Endo Pharmaceutical Inc.v.DepoMed, Inc.

Patent Trial and Appeal Board

Sep 29, 2014

10029134 (P.T.A.B. Sep. 29, 2014)

Trials@uspto.gov Paper 12
Tel: 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 IPR2014-00651
Patent 6,723,340
_______________

Before GRACE KARAFFA OBERMANN, GEORGIANNA W. BRADEN,
and TINA E. HULSE, Administrative Patent Judges.

BRADEN, Administrative Patent Judge.

DECISION
Denying Institution of Inter Partes Review
37 C.F.R. § 42.108

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I. INTRODUCTION
A. Background
Endo Pharmaceuticals, Inc. (“Petitioner”) filed a Corrected Petition
(Paper 5, “Pet.”) to institute an inter partes review of claims 1-5 and 10-13
of U.S. Patent No. 6,723,340 B2 (“the ’340 patent”) pursuant to 35 U.S.C.
§§ 311–319. Depomed, Inc. (“Patent Owner”) filed a Preliminary Response
(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.”
Upon consideration of the Petition and Patent Owner’s Preliminary
Response, we conclude Petitioner has not established a reasonable likelihood
it would prevail with respect to at least one of the challenged claims.
Accordingly, for the reasons that follow, we decline to institute an inter
partes review of claims 1-5 and 10-13 of the ’340 patent.
B. Related Proceedings
Petitioner identifies several federal district court cases relating to
the ’340 patent, including an action involving the parties titled Depomed,
Inc. v. Endo Pharmaceuticals Inc., 3:13-cv-02467-JAP-TJB (D.N.J.). In
addition, Petitioner concurrently filed several related petitions requesting
inter partes review. Pet. 2. These cases are: IPR2014-00652 (involving
the ’340 patent); IPR2014-00653 and IPR2014-00654 (involving U.S. Patent
No. 6,340,475 B2); and IPR2014-00655 and IPR2014-00656 (involving
U.S. Patent No. 6,635,280 B2).
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C. The ’340 Patent
The ’340 patent relates to drugs formulated as unit oral dosage forms
by incorporating them into matrices formed of a combination of
poly(ethylene oxide) and hydroxypropyl methylcellulose. Ex. 1001,
Abstract. The matrices swell upon exposure to gastric fluid to a size large
enough to promote retention (id. at Abstract, 11:66-67) and release of the
drugs into the stomach or upper gastrointestinal (“GI”) tract, rather than the
lower portions of the GI tract (id. at 1:10-13). The ’340 patent discloses that
when nutritive material enters the stomach, the stomach is in “fed mode” and
the pyloric sphincter is open partially. Id. at 1:62-2:9. During the “fed
mode,” particles exceeding about 1 cm in size are retained in the stomach,
because they are too large to pass through a partially open pyloric sphincter.
Id. at 2:5-11.
Poly(ethylene oxide) and hydroxypropyl methylcellulose are both
water-swellable polymers. Id. at 3:11-15; 3:23-25; 10:38-46; Fig. 5.
According to the ’340 patent, the swelling and controlled-release properties
of poly(ethylene oxide) are balanced with the predictable erosion behavior
of hydroxypropyl methylcellulose, which modulates the extent and progress
of the overall swelling of a combined polymeric matrix. Id. at 3:40-43.
The ’340 patent discloses that the competing, yet complementary, actions of
swelling and erosion allow for slower and more even disintegration
compared to tablets made solely or primarily with poly(ethylene oxide). Id.
at 3:50-54.
Certain embodiments in the specification of the ’340 patent teach that
for highly soluble drugs, the poly(ethylene oxide) component of the matrix
limits the initial release of the drug while imparting gastric retention through
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swelling. Id. at 4:5-7. In other embodiments, the specification teaches that
for sparingly soluble drugs, the hydroxypropylmethyl cellulose component
of the matrices prevents premature release of the drugs by retarding the
erosion rate of the poly(ethylene oxide), while the poly(ethylene oxide)
provides gastric retention. Id. at 4:10-14.
The specification further teaches that prolonged 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 7:44-49.
D. Illustrative Claim
As noted above, Petitioner challenges claims 1-5 and 10-13 of the
’340 patent, of which claim 1 is the only independent claim. Claim 1 is
illustrative of the challenged claims and is reproduced below:
1. A controlled-release tablet for releasing a drug into at least a portion
of a region defined by the stomach and the upper gastrointestinal
tract, said tablet comprising
a solid monolithic matrix with said drug dispersed therein,
said matrix comprising a combination of poly(ethylene oxide) and
hydroxypropyl methylcellulose at a weight ratio that causes said
matrix to swell upon contact with gastric fluid to a size large enough
to provide gastric retention,
wherein said drug has a solubility in water that exceeds one part of said
drug per ten parts of water, by weight, and
wherein said poly(ethylene oxide) has a viscosity average molecular
weight of from about 2,000,000 to about 10,000,000 daltons, and
wherein said hydroxypropyl methylcellulose has a viscosity of from
about 4,000 centipoise to about 200,000 centipoise, measured as a
2% solution in water.

