“While we should seek light from whatever source we can get, we should however guard against being blinded by it.” – JusticeP. Jaganmohan Reddy in Surendra Pal v. Saraswati Arora (1974) 2 SCC 600)
Intellectual Property Rights are territorial rights, aimed at incentivizing innovation by offering monopolistic rights to the inventor for a limited duration in exchange of bringing the invention in the public domain after the expiry of the duration. The poignant aspect for the present topic is that IP rights are territorial rights. Thus, these are rights the State grants to exercise within its boundaries and, more importantly, to incite innovation amongst its citizens and to confer the benefits of such inventions over its subjects. Despite the feature being rudimentary to IP jurisprudence, it is curious to note that any discussion of the Indian IP laws is deliberated and scrutinized in the light of the IP laws of Developed Countries, in particular, the United States of America. Not only do we conceptualize IP laws in India as per the model in USA, we sanctify the grievances of the US lobbyists who have been impressing their demands for stringent IP protection.
It may be argued that India, as a member of TRIPS and other relevant treatises, is bound by its international obligations. USA and other Developed Nations set an example of the purportedly strong IP regime. It is fair to state that the Indian IP laws leave a lot of questions unanswered. However, it would be grossly inaccurate to assert that the Indian IP regime falls contrary to its obligations under TRIPS. As one of the leading IP figures of India, Dr. Shamnad Basheer stated that India has merely exercised the flexibilities warranted under TRIPS and in doing so it has aimed to cater to its national developmental goals. While honoring international commitments is crucial, it is equally incumbent that the State shape the laws with due regards to its developmental priorities. It is towards identification of such policies which could balance the dual disparate concerns that the IPR Think Tank was constituted.
The National IPR Think Tank (NITT) has been shrouded in controversy, right from its constitution. Prior to the inception of the Think Tank, the Department of Industrial Policy and Promotion (DIPP) had constituted a committee of India’s leading figures in IP, namely, Dr. Shamnad Basheer, Yogesh Pai and PrabuddhaGanguli. The committee was invited to identify core principles that would form the basis of the national IPR policy. Upon the submission of a draft, the committee suggested that the draft be made public so as to invite further discussions. However, the Commerce and Industry Minister Nirmala Sitharaman, instead announced the formation of a six member panel to identify policy which captures the spirit of IP stimulated growth in India. The panel headed by Justice PrabhaSridevan, former chairperson of the Intellectual Property Appellate Board and former judge of the Madras High Court, included Prathiba Singh, Senior Advocate; Punita Bhargava, Advocate, Inventure IP; UnnatPandit, Cadila Pharmaceuticals; Rajeev Srinivasan, Director, Asian School of Business; and Narendra Sabharwal, retired DDG, WIPO.
If one were to overlook the discourteous manner in which the invaluable contribution and efforts of the leading scholars of the country was treated, the composition of NITT further raises more concerns than inspiring any confidence. The composition has drawn the ire from most quarters on the grounds that it lacks independent experts with grounding in IPR issues.To a great extent the furore over the constitution of the panel has stemmed from the non-transparent manner of selecting panellists and the allegations of nepotism is the appointment. Surely the NITT mainly comprised figures who are individuals with significant repute and experience. Nonetheless, the obvious omission of the any luminaries from the academic field gives credence to the apprehensions. It has been alleged that while the candidates in the panel accommodate representation of corporate and pharmaceutical industry, it lacks representation of the individuals who are experts in IP or who represent voice of public and social health activists.
The mission of the NITT was aimed to identify IPR policy which enable the IP laws to cater to the national objectives without compromising India’s obligations. If the IP regime of India has to be reworked, it not only requires representation of corporate interests but also inculcation of the counter narrative.
