In a landmark decision for the pharmaceutical and biotechnology industries, the UK's Supreme Court has ruled against Eli Lilly and upheld a patent on a gene sequence held by Human Genome Sciences relating to its new GlaxoSmithKline-partnered lupus drug Benlysta.
The ruling over-turned the Court of Appeal’s earlier decision to revoke a patent held by HGS covering a gene sequence, neutrokine alpha, which was attacked by Lilly. The latter had previously failed to have the patent revoked at European level, where it was upheld by the Technical Board of Appeal of the European Patent Office.
The case revolved around the concept of ‘industrial application’, which is the basis for patentability under European law. In its patent application, HGS did not provide data confirming a particular medical use for neutrokine alpha, but listed potential uses.
Lilly objected to this and challenged the patent. Commenting on the Supreme Court's verdict, the firm says it is "exploring available avenues to make its case", adding that HGS could "foreclose a whole area of research in a way that is not only harmful to the industry, but would ultimately and unjustifiably hinder the future development of new medicines."
The case is now likely to return to the Court of Appeal to determine the issues of obviousness and insufficiency, says law firm Wragge & Co. The latter says that "the message to the British biotech industry is 'keep calm and carry on'; the message to the IP community is 'stick with the EPO'.
The lawyers added that there may well be gene sequence patents in the future "which will fail for lack of industrial capability, but they will be few and far between".
Gareth Williams, partner at another law firm, Marks & Clerk, said the ruling "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". He added that "we already knew that Europe accepts that “plausible” speculation is sufficient; now we know for sure that this is the case for the UK as well".
Mr Williams went on to say that "this will be good news commercially speaking for HGS…but also anyone else with patents based on similar ‘catch-all’ indications of use. He concluded by saying that the ruling "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".