On 25 September, the World Intellectual Property Organisation (WIPO) in collaboration with the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) launched the Patent Information Initiative For Medicines (Pat-INFORMED) a database of medicines patents. So far, 20 companies contribute patent information on small molecule products for the treatment of cancer, hepatitis C, cardiovascular disease, HIV, diabetes, respiratory diseases and any other products on the WHO Essential Medicines List.
Pat-INFORMED links key patent status information with registered drugs in low, middle and high-income countries. The initiative’s ambition is to become “the global Orange Book”, after the US Food and Drug Administration (FDA) database of patents of registered medicines. But for that to happen all companies would need to participate and that is currently not the case. Mr Thomas Cueni, head of the IFPMA, said the database ‘it is a work in progress’ and it is therefor expected that others will join. The database is a response to calls from the health community for greater transparency in medicines patent status information. A call also heard in WIPO’s own Development Agenda of 2007. In principle, patents are public documents but searching them for relevant information is difficult because the international non-proprietary name (INN) – the internationally recognised generic name of a medicine – is often lacking from the document.
Browsing through the new database it is hard not to be impressed. Pat-INFORMED will certainly increase transparency of medicines patents. This is useful for a range of reasons and actors, including those involved in the procurement of medicines on the global market. It will, however, be important to expand the scope to include information from all companies and to include patent information about biologic products. For example, patent information about the breast cancer drug trastuzumab is currently missing from the database despite the fact that it is on the WHO Essential Medicines List and its patent holder Roche is one of the contributors to Pat-INFORMED.
In 2003 Medecins sans Frontieres (MSF) published the first medicines patent database for the health community titled “Drug Patents Under the Spotlight” which contained patent information about medicines used in the treatment of HIV/AIDS. The patent status information came with information about how to overcome patent barriers for the procurement of low-cost generic versions of antiretroviral medicines. This was done to re-assure procurement agencies that might think a patent listing in a country in the database meant that generic supply was blocked for that territory. Subsequently, procurement agencies began to rely on TRIPS flexibilities in the procurement and supply of medicines. See here for more details.
The MSF database formed the seed for MedsPal, the patent status database created and maintained by the Medicines Patent Pool since 2016. MedsPal holds patent information from about 110 low and middle-income countries and covers medicines used in the treatment of HIV, HCV, tuberculosis, and essential medicines. MedsPal does not rely on the information provided by the companies but works with national and regional patent offices. MedsPal also provides information about patent applications and indicates whether a patent is granted, rejected, withdrawn. MedsPal also provides information about whether licences allowing generic production or supply for a certain territory are available.
The call for patent transparency is indeed not new. In 2016 KEI published an overview of various efforts to increase transparency in medicines patent Information. In 2008 the WHO’s Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property identified the need to improve access to patent information. And it urged stakeholders to:
- facilitate access to user-friendly global databases which contain public information on the administrative status of health-related patents. This includes supporting existing efforts for determining the patent status of health products, and to
- promote further development of such global databases including, if necessary, compiling, maintaining and updating such global databases.
The WHO and WIPO subsequently published in a number of patent landscapes. See for example WHO’s patent landscape for hepatitis C products. And WIPO’s patent landscapes for the HIV medicines ritonavir and atazanavir and other products. See for additional sources here.
Expanding medicines patent transparency is a welcome development. It will be interesting to watch how Pat-INFORMED develops as a contributor to this important area of knowledge.
[This post was updated 16:00h 27 Sept. 2018]