Today, the European Patent Office (EPO) has decided that BioPorto's NGAL cutoff patent no. EP1831699 does not meet the requirements for adequate description. The patent is thus ruled invalid.
In BioPorto’s assessment, the company still has a very strong patent portfolio.This includes a divisional European NGAL cutoff patent application pending before the EPO, which covers the same area and has the same priority date as the invalidated patent. The company will seek to improve the shortcomings which led to the invalidation. In addition, a number of the company’s other important patents have been issued (NGAL Exclusion, NGAL Ratio, NGAL Trauma and NGAL Forms patents), which in combination enables BioPorto to maintain a competitive advantage. BioPorto’s product, The NGAL Test ™, has been tested in the market and is already being used with the most common analyzers. BioPorto’s marketing access for the NGAL products is not expected to be affected by the outcome.
Peter Mørch Eriksen, CEO of BioPorto, comments: "We had hoped for a positive outcome, but we still have a robust IP portfolio to fall back on with other patents and applications. The decision gives us a little more work on IP matters, but does not raise any major concerns or modifications to our new strategy. "
Further information:
Peter Mørch Eriksen, CEO
Christina Thomsen, Investor Relations Manager
Tel. +45 45 29 00 00, e-mail investor@bioporto.com
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.
About BioPorto
BioPorto Diagnostics A/S is an in-vitro diagnostics company that provides healthcare professionals in clinical and research settings a range of diagnostic tests and antibodies. Our pioneering product portfolio includes assays for underserved disease states such as NGAL for acute kidney injury. We sell our products in more than 80 countries through diverse sales channels and partners. BioPorto has its headquarters in Copenhagen, Denmark and is listed on the NASDAQ OMX Copenhagen stock exchange.
