Published Oct 06, 2026 | 7:00 AM ⚊ Updated Oct 06, 2026 | 7:00 AM
Section 100 allows the Central Government, or a person authorised by it, to use a patented invention “for the purposes of Government”.
Synopsis: The Kerala High Court has ruled that Section 100 of the Patents Act can allow the government to manufacture and supply patented medicines to needy patients on a non-commercial basis when they are unaffordable. The ruling clarifies that government use of a patent can extend to public healthcare, and that a cheaper medicine cannot automatically be treated as a substitute for a patented drug with different indications or treatment considerations.
A few years ago, a retired bank employee from Ernakulam, Keralam, was diagnosed with metastatic breast cancer. The disease was treatable, yet she soon succumbed, unable to afford the high cost of treatment.
She lived on a monthly pension of ₹28,400, while her husband received ₹46,000. The medicine prescribed to her, Ribociclib, is a patented drug that cost around ₹58,140 for just 21 days.
In 2022, before she died, she approached the High Court for relief, asking whether a life-saving medicine could remain financially out of reach simply because it was protected by a patent.
Four years later, the court has answered her question.
“The petitioner has succumbed to her illness and submits that the noble cause espoused by the petitioner should not go in vain. I am also of the considered opinion that the unfortunate death should not result in the cause espoused through this writ petition being rendered infructuous,” the court noted.
It held that Section 100 of the Patents Act can extend to the government using a patented invention to manufacture a medicine and sell it to a person, including a needy patient, on a non-commercial basis.
Maitreyi Sachidananda Hegde, the amicus curiae in the case, said the significance of the ruling lies in the fact that the court has examined Section 100 specifically in the context of exorbitantly priced patented medicines.
“This judgment is important because this is the first judgment that actually discusses Section 100 of the Patents Act in the context of the exorbitant pricing of patented medicines. All the other judgments, or the High Court judgments, the courts have made only passing remarks about Section 100. They did not discuss or interpret Section 100 in detail, especially in the context of medicines,” Hegde told South First.
One of the central questions in the case was whether the existence of a cheaper, off-patent medicine meant patients did not need access to patented Ribociclib.
Palbociclib, another CDK4/6 inhibitor, was available at a much lower price after going off patent. Earlier in the proceedings, the Centre had placed Palbociclib before the court as a cheaper alternative to Ribociclib.
But the court did not assume that two medicines could be substituted merely because they belonged to the same broad class.
The Regional Cancer Centre, Thiruvananthapuram, told the court that Palbociclib, Ribociclib and Abemaciclib were the three available CDK4/6 inhibitors for stage-IV breast cancer. It said the medicines had broadly similar progression-free survival outcomes, although their toxicity profiles differed, and that treatment choice could depend on individual patient and treatment-related factors.
The regulatory position, however, showed a distinction between the drugs.
The CDSCO affidavit before the court recorded Palbociclib’s use for advanced or metastatic breast cancer. Ribociclib was also approved for advanced or metastatic disease, but the regulatory material showed an additional indication for early breast cancer.
A Ribociclib approval dated 2 January 2026 covered early-stage breast cancer patients at high risk of recurrence. No corresponding early-stage indication for Palbociclib appeared in the regulatory material placed before the court.
The court considered the CDSCO affidavit along with the RCC’s report and concluded: “The expert opinion as above shows that ‘Palbociclib’ and ‘Ribociclib’ are not interchangeable.”
That finding is important because the availability of a cheaper drug did not, by itself, resolve the question of access to Ribociclib.
Chetali Rao of the Working Group on Access to Medicines and Treatments said the judgment had rejected the position advanced by pharmaceutical companies and the government regarding substitution.
“The Court has clearly rejected the arguments from the pharmaceutical companies and the Government that the need for Abemaciclib and Ribociclib can be substituted with a generic version of Palbociclib,” Rao said.
The court’s express finding, however, concerned Palbociclib and Ribociclib, which it held were not interchangeable based on the material before it.
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This brought the case to a provision of the Patents Act that most patients would probably never encounter in ordinary healthcare.
Section 100 allows the Central Government, or a person authorised by it, to use a patented invention “for the purposes of Government”.
The pharmaceutical companies argued that the provision had a narrower scope.
Novartis, the manufacturer of Ribociclib, argued that government use was intended for circumstances in which the invention was required for the government’s own purposes and could not simply be invoked to make a patented medicine cheaper for private patients.
The company also defended the patent system as an incentive for pharmaceutical innovation, telling the court that the development of a new drug involves failed trials, research, human resources and substantial investment.
Novartis described patent protection as a “quid pro quo” for that investment and argued that pricing should not determine whether a patent is granted or restricted.
The company also disputed the allegation that Ribociclib was being sold at an exorbitant price.
It told the court that its KRYXANA brand was available in India at an MRP of ₹23,625 for 21 tablets, including GST, with a stated “Price to Patient” of ₹18,184 before taxes. Novartis said the Indian price was among the lowest globally and that its India pricing was 57 percent to 96 percent lower than prices in other key countries.
It also pointed to existing price-control mechanisms, including the 30 percent trade-margin cap, and argued that CDK4/6 inhibitors represented only one category among several treatment options for breast cancer.
The company further argued that Section 100 could not be used simply as a mechanism to lower the price of a patented medicine for private patients.
The court nevertheless rejected the restrictive interpretation of the phrase “purposes of Government”.
Justice Menon examined Section 83 of the Patents Act, which sets out principles governing patents and states that patented inventions should be available at reasonably affordable prices to the public. The judgment also examined the legislative history surrounding Section 100 and references to government use in the public health system.
