Opinions on patents in this field are divided, with unfettered scientific progress at one end of the spectrum and the basic values accepted by society at the other. While many see an important contribution to social progress, others are mainly concerned by potential risks and ethical questions.
Despite all the disagreement, biotechnology is a growing discipline with a remarkably strong market.
This growth is also reflected in the number of biotechnology patents. For several years now, biotechnological inventions have consistently ranked among the ten largest technical fields in terms of patent applications filed with the European Patent Office (EPO).
Inventors have been filing applications for biotechnological 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 were able to synthesise – a red dye – was used in textile manufacturing.
In recent years, researchers have succeeded in better understanding 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 possible risks to individuals, society and the environment continues unabated. It affects all levels of political, economic and scientific decision-making.
The EPO either grants or refuses biotechnology patents in accordance with the relevant European patent law.
In principle, biotechnology inventions have to meet the same criteria as those in any other technical field.
What are those criteria? In a nutshell, European patent protection can be granted for any invention which:
But given the nature of biotechnology and its socio-political implications, various other rules also apply. These are partly based on the decision by the European Union (EU) to introduce secondary legislation concerning the patentability of inventions in this field.
A ten-year debate led to the adoption on 6 July 1998 of EU Directive 98/44/EC on the legal protection of biotechnological inventions, known as the "Biotech Patent Directive". Its purpose is to clarify the distinction between what is patentable and what is not.
For instance, an invention relating to individual human, animal or plant genes and gene sequences, and their functions, can be patented as long as the other patentability criteria are fulfilled.
However, the directive rules out the patenting of an entire human body in the individual phases of its creation and development. The same applies to applications for procedures designed to allow human cloning, human germ line engineering or the use of embryos for industrial or commercial purposes.
The essence of Directive 98/44/EC was incorporated into the Implementing Regulations to the European Patent Convention (EPC) as Rules 23b-e. This part of European patent law now provides the ground rules for considering the patentability of biotechnology applications – alongside the principal criteria valid for all patents.
The EPO holds no political views of its own on biotechnology patents. As the executive organ of the European Patent Organisation, it examines patent applications on the basis of the relevant law, in other words the EPC.
Articles 52 and 53(b) EPC say what can and what cannot be patented. Biotechnical inventions are basically patentable, but with the following exceptions:
Article 53(a) also prohibits the patenting of any invention whose commercial exploitation would be contrary to public order or morality.
Biotechnology itself is often represented in the media – and seen by the general public – as controversial. This has carried over into the patenting process, with a few headline-making cases where the patenting of the invention has itself been controversial.
The Harvard Oncomouse patent application of 1984 was the EPO's first-ever application involving an animal. Developed by researchers at Harvard University, the genetically modified mouse with a predisposition for developing cancer was intended for use in tests.
Criticism of the patent procedure focused on the question of whether an animal as such could be patented at all. More specific concerns were voiced about the potential for making commercial profit from engineered laboratory animals, with a number of groups proclaiming their opposition to laboratory testing on animals in general. In 1992 the EPO granted European Patent No. 0 169 672 in respect of the Harvard Oncomouse. This triggered one of the most complicated cases in the history of the EPO, as the grant was opposed by a large number of political parties, on-governmental organisations, religious groups and individuals. The final ruling on the case by a technical board of appeal, which upheld the patent in amended form, was published in 2005.
A similar situation arose in 1990, when the Lubrizol corporation filed a patent application relating to a genetic process for rapidly developing hybrid plants and seeds. This led to the grant of the first European patent for a transgenic plant.
The much discussed Edinburgh patent on modified human and animal stem cells had to be limited on moral grounds before being maintained in amended form in 2002. The invention had involved the use of embryonic stem cells, which conflicts with the EPC.
The EPC contains ample provisions for dealing with any issues regarding biotechnology patents. The implemented EU directive is a solid basis for sound decision-making, while the Enlarged Board of Appeal – the department of final instance under the European Patent Convention (EPC) – reviews new appeals.
Some areas in which case law continues to evolve: