Amgen filed a complaint against Apotex today in the Middle District of Florida, alleging infringement of U.S. Patent No. 9,856,287 based on Apotex’s aBLAs for filgrastim and pegfilgrastim biosimilars. The ’287 patent...more
Here are our picks for the top-five most significant legal developments regarding biosimilars in 2017...more
The Situation: The Biologics Price Competition and Innovation Act was considered in a November 2017 decision by the United States Court of Appeals for the Federal Circuit. The Result: The court found that the commercial...more
Below is our fall update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates (Summer...more
As we previously reported, on November 14, 2017, the Federal Circuit affirmed the Southern District of Florida’s finding of non-infringement in Amgen v. Apotex. In that case, Amgen asserted the ’138 patent against Apotex...more
As we previously reported, Amgen appealed the Southern District of Florida’s judgment of non-infringement in favor of Apotex in litigation regarding Apotex’s proposed filgrastim and pegfilgrastim biosimilars. Today the...more
As we noted earlier today, this week the Federal Circuit is holding oral argument at various venues in New York City. Two of today’s oral arguments were in biosimilar cases that we have been closely following on this blog....more
This week, six Federal Circuit panels will hear oral argument on at various venues in New York City. Two of today’s oral arguments are in biosimilar cases that we have been closely following on this blog....more
The Federal Circuit has scheduled the oral argument of Amgen’s appeal from the district court’s judgment of non-infringement of Apotex’s proposed biosimilars of Neupogen® (filgrastim) and Neulasta® (pegfilgrastim) for 2:00pm...more
Below is our summer update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates...more
Below is our spring update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates...more
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...more
Below is our midwinter update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates...more
The parties in Amgen v. Apotex have completed briefing in Amgen’s appeal to the Federal Circuit from the district court’s judgment of noninfringment. As we have previously reported, in September 2016 the District Court for...more
After reflecting upon the events of the past twelve months, Patent Docs presents its tenth annual list of top patent stories. For 2016, we identified twenty stories that were covered on Patent Docs last year that we believe...more
Here are our picks for the top-five most significant legal developments in the world of biosimilars in 2016: ..Congress passed and President Obama signed the 21st Century Cures Act. Among other things, the Act modifies...more
The Solicitor General of the United States has filed an amicus brief in Sandoz Inc. v. Amgen Inc., asking the Supreme Court to grant certiorari and reverse the Federal Circuit’s interpretation of one of the “patent dance”...more
Last week, the Solicitor General submitted its brief in Amgen v. Sandoz, arguing that the Supreme Court should review and decide in Sandoz’s favor both questions presented by the parties’ cross-petitions for certiorari. Two...more
Today, the Supreme Court denied certiorari in Apotex v. Amgen, a closely-watched case involving the interpretation of key provisions of the BPCIA. Our most recent blog coverage can be found here....more
With the U.S. biosimilar pathway created by the Biologics Price Competition and Innovation Act (BPCIA) now fully up and running, there are now seven ongoing biosimilar litigations in the U.S. Here are brief updates on recent...more
Mylan filed an amicus brief in support of Apotex’s petition for certiorari in Amgen v. Apotex. Mylan’s arguments focus on the Federal Circuit’s interpretation of the BCPIA as requiring 180 days of pre-marketing notice after...more