Patent of biotechnological innovations in India : a legal overview
The alteration of living forms and the possibility of monopolizing life itself are two reasons why biotechnological innovations frequently cause legal and ethical problems. Does the present standard for patentability apply to forms of life? This is a hotly contested topic in the legal community. Ethical arguments, on the other hand, contend that living things shouldn't be subjected to monopolistic control and question the morality of patenting life. Therefore, attaining patents for innovations in biotechnology is still a daunting task in nations such as India, even though it holds great scientific potential. The biotechnology patenting procedure is complicated, and this article aims to explore that complexity.
Acquisition of Functional Terms
The term "intellectual property rights" (IPR) refers to the legal protections afforded to creative works such as inventions, musical compositions, designs, logos, and other commercial images. The goal of these safeguards is to encourage innovation and originality by giving artists and inventors complete control over their works while also setting standards for fair competition. It stressed that concepts like copyrights, trademarks, patents, plant varieties, geographical indications, designs, and trade secrets are all forms of intellectual property, which it dubbed "property of the mind" because they are intangible assets that originate in the human mind.
A patent is like an official green light for an innovative and practical product or service. They still can't utilize the concept for their own benefit, but at least they won't be able to use it without their explicit permission for a set period. Thus, an inventor can unilaterally prohibit others from producing or selling their innovative device. Whoever receives this exclusive authorization from the patent office is simply known as a patentee. In essence, they are the innovators who, for a limited time, get to decide who can utilize their creation.
There has been a proliferation of biotechnological inventions employing genetically encoded materials. Agribusiness and food production can benefit from increased adaptability and output through genetic engineering. Methods used in biotechnology include hybridoma technology, cell and tissue culture, and recombinant DNA techniques. The ability to cultivate consistent cell lines for exact experiments is a key component of tissue and cell culture. To aid in immune system studies, hybridoma technology combines white blood cells with myeloma to produce antibodies. Genetic engineering, which includes recombinant DNA technologies, modifies DNA at the cellular level to affect protein production. The methods used to assign functions to gene sequences in Silico are based on genetics and bioinformatics. These innovations—which include the creation of genes, genetically modified organisms, and vaccines—have resulted in many patents. But then questions of law crop up, and we must look at each one carefully.
The Changing Landscape of Biotech Patents
In the field of biotechnology, patent law has experienced significant changes. It was once believed that living things were intrinsic to nature and not susceptible to exclusive ownership, which led to the denial of patents on such things. Critical decisions, such as Diamond v. Chakrabarty [2], 447 U.S. 303 (1980), however, signaled a shift in the law. The US Supreme Court struggled with the intricacies of microbe patenting in this case. It was decided that the procedure could be patented, but the organisms used were too natural to qualify, and similar instances later recognized the need for revised legal frameworks due to the fast development of biotechnology. Similar decisions substantially broadened the terrain by establishing precedent for the patenting of DNA sequences. In another case, the emphasis changed from determining if genetic material is naturally occurring to determining whether innovation is occurring, which allowed for more expansive patentability.
The case of Harvard College v. Canada [5], 2002 SCC 76 (CanLII), [2002] 4 SCR 45, which brought up the controversial issue of patenting higher living things, showed how important it is to submit thorough patent applications that meet strict invention standards. The term "manufacturing" was likewise broadened in the case of American Fruit Growers Inc. v. Brogdex Co. [6], 283 U.S. 1 (1931) to include not just conventional manufacturing techniques but also the transformation of raw materials, including live creatures, into finished products.
A sophisticated approach that welcomes innovation while negotiating ethical concerns is essentially reflected in the development of patent laws in biotechnology. Because of this development, the range of biotechnological inventions and technologies that can be patented has grown substantially.
As part of its commitment to TRIPS, India revised its Patent Act in 1970 to bring it in line with global norms. After some initial restrictions, it has been amended to align with World Trade Organization (WTO) standards, which means that patents can be granted for life forms that show novel steps but not for higher life forms. To top it all off, the Act has removed the limitations of the past by granting a 20-year patent term.
Distinguishing between discoveries and innovations and deciding whether higher living forms or microbes are patentable are both ongoing issues. With these issues in mind, the Indian government drafted the Patent Act to fight piracy, encourage national firms to participate in technical breakthroughs, and make sure that international IPR regulations are followed to avoid future patent disputes.
In contrast to India's patent policy, which has long safeguarded purely mechanical innovations, the United States now includes biological elements as patentable subject matter, a development that has implications for the laws governing the patenting of life forms. This makes us wonder what the consequences of private ownership of living things are and how inventive biological materials are. Beyond the question of whether existing patent laws should encompass biological objects, the discussion also centers on whether or not a new patent regime is required by technological advancements.
