Pharmaceutical Patents V Right To Health – Legal Remedies To Combat Evergreening In India
Author: LawSphereX
Category: Constitutional & Human Rights
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PHARMACEUTICAL PATENTS V RIGHT TO HEALTH –
LEGAL REMEDIES TO COMBAT EVERGREENING IN
INDIA
Sarferaaz Khaan, Master of Laws (Intellectual Property & Technology Law), National University of Singapore
ABSTRACT
Patents are vital for encouraging innovation, while their misuse through "evergreening"—a practice of extending patent monopolies by making minor modifications to existing drugs—poses a significant barrier to affordable healthcare. This paper examines the concept and methods of patent evergreening, particularly in the pharmaceutical sector, and its adverse impact on market competition and access to essential medicines in a developing country like India. Focusing on Section 3(d) of the Indian Patent Act, 1970, which serves as a statutory safeguard against evergreening, the paper critically analyses its interpretation, implementation, and compatibility with the TRIPS Agreement. Through a doctrinal and case-based analysis, especially the landmark Novartis AG v.
Union of India case, the study identifies key legislative and procedural gaps that enable pharmaceutical companies to circumvent the anti-evergreening provision. The paper also discusses the inadequacies in the Indian Patent Office's examination process and highlights the high error rate in granting secondary patents. In response, the research proposes concrete legislative reforms including the need for clearer definitions of "efficacy," a declaration mechanism for patent applicants, improved disclosure standards, and adoption of a standard checklist for identifying secondary patents. Additionally, the paper calls for updated examination guidelines that explicitly incorporate judicial principles established in the Novartis decision.
By strengthening India’s anti-evergreening framework, the study advocates for a balanced approach that protects both pharmaceutical innovation and public health. It concludes that India, by refining its legal stance, has the potential to set a global benchmark in ensuring that the right to health is not compromised by unchecked patent practices. Keywords: Patent evergreening, section 3(d), right to health, pharmaceutical patents, India
I. INTRODUCTION
According to Shirley Chisholm, "Health is a human right, not a privilege that can be purchased. " This implies that everyone's health is extremely important and that access to the necessary drugs is essential to that right, which is also a human right recognized by international law. Pharmaceutical patents, as intellectual property rights, also risk posing a significant threat to public health, especially in developing nations like India. Patents can promote pharmaceutical innovation but also increase market monopoly through "evergreening," preventing cheaper generic drugs from entering the market, increasing drug prices, affecting competition, and making essential treatments more difficult to obtain. With reference to section 3(d) of the Indian Patent Act, 1970, which aims to combat patent evergreening, India arguably has one of the most robust patent protection laws in the world.
However, the evergreening problem still needs to be resolved, particularly given India's enormous population. This paper aims to analyse the effects of patent evergreening on the availability of essential medicines and suggest significant reforms to the nation's patent laws, specifically to “Section 3(d) of the Indian Patent Act, 1970”, based on current legislation and practices, to understand how to maintain the right balance between the needs of the innovation process and the right to health. Hence, Part II of the paper examines what patent evergreening is and its methods. Part III looks at the obstacles posed by patent evergreening and the human rights viewpoint of it. Part IV explores India's current anti-patent evergreening legal landscape. In order to bolster India's opposition to patent evergreening, Part V makes significant legislative reforms for the Indian legal system.
The paper is concluded in Part VI.
II. PATENT EVERGREENING – CONCEPT AND PRACTICES
A patent is an exclusive privilege that the government grants to the creator of an invention. The
approach facilitates knowledge transmission through disclosure in an effort to strike a balance
between rewarding innovation and promoting development.1 For a restricted time (example,
20 years), the patent owner in the nation or area where the patent was issued has the sole
authority to forbid or prohibit anyone from using the protected invention for profit. A patent prevents an invention from being produced, used, imported, sold or otherwise used for profit without the owner's permission. The owner of the patent may file a lawsuit to seek remedies for patent infringement if third parties perform such actions without the owner's authorization. 2 Once the restricted time period of monopoly has ended, it facilitates the practice of the innovation by others. 3 Evergreening of patents The term "evergreening" describes a wide range of tactics used by patent holders to increase the privileged status that the patentee enjoys as a result of this exclusive right.
Evergreening is "artificially extending the life of a patent or other exclusivity by obtaining additional protections to extend the monopoly period," according to Robin Feldman, a professor of law at the University of California, College of Law. 4 Extending the patentee's privileged position during the base patent's protection period is the goal of evergreening. 5 Evergreening practices are prevalent in the pharmaceutical industry because of the potential financial gains from a successful patented medication. 6 Additionally, one or two of their blockbuster medications provide revenue for pharmaceutical corporations. These pharmaceutical corporations aim to maximize their profits after years of efforts into research and significant financial investments7.
