Intellectual property rights use compulsory licenses

This remains a challenge for India, as process patent would be more helpful to a country like India. Protecting traditional knowledge Traditional knowledge, especially in the field of medicine, is like a gold mine. So, this is one of the intellectual property rights issues in India. Compulsory licenses are authorizations given to a third-party by the Government to make, use or sell a particular patented product without the need of the permission of the patent owner.

It is a relaxation available to the developing countries under the TRIPS agreement, something which organizations misuse sometimes. With the Drug Price Control Order, the company needs to justify the price of the drug with regards to investments. If someone plays foul, then the government has the right to intervene.

Multinationals are asking the government to revoke this provision. However, the government is not ceding the demands to protect the interest of the masses. Some other issues Trademark Violations: India has very high level of trademark counterfeiting against which the authorities in India do not take proper actions.

Enforcement of IPR regulations is quite weak in the country because of two important reasons India is key exporter of counterfeit fake products such as foodstuffs, textiles, shoes, electronics etc Judicial delays in IPR disputes India maintains high custom duties on IP intensive products as advocated by western countries impacting the investment US puts India into priority watch list i. The grounds on which an application is opposed must be mentioned in the notice of opposition.

Any further statement or evidence can be made only with the leave of or on the requisition of the Controller. The Controller shall exercise his powers upon receiving an application under section 84 to secure the following general purposes:. The Controller while settling the terms and conditions of a licence under section 84 should seek to secure the following:. Furthermore, if in the opinion of the Central Government, it is necessary for the public interest, it may direct the Controller to authorise any licensee in respect of a patent to import from abroad the patented article or a substance or article made by a patented process.

The Controller may impose such conditions that relate to royalty and remuneration payable to the patentee, quantum of import, the sale price of the imported article and the period of importation.

All the three conditions under section 84 were fulfilled viz. Moreover, the drug was highly-priced at Rs. Subsequently, in , the Health Ministry recommended three drugs used for cancer treatment, trastuzumab, ixabepilone and dasatinib for compulsory licenses which would allow these life-saving drugs to be sold by the Government at a lower and more affordable price making it accessible to the ordinary public.

The grant of compulsory licenses to drugs has played a crucial role in the healthcare system. However, a compulsory licence can have an impact on innovation whereby the pharmaceutical companies will be more dependent on generic drugs and will be deprived of innovation. The need to fund and carry out Research and Development will be hampered since they will solely rely on procuring a compulsory licence to a generic drug. In developing and underdeveloped countries affordability by ordinary people is a serious issue.

These exceptions have been invoked by a number of countries to gain access to medicines treating HIV at affordable rates from those offered by innovators, who generally charge markedly higher prices otherwise. Despite initial successes in securing public health interests, imposing compulsory licenses has its pitfalls. Patent holders are arguably deterred from increasing investments and efforts towards a particular research or innovation, due to the fear of the future loss of exclusive rights in their invention.

Moreover, developing countries have been shying away from utilizing the advantages of compulsory licensing, due to fear of political backlash from pro-patent rights, from developed countries. Simply put, two or more companies come together to collaborate over innovations and have common licenses over their work. In contrast to compulsory licensing, which only looks at dissemination of vaccines, the pool can serve as a means to foster the production, as well as availability and accessibility, of medicines and vaccines across the globe at reduced costs.

A patent pool framework can also be used by governments and research centers to collaborate with one another to test the efficacy of a vaccine that would involve the conjunct use of two or more different patented products. In this patent pooling structure, by having the parties pool their patents together for research and development, there is a renewed scope toward third-party licensing, transparency, negotiations in equitable pricing and royalty-distribution avenues.

Further, patent pools also ensure a certain degree of product homogeneity, resulting in a similar quality of vaccine being developed across the board. This might ensure that the same quality of vaccine is distributed to all the nations in an equitable fashion.

Several countries have already publically considered compulsory licensing as part of their COVID response. AbbVie has announced that it will not enforce its patent in light of the current pandemic [ 11 ]. In order for a government to use compulsory licensing for COVID related purposes, its domestic laws must have procedures in place to authorize such government action. Several countries have already taken legislative steps to ensure their governments can swiftly issue compulsory licenses as part of their COVID response.

The amendment allows the government to issue a license for necessary innovations and to negotiate remuneration later [ 12 ]. Specifically, the resolution declares that the coronavirus pandemic constitutes sufficient justification to grant compulsory licenses for COVIDrelated technologies [ 13 ].

Similarly, a Committee of the National Assembly in Ecuador has passed a resolution requiring the Ecuadorian President and Minister of Health to provide free or affordable access to COVIDrelated preventative, diagnostic, and treatment technologies through the use of compulsory licenses [ 14 ]. Other developing countries should take similar legal and legislative steps to establish a framework for using compulsory licenses in case it is necessary. Ultimately, compulsory licensing may not be necessary.

Even if the discovered cure is patent-protected, there may be drug donations, discounts, or the patent holder may offer voluntary licenses at affordable rates. However, in case compulsory licenses do become necessary when a cure is available, countries should take the appropriate legislative steps to prepare as soon as possible. Compulsory licensing is a powerful public health tool — it can be instrumental for alleviating insufficient supplies of necessary pharmaceuticals as well as mitigating prohibitively expensive drug prices.

While the rewards of patent protection are necessary to support continual innovation, the compulsory licensing exception exists for public health emergencies such as the current COVID crisis.

Governments must do what is necessary to fight the present pandemic. International organizations can play a key role by providing the legal know-how as well as setting a supportive tone for using compulsory licensing.

In the process, pharmaceutical companies and G20 countries should not deter or retaliate against developing countries pursuing such public health measures in the time of a pandemic.

Authorship contributions: HW is the sole author. Competing interests: The author has completed the ICMJE uniform disclosure form available upon request and declares no conflicts of interest.

National Center for Biotechnology Information , U. Journal List J Glob Health v. J Glob Health.