Intellectual property protection is important for the company to make investments in research and development needed to enhance the therapeutic efficacy of our existing health solutions and to create new therapies for future generations. We recognize that responsible handling of intellectual property is essential for improving access to health in developing countries, where governments and patients face significant resource constraints and access barriers.
In 2014, Merck KGaA, Darmstadt, Germany joined , an open innovation platform sponsored by the World Intellectual Property Organization. With over 90 members worldwide, the platform accelerates early discovery for infectious diseases through intellectual property and knowledge sharing.
We have adopted a policy of not filing or enforcing patent applications in the vast majority of developing countries. In markets where we file patent applications, we are committed to enhancing data sharing with researchers and improving public access to clinical trial information. The patent status of our products is made publically available.
Merck KGaA, Darmstadt, Germany supports voluntary licensing agreements of all kinds, including non-exclusive voluntary licenses and legally binding non-assert declarations or clauses that are focused on improving access. We focus these agreements on medicines to treat non-communicable diseases such as cardiovascular diseases, diabetes, cancer, and chronic pulmonary diseases, which represent a growing health burden in developing countries. The company welcomes requests for such licenses from manufacturers that can meet our quality and performance standards. When we grant a license, we commit to supporting technology transfer that ensures the manufacture of high-quality products.
We support the World Trade Organization’s (WTO) standards for intellectual property rights, including the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights () and subsequent amendments such as the Special Declaration on the TRIPS Agreement and Public Health at the Doha Ministerial Conference in November 2001 (Doha Declaration). The Doha Declaration exempted Least developed countries (LDCs) from complying with TRIPS provisions until January 1, 2016. We support this exemption of LDCs and an extension of the exemption beyond 2016.
Patents ensure temporary exclusive rights for marketing an innovative product. However, we respect the right of developing countries to enact compulsory patent licensing in specific situations, as embodied in TRIPS Article 31 and as modified by the Doha Declaration. However, we believe that in some cases, approaches other than compulsory licensing may be more appropriate and would avoid undermining innovation in the pharmaceutical industry. For example, differential pricing and voluntary licensing can achieve improved health outcomes in developing countries.
We also promote responsible regulatory data protection policies. Such policies encourage innovator companies to conduct clinical trials and to invest in additional research and development.
We support the concept of patent pools. However, we believe patent pools should be structured to improve access to medicines and should therefore avoid anti-competitive effects and geographic limitations. We consider joining patent pools if they are relevant to our portfolio and if they meet efficacy, quality and safety requirements.