Curbing Patent Evergreening: Advancing Innovation and Health Equity for a Vikshit Bharat

As published in The Economic Times of April 27, 2025:  India’s Commerce and industry minister - “Piyush Goyal stated that India frequently receives requests to extend pharmaceutical patents for minor modifications. He criticized this practice, known as ‘evergreening,’ for prioritizing corporate profits over global healthcare access.

Against the above backdrop, I reckon, as India strides toward the goal of becoming a ‘Vikshit Bharat by 2047’, we must dismantle the hidden structural barriers that undermine self-reliance, stifle true innovation, and deny affordable healthcare to our people. One such barrier- largely invisible to the public yet devastating in its impact- is the global pharmaceutical industry’s misuse of patent evergreening.

This practice – where companies file successive, often trivial, secondary patents to extend monopolies on old drugs—chokes competition, delays biosimilars, and imposes crippling costs on patients and health systems. It is not innovation; it is legal manipulation.

India, through its bold and visionary Section 3(d) of the Patents Act, has stood almost alone in resisting this exploitation. But as pressures continues to mount from powerful trade lobbies and multinational corporations, India’s resolve is being tested.

Evergreening: Innovation’s Parasite?

The concept of evergreening is deceptively simple but deeply corrosive. When the primary patent on a blockbuster drug nears expiry, companies file dozens—or even hundreds – of minor patent claims on formulations, delivery methods, or metabolites. These “secondary patents” are designed not to protect new inventions, but to delay affordable alternatives.

Consider Humira, a biologic drug that should have gone off-patent in 2016. Through aggressive evergreening, its U.S. monopoly was extended until 2023, amassing over $240 billion in revenue—while millions of patients waited for cheaper biosimilars.

This is not an isolated case. ImatinibRituximabEnbrel, and many more biologics have seen similar fates in Western markets. These tactics have turned the global patent system into a tool for rent-seeking, rather than discovery.

If allowed unchecked, this model will undermine India’s biosimilar leadership, strain our healthcare budgets, and compromise our ambition to be a Vishwa Guru in inclusive, ethical innovation.

Section 3(d): Bharat’s Intellectual Firewall:

India’s response—crafted in the 2005 Patents Act and embodied in Section 3(d)—rejects trivial innovations from being patented. It is not anti-IP; it is pro-science, pro-accountability, and pro-Bharat.

This legal firewall has enabled Indian companies to launch biosimilars for some of the world’s most expensive biologics—at a fraction of global prices. It is why cancer patients in India don’t pay $100,000 a year for treatment. It is why generic drug diplomacy became India’s soft power during COVID-19.

Weakening Section 3(d), under global trade pressure or lobbying, would open the floodgates to evergreening in India—replacing our public health logic with corporate greed.

Vikshit Bharat Demands Patent Integrity in true sense:

To achieve the Vikshit Bharat vision, India must be both an innovation hub and a justice champion. This requires moral clarity and policy courage on the patent front.

  1. Make evergreening unprofitable: Reform examination practices, increase patent office scrutiny, and use AI to flag secondary patent abuse. No drug should get 20 more years of monopoly for marginal tweaks.
  2. Preserve Section 3(d) as a global model: Far from being “TRIPS non-compliant,” Section 3(d) should be exported to other nations. India can lead a coalition of countries in the Global South to challenge evergreening through WTO forums.
  3. Empower biosimilar innovation as strategic sector: Just as India leads in generic vaccines; we must become the world’s biosimilar leader. This is not just a market opportunity – it is a sovereignty imperative.
  4. Expose evergreening through transparency: Let public databases track all secondary patents filed, so regulators, researchers, and citizens can hold bad actors accountable.

The Moral Choice for Vikshit Bharat:

Evergreening is not merely a legal trick—it is a moral failing, where life-saving treatments are hoarded for profit. If Bharat is to be vikshit (developed) in the truest sense, then access to medicines cannot be a privilege—it must be a right.

By resisting evergreening, India is not rejecting innovation—it is defending its soul. It is declaring that patents are a means to progress, not tools of profiteering.

Let the world know: a Vikshit Bharat will not inherit broken systems—it will lead with better ones. And in doing so, it will set a new global gold standard for innovation with integrity.

