Welcome to the Big Molecule Watch!

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Goodwin’s award-winning Big Molecule Watch is the best resource for daily updates and analyses of regulatory issues, litigation, legislation, and other news in the world of biologics, biosimilars and related technologies. The editors of this blog have collectively been watching and engaging with the world of biologics and biosimilars (“big molecules”) since before the inception of the biosimilar industry in the U.S.  With extensive experience representing clients at all stages of a biologic’s or biosimilar’s lifecycle, from research and development, to patents, to regulatory application and approval, and through litigation and appeals, we are excited to share our observations and insights as the industry and the law continues to develop in this exciting area.

This blog focuses on “big molecules” as opposed to “small molecules.” Small molecule drugs have low molecular weight, a simple and well-defined structure, and are chemically synthesized. In contrast, “big molecule” drugs have high molecular weight, complex structures, and are derived from living organisms. For example, aspirin is small molecule while a monoclonal antibody is a big molecule. For further reading on big molecules, consider FDA's resources on biologics.

AbbVie Citizen Petition Update

As we reported in an earlier post, AbbVie filed a Citizen Petition on June 2, 2015 demanding that FDA impose particular labeling requirements on biosimilar applicants. Since then, several entities have submitted comments regarding AbbVie’s petition—some in support and others adamantly opposing—and AbbVie has supplemented its original petition. We’ve summarized those submissions in…

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IPR Tracker: IPR2015-01514 and IPR2015-01517 (Amgen Inc.) (U.S. Patent Nos. 8,916,157 and 8,916,158)

IPR2015-01514 (Amgen Inc.) (U.S. Patent No. 8,916,157) Petitioner: Amgen Inc. Patent: U.S. Patent No. 8,916,157 Patent Title: Formulation of human antibodies for treating TNF-α associated disorders Patent Owner: AbbVie Biotechnology Ltd. IPR2015-01517 (Amgen Inc.) (U.S. Patent No. 8,916,158) Petitioner: Amgen Inc. Patent: U.S. Patent No. 8,916,158 Patent Title: Formulation of human antibodies for…

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Update in Amgen v. Apotex: Amgen Files Preliminary Injunction Blocking Apotex from Marketing Neulasta Biosimilar

As discussed in earlier coverage, Amgen has now made good on its intention to seek a preliminary injunction against Apotex.  Amgen looks to block Apotex from marketing its Neulasta biosimilar before the expiration of the 180-day pre-marketing notice following FDA approval. Apotex has previously argued that the Federal Circuit’s panel decision…

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Amgen v. Hospira: Hospira Moves to Dismiss BPCIA Claims

As we reported in a previous post, Amgen is the plaintiff in another suit litigating the patent information provisions of the BPCIA, this time against Hospira.  Amgen’s complaint alleged that Hospira violated the BPCIA by (1) not providing manufacturing information within 20 days of FDA’s acceptance of Hospira’s biosimilar application for review…

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IPR Petition Up for Grabs

We recently posted about the PTAB declining to sanction CFAD for filing IPRs.  In light of that holding, Erich Spangenberg, owner of nXn Partners, revealed his intention to make publicly available substantially final draft versions of IPR petitions for pharmaceutical patents that he believes are invalid.  Spangenberg does not care who…

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