Shire LLC v. Amneal Pharmaceuticals, LLC

United States Court of Appeals
for the Federal Circuit
______________________
SHIRE LLC, SHIRE DEVELOPMENT INC., SHIRE
DEVELOPMENT, LLC,
Plaintiffs-Appellees
v.
AMNEAL PHARMACEUTICALS, LLC, ROXANE
LABORATORIES INC., SANDOZ INC., MYLAN INC.,
MYLAN PHARMACEUTICALS INC., JOHNSON
MATTHEY INC., JOHNSON MATTHEY
PHARMACEUTICAL MATERIALS, ACTAVIS
ELIZABETH LLC, ACTAVIS LLC,
Defendants-Appellants
______________________
2014-1736, 2014-1737, 2014-1738, 2014-1739, 2014-1740,
2014-1741
______________________
Appeals from the United States District Court for the
District of New Jersey in No. 2:11-cv-03781-SRC-CLW,
2:11-cv-04053-SRC-MAS, 3:11-cv-03787-PGS-LHG, 2:11-
cv-03886-SRC-MAS, 2:12-cv-03234-SRC-MAS, Judge
Peter G. Sheridan, Judge Stanley R. Chesler.
______________________
Decided: September 24, 2015
______________________
ANGUS CHEN, Frommer Lawrence & Haug LLP, New
York, NY, argued for plaintiffs-appellees. Also represent-
2 SHIRE LLC v. AMNEAL PHARMACEUTICALS, LLC
ed by EDGAR HAUG, PORTER F. FLEMING, SANDRA
KUZMICH, RICHARD KURZ, ANDREW SCOTT ROPER.
MATTHEW R. REED, Wilson, Sonsini, Goodrich &
Rosati, PC, Palo Alto, CA, argued for defendants-
appellants Amneal Pharmaceuticals, LLC, Roxane Labor-
atories Inc., Sandoz, Inc., Mylan Inc., Mylan Pharmaceu-
ticals Inc., Actavis Elizabeth LLC, Actavis LLC.
Defendants-appellants Mylan Inc., Mylan Pharmaceuti-
cals Inc. also represented by KATHERINE HASPER; WENDY
L. DEVINE, San Diego, CA.
DANIEL E. YONAN, Blank Rome LLP, Washington, DC,
for defendant-appellant Amneal Pharmaceuticals, LLC.
Also represented by H. KEETO SABHARWAL, MARSHA ROSE
GILLENTINE, JEREMIAH B. FRUEAUF, Sterne Kessler Gold-
stein & Fox, PLLC, Washington, DC.
ALAN B. CLEMENT, Locke, Lord, Bissell & Liddell,
LLP, New York, NY, for defendant-appellant Roxane
Laboratories Inc. Also represented by SCOTT B. FEDER,
MYOKA KIM GOODIN, HUGH S. BALSAM, Chicago, IL.
DEANNE MAYNARD, Morrison & Foerster LLP, Wash-
ington, DC, for defendant-appellant Sandoz Inc. Also
represented by BRIAN ROBERT MATSUI; DAVID CLARENCE
DOYLE, MARK ANDREW WOODMANSEE, JAMES CEKOLA, San
Diego, CA; ERIC C. PAI, Palo Alto, CA.
JONATHAN A. HARRIS, Axinn Veltrop Harkrider, LLP,
Hartford, CT, for defendants-appellants Actavis Elizabeth
LLC, Actavis LLC.
CONSTANTINE L. TRELA, JR., Sidley Austin LLP, Chi-
cago, IL, argued for defendants-appellants Johnson Mat-
they Inc., Johnson Matthey Pharmaceutical Materials.
Also represented by JOSHUA JOHN FOUGERE, Washington,
SHIRE LLC v. AMNEAL PHARMACEUTICALS, LLC 3
DC; DOUGLAS R. NEMEC, RACHEL RENEE BLITZER, Skad-
den, Arps, Slate, Meagher & Flom LLP, New York, NY.
WILLIAM M. JAY, Goodwin Procter LLP, Washington,
DC, for amicus curiae Generic Pharmaceutical Associa-
tion. Also represented by DAVID ZIMMER, San Francisco,
CA.
______________________
Before MOORE, MAYER, and LINN, Circuit Judges.
LINN, Circuit Judge.
