With third rank in terms of volume of production and
fourteenth in terms of value, the Indian pharmaceutical sector is
recognized as the leading global player in the international
market. Despite this India itself has a large unmet domestic demand
for critical medicines.
We have affirmed our commitment to the protection of
intellectual property rights. But, the global economy, the global
community, cannot afford the complete privatization of research, of
knowledge generation, especially in fields like medicine. We need
to evolve mechanisms that protect intellectual property and, at the
same time, address the needs of the poor," stated Dr.
Manmohan Singh in his remark at the Tenth Fortune Global Forum.
The provision of compulsory license (CL) provided in the Indian
Patent Act, in fact, serves to strike balance between these two
disparate objectives—rewarding patentees for their invention
and making them available to third parties in case of need. It is
an intervention mechanism that enables the government to balance
the rights of the patent holder with its obligations to ensure
working of patents, availability of the products at a reasonable
price, promotion and dissemination of technological invention and
protection of public health and nutrition.
Though after the Doha Declaration on the TRIPS agreement and
Public Health, about 52 countries have issued CLs (including
Brazil, Thailand, Malaysia, South Africa and Ecuador)1, India
granted its first CL recently in March 2012 to Hyderabad based
Natco Pharma Ltd. for producing generic version of
Bayer Corporations's patented medicine
Nexavar, used in the treatment of liver and kidney
cancer. The article discusses the international debate stirred by
the said judgment and the broader ramifications on the Indian and
global patent system as well as the apprehensions of the innovating
Natco vs. Bayer for Nexavar
Last year in July, Natco Pharma had filed application for CL in
respect of Nexavar stating that the German company's drug was
unaffordable for the average Indian. It had also claimed to sell
the copycat version of the drug for just INR 8,800 for a
month's course. Interestingly the price is about 3 % of what is
charged by the multinational giant for the same course. Natco had
earlier approached Bayer with a request for a voluntary license to
manufacture and sell the drug, which did not materialize. It is
worth noting here when the application for CL is considered by the
Controller, he also takes into account as to whether the applicant
has made efforts to obtain voluntary license from the patentee and
if the same has been rejected by the innovator company. The Patent
Office held that the conditions specified in the Patent Act, i.e.,
reasonable requirements of the public, availability to public at a
reasonable affordable price and working of the invention in India,
have not been met and hence granted the CL. It was settled that 6%
of the net sales of the drug would be paid to Bayer by Natco as
This article enunciates the recent, much awaited, and landmark judgment delivered on September 16, 2016 by Hon'ble Delhi High Court throwing light on the important provisions of the Copyright Act, 1962.
Department of Industrial Policy and Promotion recently issued an office memorandum pursuant to receiving representations from various stakeholders for guidance with respect to the applicability of the provisions of Section 31D of the Copyright Act, 1957.
An Invention Disclosure Form is the documentation of the invention. This is a means to document particulars of your invention and submitting it to the patent attorney who is filing your patent application.
The Patents Act 1970, along with the Patents Rules 1972, came into force on 20th April 1972, replacing the Indian Patents and Designs Act 1911. The Patents Act was largely based on the recommendations of the Ayyangar Committee Report headed by Justice N. Rajagopala Ayyangar. One of the recommendations was the allowance of only process patents with regard to inventions relating to drugs, medicines, food and chemicals.
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