The post 2005 and the impact of adopting stronger patent regime in the context of India generated debate not only within India but also outside, since India is one of the larger drugs/medicines manufacturing country in the world which ranks higher position in terms of production and volume. India’s export reaches a number of developing and least developed countries which show the dependency of the other countries on India. India’s pharmaceutical industry is also making footprints in the developed countries as well.
India’s transition towards the product patents came gradually. As a signatory to the Trade-Related Aspects Of Intellectual Property Rights(TRIPS) Agreement, India amended her Patent Act of 1970 once in 1999 and again in 2002 to introduce, mailbox facility to accept product patent applications, exclusive marketing rights(EMR) to provide marketing rights for products granted patents elsewhere and applied for patents in India, provisions relating to granting of compulsory license and finally granted full patent protection in all fields of technology including pharmaceuticals from 1 January 2005. While this is expected to curtail the generic industry’s capacity to introduce generic drugs during the life of the patented product, yet the amendments made to the Patent Act to a large extent ensure that India can exercise flexibility. This was passed through an ordinance in December 2004, which was followed by the Patent (Amendment) Act passed by Parliament in March 2005.
The Indian government in its second amendment to the patent law has provided for adopting Compulsory License(CL) and Sections 82 to 94 in Chapter XVI deal with Compulsory License(CL) in the amended Patent Act of India. These sections provide details of: general principles applicable to working of patented inventions; grounds for grant of CL; matters to be taken into account by the controller of patents while considering applications for CL; procedures for dealing with CL applications; general purposes for granting CL and terms and conditions of CL. Under Section 87, when the controller is satisfied that the application for the grant of a CL or the revocation of the patent after the grant of CL has a prima facie merit, the applicant will have to serve copies of the application to the patentee and to advertise the application in the official gazette. The patentee or any other person may oppose the grant of the CL within the period specified by the controller who can also extend the time. Thereafter the controller will decide on the case after hearing both sides. Any decision by the controller to grant a patent can be contested. Under Section 117 A, an appeal can be made to the Appellate Board. The applicant will be able to use the CL only if and after the Appellate Board turns down such appeals. The problem with the amended provisions is that the entire process is excessively legalistic and provides the patentees the opportunity to manipulate by litigation. The huge expenses involved in companies holding the patents may dissuade the non-patentees from applying for licenses in the first place. It’s observes that there is enough justification to carry out further amendments to simplify the general provisions of CL in the Act to enlarge its use. For any drug in the public health list, the controller may immediately after receiving an application, grant the CL fixing a royalty rate using the royalty guidelines.
Though an interesting feature of the amendments adopted to Patent Act 1970 in India(Under the Doha Declaration on TRIPS) which take care of the interests of the Compulsory License(CL) for public health emergencies, a practical implementation of the Doha Declaration on TRIPS is not administered by PM Modi’s Government for the COVID-19 vaccine manufacturing. Under the provisions of Compulsory License(CL) of Doha Declaration on TRIPS, non of the official documents/database released by PM Modi’s Government of India which underlying the granted Compulsory License(CL) to the pharmaceutical companies for the manufacturing of Covid-19 vaccine. This is not enabling the pharmaceutical companies to expand the scope of manufacturing capacity. Pursuant to the Article 51(c) of the Indian constitution 1949, India has obligations to foster respect for international law and treaty obligations in the dealings of organised peoples with one another and encourage settlement of international disputes by arbitration. As on the earliest stage of vaccine inequity, only the Serum Institute Of India’s Oxford-AstraZeneca vaccine was permitted a license under emergency sanction. This shows PM Modi’s Government ambivalence towards the deep concerns about Covid-19 vaccine inequity. Throughout the Covid-19 vaccine inequity, PM Modi’s Government struggled to purport its top trade ranking in the pharmaceutical industry in terms of export and production of medicines particularly Covid-19 vaccines. The question remains in one’s mind that has India exported vaccine doses with only one major manufacturer namely the Serum Institute Of India from January 2020? as per data released on the website of the Ministry of External Affairs of India.
Albeit the Doha Declaration simplifies the TRIPS Agreement, so that in practical terms, countries could have access to medicines, yet, the regional and free trade agreements (FTA) signed between the developing and the developed countries introduce TRIPS plus provisions which impede access to medicines. Every Free Trade Agreements (FTA)includes a chapter on Intellectual Property Rights (IPRS). But unlike the Trade-Related Aspects On Intellectual Property Rights(TRIPS) Agreement, this chapter may or may not clearly spell out the objectives and purposes of these agreements. In addition, some agreements state that parties can implement a more extensive protection and enforcement than the FTA requires. Most often, though the FTA provide minimum standards for the protection and enforcement of IPRS, but parties are free to implement more constraining provisions. Mostly, the FTA tend to add restrictions in the criteria of patentability, patent territory, patent duration and disclosure of clinical data, which restrict the flexibility otherwise provided by the agreement on Trade-Related Aspects Of Intellectual Property Rights(TRIPS)
The Doha Declaration is one of the significant achievements of the efforts of the developing and least developed countries to gain access to the patented medicines. Particularly it facilitates the use of the patent right of the innovation without authorization of the patent holder for public uses. Paragraph 6 and the waiver introduced enable now the countries to utilize the CL not only for the domestic purposes but also for export purposes which would significantly help those countries without pharmaceutical production capacities. The some of the countries that have utilized CL by importing the generic product from elsewhere. This provision nullifies the concerns among the least developed countries and health activists, created by major medicines producers such as India adhering to the TRIPS Agreement. The domestic patent law amendments made in the case of India also facilitates production of patented drugs/Medicines and thereby access to medicines to a large extent both within and outside the country.
In any case, the prior requirement in utilizing the Doha Declaration to the fullest level is in incorporating the necessary clauses in their national laws so as to utilize the flexibilities, followed by the willpower to withstand the international pressures. Though the Doha Declaration enables utilization of flexibilities, yet, countries coming under the FTA scanner have restrictions and have to look for ways to get access to medicines as these are the cases where the regional trade agreements become more powerful than the multilateral agreements. However, as the discussion highlighted, the movement of utilizing the CL as facilitated by the Doha Declaration gains more momentum, the role of drug cartels could be reduced with more contribution by medicines producers such as India.
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