Obstacles in the Process of Life Form Patenting
Biotechnology innovations are inherently complex, which makes determining their patentability a formidable task. Subject subjects that occur in nature are not eligible for patents according to the current principles of patent law since they do not provide anything new or innovative. Challenges arise when trying to ensure that biotechnological innovations are unique, useful, and non-obvious, all of which are necessary for patentability. Because of their inherent nature, identifying unique aspects of living things is extremely challenging. Furthermore, questions of obviousness arise when comparable methods are used to isolate gene sequences. Refusals stemming from a lack of perceived value are common due to the perceived stringency of utility standards for biotechnology discoveries. The patenting of naturally existing genes, such as the human genome, is controversial. In biotechnology, particularly with GMOs, the line between discovery and invention becomes blurrier. Undeserved patents may be granted due to the difficulty of accurately describing genetically altered technologies due to their complexity.
Legal Difficulty: A biotech innovation has additional hurdles to jump. It needs to be patent-eligible subject matter in addition to being unique, innovative, and having an industrial application. Sections 3(b), (c), (d), (e), (h), (i), (j), and (p) of the Patents Act 1970, however, detail particular exclusions from patentability regarding biotech patents.
If an invention's commercial exploitation or use violates public order or morals or significantly harms humans, animals, or the environment, then it cannot be protected under Section 3(b). For example, patents can only be granted for genetically engineered biological materials that are safe for both humans and the environment.
Findings of naturally occurring compounds, whether living or non-living, are not allowed to be patented under Section 3(c). For instance, because they are naturally occurring substances, patents cannot be granted for the simple act of isolating biological components. The IPO Guidelines state that only biological materials obtained through extensive human intervention can be patented and that sequences directly extracted from nature are not patentable.
The controversial Section 3(d) limits the ability to patent changes made to already-existing substances unless those changes lead to a novel form that demonstrates improved efficacy. Nevertheless, improved efficacy is still not well defined, particularly in the context of biotech innovations.
Another difficulty with Section 3(e) is that it does not include combination vaccines or other drugs that are simply mixed unless there is evidence of synergy. In the absence of explicit legislative direction, the IPO must make judgments on a case-by-case basis when deciding whether two biotech patents are synergistic.
According to Section 3(h), patents cannot be granted for techniques used in agriculture or horticulture; however, new regulations make it clear that this rule solely refers to traditional methods used in open fields.
Section 3(i) does not apply to procedures for the diagnosis or treatment of people or animals. Previous patents for in vitro diagnostic methods were approved, but new standards classify them as Section 3(i), so it's doubtful that they will be awarded again.
Provision 3(p): Objections under this provision are common, and they do not apply to innovations that are already known or that combine known qualities. To verify eligibility, claims are checked against databases of traditional knowledge, such as the Traditional Knowledge Digital Library.
Plants, animals, seeds, variations, species, and vital biological processes used in their creation or propagation cannot be patented, according to Section 3(j). Nevertheless, this limitation does not apply to procedures that necessitate a high level of human involvement.
The main concern about the patenting of living things is whether they ought to comply with the existing legal framework. Although most nations decline, the United States is an exception. The Supreme Court has been more forgiving. Because it demonstrated an innovative use of the bacteria's powers, they granted a patent to a modified bacterial species. The discovery was deemed a human innovation by the Court since "manufacturing" encompasses all things manufactured by humans. However, particularly with GMOs, there is still a lack of clarity regarding the threshold for human-caused change that warrants a patent. What kinds of biological objects can be patented remains unclear based on the court decisions that have been handed down thus far.
Ethical Concerns: The concept of genetically modified organisms (GMOs) patenting has sparked discussions over the morality of manipulating living things for financial gain. Take the Relaxin Case [9], T 0272/95, as an example. In this case, the European Court ruled that it is acceptable to patent a single gene rather than a whole human being. How ethically sound it is to patent plants that have undergone genetic modification is an open question. As a result of cultural differences, people from various nations hold varying views on what constitutes moral behavior. They take into account indigenous peoples' rights to their genetic resources and traditional knowledge in Brazil as well. It might be particularly challenging to meet these requirements in Brazil, which can impede the commercialization of information.
