W. P.(C) No. 10661 of 2021 -1-
IN THE HIGH COURT OF KERALA AT ERNAKULAM
PRESENT
THE HONOURABLE THE CHIEF JUSTICE MR.S.MANIKUMAR
&
THE HONOURABLE MR. JUSTICE SHAJI P.CHALY
WEDNESDAY, THE 18TH DAY OF MAY 2022 / 28TH VAISAKHA, 1944
WP(C) NO. 10661 OF 2021
PETITIONER/S:
1 DR.K P ARAVINDAN
AGED 66 YEARS
S/O.K.BHASKARA MENON, AMAN,VK KRISHNA MENON ROAD,
PANNIYANKARA, KOZHIKODE-673 003, KERALA
2 DR.PRAVEEN G.PAI
AGED 46 YEARS
S/O. T.N.GOPALAKRISHNA PAI, PUBLIC HEATH
SPECIALIST, KNIGHTS 10C. SKYLINE IMPERIAL
GARDENS, STADIUM LINK ROAD, KALOOR
BY ADVS.
S.PRASANTH (AYYAPPANKAVU)
VARSHA BHASKAR
MISHI CHOUDHARY
KUSHAGRA SINHA
APURVA SINGH
RADHIKA JHALANI
RESPONDENT/S:
1 UNION OF INDIA
REPRESENTED BY THE SECRETARY TO GOVERNMENT,
MINISTRY OF HEALTH AND FAMILY WELFARE, ROOM
NOS.514-B/A, NIRMAN BHAWAN, NEW DELHI-110 011
2 DEPARTMENT OF BIOTECHNOLOGY,
MINISTRY OF SCIENCE AND TECHNOLOGY, GOVERNMENT OF
INDIA, REPRESENTED BY THE SECRETARY TO
GOVERNMENT, 6TH-8TH FLOOR, BLOCK 2 CGO COMPLEX,
LODHI ROAD, NEW DELHI-110 003
3 INDIAN COUNCIL OF MEDICAL RESEARCH,
REPRESENTED BY ITS DIRECTOR GENERAL, ANSARI
NAGAR, NEW DELHI-110 029
4 DRUG CONTROLLER GENERAL OF INDIA,
CENTRAL DRUGS STANDARD CONTROL ORGANIZATION,
DIRECTORATE GENERAL OF HEALTH SERVICES, MINISTRY
W. P.(C) No. 10661 of 2021 -2-
OF HEALTH AND FAMILY WELFARE, GOVERNMENT OF
INDIA, FDA BHAWAN, KOTLA ROAD, NEW DELHI-110 002
5 CONTROLLER GENERAL OF PATENTS,
DESIGNS AND TRADE MARKS DEPARTMENT FOR PROMOTION
OF INDUSTRY AND INTERNAL TRADE , GOVERNMENT OF
INDIA, BOUDHIK SAMPADA BHAVAN, ANTOP HILL,
S.M.ROAD, MUMBAI-400037
6 DEPARTMENT OF HEALTH AND FAMILY WELFARE,
GOVERNMENT OF KERALA, REPRESENTED BY THE
SECRETARY TO GOVERNMENT, GOVERNMENT SECRETARIAT,
THIRUVANANTHAPURAM-695 00
7 SERUM INSTITUTE OF INDIA PVT.LTD
REPRESENTED BY ITS MANAGING DIRECTOR, 212/2,
HADAPSAR,OFF SOLI POONAWALLA ROAD, PUNE,
MAHARASTRA-411028
8 BHARAT BIOTECH INTERNATIONAL LIMITED,
REPRESENTED BY ITS MANAGING DIRECTOR, GENOME
VALLEY SHAMEERPET, HYDERABAD, TELANGANA-500 078
BY ADVS.
MANU S., ASG OF INDIA
SRI. JAISHANKAR V. NAIR, CGC
SRI. P. VIJAYAKUMAR
SRI.V.MANU, SENIOR GOVT. PLEADER
THIS WRIT PETITION (CIVIL) HAVING COME UP FOR
ADMISSION ON 18.05.2022, THE COURT ON THE SAME DAY
DELIVERED THE FOLLOWING:
W. P.(C) No. 10661 of 2021 -3-
JUDGMENT
Shaji P. Chaly, J.
This is a public interest writ petition filed by the petitioners seeking the following reliefs:-
"i) To issue a writ of certiorari or any other appropriate writ or order setting aside Ext.P5 Liberalised Pricing and Accelerated National Covid 19 Vaccination strategy to the extent it provides for a differential pricing between Central and State Governments;
ii) To issue a writ of mandamus or any other appropriate writ or order directing the 1st respondent to procure and distribute vaccines to the State Governments free of cost to all age groups;
iii) To issue a writ of mandamus or any other appropriate writ or order directing respondents 1 to 3 to transfer the technology of manufacturing Covaxin along with cell lines to all manufacturers interested and capable of manufacturing the vaccine;
iv) To issue a writ of mandamus or any other appropriate writ or order directing Respondents 1 and 4 to fix a price ceiling for vaccines for COVID-19;W. P.(C) No. 10661 of 2021 -4-
v) To issue a writ of mandamus or any other appropriate writ or order mandamus to the Respondent No. 1 and 5 to expedite vaccine acquisition from all available national and international resources.
vi) To issue a writ of mandamus to the Respondent No. 1 and Respondent No. 5 to grant emergency use authorization of all available vaccines including but not limited to those developed by Pfizer-BioNtech, Moderna Inc and Johnson & Johnson.
vii) To issue a writ of mandamus to the Respondent No. 1 and Respondent No. 5 to publish for the general public, all the agreements and the information pertaining to the arrangement including but not limited to the details in respect of the intellectual property on the vaccines which have received an authorization for emergency use and the ones which are in various stages of development."
2. First petitioner is a Pathologist who had retired as the Head of the Department, Department of Pathology, Government Medical College, Kozhikode, who also claims to be the former President of Kerala Sasthra Sahithya Parishad. He has also stated that he is a member of the expert panel on Covid - 19 constituted by the Government of Kerala.
3. Second petitioner is a public health specialist with expertise in Geriatrics, Gerontology and public health and is currently working W. P.(C) No. 10661 of 2021 -5- as State Technical Expert in Care, Support and Treatment in Technical Support Unit of Kerala State Aids Control Society.
4. The Union as well as the State Government are parties in the writ petition apart from other stakeholders of the Government. So also Serum Institute of India Private Limited and Bharat Biotech International Limited are respondents 7 and 8 in the writ petition.
5. The basic contention advanced in the writ petition is in respect of the pricing policy adopted by the Government for distribution and administration of "covishield and covaxin", vaccines through public and private medical institutions. According to the petitioners, the prices announced by the Serum Institute of India Private Limited and Bharat Biotech International Limited are as follows:-
"In response to the new strategy and pricing, both Bharath Biotech and Serum Institute of India have come out with their pricing. Serum Institute announced Covishiled' price at Rs.400 for State governments and Rs. 600 for private hospitals. Bharat Biotech announced that Covaxin will be available at a price of Rs 600 per dose for state governments and Rs 1,200 per dose for private hospitals. It also said that Covaxin will be exported and the export price would be between $15-20 W. P.(C) No. 10661 of 2021 -6- (Rs.1,123 to Rs 1,498 approximately). On the other hand the Central Government procures the vaccine at Rs.150/-."
6. Therefore, according to the petitioners, the three-tier pricing model announced by the Union Government and now implemented by Serum Institute of India Private Limited and Bharat Biotech International Limited goes against the principles of universal vaccination. It is the case of the petitioners that vaccination has always been universally led by the Union Government and provided free of cost in India; the Union Government procures all vaccines and then gives it free to States for administration and there has been no exception to this.
7. It is further submitted by the petitioners that it is the policy followed by every major country such as the USA, Canada and countries in Europe during Covid - 19 pandemic. However state level procurements are prevented, to ensure smooth and effective vaccination. Various other contentions are also raised in respect of the pricing policy adopted by the Union Government and M/s Serum Institute of India Private Limited and Bharat Biotech International Limited.
W. P.(C) No. 10661 of 2021 -7-
8. However fact remains that, as of now there are no issues with respect to the pricing policy especially due to the fact that the Covid - 19 pandemic has subsided considerably, though a limited number of Covid - 19 cases are reported in the State as well as the National level.
9. Therefore even according to learned counsel for the petitioners Sri. Prasanth S., most of the prayers sought for by the petitioners have become infructuous, however learned counsel submitted that the 3rd and 7th prayers sought for by the petitioners still survive to be considered and adjudicated by this Court.
10. The 3rd prayer sought for by the petitioners is for a mandamus or any other appropriate writ or order directing respondents 1 to 3, namely the Union of India represented by the Secretary to the Government, Ministry of Health & Family Welfare, New Delhi, the Department of Biotechnology, Ministry of Science and Technology, Government of India, represented by the Secretary to the Government, New Delhi and the Indian Council of Medical Research, represented by its Director General, New Delhi, respectively to transfer the technology of manufacturing Covaxin along with cell lines to all W. P.(C) No. 10661 of 2021 -8- manufacturers interested and capable of manufacturing the vaccine.
11. The 7th prayer is for a mandamus to the 1st and 5th respondents namely the Union of India represented by the Secretary to Government, Ministry of Health & Family Welfare, New Delhi and the Controller General of Patents, Designs and Trademarks, Department for Promotion of Industry and Internal Trade, Government of India, Mumbai, to publish for the general public all the agreements and information pertaining to the arrangement, including but not limited to the details in respect to the intellectual property on the vaccines which have received an authorization for emergency use and the ones which are in various stages of development.
