NATCO seeking Compulsory License application for Baricitinib in India
On 3rd May 2021, NATCO Pharma Limited has received Emergency Use approval for Baricitinib tablets, 1mg, 2mg and 4mg strengths from Central Drugs Standard Control Organization (CDSCO) in India. Baricitinib in combination with Remdesivir, is used for treatment of COVID-19 positive patients.
Summary:
In
light of the grave and life threatening public health emergency, NATCO Pharma
moved before the Controller of Patents for Compulsory License of Drug Baricitinib
in India. NATCO seeking the Compulsory License under Section 92(1) with Section
92(3) of The Patents Act, 1970.
Facts & Targeted Approach:
PATENT: IN270765 (INCYTE/Lilly: Expiry
Date: Mar 10, 2029)
Patent Covers: Baricitinib
Compound & its phosphoric acid salt.
CDSCO Approvals:
·
May 07, 2018: For the
treatment of moderate to severe active rheumatoid arthritis in adult patients
who have responded inadequately to, or who are intolerant to one or more
disease modification anti-rheumatic drugs. Baricitinib may be used as
monotherapy or in combination with methotrexate.
·
May 03, 2021: Emergency
Use approval for Baricitinib tablets, 1mg, 2mg and 4mg strengths from CDSCO.
Baricitinib in combination with Remdesivir, is used for treatment of COVID-19
positive patients.
Basis of Applying Compulsory License
·
Natco filed this Compulsory License application with
respect to Indian Patent No. IN270765, which cover Baricitinib compound. This
Compulsory License application was filed under Section 92 (1)& Section 92
(3) .
·
Section 92 deals with “Special provision for
compulsory licences on notifications by Central Government”
·
NATCO seeks the Compulsory License being in the light
of the grave and life threatening public health emergency which is currently
prevailing in India due to the resurgence of the Covid-19 virus through a
second wave since at least early February 2021.
· Reports in the public domain as of 03.05.2021 indicate that the number of people in India affected by Covid-19 is over 2 Crores. The figures also state that while over 1.6 Crore people have recovered from Covid-19, over 34 lakh people continue to be afflicted, and there are officially over 2 lakh deaths. Daily newspaper reports show an alarming rise not only in the number of cases, but also in the number of fatalities due to Covid-19.
Condition for fulfill the requirement of Section 92
·
Existence of a national public health emergency:
o
The National Disaster Management Authority declares a
pandemic in March 2020 which continues to operate as of date.
o
There is in fact a grave national public health
emergency. In support of this position, reliance is placed on the declaration of
a pandemic by the NDMA as referred to above, which has not been withdrawn.
Reliance is also placed on the DCGI/CDSCO Notification of 19.03.2020 which is
operative across all drugs useful for Covid-19 treatment.
o
On 19.03.2020, the CDSCO through the DCGI, issued a
pan-India and drug-agnostic notification declaring that any drug approved
anywhere in the world for Emergency Use Authorisation would be entitled to the
same status i.e. Emergency Use Authorisation through a Special Regulatory
Pathway in India.
o
On 29.04.2021 CDSCO/DCGI has issued an Emergency Use
Authorisation for manufacture of Baricitinib API and 1 mg, 2mg and 4mg tablets
for Emergency Use in Covid-19 pandemic.
·
Unmet need in India:
o
Brand Olumiant (Baricitinib Tablet) by Eli Lilly
facing lack of supply as well as lack of affordability in India.
o
As per the requirement to submit the working
statement, Eli Lilly discloses the sales figure in Form-27 as:
|
2019 |
||
|
Strength |
No of Tablet |
Cost |
|
2mg
tablets: |
263
unit |
849569.00
INR |
|
4mg
tablets: |
7997
unit |
25832709.00
INR |
|
Physician’s
samples: |
810
unit |
2616543.00
INR |
|
Total
|
9070
unit |
29298821.00 INR |
|
Average
|
|
3230 INR per Unit |
|
2020 |
||
|
Strength |
No of Tablet |
Cost |
|
2mg
tablets: |
1627
unit |
5255698.00
INR |
|
4mg
tablets: |
5763
unit |
18616219.00
INR |
|
Physician’s
samples: |
995
unit |
3214149.00
INR |
|
Total
|
8385
unit |
27086066.00 INR |
|
Average
|
|
3230 INR per Unit |
·
Unmet need to due to lack of supply
o
Olumiant (Baricitinib Tablet) by Eli Lilly is
currently not manufactured in India. The dependency to fulfil the need depend
upon import from Spain.
o
There is a significant lack of access in terms of
availability of such medicine to patients across India even assuming only 25%
of the Covid-19 patients are prescribed Remdesivir injection, and therefore can
also avail of the benefit of co-treatment with Baricitinib, this in itself
works out a patient population of approximately 8.5 lakh patients.
·
Unmet need due to price/lack of affordability
o
Even
if Eli Lilly undertakes to meet the full requirement, a significant barrier to
access remains the price of the product. The per tablet cost is INR 3230.00.
For a 14-day treatment regimen the price works out to INR 45220.00 per patient.
o
As
is self-evident this is not only more than the median average income of most
families, it is actually more than the monthly income of even most qualified
professionals across India.
·
Conditions of Section 92(3) satisfied
o
Eli
Lilly itself has a very narrow distribution network and it is inconceivable
that it will ever be able to service the needs of the Indian population for
Baricitinib in times of Covid-19 pandemic. Of necessity, any baricitinib
product imported by Lilly will be limited in access to at best a few urban
centers such as Delhi or Mumbai, if at all.
NATCO
Offered the Baricitinib Tablet at an affordable cost as:
· 4 mg tablet: INR 30.00 per tablet, i.e. INR 420.00 for a maximum 14day course
· 2 mg tablet: INR 20.00 per tablet, i.e. INR 280.00 for a maximum 14day course
· 1 mg tablet: INR 15.00 per tablet, i.e. INR 210.00 for a maximum 14day course
NATCO
is seeking for:
·
Manufacturing of API as well as Formulation under
Compulsory License using in-house facility.
·
Offered 7% royalty to Lilly upon profit.
Find
the Compulsory License copy here.
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