Novartis does not file or enforce patents in least developed countries (LDCs), low-income countries (LICs), or in over 80% of the lower-middle income countries (LMICs). In the small number of remaining LMICs where we do file patents, we aim to restrict patent filings to those patent applications covering new molecules or new chemical entities. In addition, we are committed to granting non-exclusive licenses to qualified third parties for supply of our patented products exclusively to LDCs or to LICs.
The United Nations designates LDCs as highly disadvantaged in their development process, for structural, historical and geographical reasons. LDCs are also characterized by their vulnerability to external economic shocks, natural and man-made disasters and communicable diseases. LICs are defined by the World Bank based on an assessment of gross national income per capita, which is influenced by factors such as income growth, inflation, exchange rates, and population change. LMICs are defined by the World Bank using the same criteria, and many (particularly the lower-income countries in the group) suffer from similar socioeconomic disadvantages to LICs and LDCs.
In 2018, the World Intellectual Property Organization (WIPO) and the International Federation of Pharmaceutical Manufacturers & Associations launched the Patent Information Initiative for Medicines (Pat-INFORMED). Pat-INFORMED, of which we are a founding member, is a unique public online resource launched to provide basic patent information for medicines of participating companies. Novartis has listed patent information for all of our small-molecule medicines in the Pat-INFORMED database, which goes significantly beyond the program’s near-term goal of capturing information for medicines in a more limited set of disease areas. In addition, we continue to drive the industry effort to include patent information for biologic medicines.
Novartis is also a founding member and signatory of the IP Principles for Advancing Cures and Therapies (IP PACT). Launched in April 2021, the IP PACT is a public statement of our patient-centric approach to IP that explains some of the ways that we and other signatory companies use, and commit to use, the IP system for the benefit of patients and society. Consistent with our longstanding company approach to IP, the 10 principles cover key themes, including
how we file and enforce IP with a patient focus;
how we use IP to advance innovation, collaboration, scientific progress, and public health;
the importance of generics and biosimilars; and
how we approach IP differently in the world’s poorest countries.
Further, we continue our pro bono efforts in the intellectual property space through the Inventor Assistance program, a WIPO initiative in collaboration with the World Economic Forum. The program, of which we are a founding member, aims to match developing country inventors and small businesses with limited financial means with patent attorneys, who provide pro bono legal assistance. In 2020, we supported the launch of the program in Peru, and aim to help expand it to additional developing countries.