12. The basic contentions advanced by the petitioners in that regard are that; the Covishield is the Indian brand name of Oxford- AstraZenecca Covid - 19 vaccine, also known as the AZD1222. AZD1222 was co- invented by the University of Oxford, its spin-out company, Vaccitech and AstraZeneca. As per a news release by the University of Oxford "A key element of Oxford's partnership with AstraZeneca is the joint commitment to provide the vaccine on a not- for-profit basis for the duration of the pandemic across the world, and W. P.(C) No. 10661 of 2021 -9- in perpetuity to low and middle-income countries." The vaccine is manufactured by the Serum Institute of India Private Limited under a licensing agreement with AstraZeneca Plc. Details of aforesaid license are not available in the public domain. When the licensor has a commitment to provide the vaccine at not for profit rates, the licensee cannot have a better right. The 1 st respondent has the duty to ensure that the vaccine is sold at a not for profit rate.
13. Petitioners have further contended that the Covaxin has been developed by the Indian Council of Medical Research (ICMR) in collaboration with Bharat Biotech International Limited. ICMR is the apex body in India for the formulation, coordination and promotion of biomedical research. It is funded by the Government of India through the Ministry of Health and Family Welfare (MoHFW). The National Institute of Virology based in Pune was instrumental in the development of this vaccine. Covaxin is based on the SARS-CoV-2 strain which was isolated in the National Institute of Virology in Pune. ICMR had transferred the strain to Bharat Biotech International Limited for development and manufacture. However, the details of the funding agreement as well as the IP sharing between Bharat Biotech International Limited and ICMR have not been made available W. P.(C) No. 10661 of 2021 -10- publicly. It is submitted that Bharat Biotech International Limited is not paying any royalty for Covaxin. Covaxin to a great extent, is the byproduct of a project that was driven by publicly funded research in India.
14. Petitioners have also contended that in April, 2021, Haffkine Institute, Mumbai, a public sector company procured rights to manufacture Covaxin via technology transfer from ICMR. Haffkine Institute is a multi-disciplinary institute which is engaged in training, research and manufacturing of anti rabies serum, anti-snake venom serum and oral polio vaccine. It is one of the oldest biomedical research institutes in India and is under the aegis of the Maharashtra State Government.
15. Referring to Rule 233 of the General Financial Rules, 2017, petitioners have contended that the IP rights on the vaccine ought to be with the Ministry of Health and Family Welfare which funded the research and development for the vaccine. Rule 233 of the General Financial Rules, 2017 reads thus:-
"Ministries or Departments of Government sponsor projects or schemes to be undertaken by Universities, Indian W. P.(C) No. 10661 of 2021 -11- Institute of Technology and similar other Autonomous Organisations such as ICAR, CSIR, ICMR etc., the results from which are expected to be in national interest.
Normally the entire expenditure of such projects on or by schemes including capital expenditure, is funded by the Ministry or Department. The funds released for such projects or schemes in one or more installments are not treated as Grants-in-aid in the books of the implementing agency. Apart from the requirement of submission of technical and financial reports on completion of the project or scheme, a stipulation should be made in such cases that the Ownership in the physical and intellectual assets created or acquired out of such funds shall vest in the sponsor. While the Project or Scheme is ongoing, the recipients should not treat such assets as their own assets in their Books of Accounts but should disclose their holding and using such assets in the Notes to Accounts specifically."
16. That apart it is contended that Mission Covid Surakhsha was announced with a provision of Rs. 900 crore to the Department of Biotechnology, Ministry of Science & Technology, Government of India, New Delhi, the 2nd respondent, for making a vaccine for Covid-
19. The document containing "Instruction for Technology Transfer and Intellectual Property Rights", as obtained from the website of the 2 nd respondent, states that in respect of joint research undertaken by an institution and an industrial entity, the Intellectual Property Rights can W. P.(C) No. 10661 of 2021 -12- be owned by them jointly. Petitioners have also submitted relevant extract from the abovesaid document which reads thus:-
"IPR generated through joint research by institution(s) and industrial concern(s) through joint efforts can by be owned jointly by them as may be mutually agreed to by them and accepted by the Department through a written agreement. The institution and industrial concern may transfer the technology to a third party for commercialization on exclusive/non-exclusive basis. The third party, exclusively licensed to market the innovation in India, must manufacture the product in India. The joint owners may share the benefits and earnings arising out of commercial exploitation of the IPR. The institution may determine the share of the inventor(s) and other persons from such actual earnings. Such share(s) shall not exceed 1/3rd of the actual earnings."
17. Relying on the abovesaid document, petitioners have contended that it would be safe to presume that the Intellectual Property held in Covaxin is supposedly held jointly by Respondent No. 2 and Respondent No. 8. It is however still not clear if the procedure laid down in the said document has been followed by the Government or not.
