Earlier this month, the Supreme Court heard arguments in Mayo v Prometheus. As we noted in an earlier blog post, the issue before the Court is whether Prometheus Labs should be allowed to patent a correlation between drug metabolite levels and patient health under 35 U.S.C. §101.The Facts of the Case
The patents at issue concern tests for the effectiveness of thiopurines, drugs that are routinely used to treat a variety of gastrointestinal disorders. Their effect depends on how they are metabolized. The patents cover the process for determining whether a given dose produces concentrations of metabolites within a recommended range and allows doctors to adjust it accordingly.
Prometheus sells a test based on its patents to hospitals and clinics. In 2004, Mayo developed a competing test, featuring different recommended levels of metabolites. Citing patent infringement, Prometheus sued.
The Legal Arguments
As we mentioned last week, patent law does not allow patents of nature and abstract ideas. Rather, patents can be issued for a machine, article of manufacture, composition of matter, or process. In many cases, it is easy to determine if an invention fits into one of these categories. However, when it comes to technology, the analysis is often more complicated.
Future medical advances, Prometheus argued in its brief, will likely concern “uniquely targeted treatments” based on an individual’s genetic makeup. In order to foster development, these discoveries should be afforded patent protection.
However, as Justice Stephen G. Breyer put it: “What has to be added to a law of nature to make it a patentable process?”
On this question, Mayo’s lawyers contend Prometheus has patented a mere observation of the body’s natural workings. The federal government seems to agree, claiming that “you can’t get a patent by tacking a mental step onto an utterly conventional process for administering drugs and testing their effects.”
The Implications
Many predict that the Supreme Court’s decision will have broad implications on the future of personalized medicine. It will also likely impact research firms and drug makers, particularly those that are studying genetic correlations that might predict a drug’s efficacy or determine the cause of a disease.
As evidenced by the questioning by the Court, there is likely no easy test to determine the patentability of medical processes. It will be interesting to see what the Court decides when its decision is issued next spring.
Source: The Washington Post
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