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`
`EXHIBIT 2
`EXHIBIT 2
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`

`

`
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`Case 2:17-cv-07111-KM-CLW Document 156 Filed 07/31/18 Page 1 of 40 PageID: 11685Case 1:23-cv-00089-TSK Document 100-2 Filed 02/14/24 Page 2 of 41 PageID #: 4159
`
`Charles M. Lizza
`William C. Baton
`David L. Moses
`SAUL EWING ARNSTEIN & LEHR LLP
`One Riverfront Plaza, Suite 1520
`Newark, New Jersey 07102-5426
`(973) 286-6700
`clizza@saul.com
`wbaton@saul.com
`dmoses@saul.com
`
`Attorneys for Plaintiffs
`Indivior Inc.,
`Indivior UK Limited, and
`Aquestive Therapeutics, Inc.
`
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`
`INDIVIOR INC., INDIVIOR UK LIMITED,
`and AQUESTIVE THERAPEUTICS, INC.,
`
`
`
`
`
`
`
`
`
`DR. REDDY’S LABORATORIES S.A. and
`DR. REDDY’S LABORATORIES, INC.,
`
`
`
`
`
`Plaintiffs,
`
`v.
`
`
`
`
`
`Defendants.
`
`Civil Action No. 17-7111 (KM)(CLW)
`Civil Action No. 18-1775 (KM)(CLW)
`Civil Action No. 18-5288 (KM)(CLW)
`(Consolidated)
`
`
`(Filed Electronically)
`
`HIGHLY CONFIDENTIAL –
`OUTSIDE COUNSEL’S EYES ONLY –
`FILED UNDER SEAL
`
`MEMORANDUM OF LAW IN SUPPORT OF PLAINTIFFS’ MOTION FOR A
`TEMPORARY RESTRAINING ORDER AND PRELIMINARY INJUNCTION
`
`

`

`
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`
`
`TABLE OF CONTENTS
`
`TABLE OF AUTHORITIES ......................................................................................................... iii
`TABLE OF ABBREVIATIONS ................................................................................................... vi
`I.
`INTRODUCTION .............................................................................................................. 1
`II.
`BACKGROUND ................................................................................................................ 2
`A.
`Suboxone Film ........................................................................................................ 2
`B.
`The ’305 Patent ....................................................................................................... 3
`C.
`DRL’s Generic Version of Suboxone Film ............................................................ 4
`D.
`DRL’s Admissions Concerning Its ANDA Product and the Prior Validity
`Findings on the Parent ’514 Patent ......................................................................... 5
`1.
`Comparison of Claim 26 of the ’305 Patent to Claim 62 of the ’514
`Patent........................................................................................................... 5
`The District Court’s Decision on Claim 62 of the ’514 Patent ................... 6
`Claim 26 of the ’305 Patent Requires a Continuously Cast Film
`Produced on a Manufacturing Line ............................................................. 7
`LEGAL STANDARD ......................................................................................................... 8
`ARGUMENT ...................................................................................................................... 9
`A.
`Plaintiffs Are Likely To Succeed on the Merits ..................................................... 9
`1.
`DRL Cannot Raise a Substantial Question of Noninfringement ................ 9
`a)
`DRL’s Proposed ANDA Product Meets Every Limitation
`of Claim 26 of the ’305 Patent ...................................................... 10
`DRL Attempts to Add Another Limitation to Claim 26 to
`Concoct a Noninfringement Defense ............................................ 13
`DRL Cannot Raise a Substantial Question of Invalidity .......................... 16
`2.
`Plaintiffs Will Suffer Irreparable Harm Unless DRL’s Launch Is Enjoined ........ 21
`1.
`Indivior Could Lose Most of Its Market Share and Revenue ................... 21
`2.
`Suboxone Film Could Irretrievably Lose Favorable Formulary
`Status ......................................................................................................... 23
`Indivior Could Suffer from Research and Development Delays and
` ......................................................................................... 25
`Indivior Would Suffer Reputational Harm and Loss of Goodwill ........... 26
`4.
`Aquestive Would Also Suffer Irreparable Harm ...................................... 27
`5.
`The Balance of Harms Strongly Supports a Preliminary Injunction .................... 27
`The Public Interest Favors an Injunction Here, Where Indivior Would
`Have to Scale Back its Role in Expanding Access to Opioid Addiction
`Treatment .............................................................................................................. 28
`THE RELIEF AWARDED SHOULD ADDRESS ANY ANDA PRODUCT
`THAT DRL HAS ALREADY SHIPPED......................................................................... 30
`
`2.
`3.
`
`3.
`
`b)
`
`III.
`IV.
`
`V.
`
`B.
`
`C.
`D.
`
`
`
`i
`
`

