Upload
anubhav-mehra
View
1.239
Download
0
Embed Size (px)
Citation preview
Current Scenario of Patent Act:
Compulsory licensing
Indian Journal Of Pharmaceutical
Education And Research
Volume 47, Issue 3, Jul–Sept 2013, page
no:26-30
Authors :
Harish Chander, Vaibhav Choudhary and Vikas
Kumar
Aim:
Brief insight into the past and present
scenario of compulsory licensing
issues related to patent around the
globe with special reference to Indian
Market.
Contents:
Introduction of Compulsory licensing
Indian perspective
Bayer vs. Natco case
Global perspective
Impact of Compulsory licensing
Conclusion
Introduction:
The Intellectual Property Rights across the world abide by a
common agreement named Trade Related Aspects of
Intellectual Property (TRIPS) which is a part of the WTO
agreement. TRIPS covers Compulsory License in detail.
Compulsory licenses came into force when the developing
countries couldn’t afford the cost of technology to produce
medicines and high price of the patented medicines.
Compulsory Licensing is defined by the WTO as “Compulsory
licensing is when a government allows someone else to
produce the patented product or process without the consent
of the patent owner.”
Compulsory license can be granted, at any time after the
expiration of three years from the date of grant of a patent,
by making an application to the Controller of patents.
Indian Perspective:Chapter XVI (Section 82-98) of the amended Indian Patent Act,
1970 is devoted to Compulsory Licensing. Section 84 of Indian
Patent Act provides for grant of CL. The grounds on which a
compulsory licence can be granted under the Act can be
sub‐divided into the following categories:
1) Abuse of patent rights [ Sec. 84 (1) ]
If the reasonable requirements of the public with respect to the
patented invention have not been satisfied.
If the patented invention is not available to the public at an
affordable price.
If the patented invention is not worked in the territory of India.
2) Public Interest [ Sec. 92 (A) ]
For export in certain exceptional circumstances
In case of national emergency
To countries having insufficient or no manufacturing capacity to
address public health problems
Bayer Vs. Natco: Case
Introduction Bayer v/s Natco was the first case of compulsory licensing
being obtained in India in pharmaceutical field of discipline.
BAYER
CORPORATION
NATCO
PHARMA LTD.
•International manufacturing
firm
•Indian generic pharmaceutical
company
•Invented a drug –
SORAFENIB(used in t/t of liver & kidney cancer
)
•Requested Bayer for voluntary
license
•Brand name – NEXAVAR •Bayer denied the request
•Obtained a patent on Nexavar•Natco filed an application for
CL
•Nexavar Cost : Rs 2.88 lakh
for a pack of 120 tablets
•Want to manufacture the low-
cost version of Nexavar
Case Overview:
On 9th March, 2012 the Controller General of India passed an order of compulsory license against Bayer’s patented drug Nexavar, which is India’s first compulsory license.
The compulsory license was granted in accordance with the grounds described under section 84 of the Indian Patent Act
The compulsory license enables Natco to sell the drug at a price not exceeding Rs 8,880 for a pack of 120 tablets (one month's therapy) as against Rs 2.88 lakh being the cost of Nexavar sold by Bayer.
The order also makes it obligatory for Natco to supply the drug free of cost to at least 600 needy patients per year.
Natco will have to pay 6% royalty on sales to Bayer for the drug on a quarterly basis.
Global Perspective:
Mainly developing countries are giving
importance to compulsory license because
of unavailability and unaffordability of
medicines while developed countries like
– U.S and Europe are opposing it
because of decline in innovation.
This table shows the instances of C.L. happened all around the
globe and grounds on which licenses where issue
Impact of Compulsory Licensing:
Innovation
The increasing cases of compulsory licensing around the globe would decline
the innovation because it will hamper the desire of the pharmaceutical
companies of the developing countries to go into the research and they may
become dependent on the generic medicines.
Furthermore, research based pharmaceutical companies will not launch
patent molecule .
Competition and Cost
Compulsory licensing ultimately will lead to increases in the competition
because more and more generic companies come into the role to capture the
high market share.
Patients
This phenomenon of compulsory licensing extensively helpful for the
financially challenged patients of developing countries by easy access to the
medicines at lower prices for maintaining good health.
CONCLUSION:
So, it can be concluded that compulsory licensing
now became the new hope for the financially
challenged patients while challenge for the
innovators and at last we can say that it turns into
the most concerned Intellectual property matter
around the globe at this present scenario.
Presented by-
Anubhav mehra
M.Pharm (D.R.A)
13/mph/2015