India Prioritizes Life in Roche-Natco SMA Drug Patent Dispute

In the quiet, sterile rooms where doctors deliver life-changing news, hope and despair often arrive at the exact same moment. For the parents of a child diagnosed with Spinal Muscular Atrophy (SMA), the words land like a physical blow. They learn that their child has a devastating genetic disease, one that methodically destroys the nerve cells controlling muscles, making it progressively harder to crawl, walk, swallow, and eventually, even to breathe. For generations, this diagnosis was a death sentence, a one-way path of decline. Then, science delivered what can only be described as a miracle: a new class of drugs, including one called Risdiplam. This medication, which a child can take orally every day, promised not just to slow the disease but to halt its relentless march, offering a genuine chance at a life filled with movement and possibility. The initial wave of overwhelming relief, however, is almost immediately followed by a second, crushing wave of despair. 

The company Roche, which markets the drug under the brand name Evrysdi, set a price so astronomically high it feels like a cruel joke. The drug costs a staggering ₹70 to ₹140 lakh for a single year of treatment. For the vast majority of Indian families, this is not a number to be budgeted for; it is an impossible, insurmountable wall. Against this heartbreaking backdrop, a Supreme Court decision on October 17, 2025, resonated far beyond the confines of the courtroom. The court chose not to interfere in a patent dispute between Roche and Natco Pharma, an Indian company that makes affordable, generic medicines. By allowing a lower court’s decision to stand, the judges gave a green light for Natco to proceed with making its own version of the drug. In that moment, they didn't just rule on a complex legal matter; they cast a powerful, decisive vote for life. Natco plans to sell its version for under ₹7 lakh a year—still a formidable sum, but one that transforms an impossible fantasy into a tangible, life-altering possibility for countless families. This case is so much more than a corporate lawsuit. It is a profound moral referendum, forcing us as a society to ask a difficult but essential question: where, precisely, must we draw the line between a company’s right to profit and a human being’s fundamental right to be healthy? 

At the very center of this high-stakes legal battle lies a sophisticated but crucial argument about the true nature of invention. Roche’s claim to an exclusive monopoly on Risdiplam rests on what patent lawyers call a "genus" patent. To simplify this concept, imagine a company patents the broad, general idea of a "self-propelled vehicle with four wheels and an internal combustion engine." Such a patent is vast and theoretical, attempting to cover an entire family of potential inventions. Natco Pharma, in a bold and credible challenge, effectively argues that while Roche may have patented this general concept of the "car," it was another party that actually invented the specific, high-performance "Formula 1 race car"—which, in this analogy, is the Risdiplam molecule itself. Natco contends that Roche’s original patent described a universe of millions of potential chemical compounds but did not specifically identify Risdiplam, nor did it provide a clear roadmap for how to create it. This is the "species" argument: that the specific, effective, and life-saving molecule is a distinct and separate invention not adequately covered by the original, overly broad patent. The fact that the Delhi HC had found Natco’s patent-invalidity challenge “credible” and weighed public interest (affordability) heavily in denying Roche relief signals a deep and growing judicial skepticism towards patents that seek to claim a monopoly over scientific territory that the patent holder has not yet fully explored or explained. It serves as a vital guardrail, preventing a company from fencing off an entire field of research based on a foundational but incomplete discovery. It is a check against a system that could allow a single corporation to lock away a life-saving medicine behind an impenetrable price wall, simply because it was the first to map the general neighborhood, even if it didn't find the specific address where the cure resides. 

