This article is written by Riya, an intern under Legal Vidhiya
ABSTRACT
The pharmaceutical industry promotes global health, scientific advancement, and economic progress. The foundation of this industry is based on Intellectual Property Rights (IPR), which govern the protection, sharing, and commercialization of innovations. There is an ongoing discussion on IPR in India’s pharmaceutical sector, especially how it affects healthcare accessibility, innovation incentives, and trade relationships. With a solid generic drug manufacturing industry and robust research capabilities, India operates within a complex environment of domestic laws, international agreements, and legal precedents. This research paper comprehensively analyzes IPR in the Indian pharmaceutical industry, examining legal frameworks, policy measures, industry practices, and socio-economic factors. The paper delves into trademarks, patents, and the impact of global agreements like the TRIPS Agreement and explores how I.P.R. influences innovation, access, and competitiveness in India’s pharmaceutical landscape. The study also presents case studies highlighting the challenges in protecting complex biological systems and the role of patents in facilitating or hindering research. Furthermore, the paper discusses India’s historical approach to patent laws, including amendments to global standards. It examines measures such as compulsory licensing to ensure that essential medicines are more widely accessible. By analyzing these aspects, the paper aims to provide a deeper understanding of the complex dynamics in the Indian pharmaceutical industry to inform policy decisions and industry strategies to promote innovation while ensuring affordable healthcare for all.
Keywords
Intellectual property rights, Pharmaceutical industry, Patent laws, trademark.
INTRODUCTION
The pharmaceutical industry is crucial in improving public health, advancing scientific innovation, and driving economic growth. At the core of this dynamic sector is Intellectual Property Rights (I.P.R.), which governs innovations’ protection, dissemination, and commercialization. In recent years, the discussion around IPR in the pharmaceutical domain, particularly in emerging economies like India, has gained significant attention due to its impact on access to medicines, innovation incentives, and global trade dynamics.
India is known for its well-established generic drug manufacturing sector and strong research capabilities. The country is engaged in a nuanced dialogue about promoting innovation and ensuring affordable healthcare for its citizens. The Indian pharmaceutical industry has witnessed tremendous growth in the past decades in market capturing and contribution to our country’s gross domestic product. India’s domestic pharmaceutical market is estimated at USD 41 billion in 2021 and is likely to reach USD 65 billion by 2024 and further expand to USD 120-130 billion by 2030.[1] The IPR landscape in India is a complex mix of domestic legislation, international agreements, and judicial precedents, which plays a crucial role in shaping the pharmaceutical ecosystem. Key elements such as patents, trademarks, copyrights, and regulatory exclusivities intersect, influencing drug discovery, development, and commercialization.
This research paper endeavors to comprehensively analyze IPR in the pharmaceutical industry within the Indian context. By delving into pertinent legal frameworks, policy interventions, industry practices, and socio-economic considerations, the study aims to elucidate the multifaceted dynamics shaping innovation, access, and competitiveness in the Indian pharmaceutical landscape.
TRADEMARK PROTECTION IN THE INDIAN PHARMACEUTICAL INDUSTRY
Pharmaceutical trademarks are commonly registered for respected pharmaceutical products and services. Regarding pharmaceutical trademarks, the brand or drug name often derives from the drug’s indication, chemical composition, or other medical terminology. For instance, if a medication for liver treatment is named LIV, the subsequent drug from the same company might be branded as “LIV. These trademarks are essential because they are directly related to public health and helpful in finding the product and its exact use, which improves the reputation of the pharmaceutical companies. Indian trademark law statutorily protects trademarks as per the Trademark Act, 1999[2], under the common law remedy of passing off. The Controller General of Patents, Designs, and Trade Marks administers statutory protection of trademarks. This government agency reports to the Department of Industrial Policy and Promotion (D.I.P.P.) under the Ministry of Commerce and Industry.[3]
The naming process for pharmaceutical trademarks often involves deriving names from the drug’s treatment, salt composition, or related medical terms, which may lack the inherent distinctiveness required for trademark status[4]. This can lead to confusion among consumers, as trademarks must not be confusingly similar to existing brands as per Section 11 of the Trade Marks Act, 1999[5]. To mitigate errors, it’s essential for customers to easily differentiate between pharmaceutical products based on their brand names, drug names, and overall packaging design.
