The US Food and Drug Administration (FDA) issued an updated draft guidance on March 7 on the nonproprietary naming of biologics, titled Nonproprietary Naming of Biological Products: Update (Guidance).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 cases show that—even given a recent US Supreme Court interpretation of the statute—uncertainty still exists about complying with the “patent dance" information exchange requirements under the Biologics Price Competition...more
The ruling found that the use of such evidence was proper for written description and enablement....more
A recent Federal Circuit ruling shifts the burden to petitioners, which will likely lead to patent owners filing more motions to amend....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
Apotex—Biosimilars Must Provide 180-Day Marketing Notice after FDA Approval July 06, 2016 According to the Federal Circuit, post-licensure notice 180 days before commercial marketing is mandatory for biosimilars....more
7/6/2016
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