BIOTECHNOLOGY AND THE CHALLENGES OF PATENTING LIFE FORMS

ABSTRACT

The article navigates the intricate landscape of patenting life forms in biotechnology, addressing legal, ethical, and practical hurdles within this domain. It commences by thoroughly examining biotechnological advancements and the evolving patent laws governing their protection. Fundamental concepts such as intellectual property rights, patents, and biotechnological inventions are dissected, illuminating their significance in today’s biotech milieu. Furthermore, it charts the trajectory of patent law in biotechnology, spotlighting pivotal cases and legislative changes that have molded existing norms.

With examples drawn from global arenas, particularly India and the US, the article scrutinizes the potential pitfalls of patenting living organisms, taking into account both legal and ethical facets. It delves into the complexities posed by prevailing patent regulations, touching upon issues of novelty, utility, and non-obviousness. Moreover, it delves into the legal and ethical ramifications of patenting genetically modified organisms, stem cells, animal cloning, and genetically modified seeds. Additionally, it evaluates the influence of international agreements like the TRIPS Agreement on patenting strategies and dissects the intricacies surrounding the interpretation and enforcement of patent laws across different jurisdictions.

In conclusion, the article stresses the necessity for nuanced approaches in patenting life forms within biotechnology, advocating for a delicate balance between innovation incentives and ethical considerations. It underscores the imperative of adapting legal frameworks to keep pace with the rapid strides of biotechnological progress, all while ensuring equitable access to knowledge and fostering an environment conducive to innovation. In sum, the article offers a comprehensive exploration of the manifold challenges and complexities inherent in the realm of patenting life forms in biotechnology, providing valuable insights for policymakers, legal experts, and stakeholders alike.

KEYWORDS

Exclusions of Patents, Legal and Ethical Issues relating to Life Patent, History of Patent in life forms, US Life Patent laws.

INTRODUCTION

Biotechnology, defined as the manipulation of living organisms to enhance their usefulness to humans, represents a convergence of various scientific disciplines, including biology, microbiology, genetics, molecular biology, biochemistry, and chemical engineering. This interdisciplinary field is witnessing a surge in global prominence.

Intellectual property, particularly patents, holds immense value for biotechnology companies, serving as a cornerstone of their assets. Despite India’s considerable potential in biotechnology, the industry faces significant obstacles due to existing legal and regulatory frameworks. Patents, in particular, are a contentious issue in modern biotechnology.

Biotechnological innovations often raise both legal and ethical concerns, given their involvement in altering life forms and the potential monopolization of life itself. Legal debates revolve around whether current patentability criteria extend to life forms. Conversely, ethical debates question the morality of patenting life, arguing that living beings should not be subjected to monopolistic control. Hence, despite its scientific promise, securing patents for biotechnological inventions remains a challenging endeavor in countries like India. This article seeks to delve into the complexities surrounding the patenting process in biotechnology.

INTERPRETATION OF ESSENTIAL CONCEPTS

Intellectual Property Rights (IPR): Intellectual Property Rights serve as legal shields safeguarding the products of human ingenuity, encompassing inventions, artistic expressions, designs, brand identifiers, and commercial imagery. These protections afford creators and innovators exclusive authority over how their creations are used, fostering an environment conducive to fresh ideas and originality while establishing guidelines for equitable competition. In the legal case Bayer Corporation v. Union of India[1], Writ Petition No. 1323 of 2013, the Bombay High Court characterized intellectual property as the outcome of human intellectual endeavors. It emphasized that intellectual property represents intangible assets derived from the human mind, such as newly conceived products, thereby dubbing them as “property of the mind.” Intellectual Property, often referred to as “Knowledgeable Goods,” spans a spectrum of categories, including copyrights, trademarks, patents, plant varieties, geographical indications, designs, and trade secrets.

