The US Food and Drug Administration (FDA) issued an updated draft guidance on March 7 on the nonproprietary naming of biologics, titled Nonproprietary Naming of Biological Products: Update (Guidance). This update is FDA’s...more
Amgen paints a different picture as to the bad actor during the parties’ negotiations pursuant to the Biologics Price Competition and Innovation Act.
Shortly after Amgen received US Food and Drug Administration (FDA)...more
Reconsideration leads to a reversal of course regarding a key claim limitation.
On October 26, 2017, in Hospira, Inc. v. Genentech, Inc., the Patent Trial and Appeal Board (PTAB) granted Hospira’s request for rehearing and...more
The ruling found that the use of such evidence was proper for written description and enablement....more
AbbVie’s arguments raised in a prior IPR were key to the PTAB’s finding of no commercial success.
The Patent Trial and Appeal Board (PTAB) found all of the claims of three AbbVie Biotechnology Ltd. (AbbVie) patents...more
FDA final guidance will have significant impact on marketing of biologics, biosimilars and related products.
This month, FDA issued its final guidance on Nonproprietary Naming of Biological Products (Naming Guidance)....more