Janssen v. Celltrion (Infliximab): District Court Enters Partial Final Judgment in Favor of Celltrion

As we previously reported, after the district court found that all the asserted claims of the ’471 patent were invalid for obviousness-type double patenting, Celltrion moved for entry of final judgment on that patent under Federal Rule of Civil Procedure 54(b), even though Janssen’s infringement claims regarding the ’083 patent are still pending.  Rule 54(b) allows a court to enter final judgment on fewer than all pending claims, but “only if the court expressly determines that there is no just reason for delay.”

Yesterday, the district court granted Celltrion’s motion and entered final judgment as to the ’471 patent.  In granting Celltrion’s motion and allowing an appeal to proceed before resolution of the ’083 patent claims, the district court found that “there is no just reason to delay the entry of final judgment concerning the ’471 patent” because the ’471 patent-related issues (chimeric antibodies including infliximab) are separate and distinct from the remaining issues concerning the ’083 patent, which relates to a different technology (cell culture medium) and raises no common questions of fact or law; the pending reexamination of the ’471 patent was not going to impact the validity of the claims; and the Federal Circuit was not going to have to decide the same issues more than once.

The district court also found that the equities favored expediting the appeal process for the ’471 patent because it would alleviate the risks of uncertainty for doctors and patients and harm to legitimate price competition, and would serve the BPCIA’s purposes of promoting the prompt resolution of claims of patent infringement by biosimilar products and encourage the sale of non-infringing, more affordable biosimilars to the benefit of public health.  In reaching that conclusion, the district court noted that expediting the appeal would help resolve uncertainty that could discourage doctors from prescribing Celltrion’s Inflectra product and affect decisions by potential investors, and would serve the public interest in clearing the path for a “less expensive biosimilar alternative to compete fairly with Remicade.”  The court also noted that because “Remicade generates more than $4 billion a year in revenue for Janssen[,] Janssen … has a financial incentive to try to delay the appeal of the finding that the ’471 patent is invalid in the hope that uncertainty concerning the infringement issue will contribute to a delay in the sale of Inflectra or discourage doctors from prescribing it.”

Stay tuned to Big Molecule Watch for updates on Janssen’s anticipated appeal and the remaining district court litigation regarding the ’083 patent.