In this co-authored post, Ambika and Rishabh break down the recent Kerala High Court ruling on government use of patented inventions under Section 100 and situate it in the broader context of other Ribociclib patents and pending litigations that will impact the drug’s access; all this, at a time when patent enforcement and drug pricing rules might be changing.
The judgment’s epilogue references popular cinema for recall value (see pg 56 here), but the real blockbuster of this story is the drug Ribociclib, said to become the highest-selling drug in Novartis’ history. On the burning question of what the Court could do to provide access to this life-saving medicine for plaintiffs who could not afford it, the Kerala High Court reflects on when government-use of patents becomes possible, what data is required, and where it could be sourced. Overall, it is a lukewarm response. The Court has entirely relinquished the application of Section 100 to government policy. Once again, the practical implementation of a public-health centric TRIPS-compliant policy lever seems like a missed opportunity.
In Re: Exorbitant Pricing of Life Saving Patented Medicines, W.P. (C) No. 18999/2022
Ribociclib, marketed internationally as Kisqali and in India as Kryxana, is a prescription medicine to treat adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (the most commonly diagnosed subtype of) breast cancer. It has unprecedented benefits in increasing median life span of advanced cancer patients by over 5 years and reducing cancer recurrence in early-stage breast cancer in young women, where the disease is the most aggressive and difficult to treat. Kisqali is a blockbuster drug, a ‘priority brand’ for Novartis that generated approx. USD 1.7 billion in global sales in the second quarter of 2026.
In India, two patents are relevant; and, at a time where patent cliff approaches for both of them, questions of access and affordability have been raised: IN 283133, expiring in 2027 and the subject of the dispute before the Kerala High Court, and some patent enforcements at the Delhi High Court; and IN 594997, an allegedly ever-greening attempt currently under scrutiny at the Delhi HC, and expiring in 2029.
We turn our attention first to the proceedings at Kerala.
A quick recap: In June 2022, a retired bank employee suffering from breast cancer and finding Ribociclib unaffordable from her pension, approached the Kerala High Court praying for government intervention under Sections 92 and 100 of the Patents Act, 1970. Directed by the Court to consider the matter, the DPIIT did so and ordered against a CL grant; the reasonableness of its decision has been questioned. The Kerala HC took suo motu cognisance following the petitioner’s death, and 4 years later, the Supreme Court took suo motu cognisance citing the High Court’s delay and inaction. For a detailed coverage of the case thus far, see previous posts by Tejaswini, Mathews, Praharsh and Rishabh.
Now coming to the final hearing of this case dated September 28, 2026. At the outset, Palbociclib, an off-patent CDK4/6 inhibitor, was found to not be a direct medical alternative to Ribociclib in early-stage treatments, thus quashing the potential of interchangeably prescribing an affordable generic drug. The Court then had to determine conditions for the application of Section 100 (a type of Compulsory license limited to “Government use”) and the data required to justify a public-health centric intervention against a granted patent.
The jurisprudence on Section 100 prior to this case is brief. Recently, the Supreme Court in Re: Distribution of Essential Supplies and Services During Pandemic, was considering, inter alia, the availability of patented Remdesivir, Favipiravir and Tocilizumab. In doing so, it emphasised Sections 66, 92, 100 and 102 as TRIPS-compatible public-health policy tools, with permission to contract third-party to manufacture the drugs and the availability of High Courts in facilitating royalty negotiation between the government and patentees. Other brief mentions of Section 100 in cases like Master Arnesh Shaw have also affirmatively recognised the access-to-medicine ethos of Section 100, while nevertheless leaving the decision to license, to the government.
The Kerala High Court’s expanded interpretation of the government-use exception to supply medicines directly to the patients is a welcome development. However, the continued absence of its practical implementation, due to it being an extra-judicial, policy-based solution that remains dependent on the government’s choice to license, leaves much to be desired on the ground.
