On July 23, 2015, Janssen Biotech, Inc. and New York University filed a brief appealing the rejection of all claims of U.S. Patent No. 6,284,471, a patent covering Remicade (infliximab), to the USPTO’s Patent Trial and Appeal Board. The ’471 patent was put into ex parte reexamination in 2013, and the examiner has rejected all claims for obviousness-type double patenting over two expired U.S. patents.
Janssen’s brief argues that the obviousness-type double patenting rejection is improper (i) because the ’471 patent is now a divisional application entitled to the 35 U.S.C. § 121 safe harbor, and (ii) because the claims of the ’471 patent would be patentably distinct from the claims of the two expired patents under the two-way obviousness test.
The ’471 patent is currently the subject of litigation in the District of Massachusetts, brought by Janssen and NYU against Celltrion and Hospira. The pleadings for that case can be found here.