Endo Pharmaceutical Inc.v.Depomed, Inc.

Patent Trial and Appeal Board

Sep 29, 2014

10045823 (P.T.A.B. Sep. 29, 2014)

Trials@uspto.gov Paper 12
571-272-7822 Entered: September 29, 2014

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

ENDO PHARMACEUTICALS INC.,
Petitioner,

v.

DEPOMED, INC.,
Patent Owner.
____________

Case IPR2014-00655
Patent 6,635,280 B2
____________

Before ERICA A. FRANKLIN, GRACE KARAFFA OBERMANN, and
TINA E. HULSE, Administrative Patent Judges.

HULSE, Administrative Patent Judge.

DECISION
Denying Institution of Inter Partes Review
37 C.F.R. § 42.108
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INTRODUCTION I.
Petitioner Endo Pharmaceuticals Inc. filed a Corrected Petition
requesting an inter partes review of claims 1, 2, 8, 9, 13–15, 43, 45, and 46
of U.S. Patent No. 6,635,280 B2 (Ex. 1001, “the ’280 patent”). Paper 5
(“Pet.”). Patent Owner Depomed, Inc. filed a Preliminary Response to the
Petition. Paper 11 (“Prelim. Resp.”).
We have jurisdiction under 35 U.S.C. § 314, which provides that an
inter partes review may not be instituted “unless . . . there is a reasonable
likelihood that the petitioner would prevail with respect to at least 1 of the
claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering
the Petition and Preliminary Response, we determine that Petitioner has not
shown a reasonable likelihood that it would prevail in showing the
unpatentability of any challenged claim. Accordingly, the Petition is denied.
A. Related Proceedings
Petitioner and Patent Owner identify various district court actions
involving the ’280 patent, including an action involving the parties titled
Depomed, Inc. v. Endo Pharmaceuticals Inc., L.P., No. 3:13-02467 (D.N.J.).
Pet. 1; Paper 8 at 2–3.
Petitioner also has filed five related petitions for inter partes review,
one involving the ’280 patent (IPR2014-00656); two involving U.S. Patent
No. 6,340,475 B2 (“the ’475 patent”), which is the parent of the ’280 patent
(IPR2014-00653 and IPR2014-00654); and two involving U.S. Patent No.
6,723,340 B2 (IPR2014-00651 and IPR2014-00652).
Previously, the Board instituted inter partes review proceedings
involving the ’280 patent (IPR2014-00377), and the ’475 patent (IPR2014-
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00378 and IPR2014-00379), which were initiated by Petitioner Purdue
Pharma LP.
B. The ’280 Patent (Ex. 1001)
The ’280 patent relates to drugs formulated as unit oral dosage forms
by incorporating them into polymeric matrices comprised of hydrophilic
polymers that swell upon imbibition of water to a size large enough to
promote gastric retention of the drug during the fed mode. Ex. 1001,
Abstract. Drugs administered by conventional tablets generally become
available to body fluids at a high rate initially, followed by a rapid decline.
Id. at 1:31–33. To address this delivery pattern, controlled drug delivery
systems were introduced in the 1970’s. Id. at 1:35–37. Many of the
controlled delivery systems utilize hydrophilic, polymeric matrices that
provide controlled release of sparingly soluble drugs. Id. at 1:44–46. For
soluble drugs, however, such matrices do not provide adequate control of
drug release. Id. at 1:46–50.
The claimed invention allows drugs that are highly soluble in water to
be administered orally in a way that will prolong their delivery time to
spread their release rate more evenly throughout the duration of the fed
mode. Id. at 5:32–36. This more even release rate reduces the problem of
transient overdosing, and controls the dosage to safer and more effective
levels over an extended period of time. Id. at 5:36–41. Moreover, particles
exceeding about one cm in size are larger than the pylorus and are retained
in the stomach for approximately four to six hours. Id. at 11:66–12:3. The
Specification states that these benefits are due to using a polymeric matrix
that is water-swellable rather than just hydrophilic, that has an erosion rate
substantially slower than its swelling rate, and that releases the drug
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primarily by diffusion. Id. at 5:57–62. Preferred polymeric matrices include
water-swellable polymers such as hydroxypropylmethylcellulose (“HPMC”)
and poly(ethylene) oxide (“PEO”). Id. at 7:54–8:51.
C. Illustrative Claim
Claims 1 and 43 of the ’280 patent are independent claims. Claims
8–15, 45, and 46 depend from claim 1, either directly or indirectly.
Claim 1 is illustrative and is reproduced below:
1. A controlled-release oral drug dosage form for releasing a
drug whose solubility in water is greater than one part by weight
of said drug in ten parts by weight of water, said dosage form
comprising one or more polymers forming a solid polymeric
matrix with said drug incorporated therein at a weight ratio of
drug to polymer of from 15:85 to 80:20, said dosage form being
one that when swollen in a dimensionally unrestricted manner as
a result of imbibition of water is of a size exceeding the pyloric
diameter in the fed mode to promote retention in the stomach
during said fed mode, that releases said drug into gastric fluid by
the dissolution and diffusion of said drug out of said matrix by
said gastric fluid, that upon immersion in gastric fluid retains at
least about 40% of said drug one hour after such immersion and
releases substantially all of said drug after such immersion, and
that remains substantially intact until substantially all of said
drug is released.

