OTSUKA PHARMACEUTICAL CO., LTD. v. TORRENT PHARMACEUTICALS LIMITED et al
Filing
166
MARKMAN OPINION. Signed by Chief Judge Jerome B. Simandle on 11/16/2015. (tf, )
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY
OTSUKA PHARMACEUTICAL CO., LTD.,
Plaintiff,
v.
TORRENT PHARMACEUTICALS LIMITED,
INC., TORRENT PHARMA INC., and HETERO
LABS LIMITED,
Defendants.
OTSUKA PHARMACEUTICAL CO., LTD.,
Plaintiff,
v.
ALEMBIC PHARMACEUTICALS LIMITED,
ALEMBIC LIMITED, ALEMBIC GLOBAL
HOLDING SA, and ALEMBIC
PHARMACEUTICALS INC.,
Defendants.
OTSUKA PHARMACEUTICAL CO., LTD.,
Plaintiff,
v.
ZYDUS PHARMACEUTICALS USA, INC. and
CADILA HEALTHCARE LIMITED,
Defendants.
OTSUKA PHARMACEUTICAL CO., LTD.,
Plaintiff,
v.
AUROBINDO PHARMA LIMITED, AUROBINDO
PHARMA USA, INC., and AUROLIFE PHARMA
LLC,
Defendants.
HONORABLE JEROME B. SIMANDLE
Civil Action Nos.
14-1078 (JBS/KMW)
14-2982 (JBS/KMW)
14-3168 (JBS/KMW)
14-3306 (JBS/KMW)
14-3996 (JBS/KMW)
14-4307 (JBS/KMW)
14-4508 (JBS/KMW)
14-4671 (JBS/KMW)
14-5537 (JBS/KMW)
14-5876 (JBS/KMW)
14-5878 (JBS/KMW)
14-6158 (JBS/KMW)
14-6397 (JBS/KMW)
14-6398 (JBS/KMW)
14-6890 (JBS/KMW)
14-7105 (JBS/KMW)
14-7252 (JBS/KMW)
14-7405 (JBS/KMW)
14-8074 (JBS/KMW)
14-8077 (JBS/KMW)
15-1585 (JBS/KMW)
15-161 (JBS/KMW)
OTSUKA PHARMACEUTICAL CO., LTD.,
Plaintiff,
v.
INTAS PHARMACEUTICALS LIMITED, ACCORD
HEALTHCARE, INC., and HETERO LABS
LIMITED,
Defendants.
OTSUKA PHARMACEUTICAL CO., LTD.,
Plaintiff,
v.
SUN PHARMACEUTICAL INDUSTRIES LTD.,
SUN PHARMA GLOBAL INC., SUN PHARMA
GLOBAL FZE, SUN PHARMA USA, SUN
PHARMACEUTICALS INDUSTRIES, INC., and
CARACO PHARMACEUTICAL LABORATORIES,
Defendants.
[Caption Continues]
MARKMAN OPINION
OTSUKA PHARMACEUTICAL CO., LTD.,
Plaintiff,
v.
MYLAN, INC., MYLAN PHARMACEUTICALS
INC., and MYLAN LABORATORIES
LIMITED,
Defendants.
OTSUKA PHARMACEUTICAL CO., LTD.,
Plaintiff,
v.
TORRENT PHARMACEUTICALS LIMITED,
INC., TORRENT PHARMA INC., and HETERO
LABS LIMITED,
Defendants.
OTSUKA PHARMACEUTICAL CO., LTD.,
Plaintiff,
v.
ZHEJIANG HUAHAI PHARMACEUTICAL CO.,
LTD., HUAHAI US INC., PRINSTON
PHARMACEUTICAL INC., and SOLCO
HEALTHCARE U.S., LLC,
Defendants.
OTSUKA PHARMACEUTICAL CO., LTD.,
Plaintiff,
v.
AJANTA PHARMA LIMITED and AJANTA
PHARMA USA INC.,
Defendants.
OTSUKA PHARMACEUTICAL CO., LTD.,
Plaintiff,
v.
TEVA PHARMACEUTICALS USA, INC.,
Defendant.
OTSUKA PHARMACEUTICAL CO., LTD.,
Plaintiff,
v.
INTAS PHARMACEUTICALS LIMITED, ACCORD
HEALTHCARE, INC., and HETERO LABS
LIMITED,
Defendants.
OTSUKA PHARMACEUTICAL CO., LTD.,
Plaintiff,
v.
SUN PHARMACEUTICAL INDUSTRIES LTD.,
SUN PHARMA GLOBAL INC., SUN PHARMA
GLOBAL FZE, SUN PHARMA USA, SUN
PHARMACEUTICALS INDUSTRIES, INC., and
CARACO PHARMACEUTICAL LABORATORIES,
Defendants.
[Caption Continues]
2
OTSUKA PHARMACEUTICAL CO., LTD.,
Plaintiff,
v.
TEVA PHARMACEUTICALS USA, INC.,
Defendant.
OTSUKA PHARMACEUTICAL CO., LTD.,
Plaintiff,
v.
AUROBINDO PHARMA LIMITED, AUROBINDO
PHARMA USA, INC., and AUROLIFE PHARMA
LLC,
Defendants.
OTSUKA PHARMACEUTICAL CO., LTD.,
Plaintiff,
v.
LUPIN LIMITED, LUPIN ATLANTIS HOLDING
SA, LUPIN PHARMACEUTICALS, INC., and
HETERO LABS LIMITED,
Defendants.
OTSUKA PHARMACEUTICAL CO., LTD.,
Plaintiff,
v.