Reclaiming Patent Integrity for Vikshit Bharat: Making Innovation Work for All:

As India marches toward Vikshit Bharat 2047, the vision of a developed, self-reliant nation hinges not just on economic growth, but on systems that are fair, future-ready, and aligned with national interest. Nowhere is this truer than in healthcare and pharmaceuticals—sectors critical to both public welfare and strategic sovereignty.

India has already earned global recognition as the “Pharmacy of the World” by supplying affordable generics and vaccines to over 200 countries. Yet, to fully realize the Vikshit Bharat vision, we must go further: from low-cost manufacturing to innovation leadership. This requires building an ecosystem where patent law rewards true invention without compromising access—a system that puts Janta (the people) and Jan Arogya (public health) at the center.

A Broken Global Model and India’s Course Correction:

The traditional model of pharmaceutical innovation is under stress. While patents were designed to incentivize breakthrough research, the global biopharma industry is increasingly plagued by “evergreening”—the strategic use of secondary patents to extend monopolies on blockbuster drugs long after their primary patents expire.

Section (3d) of the Indian Patents Act is not just a legal provision. It is a civilizational ethos: that science must serve society. That the gains of innovation should be shared, not hoarded. That Bharat’s development must include the last mile, the last person.

Patent Integrity Alongside Leadership in Ethical Regulation Are Pillars of Vikshit Bharat:

For India to become a global innovation hub under Vikshit Bharat, we must lead not only in discovery but in ethical regulation. There are three strategic imperatives:

  1. Safeguard India’s patent standards: Attempts to dilute Section 3(d) through trade pressure or lobbying must be firmly resisted. Weakening this clause would not attract innovation—it would enable exploitation. A Vikshit Bharat sets the rules, not follows them.
  2. Modernize our patent ecosystem: While the spirit of our law is sound, enforcement is uneven. Nearly 70% of drug patents granted in India are secondary in nature. We must invest in capacity-building at the Indian Patent Office, deploy AI-based scrutiny tools, and uphold transparency and scientific rigor in patent examination.
  1. Champion biosimilar access as global public good: With rising non-communicable diseases and biologics dominating pipelines, affordable biosimilars are critical to Jan Arogya. India has the scientific talent and manufacturing prowess to lead this space. But unless we protect our regulatory autonomy, we risk becoming dependent again—this time not for vaccines, but for cancer and autoimmune therapies.

A Message to Stakeholders: Innovation Must Serve Bharat:

To global pharmaceutical companies, Indian regulators, and policymakers: this is not a call to reject IP, but to restore its legitimacy. Secondary patents, when used as tools for revenue preservation rather than discovery, undermine public trust, delay life-saving access, and divert resources from genuine innovation.

The world is watching. As India negotiates trade agreements, leads the Global South, and shapes digital and health diplomacy, our stance on patent fairness will define not just our domestic health outcomes, but our moral authority on the world stage.

Conclusion: Building a Bharat That Heals and Leads:

Vikshit Bharat is not just an economic powerhouse—it is a nation where healthcare is affordableinnovation is inclusive, and laws reflect both wisdom and will. By defending the integrity of our patent regime and leading global reform on evergreening, India can prove that development does not mean adopting broken models—it means offering better ones.

Let India show the world that Atmanirbharta in healthcare is not just about making in India—it is about thinking for India, and leading for the world.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Balancing IPR with Public Health Interest: Brickbats, Power Play and Bouquets

It is now a widely accepted dictum that Intellectual Property Rights (IPR), especially pharma patents, help fostering innovation and is critical in meeting unmet needs of the patients.

However, the moot question still remains, what type pharmaceutical invention, should deserve market exclusivity or monopoly with overall freedom in pricing, keeping larger public health interest in mind.

In line with this thinking, for quite sometime a raging global debate has brought to the fore that there are quite a large number of patents on drug variants that offer not very significant value to the patients over the mother molecules, yet as expensive, if not more than the original ones. In common parlance these types of inventions are considered as ‘trivial incremental innovations’ and described as attempts to ‘evergreening’ the patents.