Patent: A patent is like a special permission slip given to someone who comes up with a new and useful idea or thing. This permission doesn’t mean they can use the idea themselves; instead, it stops others from using it without asking for a certain amount of time. So, if someone creates a cool new gadget, they can stop others from making or selling it without their say-so. A patentee is just the person who gets this special permission from the patent office. They’re basically the inventor who gets the green light to control who can use their invention for a while.

Biotechnological Inventions: Innovations involving biological materials containing genetic information are prevalent. Genetic manipulation in agriculture and food production can boost flexibility and productivity. Biotechnology utilizes methods such as tissue and cell culture, hybridoma technology, and recombinant DNA techniques. Tissue and cell culture enable the creation of consistent cell lines for precise experimentation. Hybridoma technology merges white blood cells with myeloma to generate antibodies, aiding research on the immune system. Recombinant DNA technology, also known as genetic engineering, alters DNA at the cellular level to influence protein synthesis. In Silico, techniques leverage genetic and bioinformatics to assign functions to gene sequences. These advancements encompass gene discovery, vaccine creation, and the development of genetically modified organisms, leading to numerous patent filings. Nevertheless, legal challenges arise, necessitating a thorough examination of each issue.

EVOLUTION OF PATENT LAW IN THE BIOTECHNOLOGICAL SPHERE

The trajectory of patent law within the biotechnological realm has undergone notable transformations. Initially, the rejection of patents on live organisms stemmed from the perception that these entities were part of the natural order and thus not subject to exclusive ownership. However, pivotal cases like Diamond v. Chakrabarty[2], 447 U.S. 303 (1980), marked a turning point. Here, the US Supreme Court grappled with the complexities of patenting genetically engineered microorganisms. While the process itself was deemed patentable, the organisms were considered natural and thus ineligible for patent protection.

Subsequent cases, such as Hibred International v. JEM AG Supply Inc[3]., 534 U.S. 124 (more) 122 S, underscored the acknowledgment of biotechnology’s rapid progress, prompting the recognition of the necessity for updated legal frameworks. The landscape expanded further with cases like Amgen v. Chugai[4], 927 F.2d 1200, where the patenting of DNA sequences broke new ground. Here, the focus shifted away from the natural status of genetic material towards assessing genuine innovation, paving the way for broader patentability.

The case of Harvard College v. Canada[5], 2002 SCC 76 (CanLII), [2002] 4 SCR 45, brought to light the contentious issue of patenting higher life forms, highlighting the importance of rigorous patent applications that meet stringent innovation criteria. Moreover, the interpretation of “manufacturing” underwent an expansion in American Fruit Growers Inc. v. Brogdex Co[6], 283 U.S. 1 (1931) encompassing not only traditional manufacturing processes but also the creation of new goods from raw materials, including living organisms.

In essence, the evolution of patent laws in biotechnology reflects a nuanced approach that embraces innovation while navigating ethical considerations. This evolution has led to an expansion of patentable subject matter, encompassing a wide array of biotechnological creations and technologies.

WHAT ARE THE POTENTIAL DRAWBACKS OF PATENTING LIVING ORGANISMS?

Biotechnology’s origins date back to ancient fermentation practices, which evolved into DNA manipulation and now encompass nanotechnology, offering immense potential. However, the application of patent regulations in biotechnology must be nuanced to accommodate the diverse needs of industries and the economic landscapes of both developed and developing nations. Recognizing this, countries like India have adjusted their intellectual property rights (IPR) regulations to stimulate competition and economic growth. By doing so, they aim to empower emerging markets to secure more patents, thereby encouraging innovation and expanding market access.

The sanctity of nature, encompassing all life forms on Earth, is revered for its intrinsic integrity. However, patenting transgenic animals, achieved through the transfer of genes across species, breaches natural boundaries, thus compromising the integrity of these organisms. DNA, as a marker of species identity, should remain beyond commercial control, as it is deemed inseparable from the essence of each species.

