CRISPR: the shifting sands of patentability
CRISPR/Cas9 (clustered regularly interspaced short palindromic repeat/CRISPR-associated protein 9) technology is a revolutionary method of modifying genomic sequences. Although genomic modification has been possible for many years, CRISPR technology is cheaper, easier and more accurate than the modification tools preceding it.
CRISPR technology has its basis in a naturally occurring bacterial defence system against viruses. This system has been modified in such a way that it can be deployed in mammals. CRISPR technology tools comprise an RNA sequence which is constructed to hybridise to a target DNA sequence and a bacterial protein, Cas9, which cleaves and, in certain instances, modifies target DNA sequences.
The tool has a wide array of potential applications, not least the treatment of human diseases by, for example, correcting faulty genes. An important distinction needs to be made between somatic and germ line cells. From an ethical standpoint, changes to human germ line cells, which pass on genetic information from parent to offspring, are considered to be far more problematic than changes to human somatic cells, which are not involved in the reproductive process.
Although CRISPR is not the first gene-editing tool that makes it possible to modify human germ line cells, the wide dissemination and use of the technology has sparked a renewed and vigorous debate on whether it should be permissible to modify the human germ line.
Recent developments
In January 2015, a group of interested stakeholders, including scientists at the forefront of CRISPR developments, called for a voluntary moratorium on germline genome modification for clinical application in humans while the societal, environmental and ethical implications of such activity are discussed. In spite of this, research relating to modification of the human germline has proceeded at pace.
In April 2015, a Chinese research team (Liang et al.) published a paper which described the use of CRISPR technology to modify human embryos. Although the embryos in question were stated to be not viable due to their having an extra set of male chromosomes, this work sparked a renewed debate about the potential use of CRISPR technology to modify the human germ line.
More recently, a team from London’s Francis Crick Institute announced on September 18 that it had applied to the Human Fertilisation and Embryology Authority (HFEA), which licenses all research involving human embryos in the UK, for a research licence to modify the genomes of human embryos using CRISPR technology. Editing the human germ line for therapeutic purposes is not permitted in the UK, although the HFEA may issue licences to modify the germ line of human embryos that are up to 14 days old for research purposes.
From an ethical and regulatory perspective, debate is needed on whether human germ line genetic modification is permissible for therapeutic purposes. A separate but related question is whether the use of CRISPR technology to modify the human germ line is patentable and, if so, under what circumstances.
Patentability
In Europe, the patentability of biotechnological inventions is governed by the provisions of Directive 98/44/EC on the legal protection of biotechnological inventions. Article 6(1) of the directive provides that inventions are not patentable “where their commercial exploitation would be contrary to ordre public or morality”. The meaning of ordre public is open to interpretation in different member states. However, the directive sets a minimum standard for ordre public and morality by stipulating that certain biotechnological inventions are excluded from patentability on these grounds. These include:
