Three of the biggest COVID-19 vaccine developers are heading into a legal battle. Moderna Inc. said it has filed lawsuits alleging the Pfizer Inc.-Biontech SE Comirnaty vaccine infringes patents Moderna filed between 2010 and 2016 that cover its mRNA technology. Pfizer and Biontech “unlawfully” copied the technology without permission, according to Moderna.
It’s not a done deal yet, but Teva Pharmaceutical Industries Ltd. has agreed in principle to pay up to $4.25 billion, plus about $100 million to Native American tribes, to end most of the lawsuits it’s facing across the U.S. over its opioid sales. The figure includes settlements the company already has made with some state and local governments, as well as the supply of up to $1.2 billion worth of Teva’s generic naloxone nasal spray.
The U.S. FDA has been scrutinizing surgical meshes for safety considerations for longer than a decade, but litigation continues to dot the legal landscape. An appeals court in the state of California decreed recently that Johnson & Johnson of Franklin Lakes, N.J. must pay more than $300 million over allegations that its Ethicon subsidiary had downplayed to patients the risks associated with its pelvic meshes, but J&J said its next step is to appeal the outcome in the state’s highest court.
The lawsuit filed by Illumina Inc., against officials with Guardant Health Inc., revolves around trade secrets allegedly misappropriated by two former Illumina employees, including Helmy Eltoukhy, who helped to found Guardant while still employed at Illumina. Among other things, the complaint states that Eltoukhy had asked another Illumina employee about research that ultimately ended up in the hands of Guardant despite that the document in question was explicitly labeled as confidential and for internal use only.
The FDA’s regulation of medical technology may be assumed to have a number of unintended consequences, and one of those seems to be the lawsuit between Johnson & Johnson (J&J) and Auris Health Inc. Due to a 2018 FDA policy change regarding 510(k) devices, a robotic surgery system acquired by a J&J subsidiary from Auris was forced into the lengthier de novo premarket channel. This change ultimately helped derail the development effort for the Auris Iplatform surgical system and thus played a role in the $2.35 billion lawsuit alleging that J&J had engaged in fraud in its deal with Auris over the acquisition.
Sight Sciences Inc. may have visions of a substantial settlement following Ivantis Inc.’s $60 million settlement with Glaukos Corp. this week or the Menlo Park, Calif.-based company may have its sights set on knocking a competitor out of the market entirely. Both are possible outcomes of the suit Sight Sciences announced this morning that alleges infringement of four of its patents by Ivantis for its Hydrus Microstent. Sight Sciences makes the Omni surgical system, which competes with the Hydrus and the Glaukos Istent in the minimally invasive glaucoma surgery (MIGS) space.
Rather than appeal an April decision by the U.S. Court of Appeals for the District of Columbia Circuit, the FDA is changing how it regulates imaging agents. That means the agency will transition at least some approved imaging agents from drug status to device status and, going forward, it will regulate products that meet both the device and drug definition as devices – unless Congress specifies otherwise.
More than a decade after the Biologics Price Competition and Innovation Act became law and nearly six years after the first biosimilar launched in the U.S., the country’s first potential interchangeable is on deck awaiting an FDA decision.
Three of the largest biopharma distributors in the U.S. agreed to a settlement of $1.179 billion with New York, bowing out of the state’s ongoing opioid lawsuit.
The American Clinical Laboratory (ACLA) filed an appeal to revive its lawsuit against the U.S. Health and Human Services challenging HHS’ overhaul of the medical clinical lab fee schedule over its “harmful regulatory overreach” that imposes an “unsustainable reimbursement model.”
