Public Access To Health - Pharmaceutical Patenting Issues In India

Author: LawSphereX

Category: General Law

Published: 2026-08-23T20:49:04.066486+00:00

Updated: 2026-08-26T17:09:58.599+00:00

PUBLIC ACCESS TO HEALTH: PHARMACEUTICAL

PATENTING ISSUES IN INDIA

Sara Sachin, BBA LLB (Hons), OP Jindal Global University (Jindal Global Law School), Sonipat, Haryana

ABSTRACT

With the onset of new technology, the pharmaceutical industry is shaping itself to better address public health concerns to keep up with the upcoming changes in the healthcare sector. The intersection of pharmaceutical patenting with the healthcare sector is now one of the growing concerns in the market. This comes along with great economic disparities with respect to the pricing and market regulation of drugs in the market. This paper will examine the pharmaceutical patenting issues companies face in India, especially with the onset of the Patent Act of 2005 and the public's access to health care. The balance that is needed between public health and innovation is examined with various key case studies and legislative frameworks, and suggestions are made on how the industry can do better with respect to access to public health.

Introduction India with its vast population, needs a thorough addressing of the public health issues it's facing, with 16. 4% of its population in poverty, safe access to drinking water, food, and shelter is required, but this alone is not enough as with bad living conditions, the general public also requires for adequate access to health care facilities at subsidizable rates as they are not able to afford different healthcare schemes and treatment they need. The main issue is that of drugs as many who cannot afford to go for treatment, look for the right medicines to cure themselves with. However, multiple branding companies who have now entered the market producing drugs with different names but of the same salt composition, are competing their way to the top and this recognition comes at the cost of people's lives.

India is known as the "pharmacy of the world" because of its productions of inexpensive generic medicines. It assumes a significant role in the global supply of drugs because of a large portion of low-cost medicines supplying developing countries. However, with the amendment of India's patent law in 2005 to its conformity with the terms of the TRIPS agreement, the fight between innovation, intellectual property, and public health has become increasingly complex. While the legislation was aimed at promoting innovation and foreign investment, the outcome has been one where, at certain junctures, the patent system has run counter to low-cost medicines for those conditions the public most needs, such as cancer, HIV/AIDS, and tuberculosis.

Historical Context The Patent Act of 1970: The robust pharmaceutical sector in India, before the 2005 amendments, was thriving on the Patent Act of 1970, which granted product patents on pharmaceutical processes. This encouraged generic production at home, and the price of drugs precipitously came down to make essential medicines accessible to millions. Indian pharmaceutical firms emerged as significant players in the global generic market and exported affordable drugs to developing countries. The TRIPS agreement one introduced by the WTO in India in 1995- generated a new imperative in patent policies. Pharmaceutical product patents were provided for in the

amendments to the Patent Act in 2005 that balanced a hitherto ignored public health need against increasingly intimate intellectual property protections. This was to be the manner by which to protect the intellectual property of pharmaceutical companies while inviting innovation and foreign investment. Things have in fact been much more complicated than that, for multinational corporations use their patent rights to hold life-saving drugs at a price accessible to few patients. Changes in 2005: India amended its patent laws in 2005 to bring itself in consonance with the TRIPS agreement, which would oblige the country to extend its recognition for product patents in pharmaceuticals.

This was to attract innovation as well as foreign investment; however, it inadvertently exposed the country to serious threats to public health that could come from higher prices for drugs and limited access thereto1. The Impact of Pharmaceutical Patenting on Public Health Drug Affordability and Accessibility: In general, one of the significant implications of this practice is a rise in pharmaceutical medication prices. Through patents, the drugs can be retained exclusively for the production and distribution of drugs by companies, and this significantly causes their monopolistic pricing. One vivid example of this is the story of the anti-cancer drug imatinib, popularly known as Gleevec. This illustrates how the high cost brought about by patents is extravagant enough to make essential life-saving drugs unaffordable to many patients.

