GILEAD SCIENCES, INC. et al v. Mylan Inc. et al
Filing
223
MEMORANDUM OPINION AND ORDER OVERRULING THE PLAINTIFFS OBJECTIONS 195 AND AFFIRMING THE ORDER OF THE MAGISTRATE JUDGE 190 . Signed by District Judge Irene M. Keeley on 9/22/15. (jss)
IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
GILEAD SCIENCES, INC. and
EMORY UNIVERSITY,
Plaintiffs,
v.
//
CIVIL ACTION NO. 1:14CV99
(Judge Keeley)
MYLAN INC. and MYLAN
PHARMACEUTICALS INC.,
Defendants.
MEMORANDUM OPINION AND ORDER OVERRULING THE PLAINTIFFS’
OBJECTIONS [DKT. NO. 195] AND AFFIRMING THE
ORDER OF THE MAGISTRATE JUDGE [DKT. NO. 190]
On July 14, 2015, the plaintiffs, Gilead Sciences, Inc. and
Emory University (collectively, “Gilead”), objected to the Order of
the Honorable John S. Kaull, United States Magistrate Judge,
denying its motion to compel.
For the reasons that follow, the
Court OVERRULES Gilead’s objections (Dkt. No. 195) and AFFIRMS the
Order (Dkt. No. 190).
BACKGROUND
This patent infringement lawsuit, filed by Gilead on June 9,
2014, arises under the Drug Price Competition and Patent Term
Restoration Act.
271.
See 21 U.S.C. §§ 355, 360cc; 35 U.S.C. §§ 156,
Gilead contends that the defendants, Mylan Inc. and Mylan
Pharmaceuticals,
Inc.
(collectively,
“Mylan”),
infringed
four
patents-in-suit by filing an Abbreviated New Drug Application
(“ANDA”)
seeking
United
States
Food
and
Drug
Administration
approval to market a generic version of Gilead’s Truvada®.
GILEAD, ET AL. V. MYLAN, ET AL.
1:14CV99
MEMORANDUM OPINION AND ORDER OVERRULING THE PLAINTIFFS’
OBJECTIONS [DKT. NO. 195] AND AFFIRMING THE ORDER OF
THE MAGISTRATE JUDGE [DKT. NO. 190]
On November 19, 2014, Gilead served Mylan with its first set
of requests for document production.
those requests on December 22, 2014.
Mylan objected to some of
More than six months later,
on May 28, 2015, Gilead filed a motion seeking to compel Mylan to
produce (1) documents relating to Mylan’s development of the final
formulation of its ANDA product; (2) documents evidencing certain
communications between Mylan and Teva regarding the patents-insuit, a TDF/FTC combination product, and this litigation; and, (3)
documents relating to market analysis or investigation for a
TDF/FTC communication product (Dkt. No. 160 at 2).
Mylan opposed Gilead’s motion to compel, arguing the motion
was moot because it had already produced all documents relating to
the patents-in-suit (Dkt. No. 176 at 1).
Mylan alleged that, to
the extent Gilead sought documents relating to its PEPFAR ANDA,
which was not part of this case, it had failed to file a timely
motion to compel.1
Id. at 2.
The PEPFAR ANDA, ANDA No. 90-049,
covers a product which, according to Mylan, is sold outside of the
United States, has a “different formulation,” and is “manufactured
using a different process,” making it irrelevant to the instant
lawsuit (Dkt. No. 176 at 3).
Gilead contended that documentation
1
PEPFAR is an abbreviation for the United States President’s
Emergency Plan for AIDS Relief.
2
GILEAD, ET AL. V. MYLAN, ET AL.
1:14CV99
MEMORANDUM OPINION AND ORDER OVERRULING THE PLAINTIFFS’
OBJECTIONS [DKT. NO. 195] AND AFFIRMING THE ORDER OF
THE MAGISTRATE JUDGE [DKT. NO. 190]
relating to the PEPFAR ANDA was relevant to Mylan’s defense that
Gilead’s patents are invalid for lack of enablement (Dkt. No. 183
at 3). Because Mylan raised this “new theor[y]” for the first time
on June 18, 2015, Gilead asserted that its motion to compel was
timely.2
Id.
The Court referred this discovery dispute to Magistrate Judge
Kaull for resolution (Dkt. No. 161).
After a thorough airing of
the issues in briefing and oral argument, Magistrate Judge Kaull
found that the discovery sought by Gilead was irrelevant and the
motion to compel untimely (Dkt. No. 190).