Here are a few instances of confusingly similar trademarks: “Trivedon” and “Flavedon” were said to be dissimilar. This followed a case in which the brand names “Mexate” and “Zexate” were deemed distinct even though they were rhyming words[6]. In the case of AstraZeneca U.K. Ltd. v. Orchid Chemicals & Pharmaceuticals Ltd.[7], 2006 (which was later affirmed by the Division Bench in AstraZeneca U.K. Ltd. v. Orchid Chemicals & Pharmaceuticals Ltd.[8], the Delhi High Court held that the two marks derived the prefix “Mero” from the drug “Meropenem” and that there was no similarity between them.
LEGAL FRAMEWORKS IN INDIA FOR PATENT LAWS
India has a robust legal framework for safeguarding intellectual property rights through multiple types of Intellectual Property laws, such as the Trademark Act, the Copyright Act, the Design Act, and the Patents Act. The primary objective of these laws is to offer legal protection to different forms of intellectual property and promote innovation and creativity across various sectors. Legal protection of intellectual property can stimulate innovation and creativity by giving individuals and businesses a financial incentive to invest in new concepts and creations. Without this protection, people and companies may be less likely to invest time and resources into developing innovative ideas since others could quickly copy and profit from their creations without any consequences. These laws include the Trademark Act, Copyright Act, Design Act, and Patent Act, each providing legal protection and remedies to the owners of trademarks, copyrights, industrial designs, and patents, respectively, against any potential misuse, theft, or infringement.
After India became a signatory to the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement in 1995[9], patents – one of, if not the most important aspect of intellectual property rights in the pharmaceutical industry – underwent significant changes. The country was obligated to amend its patent law to comply with the provisions of the international agreement. The first amendment, the Patents (Amendment) Act of 1999[10], introduced pipeline protection until product patents were granted for pharmaceutical inventions. It also established provisions for filing applications for product patents in the fields of drugs and agrochemicals from January 01, 1995, and introduced Exclusive Marketing Rights (EMRs) for selected applications.[11]
To comply with the second set of TRIPS obligations, India further amended the Patents Act, 1970 through the Patents (Amendment) Act, 2002[12]. This amendment provided a uniform patent term of 20 years for all categories of inventions, meaning that patents would now have a limited term of 20 years, counted from the date of filing the patent application.
THE IMPACT OF WTO ON THE PHARMACEUTICAL INDUSTRY
Establishing the World Trade Organization (WTO) has significantly impacted global trade. During the Uruguay Round of trade negotiations under the General Agreement on Tariffs and Trade (GATT), the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) was negotiated, with the pharmaceutical industry being one of the main reasons for incorporating intellectual property issues into the GATT framework. On April 15th, 1994, India signed the GATT, which made it compulsory for the country to comply with all the requirements of GATT, including the TRIPS Agreement[13]. As per the TRIPS Agreement[14], India is required to meet the minimum standards with patents and the pharmaceutical industry. The country’s patent legislation should now contain provisions for pharmaceutical products and process inventions. Patents for a minimum term of 20 years are to be granted to any invention of a pharmaceutical product or process that fulfills the established criteria.
PHARMACEUTICAL PATENTS IN INDIA
Patenting drugs in the pharmaceutical industry is a competitive race that requires staying ahead of the curve with ever-evolving drugs. Currently, the United States holds the most pharmaceutical patents, followed by China. India has also become a significant player in this race. Incentives to file pharmaceutical patents in India include drug price control amendments and other facilities and exemptions provided by the Indian Government. Automation has revolutionized the pharmaceutical industry by minimizing human intervention in handling materials, distributing medication, and manufacturing and packaging formulations. Companies are embracing advancements in A.I. technology to develop new and improved treatments and find ways to provide access to treatment quickly. Recent patents have been granted for machine learning, including classifying digital images of cells treated with different experimental compounds and for image processing and machine learning algorithms used to test compounds against samples of diseased cells based on pre-existing historical or recorded data as a control.
