The NGAL Cut-off patent issued in China

A new formidable market of +1,3 billion inhabitants  is now open to BioPorto via the Chinese (PRC) issuance of the crucial cut-off patent (250 ng/ml – lest you’ve forgotten) – The patent protects blockbustercandidate The NGAL Test, the Test now rules supreme in China –  India, Europe (the EPO-area)- and South Africa South, Korea and, and, and…

But even though India and other subcontinenents/areas/countries are important – China is, in this respect, the jewel in the crown

There is only truly remaning  “Test-of-undisputed-supremacy” before Victory can be declared – and that is the Chinese Authorities pending decision on reimbursement of the test

The Announcement.

Noteworthy also, with the Patent in hand  –  BioPorto can now at will now hinder Abbott’s/Alere’s market access, should they decide to take that path

Oh – and then there is the pending Patent Applications in The US (USPTO) and Canada – but otherwise World Domination 🙂

An interesting aspect of the Patent is that IF Abbott & Friends decide to appeal – they are not appealing against BioPorto – but against the Chinese Government – I have no idea of the likelyhood of success in such a venture – but I wouldn’t bet on Abbotts chances of winning – would you ?

Bear in mind that China today have a rapid expanding middle class – with an estimated 200 million Chinese with a living standard close to the Europeans – AND a vast number of ultramodern hospitals to service their needs…

Previously BioPorto has written the following – well actually on december 5th 2012

Through its Chinese partners BioPorto achieved two registrations in China….In China, the health authorities’ recognition of the test by registering and subsequently determining reimbursement for the test is crucial for doctors’ use of the test. The application is pending and BioPorto expect higher sales when the grant is obtained.

this is stated in the Q3 report

Reimbursement

In many different countries, central clinical validation and healthcare-economic calculations are decisive in determining whether a diagnostic immunoassay is to be recommended and deemed eligible for reimbursement. Depending on the common practice of the individual countries, reimbursement is available through health insurance or the public healthcare system. In China, the healthcare authority’s recognition of an immunoassay for registration and the subsequent determination of reimbursement for the immunoassay are crucial for doctors’ use of the immunoassay. As Abbott’s NGAL immunoassay was registered in China before BioPorto’s NGAL Test, Abbott’s immunoassay was expected to have been granted reimbursement this year. The granting of reimbursement for another NGAL immunoassay will make it easier for BioPorto to also be granted reimbursement for The NGAL Test. However, reimbursement has not yet been granted to Abbott’s immunoassay or to The NGAL Test, but BioPorto’s application is still being processed in China. BioPorto expects higher sales once reimbursement has been granted.

earlier this year more detailed info on the registration and reimbursement process was given:

The first of BioPorto’s distribution partners in China has obtained registration certification for the NGAL test through the Chinese health authorities (the State Food and Drug Administration, SFDA).This certification covers the use of the NGAL test for diagnosing acute kidney injury and is valid in every province of China.

BioPorto’s partner has taken the next step of initiating the applications required for determining the public reimbursement for the use of the test.The procedure for the processing of reimbursement applications differs from one province to another and is initially being started in Beijing and Shanghai.The first agreements concerning public reimbursement for the use of the NGAL test are expected to be obtained by the end of the year.

BioPorto’s other partners in China are also expected to obtain registration certification in 2012.