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Bioporto court case versus CCH, NGAL-test dispute

20033 stengård 25/9 2009 15:06

The role of CCH (Cincinnati Children's Hospital) in the ongoing struggle for improved renal-test that the whole world is crying out for - is indeed a shameful one...

As shareholder in evolving Danish diagnostic company BioPorto it is difficult to be unhappy with yesterday's message that CCH has finally decided to drop the completely unjustified lawsuit, filed at the Maritime & Commercial Court in Copenhagen Denmark earlier this year (march 4th 2009). The way now seems paved towards an issue of a patent from the EPO (European Patent Organization)

My normal viewpoint on this investment-blog is that of an active growth-orientated investor - with a steady gaze at the numbers - however this blog will deal primarily - (perhaps a little unusual) with some moral considerations around the lawsuit filed by CCH.

The story is briefly as follows, CCH has twice at the American Patent Organization (USPTO) been denied a patent for a test based on a biomarker (NGAL) that can detect AKI much earlier and also more precise than the conventional Serum Creatinine -test. As you are probably aware the conventional test is slow and inaccurate, so there is a strong need for a test that can address the serious problems arising from AKI. Through the EPO, CCH have obtained a largely commercially useless patent for measurement of Ischaemic renal injury. Not being satisfied with the patent they obtained - (after several denials and oral procedures at EPO), CCH decided, the very week that Bioporto was about to be granted the "real" patent for measurement of renal failures, to file a fully unjustified lawsuit in the Danish courts, thus delaying the patent, and complicating the license negotiations which were also at a very late stage. The documents can be found at EPO's homepage, under the application no. EP05820913

The very core of the matter is, that had CCH not actively sought to prohibit the patent (not only once - but twice !) - a fully workable NGAL-test would have been at the market, and many lives would probably have been saved.

If you want to read more on the subject of NGAL - I recommend this site:
Here you find substantial information about the possibilities and potential of NGAL

Yesterday CCH finally, after six and a half month of blocking gave up the legal proceeding in Copenhagen.

But before we applaud the CCH for having made the only right and decent decision, you should of course bear in mind - that CCH with their action in March, was in fact instrumental / primary reason for a test that could save thousands of life, was unnecessarily postponed, not only causing suffering to patients but also that the shareholders were experiencing financial difficulties and sending BioPorto into a survival struggle.

It is not only unreasonable, it is also distasteful that a hospital - taking the standpoint in the lawsuit that they HELP saving lives, i.e. the moral point of view against the evil capitalists and is "the good guys", for legal reasons, choose to use openly unfounded objections to the issuance of the patent?

Therefore CCH is in my opinion the indirect reason for a large number of people worldwide have died of the complications the non-test option for AKI (Acute Kidney Injury) has resulted in.

So, even though we, the shareholders of BioPorto are relieved now the case has been lifted, we must not forget the heart of the matter - namely, that patients not have received the right treatment in time. It is a major scandal in my view - that a hospital deliberately chooses to delay possible treatment of critically ill patients, CCH?s actions shows damned little respect for Hippocrates's oath...

In this context, we are not talking about 1-2-10 people have died of AKI partially due to late detection of kidney injury - but probably a significantly larger number (!!!!) alone since March 2009. Especially because it is now established without reasonable doubt through international research that you do not die WITH kidney damage - you are dying DUE TO kidney damage.

So, late at night, when the managers of CCH (and the companies behind the filings) say his/hers goodnight-prayers - they should remember the responsibilities that THEY PERSONALLY have for the unnecessary suffering of many families - who have members who have died unnecessarily of AKI recently.

This the moral outrage about the AKI-affected patients. Personally, I hope that one of the relatives of AKI-stricken - chooses to sue CCH (including the diagnostic companies behind CCH)- for willfully harming AKI- patients, thereby exhibiting the moral habitus in CCH and others.

Not because it helps the many children treated at CCH (I truly respect the work done at the Hospital for the children) - but more to get the companies behind the whole process to understand - that it is not without human cost to hundreds of patients that they (the companies) tried to even further maximize profits on their already billion-dollar earnings on test.

The only way to do it is to know they (companies) will lose prestige ...

We (BioPorto and the shareholders) could choose to say everything is now OK - and there is "no harm done" - but that is obviously not the case.

Besides the people who have lost fortunes in that may have been squeezed out by nervous banks, BioPorto has been plunged into a veritable battle for survival - and transfer to the "pink sheets" on the stock exchange.
This has in turn resulted in marginal liquidity in shares, no lending opportunities - and board and Management have had to spend a lot of time and resources to ensure BioPorto's survival, time that could have been used much more wisely benefitting the company and the surrounding community.

Because CCH and especially their "backing band of diagnostic companies" - in a fit of greed - chose to make a marginal reduction of their earnings more important than saving lives, BioPorto has now had time to develop a homogeneous test - which (with minor modifications) can be used by the most hospitals with a central laboratory. Where the potential of NGAL-test prior depended on good will of Abbott / Biosite good will - we now see the launching of a homogeneous test and I expect we will experience a growing demand from the large patient associations and interest groups across the world - who for the first time can see an opportunity to get a reasonably priced test asap

So the potential for BioPorto is not intact - it has become very much larger (even without an agreement with large producers of heterogenic test - although it will now probably come within the next months).

BECAUSE of the development in the homogeneous test BioPorto is no longer dependent on the whims of one or more corporate managers.

It ain't over till The Fat Lady Sings ... and BioPorto does not have a patent in hand yet - but although the entire opposition procedure at the EPO, was built on the action in the Maritime & Commercial Court - it is not impossible that CCH will try yet another ruse - possibly after the patent is issued - but it seems clear BioPorto that is much stronger after yesterday's surprising step down from CCH.