recro vs actavis

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
RECRO GAINESVILLE LLC,
Plaintiff,
v.
ACTAVIS LABORATORIES FL, INC.,
Defendant.
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C.A. No. 14-1118 (GMS)
CONSOLIDATED
HIGHLY CONFIDENTIAL
FILED UNDER SEAL
RECRO’S PROPOSED POST-TRIAL
FINDINGS OF FACT AND CONCLUSIONS OF LAW
MORRIS, NICHOLS, ARSHT & TUNNELL LLP
Jack B. Blumenfeld (#1014)
Maryellen Noreika (#3208)
Jeremy A. Tigan (#5239)
Megan E. Dellinger (#5739)
1201 North Market Street
P.O. Box 1347
Wilmington, DE 19899-1347
(302) 658-9200
jblumenfeld@mnat.com
mnoreika@mnat.com
jtigan@mnat.com
mdellinger@mnat.com
Attorneys for Recro Gainesville LLC
November 7, 2016
REDACTED - PUBLIC VERSION
FILED 11/14/2016
Case 1:14-cv-01118-GMS Document 131 Filed 11/14/16 Page 1 of 43 PageID #: 2688

- i -
TABLE OF CONTENTS
Page
TABLE OF AUTHORITIES ......................................................................................................... iii
INTRODUCTION .....................................................................................................................1I.
PROPOSED FINDINGS OF FACT ..............................................................................................1II.
Zohydro® ER...........................................................................................................1A.
POSA .......................................................................................................................3B.
Infringement of the ’096 Patent...............................................................................3C.
Actavis’s Ethylcellulose-Based Coating Is Equivalent to the1.
Claimed Polyacrylic Coatings......................................................................5
The Inventors Did Not Dedicate Ethylcellulose to the2.
Public ...........................................................................................................8
The Excipients Added to Actavis’s Ethylcellulose-Based3.
Coatings Are Disclosed in the Specification and Permitted
by the Claims .............................................................................................10
Infringement of the ’742 Patent.............................................................................11D.
Actavis’s Active-Ingredient-Containing Pellets Comprise a1.
First and a Subsequent Population of Particles..........................................12
Actavis’s Active-Ingredient-Containing Pellets Deliver2.
Hydrocodone “In a Pulsatile Manner”.......................................................16
a. The “Release” of Active Ingredient from Actavis’s
ANDA Products Is Pulsatile ..........................................................16
b. The Plasma Concentration Profile Is Characterized
by Two or More Peaks Interspersed with Low
Concentration Troughs...................................................................18
The Asserted Dependent Claims Are Also Infringed ................................233.
PROPOSED CONCLUSIONS OF LAW .....................................................................................24III.
Actavis Infringes Claims 1, 4, and 5 of the ’096 Patent ........................................25A.
The Inventors Did Not Dedicate Ethylcellulose to the1.
Public .........................................................................................................26

- ii -
Claim 1 of the ’096 Patent Does Not Foreclose the Use of2.
the Common Excipients Actavis Included in Its
Ethylcellulose-Based Coating....................................................................28
Actavis’s ANDA Products Infringe the Asserted Claims of theB.
’742 Patent .............................................................................................................30
Relief......................................................................................................................35C.

- iii -
TABLE OF AUTHORITIES
Page(s)
Cases
Abbott Labs. v. Baxter Pharm. Prods., Inc.,
334 F.3d 1274 (Fed. Cir. 2003)................................................................................................29
Abbott Labs. v. TorPharm, Inc.,
300 F.3d 1367 (Fed. Cir. 2002)................................................................................................30
Acorda Therapeutics Inc. v. Apotex Inc.,
C.A. No. 07-4937-GEB-MCA, 2011 WL 4074116 (D.N.J. Sept. 6, 2011).............................32
Adams Respiratory Therapeutics, Inc. v. Perrigo Co.,
616 F.3d 1283 (Fed. Cir. 2010)................................................................................................30
Advanced Cardiovascular Sys., Inc. v. Scimed Life Sys., Inc.,
261 F.3d 1329 (Fed. Cir. 2001)................................................................................................24
Allergan, Inc. v. Watson Labs., Inc.-Fla.,
869 F. Supp. 2d 456 (D. Del. 2012).........................................................................................31
Arcelormittal France v. AK Steel Corp.,
C.A. No. 10-50-SLR, 2011 WL 63417 (D. Del. Jan. 4, 2011) ................................................27
Baxter Healthcare Corp. v. Spectramed, Inc.,
49 F.3d 1575 (Fed. Cir. 1995)..................................................................................................24
Broadcom Corp. v. Emulex Corp.,
732 F.3d 1325 (Fed. Cir. 2013)................................................................................................31
E.I. Du Pont de NeMours & Co. v. Heraeus Precious Metals N. Am.
Conshohocken LLC,
No. 12-1104-HU, 2013 WL 2659533 (D. Or. June 7, 2013)...................................................29
Eastman Kodak Co. v. Agfa Gevaert N.V.,
560 F. Supp. 2d 227 (W.D.N.Y. 2008)..............................................................................33, 34
Eli Lilly & Co. v. Teva Pharm. USA, Inc.,
557 F.3d 1346 (Fed. Cir. 2009)................................................................................................35
Epistar Corp. v. ITC,
566 F.3d 1321 (Fed. Cir. 2009)................................................................................................34
Ferring B.V. v. Watson Labs., Inc.-Florida,
764 F.3d 1401 (Fed. Cir. 2014)................................................................................................33

- iv -
Grober v. Mako Prods., Inc.,
686 F.3d 1335 (Fed. Cir. 2012)................................................................................................34
Hoechst v. Celanese Corp. v. BP Chems. Ltd.,
78 F.3d 1575 (Fed. Cir. 1996)..................................................................................................29
i4i Ltd. P’ship v. Microsoft Corp.,
598 F.3d 831 (Fed. Cir. 2010)..................................................................................................31
Johnson & Johnston Assocs. Inc. v. R.E. Serv. Co.,
285 F.3d 1046 (Fed. Cir. 2002)................................................................................................26
LG Elec. U.S.A., Inc. v. Whirlpool Corp.,
798 F. Supp. 2d 541 (D. Del. 2011).........................................................................................25
Lucent Techs., Inc. v. Gateway, Inc.,
580 F.3d 1301 (Fed. Cir. 2009)................................................................................................31
Michalic v. Cleveland Tankers, Inc.,
364 U.S. 325 (1960).................................................................................................................30
Moleculon Res. Corp. v. CBS, Inc.,
793 F.2d 1261 (Fed. Cir. 1986)................................................................................................30
Norian Corp. v. Stryker Corp.,
363 F.3d 1321 (Fed. Cir. 2004)................................................................................................28
PSC Comp. Prods., Inc. v. Foxconn Int’l, Inc.,
355 F.3d 1353 (Fed. Cir. 2004)..........................................................................................26, 27
Purdue Pharm. Prods. L.P. v. Actavis Elizabeth LLC,
C.A. No. 12-5311-JLL-JAD, 2015 WL 5032650 ....................................................................31
Research Found. of SUNY v. Mylan Pharm. Inc.,
809 F. Supp. 2d 296 (D. Del. 2011)...................................................................................31, 32
Ring & Pinion Serv. Inc. v. ARB Corp. Ltd.,
743 F.3d 831 (Fed. Cir. 2014)..................................................................................................28
Riverbed Tech., Inc. v. Silver Peak Sys., Inc.,
C.A. No. 11-484-RGA, 2014 WL 4695765 (D. Del. Sept. 12, 2014) .....................................30
SanDisk Corp. v. Kingston Tech. Co., Inc.,
695 F.3d 1348 (Fed. Cir. 2012)..........................................................................................26, 28
Tate Access Floors, Inc. v. Interface Arch. Res. Inc.,
279 F.3d 1357 (Fed. Cir. 2002)................................................................................................32

- v -
Teleflex, Inc. v. Ficosa N. Am. Corp.,
299 F.3d 1313 (Fed. Cir. 2002)................................................................................................34
Toshiba Corp. v. Imation Corp.,
681 F.3d 1358 (Fed. Cir. 2012)................................................................................................30
Tuna Processors, Inc. v. Hawaii Int’l Seafood, Inc.,
No. 05-517-BMK, 2006 WL 2989248 (D. Haw. Oct. 17, 2006).............................................27
Warner Chilcott Co., LLC v. Zydus Pharm. (USA) Inc.,
C.A. No. 11-1105-RGA, 2013 WL 1729383 (D. Del. Apr. 22, 2013) ....................................28
Warner-Jenkinson Co. v. Hilton Davis Chem. Co.,
520 U.S. 17 (1997).............................................................................................................24, 25
Rules and Statutes
35 U.S.C. § 271(e) .........................................................................................................................35

1
INTRODUCTIONI.
The inventions of the patents in this case, U.S. Patent Nos. 9,132,096 (the “’096 patent”)
and 6,902,742 (the “’742 patent”), relate to an improved hydrocodone product to treat severe
pain. The ’742 patent covers a formulation to treat severe pain quickly, yet safely, over an
extended period of time. The’096 patent covers a product with features designed to deter abuse.
The result of the patents is Zohydro® ER, an extended-release hydrocodone product.
During the trial, Plaintiff Recro Gainesville LLC (“Recro”) proved by a preponderance of
the evidence that Defendant Actavis Laboratories FL, Inc.’s (“Actavis”) proposed generic
versions of Zohydro® ER (“ANDA products”) infringe the ’096 and ’742 patents. Recro’s
experts, Drs. Jürgen Siepmann and Lawrence Fleckenstein, relying on Actavis’s ANDA
documents, demonstrated that (1) the ethylcellulose-based coating on Actavis’s abuse-deterrent
(“placebo”) beads is equivalent to the polyacrylic coatings claimed in the ’096 patent and
(2) Actavis’s active ingredient-containing beads contain two populations of particles that deliver
hydrocodone in the “pulsatile manner” required by the Court’s claim construction. Actavis did
not dispute that the other limitations of the asserted claims are met and dropped its invalidity
case (Trial Tr. 461:21–22), leaving infringement as the only issue for the Court to decide.
PROPOSED FINDINGS OF FACTII.
1. The agreed description of the parties and Actavis’s ANDA No. 206952 is in the
Final Pretrial Order (D.I. 114), Exhibit 1 – Joint Statement of Uncontested Facts, ¶¶ 1–2, 12–17.
Zohydro® ERA.
2. Zohydro® ER extended-release capsules are “indicated for the management of
pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which
alternative treatment options are inadequate.” JTX 22 at 1.
3. The active ingredient in Zohydro® ER is hydrocodone bitartrate, an opioid that

