Abstract
The case of biotechnological inventions is fundamentally different from more conventional inventions and the associated challenges therein crosses the avenues of science, law, and ethics. These are some of the delicate issues that the present analysis seeks to unravel, given the fact that biotechnological advancements are not simple feats; the nature of patent laws is woven in layers of complication, and; the ethical implications that are linked with the act of patenting are somewhat of a conundrum. There is confusion as to what type of biotechnological inventions may be patented and whether certain patents are valid, which leads to legal concerns, many of which wind up in court and indefinite questions as to ownership of patents. In as much as this is so, it is scientifically factual to argue that biotechnology is growing at a higher pace than the ability of legal infrastructure to cope up and or maintain a pace with, this may lead to a ditch that can slow down the discovery, protection and commercialization of new ideas.
Another issue that has arisen from the patenting of genes and other living organisms is an extremely questionable issue of ownership and use of live organisms and the fact that, it is perceived and used as merchandise. It is in this regard that this report shall seek to provide an idea as to these difficulties, and more importantly, highlight likelihood strategies as well as likely changes in patent regulations that might assist in overcoming them where and when biotechnological research and innovation is concerned. Hence, it informs the field regarding the best practices for creating a proper context for scientific advancements or at least not hampering the advancement in the sector of biotechnology while refraining it from being exploitative.
Key words
Biotechnological products, patent, TRIPS, biopiracy, genetic engineering, bioprospecting
Introduction
In today’s world, the medical field is observing huge development in terms of its creative and sophisticated innovations, which help in curtailing the diseases and providing new solutions to curb them, well, some of the biotechnological applications in medical field include, CASPR cas9, recombinant insulin, gene therapy, molecular diagnosis, pharmacogenomics, edible vaccines[1] and so on, these biotechnological innovations is not only limited to medicine field it has extended its arms to agriculture sector, things like genetically modified seeds which improves the overall productivity of the crop.
Whenever a there is a certain invention, securing the invention for patent becomes relevant, the product invented is tested for its patentability, few inventions cannot be patented while others can be patented if they fall under certain criteria, well, the criteria is that the invention to be patentable must be new, a novel idea and the invention must consist of an inventive step and industrial applicability, the patentable innovations must be in technological nature i.e., they have to solve a certain problem.
The inventions happen in biotechnological sector too, but there are some certain legal, ethical and technological dilemmas for patenting a particular biotechnological innovation.
The most two common reasons for these kinds of dilemmas to arise are the alteration of living forms and possibility of monopolizing life itself.[2]
Research methodology
The research paper is descriptive and is a combination of both primary and secondary resources, the primary resource of the research paper is the TRIPS agreement and Indian Patent Act, 1970 and the secondary resources are various articles and research papers.
Review of literature
The legal and moral concerns related to biotechnology patents are thoroughly examined in the essay “Patent Biotechnological Innovations in India: A Legal Overview” This also covers essential court ruling that has shaped the current laws regarding patents, the historical background on the development of the patent laws and the challenges experienced when trying to patent a living organism. The article revolves around the development of patent law and the moral issues that arise from the monopolization of genetic material plus, the unique challenges India has to overcome regarding hi-tech requirements in patentability and moral issues. It underlines the fact that they strive equally to solve moral and practical problems when it is necessary to establish conditions that encourage legal development.[3]
Another paper that was reviewed under this topic is “Biotechnology and Patent Law: Ethical and Legal challenges” it was published by Harlem, the paper examines various ethical and legal challenges that are to be faced while patenting a biotechnological product, the paper has given an apt knowledge regarding the patenting process in biotechnology, it discussed the concerns surrounding the biotech product patenting, it has raised various legal issues which were discussed in detail same goes with ethical issues too. The paper was concluded by stating that invention and patenting of the biotech product and environmental sustainability along with human dignity has to go hand in hand.[4]
Legal challenges
It can be noted that the when biotechnological inventions are patented, they can pose serious questions against the public interest. There is an ongoing debate as to whether the biotechnological inventions should be patented or not, well some say that the discretions lie upto the court, in one of the instances the Kolkata High court while dealing the Dimminaco matter has held that biotech innovations are patentable.[5]
The same has been left upto in US courts the institutions upon which the discretion lies as to whether an invention is eligible to be patented or not. In 1980 Chakrabarty case the US Supreme court has stated that the newly created bacterium that can fight crude oil spills is eligible to be patented because the bacteria is neither naturally occurring bacteria nor the principles of life.[6]
But the question as to whether we can patent the genetic material still is under considerations for its ethical dilemmas and its contentious subject matter.
The TRIPS (The Agreement on Trade-Related Aspects of Intellectual Property Rights) which was established in the year 1995, it is formed to protect and enforce all intellectual property rights and to facilitate in the technological innovation. TRIPS under article 27.3(b), allows members to exclude from patentability the following:
Plants and animals other than micro-organisms and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes.[7]
In India we have Patents Act, 1970, sections 3(b), (c), (d), (e), (h), (i), (j), and (p) describe about the inventions which are to be excluded from patenting of biotech products.