Claim 43, the only other independent claim challenged in the
Petition, is directed to a method of orally administering to a subject a
therapeutic drug in a dosage form comprising a solid polymeric matrix
that, inter alia, “releases said drug into gastric fluid by the dissolving
of said drug by said gastric fluid and either erosion of said matrix or
diffusion of said dissolved drug out of said matrix,” and “releases
substantially all of said drug within about ten hours after [] immersion”
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in gastric fluid, thereby extending the release rate of the drug with time
during the fed mode.
D. The Prior Art Relied Upon
Petitioner relies upon the following prior art references:
Shell US 5,007,790, issued Apr. 16, 1991
(“the Shell ’790 patent”)
Ex. 1005
Edgren US 4,871,548, issued Oct. 3, 1989
(“the ’548 patent”)
Ex. 1006
Shell WO 93/18755, published Sept. 30, 1993
(“the Shell 1993 publication”)
Ex. 1007
Baveja Zero-Order Release Hydrophilic Matrix
Tablets of β-adrenergic Blockers, 39 INT’L J.
OF PHARM. 39–45 (1987).
Ex. 1008
Colombo Drug Release Modulation by Physical
Restrictions of Matrix Swelling, 63 INT’L J. OF
PHARM. 43–48 (1990).
Ex. 1009
Wong US 6,120,803, issued Sept. 19, 2000
(“the ’803 patent”)
Ex. 1010
E. The Asserted Grounds of Unpatentability
Petitioner challenges the patentability of claims 1, 2, 8, 9, 13–15, 43,
45, and 46 of the ’280 patent on the following grounds:
Reference Basis Claims Challenged
’548 patent § 102(b) 1, 2, 8, 9, 13–15, 43, 45,
and 46
Shell 1993 publication § 102(b) 1, 2, 13–15, 43, 45, and
46
Shell ’790 patent § 102(b) 1, 2, 8, 9, 13–15, 43, 45,
and 46
Baveja § 102(b) 1, 8, 9, 13–15, 45, and
46
Colombo § 102(b) 1, 2, 13–15, 45, and 46
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Reference Basis Claims Challenged
’803 patent § 102(e) 43

ANALYSIS II.
A. Claim Construction
In an inter partes review, the Board interprets claim terms in an
unexpired patent according to the broadest reasonable construction in light
of the specification of the patent in which they appear. 37 C.F.R.
§ 42.100(b). Under that standard, and absent any special definitions, we
give claim terms their ordinary and customary meaning, as would be
understood by one of ordinary skill in the art at the time of the invention.
In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Any
special definitions for claim terms must be set forth with reasonable clarity,
deliberateness, and precision. In re Paulsen, 30 F.3d 1475, 1480 (Fed.
Cir. 1994).
1. Previously Construed Terms
The Board previously construed the terms of the ’280 patent set forth
in the table below in the Decision instituting inter partes review in IPR2014-
00377 (Ex. 2003):
Claim Term Claim(s) Construction
“gastric fluid” 1, 43 “both the fluid in the stomach and
simulated or artificial fluids
recognized by those skilled in the
art as a suitable model for the fluid
of the human stomach” (Ex. 2003,
at 6)
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Claim Term Claim(s) Construction
“releases substantially
all of said drug after
such immersion”
1 “at least 80% of the drug has been
released” (Ex. 2003, at 7)
“releases substantially
all of said drug within
about ten hours after
such immersion”
43 “at least 80% of the drug has been
released after ten hours of
immersion in gastric fluid” (Ex.
2003, at 7)
“substantially intact” 1 “substantially retains its size and
shape without deterioration due to
becoming solubilized in the gastric
fluid or due to breakage into
fragments or small particles” (Ex.
2003, at 7–8)