NATIONAL POLICY DRAFT
The panel released the National IPR policy final draft on 18th April, 2015. The panel has laid down the objectives policy under the following heads:
- IP Awareness and Promotion
- Generation of IPRs
- Legal and Legislative Framework
- IP Administration and Management
- Commercialization of IP
- Enforcement and Adjudication
- Human Capital Development
The key findings and conclusions of the panel can be set out as follows:
- Any progress sought to be achieved by virtue of evolution of IP protection would be rendered facile, unless the advantages of IP are recognized by all the strata of the society. The NITT seeks to raise public awareness of IP laws by the use of a National slogan “Creative India, Innovative India”. IPR can be promoted by interlinking existing national development schemes like Make in India, Digital India, etc. Further the policy seeks to encourage permeation of IP monetization amongst the MSMEs, R&D and Science and technology institutes, academic institutions, etc.
- The policy highlighted its vision towards creation of IP awareness and creation of by following suggestions:
- Improving/ introducing the IP curriculum in educational institutions, by working in collaboration with WIPO, WTO and/or other foreign institutions.
- Sensitizing IP related issues by engaging the media.
- Introducing support systems for MSMEs, startups and grass root innovators in order to encourage innovation.
- The policy had proposed a sea of changes in the legislative and administrative framework, such as:
- Addressing the gaps in of laws on trade secrets and suggested recognizing Utility Models
- Formulation of a legislation/sui generis system for protection IP in the form of Traditional Knowledge and inventions from public funded research.
- First time patent fee waiver and reduction to MSMEs
- Providing statutory incentives like tax benefits based on IP creation
- Restructuring, upgrading and granting autonomy to IPOs
- Establishment of an IP Promotion and Development Council (IPPDC), aimed at under taking promotion of IP and undertaking projects to create awareness and utilization of IP.
- Creation of a Multi-Agency Task Force to coordinate between different agencies working towards IP protection.
- Setting up branches of IPAB in five regions Ahmedabad, Bombay, Calcutta, Delhi & Madras.
- Designating specialized patent bench in in the Bombay, Calcutta, Delhi & Madras High Court
- Providing better training for officials at IPOs and consider joining Centralized Access for Search and Examination(CASE) and WIPO Digital Access Services (DAS);
- The policy had identified certain key areas wherein IP protection envisages greater socio-political considerations, a brief of the proposal is as follows:
- Agriculture: NITT has proposed interlinking of interlinking and harmonization of the National IPR policy and institutional policy of Indian Council of Agricultural Research (ICAR). Establishment of Community Seed Banks in different parts of the
- Public Health: The policy states that the proposed Utility Model shall not include pharmaceuticals, biological materials or substances. Recognizing that India’s public health priorities cannot be diluted in lieu of its international commitments, the policy suggests the following:
- Encouraging innovation in institutions, universities and developing new technology platforms.
- Enhancing and encouraging research in public funded research institutes, including open source based research such as Open Source Drug Discovery (OSDD) by the Council of Scientific and Industrial Research (CSIR).
- Reduce reliance on Active Pharmaceutical Ingredients (API) imports.
- Traditional Knowledge: The policy proposes setting up a sui generis system for protection of Traditional Knowledge (TK) and Cultural Expression. Increasing the coverage of Traditional Knowledge Digital Library. Further it has been suggested that efforts should be made to TK is used as a reference point for ‘prior art’ in patent applications.
- With respect to other fields the policy prescribes to undertake:
- Restructuring of Copyright Enforcement Advisory Council (CEAC)
- Online database for copyright owners maintained by IPPDC
- Designation and promotion of certain identified “GI zones”
- Constitution of separate wing for GI at IPPDC
- Formulating of policies offering incentives to domestic technology developers by Telecommunication Standards Development Society, India (TSDSI)
- Incentivising IP creation and acquisition of IP in renewable and clean energy
The said draft National Policy was submitted to the Cabinet for approval and on 13.05.2016 Finance Minister ArunJaitley announced the approval of the Policy. While the Approved National IPR policy has retained the majority of proposals, it has not included most of the administrative suggestions. Few noticeable omissions and changes are as follows:
- The Cabinet has not included the suggestion of recognizing Utility Patent model. In light of the same it is pertinent to observe the recommendations in the Baseline Policy Draft that was proposed by the Committee constituted prior to the NITT. The draft suggests that before determining the legislation for Utility models, it is vital that India undertake a robust cost benefit analysis and ensure that the law would not defeat the benefits accrued under other IP legislations.
