26 Jun, 2024 More Skinny-Label Drama or Just Your "Run-Of-The-Mill" Induced Infringement Case? By Chad Landmon The Federal Circuit's recently issued decision in the Amarin/Hikma case continues the drama around skinny labeling for generic and...
11 Jun, 2024 Court Orders Patents Delisted from Orange Book: Is FTC's Newly Aggressive Posture Having an Impact? By Ross Blau Chad Landmon Over the past year, FTC has placed two sets of Orange Book listings in its crosshairs, but, to date, FTC has not actually begun any...
03 Jun, 2024 Can an Enhanced India-U.S. Partnership Reduce Drug Supply Chain Issues? By Chad Landmon In an effort to enhance collaboration, the Indian Pharmaceutical Alliance (IPA) recently proposed that a more formal preferred...
06 May, 2024 Will the PTO's Proposed Expansion of Filing Settlement Agreements Help to Reduce Drug Prices? By Chad Landmon Craig Minerva In a recent Federal Register notice, the PTO announced a proposed rule requiring that any settlement agreement resolving a PTAB...
16 Feb, 2024 Happy 40th Hatch-Waxman! By Chad Landmon Turning 40 is a big milestone for most of us. When I turned 40 – I won't tell you how long ago that was – I was knee-deep in Paragraph IV...
16 Feb, 2024 Pharma IPR Conference By Aziz Burgy Rebecca Clegg Chad Landmon Ted Mathias +1 more... Show less Axinn is proud to be a Platinum Partner of the Pharma IPR Conference On March 5 at 11:00 AM, partners Aziz Burgy, Ted Mathias, and...
13 Feb, 2024 CREATing Controversy: Can a Brand Manufacturer Deny Sample Requests? By Chad Landmon Ian Swan Can a drug manufacturer refuse to provide samples of its innovator product under the CREATES Act if it thinks that the requester will not...
09 Feb, 2024 Will India Replace China in the U.S. Drug Supply Chain? By Chad Landmon In a recent opinion piece in Newsweek, Dr. Rahul Tiwari asserts that pharmaceutical companies in India have an opportunity to supplant...
29 Jan, 2024 Opening Another Front in the Brand/Generic Battle? By Chad Landmon Although it's not often that I read a decision by the U.S. Court of Federal Claims, it appears that Vanda may be opening a new front in...
17 Jan, 2024 Ready for the Flood of Litigation Against Federal Agencies? By Chad Landmon Aaron Savit Ian Swan Today, the Supreme Court heard oral arguments in two related cases that may have a significant impact on litigation against federal...
15 Dec, 2023 The Inflation Reduction Act’s First Potential Impact on Biosimilars By Ted Mathias Ross Blau Chantelle Ankerman On October 31, 2023, FDA approved Amgen’s Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Janssen’s Stelara...
30 Oct, 2023 An Interchangeable by Any Other Name By Chad Landmon In the continuing debate over the uptake of biosimilars, FDA recently put a stake in the ground by recommending in a new labeling...