ZYDUS PHARMACEUTICALS USA and CADILA
HEALTHCARE LIMITED,
Defendants.
OTSUKA PHARMACEUTICAL CO., LTD.,
Plaintiff,
v.
ALEMBIC PHARMACEUTICALS LIMITED,
ALEMBIC LIMITED, ALEMBIC GLOBAL
HOLDING SA, and ALEMBIC
PHARMACEUTICALS INC.,
Defendants.
OTSUKA PHARMACEUTICAL CO., LTD.,
Plaintiff,
v.
APOTEX CORP., APOTEX INC., APOTEX
PHARMACHEM INC., and HETERO LABS
LIMITED,
Defendants.
OTSUKA PHARMACEUTICAL CO., LTD.,
Plaintiff,
v.
SCIEGEN PHARMACEUTICALS INC. and
BACTOLAC PHARMACEUTICAL, INC.,
Defendants.
[Caption Continues]
3
OTSUKA PHARMACEUTICAL CO., LTD.,
Plaintiff,
v.
AMNEAL PHARMACEUTICALS LLC, AMNEAL
PHARMACEUTICALS INDIA PVT. LTD., MSN
PHARMACHEM PVT. LTD., and MSN
LABORATORIES PVT. LTD.,
Defendants.
OTSUKA PHARMACEUTICAL CO., LTD.,
Plaintiff,
v.
HETERO DRUGS LIMITED, HETERO LABS
LIMITED, and HETERO USA, INC.,
Defendants.
SIMANDLE, Chief Judge:
Table of Contents
INTRODUCTION .............................................. 5
BACKGROUND ................................................ 9
Factual and Procedural Background ....................... 9
1.
Aripiprazole, Generally ............................... 10
2. The ’615, ’796, and ’760 Patents: Otsuka’s Aripiprazole
Polymorph Patents ......................................... 10
3.
The ’350 Patent: Otsuka’s Asserted Method of Use Patent 13
4.
Otsuka’s Infringement Litigation in this District ..... 14
CLAIM CONSTRUCTION STANDARD ............................ 16
DISCUSSION ............................................... 17
“Anhydrous Aripiprazole Crystals B” .................... 18
“mean particle size” ................................... 30
1.
Standard for Indefiniteness ........................... 32
2. The ’615 Patent fails to inform, with reasonable
certainty, the meaning of the phrase “mean particle size” . 36
“wherein said low hygroscopicity is defined as a moisture
content of [0.40%/0.10%] or less after placing said
substance/Crystals for 24 hours in a desiccator maintained at a
temperature of 60° C and a humidity level of 100%” .......... 42
“aripiprazole drug substance” .......................... 47
4
“a/the pharmaceutical composition” / “in combination with”
49
CONCLUSION ............................................... 57
INTRODUCTION
These related patent infringement actions under the HatchWaxman Act, 35 U.S.C. §§ 271, 281, generally concern Plaintiff
Otsuka Pharmaceutical Co, Ltd.’s (hereinafter, “Otsuka”)
position that Defendants’ submissions of abbreviated new drug
applications (hereinafter, “ANDAs”) infringe the various patents
covering Otsuka’s Abilify® aripiprazole product, U.S. Patent Nos.
5,006,528 (“the ’528 patent”), 7,053,092 (“the ’092 patent”),
8,017,615 (“the ’615 patent”), 8,580,796 (“the ’796 patent”),
8,642,600 (“the ’600 patent”), 8,642,760 (“the ’760 patent”),
and 8,759,350 (“the ’350 patent” and collectively, the “patentsin-suit”).
Following Otsuka’s preliminary injunction motion practice,
see Otsuka Pharm. Co., Ltd. v. Torrent Pharm. Ltd., Inc., ___ F.
Supp. 3d ____, 2015 WL 1782653 (D.N.J. Apr. 16, 2015), and the
parties’ lengthy period for claims construction discovery
(marked by a plethora of discovery disputes and discovery motion
practice before this Court), 1 the parties now request that the
Court construe the following five claim phrases:
1
For example, on September 25, 2015, this Court granted in part
and denied in part Otsuka’s motions to strike certain portions
of Defendants’ responsive Markman expert declarations, See
5
1.
“Anhydrous Aripiprazole Crystals B,” as it appears in
asserted claims 3, 4, 15, and 16 of the ’615 Patent,
claims 1 and 2 of the ’796 Patent, and claims 4 and 12
of the ’350 Patent;
2.
“mean particle size,” as it appears in asserted claims
3, 4, 15, and 16 of the ’615 Patent;
3.
“wherein said low hygroscopicity is defined as a
moisture content of [0.40%/0.10%] or less after
placing said substance/Crystals for 24 hours in a
desiccator maintained at a temperature of 60° C and a
humidity level of 100%,” as it appears in asserted
claims 3, 4, 15, and 16 of the ’615 Patent, claims 1
and 2 of the ’796 Patent, and claims 1 and 2 of the
’760 Patent;
4.
“aripiprazole drug substance,” as it appears in
asserted claims 1 and 2 of the ’760 Patent; 2 and
5.
“a/the pharmaceutical composition” / “in combination
with,” as it appears in asserted claims 1 through 18
of the ’350 Patent.
Otsuka, for its part, largely eschews the need for formal
claim construction and submits, in each instance, that the
disputed claim phrase should be construed in accordance with its
plain and ordinary meaning as understood by a person of ordinary
skill in the art.
(See, e.g., Otsuka’s Opening Claim Constr. Br
Otsuka Pharm. Co., Ltd. v. Torrent Pharms. Ltd., Inc., ___ F.
