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


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 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 speci×cation 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 of×ce. 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 justi×ed on two
counts- as it required the applicant to demonstrate proof of progress, it shifts part of
the cost of search from the patent of×ce, 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 justi×cation 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 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 signi×cant 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
conØict 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.
Author of the book Feroz Ali is a Ministry of Human Resource Development
Intellectual Property Rights Chair atthe Indian Institute of Technology Madras.
Review Author K M Gopakumar is legal researcher associated with the Third World
Network (TWN)) Details ofthe book available here

This entry was posted in Compulsory Licensing, FTA, Patent Opposition, Sec 3 (d), TRIPS, TRIPS flexibilities, TRIPS plus, Uncategorized. Bookmark the permalink.

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