What’s happening
UK patent system brought into line with Europe
Last month the Supreme Court over-turned the Court of Appeal’s earlier decision to revoke a patent held by Human Genome Sciences (HGS). The patent, which describes a gene sequence referred to as neutrokine alpha, was attacked by Eli Lilly. Lilly had previously failed to have the patent revoked at European level, where it was upheld by the Technical Board of Appeal of the EPO.
The dispute centres on the concept of whether the invention is capable of ‘industrial application’ – the disclosure of which is an essential criterion for patentability under European law. In the patent application, HGS did not provide experimental data confirming a particular medical use for the gene, but instead listed a long series of potential uses based on computer analysis that showed that neutrokine alpha was a member of a ‘superfamily’ of proteins with known effects called TNF. A specific medical use for the sequence has since been determined. The EPO ruled that the long list of potential uses did amount to a sufficient disclosure of industrial application, whereas the Court of Appeal ruled that the disclosure was not specific enough, as HGS at the time had no inkling as to which of the potential uses would come to fruition, or what diseases or conditions may be treated.
Today’s Supreme Court decision rebukes the Court of Appeal for failing to follow EPO case law, and confirms the EPO view that the HGS patent discloses its industrial application to a satisfactory degree, thus upholding its validity.
Gareth Williams, Partner at Marks & Clerk, commented: “This ruling is significant on two fronts. Firstly, this sends a clear message to innovators hoping to operate in the UK market – the level of detail it is necessary to include in a patent application is now far clearer. We already knew that Europe accepts that ‘plausible’ speculation is sufficient; now we know for sure that
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this is the case for the UK as well. This will be good news commercially speaking for HGS – which has a product on the market based on this patent – but also anyone else with patents based on similar ‘catch-all’ indications of use.
Marks & Clerk says that the ruling is significant in that it clearly reconfirms the approach taken by other recent UK judgments that European patent law should be followed unless there are very strong reasons to differ. The ruling rebukes the Court of Appeal judge for not following EPO case law and confirms that the judge had in effect been applying a stricter standard than used in the EPO. However, it is important to note that the Supreme Court was careful to say that this does not mean the UK should slavishly follow EPO decisions; as the judgment says, ‘there has to be room for dialogue between a national court and the EPO’.
This ruling is a positive one for patent owners. It affords harmony and certainty, avoiding a split between the UK and
Europe on patent law. This is positive from a commercial point of view – it is in everyone’s interest that patent law, in a market as important and large as Europe, be uniform.
Marks & Clerk added that from the perspective of the biotech field and other high-tech industries, this ruling is particularly good news. Patents are a commercial tool. This decision demonstrates the importance of making strategic investments in intellectual property protection. The Supreme Court has recognised that patents are the foundation on which research based companies attract funding for further research, and for the development of the fruits of this research into useful technologies and products. The Justices have preferred a definition of industrial applicability which is in line with the rest of Europe and less strict than the test applied by the lower courts.
This ruling is the Supreme Court’s first ruling on an IP related matter since its creation.
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