Welcome to the Big Molecule Watch!
Big Molecule Watch will be posting updates and analyses on regulatory issues, litigation, legislation, and other news in the ever-developing world of biosimilars. The editors of this blog have collectively been watching and engaging with the world of biosimilars (“big molecules”) since before the inception of the biosimilar industry in the U.S., and we’re excited to share the observations of our active watch on this new forum.
If you’re looking for a primer on biologics, check out our background post
introducing the world of biologics, biosimilars, and the Biologics Price Competition and Innovation Act (“BPCIA”).
We’ve also collected (and will continue to update) some reference documents that might be of interest to visitors of this blog—you can find them under the “Links” section to the right of this page.
As we posted here
, and here
, various amicus briefs have been submitted in Sandoz v. Amgen
. Last week, Janssen Biotech, Inc. submitted an amicus brief
in support of Amgen. Janssen’s brief emphasizes […]
This week Sanofi-Aventis and Regeneron Pharmaceuticals took aim at Amgen’s U.S. Patent No. 8,679,487 on two fronts, filing a declaratory judgment action in district court and a petition for inter partes review in the U.S. Patent & […]
yesterday that the European Commission (EC) has granted marketing authorization for AMGEVITA (biosimilar adalimumab) in all available indications, including certain adult and pediatric inflammatory diseases. AMGEVITA is Amgen’s first biosimilar approved by the EC. […]
On February 17, 2016, we reported
that Amgen and Sandoz had both petitioned the U.S. Supreme Court for review of the Federal Circuit’s decision in Amgen v. Sandoz
, each seeking to advance their respective […]
Celltrion has filed petitions for inter partes review of two patents related to Genentech’s trastuzumab: IPR2017-01121
, challenging U.S. Patent 7,846,441, and IPR2017-01122
, challenging U.S. Patent 7,892,549. According to the petitions, these two patents […]
During his presentation this month at the Cowen and Company 37th Annual Health Care Conference, Amgen’s Executive Vice President and Chief Financial Officer David Meline indicated
that Amgen has filed for approval in the EU […]
As we previously reported, in Janssen v. Celltrion
, Janssen appealed
the district court’s partial final judgment
that Janssen’s ‘471 patent, relating to monoclonal antibodies including infliximab, is invalid. As we also previously reported, Janssen filed its opening appeal […]
Celltrion has filed three petitions for IPR of Biogen’s patents related to rituximab: IPR2017-01093
, challenging U.S. Patent 8,329,172; IPR2017-01094
challenging U.S. Patent 8,557,244; and IPR2017-01095
challenging U.S. Patent 9,296,821. Rituximab is marketed […]
The PTAB has instituted inter partes
review of Genentech’s U.S. Patent 7,622,115, granting Hospira’s petition in IPR2016-01771. According to the institution decision, the patent is directed to methods for treating cancer in a patient comprising […]
The PTAB has instituted
IPR2016-01837, in which Hospira challenges Genentech’s U.S. Patent 7,807,799. The institution decision extends to all challenged claims, claims 1-3 and 5-11. According to the decision, the ‘799 patent relates to […]