`

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`
`
`PLAINTIFFS ARE PREPARED TO POST A REASONABLE BOND ......................... 31
`VI.
`VII. CONCLUSION ................................................................................................................. 31
`
`
`
`
`
`
`
`ii
`
`

`

`
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`
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases
`
`Antares Pharma, Inc. v. Medac Pharma, Inc.,
`55 F. Supp. 3d 526 (D. Del. 2014) ...........................................................................................23
`
`Apple Inc. v. Samsung Elecs. Co.,
`809 F.3d 633 (Fed. Cir. 2015)..................................................................................................27
`
`Apple Inc. v. Samsung Elecs. Co., Ltd.,
`839 F.3d 1034 (Fed. Cir. 2016)................................................................................................20
`
`AstraZeneca LP v. Apotex, Inc.,
`623 F. Supp. 2d 579 (D.N.J. 2009) ....................................................................................24, 25
`
`AstraZeneca LP v. Apotex, Inc.,
`633 F.3d 1042 (Fed. Cir. 2010)..................................................................................................9
`
`Bio-Tech. Gen. Corp. v. Genentech, Inc.,
`80 F.3d 1553 (Fed. Cir. 1996)..................................................................................................25
`
`Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp.,
`106 F. Supp. 2d 696 (D.N.J. 2000), abrogated on other grounds by Robert
`Bosch LLC v. Pylon Mfg. Corp., 659 F.3d 1142 (Fed. Cir. 2011) .....................................29, 30
`
`In re BRCA1-, BRCA2-Based Hereditary Cancer Test Patent Litig.,
`3 F. Supp. 3d 1213 (D. Utah 2014) ..........................................................................................23
`
`Butamax™ Advanced Biofuels LLC v. Gevo, Inc.,
`No. 11–54–SLR, 2012 WL 2675232 (D. Del. July 6, 2012) ...................................................30
`
`Canon Computer Sys., Inc. v. Nu-Kote Int’l, Inc.,
`134 F.3d 1085 (Fed. Cir. 1998)................................................................................................16
`
`Chrysler Motors Corp. v. Auto Body Panels of Ohio, Inc.,
`908 F.2d 951 (Fed. Cir. 1990)....................................................................................................8
`
`In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig.,
`No. 09-MD-2118-SLR, 2011 WL 1980610 (D. Del. May 20, 2011) ......................................26
`
`eBay Inc. v. MercExchange, L.L.C.,
`547 U.S. 388 (2006) ...................................................................................................................9
`
`Eisai Co. v. Teva Pharms. USA, Inc.,
`Nos. 05-5727, 07-5489 (HAA)(ES), 2008 WL 1722098 (D.N.J. Mar. 28,
`2008) ..................................................................................................................................26, 27
`
`
`
`iii
`
`

