Cordis and Johnson & Johnson tried to get a new trial and judgment as a matter of law (JMOL) following a jury verdict finding that they infringed Boston Scientific’s patent. Boston Scientific v. Cordis Corp. (08-1073).  The U.S. Court of Appeals for the Federal Circuit said that “because the court erred … in failing to […]

The U.S. Court of Appeals for the Federal Circuit ruled that the manufacture, marketing, or sale of a medical device, which is used in the development of FDA regulatory submissions, but is not itself subject to the FDA premarket approval process, is not entitled to the protection of the Hatch-Waxman Act section 271(e)(1) safe harbor […]

A panel of experts put together by the U.S. Food and Drug Administration looked at the safety concerns surrounding the more than $5 billion drug-coated stent industry. These so-called drug-eluting stents are small metal tubes implanted into blood vessels to help prop up clogged heart arteries after they have been cleared. By coating the stents […]