The Congressional Research Service (CRS) recently released a report titled “Gene Patents: A Brief Overview of Intellectual Property Issues.” The report contrasts the 50,000 gene-related patents issued by the U.S. Patent and Trademark Office with the U.S. Supreme Court’s determination in Association for Molecular Pathology v. Myriad Genetics, Inc. that human genes, to the extent they are just “products of nature” and do not involve chemical modifications, are not patent eligible. According to the authors, this decision could “make it difficult for inventors to protect early, gene-related discoveries through the patent system.” They also discuss the ethical issues involved and suggest that patients do not appear unable to use existing genetic tests due to patent protections.
Considering economic issues, the authors contend that patent protection is critical to the pharmaceutical and biotechnology sectors given the ease of chemically analyzing pills and reproducing them. And they discuss research showing that scientists have ways to work around or with patents via licensing to continue their research. They conclude that the role of patents in innovation is significant and state that “with the decision in Myriad, it remains to be seen what the effect may be on research and development in this area and on innovation in the health care arena.”