Based on the information presented at this stage of the proceeding, we
again determine that these constructions are the broadest reasonable
constructions consistent with the Specification, and, on that basis, we adopt
them for the purposes of this Decision.
In addition to the terms that we construed previously, we construe the
following terms proposed by the parties.
2. “when swollen in a dimensionally unrestricted manner”
The term “when swollen in a dimensionally unrestricted manner”
appears in independent claims 1 and 43. Petitioner contends that this term is
indefinite, but proposes that the Board adopt the construction previously
adopted by several district courts, including the court in Depomed, Inc. v.
Lupin Pharmaceuticals, Inc. Pet. 10–11 (citing Exs. 1012-1014). That is,
Petitioner contends that this limitation should be construed to mean “[t]he
dosage form, which comprises a polymeric matrix, increases in size due to
the ingress of water.” See Ex. 1012, at 12. Patent Owner contends that this
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term is not indefinite and should be construed according to its plain and
ordinary meaning. Prelim. Resp. 20.
When construing claims, we interpret claims “with an eye toward
giving effect to all terms in the claim.” Bicon Inc. v. Straumann Co., 441
F.3d 945, 950 (Fed. Cir. 2006). Thus, we decline to adopt Petitioner’s
construction because it reads out the “dimensionally unrestricted manner”
limitation. See Stumbo v. Eastman Outdoors, Inc., 508 F.3d 1358, 1362
(Fed. Cir. 2007) (denouncing claim constructions that render limitations
superfluous).
Claim 1 recites that the “dosage form compris[es] one or more
polymers forming a solid polymeric matrix . . ., said dosage form being one
that when swollen in a dimensionally unrestricted manner as a result of
imbibition of water is of a size exceeding the pyloric diameter.” Ex. 1001,
17:48–53. Moreover, the ’280 patent Specification states that the water-
swellable polymer forming the matrix “swells in a dimensionally
unrestricted manner upon imbibition of water.” Ex. 1001, 7:56–57.
Consistent with this disclosure, the Lupin district court explained: “It is not
the swelling itself that is unrestricted, but the swelling of the dimensions of
the dosage form—that is, length, the width, or other dimension of the dosage
form—based on the swelling characteristics of the selected polymer.” Ex.
1012, at 10.
On this record, given the claim language and the Specification, we
construe “when swollen in a dimensionally unrestricted manner” to mean
that the dosage form “has increased in size in such a way that is not
restricted in any dimension.”
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3. “releases said drug . . . by the dissolution and diffusion of said drug
out of said matrix” / “releases said drug . . . by the dissolving of said
drug . . . and either erosion of said matrix or diffusion of said dissolved drug
out of said matrix”
The term “releases said drug . . . by the dissolution and diffusion of
said drug out of said matrix” (i.e., the “dissolution and diffusion” limitation)
appears in independent claim 1. And the term “releases said drug . . . by the
dissolving of said drug . . . and either erosion of said matrix or diffusion of
said dissolved drug out of said matrix” (i.e., the “erosion or diffusion”
limitation) appears in independent claim 43. Patent Owner contends that the
“dissolution and diffusion” limitation should be construed according to the
district court’s construction as “rapid dissolution of the drug, followed by
slow diffusion of the drug out of the water-swollen matrix, such that the
drug is released at a rate primarily controlled by the rate of diffusion.”
Prelim. Resp. 14 (emphasis omitted). Patent Owner further contends that the
“erosion or diffusion” limitation should be construed as “releases said drug
into gastric fluid by either (a) rapid dissolution of the drug followed by slow
rate-controlling diffusion of the drug out of said matrix or (b) rapid
dissolution of the drug and rate-controlling erosion of said matrix.” Id. at
15–16. Petitioner does not propose a construction for either limitation.
Patent Owner urges the Board to adopt a construction that limits the
claims such that the rate of drug release is “primarily controlled by the rate
of diffusion” in claim 1 or by “rate-controlling” diffusion or erosion in claim
43. Prelim. Resp. 14–16. The claim language, however, does not support
limiting the construction in this manner. Nothing in claim 1 or claim 43
