Patenting Laws of NatureEffect on Cardiovascular Innovation
JAMA Cardiol. 2018;3(11):1031-1032. doi:10.1001/jamacardio.2018.3365
In June 2018, 2 important legal decisions were announced on the patenting of innovative procedures used in the management of adult and pediatric cardiovascular disease. Patents were granted in both circumstances, only later to be invalidated by the lower federal courts. These cases follow on the US Supreme Court decision in Association of Molecular Pathology v Myriad Genetics, Inc,1 where the Supreme Court held that methods to diagnose cancer propensity by identifying naturally occurring mutated DNA sequences are not patentable. Prior to Molecular Pathology v Myriad, the US Patent and Trademark Office (USPTO) allowed patents on such sequences. With cardiology on the cusp of developing new techniques in precision medicine, it is essential to innovation that we have clarification on what subject matter is and is not eligible for patent.
In Cleveland Clinic Foundation v True Health Diagnostics, LLC,2 a decision closely watched by both health care innovators and the patent bar, the issue was whether a diagnostic method used to detect myeloperoxidase levels in blood as an indicator of vascular inflammation predictive of cardiovascular disease would be eligible for patent protection. The Cleveland Clinic successfully obtained a patent on this technique, and when True Health Diagnostics developed its own test, Cleveland Clinic sued for patent infringement. In response, True Health Diagnostics countered that Cleveland Clinic’s patents were invalid because the subject matter was not eligible for patent. The US Court of Appeals agreed with True Health Diagnostics and, applying Supreme Court precedent, reasoned that the diagnostic method was directed to a “law of nature” and did not contain an “inventive concept” that would transform the underlying science (natural existence of myeloperoxidase levels predicting cardiovascular disease) into a patentable invention.2 In June 2018, the Supreme Court denied further review of this case, leaving in place the appellate decision./.../
No comments:
Post a Comment