This judicial posture is not a sudden development in India; rather, it is the modern expression of a legal and social philosophy that has been cultivated for decades. For years, India consciously built its identity as the "pharmacy of the world," a role made possible by its landmark 1970 Patents Act. This law prioritized public health above all else by refusing to grant product patents on pharmaceuticals. This deliberate policy choice allowed the nation's burgeoning generic drug industry to flourish by reverse-engineering and producing affordable versions of essential medicines. Companies like Cipla, under the visionary leadership of Yusuf Hamied, did not just supply India’s population; they revolutionized global health. At the height of the HIV/AIDS crisis, when Western pharmaceutical companies were selling life-saving antiretroviral drugs for over $10,000 per patient per year in Africa, Cipla offered a three-drug cocktail for less than a dollar a day, saving millions of lives and forcing the global industry to slash its prices. This history was profoundly challenged when India joined the World Trade Organization and, to comply with the TRIPS agreement, amended its laws in 2005 to reintroduce product patents. Many feared this would spell the end of affordable medicine in India and beyond. Instead, what has emerged is a uniquely Indian approach to intellectual property—a delicate and often contentious balancing act that respects international agreements while fiercely guarding the spirit of its constitutional commitment to the right to life. This ethos found its most powerful voice in the 2013 Supreme Court case, Novartis v. Union of India. The court rejected the Swiss pharmaceutical giant's attempt to patent a new form of its cancer drug, Glivec, by invoking Section 3(d) of the Patents Act. This provision prevents companies from getting new patents for minor tweaks to known drugs unless those changes result in a significant improvement in efficacy. The court’s message was unambiguous: patents are a reward for genuine invention, not for clever legal strategies designed to extend monopolies indefinitely. The Roche-Natco case, though centered on the validity of the original patent rather than a later modification, is animated by this very same judicial spirit. It scrutinizes the foundation of the patent itself, asking not just "Is it new?" but "Is the claim to invention genuine and deserving of the powerful monopoly being granted?" 

Naturally, this approach draws strong and persistent opposition from innovator pharmaceutical companies, and their arguments deserve careful consideration. The journey of a new drug from a laboratory concept to a patient's bedside is a perilous, long, and astronomically expensive one. It involves billions of dollars in research and development, a decade or more of painstaking clinical trials, and a staggering rate of failure where over ninety percent of candidate molecules never receive regulatory approval. The patent system, they argue, is the fundamental engine that fuels this entire enterprise of innovation. The 20-year period of market exclusivity is the promised reward that incentivizes companies to undertake such monumental financial and scientific risks. Without the realistic prospect of recouping their vast investment and generating profits to fund the search for the next generation of cures, the pipeline of new, life-saving drugs would inevitably dry up, leaving humanity to face future diseases with an empty arsenal. Proponents of this view argue that weakening patent protection, even for the most noble of reasons, is a short-sighted act that sacrifices long-term medical progress for short-term affordability. To deny Roche its monopoly on Risdiplam, the argument goes, is to send a chilling message to the entire industry, discouraging the next company from even beginning the search for a cure for the next devastating rare disease. They point to the "orphan drug" model, where research for conditions like SMA that affect a smaller population is only commercially viable if the resulting product can be priced at a premium. 

This argument is compelling, but it is also incomplete and, in many ways, misleading. It presumes that the astronomical price of a drug like Evrysdi is a direct, unavoidable reflection of its research and development costs. In reality, pharmaceutical pricing is an opaque and complex calculus, driven as much by what the market will bear, shareholder expectations, and aggressive marketing as it is by actual R&D expenses. A significant portion of the foundational scientific research—the very bedrock upon which these commercial drugs are built—is often funded by public money through government grants to universities and research institutions. Taxpayers frequently pay for the initial discovery, only to be asked to pay again through exorbitant prices once a private company commercializes the research. Furthermore, the argument for near-absolute patent protection crumbles when it confronts the sheer scale of the inequity it creates. When a medicine's price is so high that it is accessible to only a tiny fraction of the population in a country of 1.4 billion people, it ceases to be a product in a normal market. It becomes an emblem of a profound systemic and moral failure. The social contract that underpins patent law—a limited monopoly granted to an inventor in exchange for a benefit to society—is fundamentally broken when that benefit is dangled tantalizingly out of reach for almost everyone. The intervention by the Indian judiciary, therefore, should not be seen as an assault on innovation. It is a necessary and vital course correction. It is a powerful reminder that a patent is not an absolute, divine right, but a statutory privilege granted by society, and one that must coexist with other, more fundamental human rights. As the great South African leader Nelson Mandela said while fighting for access to AIDS medicines, "A fundamental concern for others in our individual and community lives would go a long way in making the world the better place we so passionately dreamt of." His words remind us that intellectual property cannot be pursued in a moral vacuum. 

