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CCHs European NGAL urine patent revoked


49650 Camel 9/12 2011 15:44
Oversigt

CCHs European NGAL urine patent revoked after a decision in the opposition case

13:05


BioPorto A/S
Company Announcement

CCHs European NGAL urine patent revoked after a decision in the opposition case

In December 2008, an NGAL patent was issued to Cincinnati Childrens Hospital
(CCH), against which BioPorto filed an opposition in February 2010. The
opposition case has developed in a satisfactory manor, in that a decision was
reached yesterday by the European Patent Office (EPO) in Munich. The patent has
been revoked as the invention is not patentable. Abbott has a license to CCHs
NGAL urine patent, to which the case pertained.

The patent in question, number EP1616184, A method and kit for detecting the
early onset of renal tubular cell injury, was issued in 2008 with the
following principal claim:



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.



As a result of the EPO decision, the patent has been revoked and the decision
is expected to be available in writing within one month. After this, the
decision can be appealed by CCH.



The kidney biomarker NGAL

Every year about 13 million people are struck by acute kidney injury worldwide,
of whom about 4 million die. Nevertheless, there has been no real progress in
methods of diagnosing kidney injury over the last half century. Existing
methods, such as serum creatinine determination, only signal kidney failure
24-72 hours after the injury has taken place. In contrast, NGAL rises to
diagnostic levels within a few hours of kidney injury and thus enables the
physician to make vital clinical decisions before the damage progresses to
potentially fatal renal shutdown. In addition to helping the patient,
cost-benefit analyses show that implementing NGAL testing will contribute to
reducing hospital costs in the management of kidney injury and its
consequences.

2012 bliver så grande for bioporto.




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