Doesn’t India Already Have an IPR Policy?

Source: Economic & Political Weekly

8 Dec 2014

The National Democratic Alliance government has constituted the IPR Think Tank which, among other things, is to draft the National Intellectual Property Rights Policy. India may not have a policy per se but it has a strong legislation on IPRs, a functioning patents office and mechanisms to grant patents as well as protect consumer interests. The Think Tank has other issues it needs to address, but is this talk of drafting an IPR policy the thin end of a wedge to dilute existing legislation?

Sunil Mani ( teaches at the Centre for Development Studies, Thiruvananthapuram.

In September, Nirmala Sitharaman, the Minister of State for Commerce and Industry, expressed the opinion that India does not have an intellectual property rights (IPR) policy but must have one: “India does not have an IPR policy. This is the first time Government will come out with an IPR policy…Developed nations are picking holes in India’s IPR regime because we do not have any policy” (The Hindu, 9 September 2014). Towards this end on 22 October 2014, the government constituted a Think Tank (so titled as well) charged with the responsibility of advising it, inter alia, to draft a National Intellectual Property Rights policy. Further the Think Tank has the following eight additional terms of reference:

(ii) to identify areas in the IPRs where study needs to be conducted and to furnish recommendations in this regard to the Ministry, (iii) to provide views on the possible implications of demands placed by the negotiating partners, (iv) to keep the government regularly informed about the developments taking place in IPR cases which have an impact upon India’s IPR Policy, (v) to advise the Government on best practices to be followed in Trademark Offices, Patent Offices and other Government Offices dealing with IPR in order to create an efficient and transparent system of functioning in the said offices, (vi) to prepare periodic reports on best practice followed in foreign countries, (vii) to highlight anomalies in the present IPR legislations and to advise possible solutions to the Ministry, (viii) to give suggestions on the steps that may be taken for improving infrastructure in IP offices and Tribunals, (ix) to examine the current issues raised by industry associations and those that may have appeared in media and to give suggestions to the Ministry on such issues (DIPP 2014).

The term of the Think Tank is not specified and so it appears that this expert group’s term will be coterminous with the current government’s term. Appointment of the Think Tank and especially the idea of drawing up of an IPR policy has raised considerable concern and doubts in the minds of many analysts who are closely following India’s legal regime on IPR which had undergone some important changes to make it compliant with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

India has a functioning legal regime in each of the IPR mechanisms such as patents, designs, trademarks and geographical indications and these are administered by the Indian patent office. All these and especially the legal regime on patents were arrived at after an extensive debate that took place both inside and outside Parliament. In the recent past, there have been many instances of India taking a decisive stand on patents to the advantage of domestic manufacturers and consumers. This, for example, is in the granting of a compulsory licence for the domestic manufacture of an anti-cancer drug on grounds of unaffordable prices being charged by the patent holder. A further example is the denial of a patent for another anti-cancer drug by the Supreme Court on the ground that the application did not meet India’s higher bar on the criteria of inventiveness contained in the amended Indian Patent Act of 1970.

US Unhappiness

Eyebrows have therefore been raised about the real intentions behind this thinking on the part of the National Democratic Alliance government to draw up a comprehensive IPR policy. The fact is that this exercise was launched after the office of the United States Trade Representative (USTR) published a special report in 2014 which, based on an analysis of the strength of India’s IPR regime, has continued to place India along with nine other countries on a priority watch list. Priority watch list countries are judged by the USTR as having “serious intellectual property rights deficiencies” that require increased USTR attention. India, of course, has the distinction of being in the priority watch list ever since the inception of the USTR special reports in 1989. The US has considered India to be an IPR offender of sorts right from inception and the recent attempts by the country to be compliant with the varied and stringent provisions of TRIPS have not dented that view. This increased attention of the USTR on India’s patent regime manifests itself in the form of an “Out of Cycle Review” of India’s IPR regime which the USTR initiated in October 2014. In the light of this, much concern has been expressed by a number of people, both from academia and civil society organisations, that the present government may be forced to give up some of the notable features of IPRS especially the country’s patent regime.