This is where the conversation must transcend the technicalities of patent law and enter the realm of constitutional morality. Article 21 of the Constitution of India guarantees the right to life and personal liberty, a provision that the Supreme Court has, through decades of progressive and humane interpretation, expanded to explicitly include the right to health. This is not merely an abstract ideal; it is a guiding principle that compels the state and all its organs, including the judiciary, to act in a manner that protects and promotes the health and well-being of its citizens. The court, when faced with a case like this, is not simply a neutral arbiter between two corporate entities. It is the ultimate custodian of the Constitution. When faced with a direct conflict between upholding a company’s statutory right to a commercial monopoly and protecting a citizen’s fundamental right to life-saving treatment, its constitutional duty is to seek a just and humane balance. The staggering 95% price reduction offered by Natco’s generic version makes the choice starkly clear. Denying Roche's request for an injunction does not permanently extinguish its patent; the company can and will continue to argue the merits of its case in the lower courts. What this decision does is refuse to allow the patent to be used as a weapon to deny treatment to dying children while the legal process unfolds, a process that could easily take years. It rightly prioritizes the patient over the patent, the immediate human cost over a delayed corporate claim. This is not judicial overreach; it is the embodiment of constitutional compassion in action. 

Looking forward, the Roche-Natco dispute illuminates the urgent need for a more sustainable and equitable global framework for pricing and accessing life-saving medicines. While challenging patent validity is one crucial pathway, other mechanisms within the existing legal framework, such as compulsory licensing, remain potent but underutilized tools. A compulsory license allows a generic company to produce a patented drug without the consent of the patent holder in situations of national emergency or extreme public health urgency, provided a reasonable royalty is paid back to the innovator. While India has formally used this provision only once, its potential as a negotiating lever and a critical safety valve cannot be overstated. The mere threat of a compulsory license can often compel innovator companies to engage in more reasonable pricing negotiations and voluntary licensing agreements. Beyond these legal remedies, governments must assume a more proactive and courageous role. This could involve direct price negotiations for essential and rare-disease drugs, exploring public-private partnerships for manufacturing to lower costs, or creating pooled procurement mechanisms to increase bargaining power on the international stage. The challenge is not to dismantle the innovation ecosystem, but to build a more just one—one where the rewards for innovation are not so disproportionately high that they place cures beyond the grasp of the very people who need them to survive. 

In the end, the echoes from the Supreme Court's chamber will be felt most profoundly not in corporate boardrooms, but in the homes of families who have been watching this case with a mixture of hope and terror. For them, the complex legalese of "genus versus species" patents and "interim injunctions" translates into the simple, powerful, and universal language of hope. The court’s decision is a powerful affirmation that in the great Indian balancing act, the scales of justice must ultimately weigh the health and life of a child more heavily than the commercial exclusivity of a patent. It sends an unmistakable message to the global pharmaceutical industry: while India welcomes and will protect genuine, groundbreaking innovation, it will not be a passive market where life-saving medicines can be priced into oblivion. It is a declaration that the soul of a nation's laws is found not in their rigid and unthinking application, but in their capacity to bend towards justice, compassion, and humanity. This single decision, in a long and complex case, will not solve the global crisis of access to medicines. But it provides a crucial, courageous, and life-affirming answer to a fundamental question that we must all confront: What is the purpose of a miracle cure, if there is no one left who can afford it?