This post is a critical comment on a recent United Kingdom Supreme Court decision, which conferred an unconventional interpretation to utility.
In, Human Genome Sciences v Eli Lilly,
HGS was seeking protection for an isolated nucleic acid molecule comprising a
polynucleotide sequence encoding a Neutrokine-á polypeptide. This was
identifiable and isolatable. The subject matter of the patent application was a
member of TNF ligand super family. The fundamental defect to the
HGS’ patent application was they were a bit in the dark as how to identify precisely the
purpose of protein composition. The applicant was sure that it has its own uses
but failed to assert exactly what is usage, or they were aware of the budding
use of the invention, but they were not entirely sure their predictions would
prove to be correct.
Article 52 of the European Patent Convention (EPC)
mandated the requirement of “Susceptible to Industrial Application” for patent
eligibility. The requirement explained in the UK legislation as capable of
industrial or agricultural (S.4 of the Patent Act 1977) application. This case
deals with the interpretation of “Susceptible to Industrial Application”
(Utility) in terms of Biotechnology.
Their patent claims were silent about the
industrial applicability. The inventors were in a dilemma as to the
contemporary appliance of their invention. Protein structures are interpreted to
tackle diseases. To state precisely this protein structure came before the
diseases being discovered. However, already identified members of TNF ligand
family had shown incredible medicinal qualities. Nevertheless, current diseases
did not demand the application of this invention. Future discovery of
industrial applicability is a possibility. This created the whole problem to
their application because “Capable of Industrial Application” means, invention
must be capable of mass production and application in the market.
The court pointed out that research field is a wide
market on which this invention has an industrial application. They also
rejected the US cases postulated the interpretation for the same by saying that
the standard of utility in the US is too high. The court said that the invention of
HGS is capable of industrial application because all the other members of the
family showed excellent result, and this invention may reveal its purpose in
the near future. “The
standard set by the Judge for susceptibility to industrial application was a
more exacting one than that used by the Board. He was looking for a
description that showed that a particular use for the product had actually
been demonstrated, rather than that the product had plausibly been shown to
be usable for the purposes of research work [Para. 151] and [Para. 154],
which the Board must be taken to have regarded as an industrial activity
in itself [pares. 155-156].”
The
Implication of the Decision
This
decision will facilitate the admission of speculative patent claims in the
biotechnology field. Notional claim means the specification will postulate
certain capabilities of the invention based on the qualities and known
functions of the previous similar class of invention. These specifications may
or may not be true. Utility has always been interpreted in relation to contemporary application. However, this decision cast away the
conventional interpretation. This decision added the word “Prospective” to “Susceptible
to Industrial Application." To quote, "[A]ll
known members of the TNF ligand family were expressed on T-cells and were able
to co-stimulate T-cell proliferation, and therefore Neutrokine-α would be
expected to have a similar function."
