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Mumbai: India’s Commerce Minister Piyush Goyal tells it like it is. Weeks after he exhorted Indian startups to work on genuine scientific innovations while drawing comparisons with China, Goyal criticised companies that reached out to him to allow incremental changes to their patents and extend the right of patent protection over a longer period. He said this is “evergreening,” adding it is sad that for super-normal profits of a select few companies and their shareholders, the world must suffer. From a Union Minister, that comes as one of the boldest statements in recent years. It assumes significance in the backdrop of the strident position taken by the US Trade Representative (USTR) on India’s laws related to intellectual property protection rights. The latest report of the USTR named India on its priority watch list, a signal of its concerns on behalf of the US companies that rely on patent protection for business growth. For years, the USTR’s position has not changed. Goyal’s statement against attempts of patent evergreening comes from a deeper perspective. In 2013, India’s Supreme Court pronounced a landmark verdict dismissing the claims of Swiss drugmaker Novartis for a product patent on its chronic myeloid leukaemia drug Gleevec. The court cited Section 3(d) of the Indian Patents Act that clearly dismissed grants of patent extensions for products (medicine) that were merely new forms of known substances and had no benefit of enhanced efficacy. The high-profile case sparked a global controversy. While it drew flak from several countries that steadfastly backed patent protection, on the other extreme, legal experts and public health agencies hailed the decision as one of the defining moments in the history of international patent laws. There are distinct reasons for that big divide. The US espouses strong IP laws as a reward or recognition for its innovation-based pharmaceutical and biotech industry. But that comes with a plethora of shortcomings. A few leading multinational companies have been granted patent extensions for several years, which not only deprived patients of their lifesaving medicines but also drained the US healthcare system of billions of dollars. Take AbbVie’s Humira (adalimumab), a hugely popular drug for autoimmune conditions like rheumatoid arthritis, psoriasis, ulcerative colitis, and Crohn’s disease. Humira was the first-ever drug to have crossed $20 billion in sales, making it the biggest blockbuster medicine before US-based Merck’s Keytruda took the crown. Although one of AbbVie’s first US patents had expired in 2016, its earliest biosimilar competition was launched in the US only in 2023. A deal was struck as part of a settlement of the patent dispute. Between 2001 and 2022, Humira had earned over $200 billion before a bunch of biosimilars trickled in. According to reports, AbbVie filed over 311 patents for the drug, also called a patent thicket. Of those, the US had granted 165 patents. There was little scope for competition. Similarly, Amgen’s earliest patents for blockbuster drug Enbrel (etanercept) were to expire in the US in 2012. Yet, in one of the most talked-about examples of patent evergreening, its drug has secured protection in the US until 2029. The irony is that while Amgen extended its own patents on Enbrel, it disputed certain patents of AbbVie’s Humira. Later, Amgen and AbbVie agreed to a settlement and delayed the biosimilar launch till 2023. These are just two of several glaring examples where the US patent laws have delayed cheaper versions of medicines and drawn flak from public health activists. The Indian patent laws, in contrast, are seen by many as carefully drafted to strike out claims of frivolous patents. As a sole exception, India used its compulsory licensing rights for Bayer’s kidney cancer drug Nexavar (sorafenib) on grounds of non-availability and affordability. That was another protracted legal fight that was based on strong merits. For Piyush Goyal, where global powers assert pressure, the fight against evergreening will get tougher. By Vikas Dandekar ,

New Delhi: An old controversial topic revolving around patents has been stirred up by Piyush Goyal , union minister for commerce and industries. ​​​Last week a news agency reported that while speaking at the World Health Summit Regional Meeting in New Delhi, the minister said, “I receive this request very often that we should also allow pharmaceutical companies the ability to have incremental changes to their patents and allow them to have a fresh patent for another long period of time. We normally understand that as evergreening of patents,” In 2013, Swiss drug maker Novartis suffered a major setback when India’s Supreme Court rejected its claims for a product patent on leukaemia drug Gleevec. The top court had cited Section 3(d) of the Indian Patent Act that clearly states mere use of new form of a known substance does not result in enhanced efficacy. The memories of that landmark verdict returned when Goyal dismissed using minor tweaks to extend patent protection of products. ​​​However, unlike the past criticism, this time some within the industry suggest that such tactics are not common and outright denial of secondary patent additions may turn out to be counterproductive for the country. "It is so sad that just for the supernatural profits of a select few companies and possibly their shareholders, the world has to suffer," he had added. Goyal’s views resonate with that of the position taken by large Indian drug makers. Drug companies as well as health activists had rallied against evergreen of patents on frivolous grounds. Some industry stakeholders defend that evergreening of patents is a rare practice in the country and attempts towards secondary patents are made to improve the product efficacy and is based on its scientific merit and therapeutic value. Speaking to ET Pharma, Kushal Suri, President - International Growth, Morepen Laboratories, voiced that, “It would be counterproductive to dismiss all secondary patents outright and every patent application — including those for incremental innovations — deserves a fair and thorough evaluation based on its scientific merit, therapeutic value. “ “Incrimental innovations offer real benefits to patients such as improved bioavailability, fewer side effects, enhanced compliance through modified-release formulations, or more effective combination therapies,” Suri added. “While the evergreening of patents does have an impact on patients but it is not a widely practiced phenomena,” RK Jain, Chairman, Confederation of Indian Pharmaceutical Industry (CIPI) told ET Pharma. Over the years a number of patients and their representative bodies have repeatedly voiced concerns over the availability and affordability of medicines and other pharmaceutical products. Many representatives have voiced concerns over the prices of patent protected drugs marketed by global MNCs and have urged respective policy makers to exercise the discretionary powers and allow companies to float their bioequivalent generics. Suri also agrees that patent extensions without meaningful therapeutic advancement should be discouraged, and focus should always remain on genuine innovation that delivers tangible value to patients. At the time of writing this story several other company spokespersons and industry stakeholders approached by ET Pharma were unavailable for comments. ​​​​In India, the patent system for drugs is governed by the ‘Patents Act, 1970’ under which a patent holder enjoys a product exclusivity of around 20 years, however Section 100 of the act allows the government to use patented inventions for government purposes meaning that it can use any invention for its purposes even after a patent is granted, by the competent authority. Strikingly, in its latest 'Intellectual Property Protection' report the United States Trade Representative (USTR) has put India on the "Priority Watch List" which includes those trading partners of the US who have insufficient IP protection or enforcement or actions that otherwise limit market access for persons relying on intellectual property protection. In this year’s Report, trading partners on the Priority Watch List present the most significant concerns this year regarding insufficient IP protection or enforcement or actions that otherwise limited market access for persons relying on intellectual property protection. The report has enlisted a total of eight countries on the “Priority Watch List” including India and will be “subject of particularly intense bilateral engagement during the coming year.” By Abhijeet Singh ,