The terminology ‘evergreeningusually ‘refers to a strategy employed by many pharmaceutical companies to extend their market monopoly by slightly changing the existing molecules and obtaining new patents to continue to enjoy market exclusivity and pricing freedom, which otherwise would not have been possible.

Path breaking or jaw-drooping ‘W-O-W’ types of innovations are not so many. Thus most of the patented drugs launched globally over the last several decades are indeed some sort of ‘me-too drugs’ and generally considered as ‘low hanging fruits’ of R&D, not being able to offer significantly greater value to patients than already exiting ones. Many of these drugs have also achieved blockbuster status for the concerned companies, backed by high voltage marketing over a reasonably long period of time. It is understandable, therefore, that from pure business perspective why serious global efforts are being made to push the same contentious system in India too.

Example of some of these molecules (not necessarily in the written order), are as follows:

  • Cemetidine – Ranitidine – Famotidine – Nizatidine – Roxatidine (to treat Acid-peptic disease)
  • Simvastatin – Pravastatin – Lovastatin – Pitavastatin – Atorvastatin – Fluvastatin – Rosuvastatin (to treat blood lipid disorder)
  • Captopril – Enalepril – Lisinopril – Fosinopril – Benzapril – Perindopril – Ramipiril – Quinalapril – Zofenopril (Anti-hypertensives)

However, pharmaceutical companies do argue that such ‘incremental innovations’ are the bedrock for growth of the pharmaceutical industry and are essential to continue to fund pharmaceutical research and development.

An interesting paper:

A paper titled, “Pharmaceutical Innovation, Incremental Patenting and Compulsory Licensing” by Carlos M. Correa argued as follows:

  • Despite decline in the discovery of New Chemical Entities (NCEs) for pharmaceutical use, there has been significant proliferation of patents on products and processes that cover minor, incremental innovations.
  • A study conducted in five developing countries – Argentina, Brazil, Colombia, India and South Africa has:
  1. Evidenced a significant proliferation of ‘ever-greening’ pharmaceutical patents that    can block generic competition and thereby limit patients’ access to medicines.
  2. Found that both the nature of pharmaceutical learning and innovation and the interest of public health are best served in a framework where rigorous standards of inventive step are used to grant patents.
  3. Suggested that with the application of well-defined patentability standards, governments could avoid spending the political capital necessary to grant and sustain compulsory licenses/government use.
  4. Commented, if patent applications were correctly scrutinized, there would be no need to have recourse to CL measures.

A remarkable similarity with the Indian Patents Act:

The findings of the above study have a striking similarity with the Indian Patents Act. As per this Act, to be eligible for grant of patents in India, the pharmaceutical products must pass the ‘two-step’ acid test of:

  • Following the inventive stepDefined under Section 2(ja) of the Patents Act as follows:

“Inventive step” means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art.

  • Passing scrutiny of Section 3(d) of the law: It categorically states, inventions that are a mere “discovery” of a “new form” of a “known substance” and do not result in increased efficacy of that substance are not patentable.

Supreme Court of India clarifies it:

The Honorable Supreme Court of India in page 90 of its its landmark Glivec judgement has clearly pronounced that all ‘incremental innovations’ may not be trivial or frivolous in nature. However, only those ‘incremental innovations’, which will satisfy the requirements of both the above Sections of the Act, wherever applicable, will be eligible for grant of patents in India. 

An opposite view:

Another paper presents a different view altogether. It states that incremental improvements on existing drugs have great relevance to overall increases in the quality of healthcare.

With the progress of the pharmaceutical industry, such drugs have helped the physicians to treat diverse group of patients. They also represent advances in safety, efficacy along with newer dosing options significantly increasing patient compliance.

The paper claims that even from an economic standpoint, expanding drug classes represent the possibility of lower drug prices as competition between manufacturers is increased’.  It states that any policy aimed at curbing incremental innovation will ultimately lead to a reduction in the overall quality of existing drug classes and may ultimately curb the creation of novel drugs.

Pricing:

Experts, on the other hand, argue, if patents are granted to such ‘incremental innovations’ at all, their prices need to be determined by quantifying ‘Incremental Value’ that patients will derive out of these inventions as compared to the generic versions of respective original molecules.