E. The Evidence of Record
Petitioner relies upon the following reference, as well as the
Declaration of Clive Wilson, Ph.D. (Ex. 1008):
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Reference Patent/Printed Publication Date Exhibit
Shell 1998
Publication
WO 98/55107
PCT/US98/11302
Dec. 10,
1998
1003
F. The Asserted Ground of Unpatentability
Petitioner challenges the patentability of claims 1-5 and 10-13 of the
’340 patent based on the following ground:
Reference Basis Claims Challenged
Shell 1998 Publication § 102 1-5 and 10-13

II. DISCUSSION
In the analysis that follows, we discuss facts as they have been
presented thus far in this proceeding.
A. Claim Construction
In an inter partes review, claim terms in an unexpired patent are
interpreted according to their broadest reasonable construction in light of the
Specification of the patent in which they appear. 37 C.F.R. § 42.100(b); see
Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,766 (Aug. 14,
2012). Claim terms are given their ordinary and customary meaning as
would be understood by one of ordinary skill in the art in the context of the
entire disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed.
Cir. 2007).
For purposes of this decision and based on the record before us, we
need not provide express constructions for any claim terms at this stage of
the proceeding.
B. Principles of Law
To prevail in its challenges to the patentability of the claims if the
matter proceeds to trial, the petitioner must establish facts supporting its
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challenges by a preponderance of the evidence. 35 U.S.C. § 316(e); 37
C.F.R. § 42.1(d). A claim is unpatentable under 35 U.S.C. § 102 if a prior
art reference discloses every limitation of the claimed invention, either
explicitly or inherently. Glaxo Inc. v. Novopharm Ltd., 52 F.3d 1043, 1047
(Fed. Cir.1995). Furthermore, the prior art reference—in order to anticipate
under 35 U.S.C. § 102—must lead to a composition that falls within the
scope of the claim “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). Thus, it is
not enough that the prior art reference discloses multiple, distinct teachings
that the artisan might somehow combine to achieve the claimed invention.
See Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371-72 (Fed. Cir.
2008) (finding a prior art reference is anticipatory only if the reference
discloses every limitation of the claimed invention arranged or combined in
the same way as in the claim).
C. Asserted Anticipation of Claims 1-5 and 10-13 by the Shell 1998
Publication
Petitioner contends the Shell 1998 publication anticipates claims 1-5
and 10-13 of the ’340 patent. Pet. 11-23. We determine Petitioner has not
demonstrated a reasonable likelihood that those claims are anticipated by the
Shell 1998 publication.
1. Overview of the Shell 1998 Publication
The Shell 1998 publication discloses drugs formulated as unit oral
dosage forms by incorporating them into polymeric matrices that can be
compressed into tablets. Ex. 1003, Abstract. The dosage forms are solid
prior to administration to a patient, water-swellable, and gastric retentive in a
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fed mode (a state triggered by food ingestion that lasts for a period of time).
Id. at 2:23-32, 3:2-5. The Shell 1998 publication specifically discloses
polymeric matrices made from (i) cellulose polymers and their derivatives,
(ii) polysaccharides and their derivatives, (iii) polyalkylene oxides, and
(iv) crosslinked polyacrylic acids and their derivatives. Id. at 5:4-6.
Particularly preferred alkyl-substituted celluloses are hydroxyethylcellulose
and hydroxypropylmethylcellulose (HPMC). Id. at 5:17-18. A particularly
preferred polyalkylene oxide is poly(ethylene oxide). Id. at 5:22-23.
The Shell 1998 publication further discloses that in terms of their
viscosities, one class of preferred alkyl-substituted celluloses includes those
whose viscosity is within the range of about 100 to about 110,000 centipoise
as a 2% aqueous solution at 20°C, while another class includes those whose
viscosity is within the range of about 1,000 to about 4,000 centipoise as
a 1% aqueous solution at 20°C. Id. at 5:13-16. For poly(ethylene oxide),
the Shell 1998 publication teaches that a preferred viscosity range is about
50 to about 2,000,000 centipoise for a 2% aqueous solution at 20°C. Id.
at 5:26-28.
The Shell 1998 publication teaches that the water-swellable polymers
it discloses can be used individually or in combination with each other. Id.
at 6:32. According to the Shell 1998 publication, “[c]ertain combinations
will often provide a more controlled release of the drug than their
components when used individually.” Id. at 6:32-34. The Shell 1998
publication gives examples of such combinations, including (i) combining
cellulose-based polymers combined with gums, such as hydroxyethyl
cellulose or hydroxypropyl cellulose combined with xanthan gum, or (ii)
combining poly(ethylene oxide) with xanthan gum. Id. at 6:34-36.
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The polymer mixture then can be impregnated or combined with a
drug and formed into particles, tablets, or retained in capsules. Id. at 7:3-4,
7:24-26. According to the Shell 1998 publication, the disclosed invention
applies to drugs that are “freely soluble” in water, meaning that one part of
the drug dissolves in less than about ten parts water. Id. at 4:7-9.
2. Analysis
The primary dispositive fact that Petitioner in this case must show is
