The theory of Intellectual Property is commonly agreed that exclusive property rights are reserved to an inventor alone, and such rights provide the ‘incentive’ to create expressive works and innovations. A Patent is a temporary monopoly granted by the State to a patentee in return for disclosure of the patentee’s invention to the public. Hence, the patent owner has the exclusive right to prevent or stop others from commercially exploiting the patented invention. Additionally, the system of Patent is designed to provide an exclusive right and as well reward inventors.
As noted above, there is no doubt that Intellectual Property encourages innovation. Presently, Biotechnology in the modern Industrial and Technological era, has been thriving. Innovation in Biotech is producing new medicines, treatments and processes with the potential to save or transform the lives of the society. The potential of biotech in Intellectual Property creates opportunities and advantages in the agriculture, health and industry sector. However, it is pertinent to note that the interconnection between biotechnology and Patent Law poses an enormous ethical and legal issues which are contrary to public interest. As a result of this, it is necessary that biotech innovations are constrained and regulated in order to satisfy the best interests of the society.
Furthermore, the exact requirements for grant of a patent, the scope of protection it provides and its duration differs depending on national legislation. However, generally the invention must be of patentable subject matter, that is, biotechnology patent applications must satisfy all of the following requirements: novelty, inventiveness and lack of obviousness. That is, one cannot obtain a patent for subject matter that was publicly known or obvious at the time the application was submitted to a patent office or filed. It is no dispute that a patent will provide a wide range of legal rights, including the right to possess, use, transfer by sale or gift, and to exclude others from similar rights. The duration usually spans for 20 years (although for only 17 years in the USA). These rights are generally restricted to the territorial jurisdiction of the country granting the patent and thus an inventor wishing to protect his or her invention in a number of countries will need to seek separate patents in each of those countries. Whilst the majority of countries provide some form of patent protection, only a few provide patent protection for biotechnology. The reasons for this may differ, but generally it has been because biotechnology has been thought inappropriate for patent protection, either because the system was originally designed for mechanical inventions, or for one or more ethical, legal or social concerns.
1.1 PATENT IN BIOTECHNOLOGY
A biological patent is a patent on an invention in the field of biology. Biotechnology generally concerns the application of cellular and molecular biology to make or modify products or processes. Thus, biotechnology comprises any technology that uses living entities, in particular animals, plants or microorganisms. According to the Organisation for Economic Cooperation and Development (OECD) biotechnology includes any technique that uses living organisms (or parts of organisms) to make or modify products, to improve plants or animals, or to develop microorganisms for specific uses. Biotechnology has faced so many problems in achieving equal protection in the Patent system. Nearly every principle of patent law has to be rethought and interpreted anew in biotechnology, which is a reason why so many leading patent law decisions of the last decade have resulted from biotechnology. For this reason and in order to explore more deeply the application of the incentive and access principles to contemporary patent law, it is worth reviewing not merely patentable subject matter, but also, how the courts have handled other core patent issues, such as novelty, non-obviousness and utility in the biotechnology field. With respect to the threshold issue of patentable subject matter, the underlying question is one of balancing the two grand economic principles of intellectual property – incentive and access. Under this economic approach, care should be taken to assure that principles of the biological sciences are not preempted through patents, but, rather, only specific technological applications, so that the basic scientific principles remain open to future innovators. Still the question whether biotech innovations are patentable subject matter has to be fought out in the courts. The Kolkata High Court has in the Dimminaco matter held that biotech innovations are patentable.
Further, what has particularly bedeviled the courts and many opponents of biotechnology research has been the frightening notion that life itself might be patented. As usually argued, this is predominantly an ethical concern, but it obviously relates to the question of what is being preempted if patents are granted. In the United States, the threshold issue was left to the courts and the issues was presented by the patent application. The breakthrough in the United States was the Supreme Court decision in the 1980 Chakrabarty case involving a patent on a living bacterium that could break crude oil down into its chemical components, a highly useful property in fighting crude oil spills. The Court simply concluded that the bacterium was ‘not nature’s handiwork’, but the inventor’s and that Parliament had got it right in the 1952 patent codification when it said that patentable subject matter ‘include everything under the sun that is made by man’. Converting this approach, it can be summarized by saying that since neither naturally occurring bacteria nor the principles of life, but rather just a newly created bacterium was the subject matter from which the patentee could exclude others, the incentive principles clearly dominated any concerns about the access principle. Because of this decision, now there are patents on such things as the famous Harvard mouse, an oncomouse that rather perversely has the highly useful property that it is particularly susceptible to carcinogens and therefore lends itself to cancer research.
