Search Results for: "janssen v celltrion"

Update in Janssen v. Celltrion: Parties Stipulate that Celltrion Will Not Sell Infliximab Biosimilar Before September 15, 2016

We previously reported that the FDA approved Celltrion’s Inflectra®, a biosimilar to Janssen’s Remicade® (infliximab) on April 5, 2016.  A year prior to the approval, Janssen filed a motion for summary judgment and preliminary and permanent injunction based on the contention that 42 U.S.C. § 262(l)(8)(A) prohibits Celltrion from commercially marketing its biosimilar…

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Celltrion Opposes Janssen's Request for Expedited Trial

We previously reported that the FDA approved Celltrion’s Inflectra®, a biosimilar to Janssen’s Remicade® (infliximab).  Last week, we also reported that in Janssen v. Celltrion, Janssen filed a letter to the court stating that the “Defendants notified us that they intend to begin commercial sales of their biosimilar in no later than 180 days…

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Janssen Seeks Expedited Trial in Janssen v. Celltrion

One week ago, we reported that FDA approved Celltrion’s Inflectra, a biosimilar to Janssen’s Remicade (infliximab). Today, Janssen filed a letter to the court in Janssen v. Celltrion informing the court that the “Defendants notified us that they intend to begin commercial sales of their biosimilar in no later than 180 days…

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Celltrion and Hospira Move for Summary Judgment on the ’471 Patent in Janssen v. Celltrion

Defendants Celltrion and Hospira in Janssen v. Celltrion have moved for summary judgment that U.S. Patent No. 6,264,471, which covers Remicade (infliximab), is invalid for obviousness-type double patenting. At the District Court status conference earlier this month, Celltrion told the court that it expects FDA approval of its infliximab biosimilar product in…

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Big Day for Celltrion’s Infliximab Product

Yesterday, the FDA’s Advisory Committee overwhelmingly supported approval of Celltrion’s infliximab product, which is a biosimilar for Janssen’s Remicade product. At the District Court status conference in Janssen v. Celltrion, which followed the Advisory Committee vote, Celltrion’s counsel said that Celltrion is expecting FDA approval in about four to eight…

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