requires the drug release to be “primarily” by diffusion or erosion. Although
the Specification states that beneficial effects are achieved “by using a
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formulation in which the drug is dispersed in a polymeric matrix . . . that
releases the drug primarily by diffusion” (Ex. 1001, 5:58–62), we decline to
import limitations from the Specification when applying the broadest
reasonable construction. This is particularly true in light of claim 43, which
allows for drug release by erosion or diffusion. Ex. 1001, 25:51–54 (reciting
the “erosion or diffusion” limitation). Accordingly, we construe the claims
according to their plain and ordinary meaning and decline to import any
requirement that the drug release occur “primarily” by diffusion in claim 1,
or by “rate-controlling” erosion or diffusion in claim 43.
4. All Remaining Terms
We determine that, for purposes of this Decision, none of the other
terms proposed by the parties requires express construction at this time.
B. Anticipation by the ’548 Patent (Ex. 1006)
1. The ’548 Patent
The ’548 patent relates to a controlled-release dosage form
comprising a drug and at least two different cellulose ethers. Ex. 1006,
1:12–16. According to the ’548 patent specification, “[an] object of the
present invention is to provide a dosage form of delivering a drug in the
gastrointestinal tract that substantially avoids a premature disintegration.”
Id. at 3:1–4. The ’548 patent specification also states that the disclosed
invention “delivers a drug at a rate of dosage form release that corresponds
to the rate of change of the integrity of the dosage form over a prolonged
period of at least eight hours.” Id. at 3:4–7.
Moreover, the dosage form uses cellulose ethers, which swell
extensively when hydrated and lessen direct drug contact with mucosal
tissues. Id. at 11:23–26. The drug delivery matrix is suitable for gastric
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retention over the releasing lifetime of the dosage system. Id. at 10:65–68.
Furthermore, “when all the drug is released, the system bioerodes into
innocuous particles and dissolved polymers that pass from the
gastrointestinal tract.” Id. at 10:68–11:3.
2. Analysis
Petitioner contends that the ’548 patent anticipates claims 1, 2, 8, 9,
13–15, 43, 45, and 46 of the ’280 patent. Pet. 13–19. Patent Owner
disagrees. Prelim. Resp. 25–30.
As support for its anticipation claim, Petitioner relies on several
different embodiments disclosed in the ’548 patent. For example, regarding
independent claim 1, as disclosure of a “drug whose solubility in water is
greater than one part by weight of said drug in ten parts by weight of water,”
Petitioner cites the ’548 patent’s disclosure of potassium chloride. Pet. 14.
But for the disclosure of “retain[ing] at least about 40% of said drug one
hour after such immersion” and “releases substantially all of said drug after
such immersion,” Petitioner relies on Example 3 and Figure 6 of the ’548
patent. Id. at 15. Example 3 and Figure 6, however, describe an
embodiment that uses ibuprofen, not potassium chloride. Ex. 1006, 9:4–15.
Similarly, for independent claim 43, Petitioner cites aspirin as
teaching a “drug [that] has at least one ionized group in the pH range of 5
through 8” (id. at 37), and again cites the ibuprofen embodiment in
Example 3 and Figure 6 as teaching a matrix that “retains at least about 40%
of said drug one hour after such immersion in gastric fluid” (id. at 38–39).
Although Petitioner also generally states that “drugs in salt form described in
the ’548 patent would have at least one ionized group in the pH range 5
through 8,” Petitioner fails to cite sufficient support for this statement in
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either the ’548 patent specification or from its witness, Dr. Clive Wilson. Id.
at 37. Thus, Petitioner has not shown that ibuprofen is a drug that has at
least one ionized group in the pH range of 5 through 8.
We, therefore, do not find Petitioner’s arguments sufficient.
Petitioner has not shown that ibuprofen is a drug whose solubility is greater
than one part by weight of drug in ten parts by weight of water or that
ibuprofen has at least one ionized group in the pH range of 5 through 8. Nor
has Petitioner shown that a dosage form with potassium chloride or aspirin
achieves the drug release limitations above. In light of these deficiencies,
Petitioner has not shown sufficiently that the ’548 patent anticipates the
claimed invention. Petitioner cannot combine parts of separate
