An online repository of various articles published by our lawyers What s In A Patent: Patenting Living Things 1 Rajah & Tann 4 Battery Road #26-01 Bank of China Building Singapore 049908 Tel: 65 6535 3600 Fax: 65 6538 8598 E-mail: eoasis@sg.rajahandtann.com Website: www.rajahandtann.com
What s In A Patent: Patenting Living Things The patenting of living things has had a long and controversial history. While most developed countries now accept that some form of patent right may be granted for living organisms or part of living organisms, the scope of grant of such patent rights is different in each country. This article looks briefly at how patents for plants, animals and even humans have been regarded and treated. Introduction The recent advances in biotechnology have made it possible to do things that were previously deemed impossible. It is now possible to genetically engineer or modify any life form, grow nerve cells or other human organs for transplant in a laboratory and to target specific genes that cause diseases. Such amazing achievements are the results of painstakingly detailed laboratory experiments by research scientists. These new technologies pave the way for advances in medicine, nutrition and environmental protection. However, to commercialise such inventions investments are needed and no wise investor is going to sink his/her money into a project that is going to be copied by others. Patents allow inventors to protect their products from piracy. Patents on biotechnology inventions have had a troubled past and will possibly have a troubled future. This week we will discuss some of the issues involved in patenting living things. In 1995 more than 150 countries signed the GATT treaty and subsequently became a member of the World Trade Organisation ( WTO ). Part of this treaty included the agreement on the Trade Related aspects of Intellectual Property ( TRIPs ). The TRIPs agreement, amongst other matters, defines the legal framework for the ownership of life. All member countries must allow microorganisms and plants to be patented. Indeed some countries have made it possible to patent anything (including all life forms) unless the commerialisation of any invention goes against public morality. Some argue that we did not invent life and that a discovery of or a manipulation of life cannot be owned. Others view it as bordering on heresy giving a human the status of creator, while others are fearful that we are heading towards the possible patenting of modified humans. Some believe that genetic resources are subject to community ownership and cannot be owned by an individual. The biotechnology industry insists that research constitutes a significant intellectual and financial investment the commercialisation of which must be protected from piracy. Where people stand on the issues of the ownership of life is dependent on their opinion of one question; Can an individual own a genetically modified organism such as a plant or a mouse? Page 1
A patent does not actually give an individual ownership of his/her invention but rather a restricted monopoly on the commercialisation of that invention. Patents are associated with ownership of inorganic inventions only because of perception and what has been patented in the past. Life forms have actually been subject to patenting as far back as the 1800 s. One of the fathers of modern microbiology Louis Pasteur actually patented a single celled yeast organism. A microorganism, an oil eating bacteria, was actually the first genetically modified organism to be patented in 1980. It was also the first and most famous biotechnology court case where the US high court stated that anything under the sun that is made by man, even if it is derived from living matter, can be patented. The ethical morals of the 1960s shied away from patenting multi-cellular organisms. It was in this mind set that the UPOV convention was established to allow plant breeders restricted monopoly rights to commercialise new plant varieties without the emotional association of a patent. It was a case of a rose/patent by any other name would not smell as foul. No such convention protects animal breeders rights possibly due to animals being in the same kingdom as humans setting off emotional alarm bells. There are curtain criteria that must be met before a patent can be granted. These are universal among jurisdictions and it is usually the extent of the requirements and the interpretations that differentiates one legal system from another. 1. A patentable product must involve an inventive step. A discovery, idea or theoretical model can not be patented there must be some human input into a real product to satisfy for a patent. 2. A patentable product must be new or novel. Anything that is common knowledge or can be made or done easily by other researches in the same field of study can not be patented. 3. A patentable product must be capable of industrial application. If a product is not useful or effective and can not be commercialised it can not be patented. What can be patented is entirely dependent on in which country a patent is applied. The USA has the most liberal patent laws. In the USA genetically modified microorganisms, plants and animals have been patented. Similarly enzymes, proteins, whole genes and gene segments of all living organisms including humans have been patented. In the USA all living organisms and biological material except humans can be patented. Patent ing humans is against the 13 th amendment on slavery in the United States Constitution. The European patent law has had a long-standing debate on patents for biotechnological inventions. Prior to 1998, you could not patent any living organisms or parts of living organisms other than microorganisms. It is now possible to patent genes for which the protein function is known and recombinant genetic constructs. Plant varieties are still protected under the UPOV convention. To date only one animal has been patented in Europe, the infamous Harvard oncogene mouse. Page 2