2
acts as a strong analgesic. Fleckenstein Tr. 178:11–161
; JTX 22 at 4. Using the technology
disclosed in Recro’s ’742 patent (JTX 2), Zohydro® ER was designed to have a “biphasic
release profile, which following oral administration, results in initial rapid release of a proportion
of hydrocodone followed by a prolonged absorption phase resulting in sustained hydrocodone
concentrations over 12 hours.” Rekhi Tr. 530:18-531:23; JTX 105 at 19.
4. This biphasic formulation design, with a first, immediate-release (“IR”)
component and a second, extended-release (“ER”) component, provides an initial rapid release of
drug for quick pain relief, followed by an extended release of drug that permits twice-a-day
dosing and improves patient convenience and compliance. Fleckenstein Tr. 181:10–182:2,
183:20–184:2; Rekhi Tr. 521:9-16; Sidwell Tr. 498:5–20. It also prevents the plasma
concentration of drug from getting too high (because the first dose is being cleared from the body
as the second dose releases), while at the same time preventing the drug concentration from
dropping so low that the analgesic effect is lost. Fleckenstein Tr. 183:8–19.
5. Zohydro® ER also utilizes the invention of the ’096 patent (JTX 3) to reduce the
risk of drug abuse by incorporating a gelling agent (polyethylene oxide or “PEO”) that traps the
drug during attempts to misuse it by, e.g., dissolving the intact or crushed beads in a liquid.
Siepmann Tr. 95:19–96:9, 97:23–98:7, 99:15–101:12; JTX 3 at 9:50–62, 10:4–8. If used as
intended, however, the invention ensures that the release of the drug is unaffected and pain relief
is achieved. Siepmann Tr. 98:13–99:14.
6. The ’096 and ’742 patents are both listed in the FDA’s Orange Book for
Zohydro® ER. Joint Statement of Uncontested Facts, ¶¶ 8–9.
1
Citations to the transcript are in the format: [Witness Name] Tr. [Page(s)]:[Line(s)]. Photos
of Recro’s witnesses and summaries of their qualifications and testimony, are in Appendix A.

3
POSAB.
7. Recro and its experts proposed the following definition for a person of skill in the
art in this case (Siepmann Tr. 74:17-75:9; Fleckenstein Tr. 184:16–185:11):
Scientists with a background in pharmacokinetics, or an analogous field such as
pharmacy, pharmacology, or biostatistics, as well as scientists who investigate
pharmaceutical formulations and have a degree in pharmaceutical sciences or an
analogous field such as pharmaceutical chemistry, chemistry, or chemical
engineering. The pharmacokineticist(s) and formulator(s) would work together
and contribute expertise from their respective fields. A formulations POSA would
have at least a master’s degree in pharmaceutical sciences or a related field like
pharmaceutical chemistry, chemistry, or chemical engineering, and at least two
years of relevant experience. A pharmacokineticist POSA would have at least a
master’s degree in pharmacy or a related field such as pharmacology,
pharmacokinetics, or biostatistics with at least two years of relevant experience.
8. Actavis and its experts proposed a different definition, which inter alia, requires a
Ph.D. or medical degree. Felton Tr. 281:2–13; Dowling Tr. 399:21-400:9; Siepmann Tr. 75:13-
19; Fleckenstein Tr. 185:19–24. Recro disagrees. Siepmann Tr. 75:20-24; Fleckenstein Tr.
185:24–186:2. In any event, the parties’ experts agree that their opinions would not change
regardless of which definition the Court adopts. Siepmann Tr. 75:25-76:3; Fleckenstein Tr.
186:3–5; Felton Tr. 281:21–23; Dowling Tr. 400:15-17.
Infringement of the ’096 PatentC.
9. The ’096 patent, entitled “Abuse Resistant Pharmaceutical Compositions,” issued
on September 15, 2015. JTX 3 at 1. Recro asserts that Actavis’s ANDA products infringe claims
1, 4, and 5 of the ’096 patent. Siepmann Tr. 95:13–16, 115:20–116:24.
10. Actavis does not dispute that its ANDA products meet all but one of the
limitations contained in claims 1, 4 and 5 of the ’096 patent (JTX 3, claim 1):
An oral pharmaceutical composition comprising a first population of beads and a
second population of beads; said first bead population comprising a
pharmaceutically active ingredient selected from the group consisting of
hydrocodone and pharmaceutically acceptable salts thereof, wherein said first
bead population is substantially free of polyethylene oxide; and said second bead

4
population comprising polyethylene oxide [PEO] and a permeable or semi-
permeable coating selected from the group consisting of an ammonio
methacrylate copolymer, a methacrylic acid copolymer and a mixture
thereof, wherein said second bead population is substantially free of any
pharmaceutically active ingredient.
11. Actavis’s ANDA products are oral pharmaceutical compositions comprising first
and second populations of beads. JTX 35 at 28; Siepmann Tr. 115:22–25.
12. The first population of beads in the ANDA products comprise hydrocodone
bitartrate as the pharmaceutically active ingredient. Felton Tr. 312:23-24; Siepmann Tr. 102:23–
25, 116:1–4; JTX 35 at 28. Hydrocodone bitartrate is a pharmaceutically acceptable salt of
hydrocodone. JTX 44 at 2; Siepmann Tr. 94:6-12.
13. The hydrocodone-containing beads in Actavis’s ANDA products do not contain
PEO and thus are substantially free of PEO. Siepmann Tr. 103:1–3; 116:5–7; JTX 35 at 28.
14. The second population of beads (the “placebo” beads) in the ANDA products
comprise PEO and an ethylcellulose-based coating. Felton Tr. 351:4-18; Siepmann Tr. 116:8–11;
JTX 35 at 28. Actavis’s ethylcellulose-based coating is equivalent to the claimed coatings
“consisting of an ammonio methacrylate copolymer, a methacrylic acid copolymer and mixtures
thereof” (collectively, “polyacrylic coatings”). Infra at ¶¶ 18–25; Siepmann Tr. 116:8–11; JTX
35 at 28. Actavis’s placebo beads have additional layers underneath the PEO. JTX 35 at 28;
Felton Tr. 294:4-295:19, 351:4-352:25; Siepmann Tr. 104:23–105:3. These additional layers are
permitted by the open-ended nature of claim 1 (i.e., “comprising”). JTX 3 at claim 1. Actavis’s
expert agreed. Felton Tr. 353:6-14.
15. The PEO-containing beads in Actavis’s ANDA products do not contain an active
ingredient and thus are substantially free of hydrocodone bitartrate or any other pharmaceutically
active ingredient. Siepmann Tr. 103:4–8, 116:13–16; JTX 35 at 28.
16. As required by claim 4 of the ’096 patent, the first bead population in Actavis’s

5
ANDA products contains hydrocodone bitartrate as the pharmaceutically active ingredient.
Felton Tr. 312:23-24; Siepmann Tr. 102:23–25, 116:17–20; JTX 30 at 4.
17. As required by claim 5 of the ’096 patent, the first bead population in Actavis’s
ANDA products contains hydrocodone bitartrate in an amount of from 5 to 250 mg because
Actavis seeks approval for 10, 15, 20, 30, 40, and 50 mg dosage strengths. Siepmann Tr. 116:21–
24; JTX 35 at 5, 15; JTX 30 at 4.
Actavis’s Ethylcellulose-Based Coating Is Equivalent to the Claimed1.
Polyacrylic Coatings
18. Actavis’s “placebo beads” contain PEO with a “release controlling polymer” coat.
Siepmann Tr. 102:17–22, 105:8–10; JTX 35 at 28. The polymer coat contains ethylcellulose,
triethyl citrate, and talc. Felton Tr. 351:10-13; Siepmann Tr. 105:15–106:5; JTX 35 at 36.
Actavis’s ethylcellulose-based coating is equivalent to the claimed permeable or semi-permeable
polyacrylic coatings in the patent. Siepmann Tr. 106:16–22; see also Sidwell Tr. 505:8–506:8.
19. According to the ’096 patent, the purpose of the coating applied to the placebo
beads is to act as a permeable or semipermeable coating. JTX 3 at 15:47–52. This coating
“provid[es] a physical barrier essentially separating or sequestering the gelling agent from the
other components of the composition [and] most important[ly] … serves to control (i.e. delay or
otherwise limit) the ingress of water … thus restraining the gelling action of the gelling agent.”
JTX 3 at 4:65–5:6.
20. Actavis’s ethylcellulose coating is a semipermeable coating. Felton Tr. 296:17-21,
355:5-18, 362:2-7. It performs substantially the same function as the claimed polyacrylic
coatings, both when the drug is used as intended or misused. Siepmann Tr. 106:23–107:10.
When the product is used as intended, both types of coatings separate the PEO from the active
beads (id. 106:23–107:4; Felton Tr. 354:15-355:4) and restrict the ingress of water in a way that