In this consolidated Hatch-Waxman Act litigation,
Amneal Pharmaceuticals, LLC, Actavis Elizabeth LLC,
Actavis LLC, Mylan Inc., Mylan Pharmaceuticals Inc.,
Roxane Laboratories, Inc., Sandoz Inc. (collectively the
“ANDA defendants”) and Johnson Matthey Pharmaceuti-
cal Materials (“Johnson Matthey”) (collectively, “defend-
ants”) appeal the district court’s decision in Shire, LLC v.
Amneal Pharmaceuticals, LLC, No. 11-3781, 2014 WL
2861430 (D.N.J. June 23, 2014) (“Op.”), granting Shire
LLC, Shire Development Inc. and Shire Development,
LLC’s (collectively “Shire’s”) motion for summary judg-
ment that claim 4 of the U.S. Patent No. 7,105,486 (the
“’486 patent”); claims 1–4 of U.S. Patent No. 7,655,630
(the “’630 patent”); claims 1–12 of U.S. Patent No.
7,659,253 (the “’253 patent”); and claim 3 of U.S. Patent
No. 7,662,787 (the “’787 patent”) (collectively, the “assert-
ed claims”) are not invalid. Defendants also appeal the
district court’s decision in Shire, LLC v. Amneal Pharma-
ceuticals, LLC, No. 11-3781 (D.N.J. May 12, 2014), affirm-
ing the magistrate judge’s decision denying defendants’
motion to amend their invalidity contentions to include an
on-sale bar claim, see Shire, LLC v. Amneal Pharms.,
LLC, No. 11-3781, 2013 WL 6858953 (D.N.J. Dec. 26,
2013) (“Magistrate Op.”). Johnson Matthey separately
appeals the district court’s decision that it induced in-
fringement of the claims of the ’630, ’253 and ’787 patents
4 SHIRE LLC v. AMNEAL PHARMACEUTICALS, LLC
(the “compound claims”) by providing the active pharma-
ceutical ingredient (“API”) L-lysine-d-amphetamine
(“LDX”) dimesylate to the ANDA defendants. Because
defendants have failed to raise a genuine issue of material
fact that the asserted claims are obvious, we affirm the
district court’s judgment of nonobviousness. Because the
district court did not abuse its discretion in denying
defendants’ motion to amend their invalidity contentions
to include an on-sale bar claim, we affirm that ruling.
Because in the circumstances of this case Johnson Mat-
they cannot be liable for induced infringement prior to the
grant of FDA approval of the application filed by the
ANDA defendants, we reverse the district court’s judg-
ment that Johnson Matthey has induced infringement of
the asserted compound claims and remand the case for
further proceedings consistent with this opinion.
I. BACKGROUND
A. The Patents-in-Suit
The ’486, ’630, ’253 and ’787 patents (collectively, the
“patents-in-suit”) share similar specifications and are all
directed to derivatives of amphetamine. Amphetamines
are a class of drugs that has long been used to treat a
variety of disorders, including attention deficit hyperac-
tivity disorder (“ADHD”). See, e.g., ’486 patent col.1 l.59–
col.2 l.12; Physicians’ Desk Reference 2992–93 (2000)
(“PDR”). A major drawback to the use of amphetamines
is their potential for abuse. ’486 patent col.2 l.13–col.3
l.12; PDR at 2992. The goal of the inventions is to “uti-
lize[] covalent modification of amphetamine to decrease
its potential for causing overdose or abuse.” ’486 patent
col.9 ll.11–13. Specifically, the patents describe modifying
amphetamine in such a way as to decrease its activity
when administered in high doses—as happens when the
drug is being abused—but to maintain activity similar to
that of unmodified amphetamine when the modified
amphetamine is delivered at lower doses. Id. at col.9
SHIRE LLC v. AMNEAL PHARMACEUTICALS, LLC 5
ll.13–21. One embodiment of the invention is LDX
dimesylate. See id. at col.8 ll.43–67.
The claims of the ’486 patent are directed to methods
of using amphetamine derivatives, with asserted claim 4
directed to using a mesylate salt of LDX to treat ADHD.
The asserted claims of the ’630, ’253 and ’787 patents are
compound claims directed to mesylate salts of LDX and
crystalline forms thereof.
