Welcome to the Big Molecule Watch!

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Big Molecule Watch will be posting updates and analyses on regulatory issues, litigation, legislation, and other news in the ever-developing world of biosimilars. The editors of this blog have collectively been watching and engaging with the world of biosimilars (“big molecules”) since before the inception of the biosimilar industry in the U.S., and we’re excited to share the observations of our active watch on this new forum.

If you’re looking for a primer on biologics, check out our background post introducing the world of biologics, biosimilars, and the Biologics Price Competition and Innovation Act (“BPCIA”).

We’ve also collected (and will continue to update) some reference documents that might be of interest to visitors of this blog—you can find them under the “Links” section to the right of this page.

UPDATE in Janssen v. Celltrion: Stipulation of Voluntary Dismissal Narrows Issues to be Litigated

The parties in Janssen v. Celltrion have filed a stipulation of voluntary dismissal narrowing the issues in the litigation.  While it does not dispose of all patent infringement claims in suit, the stipulation narrows the case as follows: Defendants will not launch any biosimilar infliximab product in the United States until after September 15, 2015, the date…

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BREAKING NEWS: PTAB Denied Motions for Sanctions Against the Coalition for Affordable Drugs VI

The PTAB decided today, in IPRs 2015-01092, 2015-01096, 2015-01102, 2015-01103, and 2015-01169, that Patent Owner Celgene failed to meet the evidentiary burden required for its Motions for Sanctions against the Coalition for Affordable Drugs VI, LLC.  The PTAB specifically rejected each of Celgene’s bases for seeking sanctions: Profit Motive: “Profit is at the…

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Janssen v. Celltrion: Motion to Modify Protective Order

In addition to the pending cross-motions for partial summary judgment on which we’ve previously reported, the parties in the Janssen v. Celltrion BPCIA litigation recently completed briefing on the issue of whether the district court should permit Janssen to use confidential information obtained through discovery as a basis for a…

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CFAD's Additional Briefing on "Abusive" IPRs

Earlier this month, PTAB asked for additional briefing on whether the two IPRs filed by the Coalition for Affordable Drugs (“Bass Group”, or “CFAD”) against NPS should be dismissed for abuse of process.  In its Brief in Response to the Board’s Request for Additional Briefing, NPS responded to the PTAB’s…

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NPS's Additional Briefing on “Abusive” IPRs

We recently posted about the PTAB asking for additional briefing on whether the two IPRs filed by the Coalition for Affordable Drugs (“Bass Group”) against NPS (which was acquired by Shire, LLC) should be dismissed for abuse of process.  The two IPRs are directed to the same patent, US 7,056,886,…

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New BPCIA Litigation: Amgen v. Hospira

Amgen has initiated new litigation over the patent provisions of the BPCIA, this time against Hospira in the U.S. District Court for the District of Delaware, regarding Hospira’s biosimilar application for FDA licensure of a biosimilar version of Amgen’s Epogen (epoetin alfa) product, which was approved by FDA in 1989…

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Janssen v. Celltrion Supplemental Briefing in Light of Amgen v. Sandoz: Opposition Brief from Celltrion and Hospira

As we reported in a previous post, the parties in Janssen v. Celltrion–a BPCIA-related case pending in the District of Massachusetts—are currently litigating whether Celltrion’s pre-FDA-licensure notice of commercial marketing was legally effective under the BPCIA. The parties have filed cross-motions for partial summary judgment on this issue, and these motions were pending when the Federal Circuit issued…

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