Use of such drugs may lead to wasteful expenditure:

A large majority of stakeholders also highlight, though many of such drugs will have cheaper or generic alternatives, physicians are persuaded by the pharma players to prescribe higher cost patented medicines with the help of expensive avoidable marketing tools, leading to wasteful expenditure for all. The issue of affordability for these drugs is also being raised, especially, in the Indian context.

  • The ‘2012 Express Scripts Canada Drug Trend Report’ unfolded that the use of higher-cost medications without offering additional patient benefits resulted in waste of $3.9 billion annually in Canada.
  • Another recent Geneva-based study concluded as follows:

Evergreening strategies for follow-on drugs contribute to overall healthcare costs. It also implies that policies that encourage prescription of generic drugs could induce saving on healthcare expenditure. Healthcare providers and policymakers should be aware of the impact of evergreening strategies on overall healthcare costs.”

  • Some other studies reportedly revealed, “Medicines sold in France are 30 times more expensive than what it costs pharmaceutical companies pay to manufacture them.” Industry observers opine, if that is happening in France what about India? Quoting experts the same report comments, “If pharmaceutical companies are forced to follow moral and human values, it could save the tax payer at least 10 billion euros, an amount which could fill up the deficit of the national health care system.
  • Yet another article questioned, “What if a physician is paid speaking or consulting fees by a drug maker and then prescribes its medicine, even if there is no added benefit compared with cheaper alternatives?

More debate:

According to a paper titled, ‘Patented Drug Extension Strategies on Healthcare Spending: A Cost-Evaluation Analysis’ published by PLOS Medicine, European public health experts estimate that pharmaceutical companies have developed “evergreening” strategies to compete with generic medication after patent termination. These are usually slightly modified versions of the existing drugs.

Following are some brands, which were taken as examples for evergreening:

S.No.

Evergreen

Medical Condition

Original Brand

1.

Levocetirizine (Vozet) Allergies Cetirizine (Zyrtec)

2.

Escitalopram (Lexapro) Depression Citalopram (Celexa)

3.

Esomeprazole (Nexium) Acid reflux Omeprazole (Prilosec)

4.

Desloratadine (Clarinex) Allergies Loratadine (Claritan)

5.

Zolpidem Extended Release (Ambien CR) Insomnia Zolpidem (Ambien)

6.

Pregabalin (Lyrica) Seizures Gabapentin (Neurotonin)

Source: Medical Daily, June 4, 2013

In this study, the researchers calculated that evergreening – where pharmaceutical companies slightly modify a drug molecule to extend its patent, had cost an extra 30 million euros to the healthcare system in Geneva between 2000 and 2008. The authors argue that ‘evergreening’ strategies, “more euphemistically called as ‘life cycle management’ are sometimes questionable benefit to society.”

As the paper highlights, in this scenario the companies concerned rely on brand equity of the original molecule with newer and more innovative marketing campaigns to generate more prescriptions and incurring in that process expenses nearly twice as much on marketing than on research and development.

Brickbats:

In this context, recently a lawmaker rom America reportedly almost lambasted India as follows:

I’m very concerned with the deterioration in the environment for protection of US intellectual property rights and innovation in India. The government of India continues to take actions that make it very difficult for US innovative pharmaceutical companies to secure and enforce their patents in India.“ 

On this, the Indian experts comment, if the situation is so bad in India, why doesn’t  America get this dispute sorted out by lodging a formal complaint against India in the WTO, just as what India contemplated to do, when consignments of generic drugs of Indian manufacturers were confiscated at the European ports, alleging those are counterfeit medicines.

Yet another recent news item highlighted a “concerted effort, which involves letters from US corporations and business groups to the president, testimony by Obama administration officials before Congress, and lawmakers’ own critiques, came ahead of US secretary of state John Kerry’s trip to India later this month (has already taken place by now) for the annual strategic dialogue, which will precede Prime Minister Manmohan Singh’s visit to Washington DC in September.”

The report stated, the above letter complained that over the last year, “courts and policymakers in India have engaged in a persistent pattern of discrimination designed to benefit India’s business community at the expense of American jobs … Administrative and court rulings have repeatedly ignored internationally recognized rights — imposing arbitrary marketing restrictions on medical devices and denying, breaking, or revoking patents for nearly a dozen lifesaving medications.” 


