Davita Inc., lost a U.S. Supreme Court ruling regarding limits to the private payer coverage for outpatient dialysis services despite, a development that took a double-digit bite out of Davita’s shares. However, shares of competitor Fresenius also took a hit, suggesting that the market sees the decision as a major setback for both companies.
It’s been a decade since the America Invents Act (AIA) transformed the U.S. patent landscape from a first-to-invent to a first-inventor-to-file system and added new contours with the creation of the Patent Trial and Appeal Board (PTAB) to hear post-grant patent challenges outside of court. While the AIA’s inter partes review process and other post-grant procedures have helped weed out weak patents, they’ve also increased the uncertainty and unpredictability of many patents. Now, 10 years on, Congress is assessing how the PTAB has developed in real life and considering what course corrections may be needed.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Biomarin, Daiichi, Ellipses, Hoth, Ikena, Krystal, Merck & Co., Mustang, Novartis, Paratek, VBI.
The U.S. FDA reported a class I recall for a single lot of the Safestar 55 breathing filter system by Draeger Inc., due to partial obstruction of the filter, which can lead to hypoxia. The affected units were part of a lot that was to be destroyed, but were instead inadvertently distributed even though they were identified as unusable after a manual inspection process at Draeger.
Novartis AG is not going quietly into the night after the U.S. Court of Appeals for the Federal Circuit reversed itself, invalidating a method patent covering a dosing regimen for the company’s blockbuster multiple sclerosis drug, Gilenya (fingolimod). After the split opinion came down June 21 from the three-judge panel, Novartis said it planned to file a petition seeking further review of the decision by the full court.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Carthera, Medtronic, Nucleix, Oxfordvr, Pictor.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Acer, Ardelyx, Beigene, Ceruvia, Eli Lilly, Eyepoint, Innovent, Medsenic, Midatech, Nuvectis, Ocumension, Phanes, Regulus, Relief, Tranquis, Xenon.
China’s National Medical Products Administration (NMPA) approved Ocumension Therapeutics Ltd.’s and Eyepoint Pharmaceuticals Inc.’s drug-device combination product, Yutiq (fluocinolone acetonide intravitreal implant), for chronic non-infectious uveitis affecting the posterior segment of the eye.
RSS