6
does not affect the release of drug. Felton Tr. 286:8–287:18, 296:17-22, 354:15-355:18, 362:2-7;
Siepmann Tr. 98:12–99:14; see also JTX 3 at 3:7–12, 4:65-5:6; 9:30–49; JTX 35 at 5. When the
product is misused, however, such as when intact or crushed beads are dissolved, both types of
coatings permit the gelling agent to release quickly, trapping the drug. JTX 35 at 5, 37;
Siepmann Tr. 107:5–10; see also JTX 3 at 9:50–62.
21. Actavis’s ethylcellulose coating works in substantially the same way as the
claimed polyacrylic coatings. Siepmann Tr. 107:11–111:6; see also Sidwell Tr. 507:3–13. When
the product is used as intended, both types of semi-permeable coatings initially restrict the
ingress of water. Felton Tr. 355:5-18, 362:2-7; JTX 3 at 2:37–40, 5:2–6, 15:42–46. Thereafter, as
described by the ’096 patent, “the permeable or semi-permeable nature of the coating enables
some water to pass through the coating thus initiating hydration of the gelling agent.” JTX 3 at
15:47–52; see also Siepmann Tr. 107:15–20, 125:20–126:4. “When the composition is
administered intact and as intended the various beads disperse along a region of the
gastrointestinal tract. Water from the surrounding environment is absorbed through the coating
of the gelling agent-containing beads which, upon contact with the gelling agent, causes the
beads to swell.” 2
JTX 3 at 9:31–36.
22. “The beads may swell to the extent that the coating ruptures, thus allowing more
rapid ingress of water.” JTX 3 at 9:31–38; Felton Tr. 354:15-355:18, 362:2-7; Siepmann Tr.
107:21–22. Dr. Felton agreed that the claimed methacrylic acid copolymers are rupturable and
so are ethylcellulose coatings. Felton Tr. 358:14-16; 355:22-25. This conclusion is well-known
and supported in the literature. PTX 56 (describing captopril cores coated with ammonio
2
When misused, both coatings break or rupture, freeing the gelling agent to trap the drug upon
exposure to water. Siepmann Tr. 107:15–16; JTX 3 at 16:24–33, 29:62–67; JTX 35 at 36–37.

7
methacrylate copolymers as “an outer rupturable layer”); Felton Tr. 358:17-359:16; Siepmann
Tr. 109:14–111:6; PTX 68 at 5 (showing the “rupture sequence” of “pulsatile release tablets …
[with] a rupturable ethylcellulose coating”); PTX 51 at 1 (“[f]ormation of the rupturable top-
coating was successfully performed using an aqueous dispersion of ethylcellulose”); PTX 72 at 1
(pellets included “a rupturable layer of plasticized ethylcellulose”); PTX 48 at 6 (“[t]he carbon
dioxide produced upon contact with water results in rupture of the outer layer leading to drug
release”); see also Felton Tr. 356:1-357:14 (discussing the rupturable ethycellulose coating in
PTX 68).
23. Although Actavis complains that Recro did not perform tests on Actavis’ ANDA
products, no such testing is necessary. Indeed, Actavis does not dispute that its ethylcellulose
coating is a semi-permeable coating that controls ingress of water, or that ethylcellulose-based
coatings, like Actavis’s, were known to rupture when exposed to liquid – just like the claimed
polyacrylic coatings. Felton Tr. 296:17-21; 355:22-25; Siepmann Tr. 109:14–111:6.3
24. Comparison of the rupture of the methacrylate coating in PTX 56 (left) and of the
ethycellulose coating in PTX 68 (right) confirms that these coatings work in the same way:
3
Actavis’s expert, Dr. Felton, questioned the effect, if any, the triethyl citrate in the coating
might have on the mechanism of ingress – e.g., forming cracks vs pores. Felton Tr. 291:1-7,
299:16-300:5. But the patent does not require any particular mechanism. JTX 3 at 15:47–52; see
also id. at 15:12–14 (explaining that, for example, pore formers may be used aid permeability). It
simply states that the coating must be permeable or semi-permeable, enabling “some water to
pass through.” JTX 3 at 15:47–52.

8
Both examples capture what the authors describe as the “rupture sequence” of the respective
coatings. PTX 56 at 6–7; PTX 68 at 5. In each instance, the tablet coatings were exposed to
water, leading to water ingress through the coating over time, and, eventually, “strong rupturing”
of the coating. PTX 56 at 6–7; PTX 68 at 5.
25. Finally, Actavis’s ethylcellulose-based coating and the claimed polyacrylic
coatings achieve substantially the same result. Siepmann Tr. 111:7–13. With either coating the
composition cannot be misused by dissolving the crushed or intact beads, but when used as
directed the patient “gets the same drug exposure as if the[re] were no polyethylene [oxide].” Id.;
Felton Tr. 354:15-24; JTX 44 at 28.
The Inventors Did Not Dedicate Ethylcellulose to the Public2.
26. Actavis contends that the inventors of the ’096 patent dedicated ethylcellulose to
the public and, therefore, Actavis cannot infringe.
27. Ethylcellulose is never mentioned in the ’096 patent. Felton Tr. 365:17-19;
Siepmann Tr. 111:22–112:3, 115:7–19, 146:23–25; see JTX 3. Although “cellulosic polymers”
are referenced generally in the ’096 patent as “[s]uitable coating materials” (JTX 3 at 5:13,
14:24–26; Felton Tr. 284:15–18; Siepmann Tr. 146:20–22), “cellulosic polymers” refers to a
broad class that encompasses “many, many” polymers. Siepmann Tr. 112:18–22, 146:20–22.
28. Cellulosic polymers are derivatives of cellulose, to which many modifications can

9
be made. Siepmann Tr. 112:18–113:18. There are many thousands of “cellulosic polymers,”
including dozens that are “commonly used” in pharmaceutical formulations. Siepmann Tr.
113:19–114:18, 146:17–19; see also Felton Tr. 365:20-22.
29. Examples of cellulosic polymers that can be used as coatings in pharmaceutical
formulations include cellulose acetate, cellulose diacetate, cellulose triacetate, cellulose
propionate, cellulose acetate propionate, cellulose acetate butyrate, cellulose acetate phthalate,
cellulose triacetate, cellulose acylate, cellulose diacylate, cellulose triacylate, cellulose
trivalerate, cellulose trilaurate, cellulose tripalmitate, cellulose trisuccinate, cellulose
trioctanoate, acetaldehyde dimethyl cellulose acetate, cellulose acetate ethylcarbamate, cellulose
acetate methyl carbamate, and cellulose acetate dimethylaminocellulose acetate. Felton Tr.
367:8-370:2; DTX 568 at 9:50–10:45.
30. Although a POSA might recognize ethylcellulose as one choice among the
thousands of cellulosic polymers, the ’096 patent does not disclose or point to the use of
ethylcellulose. Indeed, it points away from such a use. In referencing “cellulosic polymers,” the
’096 patent divides the class into three specified sub-classes: “cellulose acetates, cellulose
alkanylates, and cellulose acrylates.” JTX 3 at 5:14–15, 14:26–27; Felton Tr. 364:8-18;
Siepmann Tr. 114:24–115:6.4
According to Actavis’ expert, however, a POSA would not
understand ethylcellulose to be included in any of these sub-classes. Felton Tr. 364:21-365:5.
31. In addition to “cellulosic polymers” and its three sub-classes, the ’096 patent
names other broad classes of materials that may be “[s]uitable coating materials[:] . . .
polyamides; polyurethanes; [and] sulfonated polystyrenes.” JTX 3 at 5:13–16, 14:24–28; Felton
4
These sub-classes include, for example, cellulose acetate, cellulose diacetate, cellulose
triacetate, and mono, di, and tricellulose alkanylates. DTX 568 at 10:15–17.

10
Tr. 365:6-10. Two specific ammonio methacrylate and methacrylic acid copolymers are included
in this list, both by chemical name and by trade name (Eu[dra]git® RS and Eudragit® L). JTX 3
at 5:16–22, 14:28–35; Felton Tr. 365:11-15. But ethylcellulose is never named (Felton Tr.
365:11-19; Siepmann Tr. 111:22–112:3, 115:7–19, 146:23–25; see JTX 3), not in the paragraphs
on coating materials or anywhere else that the ’096 patent mentions cellulose derivatives as
potential gelling agents (JTX 3 at 4:38–48, 12:22–35), binders (id. at 4:62–64, 13:20–26, 18:31–
37), pore formers (id. at 15:12–17), capsule materials (id. at 6:16), or alternatives to sugar sphere
cores (id. at 12:47–50).
The Excipients Added to Actavis’s Ethylcellulose-Based Coatings Are3.
Disclosed in the Specification and Permitted by the Claims
32. The coating applied to Actavis’s PEO placebo beads contains ethylcellulose as the
“release controlling polymer” as well as two common excipients: triethyl citrate and talc. Felton
Tr. 360:6-24; Siepmann Tr. 105:6–106:5; JTX 35 at 5, 28. Triethyl citrate is a “plasticizer/pore
former.” Felton Tr. 360:6-16; Siepmann Tr. 106:2–3; JTX 35 at 28. Talc is a “glidant/anti-static”
that prevents the beads from sticking to one another. Siepmann Tr. 106:4–5; JTX 35 at 28.
Actavis asserts that it cannot infringe due to the presence of these excipients in its coating.
33. Many pharmaceutical coating formulations contain plasticizers, including triethyl
citrate, to impart flexibility. Felton Tr. 360:10-12. The incorporation of excipients into coatings
was well-known by persons of skill in the art. JTX 3 at 5:24–27, 15:5–11; Felton Tr. 360:2-16.
The ’096 patent specification states that “[a]s will be appreciated by the skilled person, the
coating may further comprise excipients designed to control the permeability of the coating
and/or the processing characteristics of the coating. For example, the coating may further
comprise one or more excipients selected from the group consisting of pore formers, plasticisers,
lubricants, glidants and anti-adherent agents and the like.” JTX 3 at 15:5–11.

