As we reported last week, the district court granted Celltrion’s Motion for Summary Judgment of Invalidity for one of the two patents-at-issue in Janssen v. Celltrion. The Korea Times reports that Celltrion shipped its first batch of its Remicade biosimilar, Remsima, to the U.S. on August 19th, the day after the ruling. Please continue to…
Following three days of hearings in Janssen v. Celltrion, the District Court for the District of Massachusetts (J. Wolf) today issued a memorandum order summarizing the Court’s rulings on several pending motions in the case. The Court granted Defendants’ Motion for Summary Judgment of Invalidity of the ’471 patent on both…
Below is a brief summary of each of the U.S. patent litigations concerning a proposed or approved biosimilar product. Please also consult our BPCIA Litigation Summary Chart for additional details.
As we previously reported, the district court in Janssen v. Celltrion (in which U.S. Patent Nos. 6,284,471 and 7,598,083 are at issue) began hearing oral argument on August 16 on Celltrion’s motion for summary judgment that all claims of the ’471 patent-in-suit are invalid for obviousness-type double patenting, as well…
As we previously reported, on June 17, Janssen filed two complaints alleging infringement of claims in U.S. Patent No. 7,598,083, one against Celltrion and Hospira, and one against HyClone Laboratories, Celltrion’s supplier of cell culture media. On August 5th, HyClone filed a motion for injunctive relief to dismiss and to…
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…
The District Court for the District of Massachusetts (Judge Wolf) yesterday decided two pending motions in Janssen v. Celltrion: Plaintiffs’ motion to stay litigation on the ‘471 patent (covering infliximab) pending appeal of the PTAB’s decision invalidating the patent; and Plaintiffs’ motion to amend the protective order to permit them to file…
We previously reported that the FDA approved Celltrion’s Inflectra®, a biosimilar to Janssen’s Remicade® (infliximab). We also reported on a series of letters concerning Janssen’s request for an expedited trial in view of a possible Celltrion launch in October of 2016. In a letter filed with the court yesterday, Janssen…
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…
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…