This article takes a detailed look at the issues so that an informed conversation takes place on the topic. The note focuses on three aspects of IPR policy. It first asks the question whether the country has an IPR policy in place. An answer to this will help us understand the very first terms of reference. Second, it will look in some more detail at the unique features of the leading IPR mechanism, namely, the patent policy, and then identify those aspects of the policy that multinational companies (MNCs) and some governments have taken exception to. Third, it will analyse whether India’s IPR regime in general and its patent regime in particular is weak enough to have had a negative effect on foreign direct investment (FDI) inflows into India. This is because there is supposed to be a positive relationship between the strength of an IPR regime of a country and the amount of FDI in technologically intensive areas that a country may actually receive.

The Think Tank on IPR is, however, headed by someone who has a fair amount of detailed knowledge and experience in her capacity as the former chairperson of the Intellectual Property Appellate Board (IPAB) – the tribunal which decides three IPR measures such as patents, trademarks and geographical indications. Justice Prabha Sridevan, the chairperson, was the former chairperson of the IPAB from 2011 to 2013 and during her tenure pronounced many landmark judgments.

IPR Policy

First of all to believe that India does not have an IPR policy is like playing with words. An unnecessary distinction seems to be made between having the legal apparatus and a separate policy as if the two are different in content. We have individual legal acts on patents, trademarks, designs and geographical indications, all of which were suitably amended in the last 20 years or so to comply with TRIPS. Further, we have the Indian patent office (although not officially denoted as such) in the form of the Controller General of Patents, Designs, Trademarks and Geographical Indications and a tribunal in the form of the IPAB.

Over the last several years many important pronouncements leading to the actual implementation of these various IPR mechanisms have also been achieved and almost all these actions have sought to favour domestic industry. The only obvious lacuna in India’s IPR policy framework is that the country does not have a policy on utility models. Utility models, for example, are ideal IPRs for incremental innovations. India’s industrial structure is characterised by a large number of small and medium firms. These firms do not make new inventions but incremental changes in known products and processes for which a utility model is the most appropriate form of IPR.

TRIPS does not specifically mention utility models. However Part I of the agreement (Articles 2, 3 and 4) refer to the provisions of the Paris Convention. Further, Article 1 mentions

Members may, but shall not be obliged to, implement in their law more extensive protection than is required by this Agreement, provided that such protection does not contravene the provisions of this Agreement.

Given this, policymakers in India are favourably disposed to including utility models in India’s IPR regime. Towards this end, the Department of Industrial Policy and Performance (DIPP) has floated a discussion paper on utility models. Several reactions from a variety of stakeholders to the inclusion of utility models have been received. So whether India should have a policy on utility models is one aspect that the IPR Think Tank may consider.

There are at least two broad aspects of India’s patent regime that have attracted the wrath of MNCs and western governments. The first is in India’s actual use of TRIPS flexibilities and the second is the introduction of the practice of pre- and post-grant opposition.

India is one of the few developing countries that has made full use of all the flexibilities inserted into the TRIPS agreement. Of all the flexibilities that are allowed, two stand out. The first one is on the issuance of compulsory licences (CL) and the second is exception to patentability.

A CL is an authorisation, which is granted by the government without the permission of the patent holder but on strict terms. This is one of the most frequently encountered flexibilities that has actually been used. It means that the government of a country under certain grounds may issue a compulsory licence to a domestic manufacturer for producing the generic version of a patented drug. Most countries have provisions for compulsory licences, either under their patent law or, as in the US, through anti-trust legislation. In 2012, India issued one compulsory licence to an Indian pharmaceutical manufacturer to manufacture and sell a patented anti-cancer drug at a significantly lower price than the original patented version.

Exemption from Patentability

A second flexibility that India has used is the exemptions from patentability. TRIPS requires patents to be granted for only inventions that are new, involve an inventive step and are capable of industrial application. A mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance, or the mere discovery of any new property, or new use for a known substance, or of the mere new use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant does not have to be granted a patent. In fact, countries have invoked this flexibility to thwart attempts by drug companies from seeking new patents on existing drugs by simply claiming improvements in its efficacy. To take care of this exemption India has added Section 3(d) to the Patent Act, which effectively places a higher bar on the criteria of inventiveness. In March 2013, the Supreme Court invoked this clause to dismiss the patent application of an MNC.

Ever since this judgment, the use of flexibilities by India has been a bone of contention and the USTR report too echoes this strong feeling against the insertion of Section 3(d). Many of the analysts who have expressed strong feelings against the terms of reference of the Think Tank are of the suspicion that they are an attempt to repeal this contentious provision on inventiveness.