11
34. Triethyl citrate is a commonly used plasticizer known to persons of skill in the art,
and is expressly listed in the ’096 patent as a “suitable plasticiser.” Felton Tr. 290:17-25;
Siepmann Tr. 147:8–10; see also JTX 35 at 32; JTX 3 at 15:29–35. The presence of triethyl
citrate does not impact release, solubility or mobility. JTX 30 at 56 (“Triethyl Citrate is used as a
plasticizer to impart flexibility to the Ethylcellulose film and its level in the formulation has a
negligible effect on drug dissolution” 5
and “both these excipients [triethyl citrate and talc] have a
negligible effect on drug dissolution”); Siepmann Tr. 127:10–128:17, 147:21–148:12, 150:13–
151:8. Rather, it is the ethylcellulose that restricts the ingress of liquid into the PEO. Felton Tr.
355:5-18, 361:7-363:25; JTX 30 at 56.
35. Talc is a commonly used glidant known to persons of skill. Siepmann Tr. 147:11–
13. Indeed, talc is used in several of the formulations disclosed in the patent examples. See, e.g.,
JTX 3 at 21:13, 21:27–28, 22:49–52, 26:58, 27:9, 27:34. Talc is used merely to prevent the beads
from sticking together during processing and does not impact the function of the coating. Felton
Tr. 297:5-10; Siepmann Tr. 106:4–5; JTX 35 at 28.
Infringement of the ’742 PatentD.
36. The ’742 patent, entitled “Multiparticulate Modified Release Composition” and
listing Dr. John G. Devane, Dr. Paul Stark, Niall M.M. Fanning, and Dr. Gurvinder Singh Rekhi
as inventors, issued on June 7, 2005. JTX 2 at 1. Recro asserts that Actavis infringes claims 1, 6,
13, 14, 16, and 19 of the ’742 patent. Siepmann Tr. 65:1-7, 92:14-94:12.
37. Actavis disputes the bolded elements of claim 1 of Recro’s ’742 patent (JTX 2):
A multiparticulate modified release composition comprising a first population
5
To the extent that Actavis asserts the quoted language refers only to the active beads,
Actavis’ documents specify that this coating layer of the placebo beads “is identical to the
extended release coating of active beads containing Ethyl cellulose with Triethyl Citrate as the
plasticizer and Talc.” JTX 35 at 6.

12
of active ingredient-containing particles and at least one subsequent
population of active ingredient-containing particles, the active ingredient
contained in the first population being an opiate and the active ingredient in the
subsequent population being an opiate or a non-opiate, wherein the subsequent
population of active ingredient-containing particles further comprises a modified
release coating or, alternatively or additionally, a modified release matrix
material, such that the composition following oral delivery to a subject delivers
the active ingredients of the first and subsequent populations in a pulsatile
manner.
38. Actavis also disputes that its ANDA products “in operation release[] substantially
all of the active ingredient from the first population prior to release of the active ingredient from
the subsequent population,” as required by claim 16. Actavis does not otherwise contest that the
limitations of the asserted claims are met.
39. As required by claim 1 of the ’742 patent, Actavis’s ANDA products contain an
opiate, hydrocodone. Siepmann Tr. 102:23–25, 116:1–4; JTX 35 at 28. They also comprise a
modified release coating based on ethylcellulose. Siepmann Tr. 68:25-69:17; JTX 44 at 8.
Actavis’s Active-Ingredient-Containing Pellets Comprise a First and a1.
Subsequent Population of Particles
40. The ’742 patent defines a “particulate” as “a state of matter which is characterized
by the presence of discrete particles, pellets, beads or granules irrespective of their size.” JTX 2
at 5:53–59. The parties agree that “particles” has its plain and ordinary meaning. D.I. 62.
A POSA would understand that “particles, pellets, beads or granules” would be used
interchangeably (Felton Tr. 379:1-12, 380:6-11 (“Yes. I would use pellet and bead
interchangeably.”)), Siepmann Tr. 137:3–138:15,149:23–150:12), which is consistent with the
patent, and Actavis’s own documents (e.g., JTX 35 at 37 (using “particle,” “bead,” and “pellet”
interchangeably in Table 21); Felton Tr. 380:12-381:19).
41. Examples 1 and 2 of the patent describe the preparation of multiparticulate
compositions according to the invention in which IR particles or beads are prepared separately

13
from ER particles or beads. JTX 2 at 11:30–14:55. These beads are then placed in gelatin
capsules for administration to patients. Id. at 10:35–43, 13:38–45. Compositions made according
to the patent are not so limited, however. “A multiparticulate modified release composition
according to the present invention may be incorporated into any suitable dosage form,” including
“that of a multilayer tablet.” Id. at 10:35–38, 47–48.
42.
The outer layer is an IR
component that rapidly releases 20 percent of the total dose of the drug. Felton Tr. 370:6-371:4.
The “ER Coat” layer controls the extended release of the inner “Drug Layer.” Id. 311:15-312:5,
373:17-374:3 (discussing JTX 30 at 47). “This two-stage coating ensures immediate release of
20 percent of the dose in the stomach followed by extended release of the remaining 80 percent
in the intestine.”6
JTX 30 at 20; Felton Tr. 372:10-373:14.
43.
6
Unless specified, emphases are added, and internal citations and quotes are omitted.

14
44.
In both
cases, after the composition is swallowed and comes in contact with the aqueous media in the
gastrointestinal tract, the IR layer of hydrocodone bitartrate rapidly dissolves. Felton Tr. 371:1-7;
Fleckenstein Tr. 166:18–21. And, in both cases, an extended release of drug comes from a drug
layer surrounded by the ethylcellulose-based ER coating. Felton Tr. 373:17-374:3; Siepmann Tr.
87:11-22. That is, after the ingestion of capsules containing separate IR beads and ER beads or
multilayered beads with IR and ER layers, in either case the active drug is provided to the patient
in the same ways. That is, an IR formulation (i.e., the IR beads or IR layer) rapidly dissolves,
quickly providing active to the patient, leaving an ER component (i.e., separate ER beads or ER
beads exposed after the IR layer dissolves) that provides drug over an extended period of time.
Felton Tr. 371:1-7, 373:17-374:3; Siepmann Tr. 86:15-88:6; JTX 30 at 47; see also PDX 113.
45.

15
46.
47. This approach is very different from that disclosed in European Patent 0 274 734
(DTX 579; “La Manna”). Actavis’s expert relied on certain statements regarding La Manna
made in a communication with the Patent Office on January 11, 2007 in a subsequent related
application. DTX 519 at 1. The La Manna statements were submitted more than a year and a half
after the ’742 patent issued (June 7, 2005) with respect to a different patent application (No.
10/827,689) that was never allowed as a patent. Felton Tr. 375:25-376:14. Regardless, the
dosage form in La Manna is not a multilayered bead – it incorporates a casing using a polymer
material impermeable to and insoluble in water. Felton Tr. 377:4-378:2; DTX 579 at 2:38–39,
2:43–45, 24 (Fig. 1). Actavis’s ANDA products do not contain anything like an impermeable
casing. Felton Tr. 378:3-6. Rather, like the modified release component described in Example 1

16
of the ’742 patent (JTX 2 at 11:60–12:23), the ANDA products are comprised of a drug layer
over-coated with a modified release coating. Felton Tr. 373:17-24; Siepmann Tr. 81:11-25; JTX
44 at 7, 22. Further, the specification of the ’742 patent lists “a multilayer tablet” similar to
Actavis’s ANDA products as a “suitable dosage form” (JTX 2 at 10:47–48) and claim 23 of the
patent claims “a multilayer tablet” (JTX 2 at 17:11–15).
Actavis’s Active-Ingredient-Containing Pellets Deliver Hydrocodone2.
“In a Pulsatile Manner”
a. The “Release” of Active Ingredient from Actavis’s ANDA
Products Is Pulsatile
48. Actavis’s own dissolution testing demonstrates that the release from its ANDA
products “provides a first pulse of an active ingredient release, followed by at least one
subsequent pulse of active ingredient release” (D.I. 69).
49. In vitro dissolution testing is the method by which POSAs “normally measure the
release of active ingredient from the dosage form itself.” Felton Tr. 328:14-17. The parties agree
that the “release” portion of the Court’s claim construction “involves in vitro release from the
dosage form.” Felton Tr. 340:8-11.
50. The ’742 patent contemplates a range of release profiles, including the
combination of an IR and a controlled (“sustained” or “extended” release) component as in
Actavis’s ANDA products. “For example, the first component may be an IR component wherein
the active ingredient is released substantially immediately upon administration. . . . The second
component may be . . . a time-delayed sustained release or extended release component in which
the active ingredient is released in a controlled fashion over an extended period of time.” JTX 2
at 8:5–16. The ’742 patent defines the number of pulses by the number of components: “The
number of pulses in the profile arising from such a composition in operation will depend on the
number of active ingredient containing components in the composition.” JTX 2 at 6:16–19.

