United States District Court, D. Delaware
PAR PHARMACEUTICAL, INC., PAR STERILE PRODUCTS, LLC, and ENDO PAR INNOVATION COMPANY, LLC, Plaintiffs,
HOSPIRA, INC., Defendant.
MEMORANDUM AND ORDER
F. Bataillon Senior United States District Judge.
matter is before the Court on the plaintiffs' objections
(D.I. 139) to the Magistrate Judge's January 16, 2019,
oral order (D.I. 139-1, Ex.5, Transcript (“Tr.”)
at 19-26) denying plaintiffs' letter request for
sanctions (D.I. 124). This is a patent infringement case
arising under the Hatch-Waxman Act, 21 U.S.C. § 355 and
35 U.S.C. § 271(e).
Par Pharmaceutical, Inc., Par Sterile Products, LLC, and Endo
Par Innovation Company, LLC (collectively,
“Plaintiffs” or “Par”) manufactures
and sells Adrenalin® brand epinephrine injection, which
is used for emergency treatment of allergic reactions,
including anaphylaxis. The defendant, Hospira, Inc.
(“Hospira”) is seeking FDA approval to market a
generic version of Par's Adrenalin® product
(“Hospira's ANDA Product”) prior to the
expiration of Par's patents covering Adrenalin®, U.S.
Patent Nos. 9, 119, 876 (“the '876 patent”)
and 9, 295, 657 (“the '657 patent”)
(together, “the Patents-in-Suit”) (D.I. 1, Exs.
1-2). The patents-in-suit are directed to epinephrine
compositions (and methods of using such compositions)
comprising particular components and having certain levels of
impurities after storage for 18 months.
motion for sanctions is based on Hospira's refusal to
produce requested samples of Hospira's ANDA Product to
plaintiffs for its infringement analysis. The requested
samples expired in December 2017. In April 2018, Par filed a
letter to compel Hospira to produce samples of its ANDA
product. The Magistrate Judge denied Par's request for
the samples on the basis that they had expired but ordered
Hospira to produce relevant stability data and testing on the
ANDA product, including testing “under the conditions
specified by claims 12-19 of the patents-in-suit.” D.I.
the parties were actively disputing the samples issue, in
March 2018, Hospira manufactured additional stability studies
with a new pilot batch. Par contends that Hospira wrongfully
failed to produce any pilot batch samples at the time, or to
notify Par of the existence of those samples. Par requested
samples upon learning of the newly manufactured pilot plant
batch after a 30(b)(6) deposition (D.I. 124). Hospira
refused, asserting that the batch was “not
representative of the ANDA product, ” and further, that
samples “are no longer available.” Id.
There is evidence that Hospira prepared the laboratory batch
at issue for the limited purpose of providing data to the FDA
regarding the light protection offered by the container
closure system of Hospira's ANDA product. Par sought
sanctions based on Hospira's alleged spoliation of
samples from the pilot plant batch (D.I. 124).
Magistrate Judge denied Par's request for sanctions,
finding that the criteria for spoliation had not been met,
and that the requested sanctions were disproportionate to the
fact that the pilot plant batch samples were no longer
available. The Magistrate Judge found the pilot plant batch
was “not representative of the product that Hospira
seeks approval to sell” and concluded that
“egregious conduct such as fraud or a desire to
suppress the truth” had not occurred. D.I. 139-1, Ex.
5, Tr. at 21. The Magistrate Judge made the factual finding
that the “pilot plant manufacturing the batch is an
R&D development facility and not a GMP facility for
exhibit batches or commercial batches. And as a result, the
controls for particulates are not as astringent [sic] as
those in a GMP manufacturing facility, ” and “the
purpose of this was to respond to that [FDA] inquiry for
photostability testing.” D.I. 139-1, Ex. 5, Tr. at 23.
