Analysis of patent litigation, PTAB practice, prosecution and pharma IP, written on the data behind LexDana.
Tagged hatch-waxman · clear
ANDA litigation remains one of the most demanding areas of patent law, where outcomes often hinge on the experience and judgment of individual attorneys. In disputes that determine when a generic drug can enter the market, the role of lead counsel is…
In a significant development for the central nervous system (CNS) therapeutics market, Axsome Therapeutics, Inc. (NASDAQ: AXSM) has reached a settlement agreement with Hetero Labs Ltd. over patent litigation concerning SUNOSI® (solriamfetol)—a…
As the pharmaceutical industry continues to face an ever-changing legal environment, staying informed about trends in ANDA litigation has never been more crucial. At Patexia, we are committed to providing stakeholders with the most reliable and up-to-date…
When several ANDA filers seek approval for the same drug, a branded pharmaceutical company may struggle to bring Hatch-Waxman Act patent infringement lawsuits against all challengers in a single court due to venue limitations. In recent years,…
In late August of this year, our ANDA Intelligence 2023 Report was released, a comprehensive study, covering the Hatch-Waxman litigation within US district courts. The report focused on the period from July 1, 2018, through June 30, 2023, encapsulating a…
The Biden administration is exploring the use of "march-in" rights established in the 1980 Bayh-Dole Act , which has never been utilized before. This provision allows federal agencies to request licensing agreements for inventions developed under…
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…
In the intricate world of pharmaceuticals, where innovation meets regulation, ANDA litigation stands as a pivotal battleground. Abbreviated New Drug Application (ANDA) litigation plays a crucial role in determining the fate of generic drugs in the market.…
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,…
Abbreviated New Drug Application (ANDA) litigation stands at the crossroads of pharmaceutical innovation and legal prowess. As generic drug companies seek to enter the market while facing patent challenges from brand-name giants, the role of skilled…
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…
When it comes to generic medications, the Abbreviated New Drug Application (ANDA) process plays a crucial role in bringing affordable alternatives to brand-name drugs to the market. At the heart of ANDA approval lies the significance of bioequivalence…
