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Patenting Biotechnical Life Forms: Analyzing Bioethics And Challenges Of Law

Biotechnology and genetic engineering have enabled the creation of new life forms, as well as the evolution of existing ones. The keywords of current scientific advancements and study include stem cell technology, somatic cell hybridization, genome technology, gene treatment, and cloning.

Pharmaceuticals, agriculture, and human healthcare have all seen substantial advancements in these fields, with drugs like insulin, erythroprotein, and interferon now being manufactured on a commercial basis. Disease-resistant plant varieties, hybrid seeds and plants, nitrogen-fixing microorganisms, new plant varieties with shorter life cycles, and other advances in agriculture and human life science, such as organ reconstruction and life creation through cloning, biotechnology, and genetic engineering, are having a long-term impact on human life.

A part of the scientific community claims that the danger of commercialising most of these scientific advances can result in substantial and irreversible environmental damage. Others believe that patenting in such places should be prohibited in order to protect biodiversity and indigenous people's rights. Some detractors of cloning and organ reconstruction technologies fear that the benefits will outweigh the risks to nature.

The reasons against patenting life forms have been grouped into the following categories: ethical and religious concerns, environmental ramifications, economic considerations, and legal difficulties. This paper has also sought to examine if life has intrinsic values and whether patenting biological forms contradicts those values. The study finishes with several key recommendations on the patenting of living organisms.

To begin, the most apparent point of contention is whether or not biological forms should be patentable. If the conditions as they are today are followed correctly, the solution is obvious. There is no creative step in a natural living form, hence it cannot be patented. Because the notion of caging is not new, a caught biological being is likewise not patentable, though a new and ingenious design of cage might be. A changed living form can be patented, but only in terms of the modification itself.

There have been fast advances in genetic engineering and other life sciences since the discovery of the double-helix structure of DNA in 1953. Thousands of patents for rights relating to DNA sequences have been issued as a result of this growth in research commercialisation. The patenting of living forms and genetically engineered organisms is the most recent area of debate. Living organisms are special in that they can be patented for a variety of reasons: First and foremost, the innovation is alive.

That is, in certain cases, the innovation can duplicate itself. Furthermore, the invention may not always be fully defined for patent specification reasons. As a result, parties have been forced to deposit their inventions in order to get a patent. For many years, stakeholders in India have been perplexed by the patenting of biological forms. The Indian Patent Office has developed through time to develop a number of measures to address the challenges of life-form patenting. Even if the measures have helped to alleviate some of the confusions, there is still more to be done.

The Indian government's view on life-form patenting has evolved throughout time. A few decades ago, India was opposed to issuing patents to living things. The same may be seen in India's call for a review of TRIPS Article 27.3 and support for the African group's request for a review of Article 27.3, which indicated that patents on life, including those on microbiological processes, should be barred. TRIPS, on the other hand, has instructed member nations to grant patents to all technology and microbes. Amendments to the Indian Patents Act, 1970 were modified between 1999 and 2005 to comply with TRIPS directives and to meet India's international commitments under TRIPS.

In today's world of progress, nothing is beyond the reach of the law, which has served as a watchdog for mankind, keeping everyone in line and safeguarding one another. Now that the world is progressing and a plethora of inventions are being introduced to mankind, there is a high risk of confusion regarding object identification, for which the importance of intellectual property rights is deemed necessary, and with reference to this paper narrowing down the focus to the importance of intellectual property rights in the field of biotechnology.

Because scientific advancements are covered by patent rules, this study focuses on a specific branch of research, biotechnology. "Biotechnology" is just a new word for an old concept: technology based on the use of other living creatures[1] (i.e., biology-based technology), particularly in agriculture, food science, and medicine. "Biotechnology" is defined by the United Nations Convention on Biological Diversity as "any technical application that employs biological systems, live creatures, or derivatives thereof to manufacture or change goods or processes for specified applications."

In this paper, the author discusses the importance of intellectual property rights in the field of biotechnology and how these laws have evolved in the face of a great deal of criticism with the help of case law. Later in the paper, the author discusses the ethical implications of patenting biotechnological innovations, as well as the TRIPS agreement and its application in the biotechnological arena.