CASE STUDY
IP Protection for Complex Biological Systems in Drug Discovery Research
The process of developing new drugs is intricate, and it involves the study of complex biological systems. However, safeguarding intellectual property rights can be challenging when the technologies used include systems lacking clear boundaries. Usually, such information is quite broad, and it refers to general categories of matter, such as a class of neural receptors, instead of specific techniques or finite entities.
There has been a lot of debate about broad patents, with some people seeing them as a hindrance to research on valuable drugs. In contrast, others view them as essential in translating research knowledge into useful products. The workshop discussion focused on the tension between the reliance of small biotechnology firms on patents and the difficulties that arise when researching complex biological systems restrained by a complicated network of patents on individual components.
When researching such systems, obtaining multiple licenses on individual components of a complex system is a significant challenge. It can lead to substantial royalty fees on any practical application derived from the product, which can be intimidating. This can be a substantial problem in gene therapy, where the most promising advances are related to rare genetic diseases that present small markets. To promote the progress of biomedical research, access to related components of biological systems is crucial. Access to such components is often blocked, which leads to problems. For instance, treating schizophrenia involves using compounds that suppress dopaminergic neurotransmission. However, many of these compounds act nonspecifically and suppress the entire family of dopamine receptors, leading to other disorders that resemble Parkinson’s disease, which is another disease involving the dopamine system. Targeting specific dopamine receptors is a rational approach to discovering improved medications for schizophrenia. However, if different companies hold patents on other receptors, the first step in developing an essential and much-needed therapeutic advance can be blocked.
During a discussion on drug discovery, it was noted that it is challenging for a single company to discover a particular type of drug and that it is beneficial for companies to share research results. This was compared to the early history of radio and television, where cross-licensing practices enabled broad access to the technology. However, companies must balance overall industry progress with their financial needs. It was also discussed that patents on research tools could protect proprietary use, generate revenues for universities, or help companies continue their development without creating an economic disadvantage. Patents were seen as essential for small biotechnology companies to survive. It was also noted that transferring material between universities has become more complicated in recent years, and university technology transfer managers are still learning. The proprietary landscape was described as likely to be complex.[15]
CHALLENGES
India had a product patent regime for all inventions under the Patents and Designs Act of 1911[16]. However, 1970, the government introduced the new Patents Act, which excluded pharmaceuticals and agrochemical products from patent eligibility. This exclusion was introduced to break away from India’s dependence on imports for bulk drugs and formulations and provide for the development of a self-reliant indigenous pharmaceutical industry. The lack of protection for product patents in pharmaceuticals and agrochemicals significantly impacted the Indian pharmaceutical industry. It resulted in the development of considerable expertise in reverse engineering of drugs that are patentable as products throughout the industrialized world but unprotected in India.
As a result, the Indian pharmaceutical industry has increased by developing cheaper versions of many drugs patented for the domestic market. Eventually, it moved aggressively into the international market with generic drugs once the international patents expired. In addition, the Patents Act provides several safeguards to prevent the abuse of patent rights and provide better drug access. Recently, there was an amendment in the Drug Price Control Orders in 2013 and 2021 regarding the incoming of foreign players.
The Patents Act also has provisions allowing compulsory licensing, a move made by the Government to ensure universal access to essential products, above prioritizing the monopoly of patent holders. After the completion of three years from the date of selling the patent, any person interested in working on the patented invention may apply for a compulsory license concerning the invention. The Controller of Patents may direct the patent holder to grant such license upon terms as may be deemed fit only if she is satisfied that the reasonable requirements of the public for the patented invention have not been met or that the patented invention is not available to the public at a reasonable price.
CONCLUSION
The pharmaceutical industry in India is at a crucial juncture where innovation, access to medicines, and economic growth intersect, all while navigating complex Intellectual Property Rights (IPR) frameworks. This research has explored the impact of trademarks and patents on the industry, highlighting their multidimensional dynamics. Trademarks are essential for ensuring clarity and safety in pharmaceutical products, while patents serve as incentives for innovation and potential obstacles to access. India’s alignment with international patent laws, particularly after the TRIPS Agreement, reflects a delicate balancing act between encouraging domestic innovation and fulfilling global obligations.
The presented case studies emphasize the challenges of protecting complex biological systems, calling for nuanced approaches to patenting that encourage research while protecting the public interest. Furthermore, discussions on compulsory licensing and other measures demonstrate India’s commitment to ensuring access to essential medicines, even in the face of patent monopolies.
