The Novartis Legacy – From Therapeutic Efficacy to Procedural Evasion

The Novartis Precedent and the Ascent of the Therapeutic Efficacy Doctrine

The Supreme Court of India's 2013 judgment in Novartis AG v. Union of India & Others was the tipping point in the history of pharmaceutical patenting and international intellectual property law. One loosely phrased clause in the Indian Patents Act, Section 3(d), was converted into a powerful doctrine that has, in turn, dictated the intellectual property rights-public health balance ever since. Through a nuanced reading of the ambit of “efficacy”, the Court not only dispelled long-standing legal ambiguity but also set a patient-centric test that resonates globally.

I. Pre-Novartis: An Era of Legislative Intent and Legal Uncertainty

The origin of the Novartis dispute is to be found in India's peculiar patent regime. For decades, India, under the Patents Act of 1970, granted only process patents for drugs and chemicals and no product patents at all. This conscious policy fostered the growth of a strong domestic generic sector, facilitating affordable access to medicines and earning India the nickname of being the “pharmacy of the developing world”.

But India's membership of the World Trade Organisation and its commitments under the TRIPS Agreement necessitated sweeping changes, a shift heavily influenced by pharmaceutical foreign direct investment trends. The 2005 Patents (Amendment) Act brought in pharmaceutical product patents, raising the spectre of long-term monopolies through cosmetic drug changes, a process commonly referred to as “evergreening”. To counter this threat, legislators drafted Section 3(d), a unique provision that barred patents on “new forms of known substances” unless they showed an “improvement of the known efficacy”. Though Parliament's intention was clear, the law's pivotal word, “efficacy”, was left undefined, leading to confusion on how to analyse the provision strictly.

This uncertainty came into sharp relief when Novartis sought a patent on a beta-crystalline form of imatinib mesylate, the active component in its best-selling cancer drug Glivec. The Indian Patent Office refused the patent, invoking Section 3(d). Novartis countered by questioning the constitutional validity of the provision in the Madras High Court in 2007. The Court upheld the legislation, holding that “efficacy” was not vaguely worded and ought to be understood as the ability of the drug to achieve the desired curative effect. Although this ruling gave some guidance, it did not settle the broader issue of how to measure therapeutic effectiveness—a question left for ultimate decision by the Supreme Court.

2. Post-Novartis: The Establishment of a Patient-Centric Standard

The Supreme Court’s April 1, 2013, decision delivered the definitive interpretation. Novartis argued that its new crystalline form of Glivec offered a 30% increase in bioavailability, contending this pharmacokinetic improvement constituted “enhanced efficacy” under Section 3(d). The Court, however, firmly rejected this argument. In a purposive reading of the law, it held that for pharmaceuticals, “efficacy” must mean “therapeutic efficacy”.

The Court went further, systematically dismantling the claim that improved physical or chemical properties automatically qualified as therapeutic improvements. Enhanced stability, better flow properties, or increased bioavailability, it explained, could not by themselves demonstrate a superior therapeutic effect. To meet the threshold of Section 3(d), patent applicants must establish, through rigorous clinical or pharmacological evidence, that such modifications translate into meaningful therapeutic benefits for patients. In Novartis’s case, no such data were produced.

By rejecting Novartis’s patent, the Court cemented a doctrine that placed patients at the centre of pharmaceutical innovation policy. It shifted the evaluative lens from the laboratory bench to the bedside, requiring a clear demonstration that a claimed invention improves human health outcomes rather than merely showing incremental technical refinements. This reasoning ensured that India’s patent regime remained consistent with its constitutional commitment to public health, while still rewarding genuine innovation.

The Novartis precedent thus achieved two critical objectives. Domestically, it reinforced the legislative intent behind Section 3(d), closing the door on trivial patents and safeguarding affordable access to medicines. Globally, it signalled to developing countries that robust, public health–oriented patent standards are not only legally defensible but also judicially enforceable. In doing so, the Supreme Court transformed Section 3(d) from an ambiguous safeguard into a powerful doctrine that continues to shape the contours of pharmaceutical patent law worldwide.

