Should plants or animals altered by microbiological manipulation be patentable in the same way as, say, modifications of penicillin are.
There has been strong opposition to the idea. The issue was discussed in the U.S. and Europe as long ago as the early 20th century. In 1980, the U.S. Supreme Court held in Diamond v. Chakrabarty that: ‘anything under the sun made by man’ is patentable. The court considered a distinction between a product of nature and a product of human invention or intervention as the decisive factor, rather than the distinction between sentient life and insentient matter. In ex Parte Allen, the Board of Appeal held that an oyster was patentable because it had been genetically altered by human intervention. In the end of the U.S. Patent Office ruled non-naturally occurring non-human multicellular living organisms, including animals, to be patentable. More recently, in 1988, Harvard University was granted a patent on a transgenic mammal named ‘Once Mouse’.
Is the situation any different in Europe? In Germany, inventions in the field of biology were not, in principle, excluded from patent protection, the Federal Supreme Court decided in the Red Dove. The European Patent Convention or EPC, signed in Munich and ratified in 1977, came into force on 1 June 1978 in the member states. Article 53 of the EPC provides that European patents shall not be granted in respect of:
a. inventions, the publication or exploitation of which would be contrary to ‘public order’ or morality, provided that the exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the contracting states;
b. plant or animal varieties or essentially biological processes for the production of plants or animals. This provision does not apply to microbiological processes or the products thereof.
This article contains three exceptions to patentability of plant and animals.
1. Animal varieties and plant varieties.
2. Essentially biological processes for the production of plant and animals.
3. Inventions which are contrary to ‘public order’ or ‘morality’.
1. What is the meaning of the term variety?
This question was debated by the Examining Division’s decision (EPOR 4 (1990)) in regard to Once Mouse. The application was made by Harvard University for a patent for a genetically modified animal which was to be used to cure cancer.
The application was refused:
a. on the grounds of non-reproducibility under Article 83 of the EPC. Although the application was based on claims related to all non-human mammalian animals, actual tests had only been done on mice: it could not be assumed that the same manipulation could be successfully performed on other mammals without inventive skill; and,
b. on the grounds that the legislators had intended to exclude animals in general from patentability under Article 53 (b).
However the Board of Appeal did not see any reason to limit the claims under Article 83. Also, the Board did not agree with the Examining Division’s interpretation of Art 53 (b) as excluding animals as such from patent protection. They pointed out that the legislators must have intended the phrase ‘animal varieties’ to be more narrowly construed than ‘animals’. The Board, therefore, held the question to the Examining Division.
On reconsideration, the Division decided that ‘Once Mouse’ did not fall under the terms of the ‘variety’ exemption. It concluded that in relation to Article 53 (b) claims directed to non-human mammals generally did not fall within the scope of the terms ‘animal variety’, (race animale).
The ‘variety’ exemption was also considered in the Giba-Geiy Case by the Technical Board of Appeal.
In- this case, the claimed invention satisfied the requirements of patentability but the Examining Division refused to grant a patent because the subject matter fall into scope of the Art. 53 (b).
Contrary to the Division’s view, the Europe Patent Office (EPO) Technical Board argued that 53(b) excludes only plant varieties and it is clear that ‘plant’ is different from ‘plant varieties’. According to the Board, ‘plant variety’ means stability of characteristics within specific tolerances after every individual propagation or propagation cycle. The Board of heed that 53(b) excludes ‘only the plants or their propagating material in the fixed form of the plant variety.’
2. Another problematic clause under Article 53(b) concerns ‘essentially biological processes for the production of plants and animals’ which are excluded with the proviso that ‘this exclusion does not apply to microbiological processes or products thereof’.
Two main question arises here. Firstly: what differentiates ‘essentially biological processes’ from ‘microbiological processes’?