B. History of the Dispute
Shire is the assignee of the patents-in-suit and mar-
kets LDX dimesylate capsules. These capsules are ap-
proved by the Food and Drug Administration (“FDA”) and
distributed under the brand name Vyvanse®. The FDA’s
Approved Drug Products with Therapeutic Equivalence
Evaluations (commonly known as the “Orange Book”) lists
all the patents-in-suit for Vyvanse®.
The ANDA defendants filed Abbreviated New Drug
Applications (“ANDAs”) for their generic versions of
Vyvanse® seeking approval prior to the expiration of the
patents-in-suit. The ANDAs included certifications
pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (2012) (com-
monly referred to as “Paragraph IV certifications”) stating
that the claims of the patents-in-suit are invalid and/or
not infringed. Pursuant to § 355(j)(2)(B), the ANDA
defendants notified Shire of the Paragraph IV certifica-
tions. In response, Shire sued the ANDA defendants for
infringing the asserted claims, along with certain other
claims not at issue in this appeal, under 35 U.S.C.
§ 271(e) (2012). In each suit, Shire also sued Johnson
Matthey. Johnson Matthey supplied LDX dimesylate to
the ANDA defendants and correspondingly filed a drug
master file with the FDA, see 21 C.F.R. § 314.420, but did
not itself file an ANDA. The district court consolidated all
the lawsuits.
6 SHIRE LLC v. AMNEAL PHARMACEUTICALS, LLC
In September of 2013, after discovery was complete,
defendants moved to amend their invalidity contentions
to allege that the claims of the ’253 patent were invalid
based on an on-sale bar. Magistrate Op. at *2. Under the
District of New Jersey Local Patent Rule 3.7, amend-
ments to contentions must be based on “a timely applica-
tion and showing of good cause.” The rule lists “examples
of circumstances that may, absent undue prejudice to the
adverse party, support a finding of good cause,” including
“recent discovery of material prior art despite earlier
diligent search.” Id.
The magistrate judge denied defendants’ motion to
amend their contentions to assert an on-sale bar. The
magistrate judge found the motion untimely because “the
summary of documents produced by Shire on May 21,
2012 indicates that Defendants had access to the infor-
mation [regarding the on-sale bar], or documentation that
should have led them to it earlier than they now claim.”
Magistrate Op. at *3. The magistrate judge also found
that defendants lacked good cause, because “[t]he alleged
prior art, as it relates to the On–Sale Bar, is referenced in
various portions of the document production,” and was
thus known for some time. Id. at *4. Finally, the magis-
trate judge ruled that allowing defendants to amend their
contentions would unduly prejudice Shire, because “Shire
ha[d] relied on Defendants’ previous invalidity conten-
tions for a year in preparing its case.” Id. at *5. The
district court affirmed. Shire, No. 11-3781 (D.N.J. May
12, 2014).
Shire then filed a motion for summary judgment that
all the asserted claims were infringed and not invalid.
The district court granted Shire’s motion in part and
denied it in part. It granted summary judgment that: (1)
the ANDA defendants infringed all the asserted com-
pound claims, Op. at *11; (2) the ANDA defendants in-
duced infringement of claim 4 of the ’486 patent, id. at
*12; (3) Johnson Matthey induced infringement of the
SHIRE LLC v. AMNEAL PHARMACEUTICALS, LLC 7
compound claims, id.; and (4) the asserted claims were
not invalid as anticipated or obvious, id. at *13–20. The
district court denied Shire’s motion for summary judg-
ment that Johnson Matthey directly infringed the com-
pound claims. Id. at *12. The district court certified its
ruling for immediate appeal under Federal Rule of Civil
Procedure 54(b). Shire, No. 11-3781 (D.N.J. July 21,
2014).
All the defendants appeal the district court’s grant of
summary judgment that the asserted claims are not
invalid as obvious under 35 U.S.C. § 103(a) (2006 1) and
the district court’s denial of their motion to amend their
invalidity contentions. Johnson Matthey separately
appeals the district court’s grant of summary judgment
that it induced infringement of the compound claims. We
have jurisdiction pursuant to 28 U.S.C. § 1295(a)(1)
(2012).
