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.

BREAKING NEWS--Federal Circuit Denies Amgen's Emergency Motion for a Temporary Injunction in Amgen v. Sandoz

The Federal Circuit has denied Amgen’s Emergency motion for a temporary injunction pending en banc consideration and review in Amgen v. Sandoz.  Per the Federal Circuit’s July 21st decision, Sandoz was enjoined from marketing its biosimilar filgrastim product, Zarxio, until 180 days from the date it received FDA approval for its product.  That original injunction…

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BREAKING NEWS – Amgen v. Sandoz:  Sandoz’s Response to Amgen’s Emergency Motion for an Injunction Pending En Banc Consideration and Review

Sandoz has filed its opposition to Amgen’s motion seeking an “emergency”  injunction from the Federal Circuit to extend the injunction blocking Sandoz from launching its Zarxio biosimilar past September 2, the date the injunction is currently set to expire.  In its opposition, Sandoz blasts Amgen’s motion as “perfunctory” and not meeting…

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BREAKING NEWS—Amgen v. Sandoz: Amgen’s Emergency Motion for an Injunction Pending En Banc Consideration and Review

Following the parties’ petitions for rehearing en banc in Amgen v. Sandoz, Amgen has filed an emergency motion for an injunction to block the launch of Sandoz’s FDA-approved biosimilar filgrastim product, pending the Federal Circuit’s en banc consideration and review.  Sandoz is currently enjoined from marketing its biosimilar product, Zarxio,…

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Update in Amgen v. Apotex: Scheduling Report

As we reported in an earlier post, Amgen v. Apotex is the first biosimilar litigation in which the parties have actually danced the entire “patent dance” through the “first wave.” The case, which concerns Apotex’s application to market a biosimilar version of Neulasta, has already been scheduled for trial beginning July…

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IPR Tracker: IPR2015-01792 (Coalition for Affordable Drugs V LLC, et al.) (U.S. Patent No. 8,163,522)

IPR2015-01792 (Coalition for Affordable Drugs V LLC, et al.) (U.S. Patent No. 8,163,522) Petitioners: Coalition for Affordable Drugs V LLC; Erich Spangenberg; Hayman Capital Management, LP; Hayman Captial Master Fund, LP; Hayman Credes Master Fund, LP; Hayman Investments, LLC; Hayman Offshore Management, Inc.; Hayman Orange Fund SPC – Portfolio A;…

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IPR Tracker Updates: Rituxan (rituximab) IPRs

As we covered in an earlier post, the PTAB has instituted two IPR proceedings concerning patents related to Rituxan® (rituximab) (see IPR2015-00417 (U.S. Patent No. 7,976,838) and IPR 2015-00415 (U.S. Patent No. 7,820,161)). The PTAB had denied institution on a third rituximab IPR petition filed by Boehringer Ingelheim (see IPR2015-00418 (U.S. Patent No. 8,329,172))….

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