Biotechnology

Biotechnology innovation is a vital part of continuing technological advancement because it leads to the betterment of mankind. However, research can be complex, time consuming and expensive. We see our role as protecting the commercial interests of those who invest time and effort into innovating in this area.

Despite the research and work involved, patenting in biotechnology has seen very strong and sustained growth in Europe. Compared to many other territories, the UK and Europe generally have an applicant-friendly approach to the patentability of life sciences technology, and biotechnology inventions in particular. Provided the usual requirements for patentability are met, the UK and Europe are attractive places for filing inventions.

However, there are specific considerations that apply to patenting biotechnology:

Are gene sequences patentable?

Nucleic acid sequences or partial sequences may be patented even if they previously occurred in nature. However, there must be a commercial purpose for the sequence and its industrial application must be disclosed in the patent application. An example could be a protein derived from a sequence – not just simply a newly isolated nucleic acid sequence for which no commercial purposes has been discovered.

Is it possible to patent cloning?

While it may be possible to obtain a patent for the laboratory techniques used to manipulate a genome, it is not possible to obtain patent protection for a process for the cloning of human beings. This is defined as any process, including techniques of embryo splitting, designed to create a human being with the same nuclear genetic information as another living or deceased human being.

Can gene therapy be patented?

Laboratory techniques used in gene therapy may be patentable. However, it is not possible to patent methods of treatment in the UK and Europe. It is also not possible to obtain a patent for processes for modifying the germ line genetic identity of human beings, i.e. a process that results in the change of a hereditary trait which would be passed on to any offspring.

Is the use of human embryos patentable?

The use of human embryos for industrial or commercial purposes in the UK and Europe is excluded from patentability. 

As set out in the case law of the European Patent Office (EPO) Board of Appeal, this exclusion applies to any patent:

“claims directed to products which – as described in the application – at the filing date could be prepared exclusively by a method which necessarily involved the destruction of the human embryos from which the said products are derived, even if the said method is not part of the claims.” – Brustle v Greenpeace.

Can plants and animals be patented?

Plant or animal varieties and plants or animals exclusively obtained by means of an ‘essentially biological process’ are not patentable in the UK and Europe. 

‘Essential biological processes’ include normal sexual reproduction, even if there was human intervention by means of crossing and selection to reach a desired offspring phenotype. However, if the plant or animal is not exclusively obtained by means of an essentially biological process (i.e. if it can be obtained by other means), and if it meets other patentable requirements, e.g. if the plant or animal originates from a new and inventive technical process or is characterised by a new and inventive technical intervention in the genome, then it may be patented. One example may be the use of a technique such a CRISPR-Cas which has been used to alter a heritable characteristic of the claimed plant or animal.

A further exclusion to the patentability is processes for modifying the genetic identity of animals which are likely to cause them suffering, without any substantial medical benefit to man or animal, as well as any animals resulting from such processes. 

However, it is possible to obtain a separate, special form of protection for new plant varieties called Plant Variety Rights (also known as Plant Breeders Rights).