Intellectual property rights and patenting
The patent system is a long-established and accepted means for stimulating research and development, ensuring that many new life-improving and life-saving medicines come onto the market. It facilitates early publication of new inventions and in return gives the inventor an exclusive right to exploit the invention commercially for a limited period of time, usually 20 years.
The process of bringing new medicines to the market is long, complicated, and very expensive. On average it takes more than 10 years to develop a new drug. The costs can amount to several hundred million dollars, and it is essential to be able to recoup these investments. Being a research-based pharmaceutical company that aspires to make a difference to the benefit of public health, patent protection is of vital importance to Novo Nordisk. However, there are also challenges associated with the patent system.
Fair and efficient administration of patents is complicated by the multitude of national and regional laws. The lack of international harmonisation gives rise to legal uncertainties. In addition, the lack of a single, common language in the European patent system makes protection of rights cumbersome and expensive.
The supply of medicines to developing countries is another complex problem that needs special attention. The challenge is to balance the industry’s need for patent protection with the special needs of developing countries. Novo Nordisk is committed to advancing human health in the global society and shares in the responsibility of solving this supply problem.
Developments in science and technology are taking place rapidly, and provide hope of new treatments to people suffering from serious illnesses. At the same time, some of these new opportunities give rise to ethical questions, such as regarding the patenting of life forms, genes and stem cells. Novo Nordisk strives to be responsive to the ethical values of all stakeholders and is always prepared to discuss the implication of our use of biotechnology and our position on intellectual property rights.
Novo Nordisk's position
Novo Nordisk is committed to advancing the responsible use of intellectual property rights for the benefit of human health.
- Novo Nordisk sees patent rights as a very important tool for promoting innovation, leading to new and better products and processes, and stimulating long-term economic growth and job creation.
- Novo Nordisk believes that it is important to harmonise the patent system in order to create clear and operational patenting criteria, and to ensure fair and effective administration of the patent system.
- Novo Nordisk will license its patents on genes for use as research tools and diagnostic agents on a non-exclusive basis under fair terms consistent with the advancement of biomedical research.
- Novo Nordisk supports the principle that the human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions (Article 53, Rule 23e(1) of the European Patent Convention) (see also Novo Nordisk’s position on stem cells).
- Novo Nordisk supports the principle that the industrial application of a sequence or a partial sequence of a gene for which patent protection is sought must be disclosed in the patent application (Article 57, Rule 23e(3) of the European Patent Convention).
- Novo Nordisk supports the principle that patents shall not be granted in respect of inventions that concern processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, or that concern animals resulting from such processes (Article 53(a), Rule 23d(d) of the European Patent Convention).
- In cases of national emergency or other circumstances of extreme urgency, or in cases of public non-commercial use, Novo Nordisk supports the flexibilities outlined in Article 31 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the amendments to TRIPS provisions approved by the World Trade Organization in December 2005 granting the right for countries to produce or import patented medicines without the authorisation of the patent holder to protect public health.
- Novo Nordisk does not enforce patents in least-developed countries as defined by the United Nations.