- The Australian Patent Office additionally disallowed Regeneron's Murphy patent application on Reverse Chimeric antibodies due to lack of enablement.
Cambridge, UK; 2 September 2019: Kymab, a clinical-stage biopharmaceutical company developing fully human monoclonal antibody therapeutics, announces that it has received a decision from the Australian Patent Office (IP Australia) rejecting on all grounds an opposition by Regeneron Pharmaceuticals Inc ("Regeneron") against the grant of a Kymab patent covering genetically modified mice containing human-mouse chimeric antibody loci, humanized antibodies from such mice, cell lines for manufacturing antibodies and pharmaceuticals containing antibodies.
IP Australia had allowed Kymab's patent application number AU 2011266843 and in July 2015 Regeneron opposed the grant of a patent from this. The grounds of opposition were an alleged lack of novelty, inventive step, clarity and fair basis. Regeneron failed on each ground, the Patent Office finding that Kymab prevailed in each instance. The Patent Office also awarded costs against Regeneron. Regeneron has appealed the decision.
In its opposition, Regeneron relied upon its own earlier patent application (WO2002/066630, the "Murphy Application" directed to mice containing "reverse chimeric" human-mouse antibody loci) as an alleged prior art reference. IP Australia found, however, that the Murphy Application does not provide sufficient information to put the "reverse chimeric" invention into practice, and therefore does not provide an "enabling disclosure" as required for the purposes of assessing novelty or inventive step. Thus, the Patent Office disregarded Regeneron's Murphy application, finding instead for Kymab on novelty and inventive step of chimaeric antibody technology. Counterparts of the Murphy Application have been litigated by third parties in the US where an equivalent Murphy patent was also found to be invalid for indefiniteness. In UK litigation on Murphy patents (EP (UK) patents 1 360287 and 2264163) the High Court found that they were insufficient, or non-enabling, although this decision was overturned by the Court of Appeal. Kymab has been granted leave to appeal on the test for enablement, which will be heard by the UK Supreme Court in February 2020.
Notes to Editors
Read the PDF version of the official release.
Kymab is a clinical-stage biopharmaceutical company developing a deep pipeline of novel antibody-based therapies in a broad range of indications. The Company generates its product candidates using its proprietary, integrated platforms collectively called IntelliSelect®. Kymab's platforms have been designed to maximize the diversity of human antibodies produced in response to immunization with antigens. Selecting from a broad diversity of fully human antibodies allows for the identification of antibodies with optimal drug-like properties.