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Abstract:
The controversial Patents (Amendment) Act 2005 was purportedly India's final step towards achieving complete TRIPS compliance. The introduction of pharmaceutical patents and the consequent threat to an internationally renowned generic industry that has, thus far, ensured the supply of affordable drugs catapulted this legislative effort to international significance, of an extent never before witnessed in the annals of intellectual property law making in India.

The 2005 Act attempts to balance out competing interests of a variety of stakeholders, including domestic generic medicine producers, the domestic research and development community, foreign multinational pharmaceutical companies, civil society groups concerned with access to medicines and (last, but certainly not least), intellectual property lawyers. Although this delicate balancing deserves some applause, an unfortunate fall-out has been the hasty introduction of provisions that go against the grain of time tested patent law principles and are likely to provide excellent fodder for litigation. This note highlights some of the main changes brought about by the 2005 Act and reflects on some of their broader implications.

Intellectual Property, India, Patents, TRIPS, 2005 Act, generics, public health, access to medicine

Abstract:
Indian patent law recently landed itself in the eye of a TRIPS storm on account of the rejection of a patent application covering Novartis' famed anticancer drug, Glivec. The rejection stemmed, inter alia, from a unique section in the Indian patent regime (section 3(d)) that seeks to prevent "ever-greening" by prohibiting the patenting of new forms of existing pharmaceutical substances that do not demonstrate significantly enhanced "efficacy."

Not only did Novartis appeal the patent office decision, but in a rather controversial move, it challenged the TRIPS compatibility and constitutionality of section 3(d). The Madras High Court ruled that section 3(d) was constitutional. It also held that it did not have jurisdiction to rule on the TRIPS issue. This paper analyses this decision within the broader framework of section 3(d) and what it seeks to achieve. It argues that although the Madras High Court was correct in concluding that section 3(d) is constitutional, the court's reasoning leaves much to be desired. In particular, the court does not fully appreciate Novartis' alleged invention and the contours of section 3(d).

Though this lack of appreciation is not fatal to the constitutionality analysis by the court, it is reflective of some of the creases inherent in the wordings of section 3(d). The need of the hour is to iron out these creases in section 3(d) and to help brighten the line between pharmaceutical inventions that are patentable and those that are not. This paper not only offers suggestions on how these creases may be ironed out, but also goes on to suggest an amendment to section 3(d).

While some of the suggestions in the paper are immediately implementable, other issues will necessarily involve a more detailed empirical/policy investigation. This paper highlights some of the factors that one might consider whilst undertaking such empirical investigation, a task which is likely to go to the very heart of the age-old debate about what constitutes optimal intellectual property norms for developing countries.

Indian Patent Law, TRIPS Compliance, Constitution of India, Pharmaceutical Patents, Developing Countries

Abstract:
With the introduction of pharmaceutical product patents for the first time (via the 2005 amendments to India's patents act), it is feared that there would be a steep rise in drug prices and a consequential adverse impact on access to important drugs. Civil society proponents argue that the TRIPS flexibilities available were not exploited appropriately and that adequate safeguards were not built in to ensure an affordable supply of medicines. While this concern by civil society has some merit, what it misses is the flexibility that already inheres in the Patent Office to tailor patent protection to suit policy needs. This article argues that the Indian Patent Office has had an interesting history of taking itself to be a policy guardian of sorts and demonstrating a rather conservative approach to the issue of patentability. This policy-style reasoning can be traced back to the Ayyangar Committee report, a document that formed the very basis for the current Indian patent regime. Underlying this report was the clear message that fewer patents resulted in a stronger indigenous industry, particularly in the area of pharmaceuticals and chemicals. This article demonstrates the influence of this policy document on the decisions of the Patent Office even today and posits that, rooted in a system that stressed the virtues of a weak patent system, it is likely that the Patent Office would continue with a conservative approach to the issue of patentability, even with regard to pharmaceutical inventions (that are patentable under the 2005 Act).

Intellectual Property, India, Patents, Patent Office, Biotechnology, TRIPS, 2005 Act, generics, public health, access to medicine

Abstract:
This paper considers some features of Europe's approach to medicine, public health and patents as it has developed during the decade since TRIPs came into force. It then reviews what rights users have in relation to such patents and what duties right holders may owe users. The following issues are discussed:
1. How patents on medicines are viewed in Europe;
2. How TRIPs has affected European law;
3. How bilateral agreements since TRIPs have affected Europe;
4. How user rights should be viewed under TRIPs;
5. Whether patents in the public health field are a special case.

