Amneal Pharmaceuticals, LLC. v. Endo Pharmaceuticals Inc.

Trials@uspto.gov 	Paper 15
571-272-7822 	Entered: June 27, 2014
UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________
AMNEAL PHARMACEUTICALS, LLC,
Petitioner,
v.
ENDO PHARMACEUTICALS INC.,
Patent Owner.
____________
Case IPR2014-00360
Patent 8,329,216 B2
____________
Before TONI R. SCHEINER, FRANCISCO C. PRATS, and
JACQUELINE WRIGHT BONILLA, Administrative Patent Judges.
BONILLA, Administrative Patent Judge.
DECISION
Service Under 35 U.S.C. § 315(b)
Designated: January 10, 2018

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INTRODUCTION
Petitioner Amneal Pharmaceuticals, LLC, filed a Petition (Paper 1)
requesting inter partes review of U.S. Patent No. 8,329,216 (“the ’216
patent”) on January 16, 2014. Patent Owner Endo Pharmaceuticals Inc. filed
a Preliminary Response (Paper 7) (“Prelim. Resp.”) asserting, inter alia, that
the Petition is time-barred under 35 U.S.C. § 315(b), which provides that an
inter partes review may not be instituted based on a petition “filed more than
1 year after the date on which the petitioner, real party in interest, or privy of
the petitioner is served with a complaint alleging infringement of the
patent.” Prelim. Resp. 6-11.
Following a conference call on May 7, 2014, among respective
counsel for Petitioner and Patent Owner, we ordered the parties to submit
additional briefing addressing the issue “of whether Petitioner was ‘served
with a complaint’ alleging infringement of the ’216 patent more than one
year before the petition was filed—i.e., more than one year before January
16, 2014,” under 35 U.S.C. § 315(b). Paper 9, 2-3. Thereafter, Petitioner
filed a Reply Brief addressing the issue (Paper 11, “Reply”), and Patent
Owner filed a Surreply (Paper 14, “Surreply”).
Based on the record before us, for the reasons that follow, we do not
deny the Petition under § 315(b).1
1 This Decision only addresses Patent Owner’s contentions in relation to
§ 315(b), but does not address any other issues affecting whether we will
institute an inter partes review in this case. We will address separately
whether to institute an inter partes review in a forthcoming decision.

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I. 	BACKGROUND
We consider arguments raised in Patent Owner’s Preliminary
Response challenging whether Petitioner timely filed its Petition for inter
partes review of the ’216 patent. Prelim. Resp. 1, 6-11. Patent Owner
initially filed a complaint against Petitioner on November 7, 2012, and then
filed an amended complaint (“First Amended Complaint”) on November 14,
2012, in the United States District Court for the Southern District of New
York, alleging infringement of patents other than the ’216 patent. Prelim.
Resp. 4-5; Ex. 2008, 14-15.
On December 11, 2012, the ’216 patent issued to Patent Owner.
Prelim. Resp. 5. On January 9, 2013, Patent Owner filed an “Unopposed
Motion to Amend Complaint Under Rule 15(a)” (“Motion to Amend
Complaint” or “Motion”). Ex. 2004; Ex. 2008, 17 (referring to “MOTION
to Amend/Correct the Amended Complaint”). The Motion to Amend
Complaint attached, as Exhibit 1, a copy of a Second Amended Complaint
for the court’s consideration, adding the newly issued ’216 patent to Patent
Owner’s allegations of infringement in the First Amended Complaint.
Ex. 2004, Exhibit 1.
Thereafter, on January 14, 2013, the court granted Patent Owner’s
Motion. Id. at 5-6; Ex. 2006. The Order granting the Motion stated that
“Plaintiff shall file the Second Amended Complaint promptly,” and that
“[a]ny response to the Amended Compliant is due on February 14, 2013.”
Ex. 2006. On January 17, 2013, Patent Owner filed its Second Amended
Complaint. Ex. 2007.

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II. 	DISCUSSION
A. 	35 U.S.C. § 315(b)
The issue before us is whether Petitioner was “served with a
complaint” alleging infringement of the ’216 patent prior to January 16,
2013, which would bar the Petition under 35 U.S.C. § 315(b). Specifically,
we address whether service on January 9, 2013, of Patent Owner’s Motion to
Amend Complaint, attaching a proposed “Second Amended Complaint” as
an exhibit, or the district court Order granting that Motion on January 14,
2013, constituted service of a “complaint,” thereby triggering the one-year
time bar under § 315(b).
The relevant portion of § 315(b) provides:
(b) PATENT OWNER’S ACTION.—An inter partes review
may not be instituted if the petition requesting the proceeding is filed
more than 1 year after the date on which the petitioner, real party in
interest, or privy of the petitioner is served with a complaint alleging
infringement of the patent.
35 U.S.C. § 315(b) (emphasis added).
Patent Owner urges us to deny the instant Petition, arguing that
Petitioner is time-barred from seeking inter partes review of the ’216 patent
under § 315(b), because Petitioner was served with a complaint on January
9, 2013, i.e., more than one year before the January 16, 2014, filing date of
the Petition in this proceeding. Prelim. Resp. 6-11.
As shown in Exhibit 2005, the district court provided a Notice of
Electronic Filing (“NEF”), via electronic mail, on January 9, 2013, in
relation to the “MOTION to Amend/Correct the Amended Complaint.

