The Biotechnology Industry Organization (BIO) is
the country’s largest biotechnology trade organization,
representing over 1100 companies, academic institutions,
and biotechnology centers in all 50 States and countries around the world.
BIO members undertake research and development
of biotechnological healthcare, agricultural, environmental,
and industrial products. BIO members
range from start-up businesses and university spin-offs
to Fortune 500 corporations. The vast majority of
BIO’s members are small companies that have yet to
bring products to market or attain profitability, and
thus rely heavily on venture capital and other private
investment. Patents on isolated DNA molecules and
other isolated molecules are frequently critical to a biotech
company’s ability to attract the investment necessary
for development of therapeutic, diagnostic, environmental,
renewable energy, and agricultural products.
The question presented in this case is thus of
great importance to BIO’s members.