Analysis of patent litigation, PTAB practice, prosecution and pharma IP, written on the data behind LexDana.
Tagged fda · clear
Written by : Ari Feinstein & Jane Dai, Ph.D. As we previously discussed , on November 7, 2023, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listings of device…
Written by : Ashley C. Morales & Michael L. Fuller On Friday, June 21, 2024, the FDA updated its Patent Listing Dispute List to indicate that the ten pharmaceutical companies who had received warning letters from the FTC in April did not make changes to…
Written by : Ari Feinstein & Jane Dai, Ph.D. As we recently discussed , the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listing of device patents in the Food and Drug…
We are proud to announce that tomorrow marks the release of the fourth edition of our ANDA Litigation Intelligence Report. This year's report is an in-depth compilation that includes not just data and rankings but also a thorough analysis of…
Written by : Kenneth O. Aruda, Ph.D. Software is increasingly used as a medical device, transforming the healthcare industry with the goal of improving patient outcomes. However, developing software as a medical device involves navigating complex and…
In the realm of pharmaceuticals, the approval process for generic and brand-name drugs holds significant importance. The Hatch-Waxman Act, a pivotal piece of legislation, governs these processes, ensuring a delicate balance between innovation,…
Written by : Philip M. Nelson Medical Device companies often need the U.S. Food and Drug Administration (FDA) to approve “indications for use” of their products–for use selling them in the U.S. Those same companies often seek U.S. patent…
British drugmaker GlaxoSmithKline (GSK) has taken American pharmaceutical giant Pfizer to court, alleging a violation of its patent rights in the creation of Pfizer's RSV vaccine. The lawsuit filed in Delaware District Court, has cast a shadow over a…
In the world of pharmaceuticals, access to affordable generic drugs is crucial for ensuring cost-effective healthcare solutions. The Drug Price Competition and Patent Term Restoration Act, commonly known as the Hatch-Waxman Act, plays a pivotal role in…
In the world of pharmaceuticals, the Abbreviated New Drug Application (ANDA) process plays a critical role in the approval and market entry of generic drugs. However, the intersection of patents and generic drug approvals can be a complex and challenging…
Written by : Nima Zargari, Ph.D. On February 24, 2023, in Jazz Pharms., Inc., v. Avadel CNS Pharms., LLC , the U.S. Court of Appeals for the Federal Circuit affirmed the United States District Court for the District of Delaware’s grant of an…
In late August, we published our third annual ANDA Litigation Intelligence Report, covering important statistics and evaluating all stakeholders in Hatch-Waxman litigation, including attorneys, local counsel, law firms, generic and brand pharmaceutical…