W. P.(C) No. 10661 of 2021 -13-
18. It is contented that 'Open Covid Pledge' is an initiative through which multiple businesses, researcher's, academics, lawyers have come together to pledge that their Intellectual Property can be used free of charge to solve the Covid - 19 pandemic and minimize the impact of the pandemic. Companies that decide to make the Pledge must make a public announcement to that effect and generally offer a nonexclusive, royalty-free, worldwide, fully paid-up license to the pledger's IP solely for the purpose of diagnosing, preventing, containing and treating COVID-19, until the earlier of one year after the World Health Organization declares the Covid - 19 pandemic to have ended on January 1, 2023. Some of the founding adopters of the pledge are companies like Facebook, Amazon, IBM, Intel, Microsoft, Hewlett Packard Enterprises among others. The pledge states that "Immediate action is required to halt the Covid - 19 pandemic and treat those it has affected. It is a practical and moral imperative that every tool we have at our disposal be applied to develop and deploy technologies on a massive scale without impediment. We therefore pledge to make our intellectual property available free of charge for use in ending the Covid - 19 pandemic and minimizing the impact of the disease. We will implement this pledge through a license that W. P.(C) No. 10661 of 2021 -14- details the terms and conditions under which our intellectual property is made available".
19. It is further contended that Open Covid Pledge provides a template for ensuring intellectual property rights do not act as an impediment for innovating means that can help end the pandemic that is wreaking havoc with our lives. It is submitted that till date, no Indian organization or company has joined the Open Covid Pledge or attempted to adapt it to Indian jurisdiction.
20. It is also contended that India along with South Africa has filed a request to the World Trade Organization (WTO) dated 02.10.2020 requesting a waiver from certain provisions of the 'Agreement on Trade-Related Aspects of Intellectual Property Rights' (TRIPS) to help prevent, contain and treat Covid - 19 pandemic.
21. According to the petitioners the proposal seeks a waiver of Sections, 1) (copyright and related rights), 4) (industrial designs), 5) (patents) and 7) (protection of undisclosed information) of Part II of the 'TRIPS' Agreement in relation to prevention, containment and treatment of Covid - 19, however the petitioners themselves have stated that the 'TRIPS' Council has not yet completed its consideration W. P.(C) No. 10661 of 2021 -15- on the waiver request. The communication is produced by the petitioners as Ext. P13.
22. The paramount contention advanced in that regard is that since the Union Government has applied for a waiver of provisions related to patents and trade secrets before the World Trade Organization, it is obligatory for the Government to apply the same principles as far as the technology under their control is concerned. It is also pointed out that as the Government has control over the technology, it is important for them to make it available to any vaccine manufacturer in India who has the ability to manufacture the vaccine. According to the petitioners a possible course of action is to make sure that the technology is made open source with access being given to everyone.
23. That apart it is submitted that ingeniously developed vaccines should be licensed to other manufacturers in India just like other companies have done, if India has to reach the goal of vaccinating the target population within a short span of time. It is also stated that India is witnessing an unprecedented level of collaboration among companies including rivals to ensure a safe and swift access to W. P.(C) No. 10661 of 2021 -16- vaccines to people around the globe.
24. Contentions are also raised by the petitioners correlating the circumstances with the policy adopted by other countries in the world and also giving thrust to the provisions of the National Disaster Management Act, 2005 and the Drugs and Cosmetics Act, 1940.
25. Though the Union Government has filed a statement with respect to the contentions raised by the petitioners in regard to the pricing aspects, it has not dealt with the contentions put forth by the petitioners in regard to the intellectual property rights.
26. The State Government has filed a very detailed statement with respect to the policy adopted by the Government in the matter of administration of vaccine and has given the facts and figures with respect to the vaccination administered; that the Covid vaccination drive started in the country on the 16th of January 2021 and the State has also taken adequate measures in ensuring the successful conduct of the drive. It is also stated that in the initial phase of vaccination, from 16th January, 2021 to 30th April, 2021, the Government of India provided entire Covid vaccines required for the vaccination drive in the State, free of cost. Within this period, from 1 st March to 30th April W. P.(C) No. 10661 of 2021 -17- 2021, Private Covid Vaccination Centres (CVCs) were also provided Covid vaccines by Government of India at a rate of Rs150/ dose and was administered to public at Rs. 250/dose (Rs.100 charged as service charge).
27. The State Government has further submitted that the Ministry of Health and Family Welfare (MOHFW) later implemented Liberalized Pricing and Accelerated National Covid - 19 Vaccination Strategy from 1st May 2021 onwards. Under this policy 50% of total vaccines produced in the country was reserved for Government of India procurement, 25% for State Government procurement and the remaining 25% for the private sector. As per the said strategy, all those who were above the age of 18 years were made eligible to get Covid vaccines from 1st May 2021 onwards. However, the Government of India provided vaccines only for those above 45 years and it was the responsibility of the State Government to procure and supply vaccines to those between 18-45 years, at the rate declared by the vaccine manufacturers. Also, Private CVCs needed to procure vaccines directly from manufacturers.
