Beyond the Patented Genome: Protecting Discovery in the New Biology Estate Space

Intellectual property (IP) drives the pharmaceutical industry because making drugs is relatively cheap; discovering them, very expensive. IP protection is essential for any industry where the costs of innovation far exceed the costs of production. Figuring out what drug to make takes huge capital investment, but once the answer is known, it can be copied at relatively small marginal costs. Without IP incentives to drive the very high costs of drug discovery, no one could reasonably be expected to invest in the business for long. The traditional IP protection of pharmaceuticals is long-standing: the composition-of-matter patent, typically covering a particular genus of small molecule. Claims to particular species, methods of making and using the claimed compounds, and pharmaceuticals containing them, often round out the portfolio. Protection of therapeutic biologics has developed along similar lines. In general, protection of investments in the development of therapeutics has traditionally revolved around patent protection of the therapeutics themselves, the endpoints of discovery.