However, as was previously noted, this kind of chance only lasts for 20 years before it becomes public knowledge and prices drastically drop. 8 For instance, after losing their patent monopolies, the prices of well-known anti-diabetics like Vildagliptin and Sitagliptin as well as cardiac medications like Valsartan have plummeted in
1 Gaurav Dwivedi et al., EVERGREENING: A DECEPTIVE DEVICE IN PATENT RIGHTS, 32 Technology in
Society 324 (2010).
2 Patents, WIPO https://www.wipo.int/en/web/patents. (Last visited: 4th March 2025, 10:57 PM).
3 Gaurav Dwivedi et al., supra note 1.
4 Robin Feldman, MAY YOUR DRUG PRICE BE EVERGREEN, 5 Journal of Law and the Biosciences 596
(2018).
5 Martina Tornvall, THE USE AND ABUSE OF PATENTS – EVERGREENING IN THE
PHARMACEUTICAL SECTOR, 38 (2013) (Master of Laws Thesis, Lund University).
6 Id.
7 Id.
8 Gaurav Dwivedi et al., supra note 1.
India in recent years. 9 Experts in the pharmaceutical sector note that generic medications may become available on the market once the patent expires, assisting in reducing healthcare costs and enhancing accessibility. As the cost per tablet decreases, the market moves toward a more reasonably priced medication that may be recommended to a wider range of patients. 10 But pharmaceutical corporations do not wish to appreciate this. Methods of Patent Evergreening Evergreening works best and is most profitable when used to safeguard pharmaceutical companies’ popular medications, which generate significant yearly profits. However, the increase in health outcomes is minimal or non-existent and these secondary patents obtained after the initial patents were modified, only meet very low requirements of creativity and ingenuity.
11 To show how prevalent patent evergreening is, I refer to a study published in December 2018. Robin Feldman examined every medication, published by the U. S FDA in a list of all approved drugs, that was sold between 2005 and 2015. 12 The findings highlighted that pharmaceutical corporations generally recycled and repurposed old medications instead of developing new ones. 78% of those linked to new patents were for already-approved medications rather than brand-new ones13. Changing a drug’s formulation from an immediate-release (IR) tablet to an extended-release (ER) version may secure a new patent. It can be marketed as an “improvement” by pharmaceutical companies and given a fresh patent. 14 Purdue Pharma's development of an extended-release version of OxyContin (oxycodone) resulted in the extension of its initial patent.
Similarly, companies can file new patents based on different strengths or dosages of an already 9 Times Of India, Sweet medicine: Price of drug going off patent to drop 50%, Times of India (May 13, 2023), https://timesofindia. indiatimes. com/business/india-business/sweet-medicine-price-of-drug-going-off-patent-todrop-50/articleshow/100196381. cms. (Last visited: 4th March 2025, 11:13 PM).
10 Id.
11 Harsha Agarwal & The Editorial Team, Secondary Patenting or Evergreening: Indian IP perspective,
Sagacius Research https://sagaciousresearch.com/blog/secondary-patenting-or-evergreening-india/. (Last visited: 4th March 2025, 11:17 PM).
12 Robin Feldman, supra note 4, at 617.
13 Id.
14 Nerella Srinivas, PATENT EVERGREENING IN PHARMACEUTICALS: IMPACT AND ETHICAL
CONSIDERATIONS, 14 International Journal of Intellectual Property Rights 34 (2024).
marketed drug. This could allow them to extent patent protection, even when the active ingredient and its formulation remain unchanged. 15 Professor Shuchi Midha of the SIES College of Management Studies (India) conducted an investigation of evergreening strategies. 16 The findings showed that the pharmaceutical companies in India often use the following evergreening methods: • “Superfluous modifications to a product that are then patented as a new application, such as redundant expansions and next-generation medication developments. A wellknown pharmaceutical business may submit patent applications covering multiple facets of the medicine, each of which may have a distinct expiration date, if it finds a novel chemical component to treat a specific illness.
When all of the listed patents expire, a generic medication business may start marketing products that use the same active ingredient. • Prior to the drug patent expiring, exclusive partnerships with the leading generic drug players in the market greatly increase the brand's value and generate royalties and keep generating royalties for their medicines. • Competitive activities or defensive pricing methods that allow innovative companies to maintain healthy competition with generic players. Innovative businesses have the option of lowering the product's pricing to match that of generic competitors or releasing better medications that outperform the generic competitors by a generation. • Prior to the emergence of competing generic competitors, the individual pioneering companies establish subsidiary entities in the generic arena.