28. Government of Kerala have also submitted that the State W. P.(C) No. 10661 of 2021 -18- purchased 12,04,960 doses of Covishield and 1,37,580 doses of Covaxin as per this policy and provided it free of cost to citizens at the rate fixed for State Government, which reads thus:-
Covishield Covaxin (INR/dose)
(INR/dose)
Central Government 150 150
State Government 300 400
Private Hospitals 600 1200
29. It is submitted that this policy was revised by the Central Government and the MOHFW implemented 'Revised Guidelines for implementation of National COVID Vaccination Program' from 21 st June 2021 onwards. The main elements of the Revised Guidelines are as follows:-
30. The Government of India will procure 75% of the vaccines being produced by the manufacturers in the country. The vaccines procured will be provided free of cost to States/UTs based on criteria such as population, disease burden and the progress of vaccination. Wastage of vaccines will affect the allocation negatively. These doses need to be administered by the States/UTs free of cost to all citizens, as per priority, through Government Vaccination Centres. In respect of the vaccine doses provided free of cost by Government of India to the W. P.(C) No. 10661 of 2021 -19- States, vaccination will be prioritized as the following:
1. Health Care Workers
2. Front Line Workers
3. Citizens more than 45 years of age
4. Citizens whose second dose has become due
5. Citizens 18 years & above (Within the population group of citizens more than 18 years of age, States/UTs may decide their own prioritization factoring in the vaccine supply schedule.)
31. That apart it is further submitted that as per the revised policy also, 25% of total vaccine production in the country is earmarked for private sector and Private Covid Vaccination Centres need to purchase vaccine directly from manufacturers at the price declared by manufacturers i.e. Rs 600+GST for Covishield and Rs.
1200+GST for Covaxin. In addition to this, the Government of India also made it clear that other vaccines, which are imported to the country like Sputnik V, will be 100% available for purchase for 'other than Government of India channels'. The Ministry, later, also introduced a capping for service charge at Rs 150/dose. This price capping is applicable only for vaccination done within PCVC. In case of workplace CVC and outreach sessions, rate may be fixed on mutual W. P.(C) No. 10661 of 2021 -20- agreement between PCVC and the concerned organization.
32. Government of Kerala have produced the details of pricing of various vaccines in Private sector and the timeline of priority groups for vaccination drive in the State are as follows:
Sl. Vaccine Price [email protected] Maximu Maximu
No declared by % (Rs) m service m price
Manufacture charge that can
r inclusive be
taxes charged
by
PCVC*
1 Covishield 600 30 150 780
2 Covaxin 1200 60 150 1410
3 Sputnik V 948 47 150 1145
Priority Group Date of inclusion
Health care worker 16/01/21
Front line worker 11/02/21
People > 60 years and those between 45-59 01/03/21
years with comorbidity
People > 45 years 01/04/21
People 18-44 years belonging to priority 17/05/21
groups defined by State
All > 18 years (along with priority groups) 25/06/21
33. Government of Kerala have also produced the vaccination coverage of various priority groups as follows:-
W. P.(C) No. 10661 of 2021 -21-
State Summary Category Wise as on 09-08-2021
Priority Group 1st Dose 2nd Dose
Health Care 553723 100% 458413 83%
Worker
Front Line 568444 100% 475226 83%
Worker
> 45 years 9777772 76% 5092164 40%
18-44 Yeas 4772409 30% 401754 3%
Total 15672348 54% 6427551 22%
Doses 2,18,43,580
Administered
34. Moreover, the 2nd respondent submitted that on an average, more than 1,200 Government vaccination centres are operating every day across the State to provide vaccination to the targeted population of 2.87 Crores. The vaccinations are also being distributed through private hospitals. Kerala is a State that administers vaccines without wasting a single drop. Vaccination is scheduled as per the availability of vaccine stock received in the State.
35. It is contended that to ensure that those who do not have access to digital media / internet are not left behind, the services of ASHA workers / Local Self Government Department Staff are being used to mobilize such beneficiaries and vaccinate them after spot registration. A special registration campaign called "Work Along for Vaccine Equity (WAVE)" has now been launched in the State to W. P.(C) No. 10661 of 2021 -22- ensure the registration of all citizens. As part of this campaign, 10,73,138 beneficiaries have so far been registered through ASHA Workers, of which 3,81,082 have been vaccinated.
36. That apart Kerala was the first State to introduce bedside vaccination for palliative care patients. This initiative nationally was acclaimed and is now followed by many States. Districts are making special efforts to ensure immunization of the tribal population, with 59% of the tribal population (> 18 years) being given the first Covid vaccine and 10% being given the second dose. The first dose was given to 97% of the inmates of geriatric centres across the State, and 25% vaccinated with the second dose. Special vaccination camps have been organized for differently abled people. Special Covid Vaccination Drive for Pregnant Women - "Mathrukavacham" was launched in the State. Also, the Government of Kerala has decided to formulate guidelines for vaccination to the people within the LSGI in which they are residing.