In Singapore, the Patent Act has no exclusions of plants, animals or isolated biological material. Technically any biotechnological invention can be patented in Singapore but this system has still not been clarified at the level of patent examination or infringement cases. Plants have been patented under the UPOV convention or as patents in the USA since the 1960 s. Similarly horticulturists have been breeding new plant varieties of flowers such as roses, tulips and orchids since the beginning of the science. That a horticulturist who has spent ten years creating a sweet-smelling, long lasting and colourful rose should have monopoly rights to commercialise this rose for a time few people would disagree. Disagreements over plant protection rights usually come into play when community knowledge is stolen or when community food security is a risk. Do plants belong to the community or do they belong to individuals who breed them to express specific traits? Th e issue of community rights verses individual rights to life will be discussed next week. There is nothing unusual in owning an animal. Animals have been considered as property for centuries, a practice, which started with early agriculture. A patent on an animal, however, classifies the animal as an invention or requires an inventive step. Can a human say s/he invented an animal or specifically that s/he invented an animal that contracts cancer or glows in the dark? Certainly without the human intervention the animal would not have these characteristics but is it ethical to make these animals have these characteristics in the first place? In 1988 Harvard molecular geneticists were awarded the first US patent for a genetically modified animal. The mouse had an oncogene or a gene that predisposed it to contract cancer that would eventually kill it. It seems cruel but it provides an animal test subject for new cancer drugs or products. Cancer is one of the major causes of human death in the world, one in four Singaporeans die of cancer. The initial patent application in Europe was rejected as it was considered immoral. After a court appeal the oncogene mouse was patented as it was deemed that the benefits to humankind out weighed the suffering of the mouse. In another case a mouse that was engineered to contract cancer and go bald was to be used to study baldness. This patent was rejected in both the USA and the EU as the benefits to humankind were not significant to warrant the suffering of the mouse. Another infamous patent for an animal is the World Intellectual Property Organisation gazetted patent that was granted for the technique to clone the sheep Dolly. This patent covers the use of the cloning technique in all animals, including humans. A more recent patent granted on stem cell methods could potentially be used to clone humans. Both groups that have been granted these patents have specified that they don t intend to clone humans. While the intention of cloning humans may not be considered by these groups embryo selection has already started. In August this year a baby produced from an embryo that was chosen after screening numerous embryos to provide life saving cells to his sister who had a degenerative bone marrow disease was born. This case may be a double miracle for the parents but it paves the way for eugenic embryo screening for less vital traits like sex, height, intelligence or Page 3
pigmentation. Ironically the new baby s name is Adam and Eve nearly joined him when an English couple with four boys requested the right to select a female embryo. The UK courts rejected this. The predictions for the future are both hopeful and grim and the future achievements of biotechnology will to some extent depend on how society regulates new developments. Ultimately the discussions on how to encourage, regulate and monitor biotechnology research and development lies with the society of each country. Singapore must decide how we want to proceed and implement the regulations that we deem to be pertinent to our needs. The soon to be formed bioethics committee to be headed by Lim Pin are to deal with some of these issues for Singapore. This article first published in The Business Times, 16 January 2001. Rajah & Tann is one of the largest law firms in Singapore. It is a full service firm and given its alliances, including US premier firm Weil, Gotshal & Manges, is able to tap into a number of countries. Rajah & Tann is firmly committed to the provision of high quality legal services. It places strong emphasis on promptness, accessibility and reliability in dealings with clients. At the same time, the firm strives towards a practical yet creative approach in dealing with business and commercial problems. The information contained in this newsletter is correct to the best of our knowledge and belief at the time of writing. Specific professional advice should be sought before any action is taken. In this regard, you may call the lawyer you normally deal with in Rajah & Tann or e-mail the Knowledge Management team at eoasis@sg.rajahandtann.com Knowledge Management. All rights reserved. Page 4