17
51. The definition of a “pulse” applied by Actavis (“a burst, an immediate release of
active ingredient” (Felton Tr. 329:20-24) to exclude an extended release (Felton Tr. 382:15-
384:5)) is thus overly restrictive and inconsistent with the specification of the ’742 patent.
52. As Actavis’s Product Development Report explains, Actavis’s ANDA products
were designed to have two pulses of hydrocodone release: “Th[e] two-stage coating ensures
immediate release of 20% of the total dose in the stomach followed by extended release of the
remaining 80% in the intestine.” JTX 30 at 20; Felton Tr. 371:1-18, 372:18-373:14.
53. In vitro data show that the release profile of Actavis’s product matches the goal
and design of its product. That data, obtained during the development of Actavis’s ANDA
products demonstrate that Actavis’s ANDA products provide a first pulse of active ingredient
release, followed by at least one subsequent pulse of active ingredient release. There is a first,
rapid pulse of active ingredient release from the IR component that is nearly complete within
fifteen minutes (Fleckenstein Tr. 193:13–21, 194:10–12, 196:12–24, 197:16–198:7, 197:4–11;
JTX 45 at 117, 129, 141, 153, 165, 177; PDX 224, 225, 229, 230), followed after a brief lag by a
subsequent pulse of active ingredient release (Fleckenstein Tr. 192:22–193:5, 193:22–194:2,
194:13–195:18, 196:19–24, 197:12–15, 197:16–198:7; JTX 42, JTX 43, JTX 45 at 51, 54, 57,
60, 63, 66, 117, 129, 141, 153, 165, 177; PDX 224, 225, 227, 229, 230).
54. In concluding that Actavis’s dissolution data did not show pulsatile release, in
addition to applying an overly restrictive definition of “pulse,” Actavis’s expert looked only at
dissolution tests that began sampling at the one hour time point (Felton Tr. 334:10-20 (referring
to JTX 45 at 52), 384:8-385:6), long after release of the active ingredient from the IR
component. JTX 30 at 46 (the IR component of Actavis’s ANDA products was designed such
that “[w]hen these pellets come in contact with the [aqueous] medium, the Hydrocodone over-

18
coat rapidly dissolves”); Felton Tr. 371:1-18, 372:18-373:14; Fleckenstein Tr. 192:4–21,
193:16–194:2; JTX 30 at 4 (hydrocodone is “a highly soluble . . . molecule”). Dissolution testing
conducted during development of the ANDA products demonstrates that the IR coat of
hydrocodone bitartrate is substantially completely dissolved within 15 minutes – long before the
one-hour time point considered by Dr. Felton. Fleckenstein Tr. 193:6–21, 196:10–24; JTX 45 at
117, 129, 141, 153, 165, 177.
55. In distinguishing the Paradissis reference during the prosecution of the parent of
the ’742 patent, the applicants argued only that Paradissis discloses pharmaceutical compositions
with a flat (constant) “zero order release” profile, not a pulsatile profile. DTX 512 at 5. The
applicants did not otherwise characterize Paradissis. Id. Further, the word “negligible” –
mentioned by the applicants (DTX 512 at 5) and relied on by Actavis’s expert (Felton Tr.
338:10-339:24) – is not included in the Court’s construction of “pulsatile.” Felton Tr. 381:20-
382:7; D.I. 69.
b. The Plasma Concentration Profile Is Characterized by Two or
More Peaks Interspersed with Low Concentration Troughs
56. Claim 1 of the ’742 patent refers to “oral delivery to a subject.” JTX 2, claim 1.
The Court’s construction of “pulsatile” adopted the plain and ordinary meaning of “a subject.”
D.I. 69. The plain and ordinary meaning of “a” is “one or more.”
57. Pharmacokineticists look at both individual and mean data, and individual data is
“very important.” Dowling Tr. 480:10-24; Fleckenstein Tr. 204:2–13. Because Actavis’s
formulation is designed to provide an initial, rapid release from the dosage form, it is important
to look at individual data plots because, as Dr. Fleckenstein explained, the use of mean values
would “average [] out” the variability and smooth out the profiles.” Fleckenstein Tr. 204:14–
205:2. For example, two different subjects can both have pulsatile plasma curves but have

19
different curve shapes such that averaging their data would hide the peaks and low concentration
troughs. Fleckenstein Tr. 271:19–272:10, 220:23–221:5.
58. The invention of the ’742 patent was intended to be flexible in its application so
that it can be tailored to obtain the desired plasma concentration curve shape. Fleckenstein Tr.
162:25–171:18, 173:12–15; JTX 2 at 7:30–8:34; supra ¶ 50. Thus, a “pulsatile” plasma
concentration curve can have various different shapes depending on factors such as the time
between release from different components, the particular active pharmaceutical ingredient(s)
used, and the proportion of the dose in each component. Dowling Tr. 468:5-21, 472:7-21,
481:13-482:5; Fleckenstein Tr. 169:7–24, 171:3–18, 173:3–15, 174:17–25; JTX 2 at 7:30–32,
8:1–34. Even the two preferred embodiments A and B depicted in Figure 1 of the ’742 patent
have different curve shapes, with different peak heights and different trough depths. Dowling Tr.
484:10-25, 485:6-19; JTX 2, Fig. 1.
59. No particular trough depth or breadth is required by the ’742 patent. See generally
JTX 2; Fleckenstein Tr. 174:17–25. A low concentration trough is a “minimum or nadir that
would follow [] the first peak and prior to the input from the second component, where there
would be a second peak.” Fleckenstein Tr. 167:8–11; Sidwell Tr. 490:12-17 (“[M]y
understanding is that that would be . . . some concentration had been achieved and then at some
later point that concentration was lower and then at some still later . . . time point that
concentration was again higher.”). Even Actavis’s expert agreed that “in general” in
pharmacokinetics, a trough is “the lowest concentration that is measured after a dose is given.”
Dowling Tr. 485:1-5.
60. Nor is there any requirement in the Court’s claim construction that a trough
persist for a particular number of sampling points. See D.I. 69. Indeed, the number of sampling

20
time points included in a trough is determined by the sampling design of the study. Cf. Dowling
Tr. 473:25-474:16 (agreeing that “the intervals between sampling times can impact the shape of
a plasma concentration curve”).
61. Nor does Claim 1 require the pulsatile plasma concentration to “mimic” two IR
doses; indeed, “mimicking” two IR doses is an additional limitation found in two (unasserted)
dependent claims. JTX 2, claims 17, 18; Dowling Tr. 474:17-475:24. Thus, Actavis’s expert’s
requirement that low concentration troughs mimic the trough characteristic of the preferred
embodiment depicted in Figure 1 of the ’742 patent (e.g. Dowling Tr. 416:8-11, 417:7-16,
419:23-420:5) is overly restrictive and imports limitations not found in the asserted claims.
Dowling Tr. 463:15–22 (agreeing that formulations A & B are “preferred embodiments”).
62. Indeed, the examples A & B in Figure 1 of the ’742 patent are not covered by the
asserted claims because the only active ingredient is methylphenidate, which is not an opiate.
Dowling Tr. 466:7–13.
63. Similarly, a “wash out” period is a preferred embodiment, not a requirement, of
the ’742 patent. JTX 2 at 6:25–28, 11:6–9. Indeed, a POSA would understand that although a
pulsatile profile can have benefits for an extended release pain medication (supra ¶¶ 3–4), a
wash out period is not desirable, because pain relief must be relatively constant to prevent
“breakthrough pain.” See Rekhi Tr. 521:4-522:17. The reference to a wash out with respect to the
“Giunchedi” article in the Description of the Prior Art in the ’742 patent merely notes that
Giunchedi does not disclose this type of embodiment and that the peak-to-trough variation is
“small” (JTX 2 at 2:47–58); it does not disavow any scope of claim 1.
64. Actavis only conducted one clinical study (ACT-15030) on the product it intends
to market. Dowling Tr. 476:17-478:1; Fleckenstein Tr. 268:8–25.

21
65. Actavis’s ANDA products were designed to release hydrocodone in two separate
pulses in two separate locations in the gastrointestinal tract: “[t]h[e] two-stage coating ensures
immediate release of 20% of the total dose in the stomach followed by extended release of the
remaining 80% in the intestine.” JTX 30 at 20; Felton Tr. 371:1-18, 372:18-373:14.
66. At least seven individuals in the ACT-15030 study had observed low
concentration troughs in their plasma profiles in the one to four hour range: subjects 1012, 1018,
1022, 1024, 1028, 1029, and 1036. Fleckenstein Tr. 205:15–207:21, 212:25–213:15; JTX 41 at
2–7. The low concentration trough is expected to occur in this time period based on the
combination of the in vitro dissolution data (which demonstrated a rapid release from the IR
component), the formulation goals described by Actavis (a release of 20% of the dose in the
stomach followed by an extended release of the other 80% in the intestine), Actavis’s
formulation designed to reach those goals (an IR layer to quickly release drug followed by an
extended release layer to slowly release drug over time), and a pharmacokinetic model of the
reference listed drug Actavis was trying to match. Fleckenstein Tr. 202:15–203:4, 209:5–210:21,
211:3–212:5; JTX 10; cf. Fleckenstein Tr. 208:3–209:4.
67. Actavis’s own ANDA documents show that the accuracy of the assay it employed
in testing the plasma profiles of the subjects in ACT-15030 was quite good – with at most
between three and five percent error. Fleckenstein Tr. 265:19–266:10, 272:21–275:17; JTX 33
at 22. The effects observed in individual plasma concentration profiles are thus real and cannot
be the result of assay error. Fleckenstein Tr. 265:19–266:10, 272:21–275:17; JTX 33 at 22.
68. The 20 percent of the dose in Actavis’s ANDA products that releases immediately
in the stomach releases very rapidly – indeed, release of this entire component is complete within
about fifteen minutes. JTX 30 at 4, 46; Felton Tr. 371:1-18, 372:18-373:14; Fleckenstein Tr.

