Janssen Files New Complaint Against Celltrion Re Infliximab

Janssen v. Celltrion (infliximab)  •  U.S. Biosimilar Litigation News

In another development in the ongoing dispute between Janssen against Celltrion and Hospira relating to infliximab, Janssen filed a new complaint on May 31, asserting infringement of U.S. Pat. No. 7,598,083.

In prior 2015 and 2016 actions against the same defendants (later consolidated), Janssen had asserted direct and induced infringement of the ‘083 patent (as well as other patents which were later dismissed or found invalid), and had also sought to enforce the patent dispute resolution provisions of the BPCIA. The Court in the consolidated action ruled that because Defendants did not properly complete the patent dance, “35 U.S.C. §271(e)(6) will not limit Janssen’s damages to a reasonable royalty for any proven infringement of the ‘083 Patent.”

According to Janssen’s complaint, Defendants then asserted that they would now participate in negotiations under 42 U.S.C. § 262(l)(4), and that Janssen must file suit within 30 days after the conclusion of the renewed BPCIA pre-litigation procedures to avoid the limitations on remedies set by 35 U.S.C. § 271(e)(6)(B).

Although Janssen denies that this renewed effort at the patent dance has any legal effect, Janssen says it filed this new action in order to avoid any future allegation that the limitations on remedies applies. The infringement allegations in the new complaint are essentially the same as the prior actions with respect to the ‘083 patent.

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