37. Further the specified time slots fixed for the vaccination helps the people to get vaccinated in a systematic way and thus avoid crowding in vaccination centres. Also, direction has been given to the W. P.(C) No. 10661 of 2021 -23- concerned to make arrangement in consultation with Police authorities to avoid crowding in vaccination Centres. As per G.O.(Rt) No. 1715/2021/H&WFD dated 10.08.2021, the Government of Kerala, have issued guidelines regarding administering of vaccination for Covid 19.
38. We have heard Sri. Prasanth S. for the petitioners, Sri. Jayashankar V. Nair, learned Central Government Counsel and Sri. V. Manu, Senior Government Pleader and perused the pleadings and material on record.
39. The sole question that comes up before us for consideration and adjudication is the contentions put forth by the petitioners in regard to the transfer of technology of manufacturing Covaxin and the liberal approach to be made to the Intellectual Property Rights.
40. In our considered opinion, these are all policy matters adopted by the Union Government resorting to the provisions of the Disaster Management Act, 2005.
41. In order to administer the vaccine, the Union as well as the State Government have issued successive notifications under the W. P.(C) No. 10661 of 2021 -24- provisions of the Disaster Management Act, 2005. Taking into account the population of India, various programmes were launched to ensure that the vaccine is administered to all in order to generate immunity by vaccination. In that process the Serum Institute of India Private Limited as well as the Bharat Biotech International Limited were tagged by the Union Government to developing the vaccines.
42. It may be true that the Union Government must have advanced money in order to bring out the vaccine at a faster pace in the larger interest of the public. It is an admitted fact that the vaccine was developed by the Serum Institute of India Private Limited as well as the Bharat Biotech International Limited by using their technology, scientific expertise and other technological aspects.
43. In our considered opinion, the Union of India has not entered into any agreement with the Bharat Biotech International limited for transferring their technology in regard to manufacture of the Covaxin. By virtue of the provisions of the statutes remaining in the country, the company is entitled to protect their Intellectual Property Rights. Even according to the petitioners, though India has communicated to the World Trade Organization for liberalizing the W. P.(C) No. 10661 of 2021 -25- provisions of the law relating to the Intellectual Property Rights, the World Trade Organization has not taken any steps as per the request made by India as well as South Africa.
44. Moreover the steps taken by the Government of India in regard to the manufacture of vaccine by entering into terms with M/s Bharat Biotech International Limited, and for administering the same to the public using the available public as well as private infrastructure is a policy evolved by the Union Government to protect the interest of the very large population the country is having.
45. It is well settled in law that unless the policy evolved by the Government is malafide, illegal, unfair or contrary to any statutory provisions, the Constitutional Courts would not interfere with the policy decisions taken by the Union Government as well as the State Government to carry out the administration of the country as well as the States.
46. A reference to some of the decisions of the Hon'ble Apex Court would enable us to reach a logical conclusion.
47. In State of Punjab v. Ram Lubhaya Bagga [(1998) 4 SCC W. P.(C) No. 10661 of 2021 -26- 117] the Hon'ble Apex Court has held that when Government forms its policy, it is based on a number of circumstances on facts, law, including constraints based on its resources and it is also based on expert opinion; therefore it would be dangerous if court is asked to test the utility, beneficial effect of the policy or its appraisal based on facts set out on affidavits; and that the courts would dissuade itself from entering into this realm which belongs to the executive.
48. In Krishnan Kakkanth v. Goverment of Kerala [(1997) 9 SCC 495] it was held by the Hon'ble Apex Court as follows:-
"36. To ascertain unreasonableness and arbitrariness in the context of Article 14 of the Constitution, it is not necessary to enter upon any exercise for finding out the wisdom in the policy decision of the State Government. It is immaterial whether a better or more comprehensive policy decision could have been taken. It is equally immaterial if it can be demonstrated that the policy decision is unwise and is likely to defeat the purpose for which such decision has been taken. Unless the policy decision is demonstrably capricious or arbitrary and not informed by any reason whatsoever or it suffers from the vice of discrimination or infringes any statute or provisions of the Constitution, the policy decision cannot be struck down. It should be borne in mind that except for the limited purpose of testing a public policy in the context of illegality and unconstitutionality, courts should avoid W. P.(C) No. 10661 of 2021 -27- "embarking on uncharted ocean of public policy".
49. In Sher Singh v. Union of India [(1995) 6 SCC 515] it was held as follows:-
"As a matter of fact the courts would be slow in interfering with matters of government policy except where it is shown that the decision is unfair, mala fide or contrary to any statutory directions."
