Back
: Section 100 Patents Act Allows Government to Make Exorbitantly Priced Drugs Affordable
In a landmark ruling that could reshape access to life-saving medications in India, the held that empowers the to manufacture or procure patented drugs being sold at exorbitant prices and sell them on a to needy patients. The decision, delivered by Justice Harisankar V. Menon, arose from a petition concerning the prohibitively high cost of patented breast cancer medicines.
The court specifically found that the phrase "" under Section 100 includes the entitlement to use a patent or invention for manufacturing the medicine covered by the patent, and to sell the same to a person—including a needy patient—on a . “Section 100 is required to be invoked in circumstances where the Government is required to intervene, such as an instance where the medicine manufactured on the basis of a patent is being sold at an ,” the judge observed.
Background: From Patient’s Plea to Intervention
The proceedings originated from a writ petition filed by a breast cancer patient who was prescribed Ribociclib, a patented drug costing approximately ₹75,000 per month. She sought a direction to the to invoke provisions of the Patents Act to make the drug more affordable. After the unfortunate demise of the petitioner during the pendency of the case, the High Court converted the matter into a petition, recognizing the systemic implications of exorbitant drug pricing.
The court heard extensive submissions from amicus curiae , senior counsel representing patent holders (manufacturer of Ribociclib) and (manufacturer of Abemaciclib), as well as from the and intervenors. The case was cited as “.”
Key Findings on Government Use Under Section 100
Justice Menon issued three clear findings to guide future action. First, a notice under Section 100 covers not only the government’s own use of a patent but also the government’s right to manufacture the patented medicine and sell it to individuals on a . Second, Section 100 is meant to be invoked in situations where government intervention becomes necessary—specifically when a patented medicine is sold at an . Third, the government is required to collate relevant data to determine whether a given medicine is affordable, and only then proceed under Section 100 if intervention is deemed necessary.
The ruling clarifies that the provision is not limited to national emergencies or extreme urgencies, but extends to cases where is warranted due to pricing that effectively blocks patient access.
Arguments For and Against
The amicus curiae highlighted the gender discrimination dimension, noting that women’s health often takes a backseat in Indian households due to societal expectations of sacrifice. She stressed that early-stage breast cancer patients need Ribociclib specifically—while Palbociclib, a cheaper alternative, is prescribed only in metastatic stages due to differing toxicity profiles. Since early intervention reduces mortality, unaffordability of the patented drug directly infringes the .
The amicus also pointed out that two Indian companies had obtained approval to manufacture generic versions of these drugs but had not applied for —an indication that Section 100 could bridge the gap.
and Eli Lilly argued vigorously against any invocation of Section 100. They contended that the provision cannot be used without first exhausting the mechanisms under Sections 84 and 92. pointed out that the trade margin on Ribociclib was already capped at 30%, and that patents incentivize billions of dollars in research and development. Granting a patent, they argued, is itself in the public interest because it leads to eventual disclosure of the invention, whereas without patent protection, companies would keep processes as trade secrets.
Eli Lilly emphasized that no national emergency exists since the three drugs (Ribociclib, Abemaciclib, and Palbociclib) are substitutable, and that the company provides free medicine schemes and affordable pricing through cancer centres. They also noted that the drug discovery process took over a decade, and the patent itself was granted only in 2018 (applied for in 2008), which already cut the intended exclusivity period by nearly half.
The , while sympathetic to affordability concerns, argued that the Patents Act is a self-contained legislation that balances the and the . It stressed that any decision to invoke Section 100 must be based on concrete data, not just individual cases. The highlighted financial repercussions—setting up factories, procuring machinery, raw materials, and expertise—and pointed to existing central schemes providing financial incentives to patients.
Legal Analysis: Striking a Balance Between Property and Health
The court’s interpretation of “” to include to individuals is significant. Section 100, traditionally seen as a tool for government use in national interest (e.g., defence or public health emergencies), has now been widened to cover . The ruling implicitly recognizes that can itself create a situation akin to extreme emergency, as it systematically denies access to life-saving treatment.
Importantly, the court did not issue a compelling the government to invoke Section 100 immediately. Instead, it provided a legal framework directing the government to gather data and make an informed decision. This preserves the while setting clear expectations on the government’s duty.
The judgment also reinforces the under . As intervenor argued, in a clash between the patent holder’s and a patient’s , the balance must tilt toward health, with adequate compensation to the patent holder—enshrined in Section 100 itself.
Implications for Patent Law and Public Health
This ruling has far-reaching consequences for the pharmaceutical industry and public health advocacy in India. It signals that courts are prepared to interpret patent law flexibly to ensure that the patent system does not become a barrier to essential medicines. Legal professionals expect this decision to encourage more proactive use of Section 100 by the government, particularly for high-price drugs used in oncology, rare diseases, and other critical therapies.
The decision may also spur legislative or policy clarifications on what constitutes “” and how affordability data is to be collated. The court’s insistence on ensures that the provision is not misused, while still placing an affirmative duty on the government to act when market-driven prices become unconscionable.
For patent holders, the ruling adds a layer of uncertainty—especially for drugs sold at high margins in India. Companies may need to re-evaluate their pricing strategies and patient assistance programmes to pre-empt compulsory government intervention. Litigation around the interpretation of Section 100 is likely to increase, with courts asked to test the contours of “” and “.”
Conclusion
The ’s judgment in marks a pivotal moment in Indian patent jurisprudence. By expanding the scope of Section 100 to cover affordable access to patented drugs, the court has equipped the government with a powerful tool to address the tension between intellectual property rights and public health. The ball now lies with the to collate data, define affordability thresholds, and decide whether and when to invoke this provision. For patients who cannot afford the high cost of life-saving medicines, this ruling offers a ray of hope—and a clear roadmap for legal recourse.