- Further, a series of administrative proposals have been overlooked. The Cabinet seeks to setup a Cell for IPR Promotion and Management under the aegis of DIPP, to facilitate promotion, creation and protection of IP. NITT had suggested formation of IPPDC, however, it did not elaborate on the scope of the body. In light of the above the conception of CIPAM has been aimed to undertake management of all IP databases and act as the nodal agency towards deliberating, analyzing and facilitating implementation of best practices with respect to IP. Nevertheless, the policy does not reflect any intention of setting up new or expanding the existing IPAB.The Approved policy has, however, stressed, at multiple occasions, on the recruitment, examinations, training of IP agents and IPO personnels.
- The Approved policy also proposes to undertake examination of Standard Essential Patents (SEPs) on fair, reasonable and non-discriminatory (FRAND) term, an issue which has recently invited a lot of discussions and debates, a point which was missing in the draft proposal.
- The Policy has proposed involving companies by promoting infusion of funds to public funded research institutions as a part of Corporate Social Responsibility.
- However, the policy does not feature any details of the measures to be undertaken to promote IPs like, GI, TK, etc. Even though the Approved Policy has suggested allowing public research institutions to have access to TKDL and even permitting usage by the private sector with safeguards in place.
- The Policy highlights India’s commitment to the Doha Declaration, which effectively indicates that Indian IP protection would not come at the cost of its developmental goals or the need of its citizens. This reflects that India will use the flexibilities under TRIPS to prevent exploitation of IP protection or address national emergency.
- The Policy proposes the engagement of research for policy development with respect to interplay between the forms of IP, IP interface with competition law and protection of Trade Secrets.
Recognizing the significance of encouraging innovation in institutions and amongst MSMEs was a vital inclusion in the policy. If we take a note from the US model, it is worth noting that US universities account for 30 of the top-50 educational institutions in the ranking of highest users of the PCT system with University of California having more publications than several popular companies as well. Furthermore, in the current Indian economy MSMEs contribute nearly 8 percent of the country’s GDP.
While the vision of the policy contemplates advancement and development spurred by intellectual property, a CIS report asserts that the vision would stand defeated by undertaking an IP maximization approach that the policy has proposed. On the same note leading IP scholars of India observed that the policy reflects the intent to promote awareness on the significance of IP protection, strengthening of IP laws and administration, etc., however,the proposal does not reflect a balanced IP policy. With respect to complying with international obligations, the policy should have inculcated the proposal of the submission by the previous Committee which suggested that to the extent it serves to the nation’s developmental goals, India will be guided by the “Principles for Intellectual Property Provisions in Bilateral and Regional Agreements” issued by the Max Planck Institute for Intellectual Property and Competition (MPI).
In terms of Farmers’ rights it is important to note that the laws in place confer on the farmers negative rights, much like other IP rights. Considering factors like the socio-economic status of farmers in India, further the absence of influential domestic competitors and the political recognition of the needs of the farmers only at the times of droughts or elections, it is not unreasonable to suggest that the policy should envisage more affirmative guidelines and interlinking with other government schemes. Having said that the policy does state that plant breeding innovations shall be disseminated and access to innovations and protected technologies will be provided through appropriate mechanisms. Further the policy is silent on several key IP issues that have surfaced with advancement of technology. Protection of inventions in bioproducts, application of patent laws or copyright for software protection, etc. are to name a few.
Major criticisms have been directed at the lack of empirical evidence in substantiating the sweeping statements and proposals suggesting that a strong IP legal framework would encourage innovation or spur invention. While the Policy stresses on IP protection it fails to consider non-IP policies to promote creation and innovation.The Policy does not address the issues faced with respect TK or proposes measures it intends to undertake towards preservation of TK. Considering India has had to oppose several patent applications, patent application on properties of turmeric, being one such instance, protection of TK should have weighed heavily in the policy.
