Posts Tagged: amgen
Federal Circuit Upholds Patent for Biologic Drug Enbrel; Judge Reyna Dissents
On July 1, the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed a holding of the U.S. District Court for the District of New …
Federal Circuit Upholds $70 Million Judgment for Amgen in Epogen Biosimilar Case
Yesterday, in an opinion authored by Judge Moore, the Court of Appeals for the Federal Circuit (CAFC) affirmed the District of Delaware’s decision that: 1) U.S. …
Federal Circuit Agrees That Argument-Based Prosecution Estoppel Barred Amgen from Succeeding on Infringement Claim
The Federal Circuit issued an opinion on July 29 affirming the District Court for the District of Delaware’s dismissal of Amgen Inc. and Amgen Manufacturing Ltd.’s (…
Other Barks & Bites for Friday, March 1
This week in Other Barks and Bites: the Senate Judiciary Committee plans to go after drug patents to promote access to generic medications; Apple faces another patent …
CAFC sides with Sandoz, Amgen’s state claims preempted by BPCIA
Originally filed in October 2014, the long-running and high-stakes battle between two powerhouse companies, Amgen and Sandoz, continues to lay out the ground rules for a growing biosimilar …
Did the Federal Circuit doom Amgen’s Enbrel® monopoly?
In the case, Amgen v. Sanofi, the Court vacated an injunction Amgen obtained against a competing drug to its new PCSK9-inhibitor. The Court’s decision turned …
Patent settlement between AbbVie and Amgen delays Humira generic until 2023
On Thursday, September 28th, a judge in the District of Delaware entered an order stipulating dismissal in a patent infringement case brought by North Chicago-based pharmaceutical firm …
CAFC denies Amgen discovery in biosimilar patent dispute
In a patent infringement case governed by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), the Federal Circuit found that it lacked jurisdiction to compel discovery …
Myths about patent trolls prevent honest discussion about U.S. patent system
A $1 trillion a year industry not wanting to pay innovators less than a 1% royalty on the innovations they appropriate (i.e., steal) for their own profits seems …
SCOTUS says OK to give notice of commercial marketing before FDA license under Biologics Price Competition and Innovation Act
42 U.S.C. § 262(l) of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) regulates “biosimilars,” biological products that are highly similar to FDA-approved biological products. Section 262(…
Industry Reaction to SCOTUS decision in Sandoz v. Amgen
The Court’s Sandoz v. Amgen decision gutted a statute that had been carefully crafted to facilitate timely resolution of patent disputes and avoid delaying market entry …
Regeneron, Sanofi-Aventis sue for declaration that dermatitis treatment Dupixent doesn’t infringe Amgen patent
Although Dupixent hasn’t been granted FDA approval as of yet, the drug has made it further than Amgen’s AMG-317, the code name for Amgen’s …
Amgen v. Regeneron: Will the permanent injunction against Regeneron’s new PCSK9-inhibitor hold up on appeal?
On January 5, 2017, the District of Delaware issued its long-awaited decision in the patent dispute pending between Amgen and Regeneron wherein the Court granted Amgen’s request for …
Biologics Applicant Must Give Post-Approval Notice to Reference Product Sponsor
The Federal Circuit held that there was no statutory language that made section (8)(A) non-mandatory. Further, Amgen v. Sandoz disposed of Apotex’s argument that (8)(A) would …
The Amgen Quagmire: Federal Circuit Rules Patent Dance Does Not Excuse Biosimilar Applicants from Providing Notice of Intent to Market
The Supreme Court is currently considering whether to review Amgen Inc. v. Sandoz Inc., the Federal Circuit’s first decision regarding the Biologics Price Competition and Innovation …
