BioPorto’s NGAL cut-off patent: assessment of the decision in the opposition case

BioPorto  A/S 

23.05.2012 11:54

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With reference to BioPorto's Announcement no. 7, issued today, BioPorto's
patent attorney Susanne Høiberg has now had the opportunity to review the
existing grounds for the decision of the European Patent Office (EPO) to reject
BioPorto's NGAL cut-off patent, which has been issued in Europe. Høiberg
concludes that the decision is erroneous and therefore expects that there will
continue to be a fully valid and appropriately applicable NGAL cut-off patent
in Europe after a future appeal. The EPO's comments on the decision and
Høibjerg's/BioPorto's assessment of them are found in the main below. 



The decision specifying that the patent is to be withdrawn is based on an
assessment by the EPO's Opposition Division that the patent is insufficiently
described (Art. 83 of the EPC). The EPO's Opposition Division justifies this by
also stating that: 



  1. 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 Opposition Division is of the opinion 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.


This argument is still based on an erroneous calculation of the specificity,
which results in the diagnosis of much too large a share of patients who do not
have a renal affection as having a renal affection. This same calculation error
was found in the Opposition Division's preliminary and non-binding opinion and
has not been changed, despite BioPorto's information stating that this error
leads to a completely erroneous result. 



  1. It has not been rendered probable that the method can diagnose all types of
     renal affection; it has not been rendered probable that chronic kidney
     injury, for instance, can be diagnosed using this method.


It is not the purpose of the invention to differentiate between different types
of renal affection as the decision implies. The method is capable of diagnosing
a renal affection, regardless of the type of renal affection, with sufficient
probability for a diagnostic assay. 



On the other hand, the Opposition Division finds that 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;
  -- not requiring the method used for carrying out an assay of the NGAL
     concentration to be specified in the claim.



The decision by the Opposition Division has been suspended until a final
decision is issued in the appeal, which is being filed with the EPO's Technical
Board of Appeal. As a result, the patent is still in force due to the appeal
and, in principle, the patent can be enforced in court. A likely time frame for
the appeal is two years. 



BioPorto is appealing the decision today and will submit material in the case
in late September 2012. 


         For further information, please contact:
         Thea Olesen, CEO
         Frank Harder, CFO
         Tel. +45 4529 0000, e-mail investor@bioporto.com
News Source: NASDAQ OMX



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