Kerala High Court says Centre can manufacture patented life-saving medicines, sell it to patients on non-commercial basis

In a significant judgment that sits at the junction of patent law and the right to health, the Kerala High Court recently held that the Union government can manufacture or authorise the manufacture of a patented life-saving medicine and sell it to patients on a non-commercial basis. The ruling, delivered on September 28 by Justice Harisankar V. Menon, is being read as one of the clearest High Court elaborations yet of Section 100 of the Patents Act, 1970.

Nevertheless, this ruling is highly unlikely to make cancer drugs like ribociclib affordable immediately. Many believe the judgment opened a legal door only to leave the key with the executive, which could once again close the door on patients.

The case

The petition began as a personal plea. A retired bank employee on a modest pension, diagnosed with HR+/HER2- metastatic breast cancer, sought government intervention because Ribociclib cost about ₹58,140 for a 21-day course. She died while the case was pending. The court converted the matter into a suo motu public-interest proceeding on exorbitant pricing of patented life-saving medicines and appointed advocate Maitreyi Sachidananda Hegde as amicus curiae.

Novartis AG (Ribociclib) and Eli Lilly (Abemaciclib) were impleaded. Cancer institutes and the Drugs Controller General of India were brought on the record. Palbociclib, already off patent, was discussed as a cheaper alternative; expert material before the court indicated it was not interchangeable for early-stage disease in the same way the government had suggested.

What the court actually held

Three findings form the core of the judgment.

First, “use of the invention for the purposes of Government” under Sections 99 and 100 is not confined to departmental or sovereign use. Reading subsections (4) and (6) of Section 100 together with Articles 21 and 47, the court held that the Centre may authorise making, using or vending a patented medicine and sell the product on a non-commercial basis to a purchaser—including a needy patient.

Second, the court held that patents are conditional. Section 83 requires that patents not impede public health, not stop the Centre from protecting public health, and that patented inventions be available at reasonably affordable prices. Parliamentary debate on the 2002 amendments was cited for the proposition that government use can serve the public-health system, including procurement and supply to hospitals or third parties.

Third, when a patented medicine is sold at an exorbitant price, Section 100 is a tool the government “is required to” invoke.

That trio is the judgment’s lasting legal importance. It treated access to unaffordable patented cancer therapy as part of the state's duty to preserve life and improve public health, and it rejected the argument that Section 100 is only for the government’s own internal use.

The court also recorded the human and fiscal backdrop: high out-of-pocket spending on cancer care, the Parliamentary Standing Committee’s 139th Report on affordability, and the fact that a large share of hospitalisation is financed by borrowing or sale of assets. An epilogue to the judgment invoked M.T. Vasudevan Nair’s Sukrutham to underline how little the lived cost of cancer has changed.

The loopholes

Those who argue the verdict will not deliver quick relief point to what the court did not do.

The Amicus and the patients wanted a mandamus—an order commanding the government to invoke Section 100 of the Patents Act, and then manufacture or authorise manufacture and supply at a reasonably affordable price. However, the court held that whether to actually invoke it is a policy decision of the central government. The court also observed that the data needed to decide whether these particular medicines are unaffordable “has not been brought on record.” Incidentally, the court asked the government to collect the necessary data nationwide. “So, the ball was then put in the government's court. The court said that the government is required to collect the data, make an assessment, and proceed under Section 100 if there is an affordability issue. But the court did not prescribe any time frame for this,” noted K.M. Gopakumar, co-convenor of the Working Group on Access to Medicines and Treatments. "So, the government can simply sit on this and keep saying, "We are assessing it, we are assessing it.'" "That's one issue. Now, which arm of the government should actually carry this out? "Notably, Gopakumar had written a letter to the Chief Justice of the Kerala High Court on July 10 this year, seeking an expeditious hearing in this case.

Gopakumar noted that now with this judgment the court closed the writ petition. “Suppose after collecting the data, the government says that Rs60,000 for a drug is affordable for Indians. What is the remedy? There is no remedy,” he says. "Imagine there is a patient in this situation. They would have to approach the court again and go through the entire legal process that might take years.”

There is also a deeper constitutional question that the judgment, according to Gopakumar, leaves unanswered. He noted that the court recognised that the high price of the medicines affects the right to health and that Section 100 can be invoked in cases of exorbitant pricing. At the same time, it treats the decision to invoke the provision as a matter of government policy.

The petition had specifically raised the question of whether such policy discretion can prevail when a fundamental right is allegedly being violated. “On the one hand, the court says that the government has a duty to protect people’s health. Then it says that deciding how to address this is for the government to decide,” Gopakumar says.

In his view, the government could pursue several routes to make the medicines affordable. But where patent protection prevents the availability of affordable alternatives, Section 100 is one of the mechanisms available to the government. “When fundamental rights are being violated, can the government still say that it is its policy decision whether or not to address that violation?” he asks.

The existing policy framework also raises questions about how such access would be sustained. The government has price-control mechanisms, but Gopakumar argues that these have not made the medicines affordable in this case. Nor are the drugs currently being provided free of cost under government schemes such as PM-JAY.

Even if the government were to procure and distribute the medicines, he argues, their price would remain a crucial factor. In a country where a large proportion of medicines are purchased through the private sector, ensuring an affordable supply would also be essential for any government procurement programme to be sustainable.

The court, however, did not examine this broader question of how affordability and long-term access to the medicines could actually be ensured.