Essentially, they follow three different approaches to get involved in the generics market and some of them combine more than one of these: o Approved Generics o Branded Generics for Emerging Markets
15 Id.
16 Shuchi Midha, STRATEGIES FOR DRUG PATENT EVER-GREENING IN THE PHARMACEUTICAL
INDUSTRY, 3 International Journal of Pharmaceutical Sciences and Business Management 11-24 (2015).
o Complete Generics Departments • When a "brand name" product patent and its associated exclusivity are about to expire, innovator companies begin directing patients' attention to the company's other products, namely a new branded product that is heavily promoted to both patients and physicians. This is known as brand migration and it is an alternative strategy used by innovator companies to extend their product life cycles and delay competition. ”17 Combination product launches are another evergreening tactic. In order to treat two concurrent ailments with a single medication, pharmaceutical companies are merging the threatened product with another branded medicinal product.
18 Thus, pharmaceutical companies are known to employ well-thought techniques to extend their patents, avoiding generic competition, rather than waiting for their patents to expire in order to maintain their monopolies and control. 19
III. IMPACTS OF PATENT EVERGREENING
The evergreening strategy used by drug companies has numerous negative effects on the market and society at large. An overview about the various impact levels caused by patent evergreening is provided below; Tussle between Pharmaceutical Companies and Generic Manufacturers As observed earlier, the pharmaceutical industry uses a patent system, mainly to encourage investment and the development of new medications. Few businesses would be prepared to risk a sizable investment without the guarantee of receiving a patent because R&D expenses can be very high.20 Generics are permitted to hit the market as soon as a biological drug's patent protection ends. They frequently have to entice customers by entering the market at a price that is far lower than the reference medicine because they are in competition with it.21 Due to health
17 Id.
18 Id.
19 Gaurav Dwivedi et al., supra note 1, at 325.
20 Ghyli Kirshner et al., THE IMPACT OF AN ‘EVERGREENING’ STRATEGY NEARING PATENT
EXPIRATION ON THE UPTAKE OF BIOSIMILARS AND PUBLIC HEALTHCARE COSTS: A CASE
STUDY ON THE INTRODUCTION OF A SECOND ADMINISTRATION FORM OF TRASTUZUMAB IN
THE NETHERLANDS, 25 The European Journal of Health Economics 1148 (2024).
21 Id.
care costs, many Indian households are below the poverty level. 22 One of the elements causing the issue of access to medications is the cost of pharmaceuticals. 23 The secret to reasonably priced medications is competition from generic businesses. Indian generic companies are able to produce medications at some of the lowest prices in the world. 24 Given this situation, I believe that pharmaceutical corporations' use of patent evergreening tactics seriously impairs people's ability to obtain necessary medications by preventing generic medications from entering the market. Issues with Access to Essential Medicines As was previously noted, pharmaceutical patents' evergreening methods contribute to the high cost of medications. Particularly in developing nations, this has been criticized as a violation of the right to health.
25 Marginalized communities and those with lower means are disproportionately affected by this, as they may be more inclined to restrict or forego prescriptions because of their high cost. 26 Exorbitant costs hinder efforts to get universal health coverage and restrict access to necessary medications in low and middle-income nations. A key element of the right to health is the availability of medications, and exorbitant drug costs may prevent this right from being realized. 27 This is also followed by arguments advancing human rights issues. Accordingly, the “WHO's Report of the Commission on Intellectual Property Rights, Innovation, and Public Health” emphasizes the significance of access to medicines by pointing out that innovation is only meaningful when people can access its outcomes, which is obviously not the case when medications are priced out of reach of those who need them.
28 Intellectual Property & Human Rights Perspective Patenting, in the first place, of life-saving medications has always resulted in a monopoly. It symbolizes two sides of a single coin. Innovation, R&D, patents and the development and
22 Prof K Srinath Reddy et al., TOWARDS ACHIEVEMENT OF UNIVERSAL HEALTH CARE IN INDIA BY
2020: A CALL TO ACTION, 377 The Lancet 761 (2011).
23 Id.
24 Anand Grover & Brian Citro, INDIA: ACCESS TO AFFORDABLE DRUGS AND THE RIGHT TO
HEALTH, 377 The Lancet 976 (2011).
25 Brian I, The Dark Side of Medicine: Exposing Human Rights Abuses in the Pharmaceutical Industry,
LinkedIn (Feb. 23, 2023), https://www.linkedin.com/pulse/dark-side-medicine-exposing-human-rights-abusesiselin-/. (Last visited: 5th March 2025, 12:27 PM).
