As we previously reported, in Janssen v. Celltrion, Janssen appealed the district court’s partial final judgment that Janssen’s ‘471 patent, directed to monoclonal antibodies including infliximab or cA2 antibody, is invalid.

On January 26, 2017, pursuant to a 30-day extension, Janssen filed its opening appeal brief, in which Janssen challenged the two district court rulings granting summary judgment that the asserted claims are invalid for obviousness-type double patenting (“OTDP”).  With respect to the OTDP ruling over the ‘444 reference patent, Janssen argues that the district court erred in extending the holding of Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F.3d 1208 (Fed. Cir. 2014) to the present case.  With respect to the OTDP ruling over the ‘195 and ‘272 reference patents, Janssen argues that the district court erred by (1) ruling that the section 121 safe harbor does not apply, (2) ruling that the one-way test applies, as opposed to the two-way test and (3) holding that the asserted claims are invalid even under the two-way test.   

Without any extensions, Celltrion’s brief is due in early March.  Stay tuned to Big Molecule Watch for further updates regarding this case.