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BioPorto A/S Announces Further Details on NGAL Cut-Off Patent Case


Wednesday, 23 May 2012 05:54am EDT 

BioPorto A/S announced that with referance to the Company's announcement issued on May 23, 2012, the Company's patent attorney Susanne Hoiberg has reviewed the grounds for the decision of the European Patent Office (EPO) to reject the Company's NGAL cut-off patent, which has been issued in Europe. She has concluded that the decision is erroneous and expects that it will continue to be a fully valid and appropriately applicable NGAL cut-off patent in Europe after a future appeal. EPO’s Opposition Division (Division) assessed that the patent is insufficiently described and justified this by stating that the cut-off threshold value of 250 ng/mL of NGAL, which is a central element in the method, is not sufficiently substantiated and is set so low that patients without renal affection will be classified as having a renal affection. The Division claims that there is no need to discuss statistics in detail and refers to passages in the patent itself stating that the cut-off threshold value is set too low. It has not been rendered probable that the method can diagnose all types of renal affection; it has not been rendered probable that certain injuries can be diagnosed using the method. The Division finds there is sufficient basis in the patent for not having to specify a certain point in time for sample-taking in relation to when the initiation of insult has occurred. The decision by the Division has been suspended until a final decision is issued. 

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