26 Id.
27 Id.
28 Ellen, PUBLIC HEALTH, INNOVATION AND INTELLECTUAL PROPERTY RIGHTS: REPORT OF THE
COMMISSION ON INTELLECTUAL PROPERTY RIGHTS, INNOVATION AND PUBLIC HEALTH, 84
Bulletin of the World Health Organization 421 (2006).
promotion of new industries are all viewed favourably from an economic perspective. 29 However, patents are seen as a negative restraint when talking about human rights, especially the right to health and access to medications. This is especially problematic in developing nations, where people frequently pay cash for medications that are protected by patents rather than through insurance or social security. 30 The most obvious structural violence committed by the international intellectual property system is the detrimental impact that stringent patents have on life-saving medications. 31 The injustice of permitting millions of avoidable deaths in the name of safeguarding powerful pharmaceutical companies is evident even to those who are not familiar with the specifics of patent law.
32 My argument over here is, while this situation exists, evergreening of patents just adds fuel to the burning fire. Evergreening activities could therefore have an impact on market competitiveness, hinder the entry of generics into the market, endanger the patent system, limit access to necessary medications, particularly in developing nations, and raise human rights issues.
IV. PATENTS AND EVERGREENING - EXISTING LEGAL FRAMEWORK IN
INDIA
Analysis of Section 3(d) of the Indian Patent Act 1970 According to S.3(d) of the Indian Patent Act of 1970 33, enhancements alone are not patentable unless they produce a novel material. The following describes the nature and meaning of the specific provision: Section 3(d) prohibits the simple use of a known process, machine, or apparatus unless it produces a new product or uses at least one new reactant, or the simple discovery of a new form of a known substance that does not increase that substance's efficacy, or the mere discovery of any new property or new use for a known substance.34 Further
29 Amishi Jain & Natasha Mittal, FROM PATENTS TO PATIENTS: EXPLORING THE NEXUS OF
INTELLECTUAL PROPERTY RIGHTS AND HUMAN RIGHTS IN GLOBAL HEALTHCARE, Jindal Forum for International and Economic Laws (July 13, 2024), https://jindalforinteconlaws.in/2024/07/13/from-patentsto-patients-exploring-the-nexus-of-intellectual-property-rights-and-human-rights-in-global-healthcare/. (Last visited: 5th March 2025, 12:39 PM).
30 Ellen ’T Hoen, PRIVATE PATENTS AND PUBLIC HEALTH: CHANGING INTELLECTUAL PROPERTY
RULES FOR ACCESS TO MEDICINES 4 (1st ed. 2016).
31 Zachary A Hale, PATENTLY UNFAIR: THE TENSIONS BETWEEN HUMAN RIGHTS AND
INTELLECTUAL PROPERTY PROTECTION, 7 The Arkansas Journal of Social Change and Public Service (2018).
32 Id.
33 The Patents Act, 1970 § 3(d), Act No.39, Acts of Parliament, 1970 (India).
34 Kriti Singh, CRITICAL ANALYSIS OF SECTION 3(D) OF INDIAN PATENT ACT, 1970, 3 International
Journal of Multidisciplinary Trends 74 (2021).
explanation was added in the amendment Act of 2005; “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. ” "Salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations, and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy”.
35 In a recent appeal case in the Madras High Court, Justice Senthilkumar Ramamoorthy analysed the contents of Section 3(d) and noted that the disjunctive "or" separates the roughly three limbs that make up the major clause of Section 3(d). The three limbs are as follows, in his opinion. i. “The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance ii. The mere discovery of any new property or new use for a known substance iii. Of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. ”36 Before moving any further, it is necessary to understand the terms “mere discovery”, “known substance” and “efficacy” placed in the provision. The expression “discovery” has not been characterized in any section of the Indian Patent act.
As per the Webster’s Third International Dictionary of the English language, the expression “discovery” alludes to the demonstration, procedure or an occasion of picking up learning or of discovering the presence of something beforehand obscure or unrecognized. 37
35 Ministry of Commerce & Industry, The Patents (Amendment) Bill 2005 passed by Indian Parliament,
Embassy of India https://www.indianembassyusa.gov.in/ArchivesDetails?id=598. (Last visited: 5th March 2025, 1:01 PM).
36 Novozymes v. Assistant Controller of Patents & Designs, (T) CMA (PT) No.33 of 2023
(OA/6/2017/PT/CHN), Para 12. 37 Definition of DISCOVERY, Merriam-Webster (Feb. 24, 2025), https://www.merriamwebster.com/dictionary/discovery. (Last visited: 5th March 2025, 1:06 PM).