`

`
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`
`
`Fresenius Kabi USA, LLC v. Fera Pharm., LLC,
`No. 15-CV-3654 (KM)(MAH), 2016 WL 5348866 (D.N.J. Sept. 23, 2016),
`appeal dismissed, No. 2017-1099, 2017 WL 8942451 (Fed. Cir. Dec. 18,
`2017) ........................................................................................................................8, 21, 22, 25
`
`Health Prof’ls & Allied Emps. AFT/AFL-CIO v. MHA, LLC,
`No. 17-13301 (JMV), 2017 WL 6550488 (D.N.J. Dec. 21, 2017) ............................................8
`
`Hoffmann-La Roche Inc. v. Cobalt Pharms. Inc.,
`Nos. 07-4539, 07-4540, 08-4054 (SRC) (MAS), 2010 WL 4687839 (D.N.J.
`Nov. 10, 2010) .........................................................................................................................22
`
`Hybritech Inc. v. Abbott Labs.,
`849 F.2d 1446 (Fed. Cir. 1988)............................................................................................8, 21
`
`Janssen Prods., L.P. v. Lupin Ltd.,
`109 F. Supp. 3d 650, 696 (D.N.J. 2014) ..................................................................................24
`
`Kyphon, Inc. v. Disc-O-Tech Med. Techs. Ltd.,
`No. 04–204 JJF, 2004 WL 2898064 (D. Del. Dec. 10, 2004) .................................................27
`
`Laryngeal Mask Co. v. Ambu A/S,
`618 F.3d 1367 (Fed. Cir. 2010)................................................................................................14
`
`Marxe v. Jackson,
`833 F.2d 1121 (3d Cir. 1987).....................................................................................................8
`
`Microsoft Corp. v. i4i Ltd. P’ship,
`131 S. Ct. 2238 (2011) .............................................................................................................16
`
`Ortho McNeil Pharm., Inc. v. Barr Labs., Inc.,
`No. 03-4678 (SRC), 2009 WL 2182665 (D.N.J. July 22, 2009) .............................................30
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005)..........................................................................................14, 15
`
`Reckitt Benckiser Pharms. Inc. v. Dr. Reddy’s Labs. S.A.,
`No. 1:14-cv-01451-RGA, 2017 WL 3837312 (D. Del. Aug. 31, 2017) ....................................4
`
`Reckitt Benckiser Pharms. Inc. v. Teva Pharms. USA, Inc.,
`No. 1:14-cv-01451-RGA, 2016 WL 3621632 (D. Del. June 29, 2016) ....................................6
`
`Reckitt Benckiser Pharms. Inc. v. Watson Labs., Inc. et al.,
`No. 1:13-cv-01674-RGA, 2016 WL 3186659 (D. Del. Jun. 3, 2016) ...................16, 17, 18, 19
`
`Regents of Univ. of Minn. v. AGA Med. Corp.,
`717 F.3d 929 (Fed. Cir. 2013)..................................................................................................14
`
`
`
`iv
`
`

`

`
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`
`
`Reilly v. City of Harrisburg,
`858 F.3d 173 (3d Cir. 2017).......................................................................................................8
`
`Sanofi-Synthelabo v. Apotex, Inc.,
`470 F.3d 1368 (Fed. Cir. 2006)..........................................................................................25, 27
`
`Serrano v. Telular Corp.,
`111 F.3d 1578 (Fed. Cir. 1997)................................................................................................14
`
`Trebro Mfg., Inc. v. Firefly Equip., LLC,
`748 F.3d 1159 (Fed. Cir. 2014)............................................................................................9, 21
`
`United States v. Telectronics, Inc.,
`857 F.2d 778 (Fed. Cir. 1988)..................................................................................................14
`
`Unwired Planet, LLC v. Apple Inc.,
`829 F.3d 1353 (Fed Cir. 2016).................................................................................................15
`
`Ventana Med. Sys., Inc. v. Biogenex Labs., Inc.,
`473 F.3d 1173 (Fed. Cir. 2006)................................................................................................15
`
`Statutes
`
`35 U.S.C. § 282 ..............................................................................................................................16
`
`35 U.S.C. § 283 ................................................................................................................................8
`
`Other Authorities
`
`Fed. R. Civ. P. 62(c)……………………………………………………………………………..30
`
`
`
`
`
`v
`
`

