We consider it our duty and responsibility to share core technological advances to improve global access to healthcare. However, this level of transparency requires a solid, transparent and reliable legal framework that protects the intellectual property rights of pharmaceutical companies and enforces patents in order to provide the opportunity to balance the initial investment in research and development.
Our approach to sharing and protecting intellectual property
The approach that we and other pharmaceutical companies take to our intellectual property impacts access to healthcare. We often refrain from filing or enforcing patents in low- and middle-income countries. In markets where we do register product patents, we are transparent and committed to sharing data to the greatest possible extent and to improving public access to clinical study data. We report on the patent status of our products via a publicly accessible database. Furthermore, we support voluntary licensing agreements of all kinds, including non-exclusive voluntary licenses, legally binding non-assertion covenants and clauses that aim to widen access to health. Moreover, we support the concept of patent pools, but believe that these should be structured in such a way that they improve access to medicines, prevent anti-competitive behavior and overcome geographic limitations. We consider joining patent pools when they are relevant to our portfolio and meet all our efficacy, quality and safety requirements.
The responsible treatment of intellectual property does not pose a barrier to health, but rather guarantees safety and high quality for patients worldwide. Nearly all medicines that address the highest burden of disease in low- and middle-income countries are not protected by patents. Studies found that between 90% and 95% of the WHO Model List of Essential Medicines are off-patent. We provide 46 essential medicines and products, 27 of which are on the WHO Model List of Essential Medicines and 29 of which are considered to be first-line treatments.
We provide access to patent information through our Access to Health initiatives and partnerships. In some cases, we even give access to parts of our chemical compound libraries. This is true for open innovation research projects and collaborative research programs that develop novel R&D platforms in search of new active substances.
How we organize access to and control of our intellectual property
The Merck Open Innovation initiative is a collaborative and cross-functional effort led by our Access to Health and Patents Healthcare units. It aims to mitigate affordability issues by sharing our intellectual property, thus accelerating early discovery in diseases with high unmet needs where we do not have expertise. We hope to foster the discovery of new generations of health solutions that will tackle the needs of the most vulnerable populations, with a primary focus on neglected tropical diseases (NTDs).
Our Open Innovation Committee provides technical expertise, strategic guidance and decision-making regarding our open innovation strategy, activities and collaborations. Co-chaired by the heads of our Access to Health subunit and the globally acting Patents Healthcare unit, the Open Innovation Committee is part of our Open Innovation Initiative.
Our commitment: Supporting transparent and reliable frameworks
We support TRIPS, an international agreement administered by the World Trade Organization (WTO) that addresses trade-related aspects of intellectual property rights, along with TRIPS addenda such as the Special Declaration on the TRIPS Agreement and Public Health (also known as the 2001 DOHA Declaration). This extends the deadline for low- and middle-income countries to apply TRIPS provisions to pharmaceutical patents until 2033.
Initiative improves access to patent information
We are a founding member of the Patent Information Initiative for Medicines (Pat-INFORMED), which was established by 20 leading research-based biopharmaceutical companies. Pat-INFORMED acts as a global gateway to medicine patent information, offering tools and resources that help determine the existence of patents relevant to products sought by national and international drug procurement agencies. This transparency should make it easier for drug procurement agencies to access a basic body of patent information needed for implementing disease management strategies and other activities that address public health needs. Pat-INFORMED features patent information for small-molecule drugs within cardiovascular, diabetes, hepatitis C, HIV, oncology and respiratory therapy areas and any products on the WHO Model List of Essential Medicines that are not within these therapy areas. The initiative is backed by the World Intellectual Property Organization (WIPO) and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).
Pat-INFORMED currently houses information on over 14,000 individual patents for 600 patent families and 169 INNs, unique names that are globally recognized and used to identify pharmaceutical substances or active pharmaceutical ingredients of medicines that cover a wide range of conditions.
Open innovation collaboration through WIPO Re:Search
We continue to take part in the WIPO Re:Search public-private partnership, whose mission is to accelerate the discovery and development of medicines, vaccines and diagnostics. This initiative aims to create new solutions for people affected by neglected tropical diseases, malaria and tuberculosis by making intellectual property and knowledge available to the global health research community. Our latest collaboration under the WIPO Re:Search platform is with the University of Yaoundé I in Cameroon (Africa) to combat the infectious disease known as Buruli ulcer. Furthermore, we are working on extending our collaboration with the University of California San Diego (United States) to find potential cures for onchocerciasis, leishmaniasis, Chagas disease and African sleeping sickness.
Drugs for Neglected Diseases initiative
In partnership with the Drugs for Neglected Diseases initiative (DNDi), we are involved in the Drug Discovery Booster project for neglected tropical diseases, pursuing an open innovation approach through which the participating companies can simultaneously search for new treatments for leishmaniasis and Chagas disease. We are joined in this project by seven other companies: AbbVie, Astellas, AstraZeneca, Celgene, Eisai, Shionogi, and Takeda).