Human Genome Sciences v. Eli Lilly (UK Supreme Court, 2 Nov 2011) [Decision] Case No. [2011] UKSC 51.
The Supreme Court of the United Kingdom (UKSC) began hearing cases in 2009 — taking on the role of court-of-last-resort formerly played by the House of Lords. The UKSC normally sits in five-member panels — here the panel consisted of Lords Hope, Walker, Neuberger, Clarke, and Collins.
This decision focuses on EPC and UK version of the utility doctrine — the requirement that a patentable invention be "susceptible of industrial application". In a unanimous decision, the court determined that US utility doctrine creates an unduly high bar of patentability. Thus, rather than requiring proof of specific, credible, and substantial utility at the time of filing, the UK court agreed that HGS's genetic sequence coding for Neutrokine-α was patentable even though there was no known use of the protein at the time the patent application was filing. The patent did not reveal how the protein "could be used to solve any particular problem" nor did it identify "any disease or condition which it could be used to diagnose or treat." Yet, the UK court held that the industrial application requirement was met because the protein a member of a "TNF ligand superfamily" and all members of that family have been associated with important biologic activity. "[A]ll known members of the TNF ligand family were expressed on T-cells and were able to co-stimulate T-cell proliferation, and therefore Neutrokine-α would be expected to have a similar function." The UK Court of Appeals (Sir Robin Jacob) had previously held the patent invalid.
In his opinion, Lord Neuberger explicitly rejected the US cases of Brenner v Manson, 383 U.S. 519 (1966) and in re Fisher, 421 F 3d 1365 (2005) — finding that "there are obvious risks in relying on US jurisprudence when considering the precise nature of the requirements of Article 57 in relation to a claim for a patent for biological material under the EPC."
There have been moves over the past fifty years (and more) to harmonise patent law across jurisdictions (the EPC and TRIPS - the Trade-Related Aspects of Intellectual Property Protection - being two important examples), and it is a laudable aim to seek to ensure that all aspects of the law of patents are identical throughout the world. However, the achievement of such an aim is plainly not currently practicable, and, although they have a great deal in common, there are significant and fairly fundamental differences (over and above the different words used in Articles 52 and 57 of the EPC and section 101 of 35 USC) between US patent law and the EPC (two notorious examples being the first to file rule in Europe, and file wrapper estoppel in the US).
Accordingly, particularly when it comes to a nice question such as the precise delineation of boundaries between patentability and unpatentability on the ground of industrial application, it would be unsurprising if the law was not identical under the two jurisdictions.
Instead of following US law, the panel instead latched onto the jurisprudence of the EPO — the body that also interprets the European Patent Convention (EPC).
Notes:
- The UK court of first instance (Kitchin J) found the patent invalid while the EPO Board had held the patent valid.
- The patent in question is European Patent 0,939,804
- IPKAT
- Of course, it is interesting that both HGS and Lilly are US-based companies.
