In re Exorbitant Pricing of Life Saving Patented Medicines (2026)

Summary

"The captioned writ petition was initially filed by a retired Bank employee" who "was diagnosed with HR+/HER2-Metastatic Breast Cancer being treated with 'targeted therapy' – CDK 4/6 inhibitors. The medicine 'Ribociclib' is stated to be one among them." (para 1) "Reference is made to the statutory provisions under the Patents Act, 1970 (hereinafter referred to as the 'Act') to contend that the Government is to intervene with reference to the provisions under Section 92/100, since on account of the grant of patent to the medicine, the same is exorbitantly costly, thereby affecting the life of patients like the petitioner." (para 2) "While the writ petition was pending, the petitioner succumbed to her illness", and the Court ordered that "this writ petition shall continue on the board of this Court, as a matter in which this Court has taken suo motu cognizance on the issue of exorbitant pricing of life saving patented medicines." (para 3) The Amicus Curiae submitted that "only Section 100 of the Act is the viable option" and that "the applicability of Section 100 alone is pressed into service." (para 9)

The Court held that "the provisions under Section 100 would include the entitlement of the Government to use the patent or invention for manufacturing the medicine covered by the patent and sell the same on a non-commercial basis to a person who can be none other than the needy patient" (para 27), that "the term 'purposes of Government' also includes the duty of the Government/State to improve public health as mandated under Article 47 of the Constitution of India" (para 30), and that "the provisions of Section 100 of the Act are required to be invoked in circumstances where the Government is required to intervene, such as when the medicine is unaffordable on account of its exorbitant price." (para 37) It held, however, that "it is for the Central Government to consider whether Section 100 of the Act requires to be invoked since ultimately the same is a policy decision" (para 39), and that "the required data to decide whether the particular medicines in question are affordable or not, has not been brought on record." (para 42) The Court "dispose of this writ petition with the following findings", the third being that "The Government requires to collate the required data and arrive at a decision as to whether a particular medicine is affordable or not and, on that basis, proceed in accordance with Section 100 of the Act, if found necessary." (p 55–56)

