The Supreme Court rules on Industrial Applicability
This article was included in the winter 2011/12 issue of snIPpets - the intellectual property newsletter.
In its first ever case concerning patent law, the Supreme Court has overturned the decision by the Court of Appeal concluding that Human Genome Sciences' (“HGS”) patent did meet the requirement of industrial applicability as set out in Article 57 of the European Patent Convention. In coming to their decision, the Law Lords made a comprehensive review of the jurisprudence of the European Patent Office on this matter. Lord Neuberger came up with 15 principles for assessing industrial application: 4 general principles; 6 principles for patents disclosing a new protein and encoding gene; and 5 extra principles for members of a superfamily. The guidelines introduce a low threshold for meeting the requirement of industrial applicability.
The case is, however, not over for the parties involved. There are still outstanding points to be decided – the case has been remitted back to the Court of Appeal to decide on sufficiency and scope of protection.
This case centred on the patentability by HGS of the nucleotide and amino acid sequence of a novel member of the anti-tumour ligand superfamily (known as the "TNF ligand superfamily"), which it called Neutrokine-a.
On 25 October 1996, HGS filed an application for European Patent (UK) 0,939,804 (the “Patent”). The patent included claims to the Neutrokine-a polypeptide, the nucleotide which encoded it, antibodies which specifically bound to it and corresponding claims to pharmaceutical and diagnostic compositions.
HGS did not use traditional “wet laboratory” techniques (i.e. conducting classical experiments in a laboratory handling actual biological material) to isolate Neutrokine-a. Instead, it used bioinformatics (also commonly referred to as computational biology), which at the time was a rapidly emerging technique for the identification of novel genes and proteins, to trawl through DNA and amino acid sequence data created and stored in publicly accessible databases.
The patent application included a long description of Neutrokine-a's activities and its uses, but that description was not supported by any data obtained by in vitro or in vivo studies: it was essentially a prediction based upon what was known about other members of the TNF superfamily.
The Patent was granted on 17 August 2005. Just before the end of the opposition period, Eli Lilly and Company (“Eli Lilly”) filed opposition proceedings before the Opposition Division ("OD") of the European Patent Office (“EPO”). Eli Lilly also commenced invalidity proceedings against HGS in the United Kingdom.
The OD revoked the Patent in June 2008 on the basis of added matter and obviousness. This decision was suspended pending an appeal from HGS. In the meantime, the Patents Court held in July 2008 that all of the claims in the Patent were invalid on three grounds: industrial applicability, insufficiency and obviousness. Both decisions were appealed.
In January 2009, the EPO Technical Board of Appeal ("TBA") received a request from the Court of Appeal to accelerate its proceedings in order to dispose of the EPO appeal before the hearing of the appeal in the parallel English proceedings. If the TBA was to confirm the revocation of the Patent, there would be no need to hold the hearing at the Court of Appeal, therefore saving the Court’s time and costs. Co-operation between the two courts was welcomed and arrangements were made for the EPO appeal to be heard before the Court of Appeal hearing. After hearing "new" evidence not before the UK courts, the TBA allowed the appeal and held the patent as amended in the proceedings to be valid.
The Court of Appeal then heard the appeal and decided to uphold the High Court's decision rather than follow the TBA. HGS appealed to the Supreme Court.
The Supreme Court
The central issue to be decided was whether the Patent satisfied the requirement for industrial applicability under Article 57 of the European Patent Convention (EPC) so as to enable HGS to claim the encoding gene for Neutrokine-a. It is worth noting the decision was a close call, with three of the five judges minded to reject the appeal. However, in the end, the five judges of the Supreme Court unanimously preferred the TBA ruling to that of the Patents Court and Court of Appeal.
Their decision was based on two main reasons, established EPO jurisprudence, and public policy.
Both parties to this case acknowledged that it was the established jurisprudence of the EPO that must be turned to for guidance on interpreting Article 57 in relation to biological material. Lord Neuberger undertook a comprehensive review of EPO case law on this point, providing a useful summary of the general principles arising from them. His conclusion was that there were a number of decisions of the TBA which had addressed the topic and which at least purported to adopt a consistent approach.
The Court felt that the Court of Appeal had not followed this established jurisprudence. Taking into consideration the common general knowledge of a skilled person, the disclosure of the existence and structure of Neutrokine-a, its gene sequence, and the fact that it was a member of the TNF family, should have been sufficient to satisfy the requirements of Article 57.
In these proceedings the BioIndustry Association ("the BIA) intervened and made a number of submissions emphasising the requirement for clarity and certainty in this area of law – bioscience companies need to be able to decide at what stage to file for patent protection. The BIA submitted that if the bar was set too high to fulfil a patent application, this would cause UK bioscience companies great difficulty in attracting investment since investors would be less certain of obtaining a patent in return for their investment.
The Court felt that the High Court had set too high a standard to satisfy the requirement of industrial applicability. They concluded that the High Court had been wrong to focus on the "speculative nature" of the therapeutic uses of the gene (i.e. did not give rise to an "immediate concrete benefit") as it was felt that it was sufficient that HGS had assigned the protein to the TNF family (which was well known), the use was plausible, and they could make it. The Court felt they did not need to determine the precise use as that would involve a "research project" and therefore would be unduly onerous.
This is the first time that the highest appellate Court in the UK has had the opportunity to consider the criteria for assessing industrial applicability. The Supreme Court has followed the trend in the last few years of being guided on this issue by the jurisprudence from the EPO.
The Judgment has created a low threshold for satisfying the criteria for industrial applicability. On the one hand, one would instinctively think this would be welcomed by the pharmaceutical industry (as well as by innovators generally) but on the other hand, other innovators may be prevented from exploiting subsequent downstream inventions because of the presence of a broad and highly speculative patent which includes claims that are not supported by data. All may not be lost, however, for such aggrieved subsequent innovators as they may be able to invalidate such broad patents based on other grounds for revocation.
Beatriz San Martin, senior Associate and Mark Hodges, Partner, IP Protection and IP Enforcement and Litigation, at Fieldfisher.