Section 100: Purposes of Government more than “For Government Purposes”
The Kerala High Court clarifies and expands the scope of Section 100 . First, it clarifies that Section 100 entitles the government to authorise manufacture of patented medicines to make them available to individual patients on a non-commercial basis. Second, it includes unaffordability as a justifying criterion for the government’s intervention. Third, it relates access to medicines to the mandates of the Constitution.
- Non Commercial Basis: The Kerala HC has observed that the “purpose of the government” must be read in the light of sub-sections (4) and (6) of Section 100. The reasoning is two-fold here. First, the said provisions provide the government the power to authorise any person to make/use/exercise/vend the products made under the patent on a non-commercial basis. Second, Section 100 places no restriction on who the purchaser may be. Therefore, the interpretation of “purposes of Government” would include making the medicine and selling it on a non-commercial basis to “none other than the needy patient”. The inclusion of “medicine or drug” in sub-section (4) further reinforces this interpretation.
- Unaffordability: it asks the Government to consider the exorbitant price before ensuring access to a patented medicine. Crucially, the question of the nature of the provision, whether it is mandatory or suggestive, once exorbitant pricing has been proved, remains open; and the Court’s findings lead in two opposite directions. From paragraph 37 and finding (ii) of the judgment, it follows that Section 100 “is required to be invoked” and “the Government is required to intervene” where a patented medicine is exorbitantly priced. However, as per paragraph 39, “It is for the Central Government to consider whether Section 100 is required to be invoked, since ultimately the same is a policy decision.” Paragraph 40 repeats this, adding that such a step ought to be taken by the Central Government after collecting the necessary statistics.
- Constitution: Finally, the Court linked the “purposes of government” to Article 47 of the Constitution, to substantiate the State’s duty to improve public health, observing that exorbitant drug pricing “virtually defeats” the mandates of Articles 21 and 47. The Court further substantiates this by reference to Section 83(g), and holds that the government’s “requirement/duty to provide patented inventions at reasonably affordable prices to the public” is within the principles of working of patented inventions.
This enhanced interpretation increases the reach of this provision by recognising a direct link between government-authorised manufacturing and the patients, when original manufacturers sell at unaffordable prices. This is great in theory, but the Court places caveats on the operationalisation of Section 100 that do little to change the status quo: first, the government retains discretion; and second, it must base its decision on data – which takes us to our next crucial point:
Data, Data, everywhere; yet no data to cite?
What could prompt the government to use Section 100? One possible direction from the Kerala HC seems to be in prong (iii) of its findings, i.e. a reliance on compelling data. As per the Court, data was needed on the number of diagnosed patients; patients consuming medicines and those not consuming them due to high cost; and patients who have benefited from existing health schemes (para 42).
The Court’s restraint on granting any actual practical relief was primarily due to the absence of this data. The data that was placed on record was evidently not sufficient for this Court: an annual treatment cost of INR 7.9 lakh versus India’s INR 2.19 lakh per capita income, data produced by Novartis on the percentage of breast cancer patients using CDK4/6 inhibitors, government pricing records, and the amicus curiae’s exhaustive report on unaffordability.
The 139th Parliamentary Report, 2022, which the Court recommends to the Government for reference, ironically, itself concludes that the National Cancer Registry Programme (NCPR), in existence since 1982, operating through Population and Hospital Based Cancer Registries (PBCR and HBCR) has been able to cover only 10% of the Indian population. The Report flags fragmentary and incomplete cancer patients’ databases. Swaraj and Sabeeh have written extensively on the absence of primary data and its effect on the cancer treatment landscape. When national statistics themselves rely on incomplete data sources (read more here, here), which are often geographically and demographically unrepresentative (see here), then expecting Section 100 to come into effect only once the Government gets hold of accurate statistics doesn’t inspire much hope.
