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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

Stock News for Human Genome Sciences (HGSI)
DateTimeHeadline
08/03/201203:00:56GlaxoSmithKline Completes Acquisition of Human Genome Sciences
07/30/201209:06:49GlaxoSmithKline Gets 79% Tenders for Human Genome Sciences Offer
07/15/201219:10:13Glaxo Eyes Human Genome Sciences for $2.6 Billion
07/15/201215:49:18Sources Say GlaxoSmithKline in Talks to Acquire Human Genome...
07/11/201212:36:14Glaxo To File Experimental Diabetes Drug Albiglutide In Early...
07/10/201208:38:08Human Genome: FDA Sets Dec. 15 Action Date For Anthrax Treatment...
07/03/201217:08:09GlaxoSmithKline Readies Candidates to Replace Human Genome's...
06/29/201209:24:03Glaxo Keeps Pressure On Human Genome By Extending Offer To July...
06/29/201207:35:49GlaxoSmithKline Sets July 20 For Expiration Of Tender Offer To...
06/15/201210:42:11GSK Gets Renewed Invitation to Human Genome Sciences Strategic...
06/08/201209:10:55GlaxoSmithKline Extends HGS Offer To June 29
06/07/201211:43:24Glaxo Seen Likely to Extend Hostile Tender Offer for Human Genome
05/30/201211:58:59GlaxoSmithKline Is Said To Plan Effort To Replace Human Genome...
05/23/201209:12:46Glaxo Amends Offer To Address HGS Shareholder Rights Plan
05/17/201217:45:35ADR Report: Shares Lower As Euro-Zone Worries Loom
05/17/201213:54:16GlaxoSmithKline Offer To Acquire HGS Represents Full, Fair Value
05/17/201207:55:44Human Genome Adopts Poison Pill With 15% Trigger To Deter Glaxo
05/09/201209:33:24WSJ BLOG/Health: A.M. Vitals: GSK's Hostile Human Genome Bid;...
05/09/201205:02:12Glaxo Goes Direct To HGS Shareholders With Hostile Offer
05/09/201202:48:24GlaxoSmithKline To Launch $13/Share Tender Offer For To Buy HGS

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