The Post-Novartis Shift in Patent Strategies

Before Novartis, companies frequently argued that improved solubility, bioavailability, or stability should qualify as “enhanced efficacy”. That approach is no longer viable. In the post-Novartis environment, pharmaceutical applicants have turned to more subtle strategies. Instead of openly challenging the interpretation of efficacy, they reframe their applications in ways that obscure the real issue. Drafting techniques and data submission practices have become the new battlegrounds, allowing applicants to present their claims in a manner that seems to fall outside the direct reach of Section 3(d). These tactics exemplify how the focus has shifted from substantive compliance to procedural circumvention.

One of the most visible tactics in this regard is the shift in drafting strategies. Companies now avoid straightforward claims to new salts, polymorphs, or derivatives, which are clearly scrutinised under Section 3(d). Instead, they embed these modifications within broader claims framed as “new formulations,” “novel dosage forms,” or “compositions of matter”. This reframing is designed to suggest that the claimed invention involves more than a mere new form of a known substance. For instance, a new salt of an existing drug might be claimed as part of a controlled-release tablet or as one ingredient in a novel combination therapy. Such drafting gives the impression of inventiveness, even when the underlying substance itself offers no demonstrable therapeutic improvement. In this way, what looks like innovation is in practice a strategic circumvention of Section 3(d).

Alongside creative drafting, the reliance on technical data has emerged as another dominant form of procedural evasion. Applicants now fill their submissions with vast amounts of non-clinical data, in vitro studies, animal models, and laboratory assays, showing improvements in properties like solubility or stability. These improvements, while scientifically interesting, often fail to translate into measurable benefits for patients. The strategy is not to provide evidence of therapeutic efficacy but to overwhelm examiners with scientific complexity. Patent officers, who already operate under considerable workload constraints, must sift through mountains of technical information, making it more difficult to identify whether the statutory requirement of therapeutic efficacy has truly been met. Here, too, the objective is less about compliance and more about procedural circumvention of scrutiny.

Another dimension of this strategy involves the submission of foreign data. Companies often present results generated in jurisdictions with more lenient patentability standards, hoping that these voluminous reports will influence Indian examiners. While Indian law is clear that therapeutic efficacy must be established in the local context, the use of foreign data exploits the limited time and resources available to the Patent Office. By relying on international approvals or patent grants, applicants attempt to import legitimacy into their filings in India without providing the clinical evidence that Section 3(d) demands. This reliance on external benchmarks represents yet another way of circumventing the intent of India’s stricter standard.

The empirical evidence from Sampat and Shadlen (2018) helps explain why circumvention of Section 3(d) has become increasingly common. Their study of over 1,200 first examination reports (FERs) shows that objections under Section 3(d) are now routine, rising from under 40 per cent of cases in the early 2000s to over 80 per cent in later years. This trend is corroborated by industry watchers who note that the changing role of Section 3(d) has forced applicants to adopt more complex prosecution strategies. Yet, instead of serving as a definitive bar, these objections often lead to prolonged negotiations. Applications facing Section 3(d) scrutiny took nearly 200 days longer to process than others, and although their success rate was lower, a significant number were eventually granted. This pattern suggests that companies anticipate Section 3(d) hurdles and strategically respond, by submitting extensive non-clinical data, fragmenting claims, or prolonging examination, thus circumventing the spirit of the provision. In effect, what was designed as a substantive safeguard against evergreening increasingly operates as a procedural hurdle that can be delayed, negotiated, and ultimately sidestepped.

Judicial Resistance and Circumvention Attempts

Despite these evolving strategies, the judiciary in India has remained consistent in applying the Novartis standard. The Indian Patent Office, the erstwhile Intellectual Property Appellate Board (IPAB), and the High Courts have all reaffirmed that applicants must demonstrate actual therapeutic benefits, not just improved physical or chemical characteristics. In several cases, courts have gone further, requiring applicants to submit comparative tables, in vitro and in vivo data, and detailed explanations correlating claimed improvements to therapeutic efficacy. This insistence on rigorous evidence has prevented the dilution of Section 3(d). However, even as courts enforce the standard, the persistence of procedural maneuvers underscores how companies attempt to sidestep substantive requirements through circumvention.