Patent law has accordingly developed certain special rules for biotechnological inventions. These include public interest exceptions to patentable subject matter. Some countries exclude patents on plants or animals, for instance and some provide special disclosure requirements relating to inventions based on genetic resources. There are also some distinctive legal mechanisms, such as the deposit of micro-organisms, when access to the actual material is needed to understand the invention. The question of patenting a genetic material continues to be a contentious issue, despite the global agreement with article 4 of the Universal Declaration on the Human Genome and Human Rights, passed by the UNESCO General Assembly in 1998, which states “The human genome in its natural state shall give rise to financial gain.” This is because there are numerous interpretations of what natural state means, given that what is being patented is not a chemical substance but the information included in the sequence.
2.1 IMPLICATIONS IN BIOTECH PATENTING
- ETHICAL ISSUES AND CONCERNS SURROUNDING BIOTECH PATENT
The ethical implications of patenting living organisms have been a subject of debate and scrutiny. The question of whether living organisms should be considered patentable subject matter raises concerns about the commodification of life. It has been contended that granting patents on living organisms may lead to the monopolization of genetic resources, potentially limiting access to biological materials and hindering scientific research and innovation.Additionally, the notion of ownership over living organisms raises ethical questions regarding the relationship between humans and nature.
The issue of ownership and control over genetic material is another significant ethical consideration in biotech patenting. As genetic sequences become patented, questions arise regarding who hold the rights to essential building blocks of life. It is argued that patenting genetic material can create barriers to research and impede the sharing of knowledge and advancements in the field. Concerns also emerge regarding the impact on indigenous communities and their traditional knowledge of genetic resources.
Also, the impact of patents on access to healthcare is a critical ethical concern. Patents can grant exclusivity to pharmaceutical companies, allowing them to set high prices for life-saving treatments and medicines. This can create barriers to access, particularly in developing countries or for individuals without adequate financial resources. Hence, the importance of striking a balance between patent incentives for innovation and ensuring affordable access to essential healthcare technologies need to be emphasized.
There have been contentions that most of these issues will not be affected by permitting patents, as the issues are similar to those existing prior to the patenting debate, that is, the distribution of wealth, international competitiveness. This issue remains contentious and the fact that different countries have conflicting policy reflects this. The issue is closely related to the commercialization of biotechnology, but some sort of information protection is already accepted as an incentive to invest in research of benefit to society. The principle benefit claimed for patents is that rewarding an inventor creates a positive environment for progress of research that leads to the betterment of society. The financial interest in a free market creates more funding for research and faster overall progress in research in important areas has been the result of the intense research efforts. The issue has been used by industry to oppose moves to block patents on biotechnology inventions that come from other ethical concerns.
It is less clear to argue that the type of research that people will buy, which supports patenting and the research investment it protects, is the research of most benefit to society. Medical and agricultural products are clearly needed, but not always the most efficient and sustainable processes and products are used, as seen for example in chemical pesticide industry or expensive pharmaceutical alternatives to existing medicines. We can also consider the amount of money people in developed countries spend on luxury products, such as cosmetics, that may be considered a waste of research investment in terms of distributive justice, when compared to life threatening diseases. The countries most supportive of patenting also appear to have been the most successful at generating research funding and making new products for use in medicine. We can think of the research supported in North America, Japan and Europe, when compared to other regions of the world. However, before accepting the results in terms of a measure in Nobel Prizes, or patent applications, we should consider how products of traditional agriculture and medicine have been applied to provide the introductions for current agricultural and pharmaceutical applications of biotechnology. Overall, the contributions of the knowledge that is free access, and seeds which are freely accessible is much greater than the contribution of patented medicines and technologies.
