However, it is not my husband, but rather my son, whom I want to talk about now. The anniversary of my son’s death was yesterday. It is probably in vain to talk about the last days of his life, because people already know that part of the story. He was part of an incredible story, but unfortunately he was on the wrong side.

My son learned at an early age how to become a man like his father, one who was devoted to his work and driven by success. His father did not spend much of his time with his family, but on those occasions that he did, he spent most of the time talking about his successes and the growing influence of his business. It was easy to tell that my son was captivated by his father’s success. To him, his father was an angel who had descended from heaven to tell him stories of miracles and wonders.

Unlike his father’s business obsession, my son developed an interest in machines. He dissembled and re-assembled all sorts of machines from a very young age and was able to combine different objects to come up with his own primitive inventions. Before he went to elementary school, he invented an automated knife that would spread butter on his bread and a machine that would bring him the remote control when triggered by pulling down on a string. Often, I found myself worrying about my son’s future education and wondering what this kid could possibly learn at school.

Unfortunately, within the first week of school, my worries about his education came true when my son was diagnosed with Attention Deficit Hyperactive Disorder (ADHD) and quickly became an outcast at school due to his hyperactivity. My divorce from his father during the same year only made things worse. I didn’t know what to do. Although it was not the best solution, I still thought it was best for my son to continue to study at a normal, public school.

In his second year, a fan club was formed to celebrate the superheroes that made this planet a better place to live. Mr. Incredible, Elastigirl, Frozone, Gazerbeam, Superman, etc., were all invitees of this club during their biweekly activities. My son, having grown up with the example of his successful father, soon developed an interest in this club. There, my son had found an excellent replacement for his father, whom he deeply missed since our divorce.

One day he returned from the club’s activities and was not the same person that usually returned from school. I hardly recognized him. The angry-looking, hyperactive outcast was gone, and in his place was a child who was destined to follow his dreams. During dinner, I asked how his day had been. He talked about a man that I “better marry,” because he wanted him as his father. Guess who it was: Mr. Incredible.

“I asked and he said he was single and he loved children,” my son insisted.

“But I’ve never met him!” I replied, smiling.

“I’m sure you’ll love him,” he said.

I was so happy that, after two years of misery and distress, we could have a dinner like mother and son.

The dream went on for a few months, until one night when he came home from a friend’s house, looking very distraught. I thought perhaps he had a fight with his friend, but it wasn’t that. He had tried to tag along with Mr. Incredible as his sidekick but had been kicked out of his car, because Mr. Incredible found him too young and didn’t want a sidekick. After all, Mr. Incredible always worked alone. Eventually, my son was able to accept the situation and he realized that what Mr. Incredible said was true, that he actually was too young. However, his awe of Mr. Incredible never faded. He always sought ways to get Mr. Incredible to accept and appreciate him.

By the time my son was in middle school, companies began to purchase his inventions. He was already well on his way to becoming as successful as his father had been. I frequently asked myself what this boy would accomplish in the future. He already had achieved what most people never would in an entire lifetime. Flying boots were his latest invention. He thought this would catch Mr. Incredible’s attention because flying would greatly improve Mr. Incredible’s ability to fight crime.

One night, he was brought home by the police. I literally freaked out. I thought he had done something horrible with one of his crazy inventions. Apparently, he had tried to help Mr. Incredible at the scene of a robbery, but everything had gone wrong and Mr. Incredible rejected him as a sidekick once more. Being an adolescent undergoing puberty he had difficulty in facing this latest rejection from his hero. He not only craved acceptance and appreciation but he needed them. From that day on, all the Mr. Incredible posters, stickers, and T-shirts were gone from our house. Instead, my son started putting up posters of villains and he started to idolize them.

I couldn’t tell anyone, but I was terrified when I found a paper in his room that said, “Revenge of the Bad Guys.” I hoped this was a sort of adolescent fury that would go away in time. And it did – at least I thought it did.

After he completed his university degree, my son started a company that focused on the research and development of defense systems. Because of his genius, he easily achieved immediate success and purchased two islands in the Pacific: one as his home to live with his fiancée and the other as his base of operations. I was a happy mother because after so many years of hard work and worries, I thought my son had finally overcome his difficulties and was moving on with his life.

My dream did not last long. After the government grounded all the superhero activities due to public unrest towards the superheroes, my son started popularizing his inventions that mimicked the abilities of these superheroes: flying boots, a machine that made any shape by freezing the humidity in the air, a never-ending rope that never broke, etc. I never thought that what he was doing was simply a disguise to hide his true goal: discovering Mr. Incredible’s secret identity and getting revenge for himself and for all those whose parents or spouses were hurt or killed by the superheroes. I found out about this from one of his journals that was later given to the police by his fiancée.

You know the rest of the story. My son was struck by a car that Mr. Incredible threw at him and was finally killed by the very jet engine he had invented and built. Mr. Incredible had once been my son’s hero and was now his murderer. What can I say? Congratulations, Mr. Incredible on another job well-done! I hope you can enjoy dinner with your family tonight as I’m writing these lines in sorrow …

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’. 

Conclusion

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.

• References
• CHRISRIE, A. (1989) ‘Patent for plant innovation’ EIPR, 3.
• CORREA, C. (1992) ‘Biological resources and intellectual property rights’ EIPR, 5.
• NOTT, R. (1992) ‘Patent protection for plant and animals’ EIPR, 3, p.79.
• PAVER, M. (1992) ‘All animals are patentable but some are more patentable than others’, Patent World, March, 9.
• WHAITE, R.& JONES, N. (1989) ‘Biotechnological patent in Europe’, The Draft Directive, EIPR, 5.