Medical Device Legal News with Sam Bernstein: Episode 18
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Taking the Pulse, A Health Care and Life Sciences Podcast | Episode 104: Dr. Nicholas Vafai, Founder and President, Viro Research
DE Talk | Navigating COVID-19 Vaccine Mandates: Employer vs Employee Rights
Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
What device companies need to know ahead of an advisory panel meeting
Denosumab Challenged Claim Types in Litigation: Claims are counted in each litigation, so claims from the same patent challenged in multiple litigations are counted more than once. Within each litigation a claim is counted...more
Novartis Pharmaceuticals Corp. v. Torrent Pharma Inc., et al., Nos. 2023-2218, -2220, -2221 (Fed. Cir. (D. Del.) Jan. 10, 2025). Opinion by Lourie, joined by Prost and Reyna. The FDA approved a New Drug Application from...more
PERSION PHARMACEUTICALS LLC v. ALVOGEN MALTA OPERATIONS LTD. Before O’Malley, Reyna, and Chen. Appeal from the U.S. District Court for the District of Delaware. Summary: The FDA’s acceptance of safety data for a...more
Federal Circuit Summary - Before Moore, Linn, and Chen. Appeal from the United States District Court for the District of Delaware. Summary: A prior art reference does not inherently disclose the elements of a claim...more
The FDA on Friday approved the first U.S. biosimilar of Humira (adalimumab), AbbVie’s best-selling biologic for treatment of inflammatory conditions. The biosimilar, Amgen’s Amjevita (adalimumab-atto), received approval for...more
Since the Biologics Price Competition and Innovation Act of 2009 (BPCIA) was signed into law in 2010, only a small handful of abbreviated Biologics Licensing Applications (“aBLAs”) have been filed and of those the FDA has...more
As we previously reported, on July 5, the Federal Circuit affirmed the district court’s grant of a preliminary injunction enjoining Apotex from launching its biosimilar version of Amgen’s Neulasta (pegfilgrastim) until it...more
Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more
Laboratory developed test (LDT) providers, previously exempt from U.S. Food and Drug Administration (FDA) oversight, under a new FDA proposal, must now consider if their LDTs constitute moderate-risk (Class II) or high-risk...more
Last week the Federal Circuit affirmed a District Court's finding of invalidity and non-infringement in ANDA litigation between Spectrum Pharmaceuticals and Sandoz. In so doing, the Court deferred to the factual...more
Diagnostic medicine is experiencing new challenges at the USPTO and the U.S. Food and Drug Administration (FDA). Under a new FDA proposal, laboratory developed test providers, previously exempt from FDA oversight, must now...more
There have been many voices raised in recent years against the patent system for a variety of political, policy, or personal reasons. Indeed, there is even a book entitled Don't File a Patent that sets out the authors'...more