The Latest View on India’s Life Sciences IP Ecosystem
This is an Insight article, written by a selected partner as part of IAM's co-published content. Read more on Insight
A country's greatness can be measured by its visionaries. Nevertheless, in today's paradigm, becoming a visionary and being competent enough to bring innovations to market is insufficient. In modern times, entrepreneurial and research rivalries have become too fierce, and any idea is capable of being duplicated and stolen, so they must be safeguarded. This is why intellectual property rights (IPR) have now been recognised as one of the core assets anyone can hold. Patenting new inventions, among other things, protects the inventor's rights, promotes entrepreneurs and simplifies the exchange of technology among recipients.
The same goes for the life sciences domain as inventors are additionally safeguarded by intellectual property rights, but he or she must establish the novelty and ingenuity of the specific item they are proposing. Section 2(1)(j) of the Patents Act 1970 discusses the innovation, highlighting that the breakthrough must be unique for it to be protected. The ongoing IPR architecture has enabled the commercialisation of a lot of life sciences and biotechnology-centric products, such as seeds,monoculture, new plant varieties, microbes and hereditarily altered organisms. But for a long time, it was necessary to find a means of developing a robust methodology that reconciles the standard intellectual property (IP) structure with the sustainable components of life sciences. That soon got revolutionised as it became very prominent as IP protection is among the major cornerstones in many companies' prospective ambitions and many Indian corporations were impacted by the covid-19 pandemic, which wreaked havoc on the worldwide economy, meaning they had to rethink their entire research and development and intellectual property procedures. The biotechnology and life sciences sectors are forecasted to increase to be worth over US$3 trillion by 2030, ushering in a new era of intellectual property and life sciences.
Owing to multiple ethical issues that legislatures and magistrates around the world have taken into consideration, it has been a major obstacle for all nations, especially for India, to adequately protect scientific advances as well as additional innovation-oriented endeavours within the disciplines of life sciences and biotechnology. Adoption of knowledge about living beings, particularly human anatomy, is typically viewed as illegal. Some laws expressly restrict patents in some fields. In other cases, courts may declare them unconstitutional for reasons unconnected to any of the normal patentability standards. Another source of uncertainty in intellectual asset protection is the flexibility given by the Treaty on Trade-Related Intellectual Property Aspects (TRIPS). This agreement requires patents to be granted in all disciplines of technology except biological sciences, including genetically modified organisms if there has been an aspect of human intervention. In India, he intellectual property rights in the life sciences sector have long been a cause of contention. This is because inventions within the life sciences sector have an impact on governance, ethical standards and the macroeconomic situation. Life sciences entities often work with an assortment of goods and procedures that can be generally categorised according to the industry in which they operate. A key issue for life sciences scholars and institutions in the past has been that patents for linked innovation are particularly vulnerable to deterioration from minor changes and technology transfer in the life sciences area, as sometimes it takes longer owing to complicated and stringent government compliance around the safety of new ideas and technologies. These challenges would eventually have an impact on the practical long-term sustainability of the substantial expenses innovation and the final product, reducing the odds of recuperating economic benefits and restricting people from implementing their IPs. Supplementary to the conventional patentability necessities of unconventionality and substantial measures, life sciences breakthroughs in India had to meet the obstacles set by section 3 of the Patents Act. Section 3 creates exclusions referred to as 'non-patentable inventions’, which have been created primarily to defend the nation's economic and social concerns. As a large amount of innovation and technological advancement in the life sciences area has a connection to the healthcare industry, the limits of section 3 of the Act's subsections (b), (c), (d), (i) and (p) have to be addressed accordingly for one to the get over the novelty aspect. Aside from the aforementioned concerns, India has witnessed a big turn of fortune and plenty of improvements in its IP practices over the preceding 10 years, with the enactment of various administrative and legislative changes that have contributed to the protection of IP. Innovative individuals, entrepreneurs and major organisations in the life sciences sector capitalised on India's position as a signatory to the Convention on Ecological Broadening, which calls for them to make contributions to the preservation of the domain, its sustainable utilisation and equitable distribution of the rewards that result from the utilisation of biological resources and specialisation.
During the recent decade's change, a slew of creative solutions to the problem of adequate safety have emerged. The most effective tactics are those that combine quantifiable and acknowledged approaches to protecting IP with the last phases of the procedure to record correct information about the innovation. These approaches are employed across nations and jurisdictions and can be beneficial commercially as well as environmentally as the life sciences have permeated into every field of technological development, culminating in one of the most complex systems of contemporary times. The field of life sciences is no longer an isolated subject; rather, it is a constantly evolving fluid realm that is swiftly extending and incorporating many different fields of study, restoring the development of an increasing number of multifaceted areas, such as the field of biotechnology computational biology, the use of nanotechnologies and biopharmaceuticals. So, in the case of IP, it has evolved into a vital tool for a wide spectrum of business operations.
The ownership and utilisation of intellectual property are essential factors in establishing a business's cognitive and monetary viability. In general, advances in biosciences-related firms need a greater investment in terms of time and resources. Such a move necessitates effective development and secure retention of extraordinarily valuable IP. IP creation and oversight for life sciences companies in India necessitate not only compliance with national IP laws, but also compliance with other national laws, restrictions and mandates. Even though numerous regulatory bodies are regularly revamping and facilitating the removal of limitations, complex regulations and laws are a key obstacle for life sciences businesses in India and interest-appropriate and timely assessment.
