Amgen v. Apotex: District Court Decides that the ’138 Patent is Not Invalid on Some Grounds; Enablement is Still an Open Issue

Amgen v. Apotex (pegfilgrastim)

As we previously reported, on July 5, the Federal Circuit affirmed the district court’s grant of a preliminary injunction enjoining Apotex from launching its biosimilar version of Amgen’s Neulasta (pegfilgrastim) until it receives FDA licensure, gives Amgen a post-licensure notice of commercial marketing, and then waits for 180 days to expire.

Trial in the district court for the Southern District of Florida regarding the validity and infringement of the ’138 patent at issue in this case concluded on July 14. Following trial, the court granted Amgen’s motion for judgment on partial findings that the ’138 patent was not proven to be invalid on grounds of anticipation, lack of written description, indefiniteness and obviousness.

The court’s order did not address another challenge based on lack of enablement.

The court also has not yet addressed Apotex’s motion for judgment on partial findings that Amgen did not meet its burden to prove infringement.

Revised findings of fact and conclusions of law are due by August 18. Redacted transcripts for the trial are scheduled to be released on October 20, 2016.

We are following this case closely and will bring you continued updates as the litigation continues.

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