We consider it our duty and responsibility to share core technological advances in the battle for global access to healthcare. This level of transparency, however, requires a solid, transparent and reliable legal framework to protect the intellectual property rights of pharmaceutical companies and enforce patents, in order to provide time and protection to balance the cost of research and development.
Our approach to sharing and protecting intellectual property
The approach that we and other pharmaceutical manufacturers take to our intellectual property impacts access to healthcare. We often refrain from filing or enforcing patents in developing countries. In markets where we do register product patents, we are transparent and committed to sharing data to the greatest possible extent and 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 to improve access to medicines, prevent anti-competition 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. We are currently only active in the Medicines Patent Pool, which recently extended its scope to include HIV, hepatitis C and tuberculosis.
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 developing 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, of which 27 are on the WHO Essential Medicines List and 29 are considered to be first line treatments.
Through our initiatives and partnerships, we provide access to patent information. In some cases, we even give access to parts of our compound libraries. This is true for open innovation research projects and collaborative research programs for novel R&D platforms in the search of new active substances.
How we organize access and control of our intellectual property
The Open Innovation initiative of Merck KGaA, Darmstadt, Germany, is a collaborative and cross-functional effort led by the Access to Health and the Patents teams. It aims to mitigate affordability issues by sharing our intellectual property to accelerate early discovery in diseases that have high unmet needs, where we do not have expertise. We hope to foster the discovery of new generations of health solutions that tackle the needs of the poorest, with a first focus on neglected tropical diseases (NTDs).
In 2015, we established the Open Innovation Committee to provide technical expertise, strategic guidance and decision-making on our open innovation activities, collaborations and strategy. The Open Innovation Committee is co-chaired by the heads of our Access to Health subunit and the globally acting Patents Healthcare unit and is part of the Open Innovation Initiative.
Our commitment: supporting transparent and reliable frameworks
Our approach to intellectual property is based on the principles set out in our Access to Health charter.
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 the least-developed 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 new tools and resources to determine the existence of patents that are 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 necessary to implement disease management strategies and other activities that address public health needs. Pat-INFORMED features patent information for small molecule drugs within oncology, hepatitis C, cardiovascular, HIV, diabetes and respiratory therapy areas and any products on the WHO Essential Medicines List 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 so-called INNs, unique names that are globally recognized and used to identify pharmaceutical substances or active pharmaceutical ingredients within medicines that cover a wide range of conditions. The initiative will soon extend to other therapeutic areas and explore the inclusion of complex therapeutics such as biologics.
Open innovation collaboration: WIPO Re:Search
Established in 2011, WIPO Re:Search is a public-private partnership administered by the World Intellectual Property Organization (WIPO) in collaboration with BIO Ventures for Global Health (BVGH). We are one of more than 100 members of the WIPO Re:Search platform. The mission is to accelerate the discovery and product development of medicines, vaccines and diagnostics to create new solutions for people affected by neglected tropical diseases, malaria and tuberculosis, by making intellectual property and know-how available to the global health research community. Through the WIPO Re:Search platform we are working on the extension of the collaboration with the University of Buea (Cameroon) and 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 2017, we formed a partnership with the Drugs for Neglected Diseases initiative (DNDi), under which we are involved in the Drug Discovery Booster project for neglected tropical diseases. This project pursues an open innovation approach in which the participating companies simultaneously search for new treatments for leishmaniasis and Chagas disease. We are joined in this project by six other companies (Astellas, AstraZeneca, Celgene, Eisai, Shionogi and Takeda).