National IPR Policy: A reality check

By K M Gopakumar, The Deccan Herald | June 5, 2016

The National Intellectual Property Rights Policy (IPR Policy) has generated unprecedented responses within and outside India. According to news reports, the US Department of Commerce is assessing India’s IP policy.

The commerce minister also made it clear that the adoption of the policy is an attempt to clear India’s stand prior the prime minister’s US visit. It is very clear that the IPR policy would figure prominently in the US India bilateral discussions in the coming week.

Though the IPR policy contains measures on various IPR rights, it predominantly focuses on measures related to patents. The Indian Patents Act 1970 denied product patent protection to pharmaceuticals, which in turn played a key role in building self-sufficiency in the medicine manufacturing.

While introducing the product patent protection to pharmaceutical inventions, India incorporated many public interest safeguards in the Patents Act to address concerns of unaffordable prices of patented medicines.

As a result, the Patents Act effectively prevents multiple patenting of known a molecule, a common practice of pharmaceutical Multinational Corporations (MNCs) to extend the patent monopoly over the molecule. Similarly, Patents Act also allows generic companies to seek licence from the patent office to produce patented medicines (compulsory licence) under various grounds, including if the patented medicine is not available at an affordable price.

Therefore, India’s Patents Act is viewed as a model patent law by many developing countries. Patents laws of Philippines and Argentina contain similar provisions against obtaining of patents on known a molecule.

Similarly, South Africa and Brazil are expected to incorporate certain provisions of the Indian Patents Act. The Indian generic industry with sufficient manufacturing capability has played an important role in lowering the prices of HIV/AIDS medicines. This public interest safeguards pose obvious threat to the pharmaceutical MNCs, as their business model relies heavily on patent monopoly.

Use of safeguards

Sensing this threat, pharmaceutical MNCs target the public interest safeguards in the Patents Act and also attempt to obstruct the use of these safeguards by the Indian pharmaceutical companies.

The legality of these safeguards cannot be challenged at the World Trade Organisation (WTO) Dispute Mechanism because the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement unequivocally allows the use of such safeguards.

The WTO Ministerial Conference in 2001 adopted the Doha Declaration on the TRIPS Agreement and public Health, which states: “We agree that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement. … we reaffirm the right of WTO members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose.” Hence, the pharmaceutical MNCs are left with no option but to seek the help of the US government, which hosts most of the MNCs headquarters, to exert bilateral pressures on India against the use of safeguards. In 2013, after the issuance of compulsory licence and Supreme Court’s rejection of Novartis’ patent application, a campaign was launched against the Indian IP regime, especially on provisions of the Patents Act.

In 2012, the Indian patent office granted a compulsory licence to an Indian company to produce and sell an anti-cancer medicine Sorafenibat Rs 8,800 per month against the patent owner’s price of $5000 per month. The US instead of challenging the India patent law, it exerted bilateral pressure on India against the use of safeguards in the Patents Act. The submission of US India Business Council creates reasonable doubts that these pressures are working, and India is accommodating the demands of the industry including an oral assurance against the use of compulsory licence.

Seven objectives

The IP policy contains the following seven objectives: IPR awareness, generation of IPRs, legal and legislative framework, administration and management, commercialisation of IPR enforcement and adjudication, and human development.

The policy contains concrete measures under each of these objectives. Even though it talks about the balance approach to IP, the policy measures substantially promote IP without any balance.

The policy advocates for an increased awareness and generation of IP. The policy without looking at the limitation of IP, states in its vision statement: “An India where creativity and innovation are stimulated by intellectual property for the benefit of all. …Knowledge owned is transformed into knowledge shared”. The IP Policy also proposes to change the approach of the patent office to make it conducive to generate more patents.

In reality, India’s development needs technology acquisition and come abreast with the developed nations in various sectors like agriculture, environment-friendly technologies, and manufacturing. Therefore, India needs a patent law with robust safeguards and limit the grant of patents only to genuine inventions. India’s own experiences of achieving self-sufficiency in manufacturing of medicines and food production through green revolution shows that patents are barrier rather than facilitating for technology transfer and dissemination.

Ideally, the policy should have focused on the effective implementation of the Patents Act, including the use of public interest safeguards. However, there is nothing in the policy to further the implementation of the public interest safeguards in the Patents Act.

The policy totally ignores the various bottlenecks in the implementation of the safeguards. Often, pharmaceutical MNCs backed with their financial resources use multiple litigations against the Indian generic companies to deter them from using such safeguards. The policy should have looked at the experiences of using the public interest safeguards, since the introduction of product patent protection and suggested measures to increase their use.

Thus the approach of the policy does not address the development needs of India and aims to accommodate the interest of pharmaceutical MNCs instead. However, it is a slippery slope for India. The pharmaceutical MNCs along with other 16 associations wrote to the US president and US lawmakers that “India just released its long-awaited National Intellectual Property Rights Policy, which falls far short of industry expectations”.

Government of India should understand that the demands from pharmaceutical MNCs if implemented would compromise the health security of India as well as millions of people living in other developing countries who are dependent on affordable generic medicines from India. Further, it is only the pharmaceutical MNCs that are complaining against the Indian Patent Act. Other industries like aircraft manufactures such as Boeing went on record to express their satisfaction on Indian Patents Act.

It’s high time that India should stop tending to the expectations of the US on IP protection, which caters needs of their business and focus towards the implementation of public interest safeguards envisaged in the Patents Act in order to fulfill India’s socio-economic needs. It is also high time to stop dancing to the US’ IP tune.

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