Furthermore, the claim that the function of patents is to regulate inventiveness rather than to regulate commercial uses of inventions is perhaps avoiding the consequences of the system. There have been some controversies regarding the commercial monopoly held by the company which was able to patent AZT, drug used to delay development of AIDS (Acquired Immunodeficiency Deficiency Syndrome) in patients infected with HIV (Human Immunodeficiency Virus), which gained large profits in view of its monopoly. It is all the more questionable whether this should be allowed because of the key roles that government funded research played in developing AZT and showing it was active against AIDS. There are other examples where the commercial monopolies obtained can not be said to be the best public good, and the existence of patent laws is certainly relevant to the least commercial uses of inventions. Therefore, in relation to the general principle of property rights, whereby, property rights are not absolutely protected in any society because of the principle of justice for the sake of “public interest”, “social need”, and “public utility”, also, it is fundamental that innovations which are contrary or aversely to “public interest”, “social need” and “public utility” should be exempted from patenting. For instance, in the USA, the commercialization of human cells and tissues is generally permissible unless it represents a strong offence to public sensitivity.
2. LEGAL ISSUES SURROUNDING BIOTECHNOLOGY REGULATION
The legal landscape of biotechnology is not without its controversies and challenges. Therefore, as biotechnology continues to advance, the legal framework surrounding it must adapt to ensure responsible innovation and address the ethical dilemmas that arise. The following are the implications that arise from biotech patent.
Fundamental to many of the new technologies is the question of ownership of biomaterial. Multinational companies providing seed, agriculture chemicals, food-processing and pharmaceuticals play a major role in biotechnology research, and are keen to see a return on their investments. However, the patent system which protects ownership rights to new biotechnologies, can also serve to block access for many who could benefit, especially in developing countries. Genetically modified (GM) seed commercialization practices have come into conflict with farmers’ customary practices of saving, reusing, sharing and developing plant varieties. The US biotechnology corporation Monsanto aggressively defends its patents, requiring some users of GM canola seeds to purchase new seed every year, with a licensing fee to use the patent rights. Gene patents have also been at the forefront of public debate, with contentious litigation both domestically and internationally. The key difficulty is the distinction between a ‘product of nature’, an altered product of nature (modified by human inventiveness) and a method of using a product of nature.
The landmark decision of the US Supreme Court in Association for Molecular Pathology v Myriad Genetics on 13 June 2013 overturned three decades of gene patent awards. The Court ruled that a naturally-occurring DNA segment is a product of nature and cannot be patented simply because it has been isolated. Myriad had originally obtained the patents after discovering the location and sequence of the BRCA1 and BRCA2 genes, mutations of which can increase the risk of breast and ovarian cancer. This enabled Myriad to develop and patent tests for cancer risk, which cost up to US$4000, precluding many from access. In a similar lawsuit brought by Cancer Voices Australia in February 2013, Australia’s Federal Court provided the opposite view: that the two genes extracted from natural cells obtained from the human body could be patented. The decision is currently on appeal before the Federal Court.
BIOPROSPECTING AND BIOPIRACY
Bioprospecting is the process of finding and commercializing new products, such as medicines and agrichemicals, based on biological resources. Bioprospecting is particularly significant in Australia due to the country’s diverse biological resources. In 2001, the House of Representatives Standing Committee on Primary Industries and Regional Services inquired into the contribution that bioprospecting may make to the development of new industries, especially in regionally Australia. Part 8A of the Environment Protection and Biodiversity Conservation Regulations 2000 provides a legislative framework for biodiscovery, establishing a legal basis for biological discoveries and providing security for investments in research and development. The regulations apply to biological resources of native species in Commonwealth areas taken research and development of any genetic resources or biochemical compounds. Bioprospecting is often based on indigenous knowledge of uses and characteristics of plants and animals. Biopiracy occurs when corporations use traditional knowledge of nature for profit, without acknowledging indigenous intellectual property rights or compensating indigenous peoples. Many patents operate to deny economic compensation to indigenous groups or prevent then from using specific plant materials. International laws in place to regulate bioprospecting and prevent biopiracy include the Convention on Biological Diversity (1992) and the Nagoya Protocol (2010).
Biosafety refers to the prevention of large-scale loss of biological integrity, particularly in health, agriculture and ecology. Biosafety in agriculture involves reducing the risks of disease outbreaks, quarantine breaches, genetic engineering and food contamination, while in medicine, biosafety procedures ensures the integrity and suitability of organs or tissues. National regimes must be commensurate with the terms and provisions of international agreements to which a country is a party. For many countries, these will include both the agreement establishing the World Trade Organization and the Convention on Biological Diversity. In Australia, under the Gene Technology Act 2000, the Office of the Gene Technology Regulator (within the Department of Health) has a mandate to protect people’s health and safety, and the environment, by identifying risks posed by gene technology and by managing those risks through regulating dealings with genetically modified organisms (GMOs). GM crops produced in Australia include canola and cotton, but experimental trials of other crops are underway. GM produce can be imported into Australia, provided it meets the usual food safety guidelines.
