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# Amgen Wants Sandoz Back in Neulasta ‘Patent Dance’
- URL: https://www.fdaweb.com/amgen-wants-sandoz-back-in-neulasta-patent-dance/
- Published: 2016-03-08T12:00:00.000Z
- Updated: 2026-09-15T02:41:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134997

> Amgen is asking a New Jersey federal court to rule that Sandoz cannot skip biosimilar “patent dance” negotiations over its Neulasta (pegfilgrastim). *Big Molecule Watch* [reports](http://www.bigmoleculewatch.com/2016/03/07/amgen-seeks-declaration-that-sandoz-may-not-exit-patent-dance-early/?ref=fdaweb.com) online that Amgen told the court that **(1)** in 11/2015, Sandoz notified Amgen that FDA had accepted Sandoz’ pegfilgrastim aBLA and provided files identified as the aBLA and information about Sandoz’ manufacturing process; **(2)** on 1/12, Amgen provided Sandoz a list of patents that Amgen believed Sandoz’ biosimilar would infringe; and **(3)** on 2/2\. Sandoz provided invalidity and non-infringement contentions, and said it no longer wanted to follow the Biologic Price Competition and Innovation Act patent dance provisions.  
>  
> Amgen asked the court to declare that Sandoz’ attempt to skip the patent dance is impermissible and that Amgen is not barred from seeking injunctive relief or lost profits for failing to file a patent infringement before 3/4\. *Big Molecule Watch* says it is notable that Amgen’s complaint includes no patent infringement claims.