Hatch-Waxman, biosimilars and the patents behind approved drugs.
40 articles · page 3 of 4
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…
Written by : Susan M. Janicki, Ph.D. & Agnes Juang, Ph.D. The Federal Trade Commission (FTC) issued a policy statement [1] on September 14, 2023, stating that “[b]rand drug manufacturers may be harming generic competition through the improper listing…
In August, our much-anticipated fourth annual ANDA Litigation Intelligence Report made its entrance into the world of pharmaceutical litigation. This report series shines a spotlight on the intricate web of ANDA (Abbreviated New Drug Application) cases and…
In a groundbreaking legal development, Eli Lilly has secured a remarkable victory in a high-stakes patent battle that has sent shockwaves through the migraine drug market. The verdict, delivered by a Massachusetts federal judge, overturns a staggering…
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…
When it comes to preparing an Abbreviated New Drug Application (ANDA), there are several common pitfalls that applicants often encounter. These pitfalls can significantly impact the approval process and delay the launch of a generic drug in the market.…
The Abbreviated New Drug Application (ANDA) process plays a vital role in the pharmaceutical industry, enabling generic drug manufacturers to bring affordable alternatives to market while respecting patent owner rights. Balancing the interests of patent…
