Patenting Recent Biotechnological Inventions

Issues and controversies in Patenting Recent Biotechnological Inventions – Is the patenting of life equivalent to owning it?

Background to biotechnology and Intellectual Property

Since the discovery of Recombinant DNA technology in the early 1970's, Biotechnology has become an important tool for many researchers and industries. Biotechnology and the inventions arising out of it have spurred the creative geniuses of many inventors and have played an important role in improving the nation's health, food supply and environment. Turning Biotechnology inventions into protected Intellectual Property, with concomitant Intellectual Property Rights have been taking place for over a century. For example, Louis Pasteur was granted a French patent in 1865 for yeast clones that he isolated from mixtures of yeast species. The application of technology to agriculture has helped contribute enormous increases in yield and quality. The isolation of adrenalin over a century ago from the human suprarenal gland was an important advance in the field of medicine.

Legal protection given to biotechnology

Patents are viewed as vital to protecting the commercial interests and intellectual property rights in biotechnology. Patents are limited rights based on a claim that a new technological invention has been created and fully communicated to the public. Patents can cover new products, processes that creates these new products, new processes for producing existing products and new processes generally. While patenting of a biotechnological invention it is important that it meets the 3 criteria's laid down by the TRIPs to meet patentability, namely which are new or novel, involves an inventive step or not obvious and capable of industrial application. The TRIPs gives the option of excluding certain forms of subject matter from patentability

# Diagnostic, therapeutic and surgical methods for the treatment of humans or animals.
# Plants and animals other than micro0organisms, and biological processes for the production of plants or animals other than non-biological and micro-biological processes.

However the patenting of new life forms raises arguments in favor of and against the issuance of such patents. Most recently, public debate has centered on the patenting of animals. Discussions regarding the patenting of a genetically engineered organism can involve questions relating to the environmental application of the organism, scientific questions, ethical issues and economic considerations.

The other forms of IP Protection that can be offered to biotechnology involve plant breeder's rights, trademarks, trade secrets and geographical indications.

Extent of legal protection offered by patents

The protection conferred by a patent on a biological material extends to any biological material derived from that biotechnologically invented material through propagation or multiplication and possessing the same characteristics. The protection conferred by a patent on a product containing the genetic information extends to all material in which the product is incorporated.

However the protection does not extend to plant-propagating material or breeding stock sold to a farmer by the holder of the patent or with his consent, provided that the farmer uses the biological material or livestock for his own agricultural purposes.

Where a breeder cannot acquire or exploit a plant variety right without infringing a prior patent, he can apply for a compulsory license for non-exclusive use of the invention protected by this patent, subject to payment of royalty.

3. Patenting of Micro-organisms and Cells

The first successful directed insertion of recombinant DNA into a host micro-organism took place in 1973, and since then scientists realized the huge potential involved in directing cellular machinery to develop new and improved products and processes. Many of these products were micro-organisms or cells. Hence with the development of the recombinant DNA technology, the potential of patenting the living organism resulting from the technology arose.

In 1980, in the Diamond v. Chakrabarty ruling, the Supreme Court of US ruled that a living micro organism could be patented. Chakrabarty had developed a genetically modified bacterium capable of breaking down the multiple components of crude oil. Since this property was not possessed by any naturally occurring bacteria, the invention was thought to have significant value. It was held that a non-naturally occurring manufacture was a product of human ingenuity. DNA compounds having naturally occurring sequences are eligible for patenting when isolated from their natural state and when it meets the statutory criteria for patentability. Hence by a 5-4 ruling it was held that a live, human made micro-organism is a patentable subject matter under section 101 as a manufacture or composition. The fact that biotechnology was not predicted as a branch of science when the congress enacted section 101 does not arrive at the conclusion that micro-organisms are not a patentable subject matter until the congress expressly authorizes such protection.

Post Chakrabarty trends

The Chakrabarty decisions and the subsequent actions enacted by the US congress provided great economic stimulus to the patenting of micro-organisms and cells, and in turn provided stimulus to the growth of the biotechnological industry in the 1980's. However, increased patenting of biotechnological inventions has led to litigation related to patent infringement issues. The patent litigation is only likely to increase in future considering the overlapping of patent claims, the high value of products, problem of prior publication and the fact that many companies are pursuing the same product. The increase in the patent claims leads to the inability of the patent offices to process the biotechnological inventions in a timely manner. Turnover amongst the patent examiners, luring them to the private sectors by offering higher pay etc are reasons for the delay in the reviewing of patents.

Patenting of Transgenic Animals

The first animal patent was issued in April, 1988 to Harvard University for a particular type of mammal, namely the Harvard oncomouse, genetically engineered to obtain a cancer- causing gene. The oncomouse has been genetically engineered to carry a particular type of gene called as the oncogene which makes it susceptible to cancer and hence makes it ideal for cancer research. Subsequently the USPTO announced that it would consider non-naturally occurring non-human, multi-cellular organisms, including animals to be patentable subject matter under its laws.

Most of the animal patents have been granted to transgenic animals produced by recombinant DNA or genetic engineering. Transgenic animals have DNA which has been modified by adding DNA from another source other than the parental germplasm, usually from different animals or humans.

Negative impacts of patenting of transgenic animals

The major concern that arises out of patenting of transgenic animals are that transferring genes from one species to another transgresses the natural barriers between them and affects the integrity of species. Species belonging to the same group, though they may slightly vary from one region to the other based on the environmental conditions, they primarily have the same gene pool. By allowing patenting of transgenic animals, the fundamental genetic architecture is being tampered with.

