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

The following IP guidance 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
  • Court of Justice decisions regarding biotechnology patents
  • Monsanto v Cefetra BV (Case C-428/08)
  • Oliver Brüstle v Greenpeace e.V (Case C-34/10)
  • International Stem Cell Corporation v Comptroller General of Patents (Case C-364/13)
  • EPO case law concerning the exclusion under Article 53(b) of the EPC
  • more

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 not necessarily specifically excluded, may fall foul of the usual requirements for novelty, inventive step and industrial applicability.

The majority of biotechnology patents are granted for pharmaceutical innovations and industrial processes, although some are also granted in the field of agriculture. Examples of patented biotechnological inventions include tests to screen donated blood for the presence of viruses and gene sequences isolated from the human body which form the basis of biopharmaceuticals.

The current regulatory framework for biotechnology patents

Biotechnology inventions may be patented and are subject to the same rules as other inventions but in addition are governed by Directive 98/44/EC, the Biotechnology Directive.

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