By Hans Sauer, Deputy General Counsel for Intellectual Property, Biotechnology Industry Organization
We are surprised and disappointed in the Court’s decision, which disregarded the considered judgment of the Executive Branch experts and numerous amici such as BIO, who warned about the unintended consequences of attempting to use patent eligibility as a basis to strike down these patents for biomarker-based diagnostic methods.
While we are still analyzing the opinion, we are concerned that it introduces new and confusing concepts into the traditional body of patent law, which patent examiners and lower courts will struggle to consistently and rationally implement. While the opinion’s lack of guidance may limit its practical impact, we are troubled that the Court’s opinion fails to appropriately recognize the importance of personalized medicine, and of the research and investment incentives needed to develop new individualized therapies for untreated diseases.
BIO will work with the Administration and the U.S. Patent and Trademark Office to ensure that the future application of this opinion does not irrationally restrict the ability of innovators to protect inventions that lead to cures, medical breakthroughs, and other technologies that make our lives and our environment cleaner, safer and healthier.