IN DISCUSSIONS ABOUT THE PATENTING OF SUCH LIFE FORMS, SOME OF THE BIGGEST LEGAL AND ETHICAL PROBLEMS HAVE BEEN LISTED BELOW:
Cloning includes a wide range of practices, from the home cloning of plants using cuttings to the industrial cloning of animals. It produces new cells or organisms that are genetically indistinguishable from the original. But the Act forbids the patenting of biological methods used in the production of plants and animals (Section 3(j)). Any innovation that could disrupt public morals or cause harm to people or the environment would likewise be illegal under Section 3(b). Critics of animal cloning point to the many health concerns seen in cloned mammals, including larger than average babies, abnormal organ development, accelerated aging, and compromised immune systems. Example: The Dolly Sheep Case, which involved cloning a 6-year-old sheep, had chromosomes that were shorter than typical and died at the age of six, which is half the average lifetime of sheep. These problems associated with cloning are still a mystery to scientists.
Here we have stem cells, which are incredibly adaptable and can differentiate into a wide variety of cell types seen in the human body. Its ethical exploitation of embryos is a cause for worry, despite its promising use in the treatment of many diseases. Though they are available, adult stem cells lack the adaptability of embryonic stem cells. But other people think it's wrong to use them since they kill embryos. Certain provisions of the law address ethical and environmental problems, which in turn prohibit the patenting of inventions pertaining to stem cells.
Biotechnology has introduced new genes with useful features, such as insect resistance, which considerably improve plant development; one example is genetically modified seeds. Genetically modified seeds can have man-made gene sequences even though the Patents Act forbids patenting plants, plant varieties, or seeds. The 2001 Act to Protect Plant Varieties and Farmers' Rights also safeguards the development of transgenic plant varieties and the seeds from such kinds. Although seeds cannot be copyrighted in India, the Patents Act does allow biotech companies to patent modified genes, which they then utilize to create transgenic seeds. Seed patents would limit farmers' ability to save and trade seeds.
Picking and Selecting Which Technologies to Protect: Countries that opt not to safeguard some technological areas tend to discourage investment in such areas. Take Brazil as an example. The country's attitude toward patenting some naturally occurring chemicals with obvious industrial uses is unclear. Some speculate that this is because they feel Brazil lacks the technological capability to manage such patents. If that's the case, perhaps other nations should join Brazil in reevaluating the situation.
Other points of view: As a means of assigning monetary worth to living things, some feel that patenting encourages a materialistic perspective on life, which raises metaphysical concerns. Nevertheless, the practice of exchanging medicinal plants and animals’ dates back hundreds of years.
Prior to the Convention on Biological Diversity, all living things were considered a shared resource that should not be used for commercial gain. One of the main arguments against patenting is the idea that it grants too much power over publicly available information.
We need to think about the bigger picture of society's effects because patent recognition is linked to the economy. But the patent argument isn't the only issue at hand; global competition and income inequality are two examples.
Profit First: Critics of contemporary biotechnology say it puts financial gain and new markets ahead of social and environmental concerns. As a result, we may end up using costly medications or chemical pesticides, which are neither efficient nor sustainable.
Who gets to own DNA?
The question of whether DNA sequencing constitutes an invention is up for debate. Many people think that DNA isn't random but rather something that every human being has. They also think that sequencers are more like discoverers than inventors. "Genomic imperialists" are the words used to describe some people who want to make money off of DNA sequencing without consulting anyone.
IN THE END
Ultimately, there are many legal, ethical, and practical obstacles to navigating when it comes to biotechnology and the patenting of living things. The matter of whether life forms should be eligible for patents is controversial, even though biotechnological advancements show great potential for improving human well-being and meeting essential societal demands. To encourage innovation while protecting ethical standards, legal frameworks like the TRIPS Agreement and national patent laws try to find a middle ground. However, there are discrepancies and disputes about patent eligibility standards since these rules are interpreted and applied differently between nations.
The commodification of life and ethical concerns about manipulating genetic material add another layer of complexity to the patenting process. Animal cloning, stem cell research, and GMOs are just a few examples of contentious biotech topics that highlight the importance of carefully weighing the ethical consequences of technical progress. It is also unclear what effect, if any, on innovation and economic growth will result from countries like Brazil's decision to exclude some inventions from patent protection.
Despite these obstacles, biotech patent laws are changing to reflect the need to encourage innovation while tackling social and ethical issues. Legislators, attorneys, and ethicists must work together to create strong regulatory frameworks that encourage ethical innovation and guarantee that everyone has fair access to potentially life-saving technologies as the biotechnology sector grows. To fully harness biotechnology for the good of humanity, a holistic strategy is necessary, one that considers and balances the interests of all parties involved.
Source: https://www.einfolge.com/case-studies/Patent-of-biotechnological-innovations-in-India-a-legal-overview
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