Ethical Issues
A number of ethical issues stem from the patenting of animals. Most of them deal with the consequences that could arise subsequent to patenting of animals while the other arguments focus on the religious, philosophical and spiritual grounds. The arguments which go against the patenting of animals are difficult to prove as many of them are factual assertions which are still to occur or to be proven. The DNA is considered to be intimately related to the species identity and hence no part of it should be controlled for commercial interest. In case of human beings, human DNA is unique and hence possesses intrinsic value of a sacred kind. It can also be put as ‘Human DNA bears the image of God' and to tamper with them and own them for commercial and economic interests would hurt the sentiments of the many. The view that plants, animals and microorganisms comprising life on earth are part of the natural world into which we are born and hence the conversion of these species, their molecules, or parts into corporate property through patent monopolies is counter to the interest of the people of the country and world, has been taken by many.

However most of the religious and ethical issues arise out of product patents which have been given to organs, cells, genes and proteins. Hence one possibility that could be accepted by such religious leaders could be the issuance of ‘process patents', whereby only the process involved in the manipulation of particular genes are patented rather than the genes in itself.
5. Patenting of Genes-
Our Genes define us, as a species as well as individuals, and hence for human genes there are strong oppositions both on the religious and secular front. Patents are being granted to genes despite there being many arguments for keeping the genes in the public domain. A patent cannot be granted on a gene as it naturally occurs. Isolation of the gene is required for it to be patentable. The patent offices have treated genes as a new chemical compound and have granted composition of matter patents. Thus a patent granted on an isolated and purified DNA composition confers the right to exclude others from any method of using that DNA composition for upto 20 years from the date of filing. However Human Beings are not patentable as human multicellular living organisms are not a patentable subject matter under section 101.

Why are genes being patented?

# Genes have been used for gene therapy though it is still in the early developmental stages. The technology used in each gene therapy will have huge commercial value in the coming future making patenting crucial. However gene therapy is not a patentable subject matter in India.

# Some of the genes encode proteins that can act as therapeutic agents. (e.g.; the human growth hormone). Hence by offering patent protection to such genes, the interests of the pharmaceutical industries will be maintained. However, the pharmaceutical industries should be granted access to the genes and not the ownership. Monopolies on genes are not in public interest.

# For Biotechnological companies, gene patents are considered as value generators and enhance the value of the company in the eyes of the investors. Most of the Biotechnological companies and research institutes have created Technology Transfer Offices (TTO) so that the patents generated by their research will generate huge financial rewards.

# Sequences of genes and genomics provide data for further research. The patenting of genes forces the disclosure of information instead of it being kept as a trade secret. Full and free access to genomics data is essential for academic research and owning gene patents are the best way to ensure hindrance free access to such data.

Morality and Patents- Is there a connection?

Law and morality are inter-connected and some areas of law require the legal adjudicators to draw on morality in considering the decision making process. The patent law especially concerning the patenting of biotechnological inventions does just this. The best example of this would be Article 53 (a) of the European Patent Convention 1973, which does not allow the grant of patents for inventions the publication or exploitation of which would be considered to be contrary to ‘ordre public or morality. Most of the national patent laws of various countries embrace the moral standards within its ambit. When the legislatures enact patent laws, the moral standards of the community to which they belong to are one of the factors which affect their content. Moreover, the patenting system cannot be considered to be an ethically neutral concept. A system can be considered to be ethically neutral when it does not affect A's interests vis-à-vis B's interest. The whole crux of patents is to exclude others from access to information contained in the claims and hence it cannot be considered to be morally or ethically neutral. This act of excluding others to protect your interest will inevitably affect some one else's rights in some way or the other.

Patenting within the biotechnological sphere and the subsequent opposition proceedings which have been undertaken by NGO's such as the Greenpeace, which have become worried by prospects such as the patenting of life, have led courts to highlight the relationship between patents and morality. However it has to be kept in mind that the concept of morality is relative to the values prevailing in society. The decisions based on morality should not be based on what some members of the public find objectionable, but should include a detailed analysis of the effect on human health, economic impact, environmental issues and opinion of the population as a whole. The main point, however is that non-patentability would only mean that the invention is not the subject of any property rights, it can still be used and worked even if it is contrary to public interest and morality as it still lies in the public domain.

Why say NO to Life patenting?

The WTO has forced countries to introduce laws that allow the patenting of life forms and living organisms. In India, this was done through the Patents Act of 1970. Due to the introduction of such a monopolistic set up where biotechnological inventions can be patented, it has led to an epidemic of biopiracy and the patenting of traditional knowledge. The following are the other reasons which have been laid down which object to life form patenting:
# Farmers would be obliged to pay royalties on every generation of plants and livestock they buy and reproduce for production purposes.
# Breeders will no longer have free access to germ plasm for developing new varieties of plants and animals.
# Consumers will end up paying high prices for food, medicine and other biotechnological products.
# In the end, public research which is paid for by all will be privatized by a few.
# Food supply will be threatened by monopolistic control over genetic resources
# The concept of Human rights will be threatened as human beings, and parts of their bodies will become the exclusive property of the patent holders.
# Animal welfare will become a thing of the past as the patent system stimulates genetic engineering of animals for production of food and medicine no matter how they suffer.
# But the main objection to the patenting of life forms are that DNA is a product of nature and not a product of human ingenuity.

Patent law Articles:
What is patent?
Patenting of Micro-Organisms in India
Patentability
Patent & Its Effect In India
Challenges to India Patent Regime
Whether Patent Law Protects Biotechnological Inventions
Patent Protection in the field of Nanotechnology

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