genes
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This article is written by Neeta, pursuing a Certificate Course in Introduction to Legal Drafting: Contracts, Petitions, Opinions & Articles from LawSikho. The article has been edited by Aatima Bhatia(Associate, LawSikho) and Smriti Katiyar (Associate, LawSikho).

Introduction

Historically, the purpose of the patent institution was to promote research and innovation so that new beneficial results could be promoted. This is a time-limited exclusivity granted to the inventor that allows him to exclude others from using the invention. Patents have existed for a long time, but their emergence in the field of genetics has confused many people. Patents on human genes have raised practical and ethical concerns, all over the world. A majority of the public opposes the patentability of life and, therefore, the patentability of human genes. 

The research community is concerned about the limitations of the research in this field. Health care professionals and payers are concerned about the impact of the patents on the cost of tests. Many industry members, particularly small and medium-sized firms, and patent attorneys are concerned about the difficulties they may face as a result of multiple licenses necessary to develop a new diagnostic kit or a new drug.

Scientists are the ones who know about the advancements of biotechnology but it is for the public to adjudge the social and moral issues that come up due to these inventions. Only society can measure the benefits and hazards of gene patenting and its impact on the general public. This can be accomplished through a properly drafted legal framework. New inventive steps in research are being introduced every day. The remarkable probability of patenting of genes is developing complexities and causing problems in granting patents. There are social and ethical objections in the field of gene patenting, which will be discussed and analyzed in this article. 

Ethically speaking, living beings are creations of God, that cannot be owned by human beings through patents. God is the maker and the only owner of all the living beings on this planet. A living being is vested with inherent dignity and integrity, which shall be protected and guaranteed. Human beings should not play with the wisdom of God by manipulating living beings. Genetic manipulation of organisms and their protection by the patent system had always raised hue and cry on moral and ethical issues. It is quite obvious that patent law cannot protect immoral inventions on the question of ethics and morality.

 According to a recent estimate, patents have been granted or patent applications have been filed for nearly 20% of human genes.  For instance, major genes for monogenic disorders (e.g. Huntington’s disease, Cystic fibrosis) and some common predisposition genes (e.g. breast cancer BRCA1 and BRCA2) have already been patented. However, after the publication of the human genome in 2001, there was a clear decrease in patent filings, and gradually the bar on patentability was lifted. In particular, the European and Japanese patent examiners have had a more stringent approach compared to that of the US Patent and Trademark Office (USPTO).

The patenting of life forms constitutes privatizing life and having life as a property, which is considered immoral. A patent is a private property that can be owned, transferred, or sold just like goods. It is viewed that patenting of life amounts to treating other organisms like private property, Hence patenting of life is nothing but commodification and marketing of life, which is a gross violation of the dignity of life. 

Techniques used in biotechnology

It is important to have a rudimentary understanding of the sciences that underpin biotechnology before we embark on a study of the legal and ethical issues surrounding the patenting of biotechnological inventions and gene patenting. Biotechnological inventions are inventions that concern a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used.  Biological material means any material containing genetic information and capable of reproducing itself or being reproduced in a biological system. Genetic manipulation in farming, agriculture, and horticulture can produce more robust varieties of animals and plants that are able to resist harsh environments and provide better yield, while genetically modified foods can last longer and may even taste better and can be of considerable assistance to populations living in the developing world.

A number of techniques have been employed by the biotechnology industry. They are as follows.

Tissue and cell culture technology involves the production of cell lines. These are immortal, self-replicating samples of cells grown outside the original host, which can be bacteria, plants, an animal, or a human being. The importance of such cell lines lies in their uniformity. Because samples in any given cell line stem from a common ancestor they have the same genetic make- up. This allows scientists to carry out highly accurate comparative tests. Cell lines are of use in the study of biological processes and play a vital role in testing the potentially harmful effects of drugs and other compounds on living matter. Stem cell lines hold considerable promise in the development of therapies in their own right.

Hybridoma technology is concerned with two essentials in the human immune response: white blood cells and antibodies. The technique involves the fusion of antibody-producing white blood cells and tumour cells (myeloma). Myeloma reproduces when injected into an antigen (a foreign body that provokes antibody response) an indefinite supply of antibodies is produced because of the immortal qualities inherited from the tumour cells. Hybridomas have proved to be invaluable in immune system research.

