UK High Court Invalidates HGS Neutrokine-alpha Patent

    By Donald Zuhn --

Earlier this month, several European news outlets reported on a decision by the UK High Court of Justice declaring a Human Genome Sciences (HGS) patent disclosing the nucleotide and amino acid sequence of Neutrokine-alpha, a novel member of the TNF ligand superfamily, to be invalid.  The High Court agreed with HGS' opponent, Eli Lilly, that the claimed invention in HGS' patent was not capable of industrial application (in U.S. patent parlance, the invention was found to lack utility).  Echoing the landmark U.S. utility case Brenner v. Manson, Lilly had argued that "a patent cannot simply operate as a hunting licence to find an industrial use," but "[r]ather the patent must describe an industrial use which is specific, substantial and credible."

While Justice Kitchin of the High Court acknowledged that HGS had identified Neutrokine-alpha and properly characterized it as a member of the TNF superfamily, and further, that the invention had ultimately yielded a potentially useful therapeutic (i.e., the monoclonal antibody lymphostat-beta for treating rheumatoid arthritis and systemic lupus erythematosus), he wrote that "simply identifying a protein is not necessarily sufficient to confer industrial utility upon it."  Justice Kitchin added that HGS' patent contained "an astonishing range of diseases and conditions which Neutrokine-alpha and antibodies to Neutrokine-alpha may be used to diagnose and treat," but lacked data in support of these assertions.  In contrast with U.S. practice, where an applicant need only assert one specific, substantial, and credible utility and the recitation of non-credible utilities does not render the claimed invention as lacking utility (see M.P.E.P. § 2107.02), Justice Kitchin determined that "[t]he skilled person would consider it totally far-fetched that Neutrokine-alpha could be used in relation to [all of the recited diseases and conditions] and, as I have found, would be driven to the conclusion that the authors had no clear idea what the activities of the protein were and so included every possibility," adding that "[t]o have included such a range of applications was no better than to have included none at all."

Taking a page out of the U.S. Supreme Court's Brenner decision, Justice Kitchin noted that HGS had "secured broad protection over an unexplored technical field without providing an adequate compensating benefit to the public."  The similarities between this decision and Brenner should not be surprising, given Justice Kitchen's citation of a number of U.S. cases, and his statement that the industrial applicability/utility principles in the UK and U.S. were consistent.

The High Court's ruling allows Eli Lilly to move forward with its Neutrokine-alpha monoclonal antibody therapeutic, which the company invested $50 million developing and expects to spend another $250 million testing in the clinic.

For additional information regarding this case, please see:

• Financial Times report
• Scrip World Pharmaceutical News report

Comments

[Kaushal Joshi]

UK court decision is landmark judgement in history of biotech patent law. Where the court successfully determined the thinline difference between industrial applicability and utility. It will be a learning example for other patent professional and preclude inventor to mention broad range of information in specification which is not supported or invented by inventor. Furthermore this decision laso save and protect the basic fundamental right of patent law by preventing monopoly of genome biosciences.