50. In Brij Mohan Lal v. Union of India [(2012) 6 SCC 502] it was held as follows:-
"96. It is a settled principle of law that matters relating to framing and implementation of policy primarily fall in the domain of the Government. It is an established requirement of good governance that the Government should frame policies which are fair and beneficial to the public at large. The Government enjoys freedom in relation to framing of policies. It is for the Government to adopt any particular policy as it may deem fit and proper and the law gives it liberty and freedom in framing the same. Normally, the courts would decline to exercise the power of judicial review in relation to such matters. But this general rule is not free from exceptions. The courts have repeatedly taken the view that they would not refuse to adjudicate upon policy matters if the policy decisions are arbitrary, capricious or mala fide.W. P.(C) No. 10661 of 2021 -28-
xxx xxx xxx
99. It is also a settled cannon of law that the Government has the authority and power to not only frame its policies, but also to change the same. The power of the Government, regarding how the policy should be shaped or implemented and what should be its scope, is very wide, subject to it not being arbitrary or unreasonable. In other words, the State may formulate or reformulate its policies to attain its obligations of governance or to achieve its objects, but the freedom so granted is subject to basic constitutional limitations and is not so absolute in its terms that it would permit even arbitrary actions."
51. In BALCO Employees' Union v. Union of India [(2002) 2 SCC 333] it was held as follows:-
"46. It is evident from the above that it is neither within the domain of the courts nor the scope of the judicial review to embark upon an enquiry as to whether a particular public policy is wise or whether better public policy can be evolved. Nor are our courts inclined to strike down a policy at the behest of a petitioner merely because it has been urged that a different policy would have been fairer or wiser or more scientific or more logical."
52. It was further held in BALCO Employees' Union (supra) that in a democracy, it is the prerogative of the each elected W. P.(C) No. 10661 of 2021 -29- Government to follow its own policy and often a change in Government may result in the shift in focus or change in economic policies; that any such change may result in adversely affecting some vested interests; unless any illegality is committed in the execution of the policy or the same is contrary to law or malafide, a decision bringing about change cannot per se be interfered with by the court.
53. As we have pointed out above, protection of the Intellectual Property Rights are remaining with the Company by virtue of the provisions of law contained under various statutes in regard to the Intellectual Property Rights. A writ court may not be right in issuing a writ of mandamus to transfer the technology of manufacturing Covaxin and publish for the convenience of the general public the details in respect to the Intellectual Property on the vaccines.
54. Apart from all the above aspects, Hon'ble Apex Court had occasion to consider the very same issue in Suo Motu Writ Petition (Civil) No. 3 of 2021 and as per order dated 30.04.2021 reported in (2021) SCC Online SC 355, it was held as follows:-
42. Several drugs that are at the core of the COVID treatment protocol are under patents in India including Remdesivir, Tociluzumab and Favipiravir. On 2 October 2020, a W. P.(C) No. 10661 of 2021 -30- communication was issued by the UOI, along with South Africa, to the Council for Trade-Related Aspects of Intellectual Property which stated that there were several reports about intellectual property rights hindering timely provisioning of affordable medical products to patients. The communication also reported that some members of the World Trade Organization had carried out urgent amendments to their national patent laws to expedite the process of issuing compulsory/government use licenses.
43. In India, the patent regime is governed by the Patents Act, 1970; Section 92 of which envisages the grant of a compulsory license, inter alia, in circumstances of national emergency and extreme urgency. Once a declaration of national emergency is made, and the relevant patents notified, any person interested in manufacturing the drug can make an application to the Controller General of Patents who can then issue a compulsory license. The patentee would be paid a reasonable royalty as fixed by the Controller General of Patents. Further, under Section 100 of the Patents Act, the Central Government can authorize certain companies to use any patents for the "purpose of the government". Indian companies can begin manufacturing the drugs while negotiating the royalties with the patentees. If the Central Government or its authorized company is not able to reach an agreement with the patentee, the High Court has to fix the reasonable royalty that is to be paid to the patentee. Another alternative is for the Central Government to acquire the patents under Section 102 from the patentees. If the Central Government and the patentee is not able to reach a consensus on the price of the patents, it is up to the High Court to W. P.(C) No. 10661 of 2021 -31- fix the royalty. Additionally, under Section 66 of the Patents Act, the Central Government is also entitled to revoke a patent in the public interest.
44. The utilization of these flexibilities has also been detailed in the Trade Related Aspects of Intellectual Property Rights Agreement. Even as TRIPS obliges countries to ensure a minimum level of patent protection, it creates a permissive regime for the carving out of exceptions and limitations that further public health objectives. ..........
45. According to the 2001 Doha Declaration, TRIPS should be interpreted in a manner supportive of the right of members to protect public health and to promote access to medicines. It recognizes the right of WTO members to use the full extent of the TRIPS flexibilities to secure this objective.
46. Whether and if so, the extent to which these provisions should be utilized is a policy decision for the Central Government. We have flagged the issue for its consideration. We have only outlined the legal framework within which the Central Government can possibly consider compulsory licensing and government acquisition of patents. The Central Government is free to choose any other course of action that it deems fit to tackle the issue of vaccine requirements in an equitable and expedient manner, which may involve negotiations with domestic and foreign producers of vaccines. We clarify that it is up to the Central Government to choose the best possible measures it can undertake during the current crisis keeping in mind that public interest is of paramount importance."