Recombinant DNA technology is also known as genetic engineering. The processes and techniques involved in rDNA technology concern the manipulation of matter at the subcellular level. In this respect, genetic engineering differs from its companion technologies. DNA is also known as Deoxyribonucleic Acid. A string of DNA is contained in the nucleus of almost all living cells with the exception of very basic forms of life such as bacteria. The purpose of DNA is to dictate the function of the cell in which it exists. It does this through genes. Genes are segments or sequences of DNA that activate the production of proteins by bringing together different combinations of amino acids which in turn combine to produce different proteins by bringing together different combinations of amino acids in particular orders. Different genes attract different amino acids which in turn combine to produce different proteins. This is a process referred to as coding for a protein. Different proteins make cells function in different ways. Proteins are also known as polypeptides- which will be frequently used in case laws.

In Silico techniques combine genetic and bioinformatics knowledge to search and compare databases of gene sequences in an attempt to attribute function to as yet unprotected sequences based on matches with already known proteins of similar function.

The sequences of DNA known as genes are themselves composed of chemical bases. There are only four of these bases and they are known by their initial letters: A, T, C, G (Adenine, Thymine, Cystosine, and Guanine). The entirety of the genetic code necessary to create a single organism is called its genome. Recombinant DNA technology is by far the most revolutionary of the techniques employed by the biotechnology industry in recent decades. 

All of these developments from the identification of full or partial gene sequences, the development of tests and vaccines based on genetic material, and the creation of genetically engineered organisms and genetic research tools have been the subject of a patent application. Many of these have been successful but a variety of objections to biotechnological patents have been raised relying on the provisions of the law and we shall consider each of these in turn.

What is gene patenting?

A genetic substance that can be reproduced using artificial means, such as the isolation and cloning of a gene, is considered an artefact, a man-made invention, and is thus patentable if the substance, its function, or a method to produce it, is an invention, if it is novel, has a specific disclosed function and is non-obvious with reference to current knowledge, and can be used industrially.

A gene patent provides the owner exclusive rights over that gene. Usually, the person who discovers or identifies the gene is granted this right by the government or an organization. This right includes sole ownership and its proprietary use for a period of 20 years.

Ethical implication of gene patenting 

The field of ethics tells us to give explanations for our actions and describe our intention. The intention to do good does not matter, what matters is that,  a reason should be given on why that particular action is being done and what is being done. The field of biotechnology needs to address three main areas:

  1. Incentives- the way scientists are promoted to research.
  2. Intentions- end results of that research.
  3. Actions- prospective applicability of the research.

The benefits of biotechnology are advertised largely but its risks are not covered properly. We cannot remain ignorant about the social, legal and ethical concerns of biotechnology. The ethical concerns related to gene patenting are:

  1. Human cloning- for the sake of utility one should not alter the genetic structure. Humans cannot be used as a commodity. Genetic material is a common heritage and one cannot have a monopoly over it.
  2. Crossing biological borders and exchanging genetic material is not ethically correct. An example is the “Dolly” sheep where the human genes were inserted into the animal genes.
  3. Genetically modified living things will be considered not less than a commodity, so all the intrinsic value will be lost. 
  4. The exploitation of women is brought about when biotechnology is used in reproductive biology. Many embryos are taken for doing various researches such as stem cell research.
  5. There are debates concerning that due to human cloning there can be the creation of slaves.
  6. Humans are used as a subject in many research institutions, the concern should be taken before conducting the research and all the procedures should be explained before any experimentation.

In John Moore for the first time, a patent was claimed upon the “cell line” of human beings. In the above case, John Moore was suffering from leukemia for “hairy cell leukemia” during his treatment the physician found out that his cell lines are helpful in preparing a particular medicine and applied for a patent. Moore contended that it was his cell line and, therefore he should be the owner of the property. It was then concluded that conferring rights over a part of the human body is a violation of human dignity and ethical principles. He sued the doctor, the drug company and the University Hospital on the grounds of, inter alia, violation of his proprietary rights. This argument was revoked. The court decided that the contention of Moore is not acceptable on the grounds because there can be no property rights over a human body. However, the claims on the breach of the fiduciary duty and lack of informed consent were approved by the Supreme Court of California.

The social implication of gene testing

Gene patents encourage investment in genetic research by offering a financial incentive in the field of research and development.  Gene patents, on the other hand, are debated to have a ‘chilling effect’ on research and innovation, rather than encouraging it. Because once a gene is patented the owner receives the exclusive right to use the patent for research and development which hinders and limits others organization and researcher to carry forward their experiment without patent infringement. 

