The US Court of Appeals for the Federal Circuit recently upheld the district court’s denial of a judgment as a matter of law (JMOL) or, alternatively, motion for a new trial, reinforcing the fine line that exists between...more
As of 2019, post-grant proceedings have been in use for seven years. Designed as an alternative to district court litigation, post-grant proceedings have offered litigants a faster and more cost-effective forum for resolving...more
Quarterly Post-Grant and Patent Litigation Update -
Welcome to our ongoing updates relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. We hope you find...more
A split Federal Circuit panel recently upheld the district court’s judgment of invalidity and noninfringement because the phrase “consisting essentially of” rendered the asserted claims indefinite and the proposed ANDA label...more
EU – REGULATORY -
Brexit, Notified Bodies, and Medical Devices -
The House of Commons Library published a briefing paper on June 12 on the UK’s product standards and safety marking compliance in light of Brexit. In the...more
8/20/2019
/ Anti-Kickback Statute ,
Asia ,
China ,
Competition ,
Data Privacy ,
Drug Pricing ,
EU ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Life Sciences ,
Medical Devices ,
Patents ,
Pharmaceutical Industry ,
UK Brexit
The US Food and Drug Administration (FDA) issued an updated draft guidance on March 7 on the nonproprietary naming of biologics, titled Nonproprietary Naming of Biological Products: Update (Guidance).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
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
/ Amgen ,
Apotex ,
Appeals ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Notice Requirements ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
Preliminary Injunctions