THE NEED FOR A NATIONAL POLICY
The importance of a policy can be seen through judicial decisions rendered by the Indian Courts. In G. Sundarrajan v. Union of India (UOI) and Ors.(2013)6SCC620 the court allowed setting up of nuclear power plant at Kudankulam in State of Tamil Nadu, basing the decision on the reasoning that the Parliament had announced its National Policy through the Atomic Energy Act, 1962 and the setting up of the reactor was in consonance with the policy. On the grounds of implementation of the policy, the Apex Court has held that, unless contrary to the Constitution, courts cannot weigh the wisdom of the legislation or decision of the Government with regard to policy matters. This demonstrates that the national policies are in the nature of guidelines in accordance to which the Government formulates its laws or takes actions at a national level. While policies are also vital in delineating the intent, vision and structure of the relevant laws for representations to the other states and for further development of the law in accordance with the proposed policy.
The need for a National IP Policy is more aptly reflected in the Objective of the draft policy by the previous committee, wherein it states the policy is required to identify common core principles which would enable the nation to negotiate with foreign trading partners and aid the protection and administration and enforcement of current intellectual property norm. Further such a policy will enable India to formulate new norms or amend the existing ones strictly based on empirical evidence. Nevertheless, the present IP policy seems to rely on the word “IP” being synonymous with “innovation”. While it is argued that IP creates incentive to innovate, there is little to no data to substantiate the averment. At best IP can be regarded as a means to an end. Although the policy attempts to represent a balanced approach, yet it is important to note that, the IP monetization approach of the Policy is not the only manner to encourage innovation and India needs to encourage research and innovation at its grass root level before embarking on a protectionist regime. While we have the examples of the several Developed Countries to inspire and direct us, it is important that we mould the laws to accommodate the Indian developmental goals and not be blinded by the light.
Shamnad Basheer, “India and TRIPS Compliance: Protectionist Policies”. Available at http://spicyip.com/2008/01/india-and-trips-compliance.html
Prof. N.S. Gopalakrishnan and T.G.Agitha
State of H.P. and Ors. v. Himachal Pradesh Nizi Vyavsayik Prishikshan Kendra Sangh(2011)6SCC597
“Where the mind is without fear
and the head is held high,
where knowledge is free.
Where the world has not been broken up into fragments by narrow domestic walls.”
~ Rabindranath Tagore
The issues with respect to Net Neutrality have come to the fore over recent undertakings by the telecom industry levying differential pricing for data services. Free Basics, one of the more popular services under scrutiny, is a partnership between Facebook and telecom service providers. In India, Free Basics allowed Reliance Telecom Subscribers access to selected websites/services without incurring data charges. The initiative given a philanthropic paradigm was purportedly aimed to provide access to selected services over the Internet to those who cannot afford data services and thereby, enhancing connectivity. It was opposed on the grounds that the Service Providers by levying differential tariffs based on the content/websites/applications/platforms impinged on tariff frameworks which elucidated principles of non-discrimination, transparency, non-predatory, non-ambiguous and not anti-competitive and effectively violated the norms of Net Neutrality. In the face of such developments the Telecom Regulatory Authority of India (TRAI) issued a consultation paper on the issue of Differential Data Pricing for Data Services, inviting opinions and suggestions. After considerable discussions, TRAI issued the Prohibition of Discriminatory Tariffs for Data Services Regulations, consequently banning differential pricing or any agreement discriminating access to data in any form and upholding Network Neutrality.
The regulation passed by TRAI was substantiated in an Explanatory Memorandum. The findings can be summarized as follows:
- The differential tariffs offerings bear positive as well as negative connotations. The discounted or zero rated pricing would enable significant part of the populous to access and avail internet services for the first time. It has been argued that differential pricing would encourage product innovation and would also bring more customers on the internet.