II. DISCUSSION
A. Standard of Review
This court reviews summary judgment decisions ac-
cording to the law of the regional circuit, here the Third
Circuit, which reviews them de novo. MobileMedia Ideas
LLC v. Apple Inc., 780 F.3d 1159, 1164 (Fed. Cir. 2015)
(citing Gonzalez v. Sec’y of Dep’t of Homeland Sec., 678
F.3d 254, 257 (3d Cir. 2012)). Accordingly, we reapply the
standard applied by the district court. See id. In the
Third Circuit:
1 Pursuant to § 3(n)(1) of the America Invents Act
(“AIA”), Pub. L. No. 112–29, amended § 103 applies to
patent applications with claims having an effective filing
date on or after March 16, 2013. Because the applications
for the patents-in-suit were filed before that date, the pre-
AIA version of § 103 applies.
8 SHIRE LLC v. AMNEAL PHARMACEUTICALS, LLC
To warrant summary judgment, the movant must
show that, viewing the evidence in the light most
favorable to the nonmoving party, there is no gen-
uine issue as to any material fact and the movant
is entitled to judgment as a matter of law. The
mere existence of a scintilla of evidence in support
of the [nonmovant’s] position will be insufficient;
there must be evidence on which the jury could
reasonably find for the [nonmovant].
Daniels v. School Dist. of Phila., 776 F.3d 181, 192 (3d
Cir. 2015) (alterations in original) (citations omitted).
The application of local patent rules is governed by
the law of this court and “[d]ecisions enforcing local rules
in patent cases will be affirmed unless clearly unreasona-
ble, arbitrary, or fanciful; based on erroneous conclusions
of law; clearly erroneous; or unsupported by any evi-
dence.” O2 Micro Int’l Ltd. v. Monolithic Power Sys., Inc.,
467 F.3d 1355, 1366–67 (Fed. Cir. 2006).
B. Obviousness
A patent is invalid “if the differences between the sub-
ject matter sought to be patented and the prior art are
such that the subject matter as a whole would have been
obvious at the time the invention was made to a person
having ordinary skill in the art to which said subject
matter pertains.” 35 U.S.C. § 103(a). As patents are
“presumed valid,” 35 U.S.C. § 282, a defendant bears the
burden of proving invalidity by “clear and convincing
evidence,” Microsoft Corp. v. i4i Ltd., 131 S. Ct. 2238,
2242 (2011). For a patent to be obvious, “some kind of
motivation must be shown . . . so that the jury can under-
stand why a person of ordinary skill would have thought
of either combining two or more references or modifying
one to achieve the patented method.” Innogenetics, N.V.
v. Abbott Labs., 512 F.3d 1363, 1374 (Fed. Cir. 2008)
(citation omitted).
SHIRE LLC v. AMNEAL PHARMACEUTICALS, LLC 9
The district court concluded that (1) the prior art did
not disclose LDX or make it obvious; (2) even if it did, the
prior art did not disclose that LDX was known as an
active drug substance; (3) even if it did, the prior art
provided no motivation to pick LDX as a starting com-
pound; and (4) even if it did, the prior art provided no
motivation to make mesylate salts of LDX. Op. at *15–17.
Shire did not introduce and the district court did not
analyze any secondary considerations.
Defendants maintain that there is a genuine issue of
material fact whether Australian Patent Application No.
54,168/65 (“AU ’168”), actually discloses LDX. Specifical-
ly, they claim that page 7 of AU ’168 identifies 18 amino
acids by name, including lysine, and states a preference
for L-amino acids and d-amphetamine. Upon reading this
passage, defendants argue, a person of skill in the art
would immediately envisage LDX. Defendants also claim
that Formula IV and Example 24 of AU ’168 disclose
LDX. Defendants also contend that there is a genuine
issue of material fact whether the prior art as a whole
rendered the mesylate salts of LDX obvious. There is also
a genuine issue of material fact, defendants argue,
whether mesylate salts of LDX were obvious and whether
there was a reasonable expectation of success that the
mesylate salt of LDX would serve its intended purpose.
In addition to AU ’168, defendants rely on several other
pieces of prior art, including U.S. Patent No. 3,843,796
(“Miller”), to bolster their obviousness argument.
Shire denies that AU ’168 discloses LDX. Shire
claims that the record fails to show that a person of skill
in the art would: “(i) start with d-amphetamine, (ii) chem-
ically modify d-amphetamine, (iii) make a prodrug of d-
amphetamine, (iv) synthesize [LDX] while ignoring other
conjugates of d-amphetamine, (v) make a salt of [LDX]
instead of using the freebase form, and finally (vi) specifi-
cally choose a mesylate salt rather than any other salt.”