Section 3(b) of the Patent Act (1970), states that inventions which are commercialized in a manner that offends against public order and morality or cause serious harm to human, animal or plant life or health and the environment are not eligible for patent protection. It is worth noting, as an example, that patents can be obtained only for genetically engineered biological materials which are considered safe for the environment and humans.[8]
Under section 3(c), natural compounds or substances neither dead nor alive discovered cannot be patented. For instance, it is not possible to get patents on merely isolating components from biologicals because these are naturally available chemicals. According to IPO Guidelines, sequences derived directly from nature cannot be copyrighted but instead require significant human intervention to make them qualify as biological materials.[9]
Section 3(d) bars patents for improvements made to existing substances unless such changes produce a different form that exhibits enhanced efficiency. However, this definition is still vague especially in the context of biotechnological advances.[10]
Another problem with Section 3(e) is that it excludes combination vaccines and other drugs which are merely mixed unless they show synergistic effects. In the absence of clear legislative guidance, the IPO has to decide on a case-by-case basis if two biotechnology patents are synergistic.[11] With regard to Section 3(h), patents cannot be granted for methods of agriculture or horticulture; although, current laws make it clear that this exclusion does not cover traditional farming practices conducted outside enclosed spaces.[12]
Section 3(i) does not cover human or animal diagnostic or treatment procedures. Though there were earlier versions of this clause, it is now labelled as clause 3(i). Consequently, it is unlikely that it will be granted again to any patent covering in-vitro method for diagnosis.[13]
Clause 3(p): Critics of this section say that inventions which combine known features or are old are not covered by the provision. Claims are checked against databases on traditional knowledge such as Traditional Knowledge Digital Library, so their validity can be confirmed. [14]Section 3(j) prohibits the claiming of plants, animals, seeds, varieties, species and essentially biological processes for their development or propagation. Nonetheless, this limitation does not extend to methods involving ‘substantial’ human intervention.
From the above arguments it is evident that the patentability of the biotechnology innovations are quite debatable for their unusual subject matter. The following are the areas where the issue of patentability can arise in the legal context.
Generally patent system protects the rights of the ownership, multi-national companies invest in enormous amount of research and development and as a consequence they also except certain amount of returns for their investment, the issue is whether the product which they have come up with is eligible to be patented or not, because a product of nature cannot be patented in the same way there is no guarantee that the altered product of nature will be given patent, also another issue which can arise is the commercialization of the product of nature.
There are instances of bioprospecting and biopiracy which pose as an obstacle for providing the patent, because the novelty element which is essential to provide a patent will be lacking hence, making it ineligible to be patented, bioprospecting is a method where the researchers search for the products sourced from the nature and commercialize them whereas, biopiracy is a method where the researchers tend to exploit the traditional knowledge which is derived from the indigenous people and commercialize it.
In the process of innovating the biotechnology products especially in genetic engineering there is a high chance that the said genetic transformation might disturb the ecology and disrupt the habitat of the living organisms, hence biosafety is required to avoid huge loss.
In the contemporary world, bioterrorism is a grave menace to mankind. It can be utilized as a weapon if genetic information falls into wrong hands. Lethal viruses or poisons with no known treatment can be manufactured by terrorists.[15]
Ethical issues
Genetically modified organisms have led to many debates as to whether they should be patented or not, given the nature of the work, many communities considering their believes and ethics they are not ready to accept the patenting of these kind of developments as they might hamper the whole believe systems and morality aspects of human beings added to these issues another aspect which sparks the debates is the monetary gain with commercialization of these products invented.
Cloning of living organisms are attached with its ethical concerns, section 3(b) of the patents act, 1970 strictly prohibits patenting any sort of product which is against the public morality the cloning of sheep which happened to be named as Dolly speaks about the process of cloning and the problems associated with it.
Here we have stem cells, which can actually differentiate into a vast array of cell types found in the human body and are remarkably versatile. Despite its promising application in the treatment of numerous illnesses, its unethical usage of embryos is reason for concern. While adult stem cells are accessible, they are not as flexible as embryonic stem cells. However, some people are against the use believe it is wrong since it involves the killing of embryos. Patenting technologies on stem cells has numerous legal restrictions which prohibit such consideration on ethical and environmental grounds.
Genetically modified seeds are a prime example of how biotechnology has brought forth new genes with awesome traits, like insect resistance, that really boost plant growth. Now, even though the Patents Act doesn’t allow patenting of plants, plant varieties, or seeds, genetically modified seeds can still have these artificial gene sequences. The creation of transgenic plant varieties and their seeds is also protected by the 2001 Act to Protect Plant Varieties and Farmers’ Rights. So, biotech companies can actually patent altered genes under the Patents Act, which they then use to make transgenic seeds, even though seeds can’t be copyrighted in India. But, if seeds were patented, it would seriously limit farmers’ ability to exchange and save seeds.