What the court decided

1. Palbociclib and Ribociclib. "In the said affidavit, with reference to the details available with that office, it is pointed out that Palbociclib is used in the treatment of 'advanced or Metastatic Breast Cancer'. However, as regards Ribociclib, it is pointed out that the same is being used for 'early Breast Cancer'." "The expert opinion as above shows that 'Palbociclib' and 'Ribociclib' are not interchangeable." (para 22)
2. Sections 99 and 100 read together. "True, Section 100 of the Act begins with a non-obstante clause. However, it requires to be noticed further that the Central Government or any person authorised in writing by it is permitted to 'use the invention for the purposes of Government' in accordance with the provisions of Chapter XVII." (para 24) "In other words, the patent/invention requires to be used by the Government alone under the provisions of Section 100 read with the provisions of Section 99." (paras 24–25)
3. Sub-sections (4) and (6). "In view of the afore provisions, this Court is of the opinion that the term 'for the purposes of Government' requires to be interpreted also taking into account the right to vend/sell the goods made using the patent and invention on a non-commercial basis to a purchaser. The provisions of Section 100 impose no restriction on who the purchaser could be. When that be so, the provisions under Section 100 would include the entitlement of the Government to use the patent or invention for manufacturing the medicine covered by the patent and sell the same on a non-commercial basis to a person who can be none other than the needy patient. This position is made further clear by the specific inclusion of 'medicines or drugs' under sub-section (4)." (para 27)
4. Garware and purposes of Government. Of Garware Wall Ropes v A.I. Chopra (2008), relied on "by the respondents (the Government and the Companies) to state that the term 'purposes of Government' is having a restrictive meaning" (para 28), the Court held: "True, the Bombay High Court held that the term 'purposes of Government' can only be of meaning: purposes of Government by any department of the Government and use by servants and agents of the Government in performance/discharge of their duties. However, it is necessary to notice the distinction, as observed by the Bombay High Court, between the provisions of Section 100 and Section 47 of the Act, which uses the words 'merely of its own use'. The term 'purposes of Government' also includes the vending of articles made using the invention, as laid down under sub-sections (4) and (6) of Section 100, as discussed earlier, and the same cannot be disputed in view of the clear language." (para 28) It added that the Nagpur Bench "has also, in paragraph 22 of the afore judgment, held that the provisions under Section 100 as well as Section 47 have been made so that the patents can be utilised by the Central/State Government for purposes other than purely departmental in the discharge of duties or the sovereign functions." (paras 28, 30)
5. Article 47 and public health. "Article 47 of the Constitution of India has laid down that the State has a duty to improve public health, being a primary duty of the State." "Therefore, the term 'purposes of Government' also includes the duty of the Government/State to improve public health as mandated under Article 47 of the Constitution of India. This has to include the use of the patent, manufacturing of the medicines, and supplying the same on a non-commercial basis under Section 100(6) of the Act to the needy patients." (paras 29–30)
6. The pandemic judgment. Of the reliance on Distribution of Essential Supplies and Services During Pandemic, In Re ((2021) 18 SCC 201), the Court held that it "may also not be apposite" and that "Therefore, the Apex Court has also held that Section 100 is required to be enforced in the interest of the public at large, particularly to ensure the protection of patients. Reference also needs to be made to the provisions of Articles 7/8 of TRIPS, wherein it is made clear that the very aim of providing intellectual property rights is for the 'mutual advantage of producers and users' alike and also to empower the member nations to 'adopt measures necessary to protect public health and nutrition'." (para 31)
7. Article 21 and access to treatment. "The right to self-preservation of one's life is to be accorded paramount importance by virtue of the mandate under Article 21." (para 32) "Therefore, there can be no doubt that the Government is required to provide all necessary facilities to citizens to ensure access to healthcare, including access to life-saving treatment, as in the case at hand. As pointed out in the case at hand, the high cost of the drug in question virtually defeats the requirements under Articles 21 and 47 of the Constitution of India. This is because, as already noticed, the 'purposes of Government' would encompass the mandate contained in Articles 21 and 47 referred to above." (paras 32, 34)
8. Section 83. "Therefore, the fact that the patent granted is subject to the right of the Government to promote public health and the public interest has been made very clear by the incorporation of the above caveat. Further sub-section (g) also speaks about the requirement/duty to provide patented inventions at reasonably affordable prices to the public." (para 35)
9. The parliamentary debates. "In response to certain apprehensions by the Parliamentarians, it has been clarified that under the provisions of Section 100 of the Act, the Government can use the patent at any time 'in the interest of the public health system'. It is further clarified that the Government can 'procure it and sell it to the hospitals or they can give it to third parties'. Therefore, the intention behind the provisions of Section 100 is also made clear as noticed above." (para 36)
10. When section 100 applies. "In the light of the afore, this Court is of the opinion that the provisions of Section 100 of the Act are required to be invoked in circumstances where the Government is required to intervene, such as when the medicine is unaffordable on account of its exorbitant price." (para 37)
11. The patentee's protection. "On account of the protection as above, the patent holder enjoys an exclusion of any other person from using the invention, till such time validity of the patent continues. Even the Government is bound by the patent, as has been clearly stated in Section 156 of the Act. If such sanctity is not being extended to a patentee, that would be a factor which would be counterproductive insofar as no one will come forward to register their patent under the statute." (para 38)
12. A policy decision for Government. "In the light of the afore, it is for the Central Government to consider whether Section 100 of the Act requires to be invoked since ultimately the same is a policy decision." (para 39) "Thus, it is for the Central Government to consider whether Section 100 requires to be invoked after collecting the necessary statistics." (para 40) "Therefore, ultimately it is for the Central Government to consider the question as to whether Section 100 of the Act requires to be invoked with reference to the factual position." (paras 39–40, 43)
13. Data to be collected. "The data requires to be collected by the Government, as to the actual number of persons affected with the particular type of cancer, the number of patients consuming the medicines in question, the cases where such medicines are not consumed by patients on account of the alleged exorbitant price, etc., by collecting such details from the hospitals across the country." "Further, the findings in the judgment as regards the scope of Section 100 of the Act would have applicability as against several other life saving drugs also." (para 42)
14. The findings. "Provisions under Section 100 of the Act would also include the entitlement of the Government to use the patent or invention for manufacturing the medicine covered by the patent and sell the same to a person, including a needy patient, on a non-commercial basis." "Section 100 of the Act is required to be invoked in circumstances where the Government is required to intervene, such as an instance where a medicine manufactured on the basis of a patent is being sold at an exorbitant price." "The Government requires to collate the required data and arrive at a decision as to whether a particular medicine is affordable or not and, on that basis, proceed in accordance with Section 100 of the Act, if found necessary." (p 55–56)
15. Obiter. Affordable access and incentives. "The Government, the people, and stakeholders should, as a joint venture, ensure that no man is refused or refuses treatment exclusively due to financial constraints. It is imperative that, we, as a community and as a system that caters to billions, strike the balance between affordable access to medical treatment and maintaining adequate incentives." (p 57–58)

Subsequent treatment

No later judicial treatment and no further appeal traced as of 5 October 2026.