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This work examines the requirements for patentability in the
context of biotechnology, with a special focus on the
non-obviousness requirement. It analyzes non-obviousness as applied
to biotechnology molecular products via a review of the relevant
case law. The work begins with a typology of recombinant
inventions, useful in determining ultimate non-obviousness and
patentability. It distinguishes three categories of recombinant
products: (1) "Translation" inventions, obtained by entering a
known molecular information into a known process, (2) "Molecular
modification" products, obtained by modifying prior art molecules,
and (3) "Combination" inventions, obtained by combining several
known functional molecular units. Recognizing the risk that many
translation inventions will be considered obvious upon maturation
of the underlying technology, the author examines possible
alternatives for protection. The author critiques and ultimately
rejects the idea of lowering the non-obviousness standard, elected
by the Federal Circuit in In re Deuel. The work describes several
current examples of sui generis intellectual property rights and
also examines a "no action" scenario, emphasizing that the rapid
changes occurring in biotechnology might ultimately make the
current problem obsolete. The text also addresses broader issues
such as the growing secrecy in basic science and its link to the
disappearance of a clear distinction between basic and applied
research. Patent law practitioners, inventors and researchers in
the biotech world, and their advisors should appreciate this
detailed, analysis.
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