Recent IP Regime Review by Parliament
THE process of India’s public engagement with the intellectual property (IP) regime including Trade Related Intellectual Property Rights (TRIPS) is a matter of worldwide interest. With the latest development on the front of public engagement with IP policy and strategy it is apparent that India stands on the verge of abandoning its opposition to the imposition of strong IP on the people of this country. Taking advantage of the Covid-19 situation when the country is occupied with the challenge of survival and livelihoods, the Rajya Sabha’s department related parliamentary standing committee (PSC) on commerce presented to the Rajya Sabha on July 23, 2021 the 161st report on the “Review of the Intellectual Property Rights Regime in India”, wherein the parliament came to accept the proposals of the big business to adopt a stronger IP regime, which were so far rejected firmly by the nation.
Pressures from “big pharma”, “big tech” and “big agribusiness”, who favour a stronger IP regime, were earlier resisted reasonably well by almost all the political parties represented in the Indian parliament. Previous reports of 2008, 2000, 1993-94 stood the pressures, did not give into such proposals and rejected the demands of big business. The nation met firmly the arm twisting and did not fall into the trap of strong IP. The 161st report has reversed the thrust of opposition to stronger corporate capital favouring IP policy. The committee report has chosen to join the bandwagon of strong IP. The report is focused on strengthening the enforcement of intellectual property rights without giving consideration to public health concerns, access to affordable medicines, the impact on generic competition and the public interest balances provided in the patent law itself.
ISSUES AND CONCERNS
Implementation of the TRIPS agreement’s intellectual property standards is having a considerable impact on access to medicines and public health. By limiting competition and local manufacturing, the danger is that TRIPS extends high drug prices and worsens the access to medicines crisis. Instead of addressing the crisis, the report ignores the crisis. With TRIPS, life-saving medicines are considered in the same vein as mere consumer goods and the devastating impact of high prices is mostly ignored. In context of the Patents Act, 1970, the PSC has made a range of recommendations including revisiting the subject matter excluded from patentability. This is in direct contradiction to previous parliamentary reports.
The PSC recommends that Section 3(b) of the Patents Act, that allows the patent controller to deny patent to subject matter that is contrary to public order, be amended to exclude only those subject matter from patentability which are otherwise barred under any law. The balance between the private interests of the patent holder and the larger interests of society is severely skewed in the report. The PSC report seems to have given in to the demands of corporations (as opposed to protecting domestic industry) recommending revisiting Section 3(k) to facilitate “inventor status”, authorship and ownership by artificial intelligence (AI), of mathematical or business methods or a computer programmes or algorithms run by AI.
The PSC suggests that feasibility of allowing grant of patent to discovery of any non-living substances occurring in nature, which is otherwise excluded from patentability under Section 3(c), must be explored. In addition, the PSC recommends conducting an analysis on the plausibility of allowing grant of patents on plants and seeds with a view to explore an amendment to Section 3(j). The PSC recommends that DPIIT should examine the aspect on giving an “expansive meaning to section 3 (d). Section 3(d) is not being used to reject all secondary patents. The PSC recommends these dilutions, and the Modi government has now a go ahead to resolve these issues of section 3 (d) bilaterally, an issue also raised in the US Special 301 report.
Even while recommending grant of compulsory licensing (CL) for Covid-19 medicines and vaccines, the PSC dilutes the implementation of CL provisions. It recommends a careful stance in respect of the issuance of CL for emergency and crisis situation. On the implementation of Form 27 which deals with the obligation of the patent owner to report on working of patent to the nation, the PSC recommends relaxed filing for universities, R&D institutions, start-ups and small enterprises. It ignores that these institutions and enterprises are getting acquired by the big business left and right, and the nation cannot afford to dilute its stand on the obligation to work the patents in the interest of industrial and technological development and access to innovation.
The PSC further recommends the use of Patent Prosecution Highway (PPH) suggesting that it would promote more filing of patent application. It goes on to state that the PPH should be used to fast track the grant of patents to vaccines, pharmaceuticals and medical devices. This recommendation will jeopardise the flexibilities available to countries that allow them to have tailored patentability standards. PSC’s recommendations supporting the PPH also raises questions on whether the patentability standards laid down in the Indian legislation would be diluted by relying on foreign patent offices to support examination of patent applications. The PSC recommends marking products as “patent pending”, even while being aware that filing patents does not ensure grant.
The PSC displays a complete lack of understanding of how IP barriers undermine domestic production of medicines and vaccines and nowhere considers the efforts of India at the WTO seeking a waiver of enforcement of intellectual property provisions of the Agreement of Trade Related Aspects of Intellectual Property Rights and appears to suggest that increasing intellectual property protection is the way to ensure access to Covid-19 tools. In a contradictory stance, the PSC goes on to note that, “generic production in large quantities without any obligation of patents would help in removal of supply constraints in availability of affordable drugs, medicines and vaccines at times of high case load and death toll due to Covid-19.” The PSC recommends specific legislation to curb counterfeiting and piracy, a ploy of the big business to control the wider availability of software and creative works and medicines.
LACK OF BALANCED
India is one of those few countries of the world where there occurred a sustained public awareness campaign against the strong intellectual property (IPR) regime being demanded by the US and other developed countries during the period of negotiations on Trade Related Intellectual Property Rights (TRIPS) in the Uruguay Round of General Agreement on Tariffs and Trade (GATT). Despite the Doha Declaration, in recent years, many developing countries have been coming under pressure to enact or implement even tougher or more restrictive conditions in their patent laws than are required by the TRIPS Agreement – these are known as ‘TRIPS plus’ provisions.
Behind the success of this campaign the name that comes to fore is the National Working Group on Patent Laws (NWGPL). It was a coalition of the trade unions, peoples’ science movement, industry groups, consumers and citizen groups and involved the members of parliament of all political parties, and several prime ministers backed the proposals prepared by the NWGPL. This coalition was created by the mass movement based non-governmental organisations (NGOs), trade unions and sections of domestic pharmaceutical industry in 1988. The author of this article was the co-convener of NWGPL and late BK Keayla, who earlier had worked with Ranbaxy, was the convener.
In the process of drafting the review, the department for promotion of industry and internal trade, ministry of commerce and industry, Confederation of Indian Industry (CII), department of pharmaceuticals, ministry of chemicals and fertilizers, department of agriculture and education, ministry of agriculture and farmers’ welfare, Federation of Indian Chambers of Commerce and Industry (FICCI) and certain firms providing legal services were consulted. Other key stakeholders who are impacted by high prices and lack of availability of treatment due to IP barriers (patient groups, treatment providers and procurement agencies, ministry of health and family welfare, academia, state governments) have not been consulted during the process of drafting and finalisation of the report.
The proposals endorsed by the committee have raised serious concerns among the people in know of the history of the discourse on the impact on India’s IP policy. We owe to the nation that this kind of ignorance and forgetting does not pass. There should be a formidable opposition registered against the proposals. At the earliest possible in the action taken report those who are concerned and aware of the consequences should be consulted and the parliament should ask the committee to agree to listen to the wider public and the citizen groups active on the issue of intellectual property.
Note: John Brittas, joined the standing committee on commerce, as a newly elected CPI(M) member of the Rajya Sabha. He submitted a note of dissent on the IPR regime review, but it was not taken on record on the plea that the committee had already done most of the work in examining the matter.