Many individuals argue that Earth’s flora, fauna, and microorganisms constitute an inherent part of the environment humans are born into, and privatizing these life forms or their constituents contradicts the common good. India underwent a paradigm shift before 2002, recognizing that concepts tied to biological entities weren’t subject to patent protection. However, in the case of Dimminaco A.G v. Controller of Patent and Design[7], Calcutta HC, 2001, the Calcutta High Court ruled that a method for producing a live viral vaccine could be patented, asserting that living entities fell under the scope of patentable subject matter. The Court reasoned that the method itself, despite yielding a live virus in the end product, constituted an inventive process. It’s noteworthy that no specific ruling has been issued regarding the application of inventive step criteria to biotech patents in India. While microorganisms can be patented in India, the lack of a defined term in the Patent Act has ignited debates on their patentability. Given the absence of a standardized definition of microorganisms and microbiological processes in the TRIPS Agreement, it becomes imperative for the nation to differentiate between outcomes of human intervention and those occurring naturally.

TRIPS: During the negotiations of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, there was contention between the US, advocating for broad biotechnological patenting, and the EU, which opposed patenting biological organisms. Article 27 of the TRIPS Agreement outlines international standards for patenting biotechnology inventions, requiring novelty, inventive steps, and industrial applicability. Member countries, like India, can exclude inventions conflicting with public order, and morality, or causing harm to life. They may also exclude therapeutic, diagnostic, and surgical methods, plants, and animals, except microorganisms, from patentability. However, the agreement lacks clarity on patenting microorganisms, raising questions about whether natural microorganisms are patentable or if human intervention is necessary for novelty. This ambiguity prompts countries like India to differentiate between naturally occurring and human-intervened products for patent eligibility.

PATENTS ACT, 1970: As a signatory to TRIPS, India amended its Patent Act to align with international standards. Initially restrictive, subsequent amendments have brought it in line with World Trade Organization (WTO) provisions, allowing patents for life forms demonstrating innovative steps while disallowing the patenting of higher life forms. Additionally, the Act now grants a 20-year patent term, addressing previous constraints.

However, challenges persist in differentiating between discoveries and inventions, as well as in determining the patentability of higher life forms and microbial organisms. The Indian government crafted the Patent Act with these complexities in mind, aiming to combat piracy, foster the participation of national enterprises in technological advancements, and ensure adherence to international IPR laws to forestall future patent disputes.

Section 3 (c) of the Patents Act, of 1970 prohibits patenting naturally occurring living or non-living beings. However, genetically modified organisms can be patented if they meet the criteria of novelty, inventiveness, and industrial application. Microorganisms are an exception to this rule and can be patented if they are modified and not naturally occurring. Section 3 (j) of the Act excludes plants and animals, as well as essential biological processes related to them, from patentability. As mentioned above in the case of Dimminaco A.G.[8], 2001 the Calcutta High Court sought a patent for a process to create a live vaccine for Bursitis in poultry. The Patent Office initially rejected the application, but the Court later ruled that processes involving living organisms can be patented if they result in a new product.

U.S. laws related to patenting life forms: In the United States, the patent regime differs from India in its inclusivity regarding ‘life patents.’ While patents traditionally protected mechanical inventions, biological materials have been included as patentable subject matter. This raises questions about the inventive status of biological materials and the implications of private ownership over life forms. The debate extends beyond whether current patent laws should cover biological objects to whether new technology necessitates a revised patent regime. Chief Justice Burger clarified that the issue is distinguishing between products of nature and human-made creations. Section 101 of U.S. patent law outlines that anything made by humans is patentable, while naturally occurring things are not. For instance, genetically engineered organisms, animals, and plants are patentable, but naturally occurring microorganisms are not.

CHALLENGES OF PATENTING LIFE FORMS

The patentability of biotechnology inventions poses significant challenges due to their inherent nature. Existing patent law principles deem naturally occurring subject matters ineligible for patents, as they lack novelty and do not contribute to new developments. Biotechnological innovations face obstacles in meeting patentability criteria such as novelty, utility, and non-obviousness. Determining novelty in living organisms is particularly difficult, as they exist naturally. Additionally, the application of similar techniques in isolating gene sequences raises issues of obviousness. Utility standards for biotechnology innovations are perceived as stringent, often leading to refusals based on a perceived lack of utility. Patenting the human genome is contentious, as it involves naturally occurring genes. The distinction between invention and discovery becomes blurred in biotechnology, especially with genetically modified organisms. The complexity of genetically engineered inventions makes precise descriptions challenging, potentially leading to undeserving patent grants.