Supp. 3d ____, 2015 WL 5665771 (D.N.J. Sept. 25, 2015), and then
separately denied Defendants Apotex Corp.’s and Apotex Inc.’s
motion for a protective order barring any additional deposition
of Graham Buckton, Ph.D (hereinafter, “Dr. Buckton” or “Dr.
Graham Buckton”). See Otsuka Pharm. Co., Ltd. v. Apotex Corp.,
___ F. Supp. 3d ____, 2015 WL 5720552 (D.N.J. Sept. 25, 2015).
2 Defendants initially requested time to argue the phrase
“aripiprazole drug substance” during the Markman hearing.
Nevertheless, by letter dated October 16, 2015, the majority of
Defendants withdrew their request to present any argument on the
term, and instead rested upon their papers. [See, e.g., Docket
Item 160 in Civil Action No. 14-1078.]
6
at 2 (arguing that claim construction proves overall
unnecessary, because the disputed phrases have “readily
ascertainable and understandable” plain and ordinary meanings).)
Defendants argue, by contrast, that the intrinsic record
provides a specific definition for each of the disputed phrases,
and/or demonstrates that the various claim phrases prove
incapable of construction on indefiniteness grounds. 3
(See,
e.g., Defs.’ Opening Claim Constr. Br. at 2-3.)
The Court has had the benefit of extensive briefing,
argument and testimony at an all-day Markman hearing. 4
For the
reasons that follow, the Court construes the disputed phrases as
follows: 5
3
Actavis staked out and briefed claims construction positions on
“Anhydrous Aripiprazole Crystals B” and “aripiprazole drug
substance” separately from the remaining generic Defendants.
(See generally Actavis’s Opening Claim Constr. Br.)
Nevertheless, because Otsuka voluntarily dismissed its claims
against Actavis on November 10, 2015, the Court need not reach
the merits of Actavis’s claims construction positions.
4 The Court conducted a Markman hearing on October 19, 2015, at
which time the Court received a technical tutorial from Otsuka’s
experts, Stephen R. Byrn, Ph.D (hereinafter, “Dr. Byrn”) and
Christoph U. Correll, M.D. (hereinafter, “Dr. Correll”), as well
as Defendants’ experts, Dr. Graham Buckton, Robin D. Rogers,
Ph.D (hereinafter, “Dr. Rogers”). In addition, the parties
conducted limited cross-examination (and redirect) of
Defendants’ experts, Dr. Buckton, Dr. Rogers, and Ira S. Halper,
M.D. (hereinafter, “Dr. Halper”).
5 The record amassed by the parties in connection with the
pending Markman submissions spans thousands of pages and
includes lengthy declarations from Otsuka’s two experts, Dr.
Byrn and Dr. Correll, and Defendants’ four experts, Dr. Graham
Buckton, Dr. Rogers, Anthony Palmieri III, Ph.D, R.Ph
(hereinafter, “Dr. Palmieri”), and Dr. Halper. Defendants
7
100%”
“aripiprazole drug substance”
patent at 22:56-64].
a drug substance that consists
of aripiprazole, either in pure
chemical form or as the active
chemical ingredient in
finalized form
a single dosage form, or
“pharmaceutical composition,”
containing at least two active
ingredients aripiprazole and at
least one of citalopram,
escitalopram and salt thereof
“a/the pharmaceutical
composition” / “in combination
with”
BACKGROUND
Factual and Procedural Background 6
As this Court has summarized previously, Otsuka holds New
Drug Application (hereinafter, “NDA”) No. 21-436, approved by
the Food and Drug Administration (hereinafter, the “FDA”), for
aripiprazole tablets, which Otsuka markets for the treatment of
certain psychiatric conditions under the trade name Abilify®.
In
connection with Abilify’s® listing in the Orange Book, the FDA’s
book of drug products approved under the Food, Drug, and
Cosmetic Act (hereinafter, the “Orange Book”), 21 U.S.C. §
355(j), Otsuka identifies, in relevant part, the ’615, the ’796,
the ’760, and the ’350 Patents. 7
6
For purposes of the pending Markman submissions, the Court need
not retrace the detailed factual and procedural history of these
complex infringement actions, and writes primarily for the
parties.
7 Otsuka’s Orange Book listing also identifies the ’528 Patent,
the primary aripiprazole compound patent, as well the ’600
Patent, which claims certain methods of treatment in connection
with the administration of aripiprazole.
9
1. Aripiprazole, Generally
Aripiprazole, an older compound with a complex molecular
structure, acts as an atypical antipsychotic agent useful for
the treatment of schizophrenia, among other central nervous
system disorders.
(See, e.g., Markman Hr’g Tr. at 21:19-22:2,
39:8-12.)
2. The ’615, ’796, and ’760 Patents: Otsuka’s
Aripiprazole Polymorph Patents
The ’615, the ’796, and the ’760 Patents issued on separate
dates, 8 but all disclose a “Low Hygroscopic Aripiprazole Drug
Substance and Processes for the Preparation Thereof.” 9
e.g., ’615 Patent at 1:45-52.)
(See,
In simple terms, these patents
claim novel forms of anhydrous aripiprazole that have low
hygroscopicity.
Prior art anhydrous aripiprazole forms proved
“significantly hygroscopic,” meaning that the forms would
readily take on water and convert to a hydrous form if exposed
to moisture.
(Id. at 1:50-57.)