embodiments disclosed in the ’548 patent to piece together the claimed
invention.
As our reviewing court’s predecessor stated, for anticipation, the prior
art reference “must clearly and unequivocally disclose the claimed
compound or direct those skilled in the art to the compound without any
need for picking, choosing, and combining various disclosures not directly
related to each other by the teachings of the cited reference.” In re Arkley,
455 F.2d 586, 587 (CCPA 1972); see also Net MoneyIN, Inc. v. VeriSign,
Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008) (holding that “unless a reference
discloses within the four corners of the document not only all of the
limitations claimed but also all of the limitations arranged or combined in
the same way as recited in the claim, it cannot be said to prove prior
invention of the thing claimed, and, thus, cannot anticipate under 35 U.S.C.
§ 102”).
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Accordingly, we determine that Petitioner has not established a
reasonable likelihood that it would prevail in showing that the ’548 patent
anticipates claims 1, 2, 8, 9, 13–15, 43, 45, and 46 of the ’280 patent.
C. Anticipation by the Shell 1993 Publication (Ex. 1007)
1. Shell 1993 Publication
The Shell 1993 publication discloses a sustained-release oral drug
dosage form that releases a solution of a drug into the stomach and that
comprises a tablet or capsule of a plurality of particles of a solid-state drug
dispersed in alkyl cellulose. Ex. 1007, 2:13–17. The alkyl cellulose “swells
unrestricted dimensionally via imbibition of gastric fluid to increase the size
of the particles . . . with consequent increase in gastric retention time of the
particles.” Id. at 2:17–21. The dosage form also “permits dissolution of the
dispersed drug by imbibed gastric fluid while the drug is within the particle
and release of the resulting solution” and “maintains its physical integrity
over at least a substantial portion of the time period during which the drug is
released into the stomach and then dissolves.” Id. at 2:23–31.
2. Analysis
Petitioner contends that the Shell 1993 publication anticipates claims
1, 2, 13–15, 45, and 46 of the ’280 patent. Pet. 17–19. Patent Owner
opposes Petitioner’s contention. Prelim. Resp. 30–33.
Like its argument with respect to the ’548 patent, Petitioner relies on
several different embodiments of the Shell 1993 publication to arrive at a
teaching of the claimed invention. For example, Petitioner relies on
potassium chloride as teaching the water solubility limitation (Pet. 17), but
relies on the drug release studies of dosage forms using aspirin as teaching
the requisite drug release limitations (id. at 18–19). For the same reasons
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stated above, we reject Petitioner’s argument. Petitioner cannot establish
anticipation by picking and choosing from the elements of different
embodiments within the Shell 1993 publication. Arkley, 455 F.2d at 587;
Net MoneyIN, 545 F.3d at 1371. Accordingly, we determine that Petitioner
has not established a reasonable likelihood that it would prevail in showing
that the Shell 1993 publication anticipates claims 1, 2, 13–15, 45, and 46 of
the ’280 patent.
D. Anticipation by the Shell ’790 Patent (Ex. 1005)
1. Shell ’790 Patent
The Shell ’790 patent discloses a sustained-release oral dosage form
that “is retained well in the stomach and releases drug as a solution into the
stomach.” Ex. 1005, 1:6-9. The dosage form comprises a plurality of solid
particles composed of a solid-state drug dispersed within a hydrophilic,
water-swellable polymer that swells in gastric fluid to increase the particle
size to a level that promotes retention in the stomach over the time period.
Id. at 1:54–61. The dosage form also “permits slow dissolution of the
dispersed drug by gastric fluid and release of the resulting solution from the
particles.” Id. at 1:61–63. Finally, the dosage form “maintains its physical
integrity over at least a substantial portion of the time period and thereafter
rapidly dissolves.” Id. at 1:65–67.
2. Analysis
a. Claims 1, 2, 8, 9, 13–15, 45, and 46
Petitioner asserts that the Shell ’790 patent anticipates claims 1, 2, 8,
9, 13–15, 45, and 46 of the ’280 patent. Pet. 19–23, 31–36. Patent Owner
disagrees. Prelim. Resp. 30–33.
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Claim 1 recites that the dosage form “upon immersion in gastric fluid
retains at least about 40% of said drug one hour after such immersion.”
