Unmasking Evergreening: Navigating the Pharmaceutical Labyrinth
In the intricate landscape of pharmaceuticals, a term known as “evergreening” looms large. Evergreening is when patent owners stretch their exclusive rights through a web of secondary patents.1 The spotlight on this term intensifies in the pharmaceutical industry, where major players strategically fortify their patent portfolios, shackling the entry of more affordable generic alternatives.
Evergreening sustains the monopoly of pharmaceutical giants over their creations. It’s a calculated move, driven by the colossal investments these companies make in drug development. From a business standpoint, extended patent protection is a lucrative maneuver, ensuring a prolonged period of exclusivity, a competitive edge, and sustained profits.
However, when we shift our gaze to the realm of public health, the consequences are starkly different. The very strategy that secures profits for pharmaceutical companies becomes a barricade, obstructing access to affordable generic drugs. This leaves a segment of the population grappling with the financial burden of expensive treatments.
This blog delves into pharmaceutical evergreening, exploring the Novartis AG v Union of India case and the clash between intellectual property rights and public health policy. It discusses solutions, emphasizing the role of global south countries in countering evergreening practices. Evergreening is a term used to describe when patent owners extend their period of patent protection through other patents.2 This term is used in the pharmaceutical industry, where brand name manufacturers strategically aggregate and enforce multiple patents to burden generic entry.3
Evergreening maintains exclusive production and in some cases marketing rights for pharmaceutical companies over the drugs they create.4 The reasoning behind extending intellectual property (IP) rights is that pharmaceutical companies invest significant resources in developing drugs and prolonging their IP rights helps secure a return on that investment.5
However, when viewed through the lens of public health policy, the strategy of “evergreening” can be detrimental. This practice essentially blocks affordable generic alternatives, leaving some consumers unable to afford expensive drugs and treatments.6 This is because the patent duration prevents manufacturers from producing more affordable generic versions of branded drugs.
The cost gap between brand-name and generic drugs is evident. For instance, Novartis holds a patent for the leukaemia drug Gleevec. In India, the monthly treatment with the brand costs Rs 1,200,000, while the generic version is only Rs 8,000 to Rs 10,000, offering a more affordable alternative.7Evergreening in the pharmaceutical industry involves extending patent protection through non-inventive modifications, often resulting in minimal and non-innovative improvements.8 Take AbbVie’s case with their anti-inflammatory biologic drug, Humira, valued at approximately 40 million USD daily. AbbVie filed a staggering 247 patent applications related to Humira, with over 100 already granted.9 If uncontested, these patents could keep legal protection in place until 2034, well beyond three decades from the original patent expiration.10
Initially, when pharmaceutical companies secure patents, they obtain exclusive rights to produce specific drugs. Secondary patents, focusing on minor adjustments of the ‘active pharmaceutical ingredients,’ are then pursued, typically by the original patent holders.11 These secondary patents often involve minor changes, such as adjusting the delivery method or creating alternative formulations for the active pharmaceutical ingredient, all aimed at extending a monopoly for the drug.12
Additionally, pharmaceutical companies employ continuation and divisional applications to prolong patent protection. These applications enable the pursuit of additional claims based on the same invention, further extending the pending status of patent applications. This tactic hinders competition and limits the entry of generic alternatives.13
The Norvatis Case
The Supreme Court of India in the case of Norvatis AG v Union of India14 made a crucial decision by rejecting a patent application from Novartis, a Swiss pharmaceutical company. The application was turned down because the drug in question didn’t meet the inventive criteria. The slight modifications mentioned in the patent didn’t demonstrate any real therapeutic impact.15 This case vividly highlights the conflict between Intellectual Property rights and the imperative to safeguard public health.
India is recognized as the global pharmacy due to its effective production of high-quality medicines at reasonable prices. An example of this capability was evident during the COVID-19 pandemic when India exported 5.84 crore doses of COVID vaccines to 70 countries by March 2022.16 In 2005, India amended its Patent Act to align with TRIPS requirements, allowing for patents in the pharmaceutical sector.17 These amendments were made with the focus on keeping India as a low-cost drug manufacturer to tender to the global market. The amendments defined ‘new invention’ as any invention or technology not anticipated by publication and not in the public domain.18 Only technical advancements made to features of an invention qualify as inventive step.19 Trivial or insignificant changes to inventions do not qualify for patent qualification.20
In the Norvatis case, the primary patent known as the Zimmerman patent protected a medicine with anti-tumor properties, specifically Imatinib. Novartis applied for a patent over Imatinib Mesylate, a salt-based version. However, the Supreme Court ruled that claiming increased solubility, as in the secondary patent, wasn’t enough to meet the efficacy requirement in Section 3(d) of the Indian Patent Act.21
3. What are not inventions.—The following are not inventions within the meaning of this Act,—…(d) 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.22
The evidence submitted to the Supreme Court showed that Novartis’s patent application over Imanitib mesylate was for a known substance previously patented through the Unites States Patent Office. The previously known substance, Imatinib, already possessed the same therapeutic substance as its salt-based version. As both substances shared the same therapeutic qualities the Supreme Court found that the patent application was not innovative. The Court ruled that the salt-based version of the active pharmaceutical ingredient did not meet the efficacy test under Section 3(d) of the Indian Patents Act. The therapeutic effects were not more pronounced in the salt-based form, the only perceived additional benefit was its improved solubility.23
Way forward for the Global South
The legal case involving the Zimmerman patent and Novartis sheds light on the delicate balance between innovation, intellectual property rights, and public access to essential medicines. The court’s meticulous evaluation emphasized that the mere discovery of a new form of a known substance should contribute to the enhancement of its efficacy, reinforcing the importance of genuine advancements in pharmaceuticals. This scrutiny, exemplified in the assessment of Imatinib Mesylate, reflects India’s commitment to upholding the spirit of its patent laws, ensuring that granted patents genuinely promote advancements and benefit the public at large.
