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 na-tional 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 supports the United Nations Universal Declaration of Human Rights, according to which “Everyone has the right to the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he is the author” (Article 27(2) of UN’s Human Rights Declaration).
• 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 supports international efforts to harmonise the patent system in order to create clear and operational patenting criteria, and to ensure fair and effective administration thereof.
• Patents should not be misused to stifle research and development, or to hinder non-commercial research.
• 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.
• In cases of national emergency, Novo Nordisk supports the right of countries to allow the production or importation of patented medicines without the authorisation of the patent holder, in order to improve access to life-saving drugs (Article 31 of the agreement on Trade-Related aspects of Intellectual Property Rights).
• 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).
