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 covered in previous posts, the Supreme Court will hear arguments regarding the Federal Circuit’s interpretation of the BPCIA’s notice of commercial marketing requirement and patent dance provisions in April 2017. Several amicus briefs in support […]
As we have previously reported
, the Supreme Court will later this year hear arguments in Sandoz v. Amgen
regarding the Federal Circuit’s interpretation of the BPCIA’s notice of commercial marketing requirement and patent dance provisions. […]
As we previously reported
, Genentech filed a complaint against Amgen in the District of Delaware seeking declaratory judgment that Amgen has violated the patent dance provisions of the BPCIA in connection with its proposed […]
As we covered in a previous post
, in April the Supreme Court will hear arguments regarding the BPCIA’s notice of commercial marketing requirement and patent dance provisions. Last week, the Biosimilars Council filed an
The PTAB has denied institution
of IPR2016-01608, in which Bioeq IP AG sought review of Genentech’s U.S. Patent 6,716,602. That patent is directed to methods for increasing the yield of a heterologous recombinant protein produced […]
Celltrion has filed a petition
for inter partes
review (IPR2017-00959) of Genentech’s U.S. Patent 8,591,897. According to the petition, the patent is directed to methods of treating a sub-type of breast cancer with a regimen […]
As we reported
last November, the NOR-SWITCH Phase IV study concluded that patients could be safely and effectively switched from originator infliximab (Remicade®) to Celltrion’s biosimilar product CT-P13 (Remsima®). On February 17, Celltrion Healthcare […]
Last week the Office of the Solicitor General (“SG”) filed an amicus brief
on behalf of the United States in support of Sandoz’s position with respect to the BPCIA’s notice of commercial marketing requirement and […]
On Friday, the United States Supreme Court set oral arguments
in Amgen v. Sandoz
for April 26, 2017. Today, the United States Court of Appeals for the Federal Circuit announced that oral arguments
in Amgen v. Hospira
The Patent Trial and Appeal Board has granted
Apotex’s petition for inter partes
review of Amgen’s U.S. Patent 8,952,138, finding that Apotex has a reasonable likelihood in prevailing in its assertions that claims 1-24 are […]