Llewelyn has assumed that ‘an essentially biological process could be defined, most simply, as one where natural methods are the dominant influence’. The EPO defined ‘essentially biological process’ as dependent on the extent to which there is technical intervention by man in the process. If such intervention plays a significant part in determining or controlling the result the process will not be an ‘essentially biological’ one.
It has been held by the EPO Board, in the context of plants in Lubrizal/Hybrid Plants, that the meaning of ‘essentially biological process’ must be judged on the basis of the essence of the invention, taking into account the totality of human intervention and its impact on the result achieved.’ Human intervention may also mean that the process is not ‘a purely biological’ one even though the intervention made by only a trivial contribution.
The Draft Directive established a new and different approach, namely that a distinction must be made between naturally occurring substance itself and the product in a useful form, which results from human intervention in isolating it from its natural environment.
Art 53(b) says that ‘essentially biological processes’ are not patentable but the Draft Directive provides that this only covers traditional biological breeding activities thereby and rescues the interventions in ‘essentially biological process’ from non-patentability.
The most significant element of Article 53(b) is its inclusion of the products of microbiological processes. This means that a plant or animal produced by a ‘microbiological process’ falls outside the scope of the exclusionary provision of Art 53 (b) and is therefore patentable. It could be said that the aim was specifically to enable products of microbiological processes to be patented, i.e. all genetically engineered plant and animal.
Again, the problem is one precise definition. How does one decide that a process which has been carried out is a ‘microbiological’ one? EPO guidelines explain that ‘microbiological’ covers the processes used by micro-organisms and processes used for producing micro-organisms. Also, ‘micro-organism’ includes material such as plasmids and viruses (which have been used to create new plant genetic matter) and cell lines. All such process are patentable. The Draft Directive similarly rules (in its Article 5) that processes which either use or operate upon a micro-organism, or result in a micro-organism, should be considered microbiological and thus eligible for patent. It goes further: ‘the word micro-organism shall be interpreted in its broadest sense as including all microbiological entities capable of replication, e.g. as comprising, inter alia, bacterium fungi . . . and cells.’
3. The third exception is on the grounds of immorality. Art 53 (a) provides that a patent should not be granted in respect of inventions, the publication or exploitation of which would be contrary to ‘Public Order’ or ‘morality’. In other words, if the public considers an invention ‘immoral’ a patent would not be granted.
But, the Examining Division ruled in regard to ‘Once Mouse’ that irrespective of whether the public considered it moral or immoral, such inventions incontrovertibly assisted mankind in the care of ‘widespread and dangerous’ diseases. The Technical Board of Appeal pointed out in its recommendations to the Division that the possible suffering to animals and risks to the environment should be balanced against the invention’s usefulness in meeting human needs (diagnosis, treatment, food supply for a rapidly growing world population) on the other hand. The Division stated that ‘the invention would reduce the overall level of animal suffering by reducing the number of animals used in conventional animal testing.
Considerable doubts remain. Whether or not ‘Once Mouse’ may help save people dying from cancer, who is to guarantee that mice or other animals will not be manipulated to which achieve a cure for baldness or other trivial (but commercially ‘compelling’) purpose. What is the excuse for creating a very unhappy, transgenic rat to cure a widespread but non-lethal condition such as acne?
Genetic engineering should be the subject of general legislation rather than ‘patent law’ especially in respect of ‘immorality’.
The development of new features in plants and animals using microbiological methods is a long, difficult, expensive process with no guarantee for success. Therefore patents which have been granted by appropriate and competent bodies need to cover not only the first generation of the altered animals or plants but also their progeny which are then the result of natural breeding: and this was allowed in the claims of the Harvard Patent.
Despite strong arguments on several grounds, a new invention related to living matter should not be prevented from securing a patent. It is also our view that the distinction between patentable and non-patentable should be made on the basis of human intervention (especially in relation to microbiological processes) rather than on the basis of sentient or insentient matter.
However the patentability of human life or any part of human life must always be regarded as unacceptable in principle because human life should not be subject to commercialism: it would open the way to a new form of slavery.