Fabry Patients Sue Genzyme Over Drug Shortage; After NIH Refuses To Allow Others To Make Fabrazyme

from the people-are-dying dept

One of the more horrifying stories of patents costing lives out there is the situation with Genzyme and Fabrazyme. As we detailed, not enough of the drug is being made allegedly due to manufacturing errors by Genzyme (for which it was fined $175 million by the FDA), and its causing serious health problems -- and even death -- to the sufferers of Fabry disease, who are caught in the middle of this. The patients asked the NIH to allow others to make the drug, via a "march-in" order, so that there would be enough supply, but the NIH refused, basically because it said that the patients (you know, the people actually suffering) couldn't make such a request. The end result, of course, is that lives remain at risk. Genzyme is apparently now rationing the drug, only giving 50% of the recommended dosage, despite a study suggesting that such reduced dosages are a problem:
Neither Genzyme nor Mt. Sinai has tested whether the reduced dosage is either safe or beneficial for treating Fabry disease. In fact, in November 2010, The European Medical Agency determined that the lowered dose of Fabrazyme resulted in patients having more strokes, heart attacks, renal disease and other symptoms including severe GI distress and pain and burning in their extremities (neuropathy). It also determined that the lowered dose actually accelerated the course of the disease in some patients. Europe recommended in October 2010 that all patients be given a full dose of Fabrazyme instead of the lowered dose. Genzyme rejected the European assessment and continued to provide only unapproved low doses to patients in the U.S.
The lawyer for some of those patients, Allen Black, alerts us to the news that his clients have now sued Genzyme and Mt. Sinai Medical School over the continuing shortages (pdf). Mt. Sinai is the actual patent holder, with an exclusive license to Genzyme. The patients are arguing for "compensation and punitive damages for lack of adequate treatment and Genzyme's failure to take adequate precautions including keeping a reserve inventory and providing second sources of manufacturing."

Part of the lawsuit is based on negligence claims -- and given the FDA fine, perhaps there's a basis for a negligence claim. The latter part of the case may be more interesting, however. I'm not sure how much of a chance it actually has, though I certainly sympathize with the plaintiffs. At a high level, it may be tough to show that Genzyme has any legal obligation to make enough of the drug (a moral obligation may be a different story). However, the lawyers make a very key point concerning patent law in making this legal argument: that the Bayh-Dole Act actually gives Genzyme a legal obligation.

The Bayh-Dole Act was designed to help universities better commercialize research in order to get those innovations out to market. For a variety of reasons, I've argued that the law has failed significantly in this regard, but these patients are picking up on a key part of Bayh-Dole, which is that the law was put in place to prevent patentees from denying citizens access to publicly funded inventions. It thus may require that certain standards be met when it comes to federally funded inventions -- which Fabrazyme certainly is. The law specifically says that it was put in place to "protect the public against nonuse or unreasonable use of inventions." And since the plaintiffs feel that this is the case here, they're arguing that they're now able to recover damages (though you'd have to imagine they'd prefer full doses). If that argument succeeds, it could lead to a very interesting series of follow-up cases concerning other federally-funded inventions.

Filed Under: bayh-dole, fabrazyme, fabry disease, patents, rationing
Companies: genzyme, mt. sinai

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  1. icon
    Mike C. (profile), 17 Mar 2011 @ 10:22am

    Re: Re: Re:

    Since we're taking it in unrealistic directions, how about another one:

    Why couldn't Genzyme go back to Mt. Sinai get an expanded license allowing them to "sub-license" for limited production runs. In other words, Genzyme gets to offer the ability to other companies to manufacture the drug. They maintain their exclusivity since they're still in control of the overall license, they have the ability to revoke sub-licenses or define them in a way such that they expire.

    This is one of the biggest complaints some people have with how the patent system works for medicine. It's been reduced to what can make a profit, not what can help make people healthy. In fact, there is zero interest in making people well because then there would be no need to purchase expensive medicines.

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