For breast cancer patients paying Rs 80,000 a month, a Kerala HC ruling offers hope of cheaper drugs

While the ruling opens up a possible route to making these medicines more affordable, patients are unlikely to see immediate relief.

What is Section 100 of the Patents Act?

Section 100 allows the Central government to use a patented invention. In its judgment, the Kerala High Court clarified that this power extends to manufacturing a patented medicine and selling it, including directly to a patient in need, on a non-commercial basis.

The court also said the government should invoke this provision when medicines are being sold at exorbitant prices. The question is significant because many newer cancer medicines remain beyond the reach of patients who need them. A real-world study from Tata Memorial Hospital found that only 1.6% of patients who needed immunotherapy were able to access it, with cost being one of the major barriers.

What needs to happen before patients can access these medicines?

The judgment does not mean that the medicines will become cheaper or more widely available immediately. Several steps remain before the government can act.

The court said the government must first collect data to establish whether a medicine is affordable. This would include the number of people affected by the particular type of cancer, how many patients are taking the medicine, and how many are unable to take it because of its price.

However, the judgment does not specify a timeline for this exercise or identify which ministry or government department should undertake it. “The court, however, has not given any timeline for the government to collect the data and arrive at a conclusion. It also does not say which arm of the government, which ministry, will undertake this exercise. And, importantly, the petition has been disposed of. This effectively means that in the absence of an appeal, the government may take a very long [time], citing that it does not have the data, by which time the medicine may come off patent anyway,” said an expert on patent law.

Other experts point to the substantial revenues pharmaceutical companies have earned from these medicines, even as their prices put treatment out of reach for many patients.

The two medicines named in the petition, abemaciclib and ribociclib, are sold by pharmaceutical companies that typically cite research and clinical trial costs of $2.6 billion for developing a medicine. Estimates prepared by the experts quoted here put the costs of developing these two medicines considerably lower.

Even if the $2.6 billion figure is taken as the benchmark, they argue, the companies have earned several times that amount in sales. Abemaciclib generated sales worth $19.6 billion and ribociclib $12.7 billion over the last six years, they said.

What are abemaciclib and ribociclib, and how do they work?

Abemaciclib and ribociclib are targeted cancer medicines. Both belong to a class of drugs called CDK4/6 inhibitors. They work by blocking proteins that help cancer cells grow and multiply, thereby slowing the progression of the disease.

They are used to treat a specific type of breast cancer that grows in response to hormones such as oestrogen and progesterone, but does not have high levels of a protein called HER2, which can fuel the growth of cancer cells when present in high amounts. Since these cancers do not have high levels of HER2, drugs such as trastuzumab, which specifically target HER2, do not work. Abemaciclib and ribociclib, on the other hand, target the CDK4/6 proteins involved in cell division, making it useful in treating this type of breast cancer.

A third medicine in this class, palbociclib, is already off patent and generic versions are available. Abemaciclib and ribociclib, however, remain patented, limiting the scope for generic competition.

For patients who cannot afford these medicines, the court’s judgment has raised the possibility of government intervention. Whether that possibility translates into more affordable treatment will depend on how quickly the government acts and what steps it takes next.