The Kerala High Court on Monday held that the Centre can invoke Section 100 of the Patents Act, 1970, to use a patented medicine for public health purposes, including manufacturing it and selling it to needy patients on a non-commercial basis.
The case dates back to 2022, when a breast cancer patient approached the court seeking government intervention to make ribociclib more affordable. The drug cost around ₹75,000 a month at the time. The petitioner died while the case was pending, following which the court continued examining the issue in the larger public interest.
So, what exactly is a drug patent, how are pharmaceutical patents regulated in India, and when can the government use a patented medicine without the patent holder’s consent?
What is a drug patent?
A patent is a statutory right granted for an invention, allowing the holder to prevent others from making, using, selling or importing it without consent for a limited period. For medicines, the patent may cover the drug itself, its formulation or its manufacturing process, depending on what has been claimed and granted. However, not every new drug, modification or use of an existing substance qualifies for a patent in India.
How are drug patents regulated in India?
India’s patent regime is governed by the Patents Act, 1970. The law was amended in 2005 to introduce product patents for pharmaceuticals, in line with India’s obligations under the WTO’s TRIPS Agreement.
According to the Act, a patent generally lasts for 20 years from the date of filing the application. Once the patent expires, patent protection ends. Section 3 excludes the mere discovery of a new form of a known substance unless it results in enhancement of that substance’s known efficacy. It also excludes the mere discovery of a new property or new use of a known substance. It also excludes certain mere admixtures, processes for the medicinal, surgical, curative, prophylactic, diagnostic or therapeutic treatment of humans and animals.
The Act also provides for pre-grant and post-grant opposition, allowing challenges to patent applications and granted patents under specified conditions.
Are all drugs patented in India?
No. A drug is not automatically protected by a patent simply because it is new or commercially available. For a patent to be granted, the claimed invention must meet the statutory requirements.
Drugs whose patent protection has expired can also be manufactured as generics, subject to other applicable regulatory requirements. This is why many commonly used medicines, including older antibiotics, pain and fever medicines, are available as generics. At the same time, newer medicines, including drugs used in areas such as cancer, diabetes, weight management and autoimmune diseases, may be protected by active patents.
Can the government override a drug patent?
Section 100 of the Patents Act, 1970, allows the Central government, or a person authorised by it in writing, to use a patented invention for public health purposes. The provision applies even after a patent has been granted and allows the government to authorise another person to use the invention.
Importantly for medicines, Section 100(4) expressly refers to the authority being given to a person to make, use or import ‘any medicine or drug’ covered by a patent. However, this does not mean that the government can simply disregard every pharmaceutical patent whenever it considers a drug expensive.
Section 100 also provides for remuneration to the patent holder in cases where the invention had not previously been recorded, tested or tried by or on behalf of the government before the relevant priority date. The terms can be agreed between the government and the patentee or, failing agreement, determined by the High Court. Where the invention had previously been recorded, tested or tried independently by the government before the priority date, government use can be free of royalty or other remuneration.
What does international law say?
The international framework is governed primarily by the WTO’s TRIPS Agreement (Trade-Related Aspects of Intellectual Property Rights), which requires member countries to provide patent protection for inventions, including pharmaceutical products, for a minimum of 20 years from the filing date. It also allows governments certain flexibilities to address public-health concerns.
Under Articles 27 and 33, WTO members must provide product and process patent protection and a minimum 20-year patent term. Article 31 allows governments to authorise the production of a patented drug without the patent holder’s consent, including in response to public-health concerns or exorbitant pricing. The poorest nations are exempted from issuing or enforcing pharmaceutical patents and data protection until at least 2033.
How do other countries regulate drug patents?
United States
The United States uses a system called patent linkage. The FDA maintains a registry called the Orange Book. If a generic company tries to register a copycat drug, the FDA automatically blocks its approval for up to 30 months if the patent holder files a lawsuit.
European Union
The European Union does not use patent linkage, it rather relies heavily on data and market exclusivity rules. Under the “8+2+1” rule, even if a drug has no patent, generic companies cannot copy the original clinical trial data for eight years, cannot launch the drug for 10 years, and face an additional year of delay if the creator finds a new medical use for the drug.
Canada
Canada has the Patented Medicine Prices Review Board (PMPRB), an independent quasi-judicial body that monitors prices of patented medicines to ensure they are not excessive. Following a hearing, it can order a price reduction and measures to offset excess revenues.
United Kingdom
In the United Kingdom, drug patents are granted and regulated by the Intellectual Property Office (IPO). It assesses applications under the Patents Act 1977 to determine whether the drug or compound is new, inventive and industrially applicable. The IPO also issues Supplementary Protection Certificates (SPCs), which can extend patent protection to compensate for time spent on lengthy clinical trials before a drug reaches the market.