Resp. Br. at 19. Shire also claims that defendants waived
10 SHIRE LLC v. AMNEAL PHARMACEUTICALS, LLC
their arguments that Formula IV and Example 24 of AU
’168 rendered the claims obvious.
On this record, there is no genuine issue of material
fact that the prior art did not disclose or make obvious the
mesylate salt of LDX. Defendants’ primary reference is
AU ’168. AU ’168 is listed on the face of the patents-in-
suit and therefore the examiner is presumed to have
considered it. Defendants therefore “ha[ve] the added
burden of overcoming the deference that is due to a quali-
fied government agency presumed to have properly done
its job, which includes one or more examiners who are
assumed to have some expertise in interpreting the
references and to be familiar from their work with the
level of skill in the art and whose duty it is to issue only
valid patents.” PowerOasis, Inc. v. T-Mobile USA, Inc.,
522 F.3d 1299, 1304 (Fed. Cir. 2008) (citations omitted).
AU ’168 discloses combining amphetamine, in any of
its stereochemical forms, with numerous amino acids, in
various stereochemistries and with many potential pro-
tecting groups. Nothing in AU ’168 specifically suggests
combining d-amphetamine with L-lysine. Page 7 of AU
’168, relied on heavily by defendants, lists 18 amino acids
“and the like,” and states they can belong to the D- or L-
series. Even this list, therefore, does not limit itself to 18
amino acids. AU ’168 expressly suggests post-
translational modifications of the amino acids, see id. at 8,
thus further increasing the potential amino acid groups to
be utilized. While page 7 states that “[a]cids of the L-
series are preferred,” AU ’168 actually describes numer-
ous D-series amino acids. Read in context of the whole
reference, a person of skill in the art would, therefore, not
focus exclusively on amino acids with the L stereochemis-
try.
As to Formula IV of AU ’168, it does not teach a finite
and limited class including LDX. Formula IV shows a
compound with a Markush group, ‘A.’ For Formula IV to
SHIRE LLC v. AMNEAL PHARMACEUTICALS, LLC 11
disclose LDX, ‘A’ must be selected to be L-lysine and the
amphetamine must be in the d-configuration. There is no
genuine issue of material fact that AU ’168 does not
disclose L-lysine as part of a limited class of compounds
for ‘A’. AU ’168 suggests that ‘A’ can be selected from one
of three lists, and as defendants’ expert candidly admit-
ted, Formula IV “does not indicate any preference” among
the different options. Thus, Formula IV discloses all the
compounds from all three lists, the first of which lists 17
amino acids (including lysine), the second of which teach-
es over a hundred possible combinations of amino acids
and protecting groups and the third of which does not
even provide a definite list of compounds. This too is not
a definite and limited class. Further, as described above,
AU ’168 does not meaningfully describe a preference for
the L stereochemistry of its amino acids.
Example 24 is similarly insufficient. Example 24 is
Nα-Tosyl-L-lysine[D(+)-1-phenyl-propyl-(2)]-amide. Exam-
ple 24 differs from LDX in that it contains a tosyl group.
On page 8, AU ’168 describes tosyl as a “protecting
group[],” and on page 14, it states that “[a] tosyl group can
be removed by . . . treatment . . . with sodium in liquid
ammonia.” According to defendants, this provides moti-
vation to modify example 24 to make LDX. The problem
for defendants is that example 24 is a final product, not
an intermediate synthesis product. Defendants therefore
have to show a reason why one of skill in the art would
decide to start with example 24 and remove the protecting
group. They have shown no such motivation. See also P.
Quitt, Synthesis of Optically Active N-Methylated Amino-
Acids, in PEPTIDES: PROCEEDINGS OF THE FIFTH EUROPEAN
SYMPOSIUM OXFORD, September 1962 165, 167 (G.T.
Young ed., 1963) (explaining that the Nα-tosyl “protected
derivative might in most cases be the desired product”).
The hindsight nature of defendants’ argument is con-
firmed by the fact that out of the thousands of possible
compounds it discloses, AU ’168 actually provides thirty
12 SHIRE LLC v. AMNEAL PHARMACEUTICALS, LLC
specific examples, none of which is LDX. Thus, read in
context, a person of skill in the art would not have any
reason to specifically select LDX.