Abstract:
The biblical David vs Goliath paradigm plays out very frequently in international trade disputes. In 2003, a tiny island state, Antigua and Barbuda (hereafter Antigua) took on the United States (hereafter US) in a WTO (World Trade Organisation) dispute, alleging that the US violated GATS (General Agreement on Trade in Services) obligations by effectively foreclosing their borders to overseas internet gambling services. It won at both the panel and the appellate levels. However, to this date, it has been unable to secure compliance by the US.

Since "traditional" retaliation (Antigua retaliating in the same sector by suspending its GATS obligations to open up it's various service sectors to US businesses) was more likely to hurt Antigua than the US, such a remedy would have been practically meaningless.

Therefore Antigua pleaded for and obtained the right to “cross retaliate” by suspending the intellectual property rights (IPR) of US corporations. Naturally, this retaliation under another agreement (namely TRIPS) has a better potential of inducing compliance by defaulting developed countries such as the US, since strong IP lobbies in such countries are likely to pressurize their governments into a compliance or settlement. The WTO granted such an authorization to Ecuador in 2000 and to Brazil more recently in September 2009, albeit conditionally.

Despite the procurement of an authorization to cross retaliate, Antigua is yet to implement it and is currently in negotiation talks with the US. More worryingly perhaps, it has not yet changed its domestic law or announced as to how it would go about operationalising the cross retaliation authorization.

One potential reason for Antigua’s failure to come up with any concrete model could be the uncertainty in determining a viable IP suspension model that remains WTO consistent by ensuring that the value of loss from the suspension of IP is equivalent from the losses caused to Antigua. This uncertainty will no doubt be exploited by the US in its negotiation talks with Antigua.

This paper therefore seeks to work out a detailed IP suspension model that could help countries such as Antigua. It proposes a “Tiered IP suspension model”, where certain kinds of IP are targeted first for suspension before others, depending on the ease of objectively ascertaining the value of IP and thereby the harm caused by the unauthorized use of such IP and/or the potential to induce compliance by the defaulting state. Illustratively, copyrights over sound recordings that have established rates for public performance are targeted first. If working with this tier of IP subject matter does not yield desired results, then the complaining state moves on to other IP where it is relatively more difficult to compute the loss caused to the IP owner (such as pharmaceutical patents) but which may be a more powerful tool to induce compliance. Such a model could be useful for a large number of developing countries such as India and Brazil, that often find that, despite WTO victories, scofflaw states such as the US and EU fail to comply. Towards this end, this paper offers a very concrete “development” oriented international trade law remedy.

WTO, Developing Countries, Retaliation, TRIPS, Intellectual Property Rights, Cross Retaliation, Antigua Gambling Dispute

Abstract:
This paper considers the impact of the new Indian patent regime on the important issue of access to affordable drugs. Access is dependent, in part, on the ability of generic manufacturers to produce cheap generic drugs. Working with the bird flu patent example, this paper will demonstrate that far from abetting 'genericide', the new regime provides adequate legal windows to aid the continued production of affordable generics. However, the mere existence of such windows/flexibilities is not enough - generic manufacturers will only exploit such windows when it is economically and politically viable to do so.

Intellectual Property, India, Patents, TRIPS, 2005 Act, generics, bird flu, public health, access to medicine, compulsory licensing

Abstract:
India's amendment to her patent regime in 2005 to introduce pharmaceutical product patents attracted unprecedented attention, both domestically and globally. While multinational pharmaceutical companies were concerned that the Act withered away their exclusive rights, civil society activists decried the new product patent regime, fearing that it would cause steep hikes in the price of life saving drugs. This politicization of patent law produced some interesting results; most recently, a recent Delhi High Court case that denied an injunction to a multinational patentee on the ground that it sold a more 'expensive' drug than the infringing generic manufacturer.

While some provisions in the new patent regime, such as Section 3(d) continue to attract a lot of attention, others have been lost in the legalese. One such provision is Section 107A(b) dealing with parallel imports, which, if read in a strict literal manner could have far reaching implications for the rights of a patentee.

This paper aims to highlight this particular provision, which has thus far not attracted the attention it deserves. It explores the ambiguities inherent in this section and discusses the gaps in the Indian law pertaining to exhaustion and parallel imports. Lastly, it goes on to suggest statutory amendments in order to remove ambiguities inherent in the section and expand the scope of exhaustion envisaged therein, whilst at the same time remaining TRIPS compliant.

The paper is divided into four sections: The first section explains the concept of exhaustion/parallel importation in relation to patents. Section two examines the ambiguities inherent in Section 107A(b). It also explores the gaps in the law relating to exhaustion in India and assesses the TRIPS compatibility of the current provision. The third section recommends a creative way of interpreting the current statutory provision so as to remove the ambiguities, and balance out the rights of patentees and parallel importers in an optimal manner without violating the TRIPS Agreement. The final section recommends statutory amendments to Section 107A(b).

