Federal Circuit Affirms Invalidation of Patent Covering Remicade (infliximab) - Big Molecule Watch

As we previously reported, on ex parte reexamination, the Examiner rejected all claims of U.S. Patent No. 6,284,471, a patent covering Janssen’s Remicade® (infliximab), as invalid for obviousness-type double patenting (“OTDP”). The USPTO’s Patent Trial and Appeal Board affirmed the rejection and Janssen appealed the PTAB’s decision to the Federal Circuit.  The ’471 patent was also previously found to be invalid on similar grounds by the United States District Court for the District of Massachusetts in Janssen v. Celltrion, and Janssen appealed that decision as well.

Yesterday, the Federal Circuit affirmed the PTAB’s decision.  The Federal Circuit agreed with the Board’s reasoning that long after the ’471 patent issued, Janssen was not entitled to retroactively amend the application that led to the patent to remove content and convert it from a “continuation-in-part” application to a “divisional” application, and thus be entitled to protection from rejection or invalidation for OTDP under 35 U.S.C. § 121.

Following the decision, the Federal Circuit dismissed as moot Janssen’s appeal of the decision invalidating the ’471 patent in Janssen v. Celltrion.

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