Public Funded R&D Bill, 2007, a legal perspective
Funded R&D Bill, 2007, a legal perspective
India’s biotechnology industry has entered into
a critical phase. Though biotech has been around for some time now, the
industry took shape in the late 1990’s when dozens of
academicians turned entrepreneurs. This is almost similar to the
situation in the US, when a remarkable piece of legislation, called
Bayh-Dole Act opened the floodgates of research centers and led to the
emergence of the biotechnology industry as we know today.
It was indeed rightly timed, the Indian Government came out with the
bill to encourage the scientific community in India whose rights is
otherwise not recognized. The US was the pioneer in this regard by
enacting the Bayh-Dole Act, 1980, that sought to empower universities
for protecting their intellectual property rights (IPRs). Many in the
industry too feel the time is conducive since we already have venture
capitals in technology development and once the bill is passed and
takes the form of an act, it will generate infrastructure as well.
At present, the universities and research institutions in India that
manage to get government funding lack the mandate to commercialize
their research results, which is largely done by the industry.
Innovations also get wasted as they belong to the funding agency. The
proposed legislation is expected to provide a legal framework to the
research institutions that would develop an active interface between
the funding agencies, academia and the industry, which has been lacking
Scientists are not expected to have profits on their mind when they
involve themselves in laboratory work. This is set to change, with the
Public Funded R&D (Protection, Utilization and Regulation of
Intellectual Property) Bill, 2007, drafted by the Central Government
and apparently being circulated among the ministries. The bill is
expected to commercialize research from public-funded institutions as
they have been largely insulated from the challenges of the competitive
environment in which private-funded research operates. Companies
typically get their research patented, following which they try to
leverage the research into a viable commercial product.
The bill seeks to encourage public sector research organizations to
patent their inventions and offer them to the industry for
commercialization on a revenue-sharing basis quite like how the
Bayh-Dole Act did for American universities. The bill will provide the
enabling mechanism to permit research institutes to own IP on
publicly-funded research projects.
Government funded R&D bodies like CSIR among others are set to
be covered under the proposed law. The legislation should be a broad
guiding framework and specifics should be left to the rules that are
made later taking into account in the changing environment.
Will the legislation bring institutions and corporations too close to
each other for public comfort? Is there a way to get the best research
on board and not just that of a high profile researcher or scientist?
And, most importantly, what happens to national interest, in terms of
pricing and access to a medicine developed through public-funded
research and subsequent commercialization?
It would be useful to incorporate penalty provisions in the proposed
bill if not included which may act as a deterrent for scientists from
infringing their rights to reap profits out of their inventions.
Scientists need to put their protected work in the public domain.
Various agreements will take place between the public and private
sectors and the technology that bears fruit from the research should be
evaluated properly with the appropriate commercial yardstick.
Some of the major features of the Bayh-Dole Act, 1980 (BDA) are,
non-profits, including universities, and small businesses may elect to
retain title to innovations developed under federally-funded research
programs; universities are encouraged to collaborate with commercial
concerns to promote the utilization of inventions arising from federal
funding; universities are expected to file patents on inventions they
elect to own and universities are expected to give licensing preference
to small businesses.
The BDA was part of the attempts of the US Congress during the 1980s to
create a unified government patent policy pertaining to inventions made
with federal support, to promote invention-related activities among the
academia. The bill has triggered another global debate on the impact of
IPRs on development and access to public health that have occupied the
centre-stage in the last decade, starting with the Doha Declaration.
The introduction of the IP bill now in India perhaps also typifies the
confused mindset of most developing countries whether to adopt or adapt
the western models of IP protection regimes for development given the
complexity of the issues.
Supporters of the IP bill, largely the government
functionaries and some section of the Indian industry, chant the IP
mantra – innovate, patent and prosper. At the other end are
the academics, civil society groups both from India and abroad
– voicing serious concern on both the bill itself and the way
it is being rushed through the Indian Parliament.
There are numerous opportunities in the biotechnology sector in India.
With enough scientific manpower, India has the vital ingredients for
success in biotech and pharmaceutical R&D. However in order to
harness this talent, care must be taken to address the above issues in
an enabling business environment with a pragmatic, entrepreneurial
mindset. The Public funded R&D bill in India should be debated
far and wide in order to make it a realistic and effective piece of
Kirit S Javali, partner,
Jafa & Javali, a full-fledged corporate law firm with niche
expertise in IPR and Biotech law, with offices in New Delhi, Bangalore