...... vs UNION OF INDIA - 2026 Supreme(Online)(Ker) 62430

Headnote:(A) Patents Act, 1970 - Sections 99 and 100 - Interpretation of "purposes of Government" - Power of the Government to use a patented invention includes the entitlement to manufacture the medicine and sell it on a non-commercial basis to needy patients - Such interpretation is consistent with the right to vend goods under Section 100(6) and the State's duty to improve public health. (Paras 27, 28, 30)

(B) Constitution - Articles 21 and 47 - Right to Health - The State has a primary duty to improve public health and ensure the preservation of human life - Access to life-saving treatment is an essential component of the right to life; exorbitant pricing of patented medicines may frustrate the mandate of these constitutional provisions. (Paras 32-34)

(C) Patents Act, 1970 - Section 83 - General principles for working patented inventions - Patents granted must not impede the protection of public health and nutrition and should act as an instrument to make the benefits of the invention available at reasonably affordable prices. (Para 35)

(D) Judicial Review - Policy Decisions - The decision to invoke the government's power to use a patent under Section 100 is a policy decision for the executive - Courts are generally not to interfere with such policy decisions unless they are arbitrary or violative of constitutional or statutory provisions, especially when the decision requires the collation of extensive factual data. (Paras 39-41)

Facts of the case:
A writ petition was initially filed by a patient seeking a direction to the Government to invoke provisions under the Patents Act to ensure a specific life-saving patented medicine for cancer was available at an affordable price. After the petitioner's death, the Court took suo motu cognizance of the issue of exorbitant pricing of life-saving patented medicines. The Court examined whether the Government's power to use an invention for "purposes of Government" included manufacturing and subsidizing expensive patented drugs for the public.

Findings of Court:
The Court found that the phrase "purposes of Government" under Section 100, read with Section 99, encompasses the duty of the State to protect public health under Article 47 and the right to life under Article 21. This includes the authority to manufacture patented medicines and sell them on a non-commercial basis to patients. However, the actual exercise of this power is a policy decision that must be based on comprehensive data regarding affordability and patient needs.

Issues: Whether the power to use an invention "for the purposes of Government" under Section 100 of the Patents Act includes providing patented life-saving medicines to needy patients on a non-commercial basis, and whether the Court can mandate the Government to exercise this power.

Ratio Decidendi: The Government's power to use a patent for "purposes of Government" includes the authority to manufacture and sell the resulting medicine on a non-commercial basis to the public to fulfill constitutional obligations under Articles 21 and 47. While Section 100 is the appropriate tool for addressing exorbitant pricing, its invocation is an executive policy decision that should follow the collection of necessary statistics on affordability and public health requirements.

Result: Writ petition disposed of with findings that Section 100 enables the Government to manufacture and sell patented medicines on a non-commercial basis and should be invoked for exorbitantly priced medicines after the Government collates necessary data.

Legal Category Hierarchy

1. Writ petition concerning exorbitant pricing of life-saving patented medicines for cancer treatment under Patents Act, 1970. (Para 2 , 3 , 4 )

2. Whether Central Government is duty-bound to invoke Section 92/100 of Patents Act to ensure affordable patented medicines. (Para 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 )

3. Section 100 includes entitlement to use patent for Government purposes, including public health under Article 21 and 47. (Para 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 )

4. Section 100 of Patents Act can be invoked by Government when life-saving patented medicines are unaffordable due to exorbitant pricing. (Para 37 , 38 , 39 , 40 )

5. Government required to collate data and decide on invoking Section 100 based on affordability of patented medicines. (Para 44 )

6. Can Section 100 of the Patents Act be invoked for public health purposes?

Yes. Section 100 includes Government's entitlement to use patent for manufacturing medicines and supplying them on non-commercial basis to needy patients for public health. (Para 27 , 28 , 30 , 35 , 37 )

7. What is the scope of 'use of invention for purposes of Government' under Section 99?

It includes making, using, exercising or vending for Central Government, State Government or Government undertaking, but also covers public health duty under Article 47. (Para 24 , 25 , 30 )

8. Does the high price of a patented medicine justify invoking Section 100?

Yes. Section 100 is required to be invoked when a medicine is unaffordable due to exorbitant price, as patent grants are subject to public interest under Section 83. (Para 35 , 37 )

9. What is the court's role in directing invocation of Section 100?

The court cannot issue positive direction to invoke Section 100 as it is a policy decision for the Central Government based on collected data and circumstances. (Para 38 , 39 , 40 , 42 )

“C.R.”

