The Supreme Court has declined to hear three cases that questioned the inter partes review (IPR) process for patent litigation, although the petition for cert for the Arthrex Inc. v. Smith & Nephew Inc.; Arthrocare Corp.; and the United States of America case is still pending. Should the Supreme Court pass on Arthrex, the remaining affected IPR cases will have to be relitigated at the Patent Trial and Appeal Board (PTAB), which may give those patent holders another chance to restore their patents.
Just the name, Strategic National Stockpile (SNS), evokes the image of a huge warehouse, or a series of warehouses spread across the U.S., strategically stocked with all the medical supplies, diagnostics and drugs that will be needed nationwide to respond to any health emergency brought on by terrorists, nuclear attacks, pandemics or other public health hazards. The reality is so much more – and so much less.
Adarza Biosystems Inc.’s Ziva platform can simultaneously detect hundreds of proteins, antibodies, or substrates from a single drop of blood, plasma or serum, providing insight into an individual’s immune response. That could be critical for both surveillance and diagnostic purposes as the nation prepares for a likely second wave of the novel coronavirus in the fall when multiple respiratory pathogens will be circulating.
The Senate Health, Education, Labor and Pensions (HELP) Committee met again June 23 to discuss the federal government response to the COVID-19 pandemic, and one clear signal that emerged from the hearing is that Congress will have to provide annual funding to build a sustainable infrastructure for vaccine development and manufacture if the nation is to deal appropriately with the next pandemic.
The bad news is, yes, the U.S. is in for a second wave of COVID-19, which is expected to hit during the upcoming flu season. The good news is the nation is much better prepared for the next wave, the NIH’s Anthony Fauci told a House Energy and Commerce Committee Tuesday.
Beverly, Mass.-based Lexagene Holdings Inc. has developed a genetic analyzer with multiplex testing capability that would enable it to determine whether a patient has COVID-19, influenza or another respiratory infection with one sample. The Lx Analyzer uses a proprietary quantitative reverse transcription polymerase chain reaction (RT-qPCR) method to automatically test for up to 27 pathogens simultaneously, all in about one hour.
The potential for neurological complications, including seizures and stroke, is a growing concern with COVID-19 patients. To ensure rapid diagnosis and treatment, Ceribell Inc., a Mountain View, Calif.-based startup, is deploying its cloud-linked, portable electroencephalogram (EEG) device to enable EEG assessments in minutes in emergency rooms and intensive care units.
The COVID-19 pandemic has fueled an unprecedented uptick in telehealth use, from medical and behavioral health services to remote patient monitoring, as federal and state regulators have relaxed certain policy restrictions to increase access to care. Sen. Lamar Alexander (R-Tenn.) recommended in a Senate hearing that certain temporary policy changes, such as elimination of the “originating site” rule and expansion of Medicare- and Medicaid-covered telehealth services, should be lasting to ensure patients retain health care access when the crisis is over.
Policymakers in the U.S. are grappling with a disastrous pandemic as well as long-standing political tensions, but one aspect of the COVID-19 pandemic that might unify them is the need to ensure that patients in the U.S. are not at the mercy of other nations for needed diagnostics and therapies.
The patent lawsuit between Merck & Co. and Microspherix LLC began when the latter sued Merck for infringement of patents for brachytherapy in Merck’s implantable contraceptive device, but Merck was unable to prevail in an inter partes review (IRP) or in an appeal of the IPR at the Court of Appeals for the Federal Circuit. After wading through questions about purported prior art, Merck failed to persuade the two courts that Microspherix’s non-provisional filing had strayed too far from the written description of the related provisional, thus handing Microspherix a win against its much larger rival in the market for drug delivery with microspheres.