CELLTRION FILES RESPONSE BRIEF IN INFLIXIMAB APPEAL

Biosimilar News  •  BPCIA and Related U.S. Statutes  •  Janssen v. Celltrion (infliximab)  •  Patent Dance  •  U.S. Biosimilar Litigation News  •  U.S. District Court Decisions

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

As we also previously reported, Janssen filed its opening appeal brief on January 26, 2017.  On March 7, 2017, Celltrion filed its response brief.  Celltrion argues that the Federal Circuit should affirm the district court’s holding that the ‘471 patent is invalid for obviousness-type double patenting (“OTDP”).  With respect to the OTDP ruling over the ‘444 reference patent, Celltrion argues that the district court was correct in applying the holding of Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F.3d 1208 (Fed. Cir. 2014) because the instant case does not differ materially from Gilead.  With respect to the OTDP ruling over the ‘195 and ‘272 reference patents, Celltrion argues that the holding should be affirmed because (1) the section 121 safe harbor only applies to divisional applications and Janssen cannot retroactively designate its continuation-in-part as a divisional; (2) the two-way test for OTDP does not apply because the Patent Office was responsible in part for the delayed issuance of the ‘471 patent; and (3) even if the two-way test were applied, the ‘471 patent’s claims are invalid because the ‘195 and ‘272 patent claims are obvious over the ‘471 patent’s claims.

Janssen’s reply brief is due on March 21, 2017.  However, on March 10, 2017, Janssen filed a motion to extend the time for filing their reply brief by 30 days.  If Janssen’s motion is granted, their reply brief will be due on April 20, 2017.  Stay tuned to Big Molecule Watch for further updates regarding this case.

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