She concluded that “it appears to me that this is not
representative of the ANDA product, ” and that Dr. Eric
Zhang had “adequately explained the difference between
exhibit batches and laboratory batches and why the laboratory
batch at issue here is not representative of the product
Hospira seeks approval to sell.” Id. at 24.
plaintiffs challenge the Magistrate Judge's conclusion
that the pilot plant batch is not representative of
Hospira's ANDA product, contending it is contrary to
Federal Circuit case law holding that the ANDA infringement
inquiry is not limited to any particular type of sample, and
that all relevant information may be considered. They also
contend the Magistrate Judge's finding of no bad faith
was an error.
on the other hand contends that the Magistrate Judge's
factual findings are correct-Hospira did not withhold
relevant evidence, did not act in bad faith, and did not
prejudice the plaintiffs. It relies on the contention that it
has maintained since the outset of this litigation that the
issue of infringement in this case is capable of being
resolved on the basis of its ANDA alone and does not require
the production of samples. The Magistrate Judge agrees that
“there is no assertion in the present case that the
ANDA itself is insufficient to establish the formulation of
the ANDA product.” D.I. 54, Memorandum and Order at 5.
District Court may modify or set aside any part of a
Magistrate Judge's order that is “clearly erroneous
or contrary to law.” 28 U.S.C. § 636(b)(1)(A);
Fed.R.Civ.P. 72(a). The district court “shall make a de
novo determination of those portions of the report or
specified proposed findings or recommendations to which
objection is made” and “may also receive further
evidence or recommit the matter to the magistrate judge with
instructions.” 28 U.S.C. § 636(b)(1)(C).
Similarly, Rule 72(b)(3) requires de novo review of any
recommendation that is dispositive of a claim or defense of a
Supreme Court has construed the statutory grant of authority
conferred on magistrate judges under 28 U.S.C. § 636 to
mean that nondispositive pretrial matters are governed by
§ 636(b)(1)(A) and dispositive matters are covered by
§ 636(b)(1)(B). Gomez v. United States, 490
U.S. 858, 873-74 (1989); see also Fed. R. Civ. P.
72(a). Under subparagraph (B), a district court may refer a
dispositive motion to a magistrate judge “to conduct
hearings, including evidentiary hearings, and to submit to a
judge of the court proposed findings of fact and
recommendations for the disposition.” 28 U.S.C. §
636(b)(1)(B); see EEOC v. City of Long
Branch, 866 F.3d 93, 99-100 (3d Cir. 2017). The product
of a magistrate judge, following a referral of a dispositive
matter, is often called a “report and
recommendation.” Id.“Parties ‘may
serve and file specific written objections to the proposed
findings and recommendations' within 14 days of being
served with a copy of the magistrate judge's report and
recommendation.” Id. (quoting Fed.R.Civ.P.
72(b)(2)). “If a party objects timely to a magistrate
judge's report and recommendation, the district court
must ‘make a de novo determination of those portions of
the report or specified proposed findings or recommendations
to which objection is made.'” EEOC, 866
F.3d at 99 (quoting 28 U.S.C. § 636(b)(1)). Review of
the Magistrate Judge's legal conclusions is de novo or
“plenary.” Haines v. Liggett Grp. Inc.,
975 F.2d 81, 91 (3rd Cir. 1992).
requires the following factors: “ the evidence was
in the party's control;  the evidence is relevant to
the claims or defenses in the case;  there has been actual
suppression or withholding of evidence; and,  the duty to
preserve the evidence was reasonably foreseeable to the
party.” Bull v. United Parcel Serv., Inc., 665
F.3d 68, 73-74 (3d Cir. 2012). To determine what sanction is
warranted for spoliation, the Court considers three factors:
“(1) the degree of fault of the party who altered or
destroyed the evidence; (2) the degree of prejudice suffered
by the opposing party; and (3) whether there is a lesser
sanction which will avoid substantial unfairness to the
opposing party, and, where the offending party is seriously
at fault, will serve to deter such conduct by others in the
future.” Id. at 74 n.5 (citation omitted).
Court has conducted a de novo review and agrees with the
Magistrate Judge's conclusion that Hospira had not
engaged in spoliation and no sanction should be imposed. The
Court finds no error in the Magistrate Judge's
determination that the laboratory batch was not prepared as
is specified in Hospira's ANDA and the samples were not
representative of the ANDA product that would be sold pending
approval of the ANDA and thus were not relevant evidence.
Further, the Court agrees that evidence of bad faith is
lacking given Hospira's use of the laboratory batch
samples in required testing. Par has not shown prejudice as a
result of any spoliation since Hospira's ANDA provides
sufficient information to adjudicate infringement, and
because Plaintiffs' expert prepared ...