- The proponents opposing the schemes have contended that Telecom Service Providers (TSPs) are merely “custodians of the public resource infrastructure” which should be made available to the subscribers in a non-discriminatory and transparent manner. The internet is a neutral end to end carrier of information and such a scheme would breach the principle and allow the TSPs to function as gatekeepers, violating the basic rights and freedom of speech and expression.
- The Authority (TRAI) underlined that the Regulation refers to price differentiation when it is content-specific. While internet comprises an amalgamation of networks that share addressing and routing system effectively allowing interconnection between networks, TSP only offers data services without any control over the internet infrastructure. In such a case permitting TSPs to discriminate in the pricing over data, it does not independently process, would impact the openness of the internet. Further, the same content being provided for free by one service provider shall be provided at another rate by the other TSPs. This levying of differential prices for the same content falls against the principles of Net Neutrality.
- Differential pricing might allow greater permeability of the services, however, significant strata of the Indian population is yet to enjoy such connectivity to the internet, will be dictated by the services rendered by the TSPs. As opposed to exercising free will, such users will rely on the internet experience shaped by the TSPs. Access to limited services deprives the user from making informed opinions, in lieu of such “Information Asymmetry”. It could also cause distortion in the consumer’s choice.
- The tariffs system would also be adverse to anti competition principles. The proposed differential tariffs favour the well-financed and established content/service providers in the market, thereby, creating entry barriers and affecting competition and innovation. Also, since over the internet at several occasions service providers are themselves content providers, it will give rise to conflict of interest.
- In light of such finding, TRAI recognized that the scheme was against the principles of Net Neutrality and prohibited any discriminatory pricing of data services. However, such pricing is permitted during times of emergency and are inapplicable to closed networks, like intranet.
Net Neutrality in India
The concept of Net Neutrality refers to the principle that Broadband providers shall treat all internet contents and/or applications equally and not discriminate between such contents/applications on any grounds if at all. The debate over Internet/Network (Net) Neutrality is not limited to the purported loss incurred by the Broadband/Service providers and neither is it restricted to, as Facebook founder Mark Zuckerberg states, “bringing affordable internet access to everyone in the world.” As noble and important, without regards to the motives of the supporters of differential pricing policies, as the propaganda might seem, it ignores the basic tenet that Internet has been associated with – Freedom and Equality. Internet provides, within purview of the law, an equal platform to all forms of business, a start-up or an established corporation; equal representation to varied arguments or disparate views and an access to information without prioritizing or discriminating between the source or content. It allows a CEO or Government leaders to publicly announce their opinions and equally gives people the opportunity to register their dissent. The postulates of Net Neutrality do not envisage free access for the user or the content provider, it posits “equal access”. An argument for equal access, draws the corollary for nondiscrimination and transparency in determinations.
Net neutrality forms a part of the all encapsulating notion of Open Internet. The Committee constituted by the Department of Telecommunications (DoT) towards examining the issues over Net Neutrality rightly observed in its report that perfect application of Open Internet is not feasible nor warranted, however, the core principles of Net Neutrality should be adhered to. It is towards the preservation of these core principles and ideals that the tryst for Net Neutrality finds force. The verses of the Indian Nobel Laureate contemplate the vitality of access to “knowledge”, but knowledge where it is unbiased and uninfluenced. The internet as we know is not the ideal source of such knowledge, but is as close an alternative that we can salvage. If equal access to knowledge is deemed to be ones basic right by TSPs, it is equally incumbent to recognize that the discrimination between the knowledge based on its source or content would render the picture as incomplete. It is equally important that the access so envisaged by TSPs should not be confined to select few but should reflect the ethos of Internet, however, the current measures allow TSPs to shape up and dictate the views of the select and favoured few, anything contrary or beyond the purview comes at an increased cost, literally!
