Kerala High Court
Dr.K P Aravindan vs Union Of India on 18 May, 2022
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;
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
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
(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.
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
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
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
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
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
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.
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
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
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
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
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
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)
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
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
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:-
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
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
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
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
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
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
"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.
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
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
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
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."
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
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
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
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
