Below are some recent updates regarding U.S. regulatory submissions and a launch in connection with biosimilar products: On September 27, 2018, Samsung Bioepis announced that the U.S. FDA…
Below are some recent updates regarding U.S. regulatory submissions and a launch in connection with biosimilar products: On September 27, 2018, Samsung Bioepis announced that the U.S. FDA…
As we previously reported, Pfizer filed a petition for IPR of certain claims of Hoffman-La Roche’s U.S. Patent No. 8,314,225 (IPR2018-01219). According to the petition, the challenged…
We previously reported on discovery disputes in the adalimumab litigation between AbbVie and Boehringer Ingelheim (BI) pending before the District of Delaware. Earlier this month, Judge Lloret…
In a complaint filed yesterday, the State of California sued AbbVie, Inc. based on an alleged kickback scheme in connection with AbbVie’s Humira® (adalimumab). The complaint alleges that AbbVie…
As we have previously reported, a jury in September 2017 issued a $70,000,000 verdict against Hospira based on its drug substance manufacturing activity in 2013-2015 in connection with its…
Genentech recently submitted two opening appellate briefs to the Federal Circuit in connection with its appeals from the Board’s final written decisions in Hospira’s IPRs, IPR2016-01771…
Below we provide updates in three pending litigations. First, in an update on the Amgen v. Coherus appeal regarding Coherus’s biosimilar application for pegfilgrastim, Amgen filed its opening…
Yesterday, September 4, 2018, Genentech filed a complaint against Samsung Bioepis in the District of Delaware alleging infringement under the BPCIA of 21 patents based on Bioepis’s filing of…
Q&A With September’s Featured Editor: Josh Whitehill Josh Whitehill is an associate in Goodwin’s New York office. BMW: Where would we find you on a Saturday afternoon? Josh: On a…
As we previously reported, last September a District of Delaware jury issued a verdict that Hospira’s manufacture of 14 batches of drug substance in connection with its proposed biosimilar…