Human Genome Sciences Wins British Supreme Court Ruling

By Joseph Mandour on November 4, 2011

Patent LawyerSan Diego – Human Genome Sciences, Inc., a biopharmaceutical company that uses human DNA sequences to develop protein and antibody drugs, recently received a ruling in its favor by the British Supreme Court in a patent dispute with Eli Lilly & Co. The dispute concerned the validity of a European patent for a gene sequence for use in developing treatments for individuals with immune diseases. Indiana based Eli Lilly and Co. initially contested the European patent owned by Human Genome on the grounds that the patent was too vague in describing its potential uses and that, if upheld, the patent would stifle research in the area of gene sequencing.

The Human Genome patent at issue was granted by the European Patent Office. The European Patent Office grants patents to inventors in 38 member countries. Patents issued by the Office are not European Union wide and must be defended in each member country.

Here, Maryland based Human Genome initially received a European patent in 2005 for a gene sequence to create a neutrokine alpha protein. The protein is a cytokine known as a Tumor Necrosis Factor protein. These proteins are involved in initiating systemic inflammation and facilitating an increase or decrease in plasma concentration in reaction to such inflammation. Human Genome, partnered with GlaxoSmithKline, planned to use the patented gene sequence to develop its Lupus drug Benlysta.

However, the Human Genome patent had been found invalid by a lower British court. Upon motion by Eli Lilly, a previous ruling in the case had invalidated the patent based on arguments from Eli Lilly that the claimed uses of the synthesized protein were too vague. A crucial element of a European patent is a designated industrial use, similar to a patent claim in the U.S. Eli Lilly alleged that rather than designating a specific industrial use, the Human Genome patent had merely listed potential uses for the gene sequence.

Upon review by the Supreme Court, judges reversed the ruling and upheld the validity of the Human Genome patent. Supreme Court Judge Robert Walker claimed that the ruling, reinstating the Human Genome patent, would prevent a chilling effect on biopharmaceutical research in the U.K. and Europe.

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