Recently, the Kerala High Court took suo moto cognizance of a drug’s unaffordability, following the unfortunate passing away of the petitioner who had earlier made a pleading for the government to use the Patent Act levers to curb the rising prices of a life-saving drug (pdf). The drug in question here is Ribociclib, which is available under the brand name(s) Kisqali (in the USA) and Kryxana (in India) and is used to treat certain kinds of breast cancer. The Court had previously directed the government to consider the request of the petitioner to use Patent Act levers and pass a “reasoned order” in the interim, after consultation with other authorities (This order was covered by Matthews here). However, owing to apparent inaction on the part of the State, and to ensure that the matter does not become infructuous consequent to the death of the petitioner, the court passed this order taking suo moto cognizance. In this post, I shall discuss what this suo moto cognizance could/should translate to and shall explore the possibilities of the outcome considering that there is at least one local manufacturer of the drug in India.
The Patent number for the Ribociclib is 283133 and is available under the title “Pyrrolopyrimidine Compounds And Their Uses”. The patent is registered under Novartis’ name and is valid till 2027. Inter alia, the description (pdf) of the invention explained it to be “directed to 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.” In Page 7 of the description, it is stated that the invention is used in treating cancers, which includes breast cancers too.
As per the order, a month’s dosage of the drug costs INR 58,140/-. A little online search supplements this as one can see that a strip containing 21 tablets of 200 gms each, is available for INR 20700/- on online pharmacies. According to Novartis, Ribociclib is to be administered in a dosage of 600 mg/ day for 3 weeks, and basing calculations on the above information, a monthly dose of the drug would amount to INR 62,100 (approximately INR 986 per 200mg tablet), which is approximately the same amount as mentioned in the order. The petitioner had previously averred that the price of the drug will reduce substantially if the drug is manufactured in India. Presently the drug is imported from Switzerland and after looking up the relevant Form 27s, I found the following:
in 2018, 8299 units of 200 mg. Ribocicilib were imported in India and were valued at INR 12,70,09,834 (pdf); and
in 2019, 24,857 units of 200 mg. were imported and were valued at INR 37,18,38,664 (pdf).
As a side note: It’s a bit unclear as to how these INR values were arrived at, as they don’t match the figure of INR 62,100/- as reached above.
Coming back to the case the court had passed its earlier order dated June 14, 2022, directing the government to consider the request to use the Patent Act levers. The matter was posted before the bench on two other occasions where the court lamented over the bureaucratic hurdles and inactions on part of the government (pdf for order dated July 18, 2022 and pdf for order dated September 02, 2022). On September 16, 2022 the court was informed that the Petitioner had unfortunately succumbed to her illness, after which the court took suo moto cognizance of the case.
Judicial intervention vis a vis access to medicines
Earlier, Rahul noted that courts have read the State’s obligation to ensure access to life-saving medicines as a part of Article 21 of the Constitution and thus argued for the need for more concrete intervention to nudge the government toward using patent law levers to fulfill these obligations. As has been argued in various posts on this blog, this is possible through a number of mechanisms, including:
- Issue Compulsory License (CL) u/s 84 or 92: Matthews, in his post above highlighted this mode of intervention, especially with regard to Ribociclib. Under this mechanism, the government is either approached by an applicant or the government invites applications for producing affordable generic medicines. In the present case, CL can be issued if the interested generic company can establish inter alia that presently the drug is not affordable (U/s 84(1)(b)); Or in case the government invites applications, then on the condition that it shall be made available for “public non-commercial use” i.e. will not be sold on ‘for profit’ basis (U/s 92(1).
- Government use u/s 100: As discussed by Prashant here, under this mode the government can authorize companies to use the patented invention for “the purposes of government”.
- Acquisition by Government u/s 102 and 47: Under this mode, the government can acquire a patent from the patentee and can import the drug to make it available in any government-run dispensary or hospital, u/s 47(4))
However, practically speaking, imposing the obligation on the State to ensure its seamless access to medicines like public goods is an extremely difficult task. The possibility to fulfill these obligations gets murkier considering that crucial stages of drug development are undertaken by private parties. Thus, despite having the legal mechanism to overcome the patent monopoly like compulsory licenses and government use, the government has rarely been keen to use it, since it may further result in other aligned issues like know-how gap and fear of unilateral sanctions by the developed nations. Furthermore, using these levers is only viable in cases where there is the availability of an alternate player who is willing to produce the drug at affordable prices.
Availability of Viable Route?
In the present case, if the government wishes to use these levers, there needs to be a player in the game with the required manufacturing prowess. Sometime in 2021, MSN Pharmaceuticals Ltd., a subsidiary of Indian generic drug manufacturer MSN Laboratories Ltd., submitted Abbreviated New Drug Application (ANDA) no. 215976 before the USFDA, seeking its approval to engage in commercial, manufacture, use or sale of 200 mg Ribociclib tablets in the USA, which are priced exorbitantly there, ranging from USD 62 per tablet to USD 115 ( INR 5074 to INR 9412) per 200mg tablet. If approved, the applicant i.e. MSN Pharmaceuticals Ltd. will be permitted to manufacture and sell the lower-cost variant in the USA (see here for a detailed explanation of how the ANDA process works). Presently this application has led MSN to a patent infringement litigation in the US against Novartis.
Even in India, MSN is listed as one of the “local manufacturers” of Ribociclib, as per a government list, which includes details of entities from whom the government can procure pharmaceutical goods under the Public Procurement (Preference to Make in India) Order 2017. Thus, it is clear that MSN has the capacity to manufacture the drug and make it available in India at a presumably cheaper price This can save the government from finding the above-discussed alternative to manufacture cheap drugs, especially considering that the drug is currently being imported by the patentee and not actually manufactured within the country. Or alternatively, can at least act as a bargaining chip in bringing the patentee to the table and negotiating on making the drug available at a reasonable price. The question now arises is whether the government has taken note of this (or possibly other similarly situated manufacturers), and if they are going to do anything about it.
With the turn this litigation has taken now, perhaps impleading MSN as a necessary party under Order 1 Rule 10 may clarify the situation. Or perhaps inquiring with the government on whether they’ve started any discussions around the above-discussed procurement provision with MSN, to help clear the air and assist the court to draw a reasoned conclusion. Presently, the matter is posted before the court for tomorrow ( September 29, 2022).
This case highlights the need for State intervention, from a policy aspect, in order to curb the number of casualties arising out of an inability to access life-saving drugs. Speaking specifically about cancer, the rising number of cancer patients serves as a robust argument to include in the list of notifiable diseases, which was also suggested by the Parliamentary Standing Committee on Health and Family Welfare recently. Doing so will inter alia assist in chalking the trend and pattern of the disease in India. Presently, the cancer statistics are monitored by various population and hospital-based cancer registries, which largely work on the goodwill of the patent organization- NCDIR, owing to the lack of any statutory backing. The reliable primary data on different cancers in the country can assist the government in introducing long-term policy changes to systematize the current laissez-faire system and will also lessen the burden on courts to intervene so frequently on a case-to-case basis.
Note: Our former blogger Rahul Bajaj has been impleaded as an intervener by the court by the order dated September 2, 2022, and has been identified as “capable of providing valuable inputs, which will be in aid of rendering a proper decision” by the court.