As a result, these prior art
forms suffered from less bioavailability and dissolubility,
batch-to-batch variability, and a “significantly decreased”
8
The ’615 Patent issued on September 13, 2011, the ’796 Patent
issued on November 12, 2013, and the ’760 Patent issued on
February 4, 2014.
9 As acknowledged by the parties, the ’615, ’796, and ’760
Patents share a common specification, and for that reason, the
Court only cites to one illustrative specification, unless
otherwise indicated.
10
shelf-life.
(Id. at 1:58-2:13; see also Markman Hr’g Tr. at
33:13-24; 60:22-61:12.)
The novel forms disclosed by the ’615, the ’796, and the
’760 Patents claim to have solved these problems, particularly
the susceptibility to moisture that plagued prior art anhydrous
aripiprazole forms.
(See, e.g., ’615 Patent at 1:45-52.)
The
anhydrous aripiprazole forms disclosed by these patents
specifically consist of “novel anhydrous aripiprazole crystals”
that have “reduced hygroscopicity,” 10 rendering them more
amenable than prior art formulations to “pharmaceutical
processing and formulation,” and enhancing their overall shelflife, dissolubility, and bioavailability.
(’615 Patent at 2:29-
52; see also Markman Hr’g Tr. at 33:7-34:4.)
In other words,
these aripiprazole crystals have a decreased tendency to take on
water, thereby enhancing the claimed aripiprazole tablets
overall efficacy for the treatment of various mood disorders.
(See generally Markman Hr’g Tr. at 33:7-34:4.)
The asserted claims of the ’615, the ’796, and the ’760
Patents, in turn, teach the process for preparing the low
hygroscopic aripiprazole (the ’615 Patent), as well as claiming
10
As explained by Dr. Byrn and Dr. Rogers, hygroscopicity
specifically refers to the tendency of a material to sorb water,
and includes both adsorption (where the water molecules interact
with, but do not penetrate the crystal surface) and absorption
(where the water molecules actually penetrate into the
crystals). (See, e.g., Markman Hr’g Tr. at 24:11-13, 39:15-21.)
11
two of its forms: one in a pure crystal form (the ’796 Patent)
and the other in a finalized form (the ’760 Patent).
Independent claims 3 and 4 of the ’615 Patent, for example,
disclose: 11
3. and 4. A pharmaceutical solid oral preparation
comprising Anhydrous Aripiprazole Crystals B having
low hygroscopicity and one or more pharmaceutically
acceptable carriers, wherein said low hygroscopicity
is a moisture content of [0.40%/0.10%] or less after
placing said Crystals for 24 hours in a desiccator
maintained at a temperature of 60°C and a humidity
level of 100%;
wherein said crystals
have a powder x-ray diffraction spectrum having
characteristic peaks at 2Ɵ=11.0°, 16.6°,
19.3°, 20.3°, and 22.1°;
have particular infrared absorption bands at
2945, 2812, 1678, 1627, 1448, 1377, 1173,
960, and 779 cm-1 on the IR (KBr) spectrum;
exhibit an endothermic peak near about 141.5°C in
thermogravimetric/differential thermal
analysis (heating rate 5° C/min);
exhibit an endothermic peak near about 140.7°C in
differential scanning calorimetry (heating
rate 5°C/min); and
have a mean particle size of 50 μm or less, wherein
said pharmaceutical solid oral preparation has at
least one dissolution rate selected from the group
consisting 60% or more at pH 4.5 after 30 minutes, 70%
or more at pH 4.5 after 60 minutes, and 55% or more at
pH 5.0 after 60 minutes.
(’615 Patent at 44:40-45:22.)
The ’796 and ’760 Patents, each
of which contain only two claims, then identify a specific low
hygroscopic form of “anhydrous aripiprazole crystals B” and an
11
Claims 3 and 4 of the ’615 Patent differ only in specific
moisture content, with claim 3 teaching 0.40% or less, while
claim 4 teaches 0.10% or less. (Compare ’615 Patent at 44:43-46
(claim 3), with ’615 Patent at 45:1-4 (claim 4).)
12
“aripiprazole drug substance,” both of which have a moisture
content below either 0.40% or 0.10% even after being placed in a
desiccator maintained at a temperature of 60° C and a humidity
level of 100%.
44:23-32.)
(See ’796 Patent at 44:23-32; ’760 Patent at
Simply put, these forms do not take on water,
despite exposure to a high-moisture environment.
3. The ’350 Patent: Otsuka’s Asserted Method of Use
Patent
The ’350 Patent, by contrast, generally relates to a method
of treating major depressive disorders through the adjunctive
use of aripiprazole in conjunction with certain serotonin
reuptake inhibitors (hereinafter, “SRIs”), and specifically
discloses a “Carbostyril Derivatives and Serotonin Reuptake
Inhibitors for Treatment of Mood Disorders.” 12
The Patent
describes, on its face, “pharmaceutical compositions” consisting
of “carbostyril derivatives ... in combination with serotonin
reuptake inhibitors in a pharmaceutically acceptable carrier”
for the treatment of “mood disorders such as depression and
major depressive disorder.”
(’350 Patent at 1:18-24.)
Independent claims 1-3, in turn, teach: a pharmaceutical
composition comprising aripiprazole in combination with at least
one serotonin reuptake inhibitor selected from citalopram,
escitalopram and salts thereof.
(See ’350 Patent at 28:64-
12
The ’350 Patent issued on June 24, 2014, and therefore serves
as the most recent of Otsuka’s asserted follow-on patents.
13
29:6.)
The remaining independent claims 9-11 then describe
methods of treating specific mood disorders by administering an
“effective amount” of the combination “pharmaceutical
composition” disclosed in claims 1-3. 13
(Id. at 29:26-30:20.)