JUDGMENT

The captioned writ petition was initially filed by a retired Bank employee, stated to have been receiving a monthly pension of Rs.28,400/-. Her husband is also a retired Bank employee, receiving Rs.46,000/- as monthly pension. She 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. The said medicine is stated to block proteins called cyclin-dependent kinases 4/6 and thereby slow the Cancer’s growth. This medicine is stated to be a costly one, costing about Rs.58,140/- for 21 days (three tablets per day). It is further stated that there are three major types of Breast Cancer, and treatment and medicines differ for each category. The major types are stated to be:

i. Invasive Breast Cancer ii. Non-invasive Breast Cancer

iii. Cancerous Phyllodes Tumors.

Invasive Breast Cancer is again stated to be classified into four categories as under:

i. HR+/HER2 – (“Luminal A”)

ii. HR-/HER2- (“Triple Negative”)

iii. HR+/HER2+ (“Luminal B”)

iv. HR-/HER2+(“HER2-enriched”)

2. The petitioner is stated to be suffering from the first type - Luminal A HR+/HER2-. The petitioner contends that the financial assistance from the part of the Government for the treatment of Breast Cancer is minimal, and that steps are required to be taken for reducing the price of such medicines. 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. In such circumstances, the petitioner has instituted the captioned writ petition on 02.06.2022, seeking the following reliefs:

“i. To declare that the concerned among the respondent nos. 1 to 3 is duty bound to take steps either under Section 92 or under Section 100 of the Patents Act, 1970 for Ribociclib and ensure availability of the same at a reasonably affordable price;

ii. To issue a writ of mandamus directing the concerned among the respondent nos.1 to 3 to take steps either under Section 92 or under Section 100 of the Patents Act, 1970 for Ribociclib and ensure availability and access of the same at a reasonably affordable price;

iii. To issue a writ of mandamus directing the first respondent to for a scheme to provide treatment for HER2-Negative Metastatic Breast Cancer patients including the petitioner, to provide Ribociclib at free of cost as part of National Cancer Control Programme; v. To issue a writ of mandamus directing the 6th respondent to maintain the data with respect to each category of Breast Cancer cases registered each year in India and publish the same in the official website;”

(SIC)

3. While the writ petition was pending, the petitioner succumbed to her illness. Taking note of the afore as well as the submissions made by the learned counsel for the petitioner, this Court issued the following order on 16.09.2022:

“Learned Counsel for the petitioner reports that the petitioner has succumbed to her illness and submits that the noble cause espoused by the petitioner should not go in vain.

I am also of the considered opinion that the unfortunate death should not result in the cause espoused through this writ petition being rendered infructuous. Therefore, 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.

Adv.Maitreyi Sachidananda Hegde is appointed as Amicus Curiae to assist the Court.

Registry is directed to substitute the petitioner’s name as ‘In Re Exorbitant Pricing of Life Saving Patented Medicines’.”

4. Pending the writ petition, additional respondents 7, 10 and 15 were also permitted to be impleaded pursuant to the orders dated 02.09.2022, 19

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2026 Supreme(Online)(Ker) 62430

IN THE HIGH COURT OF KERALA AT ERNAKULAM
Harisankar V. Menon, J
...... – Appellant
Versus
UNION OF INDIA – Respondent
WP(C) 18999/2022

The Court ruled that 'purposes of Government' under Section 100 of the Patents Act includes manufacturing patented medicines for non-commercial sale to needy patients to fulfill constitutional duties under Articles 21 and 47, although the decision to invoke this is an executive policy matter.

Legal Category Hierarchy

Table of Contents

6. Can Section 100 of the Patents Act be invoked for public health purposes?

7. What is the scope of 'use of invention for purposes of Government' under Section 99?

8. Does the high price of a patented medicine justify invoking Section 100?

9. What is the court's role in directing invocation of Section 100?

2026 Supreme(Online)(Ker) 62430

IN THE HIGH COURT OF KERALA AT ERNAKULAMHarisankar V. Menon, J...... – AppellantVersusUNION OF INDIA – RespondentWP(C) 18999/2022

The Court ruled that 'purposes of Government' under Section 100 of the Patents Act includes manufacturing patented medicines for non-commercial sale to needy patients to fulfill constitutional duties under Articles 21 and 47, although the decision to invoke this is an executive policy matter.

Legal Category Hierarchy

Table of Contents

6. Can Section 100 of the Patents Act be invoked for public health purposes?

7. What is the scope of 'use of invention for purposes of Government' under Section 99?

8. Does the high price of a patented medicine justify invoking Section 100?

9. What is the court's role in directing invocation of Section 100?

Cases Referred (9)

IN THE HIGH COURT OF KERALA AT ERNAKULAM
Harisankar V. Menon, J
...... – Appellant
Versus
UNION OF INDIA – Respondent
WP(C) 18999/2022