In the future, policymakers, industry stakeholders, and researchers must work together to navigate the changing landscape of I.P.R. in the pharmaceutical industry. This requires a holistic approach that considers the protection of intellectual property and its broader implications for public health, innovation ecosystems, and socio-economic development. By fostering an environment that encourages innovation while safeguarding access to affordable medicines, India can continue to shape the global pharmaceutical landscape while promoting health equity and sustainable development.
REFERENCES
- NATIONAL LIBRARY OF MEDICINE, https://www.ncbi.nlm.nih.gov/books/NBK233539/ (Last Visited Mar. 12, 2024).
- Patents and Designs Act, 1911 (U.K.), c. 53.
- WORLD TRADE ORGANIZATION, https://www.wto.org/english/thewto_e/minist_e/min96_e/chrono.htm (Last Visited Mar. 12, 2024).
- Official Website Of Intellectual Property India, https://ipindia.gov.in/history-of-indian-patent-system.htm#:~:text=This%20ordinance%20was%20subsequently%20replaced,such%20patents%20were%20not%20allowed (Last Visited Mar. 11, 2024).
- Anuja Saraswat & Kirit P. Mehta(Member of KHURANA & KHURANA Law Firm), India: Trademark Infringement in the pharmaceutical sector,https://www.mondaq.com/india/trademark/1173874/trademark-infringement-in-the-pharmaceutical-sector.
- INDIAN PATENT OFFICE, https://www.ipindia.gov.in/ (Last Visited Mar. 11, 2024).
- THE ECONOMIC TIMES,
https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/domestic-pharmaceutical-market-to-reach (Last Visited Mar. 10, 2024).
https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/domestic-pharmaceutical-market-to-reach (Last Visited Mar. 10, 2024).
[2] Trademark Act, 1999, No. 47, Acts of Parliament, 1999 (India).
[3] INDIAN PATENT OFFICE, https://www.ipindia.gov.in/ (Last Visited Mar. 11, 2024).
[4] INDIAN PATENT OFFICE, https://www.ipindia.gov.in/ (Last Visited Mar. 11, 2024).
[5] Trademark Act, 1999, § 11, No. 47, Acts of Parliament, 1999 (India).
[6] Anuja Saraswat & Kirit P. Mehta, India: Trademark Infringement in pharmaceutical sector,https://www.mondaq.com/india/trademark/1173874/trademark-infringement-in-the-pharmaceutical-sector
[7] AstraZeneca U.K. Ltd. V. Orchid Chemicals & Pharmaceuticals Ltd., 2006 SCC OnLine Del 1668.
[8] AstraZeneca U.K. Ltd. v. Orchid Chemicals & Pharmaceuticals Ltd., 2007 SCC OnLine Del 237.
[9] WORLD TRADE ORGANIZATION, https://www.wto.org/english/tratop_e/trips_e/intel2_e.htm
(Last Visited Mar. 11, 2024).
[10] Official Website Of Intellectual Property India, https://ipindia.gov.in/history-of-indian-patent-system.htm#:~:text=This%20ordinance%20was%20subsequently%20replaced,such%20patents%20were%20not%20allowed (Last Visited Mar. 11, 2024).
[11] Anuja Saraswat & Kirit P. Mehta, India: Trademark Infringement in the pharmaceutical sector,https://www.mondaq.com/india/trademark/1173874/trademark-infringement-in-the-pharmaceutical-sector
[12] Patents Act, No. 39, 1970, Acts of Parliament, 1970 (India).Top of Form
[13] WORLD TRADE ORGANIZATION, https://www.wto.org/english/thewto_e/minist_e/min96_e/chrono.htm (Last Visited Mar. 12, 2024).
[14] WORLD TRADE ORGANISATION, https://www.wto.org/english/thewto_e/minist_e/min96_e/chrono.htm (Last Visited Mar. 12, 2024).
[15] NATIONAL LIBRARY OF MEDICINE, https://www.ncbi.nlm.nih.gov/books/NBK233539/ (Last Visited Mar. 12, 2024).
[16] Patents and Designs Act, 1911 (U.K.), c. 53.
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