4. Otsuka’s Infringement Litigation in this District
Beginning in early January 2014, the generic Defendants
involved in these related infringement actions began to file
ANDAs with the FDA, seeking approval to market generic
aripiprazole tablets and/or orally disintegrating aripiprazole
tablets, 14 prior to the expiration of the ’615, ’796, ’760, ’350
13
The remaining claims of the ’350 Patent, namely claims 4
through 8 and 12 through 18, all depend upon independent claims
1 through 3 and 9 through 11.
14
Otsuka filed the first infringement action in this large series of actions
on February 18, 2014, see Otsuka Pharm. Co., Ltd. v. Torrent Pharm., Inc.,
Civil Action No. 14-1078 (JBS/KMW), followed shortly thereafter by a cascade
of thirty related actions: Otsuka Pharm. Co., Ltd. v. Alembic Global Holding
SA, Civil Action No. 14-2982 (JBS/KMW) (filed May 9, 2014); Otsuka Pharm.
Co., Ltd. v. Zydus Pham. USA Inc., Civil Action No. 14-3168 (JBS/KMW) (filed
May 16, 2014); Otsuka Pharm. Co., Ltd. v. Aurobindo Pharma Ltd., Civil Action
No. 14-3306 (JBS/KMW) (filed May 23, 2014); Otsuka Pharm. Co., Ltd. v. Intas
Pharm. Ltd., Civil Action No. 14-3996 (JBS/KMW) (filed June 20, 2014); Otsuka
Pharm. Co., Ltd. v. Zydus Pham. USA Inc., Civil Action No. 14-3168 (JBS/KMW)
(filed May 16, 2014); Otsuka Pharm. Co., Ltd. v. Sun Pharm. Indus., Ltd.,
Civil Action No. 14-4307 (JBS/KMW) (filed July 7, 2014); Otsuka Pharm. Co.,
Ltd. v. Mylan Inc., Civil Action No. 14-4508 (JBS/KMW) (filed July 11, 2014);
Otsuka Pharm. Co., Ltd. v. Torrent Pharm., Inc., Civil Action No. 14-4671
(JBS/KMW) (filed July 25, 2014); Otsuka Pharm. Co., Ltd. v. Zhejiang Huahai
Pharm. Co., Civil Action No. 14-5537 (JBS/KMW) (filed September 4, 2014);
Otsuka Pharm. Co., Ltd. v. Ajanta Pharm. Ltd., Civil Action No. 14-5876
(JBS/KMW) (filed September 19, 2014); Otsuka Pharm. Co., Ltd. v. Teva Pharm.
USA, Inc., Civil Action No. 14-5878 (JBS/KMW) (filed September 19, 2014);
Otsuka Pharm. Co., Ltd. v. Intas Pharm. Ltd., Civil Action No. 14-6158
(JBS/KMW) (filed October 2, 2014); Otsuka Pharm. Co., Ltd. v. Sun Pharm.
Indus., Ltd., Civil Action No. 14-6397 (JBS/KMW) (filed October 6, 2014);
Otsuka Pharm. Co., Ltd. v. Teva Pharm. USA, Inc., Civil Action No. 14-6398
(JBS/KMW) (filed September 19, 2014) (filed October 10, 2014); Otsuka Pharm.
Co., Ltd. v. Aurobindo Pharma Ltd., Civil Action No. 14-6890 (JBS/KMW) (filed
October 31, 2014); Otsuka Pharm. Co., Ltd. v. Lupin Ltd., Civil Action No.
14-7105 (JBS/KMW) (filed November 3, 2014); Otsuka Pharm. Co., Ltd. v.
Actavis Elizabeth LLC, Civil Action No. 14-7106 (JBS/KMW) (filed November 10,
14
Patents. 15
Each Defendants’ ANDA, however, included a “paragraph
iv” certification, advancing their positions that their ANDAs
would not infringe any of the valid patents-in-suit, and/or a
“section viii” statement, certifying that the applicant would
not seek approval for any indications or uses asserted to be
covered by the ’350 Patent.
See Otsuka, ___ F. Supp. 3d ____,
2015 WL 1782653, at *5, *15.
In other words, each Defendant,
2014; voluntarily dismissed November 12, 2015); Otsuka Pharm. Co., Ltd. v.
Zydus Pham. USA Inc., Civil Action No. 14-7252 (JBS/KMW) (filed November 20,
2014); Otsuka Pharm. Co., Ltd. v. Alembic Pharm., Ltd., Civil Action No. 147405 (JBS/KMW) (filed November 26, 2014); Otsuka Pharm. Co., Ltd. v. Apotex
Corp., Civil Action No. 14-8074 (JBS/KMW) (filed December 24, 2015); Otsuka
Pharm. Co., Ltd. v. Hetero Drugs, Ltd., Civil Action No. 15-161 (JBS/KMW)
(filed January 8, 2015); Otsuka Pharm. Co., Ltd. v. Amneal Pharm. Co, Ltd.,
Civil Action No. 15-1585 (JBS/KMW) (filed March 2, 2015); Otsuka Pharm. Co.,
Ltd. v. Sandoz Inc., Civil Action No. 15-1716 (JBS/KMW) (filed March 9, 2015;
voluntarily dismissed on November 4, 2015); Otsuka Pharm. Co., Ltd. v. Indoco
Remedies Ltd., Civil Action No. 15-1967 (JBS/KMW) (filed March 17, 2015;
stayed and administratively terminated on September 15, 2015); Otsuka Pharm.