Ex. 1001, 17:57–60. As disclosure of this limitation, Petitioner cites the
Shell ’790 patent’s teaching that “the polymer [is] to remain insoluble for
the desired time period, normally at least from about 4 hours to 8 hours up to
12 hours.” Pet. 21 (citing Ex. 1005, 3:7–10). But Petitioner does not
explain why the disclosure that the polymer remains insoluble for a certain
period of time discloses the limitation that at least about 40% of the drug is
retained after one hour. Because Petitioner has not established a connection
between the cited disclosure and the claim limitation, we determine that
Petitioner has not established a reasonable likelihood that it would prevail in
showing that the Shell ’790 patent anticipates claim 1 or any of its dependent
claims 2, 8, 9, 13–15, 45, and 46.
b. Claim 43
Petitioner asserts that the Shell ’790 patent anticipates claim 43 of the
’280 patent. Pet. 44-47. Patent Owner disagrees. Prelim. Resp. 32-33.
Petitioner again relies on various elements selected from different
embodiments of the Shell ’790 patent to arrive at a disclosure of the claimed
invention. For example, Petitioner relies on aspirin as disclosing the
limitation “where said drug has at least one ionized group in the pH range of
5 through 8.” Pet. 45. Petitioner then relies on drug release studies of
dosage forms using potassium chloride as disclosing “releases substantially
all of said drug within about ten hours after such immersion.” Id. at 46–47.
For the same reasons stated above, we reject Petitioner’s argument. See
Arkley, 455 F.2d at 587; Net MoneyIN, 545 F.3d at 1371. Thus, we
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determine that Petitioner has not established a reasonable likelihood that it
would prevail in showing that the Shell ’790 patent anticipates claim 43.
E. Anticipation by Baveja (Ex. 1008)
1. Baveja
Baveja discloses a dosage form comprised of a swellable hydrophilic
matrix that exhibits zero-order (i.e., constant) release of a drug. Ex. 1008,
Summary. Baveja uses β-adrenergic blockers propranolol hydrochloride,
alprenolol hydrochloride, and metoprolol tartrate as model drugs. Id. at 40.
Baveja describes tablets with different ratios of HPMC, sodium
carboxymethylcellulose (“Na CMC”), and drug, which are then subjected to
an in vitro dissolution study. The in vitro dissolution study involves placing
the tablets into a dissolution rate test apparatus with diluted HCl (pH 3.0) for
three hours and then in 0.2 M phosphate buffer (pH 7.4) for another 9 hours.
Id.
The results of the dissolution studies for tablets formed from just
HPMC and drug are shown in Figures 1–3. For example, Figure 2 is
reproduced below:
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Figure 2 illustrates the cumulative percent of metoprolol tartrate
released as a function of time from tablets containing metoprolol tartrate to
HPMC in the ratios shown. Id. at 41.
As explained by Baveja, the rate of release of the tablets made of drug
and HPMC decreases with time, which may be due to “an increase in
diffusional path length for the drug[,] which in turn may be due to slower
erosion rate of the rubbery layer and faster advancement of swelling front
into the glassy polymer.” Id.
Baveja also describes tablets formed from HPMC, Na CMC, and drug
in varying amounts that exhibit a nearly zero-order rate of release. Id.,
Summary.
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2. Analysis
Petitioner contends that Baveja anticipates claims 1, 8, 9, 13–15, 45,
and 46 of the ’280 patent. Pet. 23–28. Patent Owner disagrees, arguing,
among other things, that the Board has determined already in IPR2014-
00377 that Baveja does not expressly or inherently disclose the
“substantially intact” limitation of claim 1. Prelim. Resp. 33–35.
We agree with Patent Owner, because Petitioner relies solely on the
experiments run by Purdue’s witness, Kinam Park, Ph.D., as support for the
“substantially intact” limitation. Prelim. Resp. 26–27. According to
Petitioner, “Dr. Park’s test results confirm that the polymeric matrix used in
the ’280 tablets remain substantially intact until all of the drug is released.”
Pet. 24.
As explained in our Decision to Institute in IPR2014-00377, however,
Dr. Park never established that the dosage form that he prepared was
actually the same as the dosage form that Baveja prepared. Purdue Pharma
L.P. v. Depomed, Inc., Case IPR2014-00377, slip op. at 11 (PTAB July 10,
2014) (Paper 9). To establish this, Dr. Park could have, for example,
subjected the alprenolol tablets that he prepared to the same dissolution