Suggestions and way forward
The patent laws have to be redefined in accordance to the changing technologies, it has to adapt to the kind of inventions made in the biotechnological field. Patent laws have to give clear definitions as to what constitutes a product of nature and an artificial product.
The applications forwarded for patents has to go through a detailed process to check whether it is eligible to get patented or not, due to the difficulty present in the processing of analyzing the biotechnological products a separate training has to be given to the personals to determine the eligible products for patentability.
As the patenting of biotechnological products is burdened with all those legal, ethical and ethical dilemmas all the professionals associated with the above sectors has to work together to determine a certain procedure to be followed for patenting the products.
The major obstacle occurring in the patenting of the biotechnological products are the ethical issues, so a separate ethical guideline has to be issued and has to be followed accordingly.
The jurisdiction of the patent applicability is limited to the nations boundaries this might raise problems during inter-national products applicability, so a separate mechanism has to be brought in so that all the patenting process through-out the world is brought at the common parlance.
Conclusion
These cases highlight the enriched understandings of patenting in biotechnology, which concern the sophisticated intertwining of law, ethics, and science. The great controversies in patenting biotechnological inventions emanate from the breaks neck speed of the developments in the biotechnology industries as current regimes in place are a) Ineffective on how they address the definition and protection of biotechnological patents b) Inefficient in terms of the commercialization of patented inventions due to their inability to catch up with the speed of the growing innovations. This is somewhat compounded by legal uncertainties as well as moral concerns over biopiracy of genetic resources and living organisms.
These challenges can therefore only be overcome by what may be described as an ‘integrative and adaptive’ approach. These are the areas such as classification of new innovative legislation as well as updating of patent legislations, disposal of advanced techniques as well as updating of process of patent examination, sponsorship of multi-field research and developmental activities. Thus, it is necessary to establish the ethics that regulate justice and access to biotechnological patents for such a tension. The conditions that will foster biotechnological further development can also be set up by strengthening the high-level patent protection that is normally realized by adhering to the main criteria for patent, cooperating with the SMEs and startups and considering the numerous non-conventional paradigms of innovation.
So, the ultimate goal is to offer an efficient and reasonable patent regime that will indeed contribute to the development of biotechnological novelties, yet will effectively address the ethical, pragmatic and legal concerns. This will ensure that all biotechnological developments are beneficial to the health, wealth, and social welfare of the global society and create a better opportunity to embrace a new world that is more socially and economically equitable.
S. Srivallika Patel
Dharmashastra National Law University
References
https://ipindia.gov.in/writereaddata/Portal/IPOGuidelinesManuals/1_38_1_4-biotech-guidelines.pdf
https://www.iisd.org/system/files/publications/investment_sdc_dec_2003_8.pdf
[1] BIJUS.COM, https://byjus.com/biology/application-biotechnology-medicine/.
[2] Einfolge, Patent of biotechnological innovations in India: a legal overview, https://www.linkedin.com/pulse/patent-biotechnological-innovations-india-legal-overview-einfolge-wc3jc/.
[3] Einfolge, Patent of biotechnological innovations in India: a legal overview, https://www.linkedin.com/pulse/patent-biotechnological-innovations-india-legal-overview-einfolge-wc3jc/.
[4] Harlem, Biotechnology and patent law: ethical and legal challenges, https://www.harlemsolicitors.com/2023/12/24/biotechnology-and-patent-law-ethical-and-legal-challenges/.
[5] Harlem, Biotechnology and patent law: ethical and legal challenges, https://www.harlemsolicitors.com/2023/12/24/biotechnology-and-patent-law-ethical-and-legal-challenges/.
[6] Harlem, Biotechnology and patent law: ethical and legal challenges, https://www.harlemsolicitors.com/2023/12/24/biotechnology-and-patent-law-ethical-and-legal-challenges/.
[7] International institute for sustainable development, the TRIPS agreement and biological diversity, https://www.iisd.org/system/files/publications/investment_sdc_dec_2003_8.pdf.
[8] Indian Patent Act,1970, §3, cl. b., No. 39, Acts of Parliament, 1970 (India).
[9] Indian Patent Act,1970, §3, cl. c., No. 39, Acts of Parliament, 1970 (India).
[10] Indian Patent Act,1970, §3, cl. e., No. 39, Acts of Parliament, 1970 (India).
[11] Indian Patent Act,1970, §3, cl. h., No. 39, Acts of Parliament, 1970 (India).
[12] Indian Patent Act,1970, §3, cl. i., No. 39, Acts of Parliament, 1970 (India).
[13] Indian Patent Act,1970, §3, cl. p., No. 39, Acts of Parliament, 1970 (India).
[14] Indian Patent Act,1970, §3, cl. j., No. 39, Acts of Parliament, 1970 (India).
[15] Ethical, legal and social issues in biotech (ELSI) study guide, https://inspiritvr.com/ethical-legal-and-social-issues-in-biotech-elsi-study-guide/#:~:text=Biotechnology%20has%20made%20several%20things,society%20related%20to%20various%20issues.