Another aspect that is unique to our patent regime is the existence of a pre- and post-grant opposition to patenting. Pre-grant opposition can be filed by any person by representation in the Indian patent office within six months of the date of publication of the patent application or in case the six months duration is not available then the representation can be filed till the grant of the patent, whichever expires later. The grounds of opposition are provided under Section 25(1) of the Indian Patent Act 1970 as amended in 2005.

Pre-Grant Opposition

Some of the important grounds of opposition are wrongful obtainment, anticipation by prior publication or used or already claimed in any other patent, obviousness, and the subject matter of the invention falling into non-patentable category under Section 3 of the Act. The applicant or any party considers pre-grant opposition only after the filing of an application. The patentee is to submit her statement and evidence against the opposition within three months of the date of notification by the controller of patents. A pre-grant opposition has to be disposed off by the controller within one month by rejecting the opposition and granting the patent or by accepting the opposition and rejecting the application or amending the application and granting the patent. But the number of pre-grant opposition applications has always been a very small proportion of the total number of published cases and it too has decreased over time.

Post-Grant Opposition

Post-grant opposition can be filed by any interested persons who are engaged in or promoting research in the field of technology. Post-grant opposition can be filed within a period of 12 months of the grant of a patent. The grounds of opposition are provided under Section 25(2) of the Patent Act 1970. Some of the grounds are, wrongful obtaining of the invention by the inventor, anticipation by prior publication, use, traditional knowledge, the invention is obvious to a person in the art, non-patentable inventions, disclosure of false information to patent office, non-disclosure or wrongful disclosure of the biological source, etc. The post-grants opposition, although small in terms of the number of cases, has been increasing as a share of the total number of patents granted. Both the pre- and post-grant opposition can, in fact, improve the quality of the patents granted and will certainly rule out the granting of frivolous patents. Needless to add, one should not be recommending the watering down of these special provisions.

Strength of India’s Patent Regime

A third aspect that has come in for much discussion is the strength of India’s IPR regime, which the USTR report considers weak. A weak patent regime is thought to be a major hindrance to technology transfer (Hall 2014). The empirical evidence on this relationship is admittedly ambiguous. In any case it does not hold for India. This could be deduced from two separate but related pieces of statistics.

Foreign companies now account for a growing share of India’s industrial research and development (R&D) expenditure and patents (especially US patents). For instance, they account for about 29% of business enterprise R&D expenditure in 2011 compared to just 10% in 2003 (Mani 2014a). Likewise in terms of patents granted in the US Patent and Trademark Office (USPTO) to Indian inventors, their share is almost 82% in 2013 compared to 23% in 1995 (Mani 2014b).

FDI in general and FDI in R&D too have been very much on the increase. MNCs are unlikely to increase their R&D activities in a country which has a weak patent regime. Almost all MNC R&D centres in the country have increased their patenting based on R&D done in India. For instance, the number of US patents secured by IBM increased from just 64 in 2009 to 239 in 2013. Other US MNCs operating from India have also registered similar increases. R&D and testing services imported from dedicated US R&D centres operating from India now account for about 10% of all US imports of R&D and testing services (National Science Board 2014). Further the CEOs of some leading US MNCs such as PepsiCo; Honeywell and Boeing have expressed satisfaction at the strength of India’s patent regime. In the light of these facts, it will be hard for the Think Tank to further strengthen India’s IPR regime beyond what there is now. The pharmaceutical MNCs may be less enchanted by our IPR regime and given the fact that India’s domestic pharmaceutical industry has the technological capability to invent and manufacture a range of bulk drugs and formulations (Chaudhuri 2005), one need not worry too much about being in their good books.

Finally, the Think Tank can actually play an important and constructive role in developing a detailed database on patenting by Indian and foreign companies based on their R&D in the country. This will help us understand the process of innovative activity in our country on which we have such inadequate information. Improving the physical performance of the various institutions such as the patent office and the IPAB is another constructive one. For instance, the Indian patent office is desperately short of patent examiners. Each patent examiner has to examine 61 applications a year. The IPAB is also funded badly, affecting its work. Further, there have also been instances of bureaucrats from the line ministry interfering with its work. The Think Tank has thus plenty of constructive and practical areas to examine and recommend to the government rather than struggle to answer whether or not India has an IPR policy. India has an IPR policy and a reasonably good one too.

This entry was posted in Compulsory Licensing, Innovation, IPR policy, IPR Think Tank, Patent Opposition, Sec 3 (d), US pressure on India. Bookmark the permalink.

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