that the Shell 1998 publication is an anticipatory prior art reference.
Petitioner contends the Shell 1998 publication, as summarized above,
discloses each limitation of claims 1-5 and 10-13 of the ’340 patent.
Independent claim 1 requires a solid monolithic matrix made of
poly(ethylene oxide) (“PEO”) and hydroxypropyl methylcellulose
(“HPMC”) with a drug dispersed in the matrix. The PEO and HPMC are
characterized by a specified viscosity and the drug must have a solubility in
water that exceeds one part of the drug per ten parts of water, by weight.
The weight ratio of the polymers in the matrix must cause the matrix to
swell when the tablet gets to the stomach, thereby retaining the tablet in the
stomach. Challenged claims 2-5 and 10-13 each depend directly from
claim 1, and thus, recite all elements of claim 1.
According to Petitioner, the Shell 1998 publication focuses on a small
group of polymers, including PEO and HPMC, used to create a solid
polymeric matrix. Pet. 12-13; see Ex. 1008 ¶ 53. Petitioner explains that the
Shell 1998 publication teaches the use of the polymers individually or in
combination. Pet. 13; Ex. 1008 ¶ 55. For example, the Shell 1998
publication discloses polymeric matrices made from combinations of PEO
and hydroxyethyl cellulose. Pet. 13-14 (citing Ex. 1003, 12:13-16,
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13:27-30). The Shell 1998 publication lists hydroxyethyl cellulose and
HPMC as two “[p]articularly preferred alkyl-substituted celluloses” that can
be used in the polymeric matrices. Ex. 1003, 5:17-18. Petitioner reasons
that (i) the disclosure of PEO and HPMC individually, and (ii) the disclosure
of PEO combined with a “preferred alkyl-substituted cellulose” equates to
the disclosure of a combination of PEO and HPMC. Pet. 13. Petitioner,
thus, concludes that the Shell 1998 publication discloses the combination of
PEO and HPMC for polymeric matrices with anticipatory specificity.
Patent Owner disagrees, contending that the Shell 1998 publication
discloses thirty-one polymeric matrices, none of which comprises a
combination of PEO and HPMC. Prelim. Resp. 13. Patent Owner
specifically explains that (1) the overwhelming majority of polymeric
matrices taught by the Shell 1998 publication are made of just one polymer,
and (2) the combinations taught by the Shell 1998 publication all use
xantham gum or hydroxyethyl cellulose. Id. (citing Ex. 1003, 6:32-36,
12:13-16, 13:22-14:5). Patent Owner further contests Petitioner’s
characterization that hydroxyethyl cellulose and HPMC are interchangeable
simply because both compounds are classified as “alkyl-substituted cellulose
polymers.” Pet. 13. According to Patent Owner, hydroxyethyl cellulose and
HPMC are distinct and are not fungible. Prelim. Resp. 14 (citing Ex. 1006,
4:7-5:6).
We agree with Patent Owner that Petitioner has not shown sufficiently
that hydroxyethyl cellulose and HPMC are the same compound or are
interchangeable. In particular, Petitioner directs us to no evidence from
which we reasonably can conclude that an ordinary artisan would have
recognized the interchangeability of those compounds in the Shell 1998
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publication —for example, the declaration evidence upon which Petitioner
relies includes no objective support of such a proposition. Pet. 13 (citing Ex.
1008 ¶ 53). On this record, we determine that Petitioner has not shown
sufficiently that the Shell 1998 publication discloses a polymeric matrix
made from a combination of PEO and HPMC. Although the Shell 1998
publication teaches generally that polymers can be combined, there is no
specific disclosure of combining PEO and HPMC, which is a required
element in each of the challenged claims.
Nor is there specific disclosure of combining PEO and HPMC at the
requisite molecular weight of PEO and viscosity for HPMC. We are
unpersuaded by Petitioner’s attempts to pick and choose among the distinct
teachings in the Shell 1998 publication of individual polymers that could be
combined and could be used as drug-containing, swellable matrices to
suffice as a disclosure of a combination of PEO and HPMC. In order for a
reference to be anticipatory, it must disclose every limitation of the claimed
invention, arranged or combined in the same way as in the claim. See Net
MoneyIN, Inc., 545 F.3d at 1371-72. Based on the information presented,
the Shell 1998 publication does not disclose every limitation of the
challenged claims in the same way as recited in the claims.
Accordingly, we conclude Petitioner has not demonstrated a
reasonable likelihood it would prevail in showing that claim 1 is anticipated
under 35 U.S.C. § 102 by the Shell 1998 publication. For the same reasons,
we are not persuaded Petitioner has established a reasonable likelihood it
would prevail in showing anticipation of dependent claims 2-5 and 10-13.
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III. CONCLUSION
For the foregoing reasons, we determine Petitioner has not
demonstrated that there is a reasonable likelihood it would prevail in
establishing the unpatentability of claims 1-5 and 10-13 of the ’340 patent.
Therefore, we deny the request to institute an inter partes review of these
claims.
IV. ORDER
For the reasons given, it is
ORDERED that the Petition is denied as to all challenged claims, and
no trial is instituted.

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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