22
192:4–21, 193:16–21. The ER component of Actavis’s ANDA products then begins to release
after a short delay. Supra ¶ 53.
69. Actavis’s clinical study was designed to show bioequivalence to Zohydro® ER,
not to capture the pulsatile nature of the plasma profile; as such, the sampling times in the one to
four hour window were insufficiently frequent to capture the rapid changes in plasma
concentration during this timeframe. Fleckenstein Tr. 215:18–216:22.
70. Other factors, including individual variability, the disproportionate division of the
dose (the peak from the 80% of the dose in the second component overwhelms the peak from
and trough occurring after the 20% of the dose in the first component), and the administration of
the narcotic antagonist naltrexone to subjects in ACT-15030 for safety purposes (which tends to
pull the second peak in closer to the first peak), can also obscure low concentration troughs.
Fleckenstein Tr. 217:18–219:17, 220:23–221:5, 222:3–224:10; JTX 21 at 17, 46; PTX 74 at 6.
71. Seventeen additional individuals showed evidence of infringement in the form of
a region of flat concentration indicative of a low concentration trough (or a peak) that was not
captured: subjects 1003, 1004, 1005, 1007, 1013, 1014, 1017, 1019, 1020, 1021, 1023, 1025,
1026, 1033, 1034, 1035, and 1037. Fleckenstein Tr. 213:23–215:8, 220:8–11, 225:19–226:2;
JTX 41 at 2–7.
72. It would have been unethical for Recro to conduct clinical testing of an
unapproved Schedule II narcotic on healthy human volunteers solely for the purposes of patent
litigation. Fleckenstein Tr. 221:15–25, 271:11–15.
73. Although Actavis only conducted clinical testing on its 10 mg product, the results
of this testing – which demonstrate that the plasma concentration profile is characterized by two
or more peaks interspersed with low concentration troughs – equally apply to the 15, 20, 30, 40,

23
and 50 mg dosage strengths. That is because Actavis requested a biowaiver from the FDA,
seeking approval of those additional dosage strengths without additional in vivo bioequivalence
studies. PTX 175 at 3–4; Fleckenstein Tr. 188:5–189:3. That is, Actavis has certified to the FDA
that the in vivo behavior of its other dosage strengths of its ANDA products is the same as the in
vivo behavior of the tested 10 mg dose. PTX 175 at 3–4; Fleckenstein Tr. 188:5–189:3.
74. The Alza reference mentioned in the Description of the Prior Art section of the
’742 patent (JTX 2 at 2:11–26) does not depict either actual in vivo data or even simulations of in
vivo data but only an idealized and speculative version of what the applicant hoped might occur.
Fleckenstein Tr. 254:25–256:2; DTX 812. Such a profile could only be obtained with an
intravenous infusion where the rate of administration was gradually increased. Fleckenstein Tr.
255:9–13, 255:21–256:2. Thus, it is not a depiction, even a hypothetical one, of a region of flat
concentration disguising a missing low concentration trough. Id. Further, the ’742 patent
describes the Alza reference as “administering methylphenidate in a sustained and constantly
ascending rate.” JTX 2 at 2:12–13. Administering hydrocodone at a “constantly ascending rate”
would be dangerous, as it would put patients at risk of overdose; the pulsatile design of
Zohydro® ER, the reference listed drug for Actavis’s ANDA products, provides rapid analgesia
from the first, IR pulse, but avoids excessive drug levels because the first input is already being
cleared from the body as the second, extended release begins. Supra, ¶¶ 3–4.
The Asserted Dependent Claims Are Also Infringed3.
75. As required by claim 6, the subsequent population in Actavis’s ANDA products
comprises opiate-containing particles. Siepmann Tr. 102:23–25, 116:1–4; JTX 35 at 28.
76. As required by claim 13, “at least one of the active ingredients of the first and
subsequent populations comprises hydrocodone or a pharmaceutically acceptable salt thereof.”
Siepmann Tr. 102:23–25, 116:1–4; JTX 35 at 28.

24
77. As required by claim 14, the first (immediate release) and subsequent (extended
release) populations of Actavis’s ANDA products have different in vitro dissolution profiles. The
IR population dissolves rapidly such that it is substantially dissolved within fifteen minutes,
whereas the ER population releases gradually over about twelve hours. Fleckenstein Tr. 193:6–
194:14, 196:2–197:15, 198:9–17; PDX 224, 225, 229, 230; JTX 45 at 51, 54, 57, 60, 63, 66, 117,
129, 141, 153, 165, 177.
78. As required by claim 16, the first population of IR particles in the ANDA
products releases substantially all of the active ingredient prior to the release of the active from
the subsequent, modified-release particles. Fleckenstein Tr. 196:2–197:15, 198:18–199:3; PDX
229, 230; JTX 45 at 51, 54, 57, 60, 63, 66, 117, 129, 141, 153, 165, 177.
79. As required by claim 19, the mean in vitro dissolution data for the first
(immediate release) population is such that substantially all of the active ingredient is released
within two hours—in fact, Actavis’s dissolution testing demonstrates that substantially all of the
active ingredient is released from the IR population within about 15 minutes. Fleckenstein Tr.
193:13–21, 194:4–14, 196:12–24, 197:7–11, 199:4–12; JTX 45 at 117, 129, 141, 153, 165, 177.
PROPOSED CONCLUSIONS OF LAWIII.
80. The patent holder bears the burden of proving infringement by a preponderance of
the evidence. See Advanced Cardiovascular Sys., Inc. v. Scimed Life Sys., Inc., 261 F.3d 1329,
1336 (Fed. Cir. 2001). A product literally infringes a claim if it meets each and every limitation
of the claim. Baxter Healthcare Corp. v. Spectramed, Inc., 49 F.3d 1575, 1582 (Fed. Cir. 1995).
“[A] product or process that does not literally infringe upon the express terms of a patent claim
may nonetheless be found to infringe if there is ‘equivalence’ between the elements of the
accused product or process and the claimed elements of the patented invention.” Warner-
Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 21 (1997).

25
81. There are two tests that can be applied to determine whether an element is met
under the doctrine of equivalents:
Under the insubstantial differences test, “[a]n element in the accused
device is equivalent to a claim limitation if the only differences between
the two are insubstantial.” Under the function-way-result test, the
insubstantiality of an alleged equivalent is determined by asking whether
an element in the accused device “performs substantially the same
function in substantially the same way to obtain the same result” as the
claim limitation.
LG Elec. U.S.A., Inc. v. Whirlpool Corp., 798 F. Supp. 2d 541, 554 (D. Del. 2011). When
performing an equivalents analysis, it is appropriate to consider whether a POSA would consider
the element of the accused product to be substantially similar to the element recited in the claim.
Warner-Jenkinson, 520 U.S. at 36, 37. The doctrine of equivalents is not applied to the accused
product or process as a whole, but rather to individual claim elements. Id. at 29.
Actavis Infringes Claims 1, 4, and 5 of the ’096 PatentA.
82. Actavis does not dispute that its ANDA products meet each and every limitation
of claims 1, 4, and 5 of the ’096 patent, with one exception: Actavis denies that the
ethylcellulose-based coating on its placebo beads is substantially similar to the polyacrylic
coatings listed in claim 1.
83. Substantial evidence demonstrates that Actavis’s ethylcellulose-based coating
performs the same function as the claimed polyacrylic coatings in that both separate the gelling
agent from aqueous media when the compositions are used as directed. Findings of Fact (“FF”)
¶¶ 19–20. Similarly, when the compositions are misused, both types of coatings permit release of
the gelling agent, trapping the drug. Id.
84. There is also substantial evidence – expert testimony (from both parties’ experts
(FF ¶¶ 21–23)), literature in the field (FF ¶¶ 22, 24), and guidance in the ’096 patent (FF ¶ 21–
22) – that both types of coatings work in substantially the same way. Both coatings allow ingress

26
of water, causing the gelling agent to swell, eventually rupturing the coatings. FF ¶¶ 21–25.
85. Finally, there is no dispute that the ethylcellulose-based and polyacrylic-based
coatings achieve substantially the same result. FF ¶ 25. Accordingly, the coating limitation in
claim 1 is met under the doctrine of equivalents and because Actavis does not contest that its
ANDA products meet the other limitations contained in claims 1, 4, and 5 of the ’096 patent,
those claims are infringed as well.
The Inventors Did Not Dedicate Ethylcellulose to the Public1.
86. The disclosure-dedication doctrine does not limit the application of the doctrine of
equivalents to Actavis’s ANDA products that use ethylcellulose as “a permeable or semi-
permeable coating” on the placebo beads. “Whether the disclosure-dedication rule prevents a
patentee from pursuing a doctrine of equivalents infringement theory is a question of law . . . .”
SanDisk Corp. v. Kingston Tech. Co., 695 F.3d 1348, 1364 (Fed. Cir. 2012). The doctrine of
dedication to the public applies when a patentee discloses subject matter in the specification of a
patent but does not claim it. Johnson & Johnston Assocs. v. R.E. Serv. Co., 285 F.3d 1046, 1054
(Fed. Cir. 2002). Disclosures have been found sufficient to dedicate unclaimed subject matter to
the public where there was a “clear, precise disclosure” of “explicit alternatives to the inventions
claimed.” PSC Comp. Prods., Inc. v. Foxconn Int’l, Inc., 355 F.3d 1353, 1358 (Fed. Cir. 2004).
87. “[T]he [disclosure-dedication doctrine] ‘does not mean that any generic reference
in a written specification necessarily dedicates all members of that particular genus to the
public.’ Rather, ‘the disclosure must be of such specificity that one of ordinary skill in the art
could identify the subject matter that had been disclosed and not claimed.’” SanDisk, 695 F.3d at
1363 (quoting PSC, 355 F.3d at 1360). Thus, a generic disclosure like “other resilient materials
may be suitable for the strap” does not dedicate all unclaimed resilient materials to the public,
even if those materials were known in the art. PSC, 355 F.3d at 1360.