To combat this obstacle, Indian generic manufacturers such as Natco Pharma have been filing for compulsory licenses to manufacture more affordable variants of patented drugs in order that the mass population would be able to afford them2. The Role of Compulsory Licensing: Compulsory licensing, therefore, gives governments the latitude to allow the manufacture of a 1 Sujitha Subramanian, India’s Tryst with TRIPS: The Patents (Amendment) Act, 2005, Manupatra (2005), https://docs. manupatra. in/....

2 Pharmaceutical Patent Laws in Context with Health in India, ResearchGate (2023),

https://www.researchgate.net/....

patented product without the permission of the patent owner if such conditions as the existence of major public health concerns arise. Among the most significant cases in India, is the case from 2012 when Natco Pharma was granted a compulsory license to manufacture imatinib-an important precedent. This case shows what could be the potential of compulsory licensing to strike a balance between patent rights and public health needs, but it also attracted strong pushback from multinational pharmaceutical companies3. Innovation vs. Public Health: The debate around pharmaceutical patenting centers on the tension between innovation and public health. Patents benefit innovation in the sense that returns to inventors are guaranteed, but the bottom line has proven to be profitable drugs, not essential medicines as attention primarily addresses high-cost research and development of drugs.

As a result, many diseases common in low-income populations are left unattended by pharmaceutical companies. This creates an empty gap in access to innovative treatments for diseases more common among marginalized groups. Indeed, the India experience underlines the requirement for a balanced policy approach that encourages innovation but assures the availability of leading drugs to the masses. This can be through investment in generic manufacturing alongside public-private partnerships in research and development. Another model of incentivizing such innovation could be public funding for research or prize-based mechanisms that cut down on the over-reliance on patents in pharmaceutical innovation4.

Legislative Framework and Policy Recommendations Current Legislative Landscape: India's patent laws, under TRIPS, are therefore so weighed as to balance the protection of intellectual property with public health concerns. The government has taken steps, in particular through the provisions of compulsory licensing and, thus, certain criteria governing patentability, to intervene in public health concerns. More often than not, these steps have met 3 Compulsory License: India, Kluwer Patent Blog (Aug. 16, 2021), https://patentblog. kluweriplaw. com/.... 4 Access to Medicines in the Indian Public Health System – What Works and What Does Not? A Review of the National Health Mission Common Review Mission Reports (2007–2021), Journal of Global Health Reports (2021), https://www. joghr. org/....

with the opposition of multinational corporations, which demand more stringent patent protections as a precondition for creating innovation. Recommendations for Policy Reform:

1. Relaxation of Provision on Compulsory Licensing: India must further relax its compulsive

licensing norms so that generics can flow into the market when public health emergencies necessitate so.

2. Generic Manufacturing Incentive Policies: Encouraging domestic manufacturing of generics

can also ensure that medicines remain affordable. It includes various tax benefits and subsidies provided to local manufacturers.

3. Stimulating Collaboration with Research Institutes: Facilitating public-private partnerships

will spur neglected disease research and help to create a leveler playing field in the pharmaceutical industry.

4. Public Health Impact Assessment: The government can insist on an impact assessment

before patenting a new drug on the potential public health implications of the drug, striking a balance between the grant of patent protection and the need for access.

5. Advocacy for International Cooperation: India has long been an advocate for more elastic

international patent laws, particularly on matters of public health. India has raised its case about the appropriateness of balancing patent rights and public health concerns in the World Trade Organization and other international forums. India's efforts are all the more critical since other developing countries face similar challenges in accessing affordable medicines. International cooperation among developing nations might enable them to acquire greater bargaining power over such changes to global intellectual property rules, which would have more significance, especially in public health matters. Case Studies India’s response to patenting: Prior to the TRIPS, India's Patent Act of 1970 made it possible to manufacture generic drugs, which made drug prices plummet and made India the world leader in supplying cheap drugs,

including HIV, for these low-priced drugs. However, since India amended its laws in 2005 to comply with the TRIPS agreement, there is an increasing concern at the global level that this could also mean a curtailment of the cheap generics India was producing. The report points out that the Indian government responded to the effects by employing the flexibilities of TRIPS; thus, compulsory licensing ensured affordable medicines were available. While Indian pharmaceuticals maintained their leadership position in the domestic market, the new patent regime weighed upon them. Even though there is some evidence showing big companies have adapted by internationalizing and increasing their R&D, particularly on generics in developed markets, the overall performance of the smaller companies has been poor, with market concentration increasing and prices going up.

