IMPLICATIONS FOR BIOTECH INDUSTRY
Government of India had
announced1 its National Intellectual Property Rights (NIPR) Policy
on 12th May 2016. The NIPR Vision is to stimulate creativity and innovation by IPR.
The mission is to achieve a dynamic, vibrant and balanced IPR to foster
creativity, promote entrepreneurship and enhance development. The focus areas
are healthcare, food security and environmental protection among others. There
are seven objectives including awareness generation, announcement of legal
framework for its implementation, stimulation for commercialization of IPRs,
enforcement and adjudication procedures and human capital development. The
Patents (Amendment) Rules, 2016 has subsequently been notified2 on
16th May 2016 to implement NIPR policy. The amendment is TRIPS compliant.
India announced its
TRIPS-compliant IPR policy3 on 26th March, 1999, effective from
01/01/1995. The Patents (Amendment) Act 2002 enacted in May 2002 came into
force4 on 20th May 2003 incorporating main IP laws enacted by
legislature, replacing Patent Rules, 1972. The Patents (Amendment) Act 2005
effective 1st January 2005 introduced product patenting5 in all
fields of technology; “Swiss Claim” and expansion of exclusion under Section
3(d) were forbidden; software patentability was enforced; provisions relating
to exclusive marketing rights were deleted and modified; compulsory licensing could
be enforced only under certain conditions; and certain other arrangements
including defining “pharmaceutical substances”. The Patents (Amendment) Act
2012 specified securing some minimum marks for enabling to be a competent
Patent Agent6. The Patents (Amendment) Act 2013 introduced
provisions for recognizing the Patent Office as the Examining Authority and the
Searching Authority7 on international level for filing, searching
and examination of patents along with necessary fees. The Patents (Amendment)
Rules 2014 provided revision of patent filing fees8 for a group of
applicants of small financial means. The Patents (Amendment) Rules 2016 intend2
to stimulate creativity and innovation by IPR; the focus areas are healthcare,
food security and environmental protection among others.
India is a technology
dependent country. In the diverse areas of biotechnology, India has developed
its industries by utilizing already invented basic technologies in biological
sciences elsewhere. This is true for almost all biotech products manufactured
in India in healthcare, agriculture, environment management and industrial
applications. India has however made phenomenal progress in applications by
innovations using components of patent-expired technologies and materials9, 10. Indian public funded
institutions and engineering institutes have contributed to development of
comparatively low value biotechnologies. Very few patented technologies have
flown from such inventors to the industry. However, there has been considerable
collaboration between such institutions and industry, and such tie-up continues10. Indian modern biotech
industry comprises of about 340 units of various sizes. A handful of units conduct
basic and developmental research. A few standalone “novel” products developed
by some companies have small global sales. Most products that sell are those on
which patent has already expired for the first inventor. The R&D expenditure by Indian companies
is comparatively much smaller than transnational companies. The contributions
of small and medium enterprises are not as bright however; most of the units
deploy comparatively low value-added technologies, face severe market
competition and suffer from shortage of capital. Government is however
extending considerable support to strengthen SMEs11.
The general experience by
the Indian consumers is that IPR protected imported finished biotech substances
in all areas including Healthcare and Agriculture is very expensive. Life
saving biotech drugs is often unaffordable by most Indians. Transnational
companies have shown feeble interest in setting up basic manufacturing units in
India to produce IPR-protected biotech substances. The basic R&D setup of a
couple of multinational companies in India has been stopped/transferred/shifted,
though some transnational companies have shown interest to build and invest in such
facilities in the country12-13. It is prudent to compile the extent of
investment made by transnational companies in the country for promoting basic
research.
The present Indian
technological scenario in biotechnology does not show that India will emerge as
an “inventor” country. India would however profoundly contribute through
innovation in products and processes where IPR has already expired for the
first inventor. The present Indian IPR laws, which are TRIPs-compliant, have
considerable flexibilities to utilize IPR for public benefits. It should be the
endeavor to uphold the existing provisions through policy interventions. Separately,
efforts can be made to develop and invent world-class innovative basic
technologies in public funded institutions in specific areas through focused
policies and directed investments on top down approach.
Small and medium biotech
companies survive in the marketplace by virtue of their own innovations. Very
few utilize IPR-based technologies. Wherever an IPR is taken, this is usually
used as a marketing promotional advantage for capturing a share rather than for
holding on the competitive advantage of the invention. Small and Medium biotech
companies are tremendously hard pressed for capital and have limited capacities
to purchase IPR which are almost always very expensive, requiring large initial
capital.
Large biotech companies use
IPR-based imported technologies. Companies’ in-house expenses are mostly on
developmental costs and innovations to improve the marketability of the product
by cutting costs. Basic R&D expenditure in large biotech companies is also
not adequate. Large companies are progressing through international
collaborations.
Under these circumstances
the flexibilities available through Indian Patent laws should be utilized as
much as possible even though there are apprehensions that there could be pressures
from several quarters to interfere on rules and policies to make the Indian
laws more stringent towards inventors.
In view of the present
situation of technological competence and infrastructure available in the
country, some questions arise which need to be addressed to understand what is the
best roadmap for the country.
Question 1: In Biotechnology, new inventions are emerging in humanized monoclonal
antibodies to treat chronic diseases, gene therapy to induct tissue and organ
repair, diagnostics (based on genomics, transcriptomics and proteinomics) to
predict diseases in advance and target receptors to contain diseases. GM seeds
are being developed to improve agriculture and forestry. Genetically engineered
organisms including microbes and plants as also engineered enzymes are being
developed to deal with various industrial operations and environmental
management, among other areas. Is India prepared to invent and build world
class biotechnologies in these areas?
Question 2: By inducting more stringent private friendly IPR laws, will there be
adequate opportunity for upholding public interest causes that are endemic and
prevalent in India such as desire for adequacy of affordable medicines and enough
nutritious food for the “have-nots”?
Question 3: Is there a need to move towards IPR laws more stringent than what is
required through TRIPS compliance? TRIPS conditions set the benchmark for all
WTO Member countries.
Question 4: Is commercialization of biotechnologies in India through more thrust on
IP generation a more viable option for the country? Is there any
evidence/information on this? Is there any study to assess how many IPR based
technologies are being utilized presently by the 340 or so, modern biotech
companies in India?
Question 5: The premier Indian biotech companies have done well to the country as
well as to the world by producing quality biotech products and supplying them
at more affordable prices. Why have not any of these companies been able to
develop an innovative near-“jackpot” product thus far? Why some companies who
have invented some new products, have not been able to get those registered in
developed-country-markets like USA and Europe?
I anticipate to have stimulating discussions and comments from my
readers to enable me to become more knowledgeable on the various issues as
above.
REFERENCES
1. http://dipp.gov.in/English/Schemes/Intellectual_Property_Rights/National_IPR_Policy_12.05.2016.pdf