At a recent Congressional hearing of the United States, a Congressman reportedly expressed his anger and called for taking actions against India by saying,

“Like all of you, my blood boils, when I hear that India is revoking and denying patents and granting compulsory licenses for cancer treatments or adopting local content requirements.”

Indian experts respond to these allegations by saying, patent disputes, patent challenges, revocation of patents, compulsory licensing etc. are all following a well-articulated judicial process of the country, where Indian government has hardly any role to play or intervene. American government and lawmakers are also expected to respect the rule of law in all such cases instead of trying to denigrate the Indian system.

The Power Play:

This short video clipping captures the Power Play in America on this matter.

The Government of India responds:

Ministry of Commerce and Industries of India reportedly countered the allegations of the United States over patents to the US Trade Representive arguing that the Indian IPR regime is fully TRIPS-compliant and Indian Patents Act “encourages genuine innovation by discouraging trivial, frivolous innovation, which leads to evergreening”.

Countries adopting the Indian model:

The above report also highlighted as follows:

  • Argentina has issued guidelines to reject ‘frivolous’ patents.
  • Peru, Columbia, other South American countries have placed curbs.
  • Philippines has similar provisions.
  • Australia is contemplating making the law tougher.

Revised report of Dr. R. A. Mashelkar Committee:

Even the revised (March 2009) ‘Report of the Technical Expert Group (TEG) on Patent Law Issues’, the TEG, chaired by the well-known scientist Dr. R.A. Mashelkar, in point number 5.30 of their report recommended as follows:

“Every effort must be made to prevent the practice of ‘evergreening’ often used by some of the pharma companies to unreasonably extend the life of the patent by making claims based sometimes on ‘trivial’ changes to the original patented product.  The Indian patent office has the full authority under law and practice to determine what is patentable and what would constitute only a trivial change with no significant additional improvements or inventive steps involving benefits.  Such authority should be used to prevent ‘evergreening’, rather than to introduce an arguable concept of ‘statutory exclusion’ of incremental innovations from the scope of patentability.”

Bouquets:

As stated above, many experts across the world believe, the criticism that Section 3 (d) is not TRIPS Agreement compliant is unfounded, as no such complaint has been lodged with the World Trade Organization (WTO) in this matter, thus far. The safeguards provided in the patent law of India will help the country to avoid similar issues now being faced by many countries. Importantly, neither does the section 3(d) stop all ‘incremental innovations’ in India.

Quoting a special adviser for health and development at South Centre, a think tank based in Geneva, Switzerland, a recent report indicated, “Many developing countries will follow India’s example to protect the rights of their populations to have access to essential medicines”.

Yet another report quoting an expert articulates, “India’s top court’s decision affirms India’s position and policy on defining how it defines inventions from a patenting point of view for its development needs. It challenges the patenting standards and practices of the developed countries which are the ones really in much need of reform.

The Honorable Supreme Court in its Glivec judgment has also confirmed that such safeguard provisions in the statute are expected to withstand the test of time to protect public health interest in India and do not introduce any form of unreasonable restrictions on patentability of drug inventions.

Conclusion:

Not withstanding the report of the US-India Business Council (USIBC) titled ‘The Value of Incremental Innovation: Benefits for Indian Patients and Indian Business’, arguing for abolition of section 3(d) of the Indian Patents Act to pave the way for patentability for all types of incremental innovations in pharmaceuticals, realistically it appears extremely challenging.

As the paper quoted first in this article suggests, denial of patents for inventions of dubious value extending effective patent period through additional patents, is a significant safeguard to protect public health interest. This statutory provision will also pave the way for quick introduction of generics on expiry of the original patent.

Taking all these developments into active consideration, keen industry watchers do believe, for every effort towards balancing IPR with Public Health Interest, both brickbats and bouquets will continue to be showered in varying proportion together with the mounting pressure of power play, especially from the developed world and still for some more time.

However, in India this critical balancing factor seems to have taken its root not just deep and strong, but in all probabilities - both politically and realistically, the law is now virtually irreversible, come what may.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.