During a national emergency, the government can exercise powers under the Patents Act to ensure the availability of essential drugs, emphasizing public health needs amid a pandemic.

Headnote:(A) Patents Act, 1970 - Sections 92, 100, and 84 - COVID-19 pandemic - Urgent need for Tocilizumab injection - The court ordered the Union of India and state governments to take immediate steps to address the shortage of critically required drugs like Tocilizumab, recognizing the dire public health situation. (Paras 7, 8, 12, 14)

(B) Compulsory Licensing - The court highlighted that the Patents Act provisions allow government use licenses in emergencies, emphasizing public health considerations. (Paras 8, 9)

(C) Drug Pricing and Accessibility - The court directed the Central Government to monitor drug prices and ensure availability to marginalized populations, asserting that the pandemic creates extraordinary circumstances necessitating regulatory measures. (Paras 51, 54)

Facts of the case:
The patient was diagnosed with COVID-19 and required urgent administration of Tocilizumab, which was unavailable despite repeated requests. The court acknowledged the critical shortage of this drug across various hospitals in Delhi.

Findings of Court:
The central authorities were directed to provide detailed accounts of Tocilizumab supply and mechanisms to increase availability.

Issues: The court framed the primary issues around the availability and allocation of Tocilizumab, a critically needed drug during the COVID-19 pandemic.

Ratio Decidendi: The court emphasized that during a national emergency, provisions under the Patents Act are to be utilized to ensure necessary drugs are made available promptly.

Result: Immediate action is mandated to resolve the Tocilizumab supply shortage in Delhi.

Table of Content
1. urgent medical supply necessary for covid-19 patient. (Para 2 , 3 , 4)
2. prior supreme court commentary on drug shortages. (Para 7 , 8)
3. severe shortage of tocilizumab in delhi. (Para 10 , 11 , 12 , 13)
4. directions issued for drug supply and information. (Para 14)
5. assurances for drug availability to the patient. (Para 16 , 17)

JUDGMENT

Prathiba M. Singh, J. (Oral)--This hearing has been done through video conferencing.

2. The present petition has been filed by the brother of Shri Sudhir Kumar Agarwal, who is a COVID-19 patient (hereinafter, "patient"), and is currently admitted in Malik Radix Health Care Hospital, Nirman Vihar, New Delhi. The prayer in the petition is to issue directions to the Respondents in the petition, to urgently supply the Tocilizumab injection - Actemra 400 mg to the said hospital, so that the same can be administered to the patient urgently.

3. The patient was detected as positive for COVID-19 on 30th April 2021 and a CT scan is stated to have been conducted on him. He was diagnosed with multiple patchy areas in his lungs and with COVID-19 pneumonitis. On 3rd May, 2021, the medical condition of the patient deteriorated, and he was admitted to the said hospital. He is currently stated to be on high-flow oxygen as also BiPAP. The doctors at the said hospital, on 4th May, 2021, prescribed the drug-Tocilizumab 400 mg for being administered to the patient. However, despite repeated efforts, it is the case of the Petitioner, that the said drug/injection has not been made available for its administration to the patient. He submits that the condition of the patient is continuously deteriorating, and the said drug is urgently required.

4. The matter was taken up on the morning session today, and the Petitioner has, thereafter, filed certain further documents on record during the lunch hour, as per which, the concerned doctor at the Malik Radix Health Care Hospital has also reported that the patient has not responded to the injection Bevacizumab 400mg and thus, requires injection Tocilizumab 400 mg for recovery.

5. Ld. Counsel for the Petitioner has emailed an amended memo of parties, during the lunch hour, wherein the Petitioner now seeks to implead the GNCTD, Drug Controller of Delhi, Union of India, Drugs Controller General of India and Roche Products (India) Pvt. Ltd. He orally also seeks the impleadment of the Union of India, through the Secretary, Department of Pharmaceuticals. Ordered accordingly. The amended memo of parties, be filed by 5 P.M today by the Petitioner's Counsel and emailed to the court master accordingly.

6. The Respondent no.5, Roche Products (India) Pvt. Ltd., (`Roche India') has been impleaded on the ground that it is the company dealing with the Tocilizumab injection Actemra, which has been prescribed for the patient. Ms. Ruby Singh Ahuja, ld. Counsel, has appeared for Roche India, before this Court, and submits that she was informed of the filing of the present writ petition and the impleadment of Roche Products (India) Pvt. Ltd., by ld. Counsel for the Petitioner during the lunch hour around 2 pm, and accordingly, she has entered appearance in the matter when it was taken up at 2.30pm.

7. The issues relating to the shortage of Tocilizumab injection have been highlighted previously by the Supreme Court in its order dated 30th April, 2021 in Suo Moto WP(C) No. 3/2021 titled In Re: Distribution of Essential Supplies and Services during the pandemic, as also by the ld. Division Bench of this Court in the order dated 20th April, 2021, in WP(C) 3031/2020 titled Rakesh Malhotra v. GNCTD.

8. The Supreme Court has, in Suo Moto WP(C) No. 3/2021 (supra) in paragraphs 42 to 46 as also 51 & 54 captured the position relating to various drugs such as Remdesivir and Favipiravir, as also Tocilizumab. The scheme of the Patents Act and the provisions relating to compulsory licensing etc., have also been considered in the said order of the Supreme Court. The relevant