`

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`
`
`TABLE OF ABBREVIATIONS
`
`Plaintiff Aquestive Therapeutics, Inc., formerly known as MonoSol
`Rx, LLC
`Plaintiffs Indivior Inc. and Indivior UK Limited
`Defendants Dr. Reddy’s Laboratories S.A. and Dr. Reddy’s
`Laboratories, Inc.
`U.S. Patent No. 9,931,305 (Ex. B)
`U.S. Patent No. 8,603,514 (Ex. E)
`Reckitt Benckiser Pharms. Inc. v. Dr. Reddy’s Labs. S.A., No. 1:14-
`cv-01451-RGA (D. Del.)
`buprenorphine-containing transmucosal product for opioid
`dependency
`Food and Drug Administration
`Person of Ordinary Skill in the Art
`Exhibits attached to the Declaration of Philip S. May,
`submitted herewith
`drug content uniformity
`United States Patent and Trademark Office
`Aquestive Therapeutics, Inc., Indivior Inc., and Indivior UK Limited
`United States Patent and Trademark Office Before the Patent Trial
`and Appeal Board
`U.S. Patent No. 4,849,246 (Langer Decl., Ex. 38)
`U.S. Patent No. 6,552,024
`U.S. Patent No. 5,881,476
`U.S. Patent No. 7,067,116 (Langer Decl., Ex. 37)
`Save et al., Comparative Study of Buccoadhesive Formulations and
`Sublingual Capsules of Nifedipine, J. Pharm. Pharmacol. 1994,
`46:192–195 (Langer Decl., Ex. 39)
`Declaration of Robert S. Langer, Sc.D., Institute Professor in the
`Department of Chemical and Biomedical Engineering at MIT, the
`Whitaker College of Health Sciences, Technology, and Management
`at MIT, and the Harvard-MIT Division of Health Science and
`Technology
`Declaration of Mr. Richard Simkin, Chief Commercial and Strategy
`Officer of Indivior
`Declaration of Mr. Mark Crossley, Chief Financial Officer of
`Indivior
`Declaration of Robert Navarro, Pharm.D., Clinical Professor in the
`Department of Pharmaceutical Outcomes & Policy at the University
`of Florida’s College of Pharmacy
`Declaration of Ms. Melissa Bennis, MBA, CPA, Principal at Davis
`& Hosfield Consulting LLC
`Declaration of Mr. Keith Kendall, Chief Executive Officer of
`Aquestive
`
`
`vi
`
`“Aquestive”
`
`“Indivior”
`“DRL”
`
`“the ’305 Patent”
`“the ’514 Patent”
`“’514 Patent
`Litigation”
`“BTOD”
`
`“FDA”
`“POSA”
`“Ex. __”
`
`“DCU”
`“Patent Office”
`“Plaintiffs”
`“PTAB”
`
`“Schmidt”
`“Chen”
`“Strobush”
`“Bess”
`“Save”
`
`“Langer Decl.”
`
`“Simkin Decl.”
`
`“Crossley Decl.”
`
`“Navarro Decl.”
`
`“Bennis Decl.”
`
`“Kendall Decl.”
`
`
`
`
`
`