Co., Ltd. v. Macleods Pharms. Ltd., Civil Action No. 15-5109 (JBS/KMW) (filed
July 2, 2015); Otsuka Pharm. Co., Ltd. v. Standard Chem. & Pharm. Co., Civil
Action No. 15-6353 (JBS/KMW) (filed August 21, 2015); Otsuka Pham Co., Ltd.
v. Aurobindo Pharma Ltd., Civil Action No. 15-7584 (JBS/KMW) (filed October
19, 2015); Otsuka Pham Co., Ltd. v. Zydus Pharm. USA Inc., Civil Action No.
15-7802 (JBS/KMW) (filed October 30, 2015); and Otsuka Pharm Co., Ltd. v.
Amneal Pharm. LLC, Civil Action No. 15-7803 (JBS/KMW) (filed October 30,
2015). Three of the more recent and less advanced cases, Indoco, Macleods,
and Standard Chem., are not part of the pending Markman Defendants.
15
As the lengthy exclusivity period of the patent covering the
primary aripiprazole compound came to a close, Otsuka moved to
enjoin the defendants from launching competing generic
aripiprazole products, on the grounds that the package inserts
or labels for the proposed generic products in all of the
related infringement actions would induce infringement of claim
1 of the ’350 Patent. See generally Otsuka Pharm. Co., Ltd.,
___ F. Supp. 3d ____, 2015 WL 1782653, at *3–*4 (hereinafter,
the “TRO Opinion”). Otsuka moved to amend its Complaints in
order to assert the ’350 Patent, for the first time, against
Zydus, Torrent, and Teva. See id. On April 16, 2015, the Court
granted Otsuka's motions to amend, principally in light of the
liberal standard for amendment under Federal Rule of Civil
Procedure 15(a). See id. at *4–*6; see also Otsuka Pharm. Co. v.
Zydus Pharm. USA, No. 14-3168, 2015 WL 5950091, at *1 (D.N.J.
Oct. 13, 2015).
15
and indeed all generic defendants in these related infringement
actions, purport to seek approval for a noninfringing
aripiprazole product.
See generally id.
Otsuka filed infringement actions in this District,
alleging that these Defendants proposed generic aripiprazole
products will infringe at least one claim of the ’615, ’796,
’760, and/or the ’350 patents, among the other patents covering
Otsuka’s Abilify® product. 16
CLAIM CONSTRUCTION STANDARD 17
Claim construction focuses upon the intrinsic evidence,
“including the claims themselves, the specification, and the
prosecution history of the patent.” 18
Sunovion Pharm., Inc. v.
Teva Pharm. USA, Inc., 731 F.3d 1271, 1276 (Fed. Cir. 2013)
16
Otsuka has, in some instances, asserted different combinations
of the patents-in-suit against a particular generic Defendant,
based upon the nature of its proposed ANDA product. The slight
differences in the patents asserted in each action, however,
have no impact on the pending issue of claims construction.
17 The construction of claim terms constitutes a question of law,
Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed.
Cir. 1995), aff’d, 517 U.S. 370 (1996), and the Court need not
follow the parties’ proposed constructions. See Marine Polymer
Techs., Inc. v. HemCon, Inc., 672 F.3d 1350, 1359 n.4 (Fed. Cir.
2012) (en banc).
18 If, however, the intrinsic evidence fails to disclose the
meaning of a term, the Court may examine extrinsic evidence to
determine the meaning of particular terminology to those of
skill in the art of the invention. Phillips, 415 F.3d at 1318.
The Court of Appeals for the Federal Circuit, however, cautions
against “heavy reliance” upon extrinsic sources divorced from
the intrinsic evidence because it “risks transforming the
meaning of the claim term to the artisan into the meaning of the
term in the abstract,” and out of the context of the
specification. Id. at 1321.
16
(citing Phillips v. AWH Corp., 415 F.3d 1303, 1315–17 (Fed. Cir.
2005) (en banc); Vitronics Corp. v. Conceptronic, Inc., 90 F.3d
1576, 1582 (Fed. Cir. 1996)).
Claim terms must, however,
ordinarily be “given their plain and ordinary meanings to one of
skill in the art” at the time of the invention “when read in the
context of the specification and prosecution history.”
Golden
Bridge Tech., Inc. v. Apple Inc., 758 F.3d 1362, 1365 (Fed. Cir.
2014) (citing Phillips, 415 F.3d at 1315–17).
Nevertheless, the
Court of Appeals for the Federal Circuit has routinely stated
that “‘[t]he construction that stays true to the claim language
and most naturally aligns with the patent’s description of the
invention will be, in the end, the correct construction.’” Shire
Dev., LLC v. Watson Pharms., Inc., 746 F.3d 1326, 1330 (Fed.
Cir. 2014) (quoting Phillips, 415 F.3d at 1316).
DISCUSSION
The parties, as stated above, request construction of the
following five phrases: (1) “Anhydrous Aripiprazole Crystals B,”
(2) “mean particle size,” (3) “wherein said low hygroscopicity
is defined as a moisture content of [0.40%/0.10%] or less after
placing said substance/Crystals for 24 hours in a desiccator
maintained at a temperature of 60° C and a humidity level of
100%,” (4) “aripiprazole drug substance,” and (5) “a/the
pharmaceutical composition” / “in combination with.”
will address each claim phrase in turn.
17
The Court
In other words, Otsuka argues that the specifications
should be read in the disjunctive—requiring that the crystalline
form of aripiprazole be identified by reference to one or more,
but not all, of the analytical tests identified in the
specification.
