Making billions of investments in research and development of the pharmaceutical sector isn’t easy for all the nations around the world especially when it comes to the Least Developing Countries. This is why the notion of compulsory licensing becomes inevitable for securing public health and ensuring easy access to medicines which are the two most fundamental duties of every state. Compulsory licensing as defined by the World Trade Organisation (WTO) is when a government allows someone else to produce a patented product or process without the consent of the patent owner or plans to use the patent-protected invention itself.
It is for
the government to ensure that the public not only has easy access but also be able
to afford the medicines. One of the hurdles that might arise in the way of
achieving these goals is that of patent protection. Through patent protection,
the patentee/inventor can claim an exclusive right of using/exploiting the
invention thereby excluding all others to have a right over it. This exclusive
right might also result in situations wherein the public is deprived of bearing
the fruit of the invention especially when it comes to pharmaceutical products.
The concept of compulsory licensing thus protects the interest of the public by
ensuring that the product is brought into the public domain and can be used for
the public good. It thus protects the interest of the public by maintaining a
balance between conflicting claims of the inventors and the citizens.
Compulsory licensing has also been duly recognized by various international
conventions and treaties. For the first time, it was incorporated in Paris
Convention, 1883 which provide for the grant of compulsory license and to
prevent the abuse of patented invention. In addition to this, Agreement on
Trade Related Aspects of Intellectual Property Rights(TRIPS), 1994 too lays
down provisions for grant of compulsory licensing. It lays down that a before
applying for a compulsory license, sufficient efforts shall be made to procure
a voluntary license and it is only in case of failure that an application of
compulsory licensing can be considered. It helps in reducing the cost of the
medicines and make it affordable for the general public which is not always
well off and struggles to purchase the life-saving drugs at exorbitant prices
charged by the MNCs. When it comes to India, the case of NATCO Pharma Ltd. v.
BAYER Corporation is
a classic example of how the prices of the medicines drop significantly once
compulsory license is granted. The Indian Patent Act, 1970 also envisages
provisions which provide special powers to the controller to procure a license
in case of national emergency, extreme urgency and public non-commercial use.
Thus, the entire concept revolves around public good which is always kept at
the highest pedestal. However, while granting compulsory license the rights of
the inventor should not be ignored unreasonably. He shall be paid adequate remuneration
while his invention is exploited by others. The inventor’s rights should not be
compromised in any way. The authorities have taken progressive steps towards
it. In 2013, the controller rejected an application of BDR Pharma for the compulsory
license on the ground the absolutely no efforts were made to procure a
voluntary license first. In another case, the controller rejected the
application of Lee Pharma as it failed to prove that there was a reasonable
requirement of the drug in public. No one shall be allowed to get unjustly
enriched by the using inventor’s patented product. Thus, Compulsory licensing
acts as an exception to the general rule and protection granted to one’s
patented products. What is essential is to strike a balance between the
interest of the patentee and of the patients which is why compulsory licensing
is one of the most controversial topics in the regime of patent law.
 Order No. 45/2013, Intellectual Property Appellate Board, Chennai 0 List Table 7
Written by Priyanshi, BA LLB, 4th Year, (email@example.com), Vivekananda Institute of Professional Studies, I.P. University, Delhi