`

`
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`
`
`I.
`
`INTRODUCTION
`
`Plaintiffs Indivior and Aquestive respectfully request a temporary restraining order and
`
`preliminary injunction to enjoin DRL’s at-risk launch of a generic version of Suboxone® Film
`
`prior to this Court adjudicating the merits of this patent infringement case. DRL received FDA
`
`approval today for its ANDA Product, and represented to the Court this evening that it has
`
`launched at risk. See Ex. A (D.I. 69). If not restrained or enjoined, this at-risk launch by DRL
`
`will have devastating effects on Indivior. Indivior faces a dramatic loss in market share and
`
`revenue
`
` drastic cuts in R&D and cause other irreparable harm
`
`to both Indivior and the public at large. The irreparable harm to Aquestive further supports the
`
`issuance of a temporary restraining order and preliminary injunction. Applying the traditional
`
`four-factor test, DRL’s launch at risk should be enjoined, and the Court should enjoin further
`
`shipment of product and order that any already-shipped product be recalled immediately.
`
`Likelihood of Success on the Merits. Plaintiffs are highly likely to succeed in proving that
`
`DRL infringes the ’305 Patent.
`
`
`
`that, by themselves, establish that DRL’s ANDA Product meets nearly every limitation of
`
`Claims 26 and 1 of the ’305 Patent, and DRL’s ANDAs clearly demonstrate that its product
`
` Moreover, DRL cannot establish a substantial
`
`question of invalidity of Claim 26 or Claim 1. Indeed, these claims share critical limitations with
`
`a parent patent whose claims have withstood challenges in both the U.S. District Court for the
`
`District of Delaware and before the PTAB.
`
`Irreparable Harm and Balance of Harms. DRL’s launch of its generic version of
`
`Suboxone Film will cause Plaintiffs to suffer extreme and irreparable harm, and the balance of
`
`the harms strongly favors an injunction. Suboxone Film is Indivior’s primary source of revenue.
`
`If not enjoined, DRL’s at-risk launch could cause Suboxone Film’s market share to drop
`1
`
`
`
`
`
`

`

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`
`
`, forcing Indivior to drastically cut R&D expenditures
`
`
`
` This launch could also cause Suboxone Film to lose its favorable formulary
`
`status and damage Aquestive’s ability to develop new relationships and products. DRL faces no
`
`such harms. DRL has many generic products, and if Indivior were unsuccessful in this litigation,
`
`DRL could be compensated for any profits it was delayed in receiving as a result of the
`
`injunction.
`
`Public Interest. The public interest also strongly favors an injunction—without it Indivior
`
`would be forced to dramatically scale back its programs for expanding access to opioid addiction
`
`treatments and developing improved treatments. Indivior has been a leader in the fight against
`
`the opioid addiction epidemic. Indivior provides education to physicians, helps physicians apply
`
`for the waivers necessary to treat opioid addiction, contributes to educational and charitable
`
`programs helping addicts and their families, and conducts innovative R&D to discover new
`
`treatments. Simkin Decl. ¶¶ 30–34. If not enjoined, DRL’s at-risk launch will force Indivior to
`
`slash spending on these critical programs, harming the public. Simkin Decl. ¶ 35. Similarly, the
`
`public will be harmed if patients and healthcare providers do not have the beneficial treatment
`
`options generated through Aquestive’s film drug delivery technology.
`
`For these reasons, Plaintiffs respectfully request that the Court enjoin DRL’s at-risk
`
`launch of its ANDA Product until the Court can resolve this case on the merits.
`
`II.
`
`BACKGROUND
`
`Suboxone Film
`A.
`Indivior developed Suboxone Film with Aquestive (f/k/a MonoSol Rx), a pioneer in
`
`pharmaceutical film technology. Suboxone Film is a rapidly dissolving film that adheres to the
`
`underside of a patient’s tongue or the inside of a patient’s cheek and combines two active
`
`pharmaceutical ingredients: (1) buprenorphine, a partial opioid agonist that decreases a patient’s
`
`
`
`2
`
`

