Amgen, Inc. et al. v. Hospira, Inc.


Docket No. 2016-2179

DYK, BRYSON, CHEN
August 10, 2017

Brief summary: Amgens’s appeal for lack of jurisdiction and petition for a writ of mandamus dismissed and denied, respectively, since DC denial of Amgen’s motion to compel discovery is “reviewable from final judgment” and Amgen could have listed cell-culture patents it believes “could reasonably be asserted” under BPCIA (l)(3)(A).

Summary: Amgen appealed DC order denying its motion to compel discovery (and requested a writ of mandamus ordering the same) from Hospira in an infringement dispute regarding EPOGEN® governed by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). In a previous opinion (Amgen, FC 2016), the FC panel asked the parties to brief ‘whether this court has jurisdiction pursuant to the collateral order doctrine or under the All Writs Act”, which is addressed here. The FC panel opinion explains that the dispute “arises from the disclosure requirements of the BPCIA…recently addressed by the Supreme Court in Sandoz” (US 2017) for abbreviated approval “subsection (k)” applicants (allowing for “piggyback[ing] on the showing made by the [sponsor] of a previously [approved] biologic (reference product)”). One of the obligations on subsection (k) applicants “is to provide the sponsor with ‘a copy of the application submitted’ under subsection (k), ‘and other such information that describes the process or processes used to manufacture the biological product” (42 USC § 262(l)(2)(A)). This then “leads to a series of information exchanges…between the applicant and the sponsor that ‘channels the parties into two phases of patent litigation’”: 1) a first phase in which “patents that they would like to litigate immediately” are identified; and, 2) a second phase involving “any patents that were included on the parties’ [paragraph (l)(3)] lists but not litigated in the first phase” (§ 262 (l)(6)) (42 USC § 262(l)(3), (l)(4), and (l)(5), (l)(6) (first phase), and (l)(8) (second phase); Sandoz, US 2017; Amgen, FC 2016). Amgen wrote Hospira a letter asserting “Hospira had failed to ‘fully disclose the specific composition of the cell-culture medium used in the manufacture’ of Hospira’s biosimilar” as required under (l)(2)(A), but Hopsira contended the information was included in its application (not resolved here) (Amgen (FC 2015), “a sponsor may seek information withheld by an applicant under paragraph (l)(2)(A) ‘through discovery’”). As a result, Amgen did not disclose any cell culture-related patents in its list. The DC stated that the cell-culture information sought by Amgen had ‘essentially, no relevance to the patents that are asserted’”. Regarding jurisdiction, the FC panel explained that “an appeal must be from a ‘final’ judgment that ‘ends the litigation on the merits and leaves for the court to do but execute the judgment’” (Livesay, US 1978). There is a “small class” of exceptions where “the order conclusively determine[s] the disputed question, resolve[s] an important issue completely separate from the merits of the action, and [is] effectively unreviewable on appeal from a final judgment” (Livesay; Microsoft, US 2017; Cohen, US 1949). The issue here is whether the DC’s “order is ‘effectively unreviewable’ on appeal”. The FC panel found that it is not since it is “reviewable from final judgment” (Livesay; Kircher, US 2006 (“Congress’s decision not to provide for interlocutory review simply means that immediate appeal is not available.”)).

With respect to the Amgen’s request for a Writ, the FC panel also explained “five potential avenues available to a sponsor seeking to secure process information pursuant to paragraph (l)(2)(A)”: 1) injunction under federal law (unvailable under Sandoz); 2) injunction under state law (not raised by Amgen here); 3) sue for patent infringement flowing from the failure to comply with (l)(2)(A) (not available since under 271(e)(2) the “failure to disclose…[is] not an act of artificial infringement” (Sandoz)); 4): “sue on ‘patents descrbied in [paragraph (l)(3)…35 U.S.C. § 271(e)(2)(C)(i)…the ‘list of patents for which the…sponsor believes a claim of patent infringement could reasonably be asserted”; and, 5) “sue on a patent that ‘could be identified’ under paragraph (l)(3). Regarding (4) and (5), the FC panel noted that “Amgen did not list any of its cell-culture patents, nor did it bring suit on any of these patents as ones that ‘could be identified’”. The FC panel also explained that Amgen could have listed such patents under (l)(3)(A) which “merely requires the sponsor to list patents that it ‘believes…could reasonably be asserted” (“the reasonableness requirement of paragraph (l)(3)(A) does not preclude a sponsor from listing a patent for which an applicant has not provided information under paragraph (l)(2)(A)”; “if a sponsor forms a belief based on an inquiry limited by an applicant’s withholding of information, the sponsor has still satisfied Rule 11” (Fed. R. Civ. P. 11(b); Hoffman-LaRoche, FC 2000).

This entry was posted in Biosimilars, Generics / ANDA. Bookmark the permalink.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

This site uses Akismet to reduce spam. Learn how your comment data is processed.