Evolution Of Patent Laws In Biotechnological Arena

Patents on live organisms were first denied on the grounds that they were natural products, as defined by the theory of nature. The thought behind this denial was that living beings were natural products that belonged to everybody and were outside the monopoly of anybody.[2]

The claim in Funk Brothers Seed Co. V Kalo Inoculants Co.[3] was a mixed culture of different strains, each of which was useful in the inoculation of roots of various species of leguminous plants that were helpful in nitrogen fixation (various types of root- nodules were present in nature), and the applicants tried to combine the various species in order to develop a mixed culture suitable for inoculation of a wide variety of crops, but their attempts failed.

The patent claim was declared invalid by the USSC because it was a natural substance. The court determined that the patent claim's subject matter was a natural product, that no efforts were taken to change its status from natural to man-made, and that the only person who has authority over natural items is GOD. The Supreme Court determined that natural goods do not qualify as patentable subject matter.

The patent claim in Diamond V. Chakraburty[4] was for both the procedure and the final product of a genetically engineered micro-organism capable of consuming crude oil spills. For the first time in the history of patent law, the question of whether or not a natural object can be patented was addressed in this case.

The claimant, Chakraburty, was granted a patent on the trade secret or process, but no patent was granted on the actual bacteria developed on the grounds that it was a natural product that did not fall within the ambit of patentable subject matters, which prohibits all living objects from being patented, and bacteria, as a micro-organism, does.

Further, in Shell Development Co. V Watson[5], the term "composition of matter" was interpreted and given a broad meaning, stating that all compositions of two or more substances and all composite articles, whether a result of chemical or mechanical union or being a gas, a solid, or a liquid, are patentable subject matter.

Now, according to this view, natural substances, including biotechnological inventions, fall under the definition of composition of materials, i.e., biotechnological creations are genetic compositions from various species or sections of a living being's body. Later in the same case, the supreme court overturned the previous judgement by a 5:4 majority, stating that the congress has all the rights to promote scientific development and innovations, and that excluding the development of bacteria would negate the entire purpose of encouraging scientific developments, because science encompasses not only physics and chemistry, but also biology, zoology, botany science, and a variety of other subjects, including the study of living organisms.

Later, in HiBred International V JEM AG supply Inc. Supp[6], the US court of appeal for the Federal Circuit upheld patents on plants, stating that biotechnology is one of the fastest growing fields of science, breaking new frontiers at such a rapid pace that law is lagging behind in order to regulate it. The effectively utilized of patent law extends from plants and animals to the patenting of human genetic material, i.e., the period of contemporary biotechnology began adding another feather to its cap with the discovery of DNA[7].

The claim for extracted and purified DNA sequence in Amgen V. Chugai[8]. A HUMAN genetic material, i.e. DNA, was claimed for patent for the first time in the history of patent law. The alleged DNA codes for erythropoietin, a protein that stimulates RBC synthesis, which is beneficial to patients who suffer from anaemia, or a lack of RBCs. The creators wanted to patent the invention in order to make it commercially viable.

It's strange that the patenting of human genetic material, i.e. DNA, did not draw criticism because it's a natural product, as it did with plants and animals. Instead, the opposition's main focus was to see if the inventor had imagined the innovation for real. The innovators were discovered to have knowledge of DNA and had effectively reduced, and a patent was given in support of the same. It was decided that the idea of DNA entailed genuine knowledge of the DNA sequence, as well as its physical and chemical properties, as well as testing with the DNA, which had been effectively reduced to practise, and a patent was finally awarded. After reading this story in particular, it is clear that biotechnology is a good thing.

The question arose in Harvard College V. Canada (Commissioner of Patents)[9] as to whether higher life forms are susceptible to patent law or not. It was decided that it is the responsibility of the patent office to determine whether a patent application meets the requirements of innovation, non-obviousness, and usefulness set out in the patent statute. According to S.2,

The patentability of genetic material is a complicated problem under the Patent Act of Canada, and therefore necessitates a well designed patent application.Responses from the legislature It was also said that, given the importance of information and technology. A compulsory licencing framework for biomedical and biotechnology discovery and developmnt. It is necessary to build commercial and public research businesses. Further a patent pool for genetic patent must be contemplated, considering the benefits possible from regulated technology patent pools.[10]

The phrase "manufacturing" was given a broad interpretation in American Fruit Growers Inc. v Brogdex Co.[11], where the claim was for "coated oranges." In this instance, the word "manufacture" was construed by the court to encompass the creation of goods for use from raw or prepared materials by giving them new shapes, characteristics, attributes, and combinations, whether by manual labour or equipment. The term used here was more of an economic one, i.e. manufacturing refers to the creation of new goods from raw materials by giving them a new shape, quality, or property, or a combination of these.

