Advances in the life sciences, whether in health, agriculture or the environment, have had an extraordinary impact on life expectancy and the quality of life. Biotechnology has already provided life-saving medicines such as human insulin to treat diabetes, erythropoietin to treat anaemia and monoclonal antibodies to treat cancer, and holds promise for cures for conditions currently regarded as untreatable. In agriculture, biotechnology is used to modify plants to improve their resistance to disease, herbicides or difficult environmental conditions, or to achieve higher yields. Biotechnology has also been at the heart of many advances in environmental protection. In the past few decades biotechnology has been one of the fastest growing fields of technology, and this is also reflected in the number of patent applications filed with the European Patent Office (EPO). The field covers a wide range of areas, from micro-organisms to agriculture and medical applications,and involves techniques and products such as genetically modified plants.
Inventors have been filing applications for biotechnology patents for over a hundred years. Patent No. 3, granted in Finland on 8 November 1843, introduced a novel method for producing yeast cultures. On 29 July 1873, microbiologist Louis Pasteur patented his improved yeast-making method at the French Patent Office.
Commercial firms also sought to patent biotechnological processes, with BASF patenting alizarin in 1869. The substance the scientists managed to successfully synthesise - a red dye - was used in textile manufacturing.
In recent years, researchers have succeeded in improving their understanding of the functioning of the human body and its immune system. Biotechnology has already provided life-saving medicaments such as human insulin, erythropoietin and Herceptin, and it appears to promise cures for conditions currently regarded as untreatable.
In agriculture, biotechnology is used to modify the physiology of plants with a view to introducing specific desirable features such as resistance to disease and herbicides, or achieving higher yields.
However, the debate about potential risks to individuals, society and the environment continues unabated. It affects all levels of political, economic and scientific decision-making.
As the executive organ of the European Patent Organisation, the EPO examines European patent applications and either grants or refuses them on the basis of European patent law, as laid down in the European Patent Convention and interpreted in the case law developed by the boards of appeal, the EPO's second-instance judiciary.
To be patentable, biotechnological inventions have to meet the same criteria as those in any other field of technology. Patents can only be granted for inventions that are new, involve an inventive step and are susceptible of industrial application. A specific legal definition of novelty has developed over the years, with "new" meaning "made available to the public". This means, for example, that a human gene, which existed before but was "hidden" from the public in the sense of having no recognised existence, can be patented when it is isolated from its environment or when it is produced by means of a technical process and as long as its industrial application is disclosed in the patent application. All other requirements of patentability must also be fulfilled.
While biotechnological inventions are in principle patentable, due to the nature of biotechnology and its ethical implications there are specific rules which apply when considering the patentability of an invention in this field.
Articles 52 and 53 of the European Patent Convention say what can and cannot be patented.
Biotechnological inventions are basically patentable. However, no European patent can be granted for any of the following:
- any invention whose commercial exploitation would be contrary to ordre public or morality (Art. 53(a) EPC)
- plant and animal varieties (Art. 53(b) EPC)
- essentially biological processes for the production of plants and animals (Art. 53(b) EPC), i.e. classical breeding comprising crossing and selection
- methods for treatment of the human or animal body by surgery or therapy, and diagnostic methods practised on the human or animal body (Art. 53(c) EPC)
Discoveries (e.g. the mere discovery of natural substances, such as the sequence or partial sequence of a gene) are not patentable. However, if an inventor provides a description of the technical problem they are intended to solve and a technical teaching they move from being a discovery to being a patentable invention (Art. 52(2)(a) EPC).
In Europe, a debate on biotechnology patents started in the late 1980s with the aim of clarifying the distinction between what is patentable and what is not, and harmonising EU member states' laws in this area. This led to the adoption on 6 July 1998 of EU Directive 98/44/EC on the legal protection of biotechnological inventions ("biopatent directive"). The directive has been implemented by all EU member states. As early as 1999, the EPC contracting states decided to incorporate the directive as secondary legislation into the Implementing Regulations to the EPC. Together with the EPC articles on substantive patent law, these rules now provide the basis for deciding on the patentability of biotechnology applications at the EPO.
The incorporation of the EU directive into the EPC strengthened the practice of the EPO in biotechnology, whilst putting greater focus on ethical considerations.
For example, the directive affirmed that isolated biological material is patentable even if it has occurred previously in nature (Rule 27(a) EPC). It also confirmed that plants or animals are patentable if the technical feasibility of the invention (e.g. a genetic modification) is not confined to a particular plant or animal variety (Rule 27(b) EPC).
Furthermore, an invention relating to gene sequences can be patented as long as the industrial application of the sequence is disclosed in the application and all other patentability criteria are fulfilled (Rule 29(3) EPC).
However, the directive rules out the patenting of the entire human body in all its developmental phases (Rule 29(1) EPC). The same applies to processes for cloning human beings, processes for modifying the germ-line genetic identity of human beings and the use of human embryos for industrial or commercial purposes. Also excluded from patentability are processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and animals resulting from such processes. This catalogue of exceptions to patentability is not exhaustive (Rule 28 EPC).
In addition to the provisions of the EPC and the EU directive, the case law of the EPO's technical boards of appeal and the decisions of its Enlarged Board of Appeal (EBoA) form a further source of guidance when considering the patentability of biotechnological inventions under the EPC.
A landmark ruling on stem cell cultures was issued in November 2008. In the WARF/Thomson case (G 2/06), the EBoA decided that under the EPC it is not possible to grant a patent for an invention which necessarily involves the use and destruction of human embryos. The EBoA stressed, however, that its decision did not concern the general question of human stem cell patentability.
In a similar manner, the Court of Justice of the EU ruled in 2011, in the "Brüstle case" (C-34/10), that Article 6(2)(c) of the EU directive excludes from patentability an invention which presupposes the destruction of a human embryo irrespective of the point in time at which such destruction takes place.
With regard to plant-related inventions, the EBoA ruled in G 1/98 that plants are in principle patentable if the technical teaching of the invention is not limited to a specific plant variety or varieties. This was also the approach adopted by the EU directive and was explicitly codified in Rule 27(b) EPC in 1999. In 2010 the EBoA decided, in what is referred to as the "broccoli and tomato I case" (G 2/07 and G 1/08), that a process for the production of plants comprising the steps of crossing and selection is excluded from patentability even if it contains an additional step of a technical nature, such as the use of molecular genetic markers. The EBoA has been asked to clarify whether the products of such processes (i.e. plants or fruits) are likewise excluded from patentability. In its decisions (G2/12 and G2/13, known as “broccoli and tomato II”) of March 2015, the EBoA ruled that the products of such processes (i.e. plants or fruits) could still be patented – if the conditions of patentability are fulfilled – even if they are obtained from such a non-patentable method.