This post is a critical comment on a recently UKSC
decision, which conferred an unconventional interpretation to utility.
In, Human
Genome Sciences v Eli Lilly, HGS were 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 of dark 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 the use 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 of 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 of Industrial Application” (Utility from now on) 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 interpreted to tackle diseases. To state precisely this protein
structure came before the dieses 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 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. Speculative 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.
As
and when one read “Capable of Industrial Application”, he\she would interpret
it as a present application. However, this decision cast away the conventional interpretation.
As of now the interpretation assumed is that “an invention can be patent even
if it is showed that it can have a future industrial application provided the
similar invention has proved that they has their own capabilities in the
field”. 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."