Nor is there a genuine issue of material fact that AU
’168 does not render obvious the mesylate salts of
LDX. As described above, AU ’168 broadly teaches com-
bining amphetamine with many amino acids, protected
and unprotected, and in different stereochemistries, but
provides “no direction as to which of many possible choic-
es is likely to be successful.” Unigene Labs., Inc. v. Apo-
tex, Inc., 655 F.3d 1352, 1361 (Fed. Cir. 2011) (citations
omitted). Thus, AU ’168 does not make LDX obvious to
try. See id. Defendants can only come to LDX by “re-
trac[ing] the path of the inventor with hindsight,” Ortho-
McNeil Pharm., Inc. v. Mylan Labs., Inc., 520 F.3d 1358,
1364 (Fed. Cir. 2008). We therefore reject the hindsight
claims of obviousness. See In re Cyclobenzaprine Hydro-
chloride Extended-Release Capsule Patent Litig., 676 F.3d
1063, 1071-72 (Fed. Cir. 2012).
Miller does not overcome the deficiencies of AU ’168.
Defendants focus on Formula II of Miller, which describes
a molecule with two Markush groups, [R’] and [X]. Even
focusing on Formula II, Miller discloses that [X] can be
one of twenty amino acids—including L-lysine—or their
derivatives. Miller at col.3 ll.4–52. Defendants have
offered no rationale why a person of skill in the art would
focus on the specific embodiment of Formula II compris-
ing L-lysine. Moreover, even if [X] were chosen to be L-
lysine, Miller’s compound is still different from LDX in
two ways—to wit, Miller has an OR’ where LDX has an H
and Miller has a C-OH where LDX has a CH—i.e., the
base compound in Miller is not amphetamine. The record
provides no reason or motivation why one of skill in the
art would combine AU ’168 with Miller. Accordingly,
there is no genuine issue of material fact that the disclo-
sure in Miller does not overcome the deficiencies in AU
’168.
SHIRE LLC v. AMNEAL PHARMACEUTICALS, LLC 13
We have considered the other references cited by de-
fendants and find that they too fail to raise a genuine
issue of material fact as to whether LDX, let alone the
mesylate salt of LDX, was made obvious by the prior art.
Because all the asserted claims are limited to mesylate
salts of LDX, we need not consider whether additional
limitations found in certain claims would separately
suffice to make the claims non-obvious. See SynQor, Inc.
v. Artesyn Techs., Inc., 709 F.3d 1365, 1375 (Fed. Cir.
2013). Accordingly, the district court’s grant of summary
judgment that the asserted claims are nonobvious is
affirmed.
C. Defendants’ Motion to Amend
Defendants allege that they were timely in seeking
leave to amend their invalidity contentions, because both
Shire and third parties delayed in producing documents
relevant to an on-sale bar defense and because defendants
had to sift through more than two million pages of docu-
ments to find the relevant evidence. Relatedly, defend-
ants argue there was good cause for their delay because
they were diligent in their search for evidence. Finally,
defendants argue that there is no undue prejudice to
Shire because Shire itself was responsible for the delay.
Shire responds that the district court properly evaluated
all the factors.
Defendants have not shown that the district court
abused its discretion in denying defendants’ motion to
amend. In their opening brief, defendants have not
persuasively explained why their motion to assert an on-
sale bar defense was not filed earlier and have failed to
even challenge the magistrate judge’s finding that docu-
ments produced by Shire on May 21, 2012, contained
information “that should have led” defendants to raise an
on-sale bar argument. Moreover, defendants did not ask
Shire for permission to supplement their invalidity con-
tentions until August of 2013—more than a year later.
14 SHIRE LLC v. AMNEAL PHARMACEUTICALS, LLC
Accordingly, we find no reason to conclude that the dis-
trict court abused its discretion in denying defendants’
motion to amend as untimely and lacking good cause.
The decision to deny defendants’ motion to amend is
therefore affirmed.
D. The Claim Against Johnson Matthey
Under § 271(e)(2), Congress made it “an act of in-
fringement to submit an [ANDA] application . . . for a
drug claimed in a patent or the use of which is claimed in
a patent.” 35 U.S.C. § 271(e)(2)(A). But Congress also
provided a safe harbor in § 271(e)(1) for those engaged in
certain activities in support of the filing of an ANDA.
