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Examination Guidelines for Patent Applications relating to Biotechnological Inventions at the UK Patent Office

 Author:  Kaviraj Singh, Attorney of Trustman & Co – A Law Firm at Delhi India

The Guidelines set out the practice within the UK Patent Office as it relates to patent applications for biotechnological inventions. The 2000 Regulations came into force on 28 July 2000 and implemented the provisions of Articles 1 to 11 of the European Directive 98/44/EC on the legal protection of biotechnological inventions. 

In the UK, the Patents Regulations 2000 confirmed and clarified that inventions concerning biological material, including gene sequences, may be legitimately the subject of patent applications. In other words, these Regulations have established beyond doubt the legitimacy of biotechnology patents in the UK.

“An invention shall not be considered unpatentable solely on the grounds that it concerns (a) a product consisting of or containing biological material; or (b) a process by which biological material is produced, processed or used”

 [Paragraph 1, Schedule A2 to the Patents Act 1977]

Universally, it is an established practice that a natural substance which has been isolated for the first time and which had no previously recognized existence, does not lack novelty because it has always been present in nature.

It is generally agreed, and it is particularly relevant in the field of biotechnology, that a patent should not be granted merely because the applicant had been involved in laborious and costly effort. If the goal is known and sufficient of the theory and practice is known for the applicant to predict where he is going, without there being an original step, then an obviousness objection would be well founded.

Following the sequencing of various genomes, there is unlikely to be an inventive step in identifying from within a sequenced genome any new gene, even those without known homologues. It is obvious to trawl the genome for previously unidentified genes, and any skilled worker would have some expectation of success. In Genentech, an idea was considered obvious if “the materials in question were lying in the road and ready for a research worker to use”, even if the skilled man faced a number of obstacles in proceeding to his goal. However, if overcoming these obstacles required “a spark of imagination….beyond the imagination properly attributable to him as a man skilled in the art” then there may be some element of inventive step. The use of bioinformatics tools would not seem to pose obstacles requiring a spark of imagination to overcome.

Paragraph 2 of Schedule A2 to the British Patents Act, 1977 permits biological material which is isolated from its natural environment or produced by means of a technical process to be the subject of an invention even if it previously occurred in nature.   Claims to micro-organisms per se have been allowed on the grounds that they are products of microbiological processes. This applies even when they are merely isolated from their natural surroundings, their isolation, culture, characterization and the finding of a utility turning what would be a discovery into an invention.

Claims for micro-organisms per se which have been isolated or obtained by artificially induced random mutation, are allowed but generalizations from such specific micro-organisms to  novel species would not normally be permitted. On the other hand, claims to genetically modified micro-organisms derived from readily available known micro-organisms where the invention resides in the gene introduced, may be claimed more generally. Also claims to mutants and variants of a specified deposited micro-organism are allowed provided they possess the same inventive property as the deposited micro-organism.