study disclosed in Baveja to demonstrate that his tablets achieved the same
results as those disclosed for Baveja’s formulation. Without such evidence,
we cannot reasonably conclude that Dr. Park, in fact, tested the dosage form
disclosed by Baveja. Ex. 2003, at 10–12; see also Purdue Pharma,
IPR2014-00377 Order Denying Petitioner’s Request for Rehearing,
IPR2014-00377 (Paper 17) at 3–4.
Thus, for all the same reasons discussed in our Decision to Institute in
IPR2014-00377, we determine that Petitioner has not established a
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reasonable likelihood that it would prevail in showing that Baveja
anticipates claims 1, 8, 9, 13–15, 45, or 46 of the ’280 patent.
F. Anticipation by Colombo (Ex. 1009)
1. Colombo
Colombo relates to swellable matrix systems in the form of a tablet
comprising a mixture of the drug diltiazem, HPMC, ethylcellulose, and
mannitol. Ex. 1009, at 44. Colombo discloses three different matrices:
Case 0, the plain matrix; Case 1, the matrix coated with cellulose acetate
propionate (“CAP”) on one face; and Case 2, the matrix coated with CAP on
both faces. Id. Colombo describes “[s]welling and release experiments” in
which the matrices were swollen in deionized water, and the drug release
measurements were obtained concomitantly with the matrix swelling
observations. Id.
Colombo describes and depicts the morphological changes in the
matrices over time, observing that, in the uncoated system (Case 0), “[v]ery
quickly (after 15 min) the swelling of the matrix moves both in axial and
radial directions.” Id. Colombo also discloses the drug release profiles of
the systems. Id. at 45. Figure 5 of Colombo is reproduced below:
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Figure 5 depicts the fraction of diltiazem released over time for the
Case 0, Case 1, and Case 2 matrices.
2. Analysis
Petitioner asserts that claims 1, 2, 13–15, 45, and 46 of the ’280 patent
are anticipated by Colombo. Pet. 28–36. Patent Owner disagrees, noting
that the Board determined already that Colombo does not disclose the “upon
immersion in gastric fluid” limitation of claim 1. Prelim. Resp. 37–39.
Claim 1 of the ’280 patent requires a drug dosage form that exhibits
certain characteristics “upon immersion in gastric fluid.” Ex. 1001, 17:45–
61. Colombo, however, does not disclose immersion in gastric fluid.
Colombo discloses immersion in deionized water for its swelling and release
tests. Ex. 1009, at 44. Recognizing this difference, Petitioner’s witness
Dr. Wilson states, “Although the experiments were conducted in water, a
POSA would have understood that these matrices would have performed in
substantially the same manner [if immersed] in gastric fluid.” Ex. 1011
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¶ 73. Dr. Wilson offers no objective support for that assertion. The
statement, therefore, is of little probative value. See 37 C.F.R. § 42.65(a)
(stating opinion testimony that does not disclose underlying facts or data “is
entitled to little or no weight”); Ashland Oil, Inc. v. Delta Resins &
Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985) (stating a lack of
objective support for expert opinion “may render the testimony of little
probative value in a validity determination”).
Further, we note that Dr. Wilson states that Colombo’s matrices
would perform in “substantially the same manner in gastric fluid.” Ex. 1011
¶ 73 (emphasis added). Dr. Wilson does not explain what “substantially the
same” means in this context, or in what ways, if any, Colombo’s matrices
may respond differently when immersed in gastric fluid. See id.
Accordingly, Petitioner has not established that Colombo’s matrices would
necessarily perform in the same manner upon immersion in gastric fluid as
they do in deionized water. “To establish inherency, the extrinsic evidence
‘must make clear that the missing descriptive matter is necessarily present in
the thing described in the reference . . . .’” In re Robertson, 169 F.3d 743,
745 (Fed. Cir. 1999) (citation omitted). Inherency is not proven “by
probabilities or possibilities. The mere fact that a certain thing may result
from a given set of circumstances is not sufficient.” Id. (quotation omitted).
Because Petitioner has not shown that Colombo inherently teaches the
“upon immersion in gastric fluid” limitation of claim 1, we determine that
Petitioner has not established a reasonable likelihood that it would prevail in
showing that claims 1, 2, 13–15, 45, and 46 of the ’280 patent are
anticipated by Colombo.

