Breast cancer drugs can be made affordable by invoking the provision of Patents Act, says Kerala High Court
Central Government can exercise powers under Patents Act 1970 and make extremely expensive life-saving medicines available to patients, says Kerala High Court. The decision was made in a dispute over the price of patented drugs to treat breast cancer, which puts the right to access lifesaving medicines at the centre of the debate with the monopoly rights that patent holders claim.
Justice Harisankar V. Menon, in the suo motu proceedings In Re: Exorbitant Pricing of Life Saving Patented Medicines, noted that the government can utilise a patented invention to manufacture the medicine concerned and make it available – including to the needy patients – on a non-commercial basis under Section 100 of Patents Act.
The petitioner, a breast cancer sufferer, had sent a petition to the government for the availability of the patented drug Ribociclib at an affordable price to affected patients. The medicine is said to cost about ₹75,000 per month. Subsequently, petitioner died during the pendency of the proceedings, and subsequently the Kerala High Court initiated the proceedings as a suo motu case relating to the excessive pricing of patented life saving medicines.
The case gained more prominence when the Supreme Court also suo motu took cognisance of the larger question of the availability of life-saving medicines at affordable prices and expressed concern at the fact that the original proceedings had been pending for a long period of time.
Avoid using Section 100 as Government UseJudgment is especially relevant to Section 100 of the Act, which relates to government use of patented inventions. The Court explained that the provision may apply to the situation where the government was intervening when a patented medicine was being sold at an excessive price.
But it’s important to not mistake Section 100 for the regular compulsory-licensing path of Section 84. Section 84 allows a person to apply for a compulsory licence, when for example “new and substantial public advantages” have not been met, or the invention is not offered at a “reasonably affordable” price.
Section 83 of the Act also expressly recognises that patents should not impede public health and states that patented inventions should be available to the public at reasonably affordable prices.
The High Court did not just say that a specific drug was too expensive. Rather, it focused on an evidence-based evaluation. The government has a duty to gather relevant information and ascertain if the patented medicine in question is really affordable. If intervention is determined to be necessary, Government can act under Section 100.
This is significant because pharmaceutical companies have claimed that patents must be given to pay for the large amounts of research and development and to promote innovation. But in the process, manufacturers argued that convenience shouldn’t be measured simply against the cost of a patented medicine and the price of an alternative.
This case raises a tricky case of law. Patents are awarded for exclusive commercial rights to promote innovation, and Article 21 of the Constitution has been interpreted to include protection of life and health.
It does not eliminate patent protection or grant an automatic ‘green light’ for the government to make all of the high-cost patented medicines. Instead, it acknowledges a statutory process where government intervention can be considered when public health issues and excessive pricing warrant it.
The ruling of the Kerala High Court is remarkable in the context of the public-health jurisprudence of India. It reiterates the concept that patent rights exist within a statutory framework, which also takes into account public interest and access to medicines.
The challenge for the government now is to collect reliable evidence, objectively assess the cost and to decide if the intervention in the section 100 is warranted. It is thus clear from the case that patent system cannot be considered merely a tool that secures commercial interests, but should also be regarded as having legal instruments which can be used to solve situations in which costs associated with life-saving treatment exceed the financial capacity of the patient.
