Patents in Biopharma

Genes for production of therapeutic proteins such as hormones (insulin, growth hormone, and erythropoietin) have made treatment of medical conditions easier. Gene sequences can be used in diagnostic genetic testing for several inherited disorders. Patents have played a significant role in the nascent biotech industry helping companies recover cost of research and development (R&D) and sustain future efforts. With the patents of many of the first-generation products having expired or on the verge of expiry, several nations are focused on patenting and marketing of biosimilars and making healthcare affordable to all. Gene patents and patents for diagnostics however is becoming increasingly difficult due to reasons that are technical (whether gene sequences, or correlations between a marker and a disease condition revealed by the test is indeed patentable subject matter) and ethical (whether premium rates charged due to exclusive licensing puts testing out of the reach of the common man). Proponents of the patent system insist that a strong patent policy is required as without it innovators would not be able to sustain R&D activities. Critics however are of the opinion that patents make healthcare expensive and unaffordable to most citizens.