Knowledge Nugget: Evergreening in Patents—Why Delhi HC’s semaglutide ruling matters for your UPSC exam

Key takeaways:

1. Novo Nordisk’s semaglutide products are covered by two main Indian patents. Indian Patent No. 275964 covers the composition of semaglutide itself. It was filed in March 2006, granted in September 2016, and expired in September 2024. Indian Patent No. 262697 covers specific formulations and delivery devices designed to improve stability and administration. It was filed in March 2007, granted in March 2014, and is scheduled to expire in March 2026.

2. The expiry of the basic composition patent in 2024 opened the door to potential generic development. However, the formulation patent remains in force and continues to confer exclusive rights on Novo Nordisk. In September, the Central Drugs Standard Control Organization (CDSCO) cleared DRL’s semaglutide injection for manufacturing, marketing, and export of the drug.

3. After this, Novo Nordisk filed a patent infringement suit in the Delhi HC alleging that DRL imported substantial quantities of semaglutide active pharmaceutical ingredient (API) and manufactured finished formulations without its permission, thereby infringing Indian Patent No. 262697. API is the chemical in a medicine that produces the intended therapeutic effect.

4. On the other hand, DRL’s patent revocation petition claimed that the second patent was for an analogue of the previously patent-protected product, and that it lacked novelty and inventive step.

5. In patent law, inventive step means that a patented creation must involve a creative leap beyond what an average expert could figure out from existing knowledge. DRL claimed that the tweaks made to the earlier compound would be “obvious” to anyone skilled in the domain, and thus should not be provided patent protection.

6. The court agreed with DRL’s assertion that there is no novelty in Novo Nordisk’s second GLP-1 formulation, and thus concluded that the company had obtained two patents for the same compound. This double patenting resulted in “evergreening”, the court said.

7. Evergreening involves drugmakers making only minor changes to an existing medicine and then seeking new patents. This does not reflect any significant innovation but prolongs a company’s monopoly over a drug and keeps low-cost generics out of the market.

8. India, along with Brazil, Thailand, and South Africa, is one of the few countries with laws against evergreening. The Indian Patent Act, as amended by the Patents (Amendment) Act 2005 under Section 3(d), states that drugs cannot be patented if they result from 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. Section 3(e) of the Act restricts patenting mixtures of known compounds unless a synergistic effect is proven, and Section 3(i) prevents patents on treatment methods.

9. The objective of patents is to encourage investment in drug development by offering 20 years of exclusive market access to its holder to recover their R&D investment. However, to extend exclusivity, patent holders indulge in patent evergreening, extending the period of a drug’s market monopoly. This allows them to block and delay the entry of generics and biosimilars, thus keeping prices high.

10. Patent evergreening poses a significant threat to public health by impacting the accessibility and affordability of essential medicines. While India’s legal framework aims to curb such practices, recent studies reveal that around 72 per cent of granted pharmaceutical patents are minor or secondary. The need for stronger scrutiny and opposition is obvious.

BEYOND THE NUGGET: Semaglutide

1. Semaglutide belongs to a new class of medicines called GLP-1 (glucagon-like peptide-1) receptor agonists. It is prescribed for the management of type-2 diabetes and obesity. It mimics certain naturally occurring gut hormones called incretins (GLP-1 is one such incretin) produced in the small intestine, and is hence also known as an incretin mimicker.

2. It works by improving the secretion of insulin that allows more of the glucose in the bloodstream to enter cells where it can be used for energy; inhibiting the secretion of the hormone glucagon that stimulates the liver to release stored glucose into the bloodstream; slowing down the emptying of the stomach so that the glucose levels in the bloodstream doesn’t spike; and reducing appetite by signalling to the brain that one is satiated.

3. In addition to the 15% average weight loss, trials with semaglutide have demonstrated its ability to reduce the risk of major cardiovascular events (such as heart attacks and strokes) by 20%, and the risk of all-cause mortality by 19%. Studies have shown a 69% reduction in heart failure events.

Post Read Question

Consider the following statements:

1. In India, evergreening is allowed in the case of medicines for rare diseases.

2. Biosimilars are prohibited in India.

Which of the statements mentioned above is/are correct?

(a) 1 and 2

(b) 1 only

(c) 2 only

(d) None

(Sources: Tweaks in drug formulations to extend copyrights is a public health challenge, Why Delhi HC rejected semaglutide patent suit, Knowledge Nugget of the day: Patent evergreening, How GLP-1 drugs like semaglutide have revolutionised obesity treatment)

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