KRS July Final Jour.09. - Association of Biotechnology and Pharmacy

Current Trends in Biotechnology and Pharmacy
Vol. 3 (3) 225 - 240, July 2009. ISSN 0973-8916
sponsored research. Protection of intellectual
property rights has helped researchers and
institutions to attract research funding and has
helped firms to raise investment capital and
pursue product development. But it has also
periodically generated complaints and concerns
about its effect on the progress of science and on
the dissemination and use of new knowledge (1).
The concerns have been particularly pressing for
scientists when intellectual property rights have
threatened to restrict access to materials and
techniques that are critical for future research.
Controversy over intellectual property rights in
biomedical research has waxed and waned over
the years. The current wave of concern was
triggered in 1991 when NIH filed its first patent
application on partial cDNA sequences, or
expressed sequence tags (ESTs). Despite the later
withdrawal of the patent applications, the concern
over access to DNA sequence information
continued to generate debate, both in the US and
internationally. Another focal point of concern
has been the patenting and licensing of
polymerase chain reaction (PCR) technology. In
1992, the pharmaceutical giant Hoffman-La
Roche, who holds the patent on the enzyme used
in PCR (Taq polymerase), sued the biotechnology
company Promega for breach of contract over
the distribution of enzyme. During the course of
the litigation, many research scientists received
a letter from Promega suggesting them they had
been named as infringers against the Roche
patent. Although Roche stated they had no
intention of naming any scientists in the suit, the
letter sent a chill throughout the research
community and raised fears that patents might
be blocking access to research tools. In addition
to those controversies, less notorious
controversies have surrounded other research
tools in molecular biology.
Increasing alliances among academe,
industry, and government, driven by a
combination of economic and legal changes, have
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challenged institutions in the public and private
sectors to balance their sometimes competing
interests in the protection of intellectual property.
Over the last two decades, public investment in
research has been rewarded by a dazzling series
of advances in molecular biology. At the same
time, scientists have had to adapt to declines in
the growth of public funding to explore these
research frontiers. The commercial potential of
the advances has motivated the private sector to
provide additional resources, and a series of laws,
beginning in 1980 with the Bayh-Dole Act (2),
have encouraged the pooling of public and private
research funds. This environment has been
favorable for the development of small, researchintensive
biotechnology companies with close
links to universities. Indeed, most of the early
biotechnology companies were founded by
university professors, and many universities now
offer “incubator space” for start-up biotechnology
companies working in collaboration with
university researchers. Pharmaceutical
companies are also increasingly eager to establish
collaborations with university researchers (3).
The pervasive intertwining of public and
private interests makes molecular biotechnology
a particularly useful focal point for considering
the effect of intellectual property rights on the
dissemination and use of research tools. The
potential implications of advances in molecular
biology for human health raise the stakes of
getting the balance between public and private
right, particularly when public attention is riveted
on the rising costs of health care. In this review
we will be discussing about the research
methodology, patenting tools and patent
protection and patenting of research tools for
molecular biology and biotechnology
applications.
Research methodology
The research methodology adopted is of
a descriptive-analytical method. The data has
Firoz et.al