Supreme Court follows European lead on gene patents
A gene sequence can be patented despite there being no specific medical use for it at the time of application, the Supreme Court has held.
Human Genome Sciences (HGS), a pharmaceutical company, held a patent for a gene sequence known as “neutrokine alpha”. Eli Lilly, a pharmaceutical company, challenged the patent on the basis the invention was not capable of “industrial application”—a prerequisite for patentability.
HGS did not claim a particular medical use for the gene sequence when it made its patent application, but instead listed potential uses based on computer analysis. A specific medical use for it has since been found.
The European Patent Office (EPO) ruled that the long list of potential uses was enough to satisfy the “industrial application” test, but the Court of Appeal held the disclosure was not specific enough as HGS had no idea which of the potential uses would work.
The Supreme Court, in its first ruling on intellectual property, overturned the Court of Appeal and upheld the EPO.
Gareth Williams, partner at Marks & Clerk, said: “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 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.
“Secondly, this 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.”
Kate Taylor, partner, Harrison Goddard Foote, said the case concerned “the standard required for acknowledgment of industrial applicability, a topic on which there is very little UK case law and which frequently arise as a hurdle during the prosecution of biotechnology patent applications.
“The decision is good news for the biotech industry, as it would appear that a plausible or reasonably credible use will be sufficient to satisfy the requirements of industrial applicability in the future”.
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