`

`
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`
`
`need for opioids; and (2) naloxone, an opioid antagonist that deters abuse. Simkin Decl. ¶ 7.
`
`Since its launch in 2010, Suboxone Film has helped countless patients and healthcare providers
`
`to combat opioid dependence. See Simkin Decl. ¶¶ 5, 7; Bennis Decl. ¶¶ 14–16.
`
`Suboxone Film is the first sublingual pharmaceutical film product to receive regulatory
`
`approval, and has become the leading buprenorphine-containing transmucosal product for opioid
`
`dependency (“BTOD”). See Simkin Decl. ¶¶ 7–9; Crossley Decl. ¶ 5; Navarro Decl. ¶ 23.
`
`
`
` see Crossley Decl. ¶ 5,
`
`despite competition from generic tablets containing buprenorphine and naloxone, generic
`
`buprenorphine tablets, and other branded BTODs, see Simkin Decl. ¶ 9. In 2017, Suboxone Film
`
`accounted for approximately
`
` of Indivior’s U.S. net revenue and
`
` of global net revenue.
`
`See id. ¶ 8; Crossley Decl. ¶ 5.
`
`B.
`
`The ’305 Patent
`
`Approximately two months ago, on April 3, 2018, the Patent Office issued the ’305
`
`Patent to Aquestive. The ’305 Patent is now listed in FDA’s Orange Book as covering Suboxone
`
`Film.
`
`The ’305 Patent is directed to a continuously cast pharmaceutical film containing an
`
`active ingredient in particulate form—such as buprenorphine—where the dosage units have a
`
`uniformity in drug content that does not vary by more than 10% from the intended dose.
`
`Achieving this drug content uniformity in a pharmaceutical film was a foundational innovation
`
`of the inventors, for which their work has been widely praised. The inventors identified and
`
`overcame complex problems that led to disuniformity in earlier cast films, and in doing so
`
`succeeded where others had failed. Their inventions met a long-felt need for pharmaceutical
`
`films with sufficient drug content uniformity to ensure that patients consistently receive the
`
`intended drug dose—a prerequisite for safety and efficacy, and therefore for FDA approval. The
`3
`
`
`
`

`

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`
`
`inventions underlying the ’305 Patent led to the development of Suboxone Film, the first
`
`sublingual pharmaceutical film ever approved by FDA. DRL and others have since copied the
`
`inventors’ work.
`
`C.
`
`DRL’s Generic Version of Suboxone Film
`
`DRL has filed two ANDAs for generic versions of Suboxone Film. DRL’s ANDA No.
`
`205299 covers generic versions of two of Suboxone Film’s dosage strengths, while DRL’s
`
`ANDA No. 205806 covers generic versions of the other two dosage strengths. The infringement
`
`analysis for each dosage strength is the same for the ’305 Patent, and all will be referred to
`
`collectively as “DRL’s ANDA Product.”
`
`DRL does not, and could not, allege that its ANDA Product is missing any element
`
`recited in Claim 26 or Claim 1 of the ’305 Patent. Instead, DRL argues that an additional
`
`limitation should be imported into the claims and that DRL allegedly does not meet it.
`
`Specifically, although the claims do not contain the terms “dried” or “drying,” DRL argues that
`
`(1) those terms should be imported into the claims, and (2) they should be given idiosyncratic
`
`constructions to limit the claims to films dried using particular drying processes. Otherwise,
`
`DRL does not contest infringement. As to validity, DRL merely advances obviousness and
`
`anticipation arguments that have been rejected in prior litigation involving the parent patent,
`
`which also contains a requirement of 10% drug content uniformity.1
`
`
`1 Plaintiffs received two letters dated April 12, 2018 from DRL (DRL’s “Paragraph IV Letters”)
`(Ex. C, Ltr. re ANDA No. 205299; Ex. D, Ltr. re ANDA No. 205806), alleging that the claims of
`the ’305 Patent are invalid and not infringed by DRL’s ANDA Product.
`
`
`
`4
`
`

