course been previous "patent surveys" carried out including an earlier version of this report and a much debated article in the JAMA in 2001, often used to support a proposition that patents are not a barrier to access to medicines in Africa since "on average" there are said to be few patents (e.g. per country) in Africa. But as scientists and NGOs involved in treating people living with HIV/AIDS pointed out, the actual data presented in the survey did not support the claim: the most popular antiretroviral drug combination in Africa was patented in 37 out of 53 countries at the time. In contrast, many of the non-patented drugs are impractical for use in resource-poor settings.
Activists supporting the South African government against multinational pharmaceutical companies that had sued the government over a law intended to protect public health. The drug companies eventually dropped the case because of public pressure. April 2001.
Photo: © Christian Schwetz
The drug patents listed in this report (among others) do exist and cannot be wished away by any averaging process. Every such patent in force is either actually or potentially a barrier to access to an essential medicine. Even if there were only a single patent standing in the way of accessing a safe and effective yet cheap generic medicine, it would still be an obstacle that needs to be acknowledged and removed.
As explained in this report, a medicine is in any case very unlikely to be protected by a single patent but rather by a set of patents. We lacked time and resources to look for a complete set of patents for each medicine, but we hope that the patent numbers provided in the table will help others further investigate the patent status of essential medicines in their own country.
MSF provides care to adults and children living with HIV/AIDS in Guatemala. The country introduced patent protection for pharmaceuticals in 2001.
Photo: © Juan Carlos Tomasi