The expansion of the term "new form" and the classification of several kinds of elements that are considered to be the "same substance" are both fully outlined in the clarification to S. 3(d). 38 In this way, the new kinds of known substances should be considered unpatentable simply because they don't show any "enhanced efficacy" or, to put it another way, don't differ in any way in terms of efficacy. Section 3(d) makes it clear that new types of known substances are allowed to be patented when they differ completely in terms of their efficacy. 39 Section 3(d) is the provision in the Indian Patent Act, which places itself directly against patent evergreening.
As observed earlier, patents can be acquired for new applications of a wellknown medication, as well as for reduced dosage formulations, new production or administration techniques and ultimately try to extend the duration by an extra 20 years for different features of the same drug, before the original patent expires. 40 At its root, the development of a novel form of a recognized substance is not protected by Section 3(d) unless it improves the original substance's efficacy. Because it stipulates that the simple discovery of any new property or new use of a known material would not be patentable, it also serves as a bar against new use patents. 41 Principles established in the Novartis decision The court's decision to reject Novartis' patent application is a great illustration of an evergreening approach. Imatinib's core patent (GLEEVEC) was first submitted in 1992.
Novartis contended before the Supreme Court that it created a second invention, the specific medication salt (mesylate), subsequent to creating imatinib. 42 The Supreme Court found that the mesylate salt of imatinib was already covered by the original patent. 43 The Novartis case also offers a great illustration of the issues with medicine access caused by the patent system and some of its drawbacks as a catalyst for innovation. In order to overcome the objections under Section 3(d), the Supreme Court established a
38 Kriti Singh, supra note 34.
39 Id.
40 Law Teacher, The Need for Section 3(D) of the Indian Patents Act, Law Teacher (Aug. 31, 2021),
https://www.lawteacher.net/free-law-essays/commercial-law/section-3-of-the-indian-patents-act-commerciallaw-essay.php. (Last visited: 5th March 2025, 1:10 PM).
41 Id.
42 Carlos M Correa, The Novartis Decision by India’s Supreme Court: A Good Outcome for Public Health, South Bulletin (Oct. 7, 2013), https://www.southcentre.int/question/the-novartis-decision-by-indias-supremecourt-a-good-outcome-for-public-health/. (Last visited: 5th March 2025, 1:13 PM).
43 Id.
number of principles. The court set these principles while sustaining the IPO's ruling to deny Novartis' patent application. They were established as part of the Supreme Court’s decision in Novartis AG v. Union of India; 44 • “Determining the novel form of the well-known material and its pharmacological characteristics, including effectiveness (Paras 157, 160, 161) • Comparing the novel version of the recognized substance with its pharmacological characteristics (Para. 163) • Establishing comparative data on improved efficacy in affidavits or in the patent application itself (Para. 171) • Not taking into account “more beneficial flow properties” or other physio-chemical characteristics when evaluating treatment efficacy (Paras. 173, 187) • Only therapeutic efficacy which must be evaluated rigorously and precisely, can be used as an efficacy test for medications (Para.
180) • The application must explicitly state and provide evidence of the increased treatment of efficacy (Paras. 189) • In addition to demonstrating that the patent application is an “invention” and includes an “inventive step”, the test of enhanced efficacy need be demonstrated for patents covering novel forms of well-known chemicals and pharmaceuticals (Para. 192)” As a result, it is known that India acknowledged the necessity to both limit the evergreening of patents and provide patent protection for incremental breakthroughs following the Supreme Court's ruling in the Novartis case. Indian courts have successfully granted temporary injunctions to safeguard patent holders' rights to medicinal technologies since Novartis.
45 In the Novartis decision, the Madras High Court's ruling, which dismissed the appellant's writ petitions contesting the constitutionality of section 3(d), was also cited by the Intellectual
44 AIR 2013 SC 1311
45 World Intellectual Property Organization, AN INTERNATIONAL GUIDE TO PATENT CASE
MANAGEMENT FOR JUDGES 250 (1st ed. 2023).
Property Appellate Board (IPAB). The High Court noted: “We have borne in mind the object which the amending Act wanted to achieve namely, to prevent evergreening; to provide easy access to the citizens of the country to life saving drugs and to discharge their constitutional obligation of providing good health care to its citizens. ”46 The impact of the Novartis standard developed by the Supreme Court would mean that the applicants might not be able to prove therapeutic efficacy at the IPO, even though the court maintains that section 3(d) does not prohibit patent protection for all incremental inventions of chemicals and pharmaceutical substances. 47 It is evident from the aforementioned rulings as well that the IPO only takes clinical trial data into account when determining whether drugs have increased therapeutic efficacy.