Earlier high-profile disputes illustrate this judicial resolve against procedural evasion. The revocation of Johnson & Johnson’s patent for the TB drug Bedaquiline serves as a prime example. When the initial salt form failed to show improved efficacy, the company amended its claims to focus on other attributes, a tactic ultimately rejected for lacking clinical substance, as discussed in legal analyses of non-enforcement strategies. Similarly, the litigation over Roche’s Erlotinib highlighted how companies use overwhelming technical data to complicate validity questions and delay generic competition. In the case of Gilead’s Hepatitis C drug Sofosbuvir, the Patent Office rejected multiple applications for derivatives that failed the Novartis threshold, which proved that extensive submissions cannot mask a lack of therapeutic benefit. These cases collectively established that procedural maneuvers to obscure a lack of innovation would not pass muster.

Building on this foundation, recent rulings in 2024 and 2025 have further tightened the net around circumvention. This judicial rigour was reinforced in January 2024 by the Delhi High Court in Natco Pharma v. Novartis AG regarding the drug Eltrombopag. The Division Bench overturned an interim injunction and ruled that "enhanced bioavailability" does not essentially equate to "therapeutic efficacy" under Section 3(d), a ruling analysed extensively by legal experts. The court clarified that while pharmacokinetic properties like solubility and bioavailability are scientifically relevant, they do not satisfy the statutory requirement unless they translate into a demonstrable therapeutic advantage. This judgment effectively closed a popular circumvention route where applicants tried to pass off more soluble versions of old drugs as patentable inventions.

The judiciary has also expanded its scrutiny to upstream evergreening strategies. In Zeria Pharmaceutical Co. Ltd. v. Controller of Patents in May 2025, the Delhi High Court extended the application of Section 3(d) to intermediate compounds. The court held that even chemical intermediates used to synthesize final drugs must demonstrate enhanced efficacy if they are mere derivatives of known substances, a decision viewed as a significant blow to strategies of patenting intermediates.

Most recently, the revocation of the patent for Novartis’s heart failure drug Entresto (Sacubitril/Valsartan) in September 2025 illustrates the failure of supramolecular drafting strategies. The applicant attempted to characterize the drug not as a mere admixture of two known compounds but as a novel 'supramolecular complex' to argue that this unique crystalline structure placed it outside the scope of Section 3(d). The Indian Patent Office rejected this characterization and noted that without evidence of superior therapeutic efficacy over the individual components, the complex remained a non-patentable derivative, an outcome analyzed in detail in recent commentaries. This decision highlights that Indian authorities are increasingly adept at piercing through sophisticated chemical terminologies to identify the underlying lack of therapeutic innovation.

Conclusion – Section 3(d) Between Safeguard and Circumvention

The Novartis judgment transformed Section 3(d) from an ambiguous clause into a doctrine of therapeutic efficacy that placed patients at the centre of pharmaceutical innovation. It reaffirmed India’s constitutional commitment to public health while providing a model for other developing nations to resist evergreening. Yet, the persistence of procedural evasion reveals a deeper tension. Creative drafting, data overload, and reliance on foreign benchmarks demonstrate how pharmaceutical companies adapt to safeguard monopolies.

Judicial vigilance has so far preserved the integrity of Section 3(d), but empirical evidence shows that circumvention strategies continue to pressure the system. This ongoing struggle has prompted high-level policy reviews, including the Report of the Parliamentary Standing Committee on Commerce, which has stressed the need for strict enforcement. While government action taken reports affirm the robustness of the current regime, independent analyses and commentators on the IP balance suggest that the legislative framework must remain dynamic to counter new circumvention techniques. Ultimately, Section 3(d) stands at a crossroads: it remains a global symbol of patient-centric patent law, but one increasingly vulnerable to procedural exploitation. Its future effectiveness will depend on whether enforcement mechanisms can evolve to address not only substantive arguments but also the procedural tactics designed to undermine them.

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This article has been authored by Sana Yadav and Souvagyo Banerjee, students at School of Law, Christ (Deemed to be University), Bangalore. This blog is part of RSRR's A&A Blog Series.