UK Appeal Court invalidates HGS/GlaxoSmithKline lupus drug patent; Simcere cleared to manufacture and sell zanamivir in China

Following a patent challenge by US pharmaceutical major Eli Lilly, the UK's Court of Appeal has upheld an earlier ruling invalidating a patent on a gene sequence held by Human Genome Sciences, and thus potentially belimumab, a treatment for the auto-immune disease lupus, being developed by HGS together with UK drug giant GlaxoSmithKline.

The ruling favoring Lilly could affect future decisions by UK courts on the scope of biotechnology patents, and may also influence decisions in other European jurisdictions, observers note. It also risks a clash with the European Patent Office, which has separately upheld the patent.The case centers on a protein called neutrokine-alpha, which HGS identified and filed a patent for in 1996.

Presiding over the case, Lord Justice Jacob said the uses for neutrokine-alpha proposed in the patent were not plausible at the time it was filed, since they would have needed research to establish whether or not they were possible.