27
88. On this basis, the disclosure-dedication rule did not apply to preclude a plaintiff
from asserting the doctrine of equivalents where the claim covered only “an ultimate tensile
strength of 1500 MPa or greater” and the defendants’ products used tensile strengths of 1414
MPa and 1470 MPa because “the specification [wa]s imprecise with respect to the range of
thermal treatments that can be applied to the claimed compositions; the disclosure [was] not of
‘such specificity’ that one of ordinary skill in the art could identify the precise tensile strength
ranges disclosed but not claimed.” Arcelormittal France v. AK Steel Corp., C.A. No. 10-50-SLR,
2011 WL 63417, at *1 (D. Del. Jan. 4, 2011). Similarly, where a patent on a method for smoking
meat claimed a 250–400 °C temperature range, but disclosed text and figures demonstrating that
smoke can be generated at temperatures from 200–1000 °C, the patentee did not dedicate all
temperatures over 400 °C to the public because the “disclosure of the volume of gas released at
various temperatures is too generic” for “a person of ordinary skill to identify any disclosed but
unclaimed alternative optimal or beneficial smoking temperature.” Tuna Processors, Inc. v.
Hawaii Int’l Seafood, Inc., No. 05-517-BMK, 2006 WL 2989248, at *4 (D. Haw. Oct. 17, 2006).
89. Here, “ethylcellulose” is not mentioned in the ’096 patent. FF ¶¶ 27, 31. The ’096
patent mentions the generic category of “cellulosic polymers.” FF ¶¶ 27–31. “Cellulosic
polymers” is a broad genus that encompasses many thousands of polymers, at least dozens of
which are commonly used as pharmaceutical coating materials. FF ¶¶ 28–29. “Cellulosic
polymers” is not a “clear, precise disclosure” of ethylcellulose of such “specificity that one of
ordinary skill in the art could identify the subject matter that had been disclosed and not
claimed.” PSC, 355 F.3d at 1358, 1360. Indeed, the ’096 patent further describes “cellulosic
polymers” as comprising three sub-classes (cellulose acetates, cellulosic alkanylates, and
cellulose acrylates), but as Actavis’s expert agreed, ethylcellulose is not an example of any these

28
three identified sub-classes. FF ¶ 30.
90. It is irrelevant that ethylcellulose was a known cellulosic polymer where it was
not specifically identified but only generically included in a broad category – “[w]hether a
person of ordinary skill ultimately could employ the disclosures of the patent to implement a
purported equivalent does not amount to actually disclosing to one of ordinary skill that
equivalent as an alternative to a claim limitation.” SanDisk Corp., 695 F.3d at 1364. Nor does
foreseeability of an alternative bar application of the doctrine of equivalents – indeed, “[i]t has
long been clear that known interchangeability weighs in favor of finding infringement under the
doctrine of equivalents.” Ring & Pinion Serv. Inc. v. ARB Corp. Ltd., 743 F.3d 831, 834 (Fed.
Cir. 2014) (“[t]here is not, nor has there ever been, a foreseeability limitation on the application
of the doctrine of equivalents” and collecting cases).
Claim 1 of the ’096 Patent Does Not Foreclose the Use of the Common2.
Excipients Actavis Included in Its Ethylcellulose-Based Coating
91. The disputed limitation in claim 1 of the ’096 patent is a Markush-style element
requiring “a permeable or semi-permeable coating selected from the group consisting of an
ammonio methacrylate copolymer, a methacrylic acid copolymer and a mixture thereof.” JTX 3.
Actavis contends that this language “do[es] not allow any of ethylcellulose, triethylcitrate or talc
in a coating of a second bead population.” D.I. 114, Ex. 13, ¶ 494. That is not the law.
92. The transitional term “consisting of” is understood to be a limitation on permitted
elements under the claim, but it is not “absolutely restrictive.” Warner Chilcott Co., LLC v.
Zydus Pharm. (USA) Inc., C.A. No. 11-1105-RGA, 2013 WL 1729383, at *5 (D. Del. Apr. 22,
2013). An exception to the “closed” nature of Markush claiming applies for “unrecited
element[s] . . . ‘unrelated to the invention.’” Id. (citing Norian Corp. v. Stryker Corp., 363 F.3d
1321, 1331–32 (Fed. Cir. 2004)). For example, “[t]he presence of excipients can [] be

29
understood to be unrelated to the actual invention,” and, therefore, not excluded from the
Markush group. Id. (declining to construe a Markush group to exclude pharmaceutical excipients
where “portions of the specification [] clearly show[ed] ‘inner coating layers’ formed by a
polymer with additional excipients, solvents, or plasticizers” and noting that “[t]he Federal
Circuit has stated that ‘it is unlikely that an inventor would define the invention in a way that
excluded the preferred embodiments, or that persons of skill in this field would read the
specification in such a way.’” (quoting Hoechst v. Celanese Corp. v. BP Chems. Ltd., 78 F.3d
1575, 1580 (Fed. Cir. 1996))).
93. The use of Markush language does not preclude application of the doctrine of
equivalents. “A Markush group is a listing of specified alternatives of a group in a patent claim,
typically expressed in the form: a member selected from the group consisting of A, B, and C. . . .
It is well known that members of the Markush group are . . . alternatively usable for the purposes
of the invention.” Abbott Labs. v. Baxter Pharm. Prods., Inc., 334 F.3d 1274, 1280 (Fed. Cir.
2003). Even where a claim element is crafted in Markush format:
The proper inquiry for the court is to apply the doctrine of equivalents, asking
whether an asserted equivalent represents an “insubstantial difference” from the
claimed element, or “whether the substitute element matches the function, way,
and result of the claimed element.” . . . Courts should be cautious not to shortcut
this inquiry by identifying a “binary” choice in which an element is either present
or not present.
E.I. Du Pont de NeMours & Co. v. Heraeus Precious Metals N. Am. Conshohocken LLC, No. 12-
1104-HU, 2013 WL 2659533, at *4 (D. Or. June 7, 2013) (recognizing that “the doctrine of
equivalents, by definition, recognizes that an element is missing that must be supplied by the
equivalent substitute”).
94. Triethyl citrate and talc are common excipients disclosed in the specification and
incorporated into preferred embodiments. FF ¶¶ 32–35. These excipients are unrelated to the

30
purpose of the invention, as they do not play any substantial role in the ingress of water into the
PEO-containing core of Actavis’s placebo beads, nor in the swelling of the PEO and the
rupturing of the ethylcellulose coating, as confirmed by Actavis’s own documents. Id.
Accordingly, these common excipients are not excluded by the Markush-style claim element and
Actavis’s ANDA products infringe the asserted claims of the ’096 patent.
Actavis’s ANDA Products Infringe the Asserted Claims of the ’742 PatentB.
95. In a Hatch-Waxman case, the patentee must show that it is more likely than not
that the ANDA product would, if commercially marketed, meet the claim limitations of the
patents-in-suit. Adams Respiratory Therapeutics, Inc. v. Perrigo Co., 616 F.3d 1283, 1287 (Fed.
Cir. 2010); Abbott Labs. v. TorPharm, Inc., 300 F.3d 1367, 1373 (Fed. Cir. 2002).
96. For the reasons explained in paragraphs 40–47 above, Actavis’s ANDA products
meet the populations of particles limitations of the asserted claims of the ’742 patent, either
literally or under the doctrine of equivalents.
97. A patentee is not required to show that the defendant’s product will meet the
claims “9 times out of 10,” but, instead, that the product will more likely than not infringe.
Adams Respiratory Therapeutics, 616 F. 3d at 1287.
98. Infringement may be shown through circumstantial, as well as direct, evidence.
“It is hornbook law that direct evidence of a fact is not necessary.” Moleculon Res. Corp. v. CBS,
Inc., 793 F.2d 1261, 1272 (Fed. Cir. 1986), abrogated on other grounds by Egyptian Goddess,
Inc. v. Swisa, Inc., 543 F.3d 665 (Fed. Cir. 2008) (en banc). “Circumstantial evidence is not only
sufficient, but may also be more certain, satisfying and persuasive than direct evidence.” Id. at
1272 (quoting Michalic v. Cleveland Tankers, Inc., 364 U.S. 325, 330 (1960)). “‘Direct
infringement can be proven by circumstantial evidence.’ . . . Circumstantial evidence must show
that at least one person directly infringed an asserted claim during the relevant time period.”

31
Toshiba Corp. v. Imation Corp., 681 F.3d 1358, 1364 (Fed. Cir. 2012); see also Riverbed Tech.,
Inc. v. Silver Peak Sys., Inc., C.A. No. 11-484-RGA, 2014 WL 4695765, at *6 (D. Del. Sept. 12,
2014) (“Taken together, this circumstantial evidence is sufficient to permit a jury to reasonably
conclude that sometime during the relevant period [], more likely than not one person
somewhere in the United States performed the claimed method using the [accused] products.”).
99. Thus, it is not required that a patentee test the accused product to show
infringement. Here, where the active ingredient in the ANDA product is a Schedule II narcotic, it
would not only be impractical but unethical to conduct testing in humans with unapproved
products for the sole purpose of obtaining direct evidence for patent litigation. FF ¶ 72; Purdue
Pharm. Prods. L.P. v. Actavis Elizabeth LLC, C.A. No. 12-5311-JLL-JAD, 2015 WL 5032650,
at *18 & *18 n.9 (D.N.J. Aug. 25, 2015) (“Throughout trial, Defendants have persistently
criticized Plaintiffs for failing to test Defendants’ respective ANDA products. However, the
Court will not overlook the implications of such unapproved testing. Indeed, it would be highly
unethical to have testing performed on humans (i.e. in vivo) for unapproved products particularly
for the limited purpose of patent litigation as Defendants[] appear to suggest.” (citing Allergan,
Inc. v. Watson Labs., Inc.-Fla., 869 F. Supp. 2d 456, 500 (D. Del. 2012))).
100. Moreover, there is no requirement that a substantial number or even a majority of
products or uses infringe. “[A] finding of infringement can rest on as little as one instance of the
claimed method being performed during the pertinent time period.” Lucent Techs., Inc. v.
Gateway, Inc., 580 F.3d 1301, 1317–18 (Fed. Cir. 2009); see also i4i Ltd. P’ship v. Microsoft
Corp., 598 F.3d 831, 850 (Fed. Cir. 2010). Further, it is well-established that an accused device
that “sometimes, but not always, embodies a claim nonetheless infringes.” Broadcom Corp. v.
Emulex Corp., 732 F.3d 1325, 1333 (Fed. Cir. 2013).

