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The Kerala High Court allowed a breast cancer patient currently on Ribociclib to be impleaded in a suo motu case on the pricing of patented breast cancer drugs.
Justice Harisankar V. Menon permitted the impleadment and posted the matter to 3 September for final hearing.
The original petition was filed by another patient on Ribociclib who sought Central government intervention under Sections 83, 92 or 100 of the Patents Act, 1970; she died while the case was pending, after which the Court converted it into a suo motu petition.
The Court has sought expert opinion on whether Palbociclib, a cheaper off-patent drug manufactured locally, can substitute the patented Ribociclib and Abemaciclib.
Ribociclib is a CDK 4/6 inhibitor marketed in India by Novartis as Kryxana at close to Rs 70,000 a month; Abemaciclib costs about Rs 95,000 a month.
Cyclin-dependent kinases 4 and 6 are enzymes that push a cell from the resting phase into division. In hormone-receptor-positive breast cancer these kinases are over-active, so the tumour keeps cycling. Ribociclib, Palbociclib and Abemaciclib all block CDK 4 and CDK 6, stalling the cell cycle and halting growth and spread. None is given alone: each is prescribed alongside a hormone therapy drug, and each is used for cancer that has spread beyond the breast - either to distant organs (metastatic) or to nearby lymph nodes, muscle and skin (locally advanced). Because the same enzymes drive division in healthy cells too, the class carries real side effects that need monitoring.
Simple Analogy: CDK 4 and 6 are the ignition switch on the cell's replication engine. The drug does not repair the engine - it removes the key, so the cell cannot start the next cycle of division.
Sets out the general principles applicable to the working of patented inventions - among them that patents are granted to make the benefit of the invention available at reasonably affordable prices, and are not granted merely to enable a monopoly on imports
The general compulsory licence route. Any interested person may apply, but only after three years from the grant of the patent, on grounds including that the patented invention is not available to the public at a reasonably affordable price
The emergency route. The Central Government may by notification permit compulsory licences at any time in a case of national emergency, extreme urgency, or public non-commercial use - no three-year wait applies
Government use. Allows the Central Government, or anyone authorised by it, to use a patented invention for the purposes of government
The right to life, which the courts have read to include the right to health and to access to medical treatment - the constitutional hook for a pricing challenge of this kind
India's first compulsory licence for a pharmaceutical product, granted in March 2012 over Bayer's anti-cancer drug sorafenib (Nexavar), on the ground that the patentee had not made it available at a reasonably affordable price. Bayer's version cost around 5,000 dollars a month; Natco's generic was priced near 160 dollars. Bayer's challenges failed
Sections 92 and 100 sit at the centre of every debate on access to patented medicines in India, yet they have almost never been invoked - which is why a High Court asking the government to consider them attracts attention out of proportion to the size of the order
The Ribociclib genus patent expires on 24 May 2027. Part of the argument against a compulsory licence is simply that generic entry is close; the argument for it is that patients on treatment now cannot wait for a patent to lapse
By asking whether Palbociclib can do the same clinical work, the Court has opened a second route that bypasses patent law altogether - if an off-patent drug in the same class is an adequate substitute, the pricing problem becomes a prescribing and procurement problem
GS Paper 2 > Issues Relating to Health, Government Policies and Judiciary; GS Paper 3 > Intellectual Property Rights and Science and Technology
General Awareness > Current Affairs and Polity
An authorisation allowing a third party to make or sell a patented product without the patentee's consent, subject to royalty - permitted by the TRIPS Agreement and implemented in India through Sections 84 and 92 of the Patents Act, 1970
A case a court takes up on its own motion; here, the device that kept the proceeding alive after the original petitioner died
The addition of a new party to an ongoing case, allowed where that person has a direct interest in the outcome
A patent covering a broad class of related chemical compounds, as distinct from a species patent on one specific molecule
A drug that blocks cyclin-dependent kinases 4 and 6 to arrest cell division; Ribociclib, Palbociclib and Abemaciclib all belong to this class