The Deputy Director of the US Patent and Trademark Office
described the granting of compulsory license for Bayer’s Sorafenib Tosylate to
Natco as the “most egregious” example
of anti-TRIPS (Agreement on Trade-Related Aspects of Intellectual Property
Rights) behaviour. The denial of patent grant to the Novartis too brought
severe criticism from innovator sector of MNC pharmaceutical industry. The call
is for India to ‘Harmonise’ her patent laws and her interpretation of the TRIPs
obligations with that of mature IP economies, primarily, the US and the EU.
It was on this
subject, that Swapna Sundar, CEO of IP Dome, addressed the National Conference
on IP issues conducted by the TN Dr. Ambedkar Government Law University on the
25th of May, 2013. The presentation was well received. Below are
some of the salient points of the presentation.
What is harmonization of Patent Laws
In general, harmonization is understood as the process of
creating common standards across the internal market. Unlike unification which
contemplates the substitution of two or more legal systems with one single
system, harmonisation of law seeks to create consistency of laws, regulations,
standards and practices, so that the same rules will apply to businesses that
operate in more than one member State, and so that the businesses of one State
do not obtain an economic advantage over those in another as a result of
different rules.
There have been several efforts at harmonization, such as
the Paris Convention, the Patent Cooperation Treaty (PCT), TRIPs, and the
Patent Law Treaty (to which India is not a party). A draft Substantive Patent
Law Treaty (SPLT) was also put forward. The treaties lay down some common
minimum standards, and provide for applicants under the treaties to be treated
on par with the nationals of the country where the receiving office is
situated. Moreover, the applicant enjoys the right of preserving the priority
date. Countries are also enabled to interpret the provisions to suit the
requirements of their countries in certain circumstances. Compulsory license
provisions too have been incorporated in the TRIPs since it took effect in
1995.
What are the different types of harmonization activities going on currently
On September 16, 2011, the America Invents Act was signed
into law. The law made a crucial change in that, the person entitled to grant
of a patent was changed from ‘first to invent’, to ‘first-inventor-to-file’
system, in harmony with the rest of the world where the right belongs to the
‘first to file’. Simultaneously, the
USPTO began engaging in earnest with harmonization issues around the world. The
same year, the ‘trilateral offices’, comprising the Japan Patent Office, the
European Patent office and the USPTO
celebrated 30 years of cooperation. The Tegernsee Group comprising the Heads of
the European, Danish, French, German, Japanese, UK and United States patent
offices was set up to study key harmonisation issues include grace period,
18-month publication, treatment of conflicting applications, first-to-file, and
prior user rights.
The Five IP Offices (IP5) was set up to study harmonization
between the five largest intellectual property offices in the world. The
members of IP5 are:
the European Patent Office (EPO),
the Japan Patent Office (JPO),
the Korean Intellectual Property Office (KIPO),
the State Intellectual Property Office of the People's
Republic of China (SIPO),
and the United States Patent and Trademark Office (USPTO).
The IP5 Offices account for 90% of all patent applications
filed worldwide and for 93% of all work carried out under the Patent
Cooperation Treaty (PCT). The IP5 have formed a Patent Harmonization Expert
Panel (PHEP) to work on a comparative analysis study of the substantive laws
which govern the five Offices’ practices with an eye on identifying potential
areas in which harmonization may be achieved.
Is harmonization good for India
It is better for India to arrive at a negotiated trade-off
with the industrialised countries with respect to Patent Law Harmonisation than
to accept the ‘global best practices’ theory of harmonization. Accepting a
standardized set of rules and activities would lead to unhealthy practices
being entrenched in the system globally. For instance, methods of treatment
which are patentable in the US, but not India, would become patentable in India
as well.
Secondly, the advantages of harmonization accrue either to
the industries with large budgets for invention, or to the patent offices which
could see dramatic decrease in work pressure. MNCs would be able to benefit
from the certainty and stability offered by a globally standardized patent
regime and stronger broader patents. Harmonisation is not likely to lead to
better social conditions particularly in the third world countries. Technology
exporting countries would see a rise in royalty payments from technology
importing countries.
Thirdly, India needs a period of calm and stability in which
to devise intellectual property strategies consistent with both the TRIPS
Agreement and the needs of their own emerging national and regional systems of
innovation. We are only now learning to exploit the ‘flexibilities’ provided in
TRIPs to better the life of the people.
Finally, some writers have called harmonization a way to
‘pull up the ladder’ to prevent those who have been left behind from climbing
up. Others, have said that the harmonization agenda keeps shifting the goal
posts forcing the less mature IP economy to reach an un-achievable goal of
benefiting from IP and innovation.
Can we follow our own agenda
Swapna also called for policy makers in India to create an
India-friendly harmonization regime in the countries where Indian innovation
could result in material and social well-being of people. Some of the regions
with which India could have treaties are the neighbouring countries of
Pakistan, Sri Lanka, Nepal, Bhutan, Afghanistan and Myanmar. Countries in South
East Asia and Africa would also be good markets for India. Secondly, the
countries of the region could provide combined protection for petty patents, or
innovation patents that would be useful to their people.