32
101. This concept holds true in the Hatch-Waxman context. In Research Found. of
SUNY v. Mylan Pharm. Inc., 809 F. Supp. 2d 296, 330–31 (D. Del. 2011), aff’d in part, vacated
in part (on validity of other patents), 531 F. App’x 1008 (Fed. Cir. 2013), the Court found
infringement where, without rounding, one patient had plasma concentration levels that met the
requirements of the asserted claims and, with rounding, a total of three (out of thirty-one)
patients’ plasma levels met the claim elements. There the generic company argued that the mean
Cmin value was well outside the claimed range. Id. at 330. The Court noted that the asserted
claims “are not directed to mean values across a large population; neither claim mentions ‘mean’
values whatsoever. . . . Hence, in the context of the [patent], even if only 1 of 31 subjects in the
pivotal pK study had a Cmin of 0.3 to 0.6 μg/mL, this is a sufficient basis from which to find
infringement.” Id. at 330–31; accord Acorda Therapeutics Inc. v. Apotex Inc., C.A. No. 07-4937-
GEB-MCA, 2011 WL 4074116, at *12–13 (D.N.J. Sept. 6, 2011) (finding that plaintiff had
shown sufficient evidence from which the court could infer that some patients will meet the
claim limitation and noting that “the question is not whether there is a statistically significant
number of patients whose Cmax and somnolence are reduced. . . . [I]f a single patient attains a
reduced Cmax from [defendant’s] product, the product infringes.”).
102. Here, the ’742 patent claims reinforce that it is individuals – not mean data or a
percentage of the population – who infringe: claim 1 of the ’742 patent is directed to “a subject,”
which, under the claim construction, carries its plain and ordinary meaning: one or more
subjects. E.g., Tate Access Floors, Inc. v. Interface Arch. Res. Inc., 279 F.3d 1357, 1360 (Fed.
Cir. 2002).
103. That only some individuals, or as in the Research Foundation case, only one
individual, may be found to infringe is not the same as having an “anomalous” result as the only

33
evidence of infringement. Here, not only has Dr. Fleckenstein identified multiple individuals
whose plasma concentration data is pulsatile (FF ¶ 66), but this data was demonstrated to be
quite accurate – with errors of at most three to five percent – by Actavis’s own assay accuracy
calculations. FF ¶ 67. Dr. Fleckenstein also explained that at least another seventeen individuals
demonstrated circumstantial evidence of peaks and troughs that were not captured due to the
infrequent sampling times employed in Actavis’s clinical study (which was designed to
demonstrate bioequivalence to Zohydro® ER, not to demonstrate pulsatile plasma
concentrations), or other factors that conceal the peaks and troughs. FF ¶¶ 68–71.
104. This is different from situations like those in Ferring B.V. v. Watson Labs., Inc.-
Florida, 764 F.3d 1401, 1409 (Fed. Cir. 2014), where the district court found no infringement
when only four out of nearly 200 tablets met the claim limitations of an in vitro dissolution test.
There, the expert testified that there was obviously something wrong with the few samples that
met the claim limitations: “there was something incomplete about the coating. It lacked coating
integrity. The coating on the tablet sort of came apart and opened up. It was very atypical and
aberrant relative to all of the other 176 tablets that were examined.” Id. at 1409. Similarly, in
Eastman Kodak Co. v. Agfa Gevaert N.V., 560 F. Supp. 2d 227, 277–80 (W.D.N.Y. 2008), the
court concluded that infringement had not been established for one product where samples taken
from the same batches had different thicknesses and aspect ratios (id. at 278) but did find
infringement for another product where there was more internal consistency amongst the results.
Id. at 279–80. In doing so, the court there did not apply an arbitrary percentage for infringing
samples, noting that “[t]he extent of infringement, i.e., the percentage of the [accused product]
which infringes the [asserted patent] has yet to be determined . . . .” Id. at 280.
105. Here, Actavis’s own in vitro dissolution data for its ANDA products demonstrates

34
consistent release (FF ¶ 53), and its in vivo assay accuracy calculations (FF ¶ 67) demonstrate
that the observation that some individuals in the ACT-15030 study had low concentration
troughs in their plasma concentration curves is real and not a result of abnormalities in the
capsules or errors in blood plasma concentration measurements. Id.
106. Neither the in vitro release patterns nor the shapes of the plasma curves of
Actavis’s ANDA products were disavowed by the patentee during prosecution or in the
specification. For the in vitro release, the patentee distinguished the Paradissis reference solely
based on Paradissis’s teaching of “approaching a zero order release rate.” FF ¶ 55 (emphasis in
original). There was no discussion or distinction made over specific release profiles. Id. A
disavowal of claim scope must be “unambiguous” and “clearly and unmistakably disclaim[]
claim scope or meaning.” Grober v. Mako Prods., Inc., 686 F.3d 1335, 1342 (Fed. Cir. 2012).
107. Similarly, disavowal of claim scope in the specification requires “expressions of
manifest exclusion or restriction, representing a clear disavowal of claim scope.” Epistar Corp.
v. ITC, 566 F.3d 1321, 1335 (Fed. Cir. 2009) (quoting Teleflex, Inc. v. Ficosa N. Am. Corp., 299
F.3d 1313, 1325 (Fed. Cir. 2002)). “[D]isparaging comments alone do not necessarily show a
manifest or express disavowal of the criticized subject matter.” Id. at 1336.
108. The reference to “Giunchedi” in the Description of the Prior Art in the ’742 patent
describes that article as lacking the preferred “well defined wash out period” and notes that the
peak to trough variations are “small” (JTX 2 at 2:47–59); such a description of the prior art is not
a “clear disavowal” or “manifest restriction.” Nor does the ’742 patent’s note that an object of
the “Alza” reference is to avoid uneven blood levels (JTX 2 at 2:11–26) disavow coverage of the
dosage forms with overlapping peaks and shallower troughs that are expressly contemplated by
the specification (JTX 2 at 8:17–34). (Alza does not describe oral dosage forms where a trough

35
occurs but is concealed due to infrequent sampling times but rather a dosage with constantly
ascending plasma levels only achievable with constant intravenous infusion. FF ¶ 74.)
109. For the reasons above, Actavis’s ANDA products literally meet the pulsatile
limitations of the asserted claims. Because all elements of the asserted claims of the ’742 patent
are met, Actavis’s ANDA products infringe the asserted claims of the ’742 patent.
ReliefC.
110. Under 35 U.S.C. § 271(e)(2), a generic drug manufacturer infringes a patent by
filing an ANDA to obtain approval for a generic drug product covered by a valid and unexpired
patent. Eli Lilly & Co. v. Teva Pharm. USA, Inc., 557 F.3d 1346, 1348 (Fed. Cir. 2009).
111. Section 271(e)(4)(A) provides that for an act of infringement under § 271(e)(2),
“the court shall order the effective date of any approval of the drug . . . involved in the
infringement to be a date which is not earlier than the date of the expiration of the patent which
has been infringed.” 35 U.S.C. § 271(e)(4)(A).
112. Section 271(e)(4)(B) provides that for an act of infringement under § 271(e)(2),
“injunctive relief may be granted against an infringer to prevent the commercial manufacture,
use, offer to sell, or sale within the United States or importation into the United States of an
approved drug.”
113. As the ’096 and ’742 patents are valid and have not expired, Recro requests the
Court order that the effective date of any final approval of Actavis’s ANDA shall not be earlier
than the last to expire of the ’096 and ’742 patents, including any extensions and marketing
exclusivities, pursuant to 35 U.S.C. § 271(e)(4)(A). Recro also requests that Actavis be enjoined
from commercially manufacturing, using, offering for sale, selling, or importing its proposed
generic version of Zohydro® ER prior to the patents’ expiration, including any extensions and
marketing exclusivities.

36
MORRIS, NICHOLS, ARSHT & TUNNELL LLP
/s/ Jeremy A. Tigan
Jack B. Blumenfeld (#1014)
Maryellen Noreika (#3208)
Jeremy A. Tigan (#5239)
Megan E. Dellinger (#5739)
1201 North Market Street
P.O. Box 1347
Wilmington, DE 19899-1347
(302) 658-9200
jblumenfeld@mnat.com
mnoreika@mnat.com
jtigan@mnat.com
mdellinger@mnat.com
Attorneys for Recro Gainesville LLC
November 7, 2016
10555837

APPENDIX A
RECRO GAINESVILLE LLC’S WITNESSES
Dr. Lawrence Fleckenstein
Dr. Fleckenstein, an expert in the field of
pharmacokinetics, is professor emeritus at the
University of Iowa, College of Pharmacy, in the
Department of Pharmaceutical Sciences and
Experimental Therapeutics, in the Division of
Pharmaceutics and Translational Therapeutics.
Dr. Fleckenstein’s research is focused on the
pharmacokinetics of new drugs in human
subjects. He has taught extensively in the field of
clinical pharmacokinetics for 24 years and has
extensive experience designing, conducting, and
analyzing clinical research.
At trial, Dr. Fleckenstein testified about the in
vitro and in vivo properties of Actavis’s ANDA
products, concluding that those products meet the
“pulsatile” limitation of claim 1 of the ’742 patent
and the additional limitations present in claims
14, 16, and 19 of that patent. Fleckenstein Tr.
151:13–275:21.
Dr. Jürgen Siepmann
Dr. Siepmann, an expert in the field of
pharmaceutical formulation, is a full professor of
pharmaceutical technology at the University of
Lille in Lille, France. Dr. Siepmann’s research is
focused on drug formulation development, and he
has extensive experience in the fields of coated
dosage forms and controlled-release drug delivery
systems, in particular polymer-coated pellets
releasing drugs in a controlled manner in the
gastrointestinal tract.
At trial, Dr. Siepmann testified about the
formulation aspects of Actavis’s ANDA products,
concluding that those products infringe claims 1,
4, and 5 of the ’096 patent; claims 6 and 13 of the
’742 patent, and satisfy the formulation
limitations in claim 1 of that patent. Siepmann Tr.
55:14–151:11.

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