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EPO – NGAL patents:
1: The NGAL Cut-off.
BioPorto’s crucial key patent was issued by EPO (The European Patent Organisation) in 2009. Covering measurement of a pre-determined cut-off value. A cutoff-value is important in order to detect whether the patient is developing AKI or not, or if the patient is so severly injured that dialysis is required. (First cutoff is over 250 Ng/ml and second over 1000 Ng/ml)
Opposition against the patent was made at an early stage by CCH (Cincinatti Childrens Hospital)- backed by Abbott and Alere (formerly known as Inverness), but the patent was maintaned unchanged.
After the patent was granted, CCH tried another venture and filed a complaint at the Danish Maritime and Trade Court, but the case was later withdrawn by CCH.
In August 2010 Getica, Abbott, Alere and Phadia filed an opposition against the patent at the EPO Opposition Division.
Oral proceedings will take place in the beginning of February 2012.
[08-02-2012] EPO OD ruling decides that claim 1 is not applicable.
Early 2011 Instrumentations Laboratory bought the first non exclusive license to gain access to the patent.
In 2011 BioPorto’s patent was also issued in Japan and India. The application is under consideration by USPTO and is pending in Canada and China.
EPO has made a notice to BioPorto late 2011, that they intend to grant Bioporto a European patent.
The patent covers the use of NGAL as a marker for detecting internal injuries up til 6 hours after an injury has occured. (The patent was granted, but an opposition was filed in september 2012)
Originally the patent was intended to cover a “Triage kit”, which it does, but does in fact now also cover Aleres intended use of their Triagemachine (they only have the name in common), as the patent covers all use of NGAL as a marker of an injury caused by a physical injury. Its hard to exclude this group from the emergency rooms.
3: NGAL Ratio:
Application for the use of a cross measurement of NGAL in both urine, and blood/plasma. Potentially way more precise and secure than just testing in one of the fluids.
Application to “frame in” the other applications.
Application to use a value UNDER a determined NGAL level as a cut-off for when there is NO injury to the kidney.
Unlikely that the patent will be granted, but the application serve as a barrier to other applications novelty and inventive steps.
[11/02/2013 update: Oral proceedings regarding inventive steps are scheduled at EPO. So patent might be grated after all]
5: NGAL Individual Molucular Forms:
14/10/2013: Intention to grant.
USPTO – NGAL patents:
1: The NGAL Cut-off. (app:number: 11/722,025)
2: NGAL Triage/Trauma. (app:number: 12/302,931)
3: NGAL Ration. (app:number: 12/531,986) (Approved for issue)
4: NGAL Exclusion. (app:number: 12/375,585)
1: The APC-PCI Patent. (EPO) (Intention to grant)
2: USPTO: (app:number: 12/517,085) (Patent granted)
Patent for the use of APC-PCI to determine whether a patient would benefit from an APC treatment in case of severe sepsis. (Patent issued in US and soon in EU)