`

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`
`
`Pharms. Inc. v. Teva Pharms. USA, Inc., No. 1:14-cv-01451-RGA, Claim Construction Op. (D.I.
`
`175), 2016 WL 3621632, at *5–8, *10–11 (D. Del. June 29, 2016). The court found that DRL’s
`
`ANDA Product satisfied every other limitation of Claim 62, including limitations related to drug
`
`content uniformity and viscosity. ’514 Patent Litig. Op., 2017 WL 3837312, at *7–8.
`
`On the issue of validity, the court rejected DRL’s challenges to Claim 62 of the ’514
`
`Patent, finding the claim valid over the references DRL asserted (Schmidt and Chen), both alone
`
`and in combination with a third reference (Strobush). Id. at *14–20. The court found that no
`
`reference taught the required drug content uniformity, and that there was no motivation to
`
`combine the references to achieve such uniformity. Id. at *14–15. The PTAB also denied
`
`institution of a petition for inter partes review that DRL filed on Claim 62 of the ’514 Patent
`
`based on Chen and Bess. See Dr. Reddy’s Labs., Ltd. v. MonoSol Rx, LLC, IPR2016-01111,
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`Paper 14 (P.T.A.B. Dec. 5, 2016) (Ex. F). In finding that DRL failed to show a likelihood of
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`prevailing, the PTAB explained that DRL did “not establish[] that either Bess or Chen teaches or
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`suggests a drug delivery composition wherein the uniformity of individual unit doses, subsequent
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`to casting and drying, does not vary by more than 10% of the desired amount of at least one
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`active in the cast film.” Id. at 10–11.
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`3.
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`Claim 26 of the ’305 Patent Requires a Continuously Cast Film
`Produced on a Manufacturing Line
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`As discussed above, Claim 26 of the ’305 Patent recites a continuously cast film
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`produced on a manufacturing line. A continuously cast film refers to a particular type of film,
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`which is made by continuously depositing a coating solution onto a substrate (e.g., a liner) that
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`moves at a regulated speed. See, e.g., Ex. B (’305 Patent) at 28:35–39; see also Langer Decl.
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`¶¶ 43, 45–47. Individual dosage units are cut from a roll or sheet of the film, making
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`continuously cast films useful for commercial scale manufacture. Langer Decl. ¶¶ 44, 49–50. As
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`explained in the ’305 Patent, “[t]he uniform films of this invention can be divided into equally
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`sized dosage units having substantially equal amounts of each compositional component
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`present,” which is “particularly useful because it permits large area films to be initially formed,
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`and subsequently cut into individual dosage units without concern for whether each unit is
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`compositionally equal.” See Ex. B (’305 Patent) at 4:46–52.
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`III. LEGAL STANDARD
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`“Whether a preliminary injunction is warranted depends on four factors: (1) whether the
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`moving party is likely to succeed on the merits; (2) whether the moving party is likely to suffer
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`irreparable harm in the absence of preliminary relief; (3) whether granting preliminary relief will
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`result in even greater harm to the nonmoving party; and (4) whether an injunction is in the public
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`interest.” Fresenius Kabi USA, LLC v. Fera Pharm., LLC, No. 15-CV-3654 (KM)(MAH), 2016
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`WL 5348866, at *2 (D.N.J. Sept. 23, 2016), appeal dismissed, No. 2017-1099, 2017 WL
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`8942451 (Fed. Cir. Dec. 18, 2017) (citing Trebro Mfg., Inc. v. Firefly Equip., LLC, 748 F.3d
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`1159, 1165 (Fed. Cir. 2014)); see 35 U.S.C. § 283 (authorizing injunctions to protect patent
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`rights). “The same factors are used to determine a motion for a temporary restraining order.”
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`Health Prof’ls & Allied Emps. AFT/AFL-CIO v. MHA, LLC, No. 17-13301 (JMV), 2017 WL
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`6550488, at *2 (D.N.J. Dec. 21, 2017).
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`“These factors, taken individually, are not dispositive; rather, the district court must
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`weigh and measure each factor against the other factors and against the form and magnitude of
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`the relief requested.” Hybritech Inc. v. Abbott Labs., 849 F.2d 1446, 1451 (Fed. Cir. 1988); see
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`also Marxe v. Jackson, 833 F.2d 1121, 1128 (3d Cir. 1987). For instance, “[h]ow strong a claim
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`on the merits is enough depends on the balance of the harms: the more net harm an injunction
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`can prevent, the weaker the plaintiff’s claim on the merits can be while still supporting some
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`preliminary relief.” Reilly v. City of Harrisburg, 858 F.3d 173, 179 (3d Cir. 2017) (internal