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G. Anticipation by the ’803 Patent (Ex. 1010)
1. The ’803 Patent
The ’803 patent relates to a drug dosage form adapted for retention in
the stomach to deliver a drug over a sustained period of time. Ex. 1010,
1:10–14. The dosage form includes a drug and a polymer matrix formed of
a swellable, water-soluble polymer that expands when contacted with fluids
in the stomach, and a rigid or semi-rigid band of insoluble material in which
swelling of the water-soluble polymer is constrained. Id. at 5:12–18.
Figures 1B and 2 are reproduced side-by-side below:

Figure 1B depicts one embodiment of the dosage form with insoluble
band 15 circumscribing a portion of the polymer matrix in a form before
placement in the stomach, and Figure 2 depicts the dosage form of
Figure 1B in its initially swollen state after having expanded in the stomach.
Id. at 7:42–45.
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Similarly, Figures 4A and 4B are reproduced side-by-side below:

Figure 4A depicts a different embodiment of the dosage form with
two bands of insoluble material in a form before placement in the stomach,
and Figure 4B depicts the dosage form of Figure 4A in its swollen state. Id.
at 11:60–12:4.
The insoluble band prevents that portion of the polymer matrix that it
surrounds from imbibing fluid, thus “substantially limiting any swelling of
polymer matrix 11 at that location.” Id. at 11:47–48. The insoluble band
also “facilitates the dosage form remaining in the stomach of a subject over a
prolonged period of time.” Id. at 5:19–21.
2. Analysis
Petitioner contends that claim 43 of the ’280 patent is anticipated by
the ’803 patent. Pet. 48–51. Patent Owner opposes Petitioner’s challenge.
Prelim. Resp. 39–41.
Petitioner asserts that the ’803 patent discloses the limitation that the
dosage form is “swollen in a dimensionally unrestricted manner as a result
of imbibition of gastric fluid.” Pet. 49–50. Petitioner, however, has not
shown sufficiently that the ’803 patent teaches this limitation.
As discussed above, we have construed this limitation to mean that
the dosage form “has increased in size in such a way that is not restricted in
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any dimension.” As is clear from the specification and the accompanying
figures of the ’803 patent, the insoluble bands prevent the dosage form from
swelling in such a way that is not restricted in any manner. Indeed, the
Specification states that the band “substantially limit[s] any swelling of
polymer matrix 11 at that location.” Ex. 1010, 11:47–48. Because
Petitioner has not shown sufficiently that the ’803 patent teaches the
“swollen in a dimensionally unrestricted manner,” we determine that
Petitioner has not established a reasonable likelihood that it would prevail in
showing that claim 43 of the ’280 patent is anticipated by the ’803 patent.
CONCLUSION III.
We conclude that Petitioner has not demonstrated a reasonable
likelihood that it would prevail in showing that any claims of the ’280 patent
are unpatentable based upon any of the asserted anticipation grounds.
ORDER IV.
In consideration of the foregoing, it is hereby ordered that the Petition
is denied.

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FOR PETITIONER:

Bruce Haas
Endo-ipr@fchs.com

Henry Rend
Endo-ipr@fchs.com

Stephen Yam
syam@fchs.com

FOR PATENT OWNER:

Arlene L. Chow
Arlene.chow@hoganlovells.com