Announcement no. 23

BioPorto’s patent rights strengthened for NGAL, the new biomarker of renal disorders

Following BioPorto’s announcement no. 22 earlier today, the Company can now give further details of the significance of the decision of the European Patent Office (EPO) which was communicated to Cincinnati Children’s Hospital (CCH) at the oral proceedings concerning the latter’s patent application on the use of NGAL as a marker of renal injury by measurement in urine. The present announcement is based on a thorough evaluation of EPO’s decision undertaken by the Company’s scientific staff in conjunction with the Company’s patent advisers from Høiberg A/S.

BioPorto’s patent rights are strengthened by the published decision. This is because of the overriding consideration that with the substantially narrowed claims, CCH can only be granted a patent relating to the diagnosis of renal injury due solely to ischemia, which is viewed as having neither practical application nor a realistic possibility of commercial exploitation. It is also BioPorto’s view that the launch of an NGAL test for the diagnosis of renal injury in relevant patient groups remains unfeasible without obtaining a license to BioPorto’s patent rights.

The main claim of CCH’s patent application which EPO has approved for issue reads as follows:

“A method for detection of a renal tubular cell injury which is an ischemic renal injury in a human patient, comprising the steps of:

1) contacting a urine sample obtained from a human patient with an antibody for a biomarker consisting of NGAL, appearing within the first 24 hours of the onset of the ischemic renal injury, to allow formation of a complex of the antibody and NGAL; and

2) detecting the antibody-NGAL complex.”

This is a substantial narrowing of the claim in relation to the claims that were previously applied for, in that the patent now only covers the diagnosis of ischemic renal injury. The previous claims were all rejected on one or more of the following grounds:

1.that new matter had been added for which there was no basis in the description;

2.that the priority claimed was invalid for the presented claims;

3.that the presented claims lacked novelty over previous disclosures.

BioPorto’s NGAL cutoff patent concerns the measurement of NGAL as a diagnostic marker of renal disorders. The patent differs from other NGAL patent applications by establishing limiting values (cutoffs) of the NGAL concentration that are necessary to discriminate between the higher levels of NGAL that indicate renal injury and the lower levels that can be due to other conditions. CCH’s patent concerns the diagnosis of just one of these possible types of renal injury, namely ischemic injury. It is BioPorto’s assessment that this patent will not find practical application, as ischemic renal injury cannot be distinguished by means of NGAL measurements from renal injuries due to other causes. Nor, as a natural consequence of this, can the CCH patent be expected to have commercial applicability.

At the same time, CCH’s patent will not be able to block the use of NGAL measurement for the diagnosis of renal injury in general, which also means that BioPorto’s existing commercial products, the NGAL ELISA tests, will not be affected by the new patent, the same consideration being expected to apply to future diagnostic NGAL tests. Equally, it is not expected that other diagnostic companies will be subject to license payments to CCH for the NGAL patent which has now been approved for issue in Europe.

The present clarification of the NGAL patent situation in Europe is therefore positive for BioPorto, since the claim set for which CCH has obtained approval at the proceedings was submitted as the Main Request, which means that the decision is not subject to appeal. The clearer situation, combined with our assessment that the CCH patent effectively lacks practical and commercial applicability, signifies a strengthening of BioPorto’s position in relation to IP rights to the use of NGAL as the new biomarker for renal disorders. This strengthening will naturally have an influence on the ongoing licensing negotiations concerning access to BioPorto’s NGAL cutoff patents.

Further details:

Thea Olesen, Managing Director

Christina Tønnesen, Investor Relations

Tel.: +45 4529 0000

E-mail:investor@bioporto.com