`8
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`
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`quotation marks and citation omitted). Thus, the Court may grant a preliminary injunction where
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`“the weakness of the showing regarding one factor [is] overborne by the strength of the others.”
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`Chrysler Motors Corp. v. Auto Body Panels of Ohio, Inc., 908 F.2d 951, 953 (Fed. Cir. 1990).
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`“The decision to grant or deny … injunctive relief is an act of equitable discretion by the district
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`court.” eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388, 391 (2006).
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`To show likelihood of success on the merits, a patentee must demonstrate that it “will
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`likely prove infringement of one or more claims of the patents-in-suit, and that at least one of
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`those same allegedly infringed claims will also likely withstand the validity challenges presented
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`by the accused infringer.” AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1050 (Fed. Cir. 2010)
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`(internal quotation marks omitted). As to infringement, the patentee must show that the accused
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`product “more likely than not” satisfies all limitations of any one of the asserted claims. Trebro
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`Mfg., 748 F.3d at 1166. As to validity, an issued patent is presumed valid and the accused
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`infringer would need to establish invalidity by clear and convincing evidence. AstraZeneca, 633
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`F.3d at 1055. Therefore, at this stage, before the merits have been resolved, the patentee need
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`only show that the accused infringer is not “likely” to satisfy the exacting invalidity standard at
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`trial. Id. at 1050. Only a “substantial question” as to either noninfringement or invalidity can
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`prevent a temporary restraining order or preliminary injunction from issuing. Id.
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`IV. ARGUMENT
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`A.
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`Plaintiffs Are Likely To Succeed on the Merits
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`1.
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`DRL Cannot Raise a Substantial Question of Noninfringement
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`
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`DRL’s Paragraph IV Letters further support the conclusion that DRL infringes Claim 26.
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`DRL advances noninfringement only by arguing that it does not employ a particular drying
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`process; yet, Claim 26 has no such limitation. Indeed, DRL’s argument is rooted in a district
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`court’s claim construction of terms—“dried” and “drying”—that were removed from Claim 26
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`during prosecution of the ’305 Patent. DRL does not contest that its ANDA Product meets any
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`limitation actually recited in Claim 26.
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`Therefore, there is a substantial likelihood that Plaintiffs will succeed in establishing
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`infringement.
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`a)
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`DRL’s Proposed ANDA Product Meets Every Limitation of
`Claim 26 of the ’305 Patent
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`DRL’s ANDAs clearly show that its ANDA Product is “a continuously cast film
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`produced on a manufacturing line.”
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`
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` The findings of the court in
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`the previous litigation provide further support that DRL’s ANDA Product meets the limitations
`
`of Claim 26. Evidence establishing DRL’s infringement of Claim 26 can be summarized as
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`follows:
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`Limitation 1 (Continuously Cast Film). In its Paragraph IV Letters, DRL did not dispute
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`that its ANDA Product infringes this limitation. Nor could it.
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`
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`228–2) at 16–18 (Admitted Fact Nos. 108–116, 125); see also Ex. H (’514 Patent Litig. Trial Tr.)
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` See Ex. G (’514 Patent Litig., D.I.
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`at 526:4–6 (Fuller) (the manufacturing “line speed” can be controlled).
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`TSUB_00003114).
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`
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` See Langer Decl. ¶¶ 67–70 (citing
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` See Ex. G (’514 Patent Litig., D.I. 228–2) at 16
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`
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`(Admitted Fact Nos. 109, 111).
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`
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` see id.