The patent on Novo Nordisk's semaglutide has expired in India, opening the way for cheaper generic versions of the drug. It belongs to the class of GLP-1 (Glucagon-Like Peptide-1) receptor agonists, which mimic the natural gut hormone GLP-1. These medicines regulate blood sugar, reduce appetite and promote weight loss by stimulating insulin release and slowing digestion.
Semaglutide, developed by the Danish company Novo Nordisk, is used to treat Type-2 diabetes and obesity. It improves blood glucose control, promotes weight loss and reduces the risk of cardiovascular complications. Before the patent expired, the high cost of branded versions limited access for many patients. India has over 10 crore people with diabetes and a rising obesity burden, and affordable generics can reduce treatment costs for them.
Patents on semaglutide have also expired in China, Brazil, Canada, South Africa and Turkey. These markets open the way for Indian exports of complex generics.
Making semaglutide also lets Indian companies move from small-molecule generics to complex peptide therapeutics and advanced drug-delivery systems. The domestic semaglutide market is projected to grow strongly. The Production Linked Incentive scheme for pharmaceuticals and medical devices supports investment in research and development, API manufacturing and high-value production.
A patent is an exclusive right granted by the government to an inventor for a novel invention for 20 years, in return for public disclosure. The holder alone can make, use, sell, offer for sale, license or import the invention. Once the patent expires or lapses for non-payment of renewal fees, it enters the public domain.
The Patents Act, 1970 replaced the 1911 law, introduced process patents for food and pharmaceuticals and strengthened compulsory licensing, which enabled the growth of India's generic drug industry. After India joined the WTO in 1995, the law was amended to comply with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). The 1999 amendment brought a mailbox system for product patent applications and exclusive marketing rights during the transition, and the 2002 amendment set the term at 20 years.
The Patents (Amendment) Act, 2005 introduced product patents and pre- and post-grant opposition. It also added Section 3(d), aimed at patent evergreening, the practice of seeking secondary patents on minor modifications such as new salt forms, dosages or formulations to delay generic entry. Under the provision, a new form of a known substance is not patentable unless it shows a significant enhancement in therapeutic efficacy.
The Tribunals Reforms Act, 2021 abolished the Intellectual Property Appellate Board and moved appellate jurisdiction to the High Courts. The Patents (Amendment) Rules, 2024 cut the timeline for a request for examination from 48 to 31 months, introduced a Certificate of Inventorship, reduced working statement filing to once every three years, streamlined opposition procedures and permitted divisional applications based on disclosures in the parent application.
When Pfizer's atorvastatin (Lipitor) lost its patent in 2011, Indian firms supplied generics to regulated markets and built a stronghold in the US and European cardiovascular segments. The 2012 expiries of clopidogrel (Plavix) and sildenafil (Viagra) let Indian manufacturers scale global volumes.
In 2013 the Imatinib Supreme Court judgment prevented evergreening of Novartis's leukaemia drug patent. That allowed domestic firms to produce generics legally and brought the annual treatment cost down from over USD 25,000. The base patents for sofosbuvir, a Hepatitis C drug, expired in 2025 after voluntary licensing, which further consolidated India's role as the "Pharmacy of the Developing World".
Rapid weight loss on GLP-1 drugs can have skin and hair effects. These include facial volume loss, popularly called "Ozempic face", and intertrigo, a friction-induced fungal or bacterial infection in loose skin. Telogen effluvium, a temporary hair shedding linked to the stress of rapid weight loss and nutritional deficits in protein, iron and B12, can also occur, as can brittle nails. Early clinical reports also suggest GLP-1 drugs have anti-inflammatory properties that may help in psoriasis and hidradenitis suppurativa, particularly where they coexist with metabolic syndrome.
With reference to the patent regime in India, consider the following statements:
Which of the statements given above are correct?
Consider the following statements:
Statement-I: The 2013 Imatinib Supreme Court judgment allowed Indian firms to produce generics of Novartis's leukaemia drug legally.
Statement-II: Section 3(d) provides that a new form of a known substance is not patentable unless it shows a significant enhancement in therapeutic efficacy.
Which one of the following is correct in respect of the above statements?
Identify the legal instrument on the basis of the following information:
