Amgen’s Opposition to Motion to Expedite Briefing on Appeal of P.I. Ruling in Amgen v. Apotex

Amgen v. Apotex (pegfilgrastim)  •  Biosimilar News  •  BPCIA and Related U.S. Statutes  •  U.S. Biosimilar Litigation News  •  U.S. District Court Decisions

As we’ve covered previously, Apotex has moved to expedite the briefing schedule for its appeal of the district court order in Amgen v. Apotex, in which the district court granted Amgen a preliminary injunction prohibiting Apotex from launching its biosimilar pegfilgrastim product until at least 180 days after FDA licensure of the product.

Today, Amgen filed its opposition to the motion to expedite, arguing that Apotex has not shown good cause for why an expedited schedule is warranted. Amgen argues that Apotex has shown no support for its assertion that it will receive FDA approval during the appeal, and therefore has failed to show that an expedited schedule is necessary to avoid harm to Apotex. Amgen writes: “The district court’s order causes no immediate harm to Apotex, and does not yet compel Apotex to give 180 days’ commercial-marketing notice or prohibit Apotex from marketing its biosimilar products, because the court’s order is conditioned on FDA approval and FDA still has not approved either of Apotex’s applications. If FDA never approves those applications, the district court’s injunction will never have any consequence. If FDA approves those applications only after this Court has decided this appeal, there will have been no need to expedite the appeal.”

Amgen further argues that an expedited schedule would “depriv[e] Amgen of the full time to write its brief,” and “prejudice[] the ability of potential amici to consider and brief” the issues on appeal, which Apotex has characterized as issues of “great significance.” And, Amgen argues in closing, Amgen v. Sandoz answered the questions presented already, and in Amgen’s favor.

According to the Court’s order following Apotex’s motion to expedite, any reply by Apotex in support of its motion will be due December 22, 2015.  Apotex’s opening brief will be due December 30, 2015.

Stay tuned for those updates here on the Big Molecule Watch.

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