The WTO ruling is primarily seen as a move that has offset India’s green initiative and impeded growth of the domestic market, in particular the manufacturers of solar equipment. The ruling, while arguably rendering a correct position of law, demonstrates the predicament of developing nations in incentivizing domestic manufacturers.
Facts in Brief
India had sought to forge itself as a global leader in terms of solar energy with the Jawaharlal Nehru National Solar Mission, which was seen as the Government’s initiative aimed at promoting ecologically sustainable growth and addressing the nation’s energy security challenge. The programme was intended to be carried out in 3 phases spanning over 10 years (2012-2022). Under JNNSM, the Government had undertaken to enter into several long-term power purchase agreements with solar power producers, and the Government would in turn sell such energy, through distribution utilities, to the final consumer. The contentious issues in the mission were the implementation of subsidies and certain prerequisites, i.e. domestic content requirements (DCR) in the manufacture of solar panels and modules. The Solar mission offers a subsidy of up to Rs 1 crore per MW to solar developers sourcing components from local manufacturers. It further aimed to provide for 10% of the solar capacity target of 100,000 MW to be built with domestically manufactured solar modules, which consequently reserved a small part of the solar auction for developers employing only domestic content. The US, in 2013, made a complaint before the WTO Dispute Settlement Body (DSB) alleging that the domestic content requirement imposed was in violation of the international trading rules and obligations of the states that were members of the WTO. The argument was mainly aimed at the violation of the “national treatment” obligation of the member states, which India had breached by discriminating between imported solar cells and modules and other solar equipment which used parts from domestic or local manufacturers.
National Treatment Obligation
The principle of National Treatment is one of the core undertakings in the WTO and can be found as Article III in the General Agreement on Tariffs and Trade (GATT) and Art. 3 of the Trade Related Intellectual Property Rights (TRIPS). National treatment provisions take various forms, but their basic requirement is that nations treat foreign individuals, enterprises, products, or services no less favourably than they treat their domestic counterparts. The intent behind the principle is the protection of investment by aliens, which in turn is likely to promote investment and encourage industrial and financial enterprise in the host state, thereby, benefitting both states. The application of the principle has oscillated between phases of varying severity and laxity. In the centre of the interpretive cycles is the rudimentary friction between the commitment to unconstrained trade and the exercise of the sovereignty to regulate and legislate towards domestically determined goals.
Exceptions to the Obligation
The GATT lists out certain exceptions to the application of the National Treatment principle, government procurement and domestic subsidy being a few of them. The exception of Domestic Procurement allows member states to discriminate in favour of the domestic products when such measures are “essential to the acquisition or distribution of products in general or local short supply”.
India’s primary argument was that the measures undertaken were covered under the exception of Domestic Procurement (Art. XX(j) GATT) on the grounds that it lacks the capacity to manufacture the solar cells and modules and that the risk of any disruption in imports of the said items renders the equipment “products in general or local short supply”. The Panel ruled that the item in question was the solar panel and modules, while the subject of purchase was electricity. Therefore, the DCR was, therefore, not an instance of Government Procurement. India had also sought the defence (under Art. XX(d) GATT) that the DCR was primed to secure India’s compliance with “laws or regulations”, thus, requiring it to take steps to promote sustainable development. However, the Panel was unable to accept that the instruments identified by India constituted “laws or regulations” within the meaning of Article XX(d), or were at all laws or regulations in respect of which the DCR measures sought to “secure compliance”.
Criticisms have mostly characterised the ruling as one impeding a clean energy initiative. However, the mission was not only aimed at providing a cleaner alternative, but also targeted creating “favourable conditions for solar manufacturing capability”. It has been argued that the usage of cheaper imported material, against the inefficient and expensive domestically manufactured equipment will reduce costs. It has also been contended in favour of the decision that such domestic content measure shall adversely affect competition. It is undeniable that India must act within the ambit of its international obligations, but isn’t it equally incumbent upon the government to encourage and boost the domestic manufacturing of such equipments. Admittedly, competition must be allowed to flourish, however, the interest of domestic manufacturers needs to be equally catered for. In light of the recent developments, Dhruv Sharma, coordinator of the Indian Solar Manufacturers Association was quoted stating that India’s biggest problem was dumping of solar cells and modules by China, which required measures like imposition of anti-dumping duty or the continuation of DCR, because if neither were undertaken, the local industry would be significantly compromised.
