Sequenom, Inc. announced that the European Patent Office (EPO) has upheld, in amended form, the validity of European Patent No. 0994963B1, in a challenge to the patent brought against Isis Innovation Ltd., the technology transfer company of the University of Oxford.
Through agreement with Isis, Sequenom holds exclusive rights to the patent that is enabling for non-invasive prenatal genetic testing on fetal nucleic acids derived from maternal plasma or serum.
"We are pleased with the EPO's ruling, which strengthens our patent position," said Clarke Neumann, vice president and general counsel for Sequenom. "It is unclear whether the decision will be appealed."
Sequenom has identified considerable unmet needs for new approaches that enable non-invasive and reliable prenatal diagnostic testing for expectant mothers and is pursuing development of a portfolio of non-invasive prenatal tests based on the analysis of circulating fetal nucleic acid in pregnant women obtained from a simple blood draw from the mother. By directly testing fetal DNA, the company may provide more fundamental and reliable diagnostic information earlier in the pregnancy. With the limited exception of Rhesus D testing performed in Europe on a real-time PCR platform, the exclusively licensed patent rights from Isis enable Sequenom's development and performance of tests, including gender determination tests for social and lifestyle purposes, on any relevant platform, including the Sequenom MassARRAY system.
Sequenom holds exclusive license rights to the patent in Austria, Belgium, Denmark, Finland, France, Germany, Great Britain, Ireland, Italy, Luxembourg, Monaco, the Netherlands, Portugal, Spain, Sweden and Switzerland, as well as rights to the patent's foreign counterparts in the United States, Canada, Japan, and Australia.