Patenting genes and diagnostics

As biotechnology patents continue to grow in importance, uncertainty remains on both sides of the Atlantic as to exactly what is patentable. Simon O’Brien and David Gass take a look.

A market is developing for the application of biomarker assays as clinical diagnostics. Moreover, at a time when the number of prospective blockbuster drugs is dwindling, pharmaceutical companies are investing heavily in the potential benefits of targeted medicine—such as delivering specific treatments to specific patient populations whose genetic profile may make them more receptive to particular treatments.

While there has been a pronounced downturn in the number of biotechnology patent applications in industrialised countries since 2002, possibly due to the declining number of new human genes to be identified since the Human Genome Project, patent filings for cancer diagnostics have apparently shown very little decline since 2001. Indeed, patent activity in the biotechnology area is becoming increasingly focused on diagnostic uses of genetic information.

One of the most important and sweeping challenges with biomarker-based therapies and diagnostics is how to develop intellectual property policies that will bring opportunity and entrepreneurship in balance with meeting unmet market needs and clinical value.