Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca13-14-01736/USCOURTS-ca13-14-01736-0/pdf.json

Parties Involved:
Actavis Elizabeth LLC
Appellant
Actavis LLC
Appellant
Amneal Pharmaceuticals, LLC
Appellant
Johnson Matthey Inc.
Appellant
Johnson Matthey Pharmaceutical Materials
Appellant
Mylan Inc.
Appellant
Mylan Pharmaceuticals Inc.
Appellant
Roxane Laboratories Inc.
Appellant
Sandoz Inc.
Appellant
Shire Development Inc.
Appellee
Shire Development, LLC
Appellee
Shire LLC
Appellee

Document Text:

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 representCase: 14-1736 Document: 119-2 Page: 1 Filed: 09/24/2015
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 defendantsappellants Amneal Pharmaceuticals, LLC, Roxane Laboratories Inc., Sandoz, Inc., Mylan Inc., Mylan Pharmaceuticals Inc., Actavis Elizabeth LLC, Actavis LLC. 

Defendants-appellants Mylan Inc., Mylan Pharmaceuticals 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 Goldstein & 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, Washington, 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, Chicago, IL, argued for defendants-appellants Johnson Matthey Inc., Johnson Matthey Pharmaceutical Materials. 

Also represented by JOSHUA JOHN FOUGERE, Washington, 

Case: 14-1736 Document: 119-2 Page: 2 Filed: 09/24/2015
SHIRE LLC v. AMNEAL PHARMACEUTICALS, LLC 3

DC; DOUGLAS R. NEMEC, RACHEL RENEE BLITZER, Skadden, Arps, Slate, Meagher & Flom LLP, New York, NY.

WILLIAM M. JAY, Goodwin Procter LLP, Washington, 

DC, for amicus curiae Generic Pharmaceutical Association. 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 Pharmaceutical Materials (“Johnson Matthey”) (collectively, “defendants”) 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 judgment 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 “asserted claims”) are not invalid. Defendants also appeal the 

district court’s decision in Shire, LLC v. Amneal Pharmaceuticals, LLC, No. 11-3781 (D.N.J. May 12, 2014), affirming 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 infringement of the claims of the ’630, ’253 and ’787 patents

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4 SHIRE LLC v. AMNEAL PHARMACEUTICALS, LLC

(the “compound claims”) by providing the active pharmaceutical 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 Matthey 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 judgment 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 hyperactivity 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 “utilize[] 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 

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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 markets LDX dimesylate capsules. These capsules are approved 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) (commonly 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 certifications. 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.

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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, amendments to contentions must be based on “a timely application 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 information [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 magistrate judge ruled that allowing defendants to amend their 

contentions would unduly prejudice Shire, because “Shire 

ha[d] relied on Defendants’ previous invalidity contentions 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 compound claims, Op. at *11; (2) the ANDA defendants induced infringement of claim 4 of the ’486 patent, id. at 

*12; (3) Johnson Matthey induced infringement of the 

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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 judgment that Johnson Matthey directly infringed the compound 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) (20061) 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 according 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 preAIA version of § 103 applies.

 

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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 genuine 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 unreasonable, arbitrary, or fanciful; based on erroneous conclusions 

of law; clearly erroneous; or unsupported by any evidence.” 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 subject 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 understand 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). 

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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 compound; 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. Specifically, 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) chemically modify d-amphetamine, (iii) make a prodrug of damphetamine, (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) specifically choose a mesylate salt rather than any other salt.” 

Resp. Br. at 19. Shire also claims that defendants waived 

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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-insuit 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 qualified 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 protecting 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 Lseries. Even this list, therefore, does not limit itself to 18 

amino acids. AU ’168 expressly suggests posttranslational 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 Lseries are preferred,” AU ’168 actually describes numerous 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 stereochemistry. 

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 

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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 admitted, 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 teaches 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. Example 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 motivation 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 AminoAcids, 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 confirmed by the fact that out of the thousands of possible 

compounds it discloses, AU ’168 actually provides thirty 

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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 combining amphetamine with many amino acids, protected 

and unprotected, and in different stereochemistries, but 

provides “no direction as to which of many possible choices is likely to be successful.” Unigene Labs., Inc. v. Apotex, 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 “retrac[ing] the path of the inventor with hindsight,” OrthoMcNeil 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 Hydrochloride 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 comprising L-lysine. Moreover, even if [X] were chosen to be Llysine, 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 disclosure in Miller does not overcome the deficiencies in AU 

’168.

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We have considered the other references cited by defendants 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 documents to find the relevant evidence. Relatedly, defendants 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 onsale bar defense was not filed earlier and have failed to 

even challenge the magistrate judge’s finding that documents 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 contentions until August of 2013—more than a year later. 

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14 SHIRE LLC v. AMNEAL PHARMACEUTICALS, LLC

Accordingly, we find no reason to conclude that the district 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 infringement 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 manufacturer of the LDX dimesalyate used in their generic products. 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.

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Johnson Matthey argues that providing the ANDA defendants 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 submit an ANDA, Johnson Matthey contends that it cannot 

be liable under § 271(e)(2) for its past actions and therefore 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 infringement. 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, Johnson 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 infringement of the compound claims at issue.

Case: 14-1736 Document: 119-2 Page: 15 Filed: 09/24/2015
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 proceedings 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.

Case: 14-1736 Document: 119-2 Page: 16 Filed: 09/24/2015