The Court has also erred in noting that the Government has introduced schemes for subsidised Ribociclib, and the reach of these schemes needs to be evaluated (para 42). We were not able to locate if any such Central Government scheme exists for Ribociclib. In fact, it has been reported that “78% reduction in the current market price or a 72% reduction in the reimbursement rate of fulvestrant in the government-funded insurance program will make it a cost-effective treatment option for HR+, HER2− metastatic breast cancer patients in India.” Nevertheless, Ribociclib and Palbociclib were not accepted in the list of PM-JAY medicines, “The inclusion request for these agents was declined on the grounds of cost-effectiveness, implying that the cost of these treatments outweighs their potential benefits within the Indian health care system.” Interestingly, the NPPA, the government’s pharmaceutical price regulator, was not made a party to this suit.
Is Access to Medicine Only a Policy Decision?
The petition had originally sought four reliefs: (a) a declaration that the concerned Union respondents were duty-bound to act under Section 92 or 100; (b) a mandamus to take steps either under Section 92 or under Section 100 of the Patents Act, 1970 for Ribociclib; (c) a mandamus for a scheme providing Ribociclib free of cost under the National Cancer Control Programme; and (d) a mandamus directing ICMR to maintain and publish data on each category of breast cancer. Yet the Court disposed of the petition without any clear indication as to whether the claimed reliefs were granted or denied.
Is affordable access to a patented medicine solely a matter of administrative policy? Probably not. It’s obvious that a court cannot make policy and cannot choose how the Government exercises a statutory power. However, there are antecedent effects at play that did not feature in this decision. For instance, this Court, in a rather positivist reading of patent law (para 38), has positioned the “utmost protection” to commercialise a patent in direct conflict with a “public benefit and public interest” function of Section 100. As a consequence, in a matter concerning drug pricing, there was no consideration of the impact that pricing decisions made in the supply chain have on the final invoice given to the patient. The possibility that a medicine’s unaffordability could be a consequence of market forces remains unexplored. In a case presently pending, the Supreme Court has called the ten-fold markup over MRP of essential cancer medicines ‘daylight dacoity’ and ‘carnage’(see here; here, paywalled). This pending dispute contextualises drug price availability with retailer margins and arbitrary price-control rules. Recently, in relation to this proceeding, the NPPA has ordered a 30% trade mark-up cap on non-essential anti-cancer drugs. The actual impact of these two developments remains to be seen.
Another contributing factor to the access and affordability of Ribociclib is patent prosecutions. One would expect that market competition following generics production would reduce medicine costs after expiry of this patent in 2027. This might not be the case yet. Another patent, IN 594997 has been granted after 4 oppositions spanning 15 years. Novartis contends that this second patent specifically claims Ribociclib, while the prior patent was a broader genus patent. The grant has been challenged by Natco on alleged ever-greening. Natco argues that Ribociclib is already covered in the prior patent, evidenced by the extensive litigation by Novartis against MSN, Vachichem, Intas and others, challenging the manufacture of Ribociclib under IN 283133. In two separate pending cases before the Delhi HC, Novartis has alleged infringement by third parties purportedly manufacturing Ribociclib under Section 100. Against MSN Laboratories, the allegation concerns a public procurement notice from the Department of Pharmaceuticals. A similar development in the USA has ended in a confidential settlement and license agreement. Against CDYMAX Pharma, the allegation is against Ribocicblib manufacturer on the order of the Drug Control Department, Government of Karnataka for export purposes.
If the DHC upholds this latter patent grant, it will push generics entry to 2029. That is on the assumption that the calculation of patent term is not changed by the upcoming decision of the Supreme Court on the possible application of patent term adjustments!
The Way Ahead
Ribocliclib’s high cost prohibits its equitable access to the point that nationwide healthcare schemes have not been able to justify its procurement. The Kerala HC attributed this cost to the drug’s patent status. Despite an expansive interpretation of Section 100, the decision regarding government-authorised manufacture remains policy-dependent. The policy decision, in turn, remains data-dependent. The need for reliable data is underscored when this data is absent. This decision is not the final word on cancer drug affordability, nor might the expiry of the suit patent be the last of Ribociclib’s proprietary protection. There is an expectation of changes to the playing field by some ongoing judicial deliberations that might have radical impacts. We are keeping a close eye on these developments. In the meantime, readers are welcome to continue this discourse in the comments!