BioPorto

Legal Proceedings Report • Aug 30, 2011

BioPorto's NGAL cut-off patent, issued in Europe, is being assessed in an
opinions case before the European Patent Office (EPO). A provisional opinion of
this case by the EPO is now available, which provisionally concedes to the
opponents that the patent may have been issued too broadly or on an incorrect
basis. The EPO's opinion has been evaluated in detail by Høiberg A/S,
BioPorto's patent consultant, and Høiberg's conclusion is that there are
several ways of mitigating the objections submitted and those oral proceedings
are still to take place. Therefore after the oral proceedings on February 7 and
8, 2012, BioPorto expects have a fully valid, relevantly adequate NGAL cut-off
patent in Europe. Below are the main points of Høiberg's/BioPorto's assessment
and the EPO's remarks.

-- According to the provisional opinion from the EPO, oral proceedings have
not been deemed necessary. This is not unusual; all that is required is for
BioPorto to make known that oral proceedings are still desired. This is a
request that the EPO has to comply with as a matter of course.

-- Enlargement (Article 123(2)):
-- The EPO's opinion is that the claims issued have an enlarged scope of
protection in relation to the application as it was submitted; in other
words: claim 1 is now more broadly formulated than the text of the
application warranted. This is due to the phrase “bodily fluids”.
-- This objection can be mitigated by replacing “bodily fluids” with
“urine, serum and plasma”.

-- Insufficient description (Article 83)
-- The EPO's opinion is that there is insufficient description in the
patent to perform the method as specified in claim 1, which emphasizes
that no time is stated for when the measurements are to be taken.
-- What is crucial to the assay is precisely that no time is to be
specified for the measurement, because the cut-off is central to the
diagnostic method.

-- Novelty (Article 54):
-- The EPO recognizes that the claims are new.

-- Inventive step (Article 56)
-- The EPO's opinion is that there is no inventive step in respect of the
claims because the 250 ng/mL value is regarded as being arbitrarily
determined.
-- The 250 ng/mL value is not an arbitrary value; this can be documented by
presenting additional data.

Thus, BioPorto and Høiberg expect to be able to mitigate the opinions put
forward during the provisional opinion of the patent before the EPO.

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