If patents get pricey, Kerala HC says govt can act

The Kerala High Court ruled on Monday that the government can step in when patented drugs are too expensive, directing the Center to gather nationwide data on the affordability of life-saving patented medicines and determine if existing price controls and subsidies are ensuring patient access. This decision came in a case relating to the affordability of abemaciclib and ribociclib, two patented medicines used to treat HR-positive, HER2-negative breast cancer, which represents 55-60% of breast cancer cases in India. US firm Eli Lilly owns abemaciclib, while Swiss company Novartis supplies ribociclib.

The court emphasized that protecting public health is a crucial function of the government, rejecting a narrow interpretation limiting government use to the government's own institutional or departmental requirements or national security. Advocate Maitreyi Sachidananda Hegde pointed out that the judgment established that when access to a patented medicine becomes difficult due to its exorbitant price, Section 100 of the Patents Act could be invoked.

This provision allows the government to manufacture a patented drug for governmental use without the patent holder's consent and provide it non-commercially.

The court acknowledged exorbitant cost as a ground for government use of a patented medicine, according to IP law expert Chetali Rao. However, generic versions of palbociclib, a potential alternative, are already available in India, while abemaciclib and ribociclib remain under patent protection. The court did not specify a timeline for the government to complete data collection and decide if abemaciclib and ribociclib are affordable.

This lack of timeline might delay patient access to the necessary medicines, say Arathi PM and KM Gopakumar, respectively a women's rights activist and legal scholar, and co-convenor of the Working Group on Access to Medicines and Treatments. The ruling could set a precedent for future assessments of affordability and access to patented medicines, potentially impacting the government's use of the Patents Act's government-use provision.