India overhauls drug patent guidelines to curb evergreening and speed up cheap generics
NEW DELHI: India plans to overhaul its drug patent rules to stop pharmaceutical companies from evergreening patents through minor modifications and artificially extend market monopolies.
New draft guidelines issued by the Office of the Controller General of Patents, Designs and Trade Marks under the ministry of commerce and industry propose to set stricter evidentiary benchmarks to verify inventions and prevent patent extensions that delay generic versions.
The planned framework is significant for India’s $60 billion pharmaceutical industry, which accounts for a fifth of the world’s generic medicine supplies and ranks third globally by volume. Once a drug patent expires, the original manufacturer no longer holds a monopoly on the medicine, paving the way for other companies to make cheaper generic versions.
The updated 2014 guidelines require practical scientific proof of actual medical improvement instead of abstract descriptions.
Companies seeking patents on minor variations of known substances such as new salts, crystal structures, pure forms or derivatives must supply comparative research data showing a significant increase in therapeutic performance. Commercial advantages like longer shelf life, easier manufacturing or faster absorption won’t satisfy the legal standard for therapeutic efficacy unless supported by test data in living models proving superior disease treatment.
“It is necessary to prevent evergreening of patents and any measure that strengthens basic innovation and prevents evergreening is welcome. This will bring a balance between innovation and affordability, and innovation and access,” said Viranchi Shah, spokesperson of the Indian Drug Manufacturers’ Association.
Shah said that when India transitioned from process to product patents in 2005, robust safeguards were instituted under Section 3 (d) to limit patentability and bar small, incremental tweaks like minor salts or isomers. Globally, such minor changes have been used to indirectly prolong patent terms, he said.
A recent example is the patent for weight management and diabetes drug semaglutide, which was held by Novo Nordisk and expired in major markets including India, China and Brazil in March. This allowed Indian generic drug manufacturers Cipla, Sun Pharma and Dr. Reddy's Laboratories to produce low-cost generic versions.
In December 2025, Novo Nordisk attempted to block Indian rivals by relying on secondary patents for semaglutide. Indian drugmakers accused the company of unfairly stretching its monopoly and the Delhi high court allowed Dr. Reddy’s to make and export the medicine to countries where no patent is in place.
Semaglutide therapies Ozempic and Wegovy together accounted for two-thirds of Novo Nordisk’s revenue in 2025 – $19.2 billion from Ozempic sales and $11.95 billion from Wegovy, according to its annual report. With patented drugs commanding a large chunk of sales, some drug developers try to prolong their validity to delay the production of their generic versions.
In March 2025, the Delhi high court rejected Roche's request to block Natco Pharma from making a low-cost version of Risdiplam, used to treat spinal muscular atrophy. The court found merit in Natco’s argument that Roche’s patent was a minor tweak designed to prolong market control.
The updated Indian framework incorporates major court decisions delivered from 2013 to 2026 directly into routine examinations. To determine whether an invention is new, examiners must apply the Delhi high court's seven-pillar test, which requires evaluating claims on their own, without stitching together pieces from separate earlier publications.
Examiners must also use court-approved, multi-step tests as flexible guides rather than fixed formulas to determine whether an invention would have been obvious to a skilled technician without the benefit of hindsight.
“Standardized evaluations by examiners are key for a fair system,” said Dr Anant Bhan, a health researcher.
Dr Bhan said access to affordable medication must be kept in mind while deciding on and applying the new rules. Towards this, a comprehensive examination of the new draft rules and the applicability need scrutiny as these could impact drug production in India, especially for newer regulatory decisions, he said.
“In an attempt to bring in quality, consistency and uniformity, the office has introduced the guidelines for examination in certain key areas like pharmaceuticals. There is a need to update guidelines for examination of pharmaceutical patents with the objective that the guidelines shall help in improvement of the examination standard and shall introduce harmonious practice amongst the technical officers of the system,” the patent office said in the document.
The patent office is also curbing broad applications covering extensive chemical families, known as Markush claims. Applicants can no longer claim large groups of theoretical molecules without demonstrating how to synthesize and use them. Filings must disclose representative compounds, working preparation steps and biological test results or face refusal.
Under Section 3 (e), which stops companies from claiming patents on mere mixtures of known substances, combined drugs will be rejected unless clinical trials prove the ingredients produce a combined medical benefit greater than their individual actions.
Bans under Section 3 (i) will be strictly enforced on patenting medical, surgical or curative treatment methods, while allowing patents for physical diagnostic machines, instruments and screening kits. Additionally, biological ingredients require declared origins with deposited physical samples, and companies remain barred from expanding the scope of their original patent claims during appeals.
“I welcome stricter scrutiny to ensure protection is granted only to genuine inventions, not modifications extending monopolies,” said Nikkhil K Masurkar, CEO of Entod Pharmaceuticals, which specializes in making ophthalmic drugs. “However, patent protection alone is insufficient. I urge the government to introduce a robust Regulatory Data Protection framework that independently rewards companies investing in original clinical research and drug repurposing. Stricter patent standards and stronger regulatory protection for genuine innovation should go hand in hand without compromising patient access.”
Queries emailed to the patents office in New Delhi, the spokespersons of the health ministry and the commerce ministry and the Central Drugs Standard Control Organization on Tuesday remained unanswered.
Priyanka Sharma is a journalist at Mint, where she covers the Union Ministry of Health and the pharmaceutical industry. Her work focuses on explaining government policies and how they impact healthcare and the medicine market in India. With 12 years of experience in journalism, she has built a reputation for providing clear and honest news on important health topics that affect the entire country.<br><br>Her educational background includes a journalism degree from the prestigious Indian Institute of Mass Communication (IIMC) and specialized training in public health from the Public Health Foundation of India. Before her current role at Mint, Priyanka worked with India Today, The Pioneer, and ANI. She also served as a lead consultant for the National Health Authority, which gave her firsthand knowledge of how the government manages large-scale health programmes.<br><br>Priyanka is based in New Delhi and is an avid traveller who loves visiting the mountains. She has a great interest in regional flavours, particularly South Indian food.
Get Latest real-time updates
Catch all the Business News , Corporate news , Breaking News Events and Latest News Updates on Live Mint. Download The Mint News App to get Daily Market Updates.
More
✕
Wait for it…
Oops! Looks like you have exceeded the limit to bookmark the image. Remove some to bookmark this image.