Janssen has fired its opening salvo in its attempt to overturn two invalidity rulings at the district court level and one invalidity ruling at the PTAB with respect to U.S. Patent No. 6,284,471 (the ’471 patent) covering REMICADE® (infliximab). In its opening appeal brief (Appeal No. 17-1120), Janssen did not sugarcoat its interest in keeping the ’471 alive, calling out REMICADE®’s $4 billion-a-year sales in the U.S. alone and noting the challenge to Janssen’s empire wrought by Celltrion’s biosimilar. (See Janssen Br. at 9.) Both the district court rulings and the reexamination decision were a result of Celltrion’s efforts to clear the way for its biosimilar, which was approved by the FDA last year and launched in late 2016.

Janssen’s appeal brief filed January 26, 2017, addressed only the district court’s summary judgment rulings holding the ’471 patent invalid on two different obviousness-type double patenting theories, both delving into the intricacies of patent prosecution.  First, Janssen challenged the district court’s argument that the ’471 patent was invalid in light of the so-called Gilead rule, citing Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F.3d 1208 (Fed. Cir. 2014).  The district court held that the ’471 patent (filed before the Uruguay Round Agreements Act (“URAA”) changing patent expiration from 17 years from issuance to 20 years from earliest priority application), was invalid in light of another patent (U.S. 6,790,444) filed after the URAA, but expiring before the ’471 patent due to the change in rules. According to Janssen, this is an “important issue of first impression” (id. at 30), since Gilead was different: it involved two patents that both issued after the URAA.  Although the district court acknowledged that Gilead was distinguishable, it extended Gilead to this case on the grounds that Gilead instructed “[i]t is a bedrock principle of our patent system that when a patent expires, the public is free to use not only the same invention claimed in the expired patent but also obvious or patentably indistinct modifications of that invention.” (Janssen Br. at 12.) Janssen countered that the so-called “bedrock principle” is not as expansive as the district court believed since a patent’s expiration does not give anyone rights to practice the invention and is not a guarantee of a right to use. (Id. at 38.) For example, Janssen pointed to the BPCIA exclusivity provisions, which give the reference product sponsor 12 years of exclusivity even if all of the innovator’s patents have expired. (Id. at 39, n.6.) According to Janssen, Gilead should be limited to its facts since it would undermine Congressional intent in allowing pre-URAA patents to retain their expiration date of 17 years from issuance to allow a later filed patent to cut-off patent rights.  (Janssen Br. at 3, 11, 42.) Finally, Janssen claimed obviousness-type double-patenting only applies “where there has been an ‘improper’ or ‘unjustified’ extension of the patent term,” which does not apply to the ’471 patent, which was first to be filed and the first to issue and which would naturally expire on September 4, 2018. (Id. at 8, 12-13, 43-44.)  Of note, in its brief, Janssen does not discuss the downsides of the “17 years for issuance” rule, which allowed for “submarine” patents to be quietly working through the patent system for many years without notice to competitors, who could potentially be investing heavily in the field.

Janssen also challenged the district court’s “Safe Harbor” ruling, which held that the ’471 patent was invalid in light of U.S. Patent Nos. 5,698,195 and 5,656,272 (“the ’195 and ’272 patents”). Janssen argued that the district court improperly treated the application issuing as the ’471 as a continuation-in-part instead of a divisional, which brought the application outside the safe harbor for divisionals under 35 U.S.C. § 121.  Janssen also alleged that the district court improperly applied both a one-way test and a two-way test for obviousness-type double patenting for these reference patents, arguing only the more difficult to meet two-way test should apply. Finally, Janssen argued that the district court incorrectly applied the two-way test in comparing the claims of the ’195 and ’272 patents to the specification of the ’471 patent, instead of comparing the claims of each patent to the claims of the ’471 patent. (Janssen Br. at 3-5.)  The difference is important, according to Janssen, since the ’471 patent claims only the antibodies themselves, whereas the ’195 and ’272 patent are directed to methods of using the antibodies to treat rheumatoid arthritis and Crohn’s disease—and there is no evidence that the ’471 antibody claims would themselves have made the method of treatment claims obvious. (Id. at 27.)

Although Janssen’s brief only addressed the district court’s rulings, Janssen told the Federal Circuit it should first decide the co-pending appeal (Appeal No. 17-1257) directed to the PTAB’s reexamination invalidity decision, which also addressed obviousness-type double patenting in light of the ’195 and ’272 patents.  (Janssen Br. at 5.) Janssen noted that the ’471 patent was amended during reexamination (specifically to remove new matter added when the application was originally filed and make the application more like a true divisional), so a reversal of the PTAB decision “would supersede the district court’s ruling, which was based on the un-amended form of the ’471 patent.”

Celltrion’s reply is due in early March, 40 days from Janssen’s filing. See Fed. Cir. R. 31(a)(2). The resolution of this appeal may be somewhat delayed due to the co-pending appeal, in which Janssen’s opening brief is due February 28, 2017.  The Federal Circuit has stated that the two appeals “will be considered companion cases and assigned to the same merits panel for oral argument.” (Docket 34.)