Patents may be perceived as causing more issues than benefits in research areas where economic incentives should be irrelevant. The patent limits research by other organizations’ which limits the scope of medicines being created elsewhere. Gene patents create an obstruction for many researchers at medical centres and research centres to conduct experiments to detect rare diseases and cancer treatments. This non-accessibility to health care is unfair and socially unethical. It can also be possible that gene patenting may have an adverse impact on the cost and quality of healthcare services. A patent holder might set a higher price than would otherwise apply because patents award monopoly rights over the patented product or process. A patent holder will adopt restrictive licensing practices and limit access to a particular test, therapy or drug.

Benefit-sharing

The human genome is often described as the common heritage of humanity, a view that has been supported by the Human Genome Organization’s (HUGO) Ethics Committee and by the United Nations Educational, Scientific and Cultural Organization (UNESCO). Patents on human genetic materials are sometimes criticized because they are thought to grant exclusive rights over this common heritage to a limited number of entities. This objection rests in part on concern for fair distribution of the benefits of genetic research. 

When people’s genes are collected for testing or research, the person’s consent is necessary on a personal and national basis for study, research, experimenting, and in some situations, even modification or manufacture of other constituents. If this permission is not obtained in line with the proper procedure, ethical difficulties may arise.

The legal implication of patenting genes

Human genetic research has opened doors for research in “human genome”, “human embargo research” and “stem cell” research. These fields involve serious ethical concerns. Human genomic research employs the exploitation of genetic material in an individual, which involves a lot of ethical complications. Embargo research involves engineering or embargos to develop into a complete human being. Manoeuvring the embargo and removing the stem cells are strongly criticized. 

In the U.S the debate over ethics got aggravated when Stuart Newman applied for a patent on a non-human chimera. He manipulated human genes into an animal. It was neither a human being nor an animal. The patent office regarded for the first time principles of ethics while granting a patent it concluded that if the patent is granted it will outrage the ethical standards of the society. The court held that transgenic human beings are not eligible for patent by virtue of the principles laid down in the 13th amendment of the US constitution, therefore patent was not granted. This made things clear that human beings were restricted from patenting on moral grounds. The judiciary also clarified that patenting of human beings and cloning is prohibited under the US constitution and patent law. 

Cloning as such refers to a scientific process in which biological material is replicated which includes the ‘DNA’, ‘cell’ or ‘an organism’. As the 13th amendment restricts slavery in human beings same consideration was taken to prohibit human cloning and patenting human beings. 

Both the judiciary and patent office proposes that the “cloning of human being violates the inherent dignity of human life and patenting of human beings amount to slavery”. This was discussed in Pioneer Hibred International where cloning was restricted on the basis of ethics, morality and public order. This meant that transgenic humans cannot be patented. Lastly, the US patent Office and judiciary accepted the ethical standards regarding patenting which were not provided earlier by the US patent Law. But looking into further consideration the US laws provide patents on ‘process’ or methods of human cloning. The US law stands diversified that the process of human cloning can be patented but not human cloning. The question is why a process should be granted a patent if there is a process of cloning that may in the future lead to cloning which is against ethical issues. The US laws remained silent on this issue. 

A patient’s rights are defined in a negative sense: for example, a product patent gives its owner the exclusive right to prevent third parties from creating, using, offering for sale, selling, or importing that product for these reasons without the owner’s approval. This right necessitates the patent holder’s active supervision. By providing licenses on his patent, a patent holder can allow third parties to use his invention.

The licensing of the genes is important to promote research and advancement in the field of biotechnological innovations. If the patent rights should be licensed to reduce the burden of organization and research so that it could expand the research through the distribution of patent’s license. A patent holder, or anyone having a license for a patent, needs to abide by many rules and regulations concerning the invention; therefore it is possible that the invention may not be exploited. Licensing agreements are one form of disseminating knowledge that is protected by IPR, and they are usually beneficial to both parties.

The cost of the license fee is directly linked to the problem of royalty stacking. The Organization for Economic Co-operation and Development suggests that license agreements should include mechanisms to set a reasonable overall royalty burden for genetic invention products and services, including research tools. More conventionally, the private and public sectors should be encouraged to develop mechanisms to decrease transaction costs in acquiring rights to use technology.

