Court mandates government intervention in exorbitant pricing of life-saving drugs, invoking Section 100 of the Patents Act for public welfare.
In a landmark judgment, the Kerala High Court, presided over by Justice Harisankar V. Menon, addressed the critical issue of exorbitant pricing of life-saving patented medicines. The court ruled in favor of the government's right to utilize patented inventions under Section 100 of the Patents Act, 1970, to ensure public health and affordable access to essential medicines.
The case, titled "In Re Exorbitant Pricing of Life Saving Patented Medicines v. Union of India," was initially filed by a retired bank employee diagnosed with HR+/HER2- Metastatic Breast Cancer. The petitioner argued for government intervention under Sections 92 and 100 of the Patents Act to reduce the price of the cancer drug Ribociclib, which was prohibitively expensive at Rs.58,140 for a 21-day course.
The court recognized the government's duty under Article 47 of the Constitution to improve public health and affirmed that access to affordable life-saving treatment is an essential component of the right to life under Article 21. Justice Menon emphasized that the central government holds the authority to manufacture and distribute patented medicines on a non-commercial basis, ensuring they are available at affordable rates to patients in need.
Key to this decision was the interpretation of the term "for the purposes of Government," which the court expanded to include public health measures and affordable healthcare access. The ruling further highlighted the importance of leveraging patent laws to fulfill constitutional obligations, especially when patented medicines are priced beyond the reach of the general population.
The judgment also called upon the Central Government to gather data on the affordability and accessibility of patented medicines, urging a policy decision on invoking Section 100 of the Patents Act. The court noted that while the term "may" is used in Section 100, it should be read as "shall" in cases where public health is at stake.
The court's decision is seen as a significant step towards balancing intellectual property rights with public health needs, ensuring that life-saving drugs are not out of reach for those who need them most.
Bottom Line :
Patents Act, 1970 - Section 100 - Government's power to use patents for public health purposes - Court held that the Central Government has the authority to use patented inventions for non-commercial purposes, such as manufacturing life-saving medicines, and sell them at affordable prices to needy patients.
Statutory provision(s):
Patents Act, 1970 - Sections 83, 92, 99, 100, 156
Constitution of India - Articles 21, 47