Specifically, § 271(e)(1) states that “[i]t shall not be an act
of infringement to make, use, offer to sell, or sell within
the United States or import into the United States a
patented invention . . . solely for uses reasonably related
to the development and submission of information under
a Federal law which regulates the manufacture, use, or
sale of drugs or veterinary biological products.” 35 U.S.C.
§ 271(e)(1).
Johnson Matthey does not seek FDA approval to sell a
generic form of Vyvanse® and has therefore made no
ANDA filing. Its only involvement in this dispute arises
from its actions in supplying the ANDA defendants with
the active pharmaceutical ingredient LDX dimesylate.
The district court found it undisputed that each of the
ANDAs at issue lists Johnson Matthey as the manufac-
turer of the LDX dimesalyate used in their generic prod-
ucts. It was also undisputed that Johnson Matthey filed a
drug master file for that ingredient with the FDA in
support of the ANDA defendants’ applications and in
anticipation of the eventual commercial exploitation of
both its API and the generic products made from it. From
this, the district court entered judgment that Johnson
Matthey “has induced infringement of the compound
claims at issue.” Op. at *20.
SHIRE LLC v. AMNEAL PHARMACEUTICALS, LLC 15
Johnson Matthey argues that providing the ANDA de-
fendants with an active ingredient so they could submit
their ANDAs was reasonably related to the submission of
information under a federal law and was therefore within
the safe harbor of § 271(e)(1). Since it did not itself sub-
mit an ANDA, Johnson Matthey contends that it cannot
be liable under § 271(e)(2) for its past actions and there-
fore the district court was wrong to enter judgment
against it. Further, it asserts that because no direct
infringement has yet to occur, it cannot be liable for
induced infringement under § 271(b). It thus contends
that it should never have been named in the litigation
and should be dismissed from the case.
Shire counters by asserting that Johnson Matthey is
properly in the suit and can be liable for induced in-
fringement. According to Shire, this court’s decision in
Forest Laboratories, Inc. v. Ivax Pharmaceuticals, Inc.,
501 F.3d 1263 (Fed. Cir. 2007), held that a party can be
liable “under section 271(e)(2) for its future infringement
under section 271(b) as the ANDA-filers’ API supplier.”
Resp. Br. at 52. Shire contends that on the facts before us
“Forest cannot be distinguished.” Id. at 55 (capitalization
altered). Finally, Shire argues that under the reasoning
of Forest Labs., Johnson Matthey can be enjoined.
Johnson Matthey is correct that it cannot be liable for
the API it sold the ANDA defendants up to this point.
Johnson Matthey, as an API supplier, has thus far done
nothing more than provide material for use by the ANDA
defendants in obtaining FDA approval. As the district
court found, these sales, and the ANDA defendants’ use of
the API for filing the ANDA, were “reasonably related to
the submission of an ANDA.” Op. at *12. As such, John-
son Matthey’s activities are protected by the safe harbor
of § 271(e)(1), and the district court erred by entering
judgment that Johnson Matthey has induced infringe-
ment of the compound claims at issue.
16 SHIRE LLC v. AMNEAL PHARMACEUTICALS, LLC
Moreover, as Johnson Matthew did not submit an
ANDA, it cannot be liable for infringement under §
271(e)(2). We do not agree with Shire that this Court’s
decision in Forest requires a different result. To the
contrary, Forest involved the scope of an injunction under
§ 271(e)(4). No such injunction has been issued against
Johnson Matthew here and thus Forest is inapposite.
Johnson Matthey is therefore not currently liable for
infringement.
Accordingly, we reverse the district court’s judgment
that Johnson Matthey has induced infringement of the
compound claims at issue and remand for further proceed-
ings consistent with this opinion.
III. CONCLUSION
For the foregoing reasons the district court’s grant of
summary judgment that the asserted claims are not
invalid as obvious is affirmed; the district court’s denial of
defendants’ motion to amend is affirmed; and the district
court’s judgment that Johnson Matthey has induced
infringement is reversed. The case is remanded for
further proceedings consistent with this opinion.
AFFIRMED-IN-PART, REVERSED-IN-PART, AND
REMANDED
COSTS
Each party shall bear its own costs.