Specifically, he
concluded that the PEPFAR ANDA materials were irrelevant to Mylan’s
invalidity defense, which “looks no further than the four corners
of initial patent and patent application.”
Id. at 3.
He also
concluded that Gilead had been aware of Mylan’s lack of enablement
defense since August 12, 2014, when it appeared in Mylan’s answer.
Id. at 4.
Because Gilead waited 158 days before filing its motion
to compel, Magistrate Judge Kaull found that the motion was
untimely and denied it.
Id. at 5.
2
Gilead does not explain how Mylan raised this defense for
the first time on June 18, 2015; the docket, however, indicates
that
Mylan
served
supplemental
responses
to
Gilead’s
interrogatories on that date (Dkt. Nos. 174, 175).
3
GILEAD, ET AL. V. MYLAN, ET AL.
1:14CV99
MEMORANDUM OPINION AND ORDER OVERRULING THE PLAINTIFFS’
OBJECTIONS [DKT. NO. 195] AND AFFIRMING THE ORDER OF
THE MAGISTRATE JUDGE [DKT. NO. 190]
Gilead objected to Magistrate Judge Kaull’s Order, contending
it was “premised on a fundamental misunderstanding of relevant
patent law.”
(Dkt. No. 195 at 1).
Gilead argued that the PEPFAR
ANDA documents are directly relevant to whether Mylan was able to
make “multiple, different stable fixed dose combinations of FTC and
TDF without undue experimentation,” an element of the lack of
enablement defense.
Id. at 3.
It contended that Magistrate Judge
Kaull’s lack of timeliness ruling was “inextricably intertwined
with the Order/Opinion’s erroneous conclusion that the documents
were not relevant . . . ,” but that, at any rate, it was unaware of
Mylan’s defense until June 18, 2015.
Id. at 5.
In response, Mylan urged the Court to affirm the magistrate
judge’s Order because Gilead had failed to file a timely motion to
compel under LR Civ. P. 37.02(b) (Dkt. No. 198 at 1).
According to
Mylan, Gilead’s assertion that it was unaware of the relevance of
the PEPFAR ANDA until June 18, 2015, is a tacit admission that its
document requests seeking the PEPFAR materials had no basis at the
time they were made.
Id. at 2.
Mylan further contended that the PEPFAR ANDA materials are
irrelevant to its lack of enablement defense because (1) the PEPFAR
product is different from the product accused of infringement in
the instant case; (2) the PEPFAR documents were generated years
4
GILEAD, ET AL. V. MYLAN, ET AL.
1:14CV99
MEMORANDUM OPINION AND ORDER OVERRULING THE PLAINTIFFS’
OBJECTIONS [DKT. NO. 195] AND AFFIRMING THE ORDER OF
THE MAGISTRATE JUDGE [DKT. NO. 190]
after the relevant time point for evaluating enablement; and, (3)
Mylan’s product is legally irrelevant to enablement.
Id. at 7-8.
In replying to this argument, Gilead asserted that post-filing
evidence of enablement can be relevant to whether the patent was
enabling (Dkt. No. 203 at 2). It further contended that its motion
to compel was timely because, until June 18, 2015, Mylan had
“simply invoked 35 U.S.C. § 112 and/or the word ‘enablement’ as
defenses.”
Id.
The
matter
is
fully
briefed
and
ripe
for
disposition.
STANDARD OF REVIEW
The Court reviews a magistrate judge’s non-dispositive pretrial ruling for clear error.
Shoop v. Hott, No. 5:08CV188, 2010
WL 5067567, at *2 (N.D.W. Va. Dec. 6, 2010) (Stamp, J.) (“[A]
magistrate judge’s ruling may be reversed only on a finding that
the order is ‘clearly erroneous or is contrary to law.’”); Fed. R.
Civ. P. 72(a); 28 U.S.C. § 636(b)(1).
A finding of clear error is
only appropriate when, “although there is evidence to support it,
the reviewing court on the entire evidence is left with a definite
and firm conviction that a mistake has been committed.”
Shoop,
2010 WL 5067567, at *2 (internal quotation marks omitted)(quoting
United States v. United States Gypsum Co., 333 U.S. 364, 395
(1948)).
“In light of the broad discretion given to a magistrate
5
GILEAD, ET AL. V. MYLAN, ET AL.
1:14CV99
MEMORANDUM OPINION AND ORDER OVERRULING THE PLAINTIFFS’
OBJECTIONS [DKT. NO. 195] AND AFFIRMING THE ORDER OF
THE MAGISTRATE JUDGE [DKT. NO. 190]
judge in the resolution of nondispositive discovery disputes, the
court should only overrule a magistrate judge’s determination if
this discretion is abused.”
