Delhi High Court
Dharmendra Kumar Aggarwal vs Govt. Of Nct Of Delhi Through The ... on 5 May, 2021
Signature Not Verified
Digitally Signed By:DINESH
SINGH NAYAL
Signing Date:05.05.2021
18:41:52
$~21
* IN THE HIGH COURT OF DELHI AT NEW DELHI
Date of Decision: 5th May, 2021
+ W.P.(C) 5173/2021 & CM APPLs. 15878-80/2021
DHARMENDRA KUMAR AGGARWAL ..... Petitioners
Through: Mr. Kunal Tandon, Ms. Niti Jain and
Ms. Kanika Jain, Advocates.
versus
GOVT. OF NCT OF DELHI THROUGH THE SECRETARY &
ANR. ..... Respondents
Through: Mr. Anuj Aggarwal, ASC, GNCTD
with Ms. Ayushi Bansal, Advocate
for R-1 &2.
Mr. Anurag Ahluwalia, CGSC with
Mr. Abhigyan Siddhant and Mr.
Nitnem Singh Ghuman, Advocates
for UOI.
Ms. Ruby Singh Ahuja, Advocate for
R-5/Roche Products (India) Pvt. Ltd.
CORAM:
JUSTICE PRATHIBA M. SINGH
Prathiba M. Singh, J.(Oral)
1. 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.
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Digitally Signed By:DINESH
SINGH NAYAL
Signing Date:05.05.2021
18:41:52
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
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Digitally Signed By:DINESH
SINGH NAYAL
Signing Date:05.05.2021
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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 portion of the order of the Supreme Court is set out below:
"F. Potentiality of Compulsory Licensing for vaccines
and essential drugs
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-
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Digitally Signed By:DINESH
SINGH NAYAL
Signing Date:05.05.2021
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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
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Digitally Signed By:DINESH
SINGH NAYAL
Signing Date:05.05.2021
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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. This is evident from a conjoint
reading of Articles 7, 8, 30 and 31 of TRIPS. Article 7
outlines the objectives of the TRIPS as being to ensure
the effective enforcement of intellectual property in a
way that, inter alia, is "conducive to social and
economic welfare‟. Article 8 gives member countries
the freedom to take measures that protect public health
and nutrition. Article 8(2) allows for the taking of
TRIPS-compatible measures aimed at preventing the
abuse of intellectual property rights. Articles 30 and 31
deal with exceptions to the rights of patent owners, by
allowing grant of compulsory licenses. It leaves
countries with significant breathing space to determine
how the compulsory licensing or government-use levers
can be triggered. While such determinations must be
made on the individual merits of each case, the
aforesaid caveat does not apply when the compulsory
license grant is for national emergency, extreme
urgency or public non-commercial use.
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. Para 5(b) of the
Doha Declaration provides the freedom to each member
to grant compulsory licenses and to determine the
grounds on which the licenses are granted. Para 5(c)
leaves it up to each nation to determine what constitutes
a national emergency or extreme urgency. In the context
of the COVID-19 pandemic, we note that several
countries such as Canada and Germany have relaxed
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Digitally Signed By:DINESH
SINGH NAYAL
Signing Date:05.05.2021
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the legal regimes governing the grant of compulsory
licenses.
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.
.....
51 We have been informed by the Central
Government in its affidavit that NPPA has revised the
maximum retail price of Remdesivir to Rs 3500.
However, it has come to our notice that several other
drugs which are being prescribed by doctors for
treating COVID-19 patients like Favipiravir,
Tociluzumab, Enoxaparin, Ivermectin,
Methylprednisolone, Paracetamol and Hydroxy-
chloroquine are being priced at exorbitant rates
creating issues of access and affordability. While this is
not a direction of this Court, the Central Government
can consider invoking its statutory powers under
paragraphs 19 and 20 of the Drugs Price Control
Order, 2013. Under paragraph 19 of the Drugs Price
Control Order, 2013 the Government in extraordinary
circumstances, if it considers necessary in public
interest, can fix a ceiling price or retail price of the drug
for a certain period. COVID-19 is a crisis of an
unprecedented nature and qualifies as an extraordinary
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Digitally Signed By:DINESH
SINGH NAYAL
Signing Date:05.05.2021
18:41:52
circumstance. It will be in public interest to ensure that
the price of essential drugs is fixed in such a manner
that it is available even to the most marginalized
sections of the society. The Government can even
monitor the prices of the drugs under paragraph 20 of
the Drugs Price Control Order, 2013 and ensure that no
manufacturer increases the prices of the drugs by more
than 10% of the maximum retail price during the
preceding 12 months and where the increase is beyond
10% of the maximum retail price, it can oblige the
manufacturer to reduce it to the level of 10% for the
next 12 months.
