Posts Tagged: amgen


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 …
By Zachary Silbersher
1 month ago 1

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 …
By Steve Brachmann
2 months ago 0

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 …
By Gene Quinn
6 months ago 13

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 …
By Gene Quinn
6 months ago 2

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 …
By Steve Brachmann
9 months ago 0

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 …
By Zachary Silbersher
11 months ago 1

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 …

Injectable migraine treatment being developed by Alder, Eli Lilly, Amgen and others

Migraines are the result of a hereditary neurological disorder which causes certain areas of the brain to become over-excited, creating the throbbing pain and increased sensitivity to …
By Steve Brachmann
2 years ago 0

Bristol-Myers, AstraZeneca and AmGen maintain strong new drug pipelines

There’s been a lot of positive activity in recent months for Bristol-Myers Squibb of New York City. In early March, the U.S. Food and Drug …
By Steve Brachmann
3 years ago 1

Biotech and Pharma Update: News for December 2013

What follows below is a review of some of the biotech and pharma news stories that caught my attention during the month of December 2013. Fitch Puts Negative …
By Gene Quinn
4 years ago 0

Pharma & Biotech News for September 2013

Mark Lemley's Firm Files DJ Against Myriad in Northern California ----- Promise Not to Infringe Insufficient in ANDA Litigation ----- Licensing Deals Stall in Pharmaceutical Sector in …
By Gene Quinn
4 years ago 0

Pharma Law and Business: A Month Roundup for February 2013

The FDA decided not to pursue a re-hearing before a federal appeals court that recently ruled the federal government could not prosecute a sales rep who promoted …
By Ed Silverman
5 years ago 0