Biotechnology patents
Produced in partnership with Nicole Jadeja and Chris Leung of Fieldfisher
Biotechnology patents

The following Life Sciences practice note Produced in partnership with Nicole Jadeja and Chris Leung of Fieldfisher provides comprehensive and up to date legal information covering:

  • Biotechnology patents
  • What is biotechnology
  • The current regulatory framework for biotechnology patents
  • What may be patented
  • What cannot be patented
  • Article 4—Plant and animal varieties and ‘essentially biological’ processes
  • Article 5—The human body and the simple discovery of one of its elements
  • Article 6—Inventions contrary to ordre public or morality
  • The exclusion under Article 53(b) of the EPC
  • Court of Justice decisions regarding biotechnology patents
  • More...

On 31 January 2020, the UK ceased to be an EU Member State and entered an implementation period during which it continues to be treated by the EU as a Member State for many purposes. As a third country, the UK can no longer participate in the EU’s political institutions, agencies, offices, bodies (except to the limited extent agreed), but it continues to be subject to EU law and must submit to the continuing jurisdiction of the Court of Justice of the EU in accordance with the transitional arrangements in Part 4 of the Withdrawal Agreement. For further reading, see: Brexit—Life Sciences and News Analysis: Brexit Bulletin—key updates, research tips and resources.

What is biotechnology

Biotechnological inventions are defined in Rule 26(2) of the European Patent Convention (EPC) as:

‘inventions which concern a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used.’

Biological material is further defined in Rule 26(3) as:

‘any material containing genetic information and capable of reproducing itself or being reproduced in a biological system.’

Biotechnological inventions are, in principle, patentable. While there is no general exclusion against them in the Patents Act 1977 (PA 1977) or the EPC, there are specific rules governing the patentability of such inventions (see: The current regulatory framework for biotechnology patents below). Further, in practice, certain biotechnological inventions, while

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