Important decision for the biotech industry from UK Supreme Court

The UK’s Supreme Court yesterday gave guidance on the patentability of gene sequence inventions, with its judgment in Human Genome Sciences (Nasdaq: HGSI) versus Eli Lilly (NYSE: LLY), the first patent case that it has considered.

Following a patent challenge by US pharmaceutical major Eli Lilly, the UK’s Court of Appeal last year upheld an earlier ruling invalidating a patent on neutrokine-alpha - a gene sequence held by Human Genome Sciences, and thus potentially Benlysta (belimumab), a treatment for the auto-immune disease lupus, being developed by HGS together with UK drug giant GlaxoSmithKline and which has since been approved for marketing (LSE: GSK; The Pharma Letter February 11, 2010).

The primary issue on appeal was how far must an applicant for a patent go in disclosing potential therapeutic uses for new genes? The UK Court of Appeal’s judgment, which was appealed by HGS, appeared to require expensive and time consuming clinical tests to be performed prior to filing a patent application. The effect of this requirement would seem to place a higher burden on companies filing for patent protection in the UK than elsewhere in Europe.