Summary
Berni Hambleton of Sterling IP initiated proceedings under section 72(1)(a) of the Patents Act 1977 for revocation of the patent on the grounds that the invention as defined in claims 1, 21 to 25 and 34 was not entitled to its earliest priority date, and that the invention as such lacked an inventive step over the cited prior-art. The patentees, Cold Spring Harbor, deny this and maintain that the invention is entitled to its priority date and that therefore the documents alleged to impugn its inventive step do not form part of the state of the art.
The patent provides a method of identifying a transformed or abnormally proliferating cell by determining the subunit composition of a complex that includes D-type cyclins and comparing it to the equivalent complex in normal cells. In normal cells, a quaternary complex of cyclin-dependent kinases (CDK), proliferating cell nuclear antigen (PCNA) and p21 is formed, but in transformed cells this complex is disrupted and the CDK becomes associated with a protein p16 whilst the cyclin is associated with another protein p19. The patent includes claims to the purified and/or recombinant polypeptide known as p16 (including the amino nucleic acid sequences thereof) and to antibodies to the proteins, and associated diagnostic test kits for use in the identification and treatment of cancer.
The Hearing Officer concluded that the invention was entitled to its priority date and that the cited priori art did not form part of the state of the art and hence the patent was considered valid and to involve an inventive step.