Entia non sunt multiplicanda praeter necessitate.
William of Ockham (c. 1285-1349), author of the Ockham’s Razor principle.
PATENTS
Worldwide patents and patents pending
A US patent (US 11,541,192 B2) has been granted for claims covering the formulation of heparin and derivatives of heparin for delivery from a vibrating mesh nebuliser. More recently a continuation patent (US 12,083,268 B2) has been granted and covers the treatment of obstructive airways diseases including CF and NCFBE. In Europe, a patent (EP3478298), with similar claims to the above, is in very advanced stages of examination at the EPO.
This Intellectual Property and further applications under consideration deriving from worldwide application (WO2018007796) reflects a broad range of protections available for inhaled heparin. This worldwide application is being taken through the PCT process to gain worldwide patent coverage.
Orphan drug status
In 2006, the EMA granted orphan drug status (EU/3/06/371) to Ockham Biotech for heparin as an inhaled therapy for lung disease in patients with cystic fibrosis.
Orphan drug status has also been granted by the FDA.