[Ip-health] NIH Denies Patient Bid To Break Genzyme Patent

Joana Ramos jdr at ramoslink.info
Tue Dec 7 07:35:34 PST 2010

Reported on Pharmalot today:


Despite an ongoing shortage of a much-needed med for Fabry’s disease, 
the National Institutes of Health has denied a bid by three patients to 
obtain a license that would allow them to produce a new treatment. The 
move comes as Genzyme, which makes Fabrazyme, continues to struggle with 
supplies after more than a year of severe manufacturing problems.


But the NIH has denied their request by explaining such a move would not 
address the problem in the short run, due to the length of time required 
to conduct the necessary clinical trials and receive FDA approval. The 
NIH also cited the fact that, since no manufacturer has previously 
requested a license, an open license will not be granted based on the 
patient request (Shire Pharmaceuticals recently withdrew its application 
with the FDA for its Replagal med while more clinical data is obtained).

At the same time, the NIH is keeping the door open by encouraging other 
drugmakers to request a license to produce a med and will allow a 
so-called march-in petition if Genzyme is unable to make good. “It is 
more than NIH has ever done, even though it really may just be lip 
service,” says Allen Black, the attorney for the patients. “Presumably, 
a qualified third party may still be able to get a license, although its 
unclear given the circumstances if anyone will even bother.”

Joana Ramos, MSW
Cancer Resources& Advocacy
Seattle WA USA

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