LEGAL COMPLICATIONS: In addition to fulfilling the criteria for patentability concerning novelty, inventive step, and industrial application, a biotech innovation must also qualify as patent-eligible subject matter. However, certain exclusions from patentability are outlined in Sections 3(b), (c), (d), (e), (h), (i), (j), and (p) of the Patents Act 1970, specifically for biotech patents.

Section 3(b): states that an invention cannot be protected if its use or commercial exploitation goes against public order, or morality, or causes significant harm to human, animal, plant life, or the environment. For instance, only genetically modified biological materials that pose no harm to living organisms or the environment can be patented.
Section 3(c): prohibits the patenting of discoveries of living or non-living substances occurring naturally. For example, merely isolating biological materials is viewed as discovering a naturally occurring substance and is therefore not eligible for patent protection. According to IPO Guidelines, sequences directly isolated from nature are not patentable, and only biological materials obtained through substantial human intervention can be patented.
Section 3(d): is contentious as it restricts patentability for modifications of existing substances unless they result in a new form showing enhanced efficacy. However, the definition of enhanced efficacy, especially in biotech inventions, remains unclear.
Section 3(e): also poses challenges by excluding substances obtained through mere admixture, such as combination vaccines, unless they exhibit synergism. The determination of synergism for biotech patents lacks clear statutory guidance, leading to case-by-case decisions by IPO.
Section 3(h): methods related to agriculture or horticulture are ineligible for patents, though recent guidelines clarify that this applies only to conventional methods in open fields.
Section 3(i): excludes processes related to treatment of humans or animals, including diagnostic methods. While past patents for in vitro diagnostic methods have been granted, recent guidelines bring them under Section 3(i), making future grants unlikely.
Section 3(p): Objections under this section arise frequently, excluding inventions that are traditional knowledge or aggregations of known properties. Claims are examined against traditional knowledge databases, like the Traditional Knowledge Digital Library, to ensure eligibility.
Section 3(j): prohibits the patenting of plants, animals, seeds, varieties, species, and essential biological processes for their production or propagation. However, processes involving substantial human intervention are exempt from this restriction.

This big question about patenting life forms is whether they should fit into the current legal rules or not. While most countries say no, the U.S. Supreme Court has been more open-minded. They gave a patent to a modified bacterial species because it showed a creative use of the bacteria’s abilities. The Court said that “manufacturing” covers anything made by humans, so the discovery counted as a human invention. But, there’s still confusion about when something changed by humans is enough to get a patent, especially with Genetically Modified Organisms (GMOs). The legal decisions so far haven’t made things clearer about what kinds of biological things can be patented.

ETHICAL COMPLICATIONS: The idea of patenting genetically modified organisms (GMOs) has raised ethical questions about whether it’s right to manipulate life for profit. For example, In Relaxin Case[9], T 0272/95, there was a case about patenting a human gene called Relaxin, The European Court decided that patenting a single gene isn’t the same as patenting a whole human, so it’s okay. But there’s still debate about whether it’s morally okay to patent genetically altered plants. Different countries have different ideas about what’s morally acceptable, depending on their social values. Similarly also in Brazil, they consider the rights of indigenous peoples over their traditional knowledge and genetic resources. Meeting these requirements, especially in Brazil, can be tough and can block the commercialization of knowledge.

