When patents kill: Genzyme's patent-protected, life-saving drug
Should intellectual property protect the rights of a pharmaceutical company who can't produce enough of a key medication?
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Here’s Masnick’s post:Skip to next paragraph
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from the patents-costing-lives dept
Earlier this year, we wrote about the situation with a petition to the National Institute of Health (NIH) to let other companies produce Fabrazyme, a drug that treats Fabry disease. Fabry disease is an enzyme deficiency that can create very serious problems in those who have it — including kidney failure and heart attacks. Genzyme holds the patent on Fabrazyme, but has a problem: it can’t produce enough of the drug. That means people die. A group of Fabry patients petitioned the NIH to see if other companies could be allowed to produce just a little more Fabrazyme. They didn’t ask to break the patent. All they wanted was to let others make the drug, and pay Genzyme a royalty. On top of this, it’s worth noting that the key research for the development for Fabrazyme wasn’t actually done by Genzyme, but was done by the Mount Sinai School of Medicine and was financed with taxpayer money from the NIH.
At the time, we doubted the petition would be approved — and indeed, the NIH has rejected the petition. An opening was left for an appeal, if another petition is filed by a company that wants to make Fabrazyme, rather than the patients (you know, the folks actually suffering). As the statement of Robert Weissman from Public Citizen makes clear, this is a ridiculous situation:
Why is NIH resorting to legal gymnastics to avoid exercising its legal authority to ensure an adequate supply of an important medicine? NIH agrees Genzyme is failing to produce an adequate supply of the important medicine Fabrazyme. It is plain that removing the patent monopoly on the drug is a necessary condition to enabling other potential manufacturers to enter the market. Yet NIH chooses to deny a request to issue open licenses for the Fabrazyme patents — a request for which it has undisputed legal authority — on the Alice-in-Wonderland, self-justifying grounds that there are as yet no competing suppliers. Of course there are no competing suppliers — why would any firm try to enter a market it believed closed by a patent monopoly?
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