Reading the decision, it may be deduced that, unlike in the past, when live items were not subject to patent law, existing living creatures are now being exploited as raw materials in the development of new biotechnology inventions. The modification and manifestation of a resultant live entity to give it a new look, feature, or property that it did not have before was the end product or the ensuing living item.

As a result of the decision, biotechnological inventions fall under the definition of "manufacturing" and hence qualify as patentable subject matter.

Further, The USPTO Board of Patent Appeals and Interferences determined that seeds, plant tissue cultures, and plants were patentable subject matter for utility patents in the case of Ex Parte Hibberd. The Supreme Court stressed the patentability of plants in the case of J.E.M v. Pioneer in 2001, finding that newly established plant breeds are within the range of patent able subject matter under 101 and that 101 is not limited by the Plant Patent Act or the Plant Variety Protection Act.

What Could Go Wrong In Patenting Lifeforms?

Nature's creation, which includes everything that has life on our earth and is considered holy, has its own integrity. Patenting transgenic animals by transferring genes from one species to another violates natural boundaries and, as a result, the integrity of those species. Because DNA is thought to be strongly tied to species identification, no portion of it should be controlled for commercial purposes.

Many people believe that the plants, animals, and microbes that make up life on Earth are part of the natural environment into which humans are born, and that turning these species, their molecules, or components into corporate property is against the public interest. Prior to 2002, there was a shift in India's understanding that ideas linked to biological forms were not protected by patents. The Calcutta High Court, however, concluded in Dimminaco A.G v. Controller of Patent and Design that a process for preparing a live viral vaccine is patentable since even living entities are covered by the term manufacturing.

According to the Court, even if the finished product contains a live virus, the method involved in pulling it out becomes an invention. It should be emphasised that no judgement has been made specifically on the application of inventive step requirements to biotech patent inventions in India to yet. Microorganisms can be patented in India, however there is no definition of the word under the Patent Act. This has sparked far too many debates over the patentability of microorganisms. Due to the lack of an uniform description of the microorganism and microbiological process in the TRIPS Agreement, it is necessary for the nation to create a distinction between the outcome of unique human activity and that which occurs naturally.

Moral And Ethical Issues

The core of morality, i.e. the basic ideas indicating what is good and bad, is known as morality. Now that biotechnology is one of the most rapidly increasing fields of scientific and industrial innovation in modern times, it has earned a position in the public debate, particularly in terms of the ethical ideals linked with it.[12]

The main difference between patenting biotechnological innovations and patenting other fields is that patenting biotechnological innovations has introduced ethics into the Patent Laws, as a number of ethical questions have been raised while deciding whether or not to grant patents in a number of cases, most notably on the grounds that biotechnological innovations are products of nature, as defined by the Doctrine of Product of Nature.

All living beings are created by God and are beyond the control of human brains, and God is the sole owner of any and every living object present on this planet, thus are vested with inherent dignity and integrity, and attempting to modify these inherent characteristics and to patent them takes away this dignity and integrity, which is basically going against God's wisdom.

The patenting of higher life forms such as human cells, genes, mice, and other living things has sparked a slew of ethical concerns. Many of them are religious in nature, believing that patenting God's creations reduces them to simple material items and lowers the God-given dignity of living forms by making them one's personal property. However, there should be some form of check on humans who try to play God by inventing new technologies and obtaining patents on them. The European Court of Justice addressed this problem in the Relaxin case. [13]

The claim was for the patenting of human gene encoding for Relaxin in this case. The patenting of a single human gene, it was decided, has nothing to do with the patenting of human existence. Here, the claim was for patenting human gene encodes for Relaxin. It was held that patenting of a single human gene has nothing to do with patenting human life. Even if every gene in human genome were cloned it would be impossible to reconstitute a human being from the sum of its gene. And such patent do not confer any right over any individual human being.

The tissue is taken with consent within the framework of gynecological operations. Many life saving substances were isolated in this way and thus serve social purpose, by contributing to humanity, life saving drugs and such inventions are industrially applicable technical solutions to a technical problem. Hence, they are patentable. Thus, using DNA technique gene was cloned making it possible subsequently, to produce synthetic Relaxin a hormone which relaxes the uterus during the child birth. Until it was isolated, gene coded for Relaxin was unknown hence, it was held that it is not mere discovery.

Moving on to the TRIPS agreement, which includes ethics, morals, and public order, new reasons for excluding patentability of any innovation have emerged.[14] Not only that, but the agreement also states that innovations that harm the health of animals, plants, or any other living creature for that matter, or even worsen environmental circumstances, are subject to patentability restrictions.

