NEW DELHI: The Kerala high court has said the Centre can invoke provisions of the Patents Act to manufacture and distribute a patented medicine to patients in need when the drug is being sold at an exorbitant price.The court made the observation while dealing with a 2022 petition filed by a woman suffering from breast cancer, who had sought affordable access to the drug Ribociclib, news agency PTI reported. She died while the case was pending.Justice Harisankar V Menon, in a 65-page judgment, said the Centre can use a patent or invention to manufacture a patented medicine and sell it on a non-commercial basis to a person in need under Section 100 of the Patents Act, which deals with the government’s power to use inventions for government purposes.The court held that Section 100 “is required to be invoked in circumstances, where the government is required to intervene”, including cases where a patented medicine is being sold at an exorbitant price, PTI reported.The court, however, said the government would first have to collect the relevant information and assess whether the price of a particular medicine is affordable before taking action under the provision.The petition was filed by a former bank employee who had been diagnosed with HR+/HER2-metastatic breast cancer and was undergoing treatment with a CDK 4/6 inhibitor, Ribociclib.According to the petition, the medicine cost around Rs 58,140 for a 21-day course. She had approached the court seeking a reduction in its price or access to the drug at an affordable cost.After her death, the high court took suo motu cognisance of the larger issue of the high prices of patented life-saving medicines, PTI reported.During the proceedings, the Centre and pharmaceutical industry representatives argued that Section 100 could be invoked only for government purposes and could not be used in the circumstances before the court.The high court rejected that interpretation.The court said the expression “for the purposes of government” must be understood to include the government’s power to sell or supply products manufactured using a patent or invention to a buyer on a non-commercial basis.“In that event,” the court said, Section 100 would include the government’s entitlement to manufacture the patented medicine and sell it on a non-commercial basis to a person who could be “none other than the needy patient”.The court also said the government has an obligation to ensure access to healthcare, including life-saving treatment.In reaching its conclusions, the high court referred to the 139th Report of the Department-Related Parliamentary Standing Committee on Health and Family Welfare on cancer treatment. The report had emphasised the need for government and private-sector participation to make cancer care more affordable.The court also referred to the Malayalam film ‘Sukrutham’, starring Mammootty, which depicts the difficulties faced by cancer patients and their families.
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The court observed that it was “highly distressing” that despite nearly three decades having passed since the film’s release, the situation had not changed substantially.The judgment stressed the need for a balance between ensuring affordable access to medical treatment and maintaining adequate incentives for innovation.“It is imperative that, we, as a community and as a system that caters to billions, strike the balance between affordable access to medical treatment and maintaining adequate incentives,” the court said.