Id. (citing Detection Sys., Inc. v.
Pittway Corp., 96 F.R.D. 152, 154 (W.D.N.Y. 1982)).
ANALYSIS
After carefully considering Magistrate Judge Kaull’s Order and
the
parties’
briefing
on
both
the
motion
to
compel
and
the
objections, the Court is convinced that the Order is not clearly
erroneous.
Shoop, 2010 WL 5067567, at *2.
bifurcated
his
Order
into
two
sections
Magistrate Judge Kaull
regarding
both
the
substantive law behind Mylan’s invalidity defense and timeliness
(Dkt. No. 190 at 2-4).
Notwithstanding Gilead’s admonition that
the two issues are “inextricably intertwined,” the Court finds
overwhelming evidence to affirm Magistrate Judge Kaull’s ruling
based on the timeliness issue, and need not address the invalidity
defense.
In Mylan’s answer, filed on August 12, 2014, it alleged that
the patents-in-suit are invalid for failure to satisfy 35 U.S.C. §
112 (Dkt. No. 24 at 25).3
On November 19, 2014, Gilead served
Mylan with discovery requests, including a request for “documents
3
Mylan reiterated this defense in its answer to the amended
complaint, filed on February 9, 2015 (Dkt. No. 97 at 30).
6
GILEAD, ET AL. V. MYLAN, ET AL.
1:14CV99
MEMORANDUM OPINION AND ORDER OVERRULING THE PLAINTIFFS’
OBJECTIONS [DKT. NO. 195] AND AFFIRMING THE ORDER OF
THE MAGISTRATE JUDGE [DKT. NO. 190]
relating to the development of the final formulation of Mylan’s
ANDA product, including . . . attempts to develop a product
employing a formulation other than that of Mylan’s ANDA product,
and all testing data concerning those formulations.” (Dkt. No. 160
at 2). Gilead’s document request defined “Mylan’s ANDA product” as
“the product for which Mylan Pharmaceuticals Inc. filed ANDA No.
20-6436.”
(Dkt. No. 176 at 3).
Mylan responded to Gilead’s
document request on December 22, 2014, agreeing to produce all
relevant, non-privileged documents except those relating to the
PEPFAR ANDA.
Id. at 2.
Gilead claims that it was unaware of Mylan’s non-enablement
defense until June 18, 2015 (Dkt. No. 302 at 2-3).
This statement
is belied by the fact that Gilead filed its motion to compel on
May 28, 2015, three weeks before June 18, 2015 (Dkt. No. 160).
Gilead, thus, seems to be alleging that it filed a motion to compel
documents relating to the PEPFAR ANDA on May 28, although it was
unaware of the specific details of Mylan’s defense until three
weeks later.
As Mylan points out, this argument implies that
Gilead’s request for PEPFAR ANDA documents had no relevant basis
when originally made in November, 2014 (Dkt. No. 198 at 6).
Gilead’s argument, that it was unaware of the non-enablement
defense until six months after it sought discovery related to the
7
GILEAD, ET AL. V. MYLAN, ET AL.
1:14CV99
MEMORANDUM OPINION AND ORDER OVERRULING THE PLAINTIFFS’
OBJECTIONS [DKT. NO. 195] AND AFFIRMING THE ORDER OF
THE MAGISTRATE JUDGE [DKT. NO. 190]
PEPFAR patents and three weeks after it filed a motion to compel
that discovery, strains credulity.
In this district, a motion to
compel “is deemed waived” unless filed within thirty (30) days
after the discovery response was due.
LR Civ. P. 27.02(b).
An
exception exists if “failure to file the motion was caused by
excusable neglect or by some action of the non-moving party.”
Neither ground exists here.
Id.
Gilead therefore waived its motion to
compel by failing to file the same within thirty days after Mylan
objected on December 22, 2014. Magistrate Judge Kaull’s conclusion
that Gilead’s motion was untimely was not clearly erroneous.
The
Court therefore AFFIRMS the Order (Dkt. No. 190) and OVERRULES
Gilead’s objections (Dkt. No. 195).
It is so ORDERED.
The Court directs the Clerk to transmit copies of this Order
to counsel of record.
DATED:
September 22, 2015.
/s/ Irene M. Keeley
IRENE M. KEELEY
UNITED STATES DISTRICT JUDGE
8
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