Janssen’s suit against Celltrion in the District of Massachusetts (C.A. No. 1:15-cv-10698) relating to a biosimilar of Janssen’s Remicade® (infliximab) is one of the few currently pending BPCIA litigations. Over the last week, there have been two important developments with respect to Janssen’s infringement claims: (1) the invalidation of the asserted ’471 patent by the district court and (2) Celltrion’s motion for entry of final judgment to allow for a speedy appeal and final resolution of any infringement claims with respect to that patent.
After Celltrion submitted an aBLA for a proposed infliximab biosimilar in 2014, the parties began to engage in the “patent dance” provisions of the BPCIA. Celltrion produced its application, including manufacturing information, within the statutory 20-day window, and Janssen served its patent list. In response, Celltrion provided a detailed statement and skipped the rest of the dance by summarily agreeing that all of the patents identified by Janssen would be the subject of the first wave of litigation. On the same day, the defendants served a notice of commercial marketing, disclosing that they would be doing commercial marketing of their biosimilar product as early as August 2015.
On March 6, 2015, Janssen sued Celltrion under 35 USC 271(e)(2)(c) for technical infringement of six patents (U.S. Patent Nos. 6,284,471; 7,223,396; 5,807,715; 7,598,083; 6,900,056 and 6,773,600) and to enforce dispute resolution procedure portions of the BPCIA. Janssen also claimed that Celltrion failed to give proper notice of commercial marketing under § 262(l)(8)(A).
Janssen’s infringement claims relating to four of the six patents have since been dismissed, leaving only two patents at issue: U.S. Patent No. 6,284,471 (the ’471 patent, discussed below) and U.S. Patent No. 7,598,083 (the ’083 patent). The ’471 patent covers the composition of a specific antibody used in the anti-TNFα drug infliximab. The ’083 patent relates to cell culture media.
On April 5, 2016, the FDA approved Celltrion’s biosimilar Inflectra. Celltrion then served a second notice of commercial marketing. In response to the Federal Circuit’s decision in Amgen v. Apotex, No. 2016-1308 (Fed. Cir. July 5, 2016), Celltrion agreed not to sell its biosimilar in the United States until October 3, 2016, 180 days after Celltrion served its second notice of commercial marketing. (Dkt. No. 206; Dkt. No. 207.) This mooted Janssen’s complaint about ineffective notice of commercial marketing.
Janssen filed a second action against Celltrion in June 2016 (16-cv-11117), alleging actual infringement of the ’083 patent under 35 U.S.C. § 271(a) and (b). This case has been consolidated with Janssen’s initial suit against Celltrion for all pre-trial and trial matters.
In June 2016, Janssen also filed a complaint against Celltrion’s cell culture supplier, HyClone Laboratories, in the District of Utah, also alleging infringement of the ’083 patent under 35 U.S.C. § 271(a).
’471 PATENT INVALIDITY RULING
At a hearing on August 18, 2016, Judge Wolf invalidated the ’471 patent on two grounds. First, the court granted Celltrion’s motion for summary judgment that Janssen’s ’471 patent was invalid for obviousness-type double patenting. In the accompanying memorandum and order, the court stated that “the ’471 Patent is not patentably distinct from the ’444 Patent.” (Dkt. 221 (Memo.) at 1 (citing Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F.3d 1208 (Fed. Cir. 2014).) The court explained that “a later-issuing, earlier-expiring patent can act as a double patenting reference for an earlier-issuing, later-expiring patent.” (Id.) The ‘444 patent issued on September 14, 2004, and expired on July 11, 2011, whereas the ’471 patent issued on September 4, 2001, and was due to expire in 2018. (Id.) The ’444 patent expired earlier because of patent term changes resulting from the Uruguay Round Agreements Act. (Id. at 2.)
The court also allowed the defendants’ other motion for summary judgment, which argued that the ’471 patent is invalid for an obviousness-type double patent based on U.S. Patent Nos. 5,698,195 and 5,656,272. The court explained that the ’471 patent is not entitled to the statutory safe harbor provided in 35 U.S.C. § 121 because the safe harbor only applies to divisional applications. Here, the application that issued as the ’471 patent was filed as a continuation-in-part of U.S. Pat. App. No. 08/013,413, not a divisional. The court also concluded that the ’471 patent claims would be obvious regardless of whether it applied the “one-way test” for obviousness (considering whether an application’s claims are obvious over issued patent claims) or the “two-way test” (considering “whether the reference patent claims are obvious over the challenged patent claims”). (Memo. at 4-5.)
CELLTRION MOVES FOR FINAL JUDGMENT ON ’471 PATENT INVALIDATION
On August 22, Celltrion moved for entry of judgment under Fed. R. Civ. P. 54(b) on Count 3 of Plaintiffs’ complaint, which alleged infringement of the ’471 patent. (Dkt. No. 229.) Among other requirements, Rule 54(b) requires that “there [be] no just reason for delay” in entering final judgment. Celltrion argued that delaying appeal would “maintain a cloud of uncertainty over Defendants’ product at the expense of patients.” (Dkt. No. 230 at 1.) It also pointed out that all other pending claims are distinct from infringement of the ’471 patent: the ’083 patent involves different inventors and technology and the claims relating to the BPCIA “patent dance” requirement share “no common question of fact or law with the ’471 patent infringement claim.” (Id. at 2, 6-8.) As such, Celltrion argued that there is no risk that the Federal Circuit will be called upon to adjudicate the same issues multiple times. (Id. at 9-10.) Celltrion’s motion shows that it is hoping to resolve this potential infringement claim as soon as possible, given that it may launch its product “as soon as October 3, 2016.” (Id. at 10.)
Trial in this case is scheduled for February 2017. Because the court consolidated Janssen’s 2015 and 2016 actions, this trial will include Janssen’s claims for infringement of the ’083 cell culture patent under § 271(a) and (b), as well as any remaining claims in the 2015 action. We will continue to monitor this case as it develops and provide updates.