A landmark judgement named Bayer Corporation v. Union of India
, in 2019
passed to resolve the issue of granting of a compulsory license under Section
84. This case is first in India dealing with this issue.
Compulsory license means authorizing or permitting to sell a patented particular
product or use a patented particular process, without the need of the permission
of the patent owner. This license is provided by Government to third party.
There are some statutory provisions on national level regarding compulsory
license in Chapter XVI (Section 84, 92) Patents Act, 1970. And there are some
other provisions also on international level which are provided in TRIPS (Trade
Related aspects of Intellectual Property Rights) Agreement. But there are
certain conditions to be fulfilled to take the grant of compulsory license,
which are clearly mentioned in Section 84 and 92 of the Patents Act.
Patent is a exclusive right provided to a person who invents a new product or
new process and that new technology must be useful. It is provided by means
of granting a license to a particular person, and it is granted for a certain
period of time only to the inventor. There has been three amendments in The
Patents Act, 1970 as first in 1999, second in 2022 and third in 2005. These
three amendments are done to specify the concept of ‘compulsory license' and are
mentioned in the Section 82 to 94 of Act of 1970 respectively.
Procedure for filing the application of Compulsory license under Section 84:
When an application is filed for grant of compulsory license before controller,
it must contain all the relevant facts and evidence supporting the same. Then it
is the discretion of controller, he will examine the case and analyse the prima
facie things in application made against patentee. Controller will analyse some
factors on which basis he will decide whether to grant the compulsory license or
to reject the application of granting license.,, Such factors are:
Nature of the invention: Invention of a particular thing or process must be new and useful
Ability of applicant: An applicant must be capable to work for invention
Efforts of the applicant: Applicant must made some efforts to obtain the license from patentee on
reasonable terms and convince controller from his efforts.
After considering all the factors, if controller is satisfied than he may grant
compulsory license and if he is not satisfies with the application then he will
reject the grant of compulsory license by issuing of a notice which contains
the information about same. In this case, applicant may also have some issues
regarding this rejection. If yes, then he may request for a hearing with
controller thereafter, within one month from the date of issuance of such
rejection notice. However, the controller will decide whether the hearing with
applicant based on rejection application will held or not.
According to the Section 84 of Patents Act, 1970 : At any time after the
expiration of three years from the date of the grant of a patent, somebody
interested may make an application to the Controller for grant of compulsory
license on patent on any of the subsequent grounds, namely:
- That the reasonable requirements of the general public with reference to
the patented invention haven't been satisfied,
- that the patented invention isn't available to the general public at a
fairly affordable price,
- that the patented invention isn't worked within the territory of
As per Section 84, somebody who is interested or already the holder of the
license under the Patent can make asking to the Controller for grant of
compulsory license on expiry of period three years only when the conditions
are fulfilled which are mentioned above in Section.
Sometimes, compulsory licenses may also be granted, when:
Section 92: Export can be done under exceptional circumstances only.
Section 92A: Compulsory license can be granted case of national emergency where it has
been notified by Central Government that it is extremely urgent for public
Section 92 A (1): Compulsory license will be granted to country which does not have sufficient
means to work for public health or does not have enough manufacturing means
in pharmaceutical sector.
There has been a global perspective of compulsory license always, as this is
a highly debatable issue all over the world. Developed countries are working on
getting compulsory license but developed countries are not trying this.
Developed countries are opposing this as it would increase difficulty for
invention for pharmaceutical companies. Developing countries are giving that
much importance to compulsory license because of the unavailability and
unaffordability of the medicines, drugs to all people at reasonable price.
Developing counties are continuously granting more compulsory licences.
India's first case of granting compulsory license was granted by the Patent
and Trademark Office Database in 2012 to an Indian Company called Natco Pharma
for the generic production of company named Bayer Corporation's Nexavar. All
the three conditions of Sec 84 was fulfilled that the reasonable requirements of
the general public weren't fulfilled, which it had been not available at an
inexpensive price which the patented invention wasn't worked around in India.
This medicine is employed for treating Liver and Kidney Cancer, and one month's
worth of dosage costs around Rs 2.8 Lakh. Natco Pharma offered to sell it around
for Rd 9000 making this potentially lifesaving drug easily accessible to any or
all parts of the society and not just the rich people. the govt. took this
decision for the overall public benefit.
However, it had been heavily criticized by the Pharmaceutical Companies as they
felt the license mustn't are given. However, Natco Pharma is paying the
royalties to Bayer at a rate of 6% of all sales which are based on quarterly
basis according to the rules which are set by the United Nation Development
Programme (UNDP). The Health Ministry of India, in January 2013 recommended
three anti-cancer drugs trastuzumab, ixabepilone, and dasatinib for granting of
compulsory licenses. This can allow the government to sell these drugs at a
significantly cheaper price and can also allow the those who cannot afford the
drugs originally, access to those drugs.
