BioPorto

Legal Proceedings Report • May 23, 2013

With reference to announcement no. 8, 2012, the European Patent Office (EPO)
has set the date of processing of the appeal concerning rejection of BioPorto’s
NGAL cutoff patent, issued in Europe. The case is set at the EPO Boards of
Appeal on August 27, 2013.

The decision specifying that the patent is to be withdrawn is based on an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.

Additional material has been submitted and the EPO Boards of Appeal can issue a
preliminary and non-binding opinion prior to the proceedings. If so, BioPorto
will evaluate the preliminary opinion when it has been issued.

For further information, please contact:

Christina Thomsen, Investor Relations

Thea Olesen, CEO

Tel. +45 4529 0000, e-mail investor@bioporto.com