Evergreening of Patents in India: Legal Precedents Shaping the Pharma Sector

Introduction to Patents and Their Role in Innovation

A patent is a legally granted form of intellectual property that gives a patent holder the right to prevent others from producing, using, or commercializing an invention for a limited period. Patents in India are jurisdiction-specific, meaning they are only enforceable in the countries or regions where they are granted. In exchange for the temporary exclusivity, the technical details of the invention must be publicly disclosed, enabling others to build upon it once the patent expires. Enforcement of patent rights is largely the responsibility of the patent holder, who must take legal action if infringement occurs. Patents are crucial across multiple sectors such as pharmaceuticals, electronics, biotechnology, chemicals, automotive engineering, and manufacturing, because they secure the returns on substantial research and development investments.

In the pharmaceutical industry, patents help sustain high-risk, capital-intensive drug development cycles. They give companies a period of exclusivity to recoup investment costs and fund further therapeutic innovations. This protection supports biomedical progress and ensures that new treatments can be brought to market in a commercially viable manner.

Patent Law in India: Framework and Public Health Orientation

Patents in India regime is rooted in the Patents Act, 1970, which underwent major reform in 2005 to align with the TRIPS Agreement. The 2005 amendment reintroduced product patents for pharmaceuticals and chemicals, previously prohibited, while incorporating unique safeguards such as Section 3(d), which prevents evergreening by requiring enhanced therapeutic efficacy for modified forms of known substances.

The legislative framework reflects India’s dual policy objective: supporting meaningful innovation while ensuring that essential medicines remain accessible and affordable. India’s law also includes provisions for compulsory licensing, enabling the government to authorize generic production in circumstances where patented drugs are overpriced, unavailable, or not adequately worked in the country.

Understanding Evergreening in the Pharmaceutical Sector

“Evergreening” describes strategies used by pharmaceutical patent holders to extend their market exclusivity through marginal or incremental modifications to existing drugs, adjustments in formulation, dosage, crystalline structure, or delivery mechanisms, without contributing significant therapeutic improvement. Although framed as innovation, such variations often serve primarily to delay generic competition.

India’s legal architecture, particularly Section 3(d), was designed to distinguish between genuine scientific advancement and attempts to prolong monopolies. Compulsory licensing mechanisms further reinforce this access-centric approach. A landmark example occurred in 2012 when the cancer drug sorafenib became the first subject of a compulsory licence, highlighting India’s readiness to invoke TRIPS-compatible measures in the interest of public health.

Evolution of India’s Anti-Evergreening Jurisprudence

The post-2005 era has seen the gradual crystallization of India’s anti-evergreening principles through both administrative practice and judicial intervention. Section 3(d) emerged as the centrepiece of this framework, demanding proof of therapeutic superiority for modified forms of existing drugs. As a result, India has maintained a robust generic industry and cultivated a reputation as a global supplier of affordable medicines.

Key legal milestones illustrate how Indian courts have interpreted and enforced these provisions:

Table 1: Events Shaping India’s Pharmaceutical Patent Landscape

Patents (Amendment) Act, 2005

With the 2005 amendment, India shifted from a process-only patent system to one recognizing product patents for pharmaceuticals and agrochemicals. To prevent misuse of this expanded protection, lawmakers crafted Section 3(d), which bars patents for modified forms of known substances unless they substantially improve therapeutic efficacy. This provision became the benchmark for distinguishing legitimate invention from incremental, market-extending changes.

Roche v. Cipla (2006)

In one of the earliest tests of the 2005 reforms, Roche contested Cipla’s generic version of erlotinib. Although the Delhi High Court acknowledged Roche’s valid patent, it declined to issue a permanent injunction. The Court emphasized that the high cost of Roche’s drug would significantly limit patient access, thereby justifying denial of relief. This case set an important precedent by demonstrating that patent rights in India would be examined through the lens of public interest and access to essential medicines.

Natco Pharma v. Bayer (2012)

Natco’s request for a compulsory licence on Bayer’s patented drug sorafenib marked a turning point. The Patent Controller agreed that Bayer’s pricing and limited availability restricted access for Indian patients and that the patent was insufficiently worked in India. Granting the licence allowed Natco to supply a far more affordable version while paying royalties to Bayer. The decision confirmed India’s willingness to employ TRIPS flexibilities as a tool for advancing public health priorities.