.....
54 It has been submitted on behalf of the Central
Government that on 24 April 2021, DoP, NPPA and
DGCI reviewed the production and supply of drugs such
as Favipiravir, Enoxaparin, Ivermectin,
Methylprednisolone, Paracetamol and Hydroxy-
chloroquine. The supply of Remdesivir and Tociluzumab
is already under the consideration of the Central
Government. A meeting was also held on 25 April 2021
by DoP, NPPA and DGCI with the manufacturers to
review stock position, availability and production plans.
The Central Government should provide details of
estimated demand of essential drugs mentioned above,
production capacity, existing stocks, details of
allocation and supply of such drugs."
9. Similarly, the ld. Division Bench of this court has also dealt with this
position in its order dated 20th April, 2021 in Rakesh Malhotra (supra),
observing that:
27. There are a number of other drugs which are
being used for treatment Covid-19 patients, such as
Tocilizumab, Favipiravir, Ivermectin, Dexamethasone,
Methylprednisolone, Dalteparin, Enoxaparin, HCQ and
Baricitinib. As per news reports, there are shortages of
some, if not all, of the aforesaid drugs. Looking to the
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Digitally Signed By:DINESH
SINGH NAYAL
Signing Date:05.05.2021
18:41:52
emergent situation, we direct the Central Government to
immediately reach out to the manufacturers/ patent
holders/ licensees so as to forthwith ramp up the
production capacities of the above, and all such other
medications, as are essential for treatment of Covid
positive patients. We may take note of the fact that the
Patents Act provides for Compulsory Licenses under
Section 84, and Special Provision for Compulsory
Licenses or Notifications by the Central Government,
under Section 92. Section 100 provides the power of
the Central Government to use inventions for purposes
of the Government.
28. Looking at the present day situation, there can be
no doubt that a case is made out for exercise of its
power by the Central Government/ Controller under the
aforesaid provisions of law. At the same time, the
interests of the Patent holders/ licensees should be kept
in mind, since it on account of their investments,
inventions and hard work that such like medicines are
made available to the public at large. The best
course would be to encourage the existing
manufacturers to ramp up their production on a war
footing. They should also be encouraged to grant
voluntary licenses to other entities to manufacture
the requisite drugs.However, if such efforts do not
fructify soon enough, the Government/ Controller
should not hesitate to invoke their jurisdiction and
powers under the aforesaid provisions of the
Patents Act, since the lives of thousands of people are
being lost each day in the country due to COVID. The
lives of the people take priority over everything else.
Even if such like powers are exercised, the patent
holders/ manufacturers can be adequately compensated
by fixation of fair license fee. The Central Government
should swing into action in terms of this order in
this regard without any delay, and report progress on
the next date of hearing."
Signature Not Verified
Digitally Signed By:DINESH
SINGH NAYAL
Signing Date:05.05.2021
18:41:52
10. A perusal of the two orders above, clearly shows that there is a severe
shortage of the drug Tocilizumab across the country. A reading of the above
orders also shows that the issues relating to pricing, shortages and steps to
be taken at the National level, including by the Central Government are
being considered therein. In Delhi too there is shortage and several critical
patients are being prescribed this drug.
11. Presently this Court is considering the question of immediate
availability of the drug to the Petitioner and considering that there may be
similarly situated patients in Delhi, submissions have been heard. As per the
recent allocation letter dated 30th April 2021, issued by Mr. Rajiv
Wadhawan, Director, Ministry of Health Welfare and Mr. Navdeep Rinwa,
Joint Secretary, Department of Pharmaceuticals, Government of India
initially an interim allocation of 3245 vials of Tocilizumab was made for
States/UTs along with Central institutions. A further quantity of 1200 vials,
have been allocated to it for further allocation to the North Eastern States,
UTs and Central Government institutions. From the said quantities the
States/UTs/Ministries have been asked to approach the Ministry in case of
requirement. Out of the said vials recently received, which have been
distributed across the country, Delhi has been allocated a total quantity of
500 vials.
