Innovator pharma companies could face a loss of control over patented medicines in India if the government finds that their prices are “exorbitant”. The Kerala High Court on Monday held that Section 100 of the Patents Act can be used by the government to intervene in such cases. In the judgement, the court made it clear that government use of a patent is not restricted to medicines consumed by government departments. The provision can also cover the manufacturing of a patented medicine and its non-commercial supply to people who need it, including needy patients.
According to the ruling, the patent itself remains with the innovator. But it allows the government, in specified circumstances, to authorise another entity to manufacture the patented medicine and supply it to patients on a non-commercial basis. The patent holder would still be entitled to remuneration for such use with the payment to be agreed between the government and the patentee or determined by the High Court, taking into account the economic value of the patent’s use.
However, the court did not direct the government to invoke Section 100 in any particular case. It said the central government has to first collate the necessary data and determine whether a particular medicine is affordable before deciding whether to proceed under the provision.
“In the light of the afore, this court is of the opinion that the provisions of Section 100 of the Act are required to be invoked in circumstances where the government is required to intervene, such as when the medicine is unaffordable on account of its exorbitant price,” the ruling said.
Experts said the judgment could pave the way for greater use of Section 100 in cases involving unaffordable patented medicines. “Following the judgement, people may make use of Section 100. It’s a stepping stone to use Section 100 effectively,” said Maitreyi Hegde, founder and senior partner at NyaayanishthaLegal Associate.
“When the patent protection comes in way to prolong the life of patients, this judgment is going to gain prominence,” said K.M. Gopakumar, KM Gopakumar, co-convenor, Working Group on Access to Medicines and Treatment.
The court also linked the government’s power under Section 100 to its constitutional duty to improve public health. It said Article 47 places public health among the primary responsibilities of the government. “There can be no doubt that the government is required to provide all necessary facilities to citizens to ensure access to healthcare, including access to life-saving treatment, as in the case at hand. As pointed out in the case at hand, the high cost of the drug in question virtually defeats the requirements under Articles 21 and 47 of the Constitution of India,” the court stated.
The ruling came out of a case involving the high price of Ribociclib, a patented drug used to treat breast cancer. The case was originally filed by a breast cancer patient who sought government intervention to make the medicine more affordable. It also examined whether Palbociclib could be considered an alternative to Ribociclib, as its patent had expired. Based on the medical evidence placed before it, the two medicines were found to be not interchangeable.
The bench then considered whether Section 100 could be used to address the high price of Ribociclib. It held that the provision can be used in appropriate circumstances, including when a patented medicine is unaffordable because of its price.
Importantly, the ruling did not direct the government to manufacture Ribociclib or immediately override the patent. It said the government must first collect the necessary data and determine whether a medicine is affordable.