Last updated: November 28, 2016
Below is a summary of the BPCIA litigations that have been filed to date. Please also read our quarterly BPCIA litigation round-up posts for additional information about these cases (Summer 2016; Fall 2016).
|Case Name||Court||Case Status||Patent Dance Posture||Notice of Commercial Marketing Issue(s)|
|Amgen v. Sandoz
Fed. Cir. 15-1499
S.Ct. 15-1039, -1195 (petitions pending).
|S.Ct.: Sandoz and Amgen filed cert. petitions regarding the CAFC’s interpretation of (l)(2)(A) and (l)(8)(A). The Solicitor General has been invited to file a brief on whether cert. should be granted.
D.Ct.: Parties proposed a 7- to 9-day jury trial to begin the week of Dec. 11, 2017. Sandoz’s biosimilar product is approved and on the market.
Sandoz did not provide Amgen its (k) application or manufacturing information within 20 days of FDA’s notification of acceptance.
|Notice given before and after FDA approval
Sandoz claimed to give notice of commercial marketing when it notified Amgen that FDA had accepted Sandoz’s biosimilar application for review. After FDA approved Sandoz’s biosimilar product, Sandoz gave Amgen another notice of commercial marketing. The Fed. Cir. held that Sandoz’s pre-approval notice was ineffective under the BPCIA, and thus enjoined Sandoz from marketing its approved Zarxio product until 180 days after the date of FDA approval, when Sandoz had given another notice of commercial marketing. Sandoz has filed a cert. petition.
|Amgen v. Sandoz
|Consolidated with filgrastim case for discovery and trial.||Danced
The parties agreed that U.S. Patent Nos. 8,940,878 and 5,824,784 were properly included in an immediate infringement action.However, initially, after receiving Amgen’s list of 2 patents Amgen believed a claim of infringement could reasonably be asserted, Sandoz provided invalidity and non-infringement contentions regarding those 2 patents and then “waived” or declared unnecessary the remaining exchange and negotiation steps that would otherwise precede immediate litigation under (l)(6). Amgen filed a complaint in D.N.J. seeking a declaratory judgment that Sandoz violated the BPCIA by exiting. Sandoz later restarted the patent dance negotiation and the D.N.J. case was dismissed.
|Not raised in Complaint|
|Janssen v. Celltrion
Fed. Cir. 17-1120 (docketed).
|2 patents-in-suit: ‘781 and ‘083. Court found the ‘471 invalid for double patenting and entered partial final judgment. Janssen has appealed. A motion for summary judgment of non-infringement of the ‘083 is pending and scheduled for a hearing on Dec. 21-22, 2016. A jury trial is scheduled to begin Feb. 13, 2017. Celltrion’s biosimilar product is approved, and Pfizer has announced that intends to launch in late November 2016.||Some dance
Celltrion produced its application, including manufacturing information (the completeness of which Janssen disputes), within the statutory 20-day window.Janssen served its patent list, Celltrion provided a detailed statement in response, and agreed that all of the patents identified by Janssen would be the subject of the first wave of litigation.
|Notice before FDA approval
The defendants served a purported notice of commercial marketing on Feb. 5, 2015. Janssen argued that this notice is ineffective under the BPCIA. Celltrion responded that under Amgen v. Sandoz, it is not required to provide notice of commercial marketing because it has engaged in the patent dance. Celltrion stipulated not to sell its biosimilar product “for use by doctors or patients” before Oct. 3, 2016.
|Amgen v. Apotex
(pegfilgrastim) and Neupogen®
Fed. Cir. 17-1010 (docketed).
S.Ct. 16-332 (petition pending).
|S.Ct.: Apotex has filed a cert. petition challenging the CAFC’s interpretation of (l)(8)(A) and affirmance of the district court’s grant of a preliminary injunction enjoining Apotex’s launch. Briefing has concluded, and the case has been distributed for conference on December 9, 2016.||Dance completed through first wave
Amgen and Apotex reached agreement upon a list of patents that should be the subject of a first wave of patent litigation.
|Notice before FDA approval
Apotex sent Amgen a purported notice of commercial marketing on April 17, 2015. Amgen sought a declaratory judgment that Apotex can provide an effective 180-day notice of commercial marketing only after FDA licenses its proposed biosimilar product. The district court issued a preliminary injunction enjoining Apotex from launching prior to 180-days after providing an effective, post-licensure notice. The Federal Circuit affirmed. Apotex has filed a cert. petition.
|Amgen v. Hospira
re: Epogen®/ Procrit®
Fed. Cir. 16-2179 (briefing).
|D. Ct.: The court denied Hospira’s motion to dismiss Amgen’s BPCIA notice claims. More recently, the court denied Amgen leave to amend its complaint to add three new defendants but granted leave to add new infringement theories. A jury trial is set for Sept. 18, 2017.||Some dance
Hospira provided its biosimilar application to Amgen within the 20-day statutory window, but allegedly has not provided manufacturing information. Amgen provided a list of patents that could be asserted, and Hospira provided responses and agreed that every patent Amgen listed would be the subject of the first wave of litigation.
|Notice before FDA approval
Hospira provided a purported notice of commercial marketing on April 8, 2015. Amgen argues that this notice is legally ineffective under the BPCIA. Hospira argues that it is not required to give any notice under the Federal Circuit’s interpretation of the notice provision of the BPCIA, and moved to dismiss Amgen’s notice claims. The court denied that motion.
|Immunex Corp. v. Sandoz Inc.
(J. Cecchi; Mag. J. Clark)
|A scheduling order has been entered. Although Sandoz’s product is approved, Sandoz has stipulated not to launch its product before a date that is not publicly disclosed. A bench trial is set for Apr. 17, 2018. Sandoz’s biosimilar product is approved.||Some dance
According to the Complaint, Sandoz “provided Immunex with remote access to a Sandoz-hosted database of TIFF images…that Sandoz represented to constitute its aBLA and [manufacturing information],” and later provided additional documents related to the manufacturing process after a request from Immunex for further information. After Immunex provided Sandoz a list of patents for which Immunex believed a claim of infringement could reasonably be asserted based on Defendants’ proposed etanercept product, Sandoz responded by “agreeing” to immediate litigation on Immunex’s list of patents.
|None raised in the Complaint|
|AbbVie v. Amgen re: Humira®
|D.Del. 1:16cv666(J. Robinson).||Initial pleadings have been filed. A scheduling order has been entered, with a 20-day bench trial set for Nov. 4, 2019. Amgen’s biosimilar product is approved.||Some dance
According to the complaint, Amgen provided its aBLA but no additional manufacturing information. AbbVie then identified 61 patents pursuant to (l)(3)(A) and (l)(7). Unable to agree on the patents to litigate in the First Wave, Amgen indicated that it was willing to litigate 6 patents. Each side identified 6 patents, 2 of which overlapped, resulting in 10 patents being litigated in the First Wave.
|In the complaint (filed before Amgen obtained approval), AbbVie alleged that Amgen failed to confirm that it intended to comply with the notice of commercial marketing provision and asserted a claim seeking to compel Amgen to comply and to enjoin Amgen from launching its product until 180 days after Amgen provides proper notice. In its counterclaims and answer (also filed before Amgen obtained approval), Amgen asserted that it intends to fully comply with its obligations under (8)(A) as interpreted by the Federal Circuit in Amgen v. Sandoz and Amgen v. Apotex.|