Position Statements

…This case concerns whether material derived from human genes — isolated DNA — is patentable subject matter under Section 101 of the Patent Act. Amicus believes that efforts to undermine DNA sequence patents in the United States endanger this future by pushing inventors away from molecular diagnostics technology. Without their continued investment, private industry will no longer be able to subpport the same breadth of expensive and complex research, development, and commercialization of these critical health care products. This will cause serious harm to the well-being of patients who would otherwise benefit from personalized medicine. In view of amicus’s role in the genetic diagnostic field, it has a unique perspective on and keen interest in the question presented.

…The Coalition submits that, in reviewing and reissuing the March 2014 Guidance, the Office can follow a few general signposts that will ensure proper deference to binding precedent without overextending such precedent to remove large swaths of previously eligible subject matter from the invaluable incentives of the patents system.