TWN Info Service on Health Issues (Jul17/04)
31 July 2017
Third World Network

Dear friends and colleagues,

We are pleased to share with you a review of a new publication by Oxford University Press titled "The Access Regime: Patent Law Reforms for Affordable Medicines". The author is Feroz Ali, Ministry of Human Resource Development Intellectual Property Rights Chair at the Indian Institute of Technology Madras.

The book provides a detailed examination of the Indian patent law that "incorporates a remarkable array of flexibilities" available in the Agreement on Trade-related Aspects of Intellectual Property Rights, and that can provide a unique route for other countries to promote public interest, in particular public health.

With best wishes,
Third World Network

An Access Regime based on Indian Patents Act - Review Of “The Access Regime” by Feroz Al

Author of the book Feroz Ali is a Ministry of Human Resource Development Intellectual Property Rights Chair at the Indian Institute of Technology Madras.

Review Author K M Gopakumar is legal researcher associated with the Third World Network (TWN)

Details of the book:

Even though the Agreement on the trade-related aspects of intellectual property rights (TRIPS) set the minimum standards of protection and enforcement of intellectual property (IP) rights, it could not harmonise the various national patent laws. Irrespective of the regional patent system still patent rights are territorial. As a result, a patent granted in one country does not automatically translate into a patent in another country.

Using the flexibilities contained in the TRIPS many developing countries designed their patent laws to address their critical development concerns especially on access to medicines. Disappointed by this IP maximalists through developed countries are using various means to harmonise the patent law with developed countries’ patent law.

The primary route is by pushing developing countries to implement IP  protection and enforcement obligations that go beyond the TRIPS Agreement.   Towards this purpose developed countries have initiated various unilateral, bilateral, plurilateral and multilateral initiatives. The ultimate aim of these initiatives is to eliminate the current diversity existing in the substantial patent law and to replace it with a harmonised patent law favouring patent holders. These efforts, if succeeded, would have adverse economic and social implications for developing countries.

Prof, Feroz Ali in his book Access Regime: Patent Law Reforms for Affordable Medicines proposes an alternative harmonisation strategy to safeguard the public interest especially to ensure affordable medicine. The author calls this alternative harmonisation agenda as counter harmonisation to create an access regime.  Prof. Ali writes: ” The Access Regime refers to a regime that promotes and facilitates access to patented medicines. Patents are seen as the biggest barrier to access to medicines through the world. The access regime would facilitate access to patented medicines not just locally but also internationally”.

The primary elements of the alternative harmonisation agenda are drawn from the three features of the Indian Patents Act viz. pre and post grant opposition, the high threshold level of patentability and compulsory license. Prof. Ali states his book is an attempt to answer the following three questions. “ Is Indian Patent Regime unique? What explains its uniqueness? What are the consequences of emulating India’s example?

Answers to these questions contain in the seven chapters of books, which is divided into three parts. First part articulates the public aspects of the patent law mainly drawing from the experience of US and India.  Second part locates the public aspects of patent law in the Indian Patents Act during the post-TRIPS period. This chapter analyses three important provisions of the Indian Patents Act viz. pre-grant opposition, patentability criteria and compulsory license. The third part articulates the creation of access regime through the alternative harmonisation and its creation, working and pathways of the access regime.

The first chapter provides the history with the marginalisation of public aspects of patent law in nutshell.  The textualization of invention i.e. the shift from the submission of models to patent specification offers the advantage of disclosure and possibilities of public participation. However, the textualization in effect resulted in the estrangement of public and shifting the burden of proof to the patent office. The book attributes the marginalisation of public aspects in the patent law to neoliberalism.  It is true that marginalisation of public aspects of patent law accelerated under the globalisation of neoliberalism, but the beginning of marginalisation goes back to the 19h century i.e. prior to the advent of neoliberalism. All neoliberals are not on the same page in supporting patent maximalist agenda. It is worth to note that economist like Jagdish Bhagwati is a critic of the TRIPS Agreement.

The second part of the book starts with an analysis pre-grant opposition system under the Indian Patents Act. The analyses also provide an evidence to show the effectiveness of pre-grant opposition in India. Further, it analyses the heightened standards of patentability. The uniqueness of the 2005 amendment of the – Indian Patents Act is the Section 3 (d) of the patents act. This provision supposed to eliminate the patentability of a known substance. The book concludes the discussion on India’s heightened patentability standard: “The heightened patentability standard is justified on two counts- as it required the applicant  to demonstrate proof of progress, it shifts part of the cost of search from the patent office, traditionally known for its resource limitations, the applicant; further, in a patent system that offers multilevel challenges mechanisms like pre-grant and posit grant oppositions, it increases the chances a validity challenge addressing the issues relating to information asymmetry”.

Largest chapter of the book (part 2) is devoted to analysing the compulsory licensing. It provides a justification for the compulsory license and differentiates compulsory license into two viz. market initiated compulsory license and government use compulsory license. This chapter builds up a strong case for the market initiated compulsory license illustrating the analyses the Nexavar case.

The book while proposing the alternative harmonisation agenda for the creation of access regimes underplays the most important threat to such regime.  Political pressures from the developed countries especially from US and EU seriously threatens any move towards alternative harmonisation. The book states: “ persuasion methods such as the ones employed by the US in releasing the annual Special 301 Report on the compliance of other countries will be a significant factor that will restrict the Access regime”. It is important to note that  Special 301 threat is not a persuasive instrument but a mechanism backed by a US legislation. A preferred foreign country status in the Special 301 Report is supposed to be followed up with bilateral negotiations and ultimately to trade measures such as the withdrawal of trade concessions. Its potential conflict with WTO regime makes the US go slow on unilateral trade measures.  Therefore, Special 301 can have a chilling effect on small countries.  Apart from Special 301 US also uses many another mechanism especially bilateral pressures against the use of public interest safeguards. India is an illustrative example of the victim of US pressure.

Further, readers could have made an informed opinion if the book would have explained the shortcomings in the working of  pre-grant, patentability standards and compulsory license under the Indian Patents Act.

While pharmaceutical TNCs are working tirelessly to dismantle the unique features of the Indian Patents Act the book clearly establishes a case for the emulation of the public interest safeguards of the Indian Patents. Further it provides evidence of such emulation from countries like the Philippines, Argentina and efforts in China, Brazil and South Africa. This book builds up a clear case for a public interest oriented patent regime.