Driving Health Innovation Using Intellectual Property

Global health challenges are growing increasingly complex, ranging from addressing neglected tropical diseases to accelerating vaccine development during global pandemics. In this landscape, intellectual property (IP) policies and strategies of key stakeholders in the global health sector play a crucial role in transforming innovative ideas into market-ready solutions.

Pharmaceutical companies, research institutions, not-for-profit organizations, and public–private partnerships established to develop and provide access to new health products (also known as Product Development Partnerships or PDPs) collectively contribute their expertise, insights and resources to respond to public health challenges.

These players engage in dynamic collaborations with each other, and their IP policies are central to fostering structures of coordination and cooperation. This, in turn, can assist in securing investments and help in the deployment of new technologies to respond to the needs of underserved populations.

Put in simple terms: effective IP management can enable diverse partners to share expertise and innovation, while safeguarding their proprietary knowledge, interests, and creations of the mind.

IP policies of PDPs

PDPs are important stakeholders in responding to global health needs. They adopt a targeted approach to developing drugs, including for neglected tropical diseases.

Examples of PDPs include the Drugs for Neglected Diseases initiative (DNDi) and the Global Antibiotic Research and Development Partnership (GARDP). 

Each PDP is unique in terms of its mission, organizational structure, and its approach to executing public health-related activities.

For instance, a PDP may target poverty-related geographical areas in response to a lack of investment in finding solutions to treat neglected tropical diseases, pooling multisector expertise to advance innovation to reduce the burden of these diseases.

A PDPs could be established by governmental, inter-governmental or not-for-profit organizations.

PDPs leverage IP policies as a tool to help manage IP and technology transfers in a manner that is efficient and protects partners’ interests as they ultimately seek to increase access to healthcare for underserved populations.

DNDi

DNDi was founded in 2003 by seven partners, including the World Health Organization (WHO), to respond to the challenges faced by healthcare professionals regarding ineffective and unsafe medicines.

Its IP policy indicates its intent to protect patents, trade secrets and other IP forms in order to further its mission of developing treatments for neglected diseases. The policy also recognizes the need for IP to help facilitate contracts and engage with various partners, while securing rights to develop molecules.

Further, the policy encourages the timely acquisition of IP, conducting Freedom to Operate (FTO) analyses to evaluate if a product can be safely marketed without violating any patents, and publishing model contracts or templates for collaboration and licensing agreements. These agreements are used in partnerships with both public and private entities.

Malaria Medicines Venture

Malaria Medicines Venture (MMV) is a Switzerland-based NGO which seeks to develop innovative medicines that can cure and protect vulnerable and under-served populations at risk of malaria.

Its IP policy differentiates between “background IP” and “foreground IP”. “Background IP” refers to pre-existing IP like compounds, technology, data and know-how. For “background IP”, when a partner brings pre-existing IP into the collaboration, MMV is granted a non-exclusive license to use it for project-related activities. On the other hand, if the background IP belongs to MMV, it grants its partners similar non-exclusive licenses for the collaboration.

“Foreground IP” includes IP generated by partners over the course of the collaboration. For “foreground IP,” the terms are negotiated on a case-by-case basis. These type of IP rights come with an obligation for the rights holder to develop the products resulting from the IP and ensure their accessibility to patients in need.

Through this demarcation of IP, MMV aims to promote continuity of research and development in case the partner fails to fulfil its manufacturing obligations.

Biopharmaceutical firms and IP policies

Medical innovation demands significant time and financial investment, with drug development often spanning over a decade.

For businesses committed to research and development (R&D), IP protections remain indispensable to secure investment, recoup costs, and fund future breakthroughs.

Novartis

Novartis, a Swiss biopharmaceutical, views strong IP rights as a cornerstone for medical progress.

According to the company’s position on IP, they “use patents and other IP rights to enable the discovery and development of breakthrough medical innovations, to facilitate their delivery to the patients who need them, and to advance scientific, medical and technological progress for patients and society.”

Novartis has also adopted policies not to seek or enforce patents in least developed countries, as defined by the United Nations, and low-income countries, as defined by the World Bank.   

Roche

Roche is another biopharmaceutical firm based in Switzerland. It views IP rights as essential drivers of innovation in healthcare, noting that IP encourages the development of innovative solutions to global health challenges.

According to its IP policy: “For innovative companies, it is the existence of robust IP provisions that makes it possible to identify, develop and deliver innovative solutions to some of the world’s most challenging health issues.”

More than thirty medicines developed by the firm are included in the WHO Model Lists of Essential Medicines, including antibiotics, antimalarials and chemotherapy drugs.  

Similar to Novartis, Roche does not file for new patents or enforce existing patents in least developed counties, as defined by the United Nations, and low-income countries, as defined by the World Bank.

Biopharmaceutical R&D is an expensive effort with an average development timeline of 10-15 years per medicine. According to Novartis: “For chemistry-based pharmaceuticals, as few as 1 in 10,000 substances tested in the laboratory will ultimately be approved as a medicine.”

IP provides a practical means to attract investments needed to conduct and sustainably finance R&D.

Examples from other sectors

The Wellcome Trust (Trust) is an independent global charitable foundation dedicated to improving health through research. Its goal is to ensure that research outcomes are both innovative and widely accessible.

The Trust’s IP policy covers patents for new drugs and medical devices. It also supports researchers by allowing them to avail funding for initial IP protection costs. However, subsequent costs for IP maintenance and commercialization are the responsibility of the researchers’ institutions. 

If an award holder wants to develop or commercialize the Trust-funded IP, it must be in compliance with revenue and equity sharing policies. Moreover, the award holder is required to ensure that the technologies are made affordable and available, particularly in low- and middle-income countries.   

The organization’s “Equitable Access to Healthcare Interventions” statement advocates for tools such as voluntary licensing and patent pooling. In exceptional cases where the IP is shelved or unused, the Trust can access the unexploited IP to benefit underserved populations.

Strategic IP use for global health benefits

The global health sector comprises of diverse organizations that share a common goal: improving global health outcomes.

PDPs prioritize collaboration and access through flexible licensing and patent pooling. Pharmaceutical companies balance IP protection for R&D investments with market access strategies. Public research institutions often focus on open access to scientific knowledge while securing IP for commercialization.

While each of these stakeholders operates under different constraints, they all recognize the central role of IP in driving innovation and ensuring equitable access to health.

Ultimately, effective IP management is essential for fostering a thriving innovation ecosystem in global health. By striking the right balance between protection and access, these organizations contribute to a healthier future for all.

About WIPO’s Global Health Unit

The Global Health Unit at WIPO seeks to raise awareness and understanding of the complex linkages between global health and access to medical technologies, innovation, technology transfer and trade. The goal is to leverage IP as a tool that contributes to meeting the world’s most pressing health needs.

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