PROMETHEUS
The US Supreme Court’s decision to invalidate patents for two blood-monitoring patents could have huge implications for the future of personalised medicine. WIPR investigates.
In classical mythology, Prometheus stole fi re from the Gods and gave it to humans. T ere was no patent protection and he didn’t charge a licensing fee. Indeed, if anyone paid for the giſt , it was Prometheus himself: strapped to a rock and tortured by a liver-eating eagle as punishment for his theſt (or, depending on which way you look at it, for his selfl ess commitment to sharing the fruits of innovation).
Prometheus Laboratories, a therapeutics and diagnostics company owned by multinational Nestle, is no selfl ess hero, but some would nonetheless say that the US Supreme Court’s recent decision treats it, if not quite with liver- eating harshness, then very harshly indeed. But as is the way with patent cases at the Supreme Court, that’s far from the only view.
Prometheus owned two patents for blood- monitoring medical tests that could help with deciding the correct dosage of a drug to give to a particular patient. T e tests helped doctors work out the correct level of thiopurine, a drug used to treat auto-immune disorders such as Crohn’s disease, by monitoring a patient’s blood. Such
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treatment is an example of so-called personalised medicine, where treatment regimens are adjusted on a holistic basis to the specifi c needs of an individual patient.
Until 2004, Mayo Clinic was a customer of Prometheus, paying to use the latter’s tests. T en, it announced it would use its own, improved version of the test, at which point Prometheus sued for patent infringement.
T e district court initially ruled in Mayo’s favour, but the US Court of Appeals for the Federal Circuit overturned that decision, fi nding that the patent constituted a transformative process (one of the criteria the Supreme Court had declared patent-eligible in its Bilski decision), and was not merely using a natural phenomenon. T e patents in question advanced method claims for “optimizing therapeutic effi cacy” by (in one) “administering a drug” and (in both) “determining the level” of antimetabolites in order to assess the level of treatment.
T e Supreme Court ruled on March 20 that Prometheus’s patents were invalid. In Justice Breyer’s opinion, written on behalf of a
World Intellectual Property Review March/April 2012 17
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