A GEN poll reveals that people mostly believe that the U.S. can develop a system to protect innovator diagnostic firms as well as safeguard those offering confirming tests against patent infringement. Some two-thirds of respondents (66.7%) expressed such confidence, while the remainder (33.3%) was undecided, and no respondents disagreed.
The U.S. Patent & Trademark Office (USPTO) faces a June 16 deadline for submitting to Congress a study on “effective ways to provide independent, confirming genetic diagnostic test activity where gene patents and exclusive licensing for primary genetic diagnostic tests exist.” USPTO is expected to take its first step toward such recommendations in mid-January, when it is to announce dates and places for hearings on confirming genetic diagnostic tests. Advocates for such testing say the current system based on patent eligibility drives up costs, limits patient options, reduces innovation, and harms medical practice. Diagnostic developers counter that patent eligibility provides the financial incentives that allow them to recoup the costs of developing the tests