12. As per Mr. Anuj Aggarwal, ld. Counsel appearing for the GNCTD,
the said 500 vials, which have been received by the GNCTD from the Union
of India, have been further distributed within Delhi to various government as
well as private hospitals and in fact, it has been admitted that a large number
of hospitals could not even get the said drug for administration to their
patients. Ld. Counsel further submits that there are at least 200
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Digitally Signed By:DINESH
SINGH NAYAL
Signing Date:05.05.2021
18:41:52
hospitals/establishments currently treating COVID-19 patients, and it is a
matter of public knowledge that this drug- Tocilizumab is being prescribed
to a large number of critically ill patients.
13. Considering that there are a large number of hospitals in Delhi, that
are currently treating COVID-19 patients, there is a severe shortage in the
availability of the said drug - Tocilizumab, and 500 vials, being made
available, would not be sufficient. There is therefore an imminent need for
the said drug in Delhi for critically ill patients who are being prescribed the
same.
14. From the publicly available records it is clear that certain patents are
stated to have been granted in respect of this drug. The order of the Supreme
Court clearly records that the drug is not being manufactured in India.
Considering the demand for the drug, even to those patients who are willing
to pay and purchase the same, it is clear that adequate quantities are not
being made available. The rationing of critical medicines in this manner,
owing to lack of supplies from foreign shores and no local manufacturing, is
completely unacceptable in a pandemic situation, especially when the
consumers are willing to purchase the drug. In order to ensure immediate
availability of the drug for administration of the same to critically ill
COVID-19 patients who are prescribed the same, in Delhi, the following
directions are issued:
i. The Union of India to inform this Court, on the next date
of hearing, as to how much further stock of Tocilizumab is
available for distribution to the hospitals/medical
establishments in Delhi.
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Digitally Signed By:DINESH
SINGH NAYAL
Signing Date:05.05.2021
18:41:52
ii. The UOI to also place on record the details of entities to
whom approvals have been granted of Tocilizumab for
manufacturing, marketing, importing or selling in India.
iii. Qua the 500 vials of Tocilizumab, which were already
allocated to the GNCTD by the Union of India, the
GNCTD to inform this Court as to how much of the said
stock has been consumed, and if any of the said stock is
currently available for administration to any further
patients who are being treated in smaller hospitals/ medical
establishments, as also to the hospitals where the initial
quantity of allocation could not be distributed.
iv. Insofar as the company Roche Products (India) Pvt. Ltd. is
concerned, the said company to place before this Court the
following data and information:
a) Whether immediate quantities of the drug
Tocilizumab can be obtained from any of the
manufacturing units engaged in manufacture of the
said drug, and made available in India, for the
purpose of administration to Covid-19 patients in
India?
b) The quantities of the drug Tocilizumab to be made
available in India either through itself or through
its licensee(s) in India on a monthly basis for the
next four months.
c) What is the total quantity of this drug-
Tocilizumab, that has been imported/sold in India,
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Digitally Signed By:DINESH
SINGH NAYAL
Signing Date:05.05.2021
18:41:52
since March 2020 - either by the company itself or
through its licensee(s) or approved importer(s) in
India.
15. On a query to Ms. Ahuja as to what percentage of the global
quantities of Tocilizumab manufactured, is being allocated to India, she
submits that the said data may not be readily available by tomorrow but she
agrees to endeavour to obtain the same.
16. It is further noted, that insofar as the Petitioner's brother i.e., the
patient in the current petition is concerned, the Union of India and the
GNCTD assure this Court that they would make efforts through their good
offices, to make the required doses of the said drug- Tocilizumab 400 mg
available to the brother of the Petitioner.
17. List on 6th May, 2021 at 2:30 pm.
PRATHIBA M. SINGH
JUDGE
MAY 5, 2021/dk/Ak