Hegde said this was one of the most significant aspects of the ruling. “In this case, the High Court actually discusses Section 100. The argument of the government was that this provision could be used only for the departments of the government and not for anything else. But that argument was refuted by the court,” she said.
She added: “The court held that ensuring that your citizens have equal access to the healthcare system is also a responsibility of the government, and thus, purposes of government,” Hegde said.
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The judgment stops short of directing the government to invoke Section 100 for Ribociclib or any other specific medicine.
The court said it was ultimately for the Central Government to consider whether Section 100 needed to be invoked, describing that as a policy decision.
It further held that the government must collate the required data and determine whether a particular medicine is affordable and then proceed under Section 100 if necessary.
That means the judgment establishes the legal route but does not itself activate it.
Hegde said the government’s reliance on the need for data should not be mistaken for a statutory condition written into Section 100. “The data argument from government is not really a caveat in Section 100. The section does not say that there has to be a considerable number of people affected for the government to take steps under Section 100. That is not what the Act says,” she said.
“The issue is that the government has to collect the required data and arrive at a decision as to whether a particular medicine is affordable or not. That is what the judgment says. That requirement is not there in Section 100. Section 100 essentially says that the government can use an invention for a public purpose,” Hegde said.
She added: “In an ideal society, this judgment should have a broader impact. If the government or parties go in appeal, we don’t know what the outcome will be.”
The Centre had argued during the proceedings that affordability could not simply be assumed from the price of the drug and pointed to existing price-control mechanisms.
The government also placed before the court data on Ribociclib prices, including a reduction following a cut in basic customs duty.
The judgment ultimately did not itself determine whether Ribociclib was affordable.
Instead, it placed that assessment with the government.
Hegde described the judgment as non-remedial, even while stressing its importance for interpreting Section 100. “This judgment in itself is not remedial. It does not actually give any substantial remedy to the impleading petitioner, or other citizens,” Hegde said.
In a separate statement issued after the judgment, however, Hegde took a stronger position on what she believes the ruling means for government intervention.
“The judgment of the High Court of Kerala unequivocally states that whenever access to a patented medicine is compromised due to exorbitant price and the government is required to intervene, it must make use of Section 100. Thus, the court clearly recognizes exorbitant cost as a ground for issuing a government use license. This declaration is critical for the affordable access to patented medicines in India,” she said in the statement.
The court’s own language is more qualified. It leaves the decision on whether to invoke Section 100 with the Centre as a policy decision, rather than directing the government to exercise the power.
KM Gopakumar, co-convenor of the Working Group on Access to Medicines and Treatments, said the ruling nevertheless did not provide an immediate remedy to patients.
“While agreeing that there is an exorbitant price and Palbociclib cannot be used to substitute for Ribociclib and Abemaciclib, leaving the decision regarding the use of Section 100 to the policy discretion of the government is a denial of justice to breast cancer patients who badly require access to these two patented medicines,” he said.
The judgment also does not set a timeline for the Centre to complete the affordability assessment.
Arathi PM said this could leave patients waiting for a government decision. “The denial of access to Abemaciclib and Ribociclib has resulted in a large number of avoidable deaths in the country. The lack of a timeline for the government to carry out the exercise of finding whether prices of these cancer medicines are affordable or not would result in indefinite waiting for justice for thousands of HR Positive HER2 Negative breast cancer patients in India,” she said.
She added: “We demand the Ministry of Health to immediately carry out such an exercise on these two medicines and put an end to the denial of the right to life.”
The Working Group said the issue is particularly significant because HR-positive, HER2-negative breast cancer accounts for nearly 55-60 percent of the breast cancer burden in India, according to its statement.
The High Court also placed the Ribociclib dispute against the wider financial burden of cancer care.
It referred to the 139th report of the Parliamentary Standing Committee on Health and Family Welfare, which noted that out-of-pocket spending on cancer care in private facilities was about three times that in public facilities and that around 40 percent of cancer hospitalisation cases were financed through borrowings, sale of assets and contributions from friends and relatives.
Hegde said the judgment’s significance could extend beyond Ribociclib and other breast cancer medicines, but only where the circumstances make government intervention necessary.
She used Risdiplam, marketed as Evrysdi, as an example. “Take the example of Risdiplam. Risdiplam (Evrysdy) is the medicine by the patent holder, and there is now a generic drug produced by Natco, NATSMART. The original medicine costs around ₹72 lakh per annum, whereas the generic costs around ₹5 lakh per annum,” Hegde said.
She pointed out that the availability of a cheaper generic could change the circumstances in which Section 100 becomes relevant.
“So, when there are such cases, Section 100 may not be invoked because there is already an affordable option available. It may not be affordable to everyone, but at least some kind of generic option is available,” she said.
She contrasted that with medicines for which no comparable affordable option exists.
“But that is not the case with Ribociclib or other medicines where there is no such option. If the medicine becomes unavailable, or if these medicines are not included in insurance or any government schemes, then Section 100 could come into play,” she said.
She also cited Trikafta, used for cystic fibrosis, as another example of how the availability of an alternative could alter the case for government intervention.
“Trikafta is prescribed for cystic fibrosis, which is a rare disease. It affects children. It is genetic disorder that causes severe damage to the lungs, digestive system, and other organs. Trikafta is a newer medicine for this condition. There was a period in India when Trikafta was not available and was very expensive. During that period, Section 100 could have been invoked,” Hegde said.
She added that the availability of a generic version had subsequently changed the access situation.
“More recently, a company in Bangladesh started producing a generic version, and several hospitals in India have been importing this medicine from Bangladesh. So, Trikafta has become somewhat more affordable and accessible,” she said.
(Edited by Dese Gowda)