“We set sail on this new sea because there is new knowledge to be gained, and new rights to be won, and they must be won and used for the progress of all people… Whether it will become a force for good or ill depends on man…” President John F. Kennedy, in his speech persuading the American masses to support the manned mission to the Moon.
The quest for knowledge and desire to unravel the unexplained, are deeply rooted in human nature and have propelled mankind to innovate and realize that which had once seemed impossible, maybe even divine. The promotion of national creativity and innovation is the bedrock on which the foundations of national industrial and economic progress rest, and the promotion of such innovation is the fundamental postulate of intellectual property laws. The words of President J.F. Kennedy were aimed to encourage people to endeavor for the unimaginable, and to do so only for the progress and the greater good of all. IP laws have, indeed, incited innovation and created a valuable incentive for inventors, but this development begs the vital question: if IP laws have been used for the progress of all people. With the state of things, as they stand today, it can be safely asserted that whether the advantages that IP laws offer are used as a force for good or ill depends on how efficiently the States balance the conflicting interests that present themselves in the subject.
Protection of IP in India has been subjected to stark criticism and vitriol, drawn mostly from Developed Countries and directed at the allegedly inefficient protection offered to Pharmaceutical Products. India became a signatory to the Trade Related Aspects of Intellectual Property Rights Agreement (TRIPS) in April 1995. Thereafter, India was taken to the WTO panel twice at the instances of USA and European Communities. It was by a decision dated 19th December, 1997 that the Dispute Settlement Body requested India to bring its legal regime for patent protection of pharmaceutical and agricultural chemical products in conformity with India’s obligations under TRIPS. Pursuant to its obligations India made significant Amendments to The Patents Act, 1970. Nevertheless, India is still threatened and pressurized to liberalize its Patent laws, whereof, in the early 2015, several Developed Countries had shown inclination to initiate WTO proceedings against India. USA had listed India in the category of “Priority Watch List” of its Special 301 Report of 2015, a tag that is generally given to the worst intellectual property offenders, and is also a classification that could trigger trade sanctions.
With the Developed Countries lobbying for stringent application of IP protection, the Developing Countries have found some reprieve in the Doha Declaration which, after recognizing the public health problems affecting many developing countries, provided that TRIPS does not and should not prevent members from taking measures to protect public health and promote access to medicines for all. Under the Declaration, Member Countries were provided certain flexibilities which included the right to grant compulsory licence and also delineated the grounds upon which it could be granted.
While the pharmaceutical companies aim to stifle the generic drug manufacturers by seeking stricter application of IP, India and other Developing Countries are constrained to exercise the flexibilities under TRIPS to facilitate access to cheap medicines. An example of the dichotomy between right to monopolize one’s IP and right to access to medicine can be seen in the case of Bayer Corporation v. UOI, wherein, the first ever Compulsory License granted in India was contested. It was noted before the Mumbai High Court that Bayer had made available, its patented-invented drug, i.e. Nexavar, used in treatment of Kidney and Liver Cancer, at an estimated cost of Rs. 2,80,428/- per month, which was available to barely 200 patients in the year 2011, out of an aggregate of 8842 patients who required the patented drug.
In the wake of such criticisms against the Patent laws, not only have the leading Indian scholars argued that India has duly complied with TRIPS, international bodies like WHO and Doctors without Borders have also supported India’s stand. India is celebrated by under developed and Developing Countries for its role as a major pharmaceutical hub. Nevertheless, the biggest challenge for Indian Patent regime is to find the elusive balance between the commercial interests of inventors and the constitutional right of access to affordable medical care.