Patents, India, TRIPS, Parallel Imports, Exhaustion, Pharmaceuticals

Abstract:
The appropriate standard of protection for regulatory data (pharmaceutical and agro-chemical) under Article 39.3 of TRIPS is the subject of considerable controversy. This paper finds that the minimum standard mandated by Article 39.3 is neither one of data exclusivity (as argued by the US and EU) nor one of 'permissive reliance' (as argued by Professor Carlos Correa and others).

Rather the term 'unfair commercial use' in Article 39.3 in effect envisages a 'compensatory liability' model, whereby regulatory data that complies with the pre-requisites of Article 39.3 (i.e. it relates to pharmaceutical or agricultural new chemical entities, is undisclosed and its origination involves considerable effort) cannot be used by any person, including a regulatory authority that uses such information to approve another product, without some compensation being paid to the originator of such data. The paper discusses some examples of such compensatory liability models.

The paper also finds that Indian law does not currently comply with Article 39.3.

regulatory data protection, data exclusivity, pharmaceuticals, drugs, Article 39.3, TRIPS, Indian law, compensatory liability model, compulsory licensing

Abstract:
With an impending Avian influenza or bird flu pandemic, the issue of patents and public health has once again taken centre stage. Oseltamivir (known by its brand name 'Tamiflu'), a patented antiviral pill, has emerged as the world's first line of defence against bird flu. A key priority for most nations is to create sufficient stockpiles of this pill that can then be easily distributed and administered during a pandemic. Keeping this end in mind, this paper explores the patent position in India and looks at ways to work around a patent, should one issue in future. The paper recommends various strategies for creating an optimal and affordable stockpile and calls on the government to take a more definite stand in the matter.

bird flu, patents, india, roche, cipla, compulsory licensing

Abstract:
Glivec, a path-breaking anticancer drug by Novartis propelled Indian patent law onto the world stage in an interesting theatre involving TRIPS and the yet unresolved issue of pharmaceutical patents and their impact on access to medicines.

In 2006, the Indian patent office rejected a patent application covering Glivec (or "Gleevec" as it is known in the United States). The rejection stemmed, inter alia, from a unique section in the Indian patent regime (section 3(d)) that prohibits the patenting of new forms of existing pharmaceutical substances that do not demonstrate significantly enhanced "efficacy."

Not only did Novartis appeal the patent office decision, but in a rather controversial move, it challenged the TRIPS compatibility and constitutionality of section 3(d). The Madras High Court ruled that section 3(d) was constitutional. It also held that it did not have jurisdiction to rule on the TRIPS issue. This paper will critically examine the constitutionality and TRIPS compatibility issues thrown up by section 3(d). It will argue that the court was right in defending the constitutionality of section 3(d). It will also go on to demonstrate that section 3(d) is compatible with TRIPS.

However, it will question the court's "ducking" of the TRIPS issue by claiming that it lacked "jurisdiction" on this count. In particular, it critiques the reasoning of the court on this count and argues that the court ignored a number of sound Indian precedents in favour of outdated case law from abroad.

Abstract:
The biopharmaceutical industry is characterized by the 'cumulative innovation' paradigm, wherein the discovery of a gene sequence is only the first step. In order to convert such sequence information into viable products, tests and cures for genetic conditions and diseases, vast amounts of additional time, effort and money have to be spent. It is feared that patents over upstream gene sequences may 'block' further downstream research and consequently adversely impact drug discovery, as many diseases today are known to have genetic origins.

This 'blocking' or 'restricted access' issue has been the subject of several important papers and a wide array of solutions have been suggested. However prior to finding solutions, we need to revisit a fairly basic question: Is there a blocking or restricted access issue in the first place? A key determinant of this issue often is: How essential is a patented gene? This paper shows that not all gene patents are absolutely essential but that in many cases, viable substitutes do exist. By computing the essentiality of such patents on a case by case basis, one can determine the existence and extent of blocking. This paper uses the essential facilities doctrine under competition/antitrust law to draw out a framework for computing essentiality.

gene patents, blocking, compulsory licensing, essential facilities doctrine, amgen epo

Abstract:
The WIPO Development Agenda is in many ways, a reaction to the "one size fits all" mantra that has plagued international intellectual property (IP) law making for many years now. In an effort to counter this disturbing trend that does not pay heed to either the relative economic status of the member countries (particularly the developing ones) or of technological specificity, the Development Agenda clearly spells out that future "norm setting activities shall take into account different levels of development".

Unfortunately, some of the IP and development literature that is sceptical of the above trend runs the risk of falling into the same trap of endorsing a one size fits all mentality. At the risk of oversimplification, the broad notion in the literature is this:

Developed countries may need strong IP regimes, as they are highly innovative and strong IP regimes provide the requisite incentives in this regard. Developing countries however ought to implement only minimalist IP regimes, as they are hardly innovative and are often net importers of technology.