W. P.(C) No. 10661 of 2021 -32-
55. Taking into account the abovesaid aspects, we are of the view that the petitioners are not entitled to secure any order of mandamus for transfer of technology of manufacturing Covaxin and publish the details with respect to Intellectual Property on the vaccines. Therefore the said reliefs sought for by the petitioners are liable to be dismissed, accordingly we do so.
56. As we have pointed out above, the other reliefs sought for by the petitioners have virtually become infructuous consequent to the policy adopted by the Union as well as the State Government for price fixation and administration of vaccine to the citizens, and has implemented the same considerably and substantially to the common advantage of the citizens of the country, which also was a policy adopted by the respective Governments in larger public interest, taking into account the fundamental duties and obligations guaranteed to the citizens under part III of the Constitution of India.
57. Taking into account the factual and legal aspects deliberated above we are not inclined to interfere with the policy decisions taken by the Union Government invoking the writ jurisdiction. But ultimately these are all aspects to be considered by the Government in W. P.(C) No. 10661 of 2021 -33- terms of the directions issued by the Apex Court in suo motu writ petition Civil No. 3 of 2021 referred to above.
Assimilating the facts and circumstances and the law as above, we do not think the petitioners are entitled to get any reliefs, the writ petition is accordingly dismissed.
Sd/-
S. MANIKUMAR CHIEF JUSTICE Sd/-
SHAJI P. CHALY JUDGE Eb ///TRUE COPY/// P. A. TO JUDGE W. P.(C) No. 10661 of 2021 -34- APPENDIX OF WP(C) 10661/2021 PETITIONER EXHIBITS EXHIBIT P1 TRUE COPY OF THE CUMULATIVE VACCINATION COVERAGE REPORT AS ON 24.04.2021 OBTAINED FROM THE WEBSITE OF THE MINISTRY OF HEALTH AND FAMILY WELFARE EXHIBIT P2 TRUE COPY OF THE EXTRACT OF THE DOCUMENT TITLED "POVERTY MEASUREMENT IN INDIA: A STATUS UPDATE", PUBLISHED IN SEPTEMBER 2020 REF.NO.WORKING PAPER NO.1/2020 BY MINISTRY OF RURAL DEVELOPMENT EXHIBIT P3 TRUE COPY OF THE PRESS RELEASE DATED 28.02.2021 ISSUED BY THE MINISTRY OF HEALTH AND FAMILY WELFARE EXHIBIT P4 TRUE COPY OF THE PRESS RELEASE DATED 19.04.2021 ISSUED BY THE MINISTRY OF HEALTH AND FAMILY WELFARE EXHIBIT P5 TRUE COPY OF THE LIBERALISED PRICING AND ACCELERATED NATIONAL COVID 19 STRATEGY AS ON 21.04.2021 OBTAINED FROM THE MINISTRY OF HEALTH AND FAMILY WELFARE EXHIBIT P6 TRUE COPY OF THE MEDIA STATEMENT ISSUED BY THE CEO, SERUM INSTITUTE OF INDIA LTD EXHIBIT P7 TRUE COPY OF THE ANNOUNCEMENT ISSUED BY THE CHAIRMAN AND MANAGING DIRECTOR, BHARAT BIOTECH INTERNATIONAL LTD EXHIBIT P8 TRUE COPY OF THE BACKGROUND NOTE ON IMMUNIZATION IN INDIA BY THE NATIONAL HEALTH MISSION AS OBTAINED FROM THE WEBSITE OF NATIONAL HEALTH MISSION EXHIBIT P9 TRUE COPY OF THE NATIONAL VACCINE POLICY EXHIBIT P10 TRUE COPY OF THE RELEVANT PORTION OF NATIONAL HEALTH PROFILE 2019 ISSUED BY THE CENTRAL BUREAU OF HEALTH INTELLIGENCE EXHIBIT P11 TRUE COPY OF THE NEWS STATEMENT DATED 23.11.2020 PUBLISHED ON THE WEBSITE OF THE UNIVERSITY OF OXFORD EXHIBIT P12 TRUE COPY OF THE DOCUMENT TITLED "INSTRUCTIONS FOR TECHNOLOGY TRANSFER AND INTELLECTUAL PROPERTY RIGHTS" AS OBTAINED FROM THE WEBSITE OF RESPONDENT W. P.(C) No. 10661 of 2021 -35- NO.2 EXHIBIT P13 TRUE COPY OF THE COMMUNICATION FROM INDIA AND SOUTH AFRICA REGARDING WAIVER FROM CERTAIN PROVISIONS OF THE TRIPS AGREEMENT FOR THE PREVENTION, CONTAINMENT AND TREATMENT OF COVID-19