Two weeks ago we discussed Vanda Pharmaceuticals' ambitious cert petition asking the Supreme Court to discontinue the "reasonable expectation of success" standard for patent.
The U.S. Food and Drug Administration ("FDA") has proposed updated guidance, intended to assist individuals in meeting the cybersecurity requirements for FDA medical device submissions.
The IPO Law Journal recently published a paper titled "Patent Marking Regarding Software Medical Devices." The paper discusses an overview of patent marking-related case law.
On April 12, 2024, the Federal Circuit dismissed CAFC Appeal No. 24-1402 and Cross-Appeal No. 24-1405 for lack of jurisdiction following its February 22, 2024 order directing Regeneron and Mylan / Biocon.