This black and white categorisation ignores technological heterogeneity between developing countries. It also ignores technological specificity between sectors in the same country. In other words, emerging economies such as India, China, Brazil and Russia which are technologically more proficient in one or more areas of technology may require different IP norms than their relatively less proficient counterparts such as Nepal and Uganda.

We need to therefore move away from an antiquated "developed-versus-developing" classification and differentiate developing countries according to their technological/innovative proficiencies. Such differentiation would help calibrate IP norms according to the specific developmental needs of the country in question.

We use certain technology/innovation indicators to arrive at our list of "technologically proficient" developing countries (TPDC); countries that may require different IP norms, when compared with their less technologically dynamic countries.

This paper does not seek to spell out the precise nature of IP norms that developing countries ought to adopt and implement. Rather, it is to suggest that this determination will vary from case to case and depends on factors such as the "technological capability" of the country in question and the specific "technology" sector under consideration. This paper therefore cautions one against the tendency to swing from a one "super size" fits all model to a one "micro-mini" fits all model. The technology/innovative capability indicators deployed and the TPDC list arrived are not precise and may need to be refined further. In other words, the list could serve as a starting point towards a more nuanced classification at the WTO/WIPO.

Failing to acknowledge the technological differences between countries and of the different needs of TPDCs in particular may result in a weak development agenda implementation. The inherent schisms between these countries is likely to lead to tension and impact the progress of the agenda. Explicitly recognising these differences and leveraging them to further the cause of the agenda may be far more strategic in the long run.

Abstract:
With Avinash Bajaj out on bail and an intervening Tsunami, the noise around the Baazee case has all but died out. The issues that it brought into sharp focus however still await resolution - in particular, the issue pertaining to online intermediary liability. We thought this an opportune time to bring back this case into public focus. We noticed that the 'law', which for good or for bad, continues to occupy centre stage in this debate has not been articulated clearly enough - and in fact in many instances has been wrongly stated. Writers have either let their emotions get the better of their propensity to objectively lay down the law or have not been bothered with associating themselves with what they consider to be the trivialities of the law.

Our task is therefore a fairly modest one - to try and articulate the law in a manner that would provide a decent enough spring board to engage in broader policy debates.

online intermediary liability, isp liability, pornography, criminal law

Abstract:
The Patents (Amendment) Act 2005 (hereafter ‘2005 Act’) was India’s last step towards achieving complete TRIPS compliance. This Act has had a long fairly long innings and generated considerable debate, both domestically and internationally. Despite the passing of this Act, which contained a number of safeguards against non meritorious pharmaceutical patents, the Left Parties wanted more and in particular wanted to introduce a provision that would have limited patent grants to only New Chemical Entities (NCEs).

Sensing that this could violate TRIPS, the government referred this issue to an expert committee headed by noted technocrat, Dr RA Mashelkar. In particular, it requested the Committee (or Technical Expert Group or TEG) on April 5, 2005 to study:

"a) whether it would be TRIPS compatible to limit the grant of patent for pharmaceutical substance to new chemical entity or to new medical entity involving one or more inventive steps; and

b) whether it would be TRIPS compatible to exclude micro-organisms from patenting."

The Technical Expert Group (TEG) solicited the opinions of IP stakeholders and others interested in the issues that it was meant to resolve. In this regard, I was requested by the Intellectual Property Institute (IPI), London to provide a comprehensive and independent opinion on the foregoing issues.

My report finds as follows:

1. Limiting the grant of patents to new chemical entities and thereby excluding other categories of pharmaceutical inventions (the ‘proposed exclusion’) is likely to contravene the mandate under Article 27 of TRIPS to grant of patents to all ‘inventions’. Neither Articles 7 and 8 nor the Doha Declaration can be used to derogate from this specific mandate under Article 27. 2. The proposed exclusion amounts to an ‘unjustified differentially disadvantageous treatment’ of pharmaceutical inventions and is therefore likely to violate the ‘non discrimination’ mandate under Article 27. 3. If the aim of the proposed exclusion is to prevent a phenomenon loosely referred to as ‘ever-greening’, this can be done by a proper application of patentability criteria, as present in the current patent regime. 4. Lastly, it is important to distinguish the phenomenon of ‘ever-greening’ from what is commonly referred to as ‘incremental innovation’. While ‘ever-greening’ refers to an undue extension of a patent monopoly, achieved by executing trivial and insignificant changes to an already existing patented product, ‘incremental innovations’ are sequential developments that build on the original patented product and may be of tremendous value in a country like India.

India, TRIPS, Patents, Pharmaceuticals, Drugs, Mashelkar Committee, Developing Countries