Consequently, candidates will find it more difficult to get past section 3(d). Section 3(d) and the TRIPS Agreement In the 2013 Supreme Court of India case Novartis AG v. Union of India48, the petitioner also contested the legality of section 3(d) before the Madras High Court, arguing that it is unlawful because it ignores TRIPS provisions and the Indian Patent Act does not define the term "efficacy" and grants the controller unrestricted authority, making it discretionary, arbitrary, and ambiguous. 49 Regarding the first contention, the court determined that the WTO's dispute settlement provides a complete dispute system and the exclusive remedy for violations of the TRIPS Agreement. After looking into the dispute between domestic and international law, the High Court decided that domestic law would take precedence.
50 Whether Section 3(d) is consistent with TRIPS, is not necessary to be considered here in my opinion because, each country is free to set up its own standards of patentability as long as it conforms to the TRIPS Agreement, under Article 1. 151. Furthermore, by demanding a higher level of patentability, it can be argued that Section 3(d) discriminates against pharmaceutical patents. However, a WTO panel ruled in a prior dispute against Canada that Article 27 of the TRIPS Agreement does not forbid differential treatment to address issues that might arise in
46 Novartis AG v. Union of India AIR (2013) SC 1311, Para 18.
47 Novartis AG v. Union of India AIR (2013) SC 1311, Para 191.
48 (2007) 4 MLJ 1153.
49 Kriti Singh, supra note 34, at 75
50 Id.
51 WTO, URUGUAY ROUND AGREEMENT: TRIPS, World Trade Organization
https://www.wto.org/english/docs_e/legal_e/27-trips_03_e.htm. (Last visited: 5th March 2025, 1:38 PM).
certain product areas.52 By the way, India has implemented Section 3(d) to address the issue of evergreening patents, which is a common concern in the pharmaceutical industry. Therefore, it is improbable that Section 3(d) violates the TRIPS Agreement.
V. LEGISLATIVE REFORMS FOR INDIA’S ANTI-EVERGREENING STANCE
India has likely one of the strictest patent laws in the world, with all of the noted legislative positions it has adopted, particularly under Section 3(d) of the Indian Patent Act 1970, which directly opposes the practice of evergreening. Through Section 3(d), it is established that India's strategy places a high priority on public health and affordable medication access while attempting to strike a balance between the necessity of innovation and the requirement for accessible healthcare. 53 I believe that some gaps in the position need to be addressed with additional regulations in order to make it more complete. Where do the existing gaps lie? Before rushing into suggesting legislative reforms for a system which is already one of the strictest out there, it is necessary to understand where exactly do the gaps lie in this robust framework.
Although section 3(d) is compatible with the TRIPS agreement, it has also been understood that the wording is insufficiently clear in relation to the relevant clause. The definition and extent of “enhanced efficacy” are not explicitly defined in the act, nor are there any norms or standards to that effect. 54 According to a 2018 field investigation by a team of scientists, professors, and IP specialists, India's Patent Office has granted a large number of pharmaceutical patents while being utterly negligent in implementing the safeguards. 55 It also showed that secondary patents, which were awarded for slight enhancements to previously known medications for which main patents already exist, make up the majority of pharmaceutical patents. The report demonstrates why the system has to be changed and how the opposition to evergreening was feeble. 56
52 DS114 Canada – Patent Protection of Pharmaceutical Products, 2000, 171
https://www.wto.org/english/tratop_e/dispu_e/cases_e/ds114_e.htm (Last visited: 5th March 2025, 1:48 PM).
53 Keshav Mittal & Shrey Shah, PATENT EVERGREENING LAWS IN INDIA VS USA, SSRN (2024).
54 Kriti Singh, supra note 34, at 76.
55 Latha Jishnu, Evergreening rampant in India, Down To Earth (June 19, 2018),
https://www.downtoearth.org.in/economy/evergreening-rampant-in-india-60894. (Last visited: 5th March 2025, 1:55 PM).
56 Id.
All of India's patent awards from 1995 to 2016 were identified and considered by the researchers. Further analysis revealed that the Indian Patent Office (IPO), had a 72% mistake rate when it comes to approved pharmaceutical applications. 57 As a result of overcoming antievergreening and other rejections that the IPO could raise, 1654 secondary patents were issued. This translates to a 72% mistake rate across secondary patents, of which 1206 were awarded for formulations/compositions, 297 for combinations, 88 for physical variations, applications, salts, isomers, enantiomers, and prodrugs, and 63 for a treatment technique. It was therefore implied by the results that all secondary pharmaceutical patents issued during the specified time frame most certainly violated Section 3(d) requirements.