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Document filed by Endo Pharmaceuticals Inc., Grunenthal GMBH,” and
“Attachments,” including “# (1) Exhibit 1 Proposed Second Amended
Complaint, . . . .” Prelim. Resp. 5; Ex. 2005, 1.
Patent Owner points us to district court Local Rule 9.1 on electronic
filing, which provides that the “[t]ransmission of the NEF constitutes service
upon all Filing and Receiving Users who are listed as recipients of notice by
electronic mail.” Prelim. Resp. 8 (citing Ex. 2009 (Southern District of New
York “Electronic Case Filing Rules and Instructions”), 9, § 9.1). Thus,
according to Patent Owner, when the district court electronically mailed the
NEF regarding the Motion to Amend Complaint and Exhibit 1 attachment to
Petitioner, it “effected service of the Second Amended Complaint on
January 9, 2014.” Prelim. Resp. 8-9. Because § 315(b) refers to being
“served,” Patent Owner contends that it does not matter that Patent Owner
did not file the Second Amended Complaint until January 17, 2013. Id. at
10. Rather, it only matters when Patent Owner served the Second Amended
Complaint, which, according to Patent Owner, occurred on January 9, 2013.
Id. at 10-11.
In response, Petitioner does not dispute that on January 9, 2013,
Patent Owner served its Motion to Amend Complaint and a “Proposed”
Second Amended Complaint, attached as an exhibit. Reply 1. Petitioner
counters, however, that the filing and service of that Motion and exhibit
“cannot and did not trigger § 315(b).” Id. at 4. According to Petitioner,
Patent Owner did not “have the legal right to file or serve the Second
Amended Complaint (‘SAC’) until the District Court granted it leave to do

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so on January 14, 2013.” Id. at 1, 3. Petitioner cites Federal Rule of Civil
Procedure 15(a)(2), which permits a party to file an amended pleading “once
as a matter of course,” but requires that “in all other cases, a party may
amend its pleading only with the opposing party’s written consent or court’s
leave.” Fed. R. Civ. P. 15(a)(2). Under this rule, according to Petitioner,
Patent Owner required the district court’s leave to file the SAC. Reply 3.
Thus, Patent Owner filed and served the SAC on January 17, 2013, after the
court granted that leave. Id. at 4. Petitioner contends the one-year period
under § 315(b) did not begin until January 17, 2013, when Patent Owner
actually filed and served its SAC. Id. at 2.
In its Surreply, Patent Owner refers to cases from other district courts
that have based “service-dependent deadlines on the date the court granted
the motion to amend” a complaint, where that motion attached a “proposed”
amended complaint. Surreply 2-3. Thus, according to Patent Owner, it
properly served its SAC when it served a copy of the proposed amended
complaint on Petitioner on January 9, 2013. Patent Owner further contends
that, as of January 14, 2013, when the district court granted the Motion to
Amend Complaint, “the Second Amended Complaint had legal effect
because the court ordered Petitioner to respond to it by February 14, 2013,
. . . despite Petitioner’s request to be given one month from the date of filing
of the Second Amended Complaint to answer.” Id. at 3-4 (emphasis in
original) (citing Ex. 2010, Fed. R. Civ. P. 15(a)(3)). In addition, Patent
Owner argues that “Petitioner’s contention that service of the Second
Amended Complaint was not authorized until it was actually filed is wrong

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because Petitioner expressly consented to its filing.” Id. at 4-5 (citing
Fed. R. Civ. P. 15(a)(2)).
We have considered the arguments and evidence provided by
Petitioner and Patent Owner in view of the requirements of § 315(b), local
court rules, and the Federal Rules of Civil Procedure. For example, we note
that the district court’s docket sheet and NEF confirm the filing of the
Motion to Amend Complaint, including its “Exhibit 1 Proposed Second
Amended Complaint,” on January 9, 2013. Ex. 2008, 17; Ex. 2005. The
docket sheet and other evidence also confirm that Magistrate Judge Gabriel
Gorenstein granted the Motion on January 14, 2013, in an Order stating that
Patent Owner “shall file the Second Amended Complaint promptly” and that
Petitioner’s response “is due on February 14, 2013.” Ex. 2008, 17;
Ex. 2006. The docket sheet further confirms that Patent Owner filed the
Second Amended Complaint three days later, on January 17, 2013.
Ex. 2008, 17-18. At that time, service of the Second Amended Complaint
was accomplished via the court’s electronic filing system.2
In view of the record before us, we conclude that on January 9, 2013,
Patent Owner served Petitioner with a Motion to Amend Complaint seeking
permission to file its Second Amended Complaint, but did not serve a
“complaint” for purposes of § 315(b). On that date, Patent Owner requested
that the court grant “leave to file a Second Amended Complaint for patent
2 The local court rules provide that transmission of an NEF, which the court
sends automatically by e-mail, satisfies the “service” requirement. Ex. 2009,
9, §9.1; 5, §1.

