Friday, August 11, 2017

Amgen loses appeal at CAFC in Hospira / Epogen case

The issue was appeal of a denial of a motion to compel:

Amgen Inc. (“Amgen”) appeals an order of the United
States District Court for the District of Delaware denying
Amgen’s motion to compel discovery from Hospira, Inc.
(“Hospira”) in a patent infringement case governed by the
Biologics Price Competition and Innovation Act of 2009

The material in question was Epogen:

Hospira filed a subsection (k) application with the
FDA in December 2014 seeking approval of a biosimilar of
EPOGEN®, a biological product developed by Amgen and
approved by the FDA under section 262(a) in 1989. In
accordance with paragraph (l)(2)(A), Hospira provided a
copy of its application to Amgen. Hospira did not separately
provide information concerning “the process . . .
used to manufacture the biological product”—again, as
required by the statute—but contends that such information
was disclosed in its application.

The motion to compel was denied by D. Delaware for lack of

Hospira refused Amgen’s discovery requests, and
Amgen ultimately filed a motion to compel discovery. The
district court denied Amgen’s motion, stating that the
cell-culture information sought by Amgen had “essentially,
no relevance to the patents that are asserted,” J.A. 37,
a conclusion that Amgen does not now dispute.
Amgen appealed the district court’s interlocutory order.
Hospira then moved this court to dismiss Amgen’s
appeal for lack of jurisdiction. We denied Hospira’s motion,
but asked the parties to brief “whether this court has
jurisdiction pursuant to the collateral order doctrine or
under the All Writs Act.” Order, Amgen, Inc. v. Hospira,
Inc., No. 16-2179 (Fed. Cir. Aug. 12, 2016), ECF No. 16

Of note in the case:

Nothing in Sandoz suggests that the BPCIA somehow
supplants the preexisting rules of civil procedure. Our
opinion in Amgen merely acknowledged that a sponsor
“can access the required information through discovery,”
794 F.3d at 1356, but our statement did not purport to
hold that the usual rules governing discovery do not apply
in the BPCIA context. Nor does anything in Sandoz
suggest otherwise


Under Amgen’s reading of the statute,
an applicant could effectively control the scope of litigation
under the BPCIA by withholding information under
paragraph (l)(2)(A), thereby preventing the sponsor from
identifying and bringing suit on patents related to the
biological product that the sponsor “believes a claim of
patent infringement could reasonably be asserted” under
paragraph (l)(3)(A). We note that the statute penalizes
sponsors that decline to participate in the BPCIA’s information
exchanges because under 35 U.S.C. § 271(e)(6)(C),
a sponsor that fails to list a patent that “should have been
included in the list described in [paragraph (l)(3)(A)] . . .
may not bring an action under this section for infringement
of the patent with respect to the biological product.”
In contending that a sponsor would be unable to list a
patent under paragraph (l)(3)(A), Amgen emphasizes that
the sponsor must form a good-faith belief that a patent
listed under paragraph (l)(3)(A) “could reasonably be
asserted.” Amgen asserts that a sponsor listing a patent
without the benefit of the applicant’s paragraph (l)(2)(A)
disclosures would later be subject to sanctions under
Federal Rule of Civil Procedure 11 or antitrust liability
for asserting baseless claims of patent infringement.


Amgen’s argument misunderstands the statute. Paragraph
(l)(3)(A) merely requires the sponsor to list patents
that it “believes . . . could reasonably be asserted.” (emphasis
added). The statute provides no sanction for holding
or asserting a mistaken belief in good faith. Moreover,
once a patent is listed by the sponsor, the BPCIA’s information
exchange further requires the applicant to “provide
to the . . . sponsor, with respect to each patent listed
. . . a detailed statement that describes, on a claim by
claim basis, the factual and legal basis of the opinion of
the subsection (k) applicant that such patent is invalid,
unenforceable, or will not be infringed.” 42 U.S.C.
§ 262(l)(3)(B)(ii) (emphases added). In other words, once a
sponsor lists a patent under paragraph (l)(3)(A), the
applicant must once again come forward with additional
disclosures under paragraph (l)(3)(B) that inform whether
“a claim of patent infringement . . . could” or could not
“reasonably be asserted.” If the applicant fails to comply
with its obligation to respond under paragraph (l)(3)(B),
the sponsor would have a reasonable basis for asserting a
claim of patent infringement.
Furthermore, under Rule 11, one submits a filing “to
the best of the person’s knowledge, information, and
belief, formed after an inquiry reasonable under the
circumstances.” Fed. R. Civ. P. 11(b). The rule also expressly
permits factual allegations that “will likely have
evidentiary support after a reasonable opportunity for
further investigation or discovery.” Fed. R. Civ. P.
11(b)(3). Thus, 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. See, e.g.,
Hoffman-La Roche Inc. v. Invamed Inc., 213 F.3d 1359,
1363–64 (Fed. Cir. 2000) (affirming denial of Rule 11
sanctions where patentees unsuccessfully sought manufacturing
information from defendants before suit and
“attempted to ascertain whether the processes so used
were infringing, but were unable to do so”); Morda v.
Klein, 865 F.2d 782, 785–86 (6th Cir. 1989) (affirming
denial of Rule 11 sanctions because “[i]t would be particularly
difficult to fault plaintiffs for a lack of prefiling
inquiry when, as here, defendants have refused plaintiffs
access to material information that would bear on certain
allegations made in the complaint”). The Supreme Court
appears to have contemplated the filing of suit after an
applicant fails to disclose information under paragraph
(l)(2)(A). See Sandoz, 137 S. Ct. at 1676 (“If the applicant
failed to provide that information, then the sponsor but
not the applicant, could bring an immediate declaratory
judgment action pursuant to § 262(l)(9)(C).”).

There was reference to a Supreme Court decision on finality.

A final decision of a district court means, with limited exceptions, an order that ends the litigation on the merits and leaves nothing for the district court to do but execute the judgment. Coopers & Lybrand v. Livesay, 437 U.S. 463, 467, 98 S. Ct. 2454, 2457, 57 L. Ed. 2d 351 (1978).


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