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UK Supreme Court Upholds HGSI, Glaxo Lupus Drug Patent

LONDON -(Dow Jones)- The U.K.'s Supreme Court on Wednesday upheld a patent on a gene sequence held by U.S.-based Human Genome Sciences Inc. (HGSI) related to its new lupus drug Benlysta, thus handing a defeat to drug maker Eli Lilly & Co. (LLY). The ruling by the U.K.'s highest court echoed a previous opinion voiced by the European Patent Office and overturned an earlier U.K. Court of Appeal decision to revoke the patent, which describes a gene sequence referred to as neutrokine alpha and which was challenged by Eli Lilly. In its patent application, Human Genome Sciences didn't provide experimental data confirming a particular medical use for the gene, but instead listed a long series of potential uses based on computer analysis showing that neutrokine alpha was a member of a family of proteins with known effects, called TNF. A specific medical use for the sequence has since been determined. The EPO, which is based in Germany, ruled that the long list of potential uses did amount to a sufficient disclosure of industrial application, whereas the Court of Appeal ruled that the disclosure wasn't specific enough, given that Human Genome Sciences didn't know which of the potential uses would become reality, or what diseases or conditions could be treated. Legal experts said that Wednesday's Supreme Court decision effectively rebukes the Court of Appeal for failing to follow EPO case law, and confirms the European Union's patent office's view that the HGS patent discloses its industrial application to a satisfactory degree, thus upholding its validity. "We already knew that Europe accepts that "plausible" speculation is sufficient; now we know for sure that this is the case for the U.K. as well," said Gareth Williams, a partner with intellectual property firm Marks & Clerk. "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." Benlysta, also known as belimumab, is the first new lupus treatment in 50 years and represents a milestone in the effort to mine data from the human genome to discover and develop new medicines. The medicine is jointly marketed by HGS and GlaxoSmithKline PLC (GSK). Analysts expect billions of dollars in sales for the drug. -By Sten Stovall, Dow Jones Newswires; +44 207 842 9292; sten.stovall@dowjones.com

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