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infringement (attached hereto as Exhibit 1).” Ex. 2006 (emphasis added).
In other words, on January 9, Patent Owner requested, but had not obtained
yet, permission to file a Second Amended Complaint. At the point of filing
the Motion to Amend Complaint, the attachment to the Motion was merely a
proposed complaint, and Petitioner was not yet a defendant in a lawsuit with
respect to the ’216 patent.
“We do not believe that the Congress intended to have the [one-year]
time period start before a petitioner is officially a defendant in a law suit.”
Motorola Mobility LLC v. Arnouse, IPR2013-00010, Paper 20, 5 (Jan. 30,
2013). Moreover, as stated by the Supreme Court as “a bedrock principle,”
an “entity named as a defendant is not obliged to engage in litigation unless
notified of the action, and brought under a court’s authority, by formal
process.” Murphy Bros. v. Michetti Pipe Stringing, 526 U.S. 344, 347
(1999). Here, Petitioner was not “brought under a court’s authority, by
formal process,” i.e., was not officially a defendant, in relation to the ’216
patent, by virtue of the filing of the Motion to Amend Complaint on January
9, 2013. Id. Patent Owner’s request for the court’s leave did not obligate
Petitioner to engage in litigation in relation to that patent.
In relation to Federal Rule of Civil Procedure 15(a)(2), which states in
relevant part that “a party may amend its pleading only with the opposing
party’s written consent or the court’s leave,” we note that it is undisputed
that Patent Owner requested the court’s leave in this case.3 Thus, regardless
3 We also note that Fed. R. Civ. P. 15(a)(3) states that “[u]nless the court

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of any prior “consent” by Petitioner, on January 9, 2013, Patent Owner
requested leave to amend its pleading and make Petitioner a defendant with
respect to the ’216 patent, which left the matter in the court’s hands to
decide. The attachment to the Motion was merely a proposed complaint, not
an actual “complaint” within the meaning of § 315(b).
Moreover, Petitioner was not “served with a complaint” for the
purposes of § 315(b) when the district court granted Patent Owner’s Motion
to Amend Complaint on January 14, 2013. While the Order stated that
Patent Owner “shall file the Second Amended Complaint promptly,” the
Order did not indicate that the Second Amended Complaint was filed or
served on Petitioner as of January 14, 2013, or retroactively on January 9,
2013. Ex. 2006. Rather, the court specified the timing of the filing of the
Second Amended Complaint, i.e., that it must be filed “promptly.” Id.
Patent Owner then filed its complaint three days later, on January 17, 2014.
Patent Owner could have filed its Second Amended Complaint earlier, for
example, on January 15, 2013, but chose to file when it did. Petitioner was
“brought under a court’s authority, by formal process,” and became “obliged
to engage in litigation” in relation to the ’216 patent, on January 17, 2013,
when Patent Owner actually filed its Second Amended Complaint, and not
orders otherwise, any required response to an amended pleading must be
made within the time remaining to respond to the original pleading or within
14 days after service of the amended pleading, whichever is later.” Here, the
court clearly “orders otherwise.” The court did not require a response
“within 14 days after service” of either the Motion to Amend Complaint or
the Second Amended Complaint, for example. Ex. 2006.

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beforehand. Murphy Bros., 526 U.S. at 347.
In view of the record before us, we conclude that Petitioner was not
“served with a complaint” alleging infringement of the ’216 patent for the
purposes of § 315(b) before January 17, 2013. Because Petitioner filed its
Petition within one year of that date, i.e., on January 16, 2014, we conclude
that 35 U.S.C. § 315(b) does not bar institution based on the Petition in this
case.
III. 	CONCLUSION
For the foregoing reasons, we determine that 35 U.S.C. § 315(b) does
not bar institution based on the Petition in this case.

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For PETITIONER:
Eldora Ellison
Eellison-PTAB@skgf.com
Dennies Varughese
Dvarughe-PTAB@skgf.com
For PATENT OWNER:
Joseph Mahoney
jmahoney@mayerbrown.com
Erick Palmer
ejpalmer@mayerbrown.com