Monday, May 21, 2012

Human Gene Analysis

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."