The majority of patent applicants had failed to meet the Novartis case's barrier or the IPO's previous rulings' threshold, meaning that all of those patents were dubious or flawed and should not have been awarded in the first place. 58 This suggests that even in the post-Novartis era, the anti-evergreening regulations still have issues with how "enhanced efficacy" is defined and interpreted, the Indian Patent Office's inefficient operations and pharmaceutical patents' ability to circumvent the Novartis principles with some effort. Suitable reforms to address the gaps The field of definitions and interpretations should be examined first, as I feel that it could be a crucial step in addressing the gaps. The terms invention, inventive steps, and industrial application are not defined in Article 27. 1 of the TRIPS Agreement.
59 By that way, it can be said that there is nothing to stop Section 3(d) from utilizing an "efficacy" requirement in the absence of a clear definition of patentability. 60 The reason for this is because phrases like "enhanced therapeutic efficacy" and "differ significantly in properties with regard to efficacy" are not attempted to be defined by the Indian Patent Act of 1970. An incorrect understanding of the compounds that qualify for patent protection has resulted from the absence of definitions and guidelines for these terms as well
57 Feroz Ali et al., PHARMACEUTICAL PATENT GRANTS IN INDIA: HOW OUR SAFEGUARDS
AGAINST EVERGREENING HAVE FAILED, AND WHY THE SYSTEM MUST BE REFORMED,
Accessibsa 32 (2018).
58 Id.
59 WTO, URUGUAY ROUND AGREEMENT: TRIPS, World Trade Organization.
60 Kriti Singh, supra note 34, at 76.
as the process for determining efficacy. 61 Although there was a chance to interpret section 3(d) of the Act even in the Novartis case, the judgment's main focus was on the word "efficacy”. 62 There is another way to look at it. The Indian Patent Office's interpretation of Section 3(d) now focuses on direct evidence for improving the drugs' efficacy, which is a valid point to address when it comes to pharmaceutical patents. Furthermore, the current explanation adopted under section 3(d) is derived from the definition of “generic medicinal product” under “Directive 2001/83/EC if the European Parliament”. 63 Automatically, it becomes necessary to make an interpretation of section 3(d) pertaining to the scope and intent of the Directive of the European Parliament, in the first place.
64 According to “Directive 2001/83/EC's Part II, Annex 1”, generic drugs must have the same therapeutic component as the novel drug. The substance will be regarded as a new active substance if such is not the case. Derivatives that differ in their therapeutic moiety, have uncertain efficacy, or have markedly different enhanced or decreased recognized efficacy are not deemed generic substances under the Directive, which views derivatives as generic drugs. 65 But it's also critical to think about what might make two substances different in terms of efficacy. The European Medicines Agency suggests that significant adjustments can made to the frequency of dosing, demonstrating clinically significant modifications, improving the drug's suitability for widespread patient use, reducing the amount of time needed for pain relief, lowering death rates, and so on.
66 Based on these suggestions, section 3(d) of the Patent Act 1970 can be broadened to include the definitions and interpretations relating to “enhanced efficacy”. Furthermore, thresholds can be placed on what and what does not constitute efficacy. I think the rationale behind this could be to limit the possible number of interpretations with regards to “enhanced efficacy”. 61 Naresh Asuri, Proper Interpretation of Section 3(d) of the Indian Patent Act Could Save Incremental Innovations of Existing Pharmaceutical Substances, IP Watchdog (June 22, 2019), https://ipwatchdog. com/2019/06/22/proper-interpretation-section-3d-indian-patent-act-save-incrementalinnovations-existing-pharmaceutical-substances/id=110581/. (Last visited: 5th March 2025, 2:03 PM).
62 Id.
63 Article 10.2.b, DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
(2001).
64 Naresh Asuri, supra note 62.
65 DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL (2001).
66 Committee for Medicinal Products for Human Use, REFLECTION PAPER ON CONSIDERATIONS GIVEN
TO DESIGNATION OF A SINGLE STEREO ISOMERIC FORM (ENANTIOMER), A COMPLEX, A
DERIVATIVE, OR A DIFFERENT SALT OR ESTER AS NEW ACTIVE SUBSTANCE IN RELATION TO
THE RELEVANT REFERENCE ACTIVE SUBSTANCE, European Medicines Agency 4 (2012).
