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FDA and USPTO: Joint Killers

In my posts Update: Patents Kill: Compulsory Licenses and Genzyme’s Life Saving Drug and Patents Kill: Compulsory Licenses and Genzyme’s Life Saving Drug, I noted that, due to the monopoly granted by patent, people suffering from the genetic illness Fabry disease are unable to obtain the drug Fabrazyme, which is in short supply because the sole, monopolistic manufacturer, Genzyme, can’t make enough quickly enough–and no one else is permitted to make it due to the patent.

In the latest round of this saga, lawyer Allen Black, representing two of the victims pro bono, filed a petition for “march-in” rights with the Secretary of the Department of Health and Human Services, requesting that the DHHS provide a license in order to manufacture Fabrazyme. Sadly, the NIH denied the march-in request in December. But, as Black explained in an email,

the NIH denied the petitioners march-in request stating that they did not believe that allowing other manufacturers to make the patented product would remedy the shortage because administrative laws of its sister agency (the FDA) make it impossible to timely manufacture the drug.

Or, as Black’s press release notes, “the NIH stated that the FDA regulations prevented a manufacturer from entering the market in time to remedy the current shortage.”

So: government issued patent monopolies cause a shortage. The government that grants these odious monopolies has statutory authority to issue compulsory licenses–i.e., to partially weaken the monopoly privilege they previously granted. But they choose not to here, because the FDA’s regulations would prevent any competitors from using the license in time to meet the shortage. This resembles the law school hypos about cause-in-fact (sometimes called “but-for” causation): if A and B both shoot C at the same time, A can say he is not a cause-in-fact of C’s death since even if he had not pulled the trigger, B’s bullet would have killed C. Of course, B can make the same argument. If such legal legerdemain is permitted, both A and C could avoid responsibility by pointing the blame at each other. The proper approach is to consider A and B to both be C’s murderer. And so it is here: the combined effect of the FDA and patent office is killing people–in other words, the American central state.


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To the extent possible under law, Stephan Kinsella has waived all copyright and related or neighboring rights to C4SIF. This work is published from: United States. In the event the CC0 license is unenforceable a  Creative Commons License Creative Commons Attribution 3.0 License is hereby granted.