People who argue against patenting living organisms argue that patenting any type of living organism violates the main purpose of the TRIPS agreement on ethical grounds, whereas those who argue in favour of patenting living organisms argue that while the TRIPS agreement prohibits patenting of natural plants, animals, and human genetic material, it does not prohibit patenting of non-natural, genetically engineered plants or a living organism.

Hence it can be said that patents should be granted to all those who engage into an extensive research work and develop something new provided that the ethical and moral grounds and the inherent natural rights of any living being remain intact not are not violated.

Intervention Of TRIPS

The origins of biotechnology may be traced back to the early phases of its development, when the fermentation process was initially employed to prepare food before being used to the production of alcohol and other therapeutic products. Modern biotechnology began with DNA methods and the cloning of live beings, and has now advanced into nanotechnology, which has opened up new frontiers for the human race to explore and exploit.

Patents cannot be made universal, i.e., rules pertaining to IPR in Biotechnology must be bifurcated according to the demands of the industries and the profit and loss they would make from these arrangements in both developed and developing nations. Developing nations are still not in the league of "countries with enough resources" to carry out their research and development, putting them at a disadvantage, and wealthy countries have a monopoly on the Biotechnology market.

Countries like India, which is growing and has recently signed the TRIPS agreement, have had its IPR regulations relaxed so that they may compete with industrialised countries while profiting. The fundamental motivation for this relaxation was to allow emerging markets to register more patents, as evidenced by the fact that after India joined the TRIPS agreement, over 1400 patent applications were submitted to the government for clearance.

After the United States, this was the country with the second-highest number of applications. Patent rules in developing countries should be tailored to inventors' requirements so that they can innovate their ideas, and access to national and international resources should be made available to expand the capital market for biotechnology patents.

The US and the EU had a disagreement on the question of patenting biotechnological inventions during the Uruguay Round TRIPS discussions. On the one hand, the US felt that everything under the sun produced by man, save human people, was patentable; on the other hand, the EU disagreed and opposed bringing biological organisms under patentability.[15] Because the argument between the two international players had not been resolved, WTO members in Europe agreed to a limited agreement (under Article 27.3(b)) while agreeing to reexamine the issue four years after the TRIPS Agreement took effect.

Article 27 of the TRIPS Agreement defines which inventions nations are required to patent and which inventions are exempt from patenting. This article also stipulates that a patent must be available for both the product and the process, whereas Article 27.3(b) allows governments to exclude plants, animals, and essentially biological processes from patentability. There isn't a clear bifurcation under TRIPs with regards to microbiological process and essentially biological process and thus are subject to varied interpretation by experts in same and different jurisdictions, which calls for anothet controversy.

India's Post Trips Agreement Regime

India is one of the signatories to the TRIPS agreement, and its rules are in line with those of other nations. To be completely compliant with TRIPS and other nations' regulations, the Patent Act required to be amended. Until date, the patent regulation structure has been extremely tight, and its reach has been limited in sectors such as biotechnology. The TRIPS agreement provided developing nations with a new path forward by disseminating information and boosting people's access to diverse technologies and research projects.

Developing nations were encouraged to sign the TRIPs agreement, obey WTO regulations, and provide leeway for their own legislation within that framework.

Although the Indian Patent Act has a limited scope, the World Trade Organization (WTO) has established a larger framework to include product patents and all associated disciplines. The WTO allows patents in life forms if any innovative step is made in conjunction with a readable subject-matter of invention, while the Indian Patents Act prohibits patenting of higher life forms. The WTO provides for a 20-year patent life, but the Indian Patents Act did not catch up until the third amendment; previously, the patent term was just seven years.

In the biological space, the key locations where the problem exists are:
  1. No clear bifurcation between discoveries and inventions has been done
  2. Scope of patentability in higher life forms like plants, animals
  3. Scope of patentability in lower life forms � microbial organisms
  4. Condition of depositions covering living organisms connected with patentable inventions.

The Patent Act was drafted by the Indian government with the TRIPs agreement's ambiguities and ramifications in mind. Government policies combat piracy and assist national enterprises in gaining access to and participating in different technical breakthroughs, as well as investing their money in something that would earn them profits and provide them with patentability over items created under the TRIPs agreement. The major goal is to achieve maximum enforcement of IPR-related international laws and regulations in compliance with international authorities so that no claim over previously patented items occurs in the future.