Negotiations for an internationally binding protocol, which would focus on the transboundary movement of living modified organisms (LMOs), were started in 1996 under the auspices of the Convention. It was anticipated that the eventual Protocol would provide both a blueprint for a national biosafety regime and some effective protection against the importation of LMOs while a national regulatory framework was being built. After five years of negotiation, the text of the Protocol was agreed at a meeting in Montreal in January 2000 and opened for signature at the CBD’s Fifth Conference of Parties held in Nairobi in May 2000.
In areas where consensus could not be reached between the negotiating parties at the final session in Montreal, compromises were made in the provisions and wording of the final text. These compromises are likely to present significant challenges for implementation. The first limitation of the Protocol is that it applies only to the transboundary movement of LMOs and not to the release of LMOs developed within national borders. Second, under the Protocol, some classes of LMOs were excluded from its scope such as pharmaceuticals, and others are exempt from its provisions for Advanced Informed Agreement (including mandatory Risk Assessment). This latter category includes LMOs in transit, and those that are intended for direct use as food or feed, or for processing. It is therefore likely that national regimes for biosafety will go beyond implantation of the Protocol.
One potential problem in developing a national regime for biosafety based on the principles of the Cartagena Protocol is that the provisions of the latter do not supersede countries with the obligations under the WTO Agreements (if of course, a country is a member of the WTO). The wording of the Protocol leaves the relationship between it and other international agreements unclear. If and when conflicts arise, they, the WTO or the CBD, will probably be subject to interpretation on a case-by-case basis, but it is unclear whether dispute settlement mechanism will be used. There are four relevant WTO Agreements in respect of biosafety the General Agreement on Tariffs and Trade (GATT), the TRIPS Agreement, the Agreement on the Application of Sanitary and Phytosanitary measures, and the Agreement on Technical Barriers to Trade. There are provisions in these Agreements to allow the restriction of imported technologies and products on the ground of risk to public order or morality, or to human, animal or plant health. In the case of the TRIPS Agreement, the restriction extends only to the patentability of the technology or product, and does not prevent its import or distribution.
However, the Precautionary Principle is not without its problems. Its implementation is likely to prove complex, and potentially problematic, not least in respect of possible disparities between obligations under the Protocol and those under the WTO. One final point here is that, so far, no disputes have arisen on this basis, and there is no consensus on whether disparities between the CBD and WTO will emerge in future. Other international organizations concerned with biosafety regulation and capacity building include the Food and Agriculture Organization (FAO), the United Nations Industrial Development Organization (UNIDO), the Organization for Economic Co-operation and Development (OECD). In terms of direct measures which support national regulation, the greater part of international assistance has so far been in providing internet-based information. However, “hands-on” training courses in risk assessment are run by International Centre for Genetic Engineering and Biotechnology (ICGEB), an agency founded by UNIDO, with headquarters in Italy and India. ICGEB is unable to provide financial support for participants from those countries that are not full members. This may prevent or constrain the benefits of ICGEB’s activities in those countries which are in most need. Therefore, it is clear that the legal framework surrounding biotechnology must continue to evolve and adapt.
It is established that the Biotechnology industry is invaluable to our society and as such the methods employed or utilized have an opportunity to get improvements for considering the fact that biotech is currently undergoing an early stage. Undisputedly, it is necessary that the existing legal provisions relating to biotechnology address all aspects of ethical, social and legal concerns of biotechnology innovation in order to forestall any issues that may be arising from biotech inventions. Hence, the legal framework surrounding biotechnology must continue to evolve and adapt to the social, ethical and legal need of a society.
This evolution must be guided by principles that priorities the common good, environmental sustainability and the protection of human dignity. It is shared responsibility among scientists, policymakers, ethicists and society at large to strike the right balance between fostering innovation and upholding ethical values. Although the legal landscape around biotechnology is complicated and dynamic, it holds enormous promise for the advancement of humanity.
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