compulsory license

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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

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Page 1: Compulsory license

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

Page 2: Compulsory license

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.

Page 3: Compulsory license

Contents:

Introduction of Compulsory licensing

Indian perspective

Bayer vs. Natco case

Global perspective

Impact of Compulsory licensing

Conclusion

Page 4: Compulsory license

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.

Page 5: Compulsory license

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

Page 6: Compulsory license

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

Page 7: Compulsory license

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.

Page 8: Compulsory license

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.

Page 9: Compulsory license

This table shows the instances of C.L. happened all around the

globe and grounds on which licenses where issue

Page 10: Compulsory license

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.

Page 11: Compulsory license

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.

Page 12: Compulsory license

Presented by-

Anubhav mehra

M.Pharm (D.R.A)

13/mph/2015