Novartis v. Union of India (2013)

The Supreme Court’s ruling in the Novartis case remains the most authoritative interpretation of Section 3(d). Novartis sought a patent for a beta-crystalline form of imatinib mesylate, arguing improved bioavailability. The Court held that increased bioavailability, without proof of therapeutic enhancement, was insufficient. It emphasized that “efficacy” must be understood in therapeutic terms and reaffirmed the constitutional legitimacy of Section 3(d). This decision firmly entrenched India’s anti-evergreening doctrine and shaped the global debate on access-oriented patent standards.

Impact of Section 3(d): Achievements and Criticisms

Following the Novartis ruling, the Patent Office and judiciary have applied Section 3(d) consistently, rejecting applications for salts, polymorphs, isomers, metabolites, and dosage variants that fail to demonstrate therapeutic advancement. This has accelerated generic entry, contained drug costs, and supported the availability of medicines for millions of patients.

Critics argue, however, that Section 3(d) is excessively restrictive and may discourage incremental innovations that, while not life-altering, could still offer clinical advantages. Multinational pharmaceutical companies contend that stringent standards reduce incentives to introduce advanced therapies in India. Nonetheless, India continues to prioritize affordability and public health over prolonged exclusivity.

CRISPR-Cas9 Patent Disputes: A Global Perspective

India’s access-oriented patent system contrasts sharply with the competitive global environment surrounding CRISPR-Cas9 technologies. Internationally, disputes have primarily involved the University of California, Berkeley and the Broad Institute, each asserting priority over key aspects of CRISPR gene-editing. The debate focuses not only on who first invented the technology but also on the scope of its application, especially in eukaryotic cells—a domain with immense commercial and medical potential.

CRISPR, derived from bacterial immune mechanisms, has transformed genetic engineering by enabling precise edits to DNA. Its sweeping applications in medicine, biotechnology, and agriculture have heightened the value of foundational patents.

In the United States, the Patent Trial and Appeal Board has issued nuanced decisions: sometimes validating the Broad Institute’s eukaryotic cell claims without negating Berkeley’s broader discoveries. In Europe, the EPO has seen revocations, amendments, and prolonged opposition proceedings, influenced in part by strict priority-filing rules. These varied outcomes reveal how different jurisdictions grapple with rapidly evolving biotechnologies.

CRISPR Patenting in India

India granted a key CRISPR patent (IN 397884) to ERS Genomics in 2022, but its strength has been questioned given the revocation of related patents in Europe. Post-grant opposition proceedings reflect growing scrutiny. CRISPR inventions must also navigate several statutory provisions:

• Section 3(b) – concerns related to morality and germline editing
• Section 3(c) – exclusions for naturally occurring biological materials
• Section 3(i) – limits on diagnostic and therapeutic methods
• Section 3(j) – exclusions for biological processes

Taken together, these provisions make India’s CRISPR patent regime among the more restrictive internationally.

Importantly, even though CRISPR is not a pharmaceutical substance, the logic of Section 3(d) continues to influence evaluation of incremental innovations, such as modified Cas enzymes or improved guide RNAs, which may face heightened scrutiny unless they demonstrate meaningful technical improvements. This approach may also help prevent the formation of patent thickets that could otherwise hinder domestic research and innovation.

Policy and Governance Challenges

India’s governance of emerging biotechnologies faces several challenges. The absence of detailed biotechnology-specific examination guidelines can lead to inconsistent review of CRISPR applications. While pre- and post-grant opposition mechanisms have proven essential for filtering weak pharmaceutical patents, similar vigilance is needed for foundational gene-editing technologies. Although compulsory licensing could theoretically apply to CRISPR in exceptional circumstances, its use in this field remains purely speculative. Ethical concerns including biosafety oversight, responsible innovation, and human-subject protections, must also inform future patent policy.

Conclusion

India’s anti-evergreening jurisprudence, shaped most prominently by Section 3(d) and the Novartis decision, continues to exert influence far beyond the pharmaceutical sector. As transformative technologies like CRISPR-Cas9 advance, India must refine its policy tools to ensure that patent protection incentivizes real innovation without compromising public interest. How India navigates CRISPR patenting with lawyer patent guidance will not only shape its domestic biotechnology landscape but also contribute to global standards for governing gene-editing technologies in the years ahead.