The Medicines Patent Pool (MPP)’s patents and licences database MedsPaL is a free resource that provides information on the intellectual property status of selected patent essential medicines in low- and middle-income countries (LMICs).
MedsPaL was launched in October 2016 focusing on medicines for three diseases: HIV, hepatitis C and tuberculosis. In December 2017, it was expanded to cover all patented medicines on the World Health Organization Model List of Essential Medicines (WHO EML). After the new WHO EML was released in July 2019, MedsPaL was updated to include patent information on 18 newly-listed medicines. In March 2020, it was expanded further to provide patent information on treatments currently being tested for COVID-19.
The database includes patent and licensing data covering over 10,500 national patent applications on 135 priority medicines (260 formulations) in more than 130 LMICs.
We also collaborate with national and regional patent offices, to collect information for the database. See more
Q&A ON MEDSPAL
The database lets you search patent and licence information by country, medicine name and disease areas. It also enables free text searches, such as by patent numbers, product brand name, applicant name, patent status or any combination of these. Wherever a patent has been applied for or granted in a given jurisdiction, a patent card provides detailed information about the application, and links to further information. Wherever a licence has been signed for a specific medicine, a licence card provides detailed information about the licence agreement.
The database covers patented medicines that are included in the WHO Model List of Essential Medicines across all disease areas. In addition, the database includes some other promising new medicines or pipeline compounds for the treatment of HIV, tuberculosis or hepatitis C. In March 2020, the database was expanded to patent and licensing data on treatments being tested for COVID-19.
MedsPaL includes patent and licensing information for low and middle-income countries as defined by the World Bank, for which patent data could be obtained. In addition, we have also included some high-income countries that only recently changed from middle-income country status or that are included in some of MPP’s licences.
We identify patents relevant to the selected medicines in four different ways:
- Patents disclosed in the US FDA Orange Book and Health Canada Patent Register: both agencies list patents relevant to approved medicines that are provided by market authorization holders. The US FDA lists patents that claim a drug substance (active ingredient), drug product (formulation and composition) or method of use. Health Canada lists patents that contain a claim for the medicinal ingredient, a claim for a formulation, a claim for a dosage form or a claim for the use of the medicinal ingredient. Process patents related to intermediate steps or full manufacturing of the medicine are not disclosed in these databases.
- Patent data disclosed by licensors in licence agreements (where available). These lists of patents are often more comprehensive as they are not subject to the restrictions above.
- Patent landscapes and analysis from reputable sources, such as those commissioned by Unitaid or the WHO.
- Patent searches undertaken by MPP: particularly when a medicine is not yet approved in US or Canada, MPP undertakes its own searches to identify relevant patent families.
In MedsPaL, we provide the source of the patent family under ‘Patent Family Identification’ in each patent card. However, as noted in the disclaimer, patent information provided by MedsPaL is not a ‘freedom-to-operate’ analysis: some patents or patent families may be missing, while others displayed by MedsPaL may not prevent generic competition.
We obtain patent applications filed at national and regional level through:
- automated data feeds from the European Patent Office (EPO) Open Patent Service
- information obtained directly from national and regional patent offices, including through collaboration agreements with some of those offices (see list of patent offices with whom we have collaboration agreements)
- national and regional patent offices’ databases
- reports on corresponding foreign applications and grants required by some patent offices
- applications and grants disclosed in licence agreements
- national phase information provided by WIPO PatentScope
- the Pat-INFORMED database hosted by WIPO
- patent searches commissioned to local patent attorneys or other national experts
Whenever possible, we cross-check information from multiple sources. Wherever there are discrepancies between different sources, information from the national/regional patent offices prevails.
While we try to update patent data in MedsPaL regularly, some data may be incomplete or outdated. We advise you to contact the relevant national or regional patent office or consult local patent counsel to obtain up-to-date information on any given patent or patent application identified in MedsPaL. We also invite you to tell us about any incomplete or inaccurate data, so that we can correct it. Please contact: medspal@medicinespatentpool.org
We update patent data on MedsPaL on a regular basis. For certain countries, for which data is available on the European Patent Office’s Open Patent Service, the information is updated on a monthly basis. For other countries, for products that are regularly searched on MedsPaL and attract the most attention, we undertake updates on a quarterly basis. For other products, information is updated at least once a year.
MedsPaL indicates that a patent application is not filed in certain jurisdictions for a given patent family when:
- the national patent office has told us that no equivalent patent was filed in the country
- no patent application for the country and product was disclosed in the licence agreement, which provides a comprehensive overview of patent applications filed and granted patents. Not all licence agreements provide a complete patent landscape however
- no patent application for the country in question was disclosed as part of the mandatory requirements of corresponding foreign applications and grants required by some patent offices
- if filed, the corresponding patent would have expired even if possible patent term extension(s), where applicable, are taken into consideration.
