• We believe that having strong and predictable intellectual property (IP) rights is an essential part of stimulating innovation. They ensure new medicines are developed and reach patients in need.
  • IP rights are core to the rules based international governance frameworks (e.g. TRIPS agreement).
  • Regulatory data protection is a key mechanism for safeguarding the development of new medicines where innovation and generating the costly clinical data takes longer than usual.
  • Compulsory Licensing should only be referred to as a last resort in exceptional circumstances, and in many cases will not lead to improved access or availability.

At Novo Nordisk we are committed to doing business in a way that is financially, socially, and environmentally responsible. We always strive for what is best for the patient, and we always consider how our actions may impact people, communities, and the environment.

We choose to do so, because we believe this approach will ensure that Novo Nordisk will be a sustainable business adding value to society and to our future business.

For more than 100 years we have been translating the unmet medical needs of people living with a serious chronic disease into innovative medicines and delivery systems; we are discovering and developing innovative biological medicines and making them accessible to patients throughout the world.

Pharmaceutical research and development is a complex and inherently risky process, requiring significant investments to bring new, safe and effective medicines and treatments to patients.

On average it takes more than ten years1 to develop a new medicine and make it available to patients, with total costs averaging $1,5 billion2. Fewer than 10% of new drug candidates complete all clinical trial stages and secure marketing authorisation1.

Intellectual Property (IP) rights are incentives fundamental to stimulating the research and development of novel medicines and delivering improved human health globally. Global and national IP frameworks offer a predictable system enabling the innovative pharmaceutical industry to operate and to ensure investors are willing to allocate capital to the long term and high-risk endeavour of developing a new medicine.

Patents play a critical role in incentivising not only research and development, but also commercialisation of innovative medicines across wide geographies.

Patent protection is necessary to attract capital investment, incentivise the discovery of new treatments, facilitate competition, promote collaboration, and accelerate access to medicines.

  • Novo Nordisk supports the rules set out in the WTO Agreement on Trade Related Aspects of Intellectual Property Rights3 (TRIPS agreement) and strongly believes that IP protection is an essential part of stimulating innovation. Governments should uphold the minimum standards of the TRIPS agreement and not exert political pressure to erode IP protection in the attempt to achieve short sighted and short-term cost containment.

Novo Nordisk exercises IP rights in a responsible way. We abstain from obtaining patents in least developed countries (LDCs, as defined by the United Nations) and low-income countries (as defined by the World Bank), and never enforce patents in these countries.

  • Novo Nordisk sees Regulatory data protection (RDP) as a key component in protecting the innovation of new medicines. Any reduction in baseline RDP will mean that some investments are not made, and scientifically viable medicines may never reach patients due to reduced predictability of investment decisions.
  • Novo Nordisk sees that in accordance with TRIPS, compulsory licenses must be referred to as a narrow and “a limited exception”4 to the patent holder’s right to exclude, and these exceptions are subject to strict conditions5 (such as national emergency, circumstances of extreme urgency or non-commercial public use, …), and should only be used as a last resort, when all attempts at voluntary licensing have failed.

Our ambition is to provide access to affordable care to vulnerable patients in every country. Through a combination of strategic initiatives and partnerships, we aim to help people access the care they need, no matter where they live.

Novo Nordisk is the largest provider of human insulin worldwide. We remain dedicated to our Access to Insulin Commitment, which sets a ceiling price of USD 3 per human insulin vial to governments in 76 low-to-middle income countries.

1. Thomas, D. et al., Clinical Development Success Rates and Contributing Factors 2011–2020 (BIO, Informa Pharma Intelligence & QLS Advisors, February 2021).

2. Wouters O.J. et al. Estimated Research and Development Investment Needed to Bring a New Medicine to Market, 2009-2018. JAMA 2020:323(9):844-853

3. “The TRIPS Agreement requires Member countries to make patents available for any inventions, whether products or processes, in all fields of technology without discrimination, subject to the normal tests of novelty, inventiveness and industrial applicability. It is also required that patents be available and patent rights enjoyable without discrimination as to the place of invention and whether products are imported or locally produced” (Article 27.1) “The exclusive rights that must be conferred by a product patent are the ones of making, using, offering for sale, selling, and importing for these purposes. Process patent protection must give rights not only overuse of the process but also over products obtained directly by the process. Patent owners shall also have the right to assign, or transfer by succession, the patent and to conclude licensing contracts” (Article 28)

4. TRIPS article 30

5. TRIPS article 31