The English Court of Appeal has recently been asked to consider whether a patent granted to Human Genome Sciences Inc. covering a human gene was valid. The Court has ruled that human genes are patentable, but that the patent must describe at least one way that the gene or the corresponding protein can be exploited commercially

Human Genome Sciences Inc.'s patent related to a polypeptide called Neutrokine-α (EP(UK) 0 939 804). The claims covered isolated polypeptides, antibodies against the polypeptide and isolated genes encoding the polypeptide. HGS had discovered the sequences of the gene and polypeptide, and then had used computer-based predictions (i.e. sequence-based similarities with known polypeptides) to assert that the polypeptide, and antibodies against it, would be useful for the treatment of diseases such as angiogenesis, wound healing, osteoarthritis and rheumatoid arthritis. However, there was no experimental data in the patent to support these assertions; information on the function of the protein was merely speculative.

The validity of the patent was challenged by Eli Lilly. In the first trial, before the English Patents Court in 2008, the Judge found the patent to be invalid on grounds of lack of industrial application, insufficiency (lack of enablement) and obviousness. HGS then filed an Appeal to the Court of Appeal. In the latter Court, the Judges concentrated on the issue of industrial application.

"Industrial application" is one of the criteria that all patentable inventions must satisfy. The English patent laws require that the invention must be capable of being made or used in any kind of industry; other countries have similar rules. (In the US, the corresponding rule is known as the "utility" of the invention.) Generally, this rule is not difficult to satisfy and the hurdle is set at a relatively low level. However, following the implementation of the EU Biotech Directive (98/44/EC), specific rules have been introduced into English (and European) patent law relating to the requirements that gene sequences must satisfy in order to be patentable. In particular, the rules of the EU Biotech Directive (Article 5(3)) state that "the industrial application of a sequence ... of a gene must be disclosed in the patent application". The Recitals of the Directive (Recitals 23 and 24) clarify this point further and state that:

"... a mere DNA sequence without an indication of function does not contain any technical information and is therefore not a patentable invention"

and that

"in order to comply with the industrial application criterion it is necessary in cases where a sequence or partial sequence of a gene is used to produce a protein or a part of a protein, to specify which protein or part of a protein is produced or what function it performs."

These rules were passed as a reaction to the practice of certain organisations in the 1990s to sequencing large parts of the human genome and then filing patent applications covering such raw sequence. The rules now ensure that patents are not granted for gene or polypeptide sequences under circumstances where the Patentee has no knowledge of what the function of the gene or protein is.

In the HGS case, the Judges were asked to decide whether the predictions made by HGS on the function of the claimed polypeptide on the basis of gene sequence similarities were enough to satisfy the above rules.

There have been relatively few gene patent cases in England, and hence the Judges started by reviewing - in some depth - the relevant case law from the European Patent Office (EPO). In particular, some recent cases from the Technical Boards of Appeal of the EPO had laid down a requirement for the patent to disclose a "practical application [for the invention] derivable in a straightforward manner"; others stated a requirement for the invention to be "plausibly shown to be usable" in a therapeutic context.

In the first trial (before the English Patents Court), the Judge applied the abovementioned criteria and ruled that "the patent does not of itself identify any industrial application other than by way of speculation". Furthermore, he stated that it was "far-fetched that the Neutrokine-α could be used in relation to" all of the alleged therapeutic uses. The Judge therefore concluded that HGS's patent left the reader with "a research programme" to try to find out the real use of Neutrokine-α.

HGS's corresponding European Patent was also challenged by Eli Lilly, using the EPO's Opposition and Appeal procedures, and the issue of industrial application was raised there. In that case, on the basis of different evidence to that which was before the English court, HGS's European patent was found to be valid.

However, after considering both the lower Court's decision and the EPO's decision, the Court of Appeal Judges ruled that, in their opinion, HGS's UK patent was invalid.

It is understood that HGS is currently seeking permission to appeal the decision of the Court of Appeal up to the English Supreme Court (previously known as the House of Lords). Hence there still remains the possibility that the Court of Appeal decision will be overturned.

From a legal perspective, this case shows the continued willingness of English judges to follow basic patentability principles which have been laid down by the EPO with a view to harmonising patent practice throughout Europe. Such harmonisation will be welcomed by practitioners in this area. This case does highlight yet again, however, certain deficiencies in the capability of the EPO to handle evidence and expert data; such issues are handled much more rigorously by the English courts. Until such matters are addressed, there will inevitably continue to be discrepancies in the decisions given by the EPO and the English courts in some cases.

The take-home message for biotech companies and those against gene patents is that the "industrial application" rules of the EU Biotech Directive are indeed being enforced. Hence those opposed to gene patents (from a commercial or moral perspective) have a further weapon in their armoury against such patents. Furthermore, the ever-increasing amount of sequence information which is being added daily to the public databases means that the novelty and inventive step hurdles are also rapidly being raised. However, the gene patent industry is far from dead: there are still rich pickings to be had in the areas of human splice-variants, plant and animal genomes, and synthetic genes, and in determining uses for the newly-discovered human genes and proteins.

Philip Webber, Partner
First published in The Journal of Commercial Biotechnology, June 2010