Genzyme's manufacturing woes with both its Cerezyme and Fabrazyme therapies have been well documented at their Allston facility which is currently under an FDA consent decree. Now, 3 patients with Fabry's disease are raising the stakes. They've asked the Department of Health and Human Services to revoke Genzyme's right to use patents to produce Fabrazyme as described in the Pharmalot blog.
The patients hope that by overriding the patents -- by exercising "march in" rights -- another Company can be attracted to produce the needed drug - while Genzyme is getting its act together and while Shire is able to get its drug, Replagel, on the US market. Three "march in" attempts have failed in the past with other therapeutics - but these patients lawyers claim the circumstances are different as these patients are actually being harmed while awaiting their therapy.
The circumstance of this case seem to be very similar to what was anticipated by Bayh-Dole when the concept of "march in" was adopted as part of the law. This should be very interesting. One also has to think that Sanofi shareholders and management would be watching this situation carefully as well.
Posted by Bruce Lehr August 4th 2010.