Gene patenting in India

Section 3(C) of the Patent Act, 1970, disallows “discovery of any living thing or non-living substance occurring in nature” as a patentable subject matter. Section 3 (j) of the Indian Patent Act, 1970 includes objection to plants and animals, in whole or any part thereof, other than micro-organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals to be patentable.

Recently, patenting in India has been evolving considerably. Therefore to cater for the global developments in biotechnology and its parallel growth in the Indian economy, the India Patent Office issued the Indian Biotechnology Guidelines, 2013 and Manual of Patent Office Practice and Procedure, 2005.

The Manual of Patent Office Practice and Procedure, 2005 focuses on recombinant DNA, plasmids and processes of manufacturing which are patentable provided they are produced by substantive human intervention. The Manual includes the following conditions to be satisfied for granting a patent for any gene:

  • The genetically modified gene sequence/amino acid sequence should be novel, must involve an inventive step and  have industrial applicability;
  • The method of expressing the genetically modified gene sequence/amino acid sequence is novel;
  • an antibody against that protein/sequence that is genetically modified can be claimed to be protected; or
  • That product made from the antibody/sequence can be claimed to be protected.

The criterion to be met for patenting the recombinant DNA and is that “novelty owing to substantial human intervention”, as stated in the abovementioned Manual. The manual provides a proper guideline for patenting of biotechnological inventions and is open for new amendments based on new inventions. 

Conclusion

An invention should be novel, non-obviousness, should have industrial applicability and should have a written description to qualify the requirements of patentability. An invention that qualifies all these criteria only then a patent can be granted. Until the Diamond v. Chakrabarty, 447 U.S. 303 (1980) case, living beings were not patentable. The United States brought living beings that are made through man-made processes like biotechnology under the category of the subject matter of patentability.

The TRIPS agreement brought many changes in the patent law. All the members of the TRIPS agreement including the US, Europe and India now have provided patents on plants, animals and human genetic material. 

Ethical and moral standards should be considered as a parameter to keep check and balance on the development of gene patenting. The biotechnological invention can be used to produce a mass destructive biological weapon through viruses and bacteria. Coming up with such an invention will cause serious effects on human beings and the environment. There is a threat of releasing transgenic animals in the natural environment which may cause an ecological disturbance which is a threat to the biosafety principle.

 In order to control in an efficient way what is being invented the authorities should make sure a debate takes place about what should be protected through patents and which invention should be allowed to reach the market, whether there is a need for cooperation between the various agents concerned. Policymakers have a responsibility to regulate research in general. If they want to encourage research to help foster the creation of useful products and processes, then patent law is an effective mechanism to achieve that goal, through the incentives it is supposed to give to inventors. But as a consequence, policymakers have a responsibility to enact rules describing the requirements for an invention to be patented, and they perhaps should do so by incorporating more scientific and ethics specialists in the drafting of the rules. If policymakers want the ethical aspects of patents to be addressed by patent officers, they should clearly indicate these inadequate legal provisions. If not other specialized agencies, such as ethics committees, should be in charge of such evaluation.

Clear guidelines and institutional safeguards should be put in place, and effective means of control should be guaranteed, coupled with transparent information aimed at the public. Patent applicants, on their side, should develop a sort of ethical sensibility and weigh the possible socio-political impacts of their inventions. In this regard, as already said, the solution is to regulate the field of research itself and make sure that only inventions that have a positive impact on society at large are encouraged.

Lastly, patent examiners should broaden their horizons and make sure the dialogue takes place between the various agents involved in the process of issuing a patent. Any person or group having an interest in the invention at stake should be allowed to intervene in the process of granting a patent. In the end, courts are in charge of deciding on the most controversial cases and reflecting the social acceptance of inventions stemming from new technologies.

References

  1. Moore v. Regents of the University of California,(51 Cal. 3d 120; 271 Cal. Rptr. 146; 793 P.2d 479)
  2. Pioneer Hibbred International v. Holden Foundation Seeds Inc., 35F, 3d. 1226.3, USPQ, 2d. 1385 ( 8th Cir. 1994)
  3. HUGO Ethics Committee, Statement on the Principled Conduct of Genetics Research (1996); Universal Declaration on the Human Genome and Human Rights, 11 November 1997, UNESCO, art 12(a)
  4. Nuffield Council on Bioethics, The Ethics of Patenting DNA (2002)

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