What is more fascinating to note other than the research segment in India is the start-up culture in India. With over 210 incubation centres and approximately 15–20 start-up engagement expeditions, India is making advances toward developing a start-up community. Entrepreneurs have also provided much contributing seed funding to take the domain to a new height and also advise emerging companies on strategies that will result in success. The Indian government has also dipped in and launched the 'Start-up India' programme, which supports entrepreneurs and innovators to start as well as transition into the start-up game. A lot of life sciences-based start-ups in India helped reform and support the nation during covid-19 crisis. One example is when going to hospitals for ordinary ailments is perilous, online pharmacies have helped to reduce the need for unneeded travel and the likelihood of infection, opening a new gateway for pharma-based organisations. Life sciences start-ups in India surged at a 50 per cent compound annual growth rate, making up 14 per cent of the 9,200 start-ups established during this time frame. What's most fascinating is that life sciences are not just linked to biological fields, but have also taken the aspect of artificial intelligence used by 65–67 per cent of the aforementioned start-ups, while Internet of Things technologies are employed by 45–46 per cent. Even though India's entrepreneurial scene is still in its infancy, the nation currently ranks in the top 10 for global patent applicants, as most life sciences patents are getting filed in India, followed by South Korea, Australia and Japan. Although many of the companies have only filed patents in single digits, they opted to protect their innovations in many jurisdictions and have proven that IPRs are crucial to the life sciences industry. To maintain the current uptrend of the IPR ecosystem in India, the government has come up with the recent National Intellectual Property Awareness Mission (NIPAM) initiative, a prestigious initiative for imparting IP exposure and foundational education. It was launched on 8 December 2021 during the Azadi Ka Amrit Mahotsav celebrations. The effort is being carried out by the Intellectual Property Office, the Office of the Controller General of Patents, Designs and Trade Marks, and the Ministry of Commerce and Industry. Over a million students have received IP education and core training from the NIPAM, which continues to work closely with researchers and innovators to build a brighter future. As the risks are connected with these lengthy developmental periods and legal constraints, business interests tend to get the highest quality IP rights. As new technologies, personalised medicine and specific therapies offer potential treatments for chronic diseases, novel viewpoints on agricultural repercussions and industrial breakthroughs, the life sciences industry is extremely competitive. The simplicity of sequencing search and patent synthesis may now yield significant financial and strategic benefits. In an industry seeing expansion in the biosimilar and equivalent marketplaces, information and exclusivity in the marketplace are becoming increasingly crucial.
India has been and is traversing a new world setup, transitioning from an era of complete lack of IP attention to where it is now, with a proactive pursuit of IP in the margins of creativity as it begins turning into an international centre of world-class IPR solutions in every sector, with life sciences at the forefront. Having seen India's IP potential in the past, the time has come to embrace the vitality of the biotechnology and life sciences sectors. Although development has been made after the first patent legislation was introduced in the last century, known as the Patents Legislation of 1970, while the need to conserve IPR has been recognised in government circles, the amount of safeguarding may not be limited. In 2023, the government announced a number of national IPR policies to foster innovation and entrepreneurship, as well as to review and reinforce existing rules.
For many years, there has been a lot of backlash to greater IPR protection from people who fear it will harm India's interests. A tighter IPR policy is expected to make pharmaceuticals and therapies substantially more difficult to develop and distribute. This is not the case, as it is merely an absence of awareness. According to a study titled ‘Intellectual Property: Rights, Need, and Awareness’, a startling number of students, scholars, professors and managers from more than 200 educational institutions in South India were unaware of the benefits of IP and other related issues. Ensure a prosperous future of IPR in India in the field of life science will depend on three major things:
- awareness of IPR benefits;
- streamlined and robust enforcement; and
- promoting a more innovative culture.
India has begun to take IPRs much more seriously and has started developing ways to foster IPRs and the culture of start-ups in populous India, making enormous strides in fields such as scientific and academic producing, agricultureand culture, in particular in the field of life sciences, which have recently experienced a tremendous boom. To maintain this increasing trend, government officials must strike a delicate balance between national interests and the protection of intellectual property, as well as incubation and acceleration devices, because creative and innovative ideas cannot survive without strong intellectual property protection. The Indian Institutes of Technology, Centre for Scientific and Industrial Research and Council of Industrial Innovation and Research are institutions that have contributed significantly to the advancement of science. However, owing to a shortage of IPR streaming platforms and utility, much research is stalled and is unable to be commercialised. Probably, large firms and organisations are not going to be the sole ones to benefit. Improved legal protection will spur grassroots innovation and improve the lives of regular Indians. When dealing with these problems and laws, authorities, such as the patent office or other associated premises, have struck a balance between encouraging innovation, preserving socioeconomic rights in society and defending domain interests. Bottom-up, decentralised, evidence-based and inclusive stakeholder interactions are critical in achieving legal and regulatory reforms in the intellectual property ecosystem as India gradually grows into the hub of innovation and research that we all envision.