While politicians had promised that TRIPS would promote R&D for new drugs, the research shows that most Indian firms have fixated on the generic market instead of developing NCEs to meet local demand. More recently, larger companies have also made alliances with MNCs, but these are largely skewed in the interests of the MNCs at the expense of consumers. The conclusion reached in the study is that India did relatively well in the post-TRIPS regime but that the R&D benefits of the TRIPS regime were minimal. There were recommendations for policy reforms for the effective preservation of India's role as a supplier of affordable medicines through compulsory licensing and rejection of TRIPS-plus measures5.

Lee Pharma vs Astrazeneca: Lee Pharma moved for a compulsory license under Section 84(1) of the Indian Patent Act over AstraZeneca's patent relating to the drugs, Saxagliptin®, prescribed for diabetes. The reasons for such a license were that the medicine was not available at an affordable price; it did not meet public demand, and there was no working of the invention within India. Key Grounds for Rejection:- Public Demand Not Proven: Lee Pharma could not prove that the reasonable demand of the public for Saxagliptin® was not met. They also were not able to provide comparative evidence

5 United Nations Development Programme, Five Years Into the Product Patent Regime: India’s Response

(2013), available at https://www.undp.org/india/publications/five-years-product-patent-regime-indias-response.

regarding the demand of the public for Saxagliptin® with other drugs for Type-II diabetes. Affordability Not Proved: The argument of the unaffordability of Saxagliptin could not be proved. It was noticed that the medicine cost was on par with similar ones for diabetes and did not establish their argument that it was not affordable. No Proof of Domestic Demand Necessity: Lee Pharma did not provide any details as to the domestic demand for Saxagliptin® in India. The applicant could not prove that local production is necessary. Therefore, the application for the grant of compulsory license was refused as Lee Pharma could not establish a prima facie case on any of the three premises provided in Section 84(1) Indian Patent Act6. The TB Drug Controversy: Tuberculosis continues to be a major public health issue in India.

The costly and mostly outof-reach patented drug “Bedaquiline” is available, though it is effective. Activists demanded increased production of generics as well as mandatory licensing in order for TB patients to be treated without the need to empty their pockets. The Case of HIV/AIDS Treatments: Global HIV/AIDS Epidemic to International Exposure and the India HIV/AIDS Epidemic Sharpens Access Issue The crisis in the HIV/AIDS epidemic globally would focus international and, more pertinent for India, national attention on issues of drug access. Treatment was unaffordable when generic ARVs were non-existent but hugely improved with affordable prices when Indian manufacturers like Cipla reduced them to affordable levels. The Indian response to the HIV/AIDS crisis highlights the role of generics in dealing with public health emergencies7.

6 Compulsory License: India, Kluwer Patent Blog (Aug. 16, 2021), available at

https://patentblog.kluweriplaw.com/2021/08/16/compulsory-license-india/. 7 National Informatics Centre, India Against AIDS: Aspiring for an AIDS-Free India, India.gov.in (Sept. 2021), available at https://www.india.gov.in/spotlight/india-against-aids-aspiring-aids-free-india.

Conclusion Issues relating to pharmaceutical patenting in India represent an excellent exercise in the intersection between public health and intellectual property which are not so simplistic, in that, while patents are an important engine of innovation, their use has to be balanced enough so as not to pose an access barrier to essential medications. Lessons from India's experience in compulsory licensing and the generic market have relevance to the balancing of these competing interests. It would allow the continued advocacy of policy by India for free access to medicines while creating an environment that supports innovation.