DRUG research is in dark times, as pipelines dry up and development budgets are cut. But one shaft of light pierces the gloom. “Personalised medicine” promises to craft drugs for individuals. Genetic tests will identify those who will benefit from specific medicines. Treatment will be more effective; waste will drop. Personalised medicine has sparked excitement among drugmakers, doctors, hospitals and patients. It has also sparked a legal brawl.
On December 7th America’s Supreme Court heard arguments in Mayo v Prometheus. The suit, despite a name that suggests an ancient liver sandwich, may be crucial for biotechnology firms. America is the world’s hub for drug research. By definition, personalised medicine includes the study of genetic mutations and other personal characteristics. However, American law bars patents of nature and abstract ideas. The question is which discoveries in personalised medicine may be patented.
Prometheus is part of a series of suits over biotech patents. Courts have been active because Congress has not. A recent patent reform provided little clarity. Congress merely ordered a study of genetic testing. Judges have been bolder: in July a federal court ruled that genes could be patented. On December 7th the suit’s losers appealed to the Supreme Court.
But Prometheus may have greater practical import, says Hans Sauer of the Biotechnology Industry Organisation (BIO), a trade group. Firms are studying genetic correlations that might predict a drug’s efficacy or determine the cause of a disease. Prometheus may determine whether methods using such correlations may be patented.