The areas which are able to be impacted by compulsory license are as follows:
Innovation: In Underdeveloped countries, the innovation of pharmaceutical companies are
less as they are going to be obsessed with generic drugs. They are going to
prefer getting the compulsory license to a drug instead of funding the
Research & Development separately, which is usually awfully costly thing.
- Moreover, research based pharmaceutical companies won't launch patent
module within the developing countries as there's always the chance of
losing the patent, and losing money in research.
Competition & Cost: Compulsory licensing will increase the quantity of companies producing
generic medicines. Hence the provision will go up, and therefore the cost
will come down. this can also force the innovator countries to introduce
differential pricing of their patent module in order that they'll stand on
Patients: Patients will be able get medicines at a reasonable price or significantly
cheaper rate. Also, the massive pharmaceutical companies often introduce
plans like free access to medicine to guard their patents within the
The patient versus patent issue is one in every of the foremost important
problems now under the modern healthcare system. Although India has only passed
one compulsory license yet, the quantity of compulsory licenses granted
worldwide is on the increase.
The underdeveloped and developing countries want to pass compulsory licenses,
and also the developed, and also the big pharmaceutical companies don't want the
compulsory licenses to be passed. the most reason the large pharmaceutical
companies don't want compulsory licenses to be passed is that it takes lots of
cash and energy to make the drugs, and even then there's no certainty. they need
to recoup the prices of the innovation.
Hence the businesses need to fix the value of their patented module in step with
the economic status of the country if they require to shield their product from
compulsory licensing. India, particularly, faces a challenge, as a result of the
condition of the bulk population.
On one hand, it's to comply strictly with the international standards of patent
protection and on the opposite hand, it's to safeguard public health. I would
like to say that compulsory licensing has now become the hope for financially
challenged patients in underdeveloped countries who do not have resources for
their treatment, and compulsory licensing is now one in every of the foremost
controversial topics in International Property matters.
The ruling could be a landmark precedent on access to medicines in India because
the abuse of patent rights has been checked through the issuance of a
compulsory licence for the primary time. on condition that the foremost recent
cancer drugs are a superior choice to traditional chemotherapy treatments, but
are so expensive their high cost has put them out of reach of the soul. There
are some other cases also as, BDR Pharmaceuticals International Pvt Ltd v
Bristol-Myers Squibb Co
 and Lee Pharma v AstraZeneca A
the purpose of granting of compulsory license.
Award Winning Article Is Written By Shraddha Sharma
- AIR 2014 Bom 178
- Arnold JG. International Compulsory Licensing: The Rationales and the
Reality, IDEA: The Journal of Law and Technology, 1993; 33(2): 349.
- Compulsory Licensing of Pharmaceuticals and TRIPS. TRIPS and Health:
Frequently Asked Questions; World Trade Organization. Available at https://www.wto.org/english/tratop_e/trips_e/public
_health_faq_e.htm (accessed 16 December 2015).
- Natco Pharma Ltd., India v. Bayer Corporation, USA. C.L.A No. 1 of 2011.
March 9, 2012. P. H. Kurian, Controller of Patents, Mumbai. Available at:
http://ipindia.nic.in/ipoNew/compulsory_License_12 032012.pdf (accessed 20
- Gupta R. Compulsory Licensing under TRIPS: How aFar it Addresses Public
Health Concerns in Developing Nations. Journal of Intellectual Property
Rights, 2010; 15: 357-363.
- The Patents Act, 1970 (No. 39 of 1970) [as amended by Patents (Amendent)
Act, 2005 (No. 15 of 2005)]
- The Patent Rules, 2003, Rule 98
- The Patents Act, 1970, section 84(6)
- Ibid., section 94
- Ibid., 1970, section 91
- BAYER CORP. V. UNION OF INDIA, Available at http://www.indialaw.in/blog/blog/intellectual-property-rights/bayer-corp-v-union-of-india/
- Ibid., section 87
- Natco Pharma Ltd. v. Bayer Corporation. C.L.A No. 1 of 2011. March 9,
2012. Available at: http://ipindia.nic.in/ipoNew/compulsory_License_12
032012.pdf (accessed 29 June 2014).
- Gopalakrishnan NS, Anand M. Compulsory Licence Under Indian Patent Law.
In: Liu KC, Hilty RM, editors. Compulsory Licensing: Practical Experiences
and Ways Forward. London. SpringerVerlag Berlin Heidelberg; 2015. Ibid., p.
26 The Patents Act,
- Dewan M. Compulsory License Revisited India. Available at: http://www.rkdewan.com/articledetails.php/articlede
tails.php?artid=150 (accessed 08 July 2015).
- LANDMARK JUDGEMENTS IN PATENT LAW, Available at http://www.talwaradvocates.com/landmark-judgements-patent-law/
- Current Scenario of Patent Act published by Indian Journal of
Pharmaceutical Education and Research
- Kaur A, Chaturvedi R. Compulsory Licensing of Drugs and Pharmaceuticals:
Issues and Dilemma. Journal of Intellectual Property Rights, 2015; 20):
[Denied the request for compulsory license ]
[Denied the request for compulsory license ]
Authentication No: SP31125263149-14-920