(See generally Otsuka’s Opening Claim Constr.
Br. at 7-14.)
In support of this position, Otsuka, armed with
the opinion of its expert, submits that a person of ordinary
skill would, in reviewing the Patents, use “judgment and
scientific reasoning” to select the “one or two” appropriate
techniques to characterize the aripiprazole crystals, rather
than resorting to the full panoply of characterization methods.
(Otsuka’s Opening Claim Constr. Br. at 7-14; Otsuka’s Responsive
Claim Constr. Br. at 3-11.)
Even more, Otsuka claims that
defining the term “Anhydrous Aripiprazole Crystals B” by
reference to all analytical techniques would contravene the
“cardinal rule” of claim construction, by importing a limitation
from the specifications into the claims.
62:24-63:7, 118:9-119:23.)
(Markman Hr’g Tr. at
As a result, Otsuka submits that
“Anhydrous Aripiprazole Crystals B” should be construed as an
aripiprazole form marked by “low hygroscopicity,” and identified
by one or more of the characterization techniques provided in
the specification.
(Id. at 119:16-132:12.)
Defendants, by contrast, take the position that the
specification must be read in the conjunctive, requiring that
19
all of the enumerated characteristics be present in order to
identify the claimed aripiprazole crystal form.
(Defs.’ Opening
Claim Constr. Br. at 4-10; Defs.’ Responsive Claim Constr. Br.
at 3-11.)
In support of this construction, Defendants,
supported by their own experts, submit that the specification
contains an express definition of the novel “Anhydrous
Aripiprazole Crystals B,” and therefore contend that their
proposed construction rightly incorporates the specification in
its entirety. 22
(See Markman Hr’g Tr. at 158:21-179:20.)
The Court begins by noting that the parties and their
experts all acknowledge that a person of ordinary skill in the
art would ordinarily identify a polymorph form through one or
more of the illustrative characterization techniques identified
in the specifications, namely, proton nuclear magnetic resonance
spectroscopy (hereinafter, “NMR”), x-ray powder diffraction
(hereinafter, “XRPD”), infrared spectroscopy (hereinafter,
“IR”), thermogravimetric/differential thermal analysis
(hereinafter, “TGA/DTA”), differential scanning calorimetry
22
Otsuka quibbles with Defendants’ construction on the ground
that the construction, in essence, editorializes the
specification by referencing the analytical tests by name only,
and omitting the specific metrics recited in the specification.
(See Markman Hr’g Tr. at 124:12-125:3.) Otsuka’s argument,
however, ignores the fact that Defendants’ proposed construction
plainly incorporates the specification in its entirety by
reference. (See, e.g., Defs.’ Opening Claim Constr. Br. at 4.)
For that reason, the Court finds this narrow challenge without
merit.
20
(hereinafter, “DSC”), and hygroscopicity testing.
(See, e.g.,
Markman Hr’g Tr. at 31:4-16 (testimony of Otsuka’s expert, Dr.
Byrn, concerning his practice of selecting “one or two of the
best methods”); 84:8-85:16 (testimony of Defendants’ expert, Dr.
Buckton, concerning his view that a scientist would “look at a
raft of techniques for a particular material and depending
[up]on the complexity ... would [then] decide which would be the
appropriate techniques for that material”), 90:2-8 (testimony of
Dr. Buckton concerning the ability to identify polymorphs
without reference to the “large suite of techniques”); see also
Byrn Dec. at ¶¶ 41-46.)
Indeed, the parties’ experts and their
own submissions plainly reflect the industry practice of
selecting the one or two most appropriate characterization
methods based upon the nature of the tested material.
(See,
e.g., id. at 57:20-58:12.)
Nevertheless, the parties and their experts equally
recognize that each analytical technique produces slightly
different information relative to the identification of the
polymorphic form (see, e.g., id. at 23:11-13, 31:12-16, 57:2058:12), and consistently assert that the appropriate
construction of the phrase “Anhydrous Aripiprazole Crystals B”
21
flows directly from some portion of the following language in
the specifications: 23
(See ’615 Patent at 9:36-63; ’760 Patent at 9:37-63; ’796 Patent
at 9:34-60.)
23
Although “Anhydrous Aripiprazole Crystals B” appears in
asserted claims 3, 4, 15 and 16 of the ’615 Patent, claims 1 and
2 of the ’796 Patent, and claims 4 and 12 of the ’350 Patent, no
party argues that the claims language itself provides a basis
from which to divine the meaning of the disputed term. For that
reason, the Court turns, as it must, to the specifications. See
Phillips, 415 F.3d at 1315 (citations omitted) (reaffirming the
“long emphasized” and often “‘dispositive’” importance of the
specification in claim construction); see also Safety Rail
Source, LLC v. Bilco Co., 656 F. Supp. 2d 468, 475 (D.N.J. 2009)
(citation omitted) (“the Court must consult the specification in
order to determine whether it ‘expressly defines terms used in
the claims or ... [whether] it defines terms by implication’”).
22
The ’615, ’796, and ’760 Patents each state, in their
introductory sections, that their disclosures define “Anhydrous
Aripiprazole Crystals B” for purposes of the claimed inventions.
(See ’615 Patent at 2:32-35 (noting that the ’615 Patent
identifies a novel form of aripiprazole defined as “Anhydrous
Aripiprazole Crystals B”); ’760 Patent at 2:31-34 (same); ’796
Patent at 2:28-31 (same).)
The portion of the specifications
relied upon by all parties then state, in clear language and
under a heading bearing the title “Characterization of Anhydrous
Aripiprazole Crystals B,” that the “‘Anhydrous Aripiprazole
Crystals B’ of the present invention as used herein have the
physicochemical properties given in (6)-(12) below.”