The patent description appearing on MedsPaL is a brief description we provide to help identify patents and is assigned to each patent family. MedsPaL patent descriptions are written by MPP and are not official descriptions appearing in patent documents. We provide the original titles of patents in the patent cards, when possible.
MedsPaL assumes national applications last for 20 years from the date of filing. However, patent terms may differ among countries depending on national legislation, whether patent term extensions are available, or for other reasons. Wherever we have information on an expiry date for a given country that differs from the 20 years from the filing date, we include that information on MedsPaL. When we know that a given patent has expired, we indicate that on the database. At times, however, we may expect for a given patent to have expired, but may have been unable to obtain confirmation. In such cases, the expected expiry date may be in the past.
Wherever there is public information on a licence signed on a given product for a given country, we display it along with the relevant patent information. Data on licences signed by MPP are public and have been integrated into the database with links to licence summaries and further information, including the full text of the licence agreements. For bilateral licences and commitments not to enforce patents in certain jurisdictions, we take data from the licensors’ websites, official press releases or direct communications to us from licensors. Information on bilateral licences is often limited. Wherever possible, we provide links for further information. We base data on compulsory licences on official information in government websites or from other public sources.
We collect information on pharmaceutical test data exclusivity from the relevant authorities in countries where it is provided by law, through direct communication or official websites. Information is not yet available for all countries concerned and we will gradually supplement and update it.
Users should NOT consider MedsPaL a complete and authoritative source of patent information, and it is not meant to provide a ‘freedom-to-operate’ analysis. It only provides a snapshot at a point in time, based on the information available to us.
We do not accept any legal responsibility for the accuracy of data. In particular, we do not guarantee it is complete, up to date or fit for specific purposes. Users should undertake additional country search and legal analysis before making any procurement or business decision.
A full understanding of the patent situation in any country, for a specific medicine, requires additional information and analysis not provided in this database. This includes an analysis of the specific claims of a national/regional patent application or granted patent. Users should also consider whether the country is a Least Developed Country (LDC) and may benefit from the transition period provided by the World Trade Organization TRIPS Agreement, or whether the country is making use of any of the other flexibilities available under national or international regulations.
We will try to update and improve MedsPaL regularly. By making information we have obtained publicly available to others, we hope others will help us improve the database. We invite you to submit any information that would be useful for updating or improving MedsPaL by emailing: medspal@medicinespatentpool.org
We developed MedsPaL with the support of Pascale Boulet, Patent Information Consultant, for conceptualisation and initial data management (2016-2018), Global Health Systems & Analytics for data structure, and Goji Labs for IT development. The database is managed by the Medicines Patent Pool.
On searching the patent status of medicines:
- How to Conduct Patent Searches for Medicines: A Step-by-Step Guide, World Health Organization, 2010.
- A Methodology for Patent Searches on Essential Medicines in Developing Countries, United Nations Development Programme, 2012.
- Pat-INFORMED,the Patent Information Initiative for Medicines. It is an initiative of WIPO, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and 20 leading, research-based biopharmaceutical companies.
- Patent Opposition Database
On addressing intellectual property issues in the procurement of medicines:
- Battling HIV/AIDS: A Decision Maker’s Guide to the Procurement of Medicines and Related Supplies, The World Bank, 2004.
- Report of the UN Secretary General’s High Level Panel on Access to Medicines, 2016
- Promoting Access to Medical Technologies and Innovation: Intersections between public health, intellectual property and trade, Trilateral study of WHO, WIPO and WTO.
On medicines approval:
On prices of medicines:
What partners say about MedsPaL:
When working to increase access to medicines, it is very important to understand patent status in country and any barriers to access. Communities are instrumental in advocating for the reduction of prices for HIV, TB and HCV medicines. In that sense MPP database on patents, MedsPaL, and its effort to increase transparency of patent information is instrumental to community groups working with TRIPS flexibilities.
Sergiy Kondratyuk, Project Manager, ITPC Global
January 2020
It is fundamental that countries willing to provide greater access to essential medicines can refer to a reliable up-to-date database like MedsPaL to check the patent status of the medicines they want to procure. Access to medicines is certainly an important pillar of Universal Health Coverage and MedsPaL supports its efficient implementation at country level.
Nicola Magrini, Secretary of the WHO Essential Medicines List
October 2019
When UNDP Ukraine starts its medicines procurement process, we need as much as information as possible on patent status. For this, we use different sources, government of course but also international, MedsPaL is one of those sources that we consult from.
Dorin Rotaru, Health Programme Manager, UNDP, Ukraine
January 2020
Access to comprehensive, updated patent information is essential for supplying customers worldwide and particularly those in middle-income countries. IDA Foundation has long relied on the Medicines Patent Pool for data related to HIV drugs. We welcome the launch of MedsPaL and the inclusion of Hepatitis C and tuberculosis medicines in this new database.
Edwin de Voogd, CEO, IDA Foundation
October 2016
