Q&A on MedsPaL

MedsPaL provides information on the patent and licensing status of selected HIV, hepatitis C and tuberculosis medicines in low- and middle-income countries. See disclaimer.

The database lets you search patent and licence information by country and medicine name. 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 relating to the product and country searched.

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

We identify patents relevant to the selected medicines from three main sources:

  • Listings of patents relevant to approved medicines 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. 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).

We provide the source of the patent family 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.

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.

We obtain patent applications filed at national and regional level through:

  • automated data feeds from the European Patent Office (EPO) public database Espacenet
  • information obtained directly from national and regional patent offices
  • national and regional patent offices’ databases
  • information concerning an applicant’s corresponding foreign applications and grants, required by some patent offices by 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, we supplement and cross-check information with additional sources of medicines patent analysis from other organisations 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 we try to update patent data in MedsPaL regularly, it is not immediate, so some data may be inaccurate 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 application identified in MedsPaL. We also invite you to tell us about any inaccurate data, so we can correct it. Please contact medspal@medicinepatentpool.org

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 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.

The patent description appearing on MedsPaL is a brief description we provide to help identify 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. We provide the original titles of patents in the patent cards, when available.

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 that differs to 20 years from the filing date, we include the information.

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 we sign 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 ake data from the licensors’ websites, official press releases or non-confidential 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 authoritative sources.

We get 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.

You 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 don’t accept any responsibility for the accuracy of data. In particular, we do not guarantee it is complete, up to date or fit for specific purposes. You 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 patent application or granted patent at the national and regional level. You 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 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@medicinepatentpool.org

We developed MedsPaL with the support of Pascale Boulet, Patent Information Consultant, for all IP data included in the database, Global Health Systems & Analytics for conceptualisation, and Goji Labs for IT development.