News at a Glance – Aug 2015

USPTO Updates Interim Guidance for Patents Based On Natural Phenomena. The United States Patent and Trademark Office (USPTO) has updated interim guidance regarding the interpretation of patents based on natural phenomena. The guidance stems from significant U.S. Supreme Court rulings issued in 2012 and 2013 regarding patent battles over laboratory tests. Three years ago, the high court ruled in favor of the Rochester, Minn.-based Mayo Clinic in a patent dispute with Prometheus Laboratories over an esoteric blood test. Prometheus had claimed that the observation of natural phenomena— such as the results of the test—could be patented; but the court disagreed. Similarly, the Court ruled that a patent Myriad Genetics held on BRCA testing was invalid, concluding that a single human gene could not be protected under patent law. The update responds to more than 60 public comments received concerning initial interim patent eligibility guidance issued in 2014. Those comments address six themes including a request for additional examples addressing abstract ideas and laws of nature, how examiners identify abstract ideas, and an explanation of “the markedly different characteristics analysis.” Public comments on this update must be submitted by October 28, 2015.

Drop in Senior Medicare Patrol Related Fraud Recoveries. The Senior Medicare Patrol (SMP) has been an initiative of the Centers for Medicare & Medicaid Services since the late 1990s, initially as a pilot project, and now operates initiatives in every state and territory, staffed by more than 5,000 volunteers. However, the SMP has had modest results in recent years, according to a new report from the Office of the Inspector General (OIG) for the U.S. Department of Health and Human Services. In calendar 2014, recoveries from Medicare and Medicaid fraud inquiries led to expected recoveries of ill-gotten payments totaling $661,333—a 93 percent decrease from 2013. But in 2013, much of the $9.1 million of expected recoveries were tied to what the agency called “a single event.” The OIG also noted that “we continue to emphasize that the projects may not be receiving full credit for savings attributable to their work. It is not always possible to track referrals to Medicare contractors or law enforcement from beneficiaries who have learned to detect fraud, waste, and abuse from the projects. In addition, the projects are unable to track the substantial savings derived from a sentinel effect whereby fraud and errors are reduced by Medicare beneficiaries’ scrutiny of their bills.”

Laboratory Data and Interoperability to be Focus of FDA Workshop. Recognizing that laboratory tests “influence between 70 to 80 percent of clinical decisions,” the Food and Drug Administration, Centers for Disease Control and Prevention (CDC) and the National Library of Medicine (of the National Institutes of Health) are holding a public workshop Sept. 28, 2015, to improve ease of sharing laboratory data. The agencies seek public input on “promoting semantic interoperability of laboratory data between in vitro diagnostic devices and database systems.” Also at issue are the standards for reporting laboratory data and models for interoperability. The FDA indicated a discussion paper with more detailed discussion of the workshop’s subject matter will be released online. A webcast of the workshop will also be available. Attendees must register by Sept. 18, 2015. Public comments are due by October 26, 2015. More information can be found in the FDA Notice published in the Aug. 3, 2015 Federal Register.