Q&A on MedsPaL

MedsPaL provides information on the patent and licensing status of selected HIV, hepatitis C (HCV) and tuberculosis (TB) medicines in low- and middle-income countries (LMIC) See Disclaimer.

How to search MedsPaL?

The database enables users to search patent and licence information by country and medicine name. It also enables free text searches, e.g. by patent numbers, products 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 patent application and links for further information. Wherever a licence has been signed for a specific medicine, a licence card provides detailed information about the licence agreement in relation to the product and country that were searched.

Which medicines are covered by MedsPaL?

The database covers most HIV medicines, in particular those that are included (or have been) in the WHO model List of Essential Medicines (EML) or in the WHO treatment guidelines. In relation to TB and hepatitis C, MedsPaL includes new medicines under patents that are in the WHO EML or WHO treatment guidelines. In addition, for all three diseases, promising new medicines or medicines in late-stage development may also be included. The database is periodically updated to include new HIV, HCV or TB medicines as they are developed or included in the WHO EML or relevant guidelines.

How are the relevant patent families selected?

Patents relevant to the selected medicines are identified from three main sources:

Listings of patents relevant to approved medicines that are submitted to the US FDA Orange Book and Health Canada Patent Register by medicines sponsors. Only patents that claim a drug substance (active ingredient), drug product (formulation and composition) or method of use can be listed at the US FDA. Patents are eligible for inclusion in a drug submission to Health Canada if the patent contains 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. It should be noted that process patents related to intermediate steps or full manufacturing of the medicine are not disclosed in these databases.

Patent data disclosed by patent applicants 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 World Health Organization (WHO).

The source of the patent family is provided under “Patent Identification Source” 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.

Which countries are included?

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, a small number of high-income countries that only recently transitioned from middle-income country status have also been included.

How is national/regional patent data obtained?

  • Patent applications filed at national/regional level are sourced in various manners:
  • automated data feeds from the European Patent Office (EPO) public database Espacenet;
  • information obtained directly from national/regional patent offices;
  • national/regional patent office’s databases;
  • information concerning an applicant’s corresponding foreign applications and grants, required by some patent offices as per local regulations;
  • information concerning an applicant’s applications and grants, disclosed in licence agreements;
  • patent searches commissioned to local patent attorneys and experts;
  • national phase information provided by WIPO PatentScope.

Whenever available, the information is supplemented and cross-checked with additional sources of medicines patent analysis made available by other stakeholders such as the World Health Organization (WHO), UNITAID, Initiative for Medicines, Access and Knowledge (IMAK), Lawyers Collective, Médecins Sans Frontières (MSF) or the United Nations Development Programme (UNDP).

While the MPP will endeavour to keep patent data in MedsPaL regularly updated, patent status information is not updated in real time and some data may be inaccurate or outdated. Interested users are advised to contact the relevant national/regional patent office or consult local patent counsel to obtain up-to-date information on any given patent application identified in MedsPaL.  Users are also invited to submit information on any data that is inaccurate to the MPP so that it can be corrected at gro.looptnetapsenicidemnull@lapsdem.

When does MedsPaL conclude that certain patent applications are “Not filed”?

  • MedsPaL indicates that a patent application is not filed in certain jurisdictions for a given patent family in the following cases:
  • The national patent office has indicated to MPP that no 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.

What is the patent description included in MedsPaL?

The patent description appearing on MedsPaL is a brief description provided by the MPP to facilitate identification of patents. A patent description may relate to one or several closely related patent families claiming aspects of a specific medicine. MedsPaL patent descriptions are not official descriptions of the patents. The original titles of patents are provided in the patent cards, when available.

How is the expected expiry date obtained?

MedsPaL assumes that national applications last 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 the MPP has information on a different expiry date (than 20 years from the filing date) for a given patent this information is included in MedsPaL.

How is the information on licences obtained?

Wherever there is public information on a licence signed on a given product with respect to a given country, the information is displayed along with the relevant patent information.

Data on licences signed by the Medicines Patent Pool are public and has been integrated in 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, data are sourced from the licensors’ websites, official press releases or non-confidential direct communications from licensors to the MPP. It should be noted that information on bilateral licences is often limited. Wherever possible, links are provided for further information.

Data on compulsory licences are based on official information in government websites or from other authoritative sources.

How is information on data exclusivity obtained?

Information on pharmaceutical test data exclusivity is sourced from the relevant authorities in countries where data exclusivity is provided by the law, through direct communication or official websites. Information is not yet available for all countries concerned and will be gradually supplemented and updated.

Terms of use & Disclaimer

MedsPaL should not be considered a complete and authoritative source of patent information and is not meant to provide a ‘freedom-to-operate’ analysis. It only provides a snapshot at a particular point in time, based on the information that was available to the Medicines Patent Pool.

The MPP does not accept any responsibility for the accuracy of data; in particular, the MPP does not guarantee that they are complete, up to date or fit for specific purposes. Additional country search and legal analysis is required before making any procurement or business decision.

It is also important for users to bear in mind that a full understanding of the patent situation in a given country with respect to a specific medicine requires additional information and analysis that is not provided in this database, such as an analysis of the specific claims of a patent application or granted patent at the national/regional level.  MedsPaL 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 flexibilities available under national and/or international regulations.

Improving MedsPaL data

The MPP will endeavour to update and improve MedsPaL on a regular basis. By making information we have obtained publicly available to others, we also hope that others will help us improve the database. We invite users to submit any information that would be useful for updating or improving MedsPaL by writing to: gro.looptnetapsenicidemnull@lapsdem

Development of MedsPaL

MedsPaL was developed by the Medicines Patent Pool with the support of Pascale Boulet, Patent Information Consultant, for all intellectual property data included in the database, Global Health Systems & Analytics for conceptualization, and Goji Labs for IT development.

Useful resources

On searching the patent status of medicines:

How to Conduct Patent Searches for Medicines: A Step-by-Step Guide [pdf] World Health Organization, 2010.
A Methodology for Patent Searches on Essential Medicines in Developing Countries. United Nation Development Programme, 2012.
Patent Oppositions Database

On medicines approval:

WHO Prequalified Medicines database.
WHO Drug Regulatory Status database.

On prices of medicines:

WHO Global Price Reporting Mechanism database.
Global Fund Price and Quality Reporting
Untangling the Web of Antiretroviral Price Reductions. Médecins Sans Frontières, 2016.
DR-TB drugs under the microscope: sources and prices for drug-resistant tuberculosis medicines. Médecins Sans Frontières. 2016

On addressing intellectual property issues in the procurement of medicines:

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