Date: Sat, 29 Jul 2006 07:51:32 -0700 From: Michael Perelman <[EMAIL PROTECTED]> Hari, are you saying that NO was patented? Tell me more!!!
REPLY Indeed, it is amazing is it not? A naturally occuring chemical is 'patented'. The legal aspect of this (apparently - I am not a lawyer) was argued that the 'delivery system' of the iNO - & the intent to treat infants with PPHN - was what really counted. The bottom line remained that it was the gas, and the rest was a manouevre. The US courts upheld this. There was a rival company to the patent holder, who lsot big-time on this. The Canadians were simply too dim to be watching this, & the first US company quickly filed a Canadian patent. By the time interested clinicians realised what was happening, it was almost too late - since there is a limited time-span to register a disagreement. The Canadians had a potential exit clause - IF they could prove a notion known as 'prior art'. However 'prior art' could not be shown in an exhaustive search of the medical literature. Of course that is hardly surpising, since all the interest in iNO coincided with one peer-reviewed paper. Attempts to invoke EEC precedent in Canada foundered on the US case-law. There is an awful lot of complicity about the process, between the regulatory agencies in Canada & the big companies. In my own view at any rate. It is unclear what is happening now regarding the affect of this on practice. Since meta-analysis confirms the very useful role of iNO in PPHN - I think if hospital managers crimp its use, this is going to result in malpractice suits (rightly - if it is PPHN as the diagnosis). Opening the envelope of iNO to prematures is an interesting twist to all this. Hari Kumar
