Patent subject matter eligibility under Section 101 of the Patent Act has proven controversial for patents in the U.S. thanks in no small part to Supreme Court jurisprudence in cases such as Alice v. CLS Bank and Mayo v. Prometheus. In the latest development, the court has declined to hear the American Axle case, leaving many observers despairing of any chance of restoring a decent patent system for personalized medicine, companion diagnostics and even the use of artificial intelligence in drug development.
Physician-owned distributorships (PODs) were the subject of concern by medical device makers and members of Congress as long as a decade ago, and recent events would seem to justify some of those fears. The U.S. Department of Justice (DOJ) announced July 1 that two owners of a POD have agreed to pay $1 million to settle claims that they paid kickbacks to other doctors to use medical devices supplied by the POD, the very kind of violation of the Anti-Kickback Statute that undergirded some of the earlier concerns about these business arrangements.
Patent subject matter eligibility under Section 101 of the Patent Act has proven controversial for patents in the U.S. thanks in no small part to Supreme Court jurisprudence in cases such as Alice v. CLS Bank and Mayo v. Prometheus. In the latest development, the Court has declined to hear the American Axle case, which some see as presenting an exceptionally low bar for subject matter eligibility, leaving many observers despairing of any chance of restoring a decent patent system for makers of in vitro diagnostics and other items that are among the mainstays of the medical device industry.
Companies in the device and diagnostics spaces are familiar with how government agencies react to acquisitions that bolster the acquiring company’s product pipeline, but vertical mergers provoke a different set of regulatory concerns. The European Commission (EC) recently updated its guidelines for vertical agreements, a development that could hamper some EU corporate activity going forward.
GE Healthcare issued a class I recall for Carescape R860 ventilators that covers more than 4,000 units distributed in the U.S., which was necessitated by problems with the battery backup component. No injuries or deaths have been reported in connection with the problem.
As was the case for all medical device inspections, the Medical Device Single Audit Program (MDSAP) was hampered by the COVID-19 pandemic, but the participant regulators agreed to allow the use of remote audits to fill in for live MDSAP inspections. This program has been renewed again through the end of September 2022, but the sponsoring regulatory agencies said this will be the last extension, barring exceptional circumstances.
Device servicing by third parties has been topical of late, although not in the context of continuous positive airway pressure (CPAP) systems. That seems likely to change thanks to the ongoing recall of CPAP machines made by Philips Respironics Inc., of Murrysville, Pa., which was driven by reports of degradation of foam used in the device for insulation.
The U.S. FDA reported a proposed down-classification for two device types intended for detection of melanoma, a move that would ease the premarket path for similar devices. The agency noted that it has received only one PMA application each for optical diagnostic devices and electrical impedance spectrometers, which suggests the agency sees these device types as suffering for want of interest on the part of device makers.
The COVID-19 pandemic completely rewrote the script for government responses to communicable diseases, and thus the Biden administration is wasting no time reacting to the emergence of the monkeypox virus. The administration announced June 28 that it has developed a plan to allocate the distribution of large volumes of vaccines, but the CDC has shipped tests to five major commercial lab companies, thus putting the U.S. on a strong footing to respond to the outbreak.
Patent disputes between developers of medical software might not have kept pace with the rate of disputes over in vitro diagnostic patents, but Alivecor Inc. and Apple Inc. are doing their share to keep software patents in the news. In the latest development, Mountain View, Calif.-based Alivecor reported that it won an initial determination of infringement of one of its patents by Apple Inc., of Cupertino, Calif., which could lead to an exclusion order for Apple watches if the case ultimately goes Alivecor’s way.