SOME OF THE MAJOR LEGAL AND ETHICAL ISSUES FOUND IN DEBATES ON THE PATENTING OF SUCH LIFE FORMS ARE AS FOLLOWS –

Animal Cloning: Cloning encompasses various techniques used in labs, industries, and homes, like gardeners propagating plants through cuttings. It results in genetically identical organisms or cells with the same DNA as the original. However, Section 3 (j) of the Act prohibits patenting biological processes for plant and animal production. Section 3 (b) also prohibits inventions conflicting with public order, and morality, or causing harm to the environment or life. Animal cloning faces criticism due to observed health issues in cloned mammals, such as increased birth size, organ defects, premature aging, and immune system problems. The Dolly Sheep Case, for instance, cloned from a 6-year-old sheep, had shorter chromosomes and died at six, half the average lifespan of sheep. Scientists still grapple with these cloning-related challenges.
Stem Cells: Stem cells are versatile cells capable of developing into various types of human body cells. They hold potential for treating numerous medical conditions, but their extraction from embryos raises ethical concerns. While adult stem cells are an option, embryonic stem cells are preferred for their versatility. However, their use involves destroying embryos, which some view as immoral. Legal restrictions also prevent the patenting of stem cell-related inventions due to ethical and environmental concerns outlined in certain sections of the law.
Genetically Modified Seeds: Biotechnology has greatly aided plant development by introducing new genes with beneficial traits like insect resistance. While the Patents Act prohibits patents on plants, plant varieties, or seeds, it allows for man-made gene sequences in genetically modified seeds. The Protection of Plant Variety and Farmers Rights Act, 2001, protects the creation of new plant varieties, including transgenic varieties and their seeds. However, the Patents Act permits biotech firms to patent engineered genes and use them to produce transgenic seeds, although seeds themselves cannot be patented in India. Granting patents on seeds would restrict farmers from saving and exchanging them.
Choosing What to Protect: When a country decides not to protect a certain area of technology, it discourages investment in that field. For example the situation in Brazil, It’s not clear why Brazil bans patents for certain natural substances with clear industrial uses. Some think it’s because they believe Brazil doesn’t have the technology capacity to handle these patents. If that’s true, maybe it’s time to reconsider, not just in Brazil but in other countries too.

Other Arguments:

Metaphysical Concerns: Some people worry that patenting promotes a materialistic view of life by putting economic value on living organisms. However, trading animals and medicines has been happening for centuries.

Common Heritage: Before the Convention on Biological Diversity, living organisms were seen as the common heritage of humanity and should not be exploited for profit. Opponents of patenting argue that it gives inappropriate control over shared information.

Excessive Burdens: Critics claim that patenting creates burdens on medicine, leading to increased costs for consumers and royalties for future generations. There have been controversies, like with AZT, the HIV/AIDS treatment, where a company held a monopoly and made large profits despite government-funded research playing a crucial role.

Social Consequences: Patent recognition is tied to the economic system, and we must consider the broader social impacts. However, some issues, like wealth distribution and international competitiveness, are separate from the patent debate.

Focus on Profit: Some argue that modern biotechnology prioritizes profit and market creation over environmental or societal benefits. This can lead to inefficient or unsustainable practices, such as expensive pharmaceuticals or chemical pesticides.

Ownership of DNA: There’s debate over whether sequencing DNA qualifies as an invention. Critics argue that DNA is not random but rather shared by all humans, and sequencers are more like discoverers than inventors. Some see those seeking to profit from DNA sequencing without consultation as “genomic imperialists.”

CONCLUSION

In conclusion, the patenting of life forms in biotechnology presents a complex landscape fraught with legal, ethical, and practical challenges. While biotechnological innovations hold immense promise for advancing human welfare and addressing critical societal needs, the question of whether life forms should be subject to patents remains a contentious issue. Legal frameworks, such as the TRIPS Agreement and national patent laws, attempt to strike a balance between incentivizing innovation and safeguarding ethical principles. However, the interpretation and application of these laws vary across jurisdictions, leading to inconsistencies and debates regarding patent eligibility criteria.

