Biotechnological inventions: legal protection

KEY POINTS

• Inventions which concern a product consisting of, or containing, biological material¹ or a process for the production of such biological material may be patented if they are new, involve an inventive step and can be applied industrially.
• The following are not patentable:
  • plant and animal varieties
  • essentially biological processes² for producing plants and animals
  • the human body at the various stages of its formation and development.
• However, an element isolated from the human body or produced by a technical process may be a patentable invention.
• Inventions may not be patented where their commercialisation would be immoral or against public order. In particular, the following are not patentable:
  • processes for cloning human beings
  • processes that modify the human germ line genetic identity
  • use of human embryos for industrial or commercial purposes
  • processes that may cause suffering to animals when modifying their genetic identity.
• The protection granted by a patent also extends to any biological material derived from the original biological material.
• Where a plant breeder cannot use a plant variety without infringing a patent, they may apply for a compulsory licence for non-exclusive use of the invention, subject to payment of an appropriate royalty.
• The European Group on Ethics in Science and New Technologies evaluates all ethical aspects of biotechnology.

In 2012, the European Commission set up an expert group to examine the technical development and implications of patent law in the field of biotechnology and genetic engineering. The group assists the Commission with its reporting obligations under Directive 98/44/EC.