In current age of Information Technology, new advancements in any branch of technology are unavoidable. As a consequence of the expansion in the IT industry, such as Bioinformatics, new developments are taking place, particularly in the field of Biotechnology. Since the patent has evolved as a powerful weapon for protecting intellectual property in the realm of biotechnology, care must be taken not to hinder further development and healthy competition by permitting apparent items to be monopolised.

The lack of specific standards for obviousness and degree of unpredictability of art complicates the process of obtaining a patent for biotechnology technologies. Because of many causes such as technological advancements and changing dimensions of law and judiciary, the product of nature theory is becoming not only outmoded, but also restricted in its applicability, particularly in emerging and developed nations. TRIPs do not necessitate patenting natural products, although a more isolated or modified form of any microorganism may fall within the patentability criteria of TRIPs.

While WTO members may have differing perspectives and interpret these compliances in various ways, a nation cannot prevent another country from having a different viewpoint on the same topic. The implementation of varying patentability rules in the realm of biotechnology will have a significant impact on investors and the industry's future development. As a result, it has an impact on the country's technical progression and, as a result, its economic development and scientific progress.

Granting patent protection to conventional improvements or technological advancements without true innovation, on the other hand, slows development and may, in the case of patents combining previously known parts, rob earlier innovations of their value or utility. As a result, the patent office and the courts must exercise extreme caution and vigilance while ruling on biotech patenting's conceptual concerns.

To address the shortcomings in the realm of IPR, the authors provide the following recommendations:
  1. As shown in the paper, patenting of various biotechnological inventions has been accepted over time, with the exception of transgeneric human beings; therefore, it is preferable if local statutes are modified in a way that also considers the ethical and moral standards of the society to exclude transgeneric human beings.
  2. After reading the TRIPS agreement, it is clear that an international declaration or convention prohibiting the use of cloning for the reproduction of not only humans, but also animals and microorganisms, might be approved.
  3. Given the dynamic nature of biotechnology, where some or all changes occur on a regular basis, the time term for patent awards in India should be decreased and the whole bureaucratic procedure should be modified, and patents should be awarded within three years.
  4. Because of the technicalities and complex nature of Biotechnology, an expert committee based on the field in which the patent is to be granted should be included. The TRIPS agreement can be amended to mandate compulsory licencing in the field of Biotechnological patenting if certain conditions are met.

  1. Iver P. Cooper, Biotechnology And The Law 1-1, (1st ed.,2014)
  2. Dr. Sreenivasulu.N.S. & Dr. Raju.C.B., Biotechnology And Patent Law, Pp.22-23 (1st Ed., 2008)
  3. 33 Us 127(1948)
  4. 1989 Us Sc 447 At 303
  5. 149 F. Supp. 279 (D.D.C. 1957)
  6. 2d 794 (Dalloway 1999) No.99-1035
  7. Living Beings Are Made Up Of Cells. Cell Is The Basic Part Of Every Living Being. There Are Unicellular Organisms Such As Bacteria And Multicellular Organisms Such As Plants, Animals And Humans. Cells Have A Capacity Of Self- Replication Through Which It Can Grow Into A Number As Necessary As Estimated There Are Around Three Trillion Cells In An Average Human Body. Cells Consist Of Genome Inside Which Chromosomes Are Found Made Of Dna. Gene Is A Specific Chemical Pattern Of Dna Which Controls Development Of Any Specific Characteristic Feature In Any Plant, Animal And Human Being. Genes Are Found In Sequence And They Have Specific Sequences. Inside Genome, Nucleic Acid Molecules Are Also Found (A Combination Of Dna And Ribonucleic Acid) Which Plays A Very Important Role In Replication Of Cells And Transfer Of Genetic Information.
  8. 927 F.2d 1200,18 Uspq 2d 1016 (Fed. Cir. 1991)
  9. [2002] S.Cj. No. 77, (2002), 21 C.P.R(4th) 417
  10. Veena, Biotech Patent Law, 128, The Icfai University Press
  11. 283 Us 1.11.51 S.Ct, 328,330,75 L.Ed.801 (1931)
  12. Bauer.M.W & Baskwell. G., Biotechnology- The Making Of Global Controversy , 1 (2002)Cambridge University Press, Cambridge (Uk)
  13. 1995 OJEPO 588
  14. The Trips Agreement, Art. 27(2) And (3)
  15. 6 Jayshree Watal, Intellectual Property Rights In Wto And Developing Countries, Oxford India Paperbacks, Ed.2014, P 128

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