The Ribociclib review

17 November 2022
  • Dr. Mohan Dewan


Following the tragic death of the petitioner who had earlier pleaded with the government to use the Patent Act's levers to stop the escalating costs of life-saving treatment, the Kerala High Court recently took suo moto cognizance of a drug's unaffordability i.e. Ribociclib, a medication used to treat specific types of breast cancer. Ribociclib is marketed under the brand names Kisqali in the USA and Kryxana in India. In a prior order, the Court had instructed the government to take into account the petitioner's request to use Patent Act tools and to issue a "reasoned order" in the meantime after consulting with other authorities.

However, the court issued this order taking suo moto notice due to what appears to be a delay on the side of the State and to prevent the matter from becoming infructuous as a result of the petitioner's passing. The government was instructed to take into account the request to employ the Patent Act's levers by the case court's earlier order, which was issued on June 14, 2022. On two additional occasions, the subject was brought before the bench, and the court bemoaned the red tape and inaction of the administration. After learning that the petitioner had tragically passed away as a result of her illness on September 16, 2022, the court took suo moto cognizance of the matter.


Ribociclib’s Patent


The Ribociclib patent has the number 283133 and is titled "Pyrrolopyrimidine Compounds and Their Uses." The patent is assigned to Novartis and is valid until 2027. The patent claims “methods of combination therapy for inhibiting protein kinase activity in cells, or for treating, preventing or ameliorating of one or more symptoms of cancer, transplant rejections, and autoimmune diseases in patients using the compounds of the invention or pharmaceutical compositions, or kits thereof.” The invention is utilized to cure tumours, including breast cancers, according to the description on page 7.


Dosage and Cost 


According to the Order, a month's supply of the medication costs INR 58,140. A quick web search reveals that a strip of 21 tablets, each weighing 200 grams, can be purchased for INR 20700/- from online pharmacies. Based on the information above and the dosage of 600 mg per day for three weeks as recommended by Novartis, a monthly dose of the medication would cost INR 62,100. (Approximately INR 986 per 200mg tablet). The medication is presently imported from Switzerland. Form 27 of the Patent Act relates to the statement regarding the working of a patented invention on a commercial scale. The analysis of Form 27 of patent no.: 283133 infers the following:

·       In 2018, 8299 units of Ribocicilib (200 mg) were imported and valued at INR 12,70,09,834.

·       In 2019, 24,857 units of Ribocicilib (200 mg) were imported and valued at INR 37,18,38,664.


The petitioner had claimed that if the medication is made in India, the price will drop significantly. 


Judicial intervention regarding medication access

In the past, Indian Courts have interpreted the State's duty to guarantee access to life-saving medications as a requirement under the Article 21 of the Indian Constitution and have argued for the necessity for a direct action to encourage the use of patent law levers by the Government in order to carry out the commitments. This is made possible in a variety of ways, such as:


a.     Compulsory License (CL) issued u/s 84 or 92 of the Patent Act: In accordance with this method, the Government either receives an application directly from the applicant or issues an invitation to apply. A CL may be granted if the company can demonstrate, among other things, that the drug is out of reach under section 84(1)(b); or, if the Government solicits the application, upon understanding that the drug would be made available to public for "non-commercial use," meaning it won't be sold for profit (u/s 92).

b.     The government uses u/s 100 of the Patent Act: The government may permit firms to utilize a patented invention for "the purposes of government."

c.      Government Acquisition u/s 102 and 47 of the Patent Act: In this approach, the government may purchase the patent from the patentee and make it available in any government-run dispensary or hospital.


Convincing the State to ensure a smooth access to medications is a challenging undertaking from a practical standpoint. Given that private companies carry out important stages of drug research, the likelihood of fulfilling these commitments becomes murkier. Since it could lead to other related problems including a knowledge gap and the concerns of unilateral sanctions by wealthy nations, the government has been reluctant to employ the legal mechanisms to break the patent monopoly. Additionally, employing such levers only makes sense in situations where a different entity is willing for the medicine production at a competitive price.


Viable Route?


Currently, if the government wants to employ these levers, there mandates an existence of a player with the necessary industrial prowess. A submission for an Abbreviated New Drug Application (ANDA) no. 215976 to the USFDA was made by a subsidiary of MSN Laboratories Ltd in 2021 seeking permission to manufacture, use, and sell 200 mg Ribociclib tablets in the USA. However, these tablets are expensive and the cost may range anywhere from $62 to $115.


According to a list issued by the Government under the Public Procurement (Preference to Make in India) Order of 2017, which includes information on organizations from which the Government can purchase pharmaceutical products, MSN stands listed as a "local maker" of Ribociclib. Therefore, MSN can manufacture and distribute the drug in India at a supposedly lower cost.


However, the drug is currently being imported by the patentee and not created within the nation, which prevents the government from discovering the alternatives to manufacture affordable drugs.



This instance emphasizes the necessity for state engagement from a policy perspective to reduce the number of fatalities brought on by a lack of access to life-saving medications. The number of cancer patients growing at an alarming rate is a compelling case for adding it to the list of conditions that require notification, as proposed recently by the Standing Committee of the Parliament on Health and Family Welfare. Doing so will, among other things, help to chart the disease's trend and pattern throughout India


Currently, hospital-based cancer registries keep track of cancer statistics. Due to the absence of any statutory support, these registries rely heavily on the goodwill of the National Centre for Disease Informatics and Research. The Government may introduce long-term policy adjustments to systematize the current minimal government interference system with the help of trustworthy primary data on the various malignancies that are prevalent in the nation. This will also make it less necessary for the courts to step in on an individual basis as often.


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