Ethical concerns surrounding the manipulation of genetic material and the commodification of life further complicate the patenting process. Debates on issues like animal cloning, stem cell research, and genetically modified organisms underscore the need for thoughtful consideration of the moral implications of biotechnological advancements. Additionally, the exclusion of certain technologies from patent protection, as observed in countries like Brazil, raises questions about the impact on innovation and economic development.

Despite these challenges, the evolution of patent laws in biotechnology reflects a growing recognition of the importance of fostering innovation while addressing ethical and societal concerns. As the biotechnology industry continues to advance, policymakers, legal experts, and ethicists must collaborate to develop robust regulatory frameworks that promote responsible innovation while ensuring equitable access to life-saving technologies. Only through a comprehensive approach that balances the interests of stakeholders can the full potential of biotechnology be realized for the benefit of humanity.

REFERENCES

VK Ahuja, Law Relating to Intellectual Property Rights, Page no – 03 Introduction, published by LexisNexis, 2007.
Author: Meghana Puranikmath, Article: Patenting Life Forms In India – Challenges and scope, Webpage: mondaq, Date: June 29, 2021, Link: https://www.mondaq.com/india/patent/1085388/patenting-life-forms-in-india–challenges-and-scope
Author: Abhinav Mahlawat, Article: Patenting Biotechnical Life Forms: Analyzing Bioethics and Challenges of Law, Webpage: legalserviceindia, Link: https://www.legalserviceindia.com/legal/article-8619-patenting-biotechnical-life-forms-analyzing-bioethics-and-challenges-of-law.html
Author: Sakshi Jain, Article: Issues face while Patenting Biotechnology Inventions, Webpage: blog.ipleaders.in, Date: September 19, 2021, Link: https://blog.ipleaders.in/issues-faced-while-patenting-biotechnology-inventions/
Author: Anuja Saraswat, Article: Patenting of Life Forms? A comparative Study between India and U.S.A, Webpage: GPF, Date: April 05, 2022, Time: 4: 42 pm, Link:https://www.globalpatentfiling.com/blog/patenting-of-life-forms-comparative-study-between-india-and-usa
Article: Biotech Patents, Webpage: EPO, Date: November 02, 2022, Link: https://www.epo.org/en/news-events/in-focus/biotechnology-patents
Author: Jorge Avila, Article: Intellectual Property on Life Sciences and Biotechnology: State of Affairs, Impacts and Perspectives, Webpage: National Library Of Medicine, Date: October 01, 2014, Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4204383/
Author: Darryl. R. J. Macer and Mackina Kato, Article: Biotechnology, Patents, and bioethics, Webpage: IATP, Link:https://www.iatp.org/sites/default/files/Biotechnology_Patents_and_Bioethics.htm
Article: Biotechnological Inventions In India: Law, Practice and Challenges, Webpage: IAM, Date: October 23, 2015, Link: https://www.iam-media.com/global-guide/iam-yearbook/2016/article/biotechnological-inventions-in-india-law-practice-and-challenges

[1] Bayer Corporation v. Union of India, Writ Petition No. 1323 of 2013

[2] Diamond v. Chakrabarty, 447 U.S. 303 (1980)

[3] Hibred International v. JEM AG Supply Inc, 534 U.S. 124 (more) 122 S.

[4] Amgen v. Chugai, 927 F.2d 1200.

[5] Harvard College v. Canada, 2002 SCC 76 (CanLII), [2002] 4 SCR 45.

[6] American Fruit Growers Inc. v. Brogdex Co, 283 U.S. 1 (1931)

[7] Dimminaco A.G v. Controller of Patent and Design, Calcutta HC, 2001

[8] Dimminaco A.G v. Controller of Patent and Design, Calcutta HC, 2001

[9] Relaxin Case, T 0272/95

Disclaimer: The materials provided herein are intended solely for informational purposes. Accessing or using the site or the materials does not establish an attorney-client relationship. The information presented on this site is not to be construed as legal or professional advice, and it should not be relied upon for such purposes or used as a substitute for advice from a licensed attorney in your state. Additionally, the viewpoint presented by the author is of a personal nature.