Pharmaceutical companies will automatically be trying their best to get a patent protection for their drug, by coming up with numerous interpretations – the scope of which can be subject to further scrutiny by patent offices or even courts, for that matter. But on the counter-side, given the growing number of new illnesses and medical problems, imposing a rigid interpretation method may also have the unintended consequence of stifling innovation. For instance, COVID-19 was completely unexpected, which necessitated the urgent need for novel medicines and vaccines. Thus, it is important to adopt definitions and interpretations in a balanced manner. A study attempted to “quantify” efficacy.67 The system discussed in Adams Respiratory
Therapeutics Inc. v. Perrigo Company68 is the only known pertinent quantification effort that pertains to the efficacy requirement in section 3(d), according to the study, which suggested that a new medication should only be deemed more effective if its difference from the old medication does not lie between “(-)20% and (+)25%”.69 Additionally, the study recommends establishing a benchmark (T) for efficacy based on earlier medications that received patent protection. Every patent application takes into account a number of efficacy criteria, which are subsequently given numerical values to create an efficacy score (E). Accordingly, a possible medication may be considered to pass the efficacy test under section 3(d) if its E is higher than
T value.70
I place a counter-argument here, that the "quantification" strategy requires a significant
investment in data gathering, compilation, analysis, and a vast amount of supporting evidence. Once a drug is awarded patent protection, it will not remain in labs for further testing; instead, it will be put on the market as soon as possible, allowing its manufacturers to profit from their investment. Pharmaceutical companies, for instance, can readily alter clinical trial data to ensure that their medication has the capacity to pass the quantification approach. Therefore, while it is a very apt approach towards making the “efficacy” part clear, more morally-oriented explanations and clarity are required for this endeavour. A checklist for identifying secondary patents can be used to ensure that the IPO runs flawlessly,
67 Aditya Kant, AN ATTEMPT AT QUANTIFICATION OF ‘EFFICACY’ FACTORS UNDER SECTION 3(D)
OF THE INDIAN PATENTS ACT, 18 Journal of Intellectual Property Rights 303-315 (2013).
68 616 F.3d 1283 (Fed. Cir. 2010).
69 Adams Resp. Therapeutics v. Perrigo Co., 616 F.3d 1283 (Fed. Cir. 2010).
70 Aditya Kant, supra note 68.
considering the error-rates observed above. There is no checklist for identifying secondary patents in the standard format used by the IPO to submit the First Examination Report (FER) to the patent applicant. 71 Any application suspected of secondary patenting may be subjected to a thorough examination at various stages. This could be accomplished by improving the disclosure requirements for applications that would be subject to the anti-evergreening provisions' wording. 72 By requiring the patent application to disclose that the claimed invention is for a secondary patent, the IPO will gain from an improved disclosure requirement for secondary patents (id). Here, I observe that, this places the burden of proof on the patent applicant itself i. e. , the pharmaceutical company to prove their drug’s patentability and also makes it difficult for them to run past section 3(d).
As part of section 3(d), I would also recommend adding a declaration mechanism that the patent applicant must complete. Pharmaceutical companies may be required under the declaration mechanism to attest that their proposed drug modification or efficacy does not aim to prolong the patent protection of a drug for which they currently hold a patent when they apply for patent protection. Shortly after the Novartis ruling, in 2014, the Indian Patent Office released the "Guidelines for Examination of Patent Applications in the field of pharmaceuticals. ". 73 These standards consider every potential facet of a patent award, from prior art inspection to industrial applicability, yet they totally overlook the necessity of an anti-evergreening guideline.
In order to create a strong foundation upon which the patent office can rely when processing patent applications, the rules ought to embrace the seven principles, that the Supreme Court of India adopted in the Novartis ruling. 74
VI. CONCLUSION
The paper makes it evident that patent evergreening remains as a problem when it comes to the intersection of intellectual property and human rights, more specifically, the right to health. It
71 Feroz Ali et al., supra note 57, at 37.
72 Id.
73 Office of the Controller General of Patents, GUIDELINES FOR EXAMINATION OF PATENT
APPLICATIONS IN THE FIELD OF PHARMACEUTICALS, (2014).
74 Feroz Ali et al., supra note 57, at 37.
demonstrated that evergreening practices not only affect healthy market competition but more than that, raise crucial concerns relating to the accessibility of medicines. Though the existing legal framework adopted by India stands tall among the efforts taken by various nations against evergreening practices, certain gaps were identified and appropriate recommendations were made to address those gaps, to make the framework complete and more robust, which makes it even more difficult for pharmaceutical companies to circumvent section 3(d) of the Indian Patent Act, 1970. Looking forward, India has a great potential to set a global precedent, by proving its position in the tussle against evergreening practices in the pharmaceutical industry.
In times where access to essential medicines by masses of population can mean almost a life and death situation, India’s position against evergreening should not be a policy consideration within the nation but as an international moral and legal obligation towards protecting public health.