The situation outlined above reveals a conflict between public policy goals and patent rights. If patent rights are consistently extended, it prevents the production of more affordable generic drugs, negatively impacting patients. Notably, these patent rights are often granted to companies in wealthier regions (global north) who then market their products to less affluent regions (global south).24
To address the issue of extending patent rights, it is suggested that countries in the Global South adopt more rigorous standards for patent examination.25 To counter evergreening practices, there’s a proposed solution: urging patent offices to establish clear examination guidelines with stringent criteria. Additionally, continuous training and development for patent examiners are recommended.
This approach aligns with Article 27 of the TRIPS agreement, allowing World Trade Organization (WTO) member states to set high standards for patentability.26 Importantly, it permits members to exclude certain inventions from protection, providing a legal basis for countries to safeguard public interests and avoid unwarranted extensions of patent monopolies.
In conclusion, the Norvatis AG v Union of India case underscores the delicate balance between Intellectual Property rights and public health. The Supreme Court emphasized the need for genuine advancements in pharmaceuticals, rejecting Novartis’s patent for Imatinib Mesylate due to its insufficient therapeutic impact. This conflict between public policy goals and patent rights necessitates a balanced approach, urging the Global South to adopt rigorous patent examination standards to ensure a fair system that promotes innovation and accessibility to essential medicines.
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1 In patent law, there’s no official primary or secondary patent classification, but people often use these terms, especially in the pharmaceutical industry. Imagine a drug as a recipe, and the key ingredients have primary patents. As the drug gets developed further, new patents are filed for different things like the way it’s made, the dosage, or other forms. These extra patents are called secondary patents. They might come up when the drug is being tested in clinics and new uses or changes in the recipe are discovered. WIPO, Committee on Development on Intellectual Property (CDIP), 8 January 2015.
2 Debarchan De and Samuel K, ‘Evergreening of Patents: A Barrier to New Inventions, 22 Supremo Amicus, 2020, 252. Evergreening is also known as line extension, layering, stock piling, life cycle management or clustering).
3 Dinesan A, ‘Convergence of Competition Law and Patent Law: Dominant Position Monopoly and Evergreening of Patent, 3 Jus Corpus Law Journal, 2020, 558.
4 <Teva loses $2B gamble on generic of Pfizer’s Protonix | Fierce Pharma> accessed on 16 November 2023.
5 See Christie A & Studdert D.M, ‘Evidence of evergreening in secondary patenting of blockbuster drugs’, 44(2) Melbourne University Law Review, 2021 , 534. Example GSK spent 1,289,000,000 million USD between 1991 and 2008 in creating the compound Ranitide that is a drug used to treat obstructive airway diseases.
6 Debarchan D and Samuel K, ‘Evergreening of Patents: Barrier to New Inventions’, 242.
7 Novartis AG v Union of India and Others (2013), The Supreme Court of India para 86.
8 Novartis AG v Union of India and Others (2013), The Supreme Court of India para 88.
9 Hacochen Uri Y, ‘Evergreening at Risk’, 33 (2), Harvard Journal of Law and Technology, 2020, 487.
10 Hacochen Uri Y, ‘Evergreening at Risk’ 488.
11 Christie A & Studdert D.M, ‘Evidence of Evergreening in secondary patenting of blockbuster drugs’, 537.
12 Christie A & Studdert D.M, ‘Evidence of Evergreening in secondary patenting of blockbuster drugs’, 539.
13 Congressional Research Service, Patent ‘Evergreening’: Issues in Innovation and Competition, < *Patent “Evergreening”: Issues in Innovation and Competition (everycrsreport.com)> accessed on 11 January 2024.
14 Novartis AG v Union of India and Others (2013), The Supreme Court of India.
15 Novartis AG v Union of India and Others (2013), The Supreme Court of India.
16 <Why is India the Pharmacy of the World? – Health News | The Financial Express> accessed on 16 November 2023.
17 The Patents Act, (Act No 37 of 1970).
18 Section 2 (1) (l), The Patents (Amendment) Act.
19 Section 2 (1) (ja), The Patents (Amendment) Act.
20 Section 3 (d) (3), The Patents (Amendment) Act.
21 Section 3(d), The Patents Act, (Act No 37 of 1970).
22 Section 3(d), The Patents Act, (Act No 37 of 1970).
23 Novartis AG v Union of India (2013), The Supreme Court of India.
24 Dolmo Bess Carolina, ‘Examining Global Access to Essential Pharmaceuticals in the Face of Patent Protection Rights: The South African Example, 7, Buffalo Human Rights Law Review 2001, 138.
25 Ido V, ‘Good Pharmaceutical Patent Examination Promotes Access to Medicines: South Centre Side Event to the 64th WIPO Assemblies’, South Centre News, 29 September 2023. < SouthNews: Good Pharmaceutical Patent Examination Promotes Access to Medicines: South Centre Side Event to the 64th WIPO Assemblies (mailchi.mp)> accessed on 17 November 2023.
26 Article 27, Agreement on Trade-Related Aspects of Intellectual Property Rights.