NMT Medical v. Cardia
This article was originally published in The Gray Sheet
Federal appeals court rules in NMT Medical's favor in a patent case against Cardia's Intrasept septal closure system. The U.S. district court in Minnesota initially had ruled that Intrasept did not infringe NMT's '235 patent last August. However, the appeals court found that the district court had incorrectly interpreted one of the patent's claims and incorrectly found no triable issue of fact concerning other claims. The case now goes back to the district court for further proceedings. NMT makes the StarFlex septal repair implant...
You may also be interested in...
The Environmental Working Group and Scientific Analytical Institute say inadequate testing of talc-containing personal-care products is to blame for findings of asbestos in cosmetics, including three of 21 powder-based cosmetics SAI analyzed at EWG’s request. They continue to push for updated testing standards that include electron microscopy as a core component.
Commissioner Hahn’s tweet announcing a return to inspections, while not a new policy, may be signal that FDA understands sponsor concerns with the agency’s limited ability to conduct onsite inspections. Effort may be aimed at reassuring industry even as CRLs related to manufacturing increase.
Rushed final rule seeking to impose draconian cuts on drug reimbursement rates in the Medicare Part B program is certain to face legal and political obstacles. But the data included on international price benchmarks will still have an impact.