Posts Tagged: Amgen Inc


The Ability to Synthesize DNA: Marvin Caruthers Revolutionized DNA Synthesis

The ability to synthesize DNA through chemical processes is undoubtedly a marvel among modern technological advances and figures into a wide array of industry sectors... This Tuesday, …
By Steve Brachmann
16 days ago 1

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 …
By Aubrey Haddach
7 months ago 1

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
8 months ago 1

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 …

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
1 year ago 2

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 …

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

Federal Circuit Review – Issue 61 – July 31, 2015

Amgen filed a biologics license application (“BLA”) and obtained FDA approval for its filgrastim product, Neupogen. Sandoz subsequently filed an abbreviated BLA (“aBLA”) under 42 U.S.C. § 262(…

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