(See ’615
Patent at 9:36-63; ’760 Patent at 9:37-63; ’796 Patent at 9:3460.)
Following that disclosure, the specifications delineate
six, non-conditional physicochemical properties—or, in simpler
terms, characterization techniques—in successively numbered
paragraphs.
In that way, these portions of the specifications contain
all of the features that signify a special definition of
“Anhydrous Aripiprazole Crystals B” that requires all of the
specified physicochemical properties (as advanced by
Defendants), and not merely one or more (as claimed by Otsuka).
See AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1051-52 (Fed.
Cir. 2010) (discussing special definitions revealed by
23
specifications).
Indeed, the mandatory language of the
specifications, along with their structures, lead to the simple
conclusion that the patentee intended to provide the phrase
“Anhydrous Aripiprazole Crystals B” with a particular meaning
for purposes of the ’615, ’796, and ’760 Patents.
Critically,
the specifications not only set off the term “Anhydrous
Aripiprazole Crystals B” with quotation marks—a strong
indication, by itself, that the disclosures that follow
constitute a definition—they also specifically state that the
term has a particular meaning in the context of the patents-insuit. 24
(See, e.g., ’615 Patent at 9:37-38 (“‘Anhydrous
Aripiprazole Crystals B’ of the present invention as used herein
...”) (emphasis added); ’760 Patent at 9:37-38 (same); ’796
Patent at 9:37-38 (same).)
See Abbott Labs. V. Andrx Pharms.,
Inc., 473 F.3d 1196, 1210-11 (Fed. Cir. 2007) (explaining that a
patentee may expressly define certain claims’ terms through the
use of quotation marks and phrases like “as used herein”).
24
The Court finds Otsuka’s reliance upon Aventis Pharms. Inc. v.
Impax Labs, Inc., No. 02-1322, 2011 WL 94188, at *3 (D.N.J. Jan.
11, 2011) unconvincing. In Aventis, the court considered
whether the following phrase “As used herein, the term ‘suitable
antiadherent’ includes stearic acid, cetyl alcohol ... and the
like” provided a special definition of “suitable antiadherent.”
Id. at *3. In rejecting quotation marks and the phrase “as used
herein” as an indication of a definition, the Aventis court
relied upon the fact that the accompanying sentence contained an
array of nonexhaustive “examples” for the disputed term, rather
than a clear definition. Id. at *3-*4. The disclosures
relative to “Anhydrous Aripiprazole Crystals B,” by contrast,
contain strong definitional language.
24
Numbered paragraphs (6) through (12) then teach the specific
contours of each analytical test, but provide no support for the
flexible interpretation proposed by Otsuka.
Nor any
corresponding indication (like, for example, the inclusion of
“or” between each numbered paragraph) that the characterization
techniques should be viewed as interchangeable.
Rather, these
portions of the specification squarely reflect that the novel
“Anhydrous Aripiprazole Crystals B” are those identified by each
of the characterization techniques.
This construction then finds further support in the
remainder of the specifications.
The disclosures’ examples, for
instance, consistently describe “Anhydrous Aripiprazole Crystals
B” by reference to all of the characterization methods.
Example 2 provides:
25
Indeed,
(See, e.g., ’615 Patent at 26:2-37.)
In other words, Example 2
describes “Anhydrous Aripiprazole Crystals B” based upon the
results of all of the characterization techniques, namely, NMR,
XRPD, IR, TGA/DTA, DSC, and hygroscopicity.
Patent at 26:1-28:15.)
(See, e.g., ’796
Dependent Examples 2 through 10 then
consistently state that the “hygroscopic anhydrous aripiprazole
crystals” obtained through various methods exhibited “the same
... physicochemical properties of the Anhydrous Aripiprazole
26
Crystals B.”
added).)
(See, e.g., ’615 Patent at 26:39-28:16 (emphasis
This consistent usage lends itself to only one
conclusion, 25 namely, that the patentee especially defined this
term to require that the novel crystals be identified by each
crystalline characterization technique. 26
See Metrologic
Instruments, Inc. v. PSC Inc., No. 99-4876, 2003 WL 22077652, at
*9 (D.N.J. Aug. 26, 2003) (citing Bell Atl. Network Serv., Inc.
v. Covad Comm. Grp., 262 F.3d 1258, 1273 (Fed. Cir. 2001)).
25
Otsuka’s proposal of a construction that incorporates “one or
more” of the “features” identified in the specifications, by
contrast, finds no relevant support in the specification. (See
Otsuka’s Opening Claim Constr. Br. at 8; Otsuka’s Responsive
Claim Constr. Br. at 3.) Indeed, although the ’615, ’796, and
the ’760 Patents use the phrase “one or more” on 18 separate
instances, none appear in relation to the properties of
“Anhydrous Aripiprazole Crystals B.” (See, e.g., ’615 Patent at
5:58-61, 8:29-35, 12:54-67, 13:15-23, 13:29-33, and 13:43-51.)
Even more critically, Otsuka’s proposed construction claims that
NMR would, by itself, prove sufficient to identify the claimed
aripiprazole crystal, despite the fact that no party disputes
that NMR identifies only the underlying compound (i.e., it
identifies the presence of aripiprazole), and therefore cannot
differentiate between various crystalline forms of aripiprazole.
(See, e.g., Markman Hr’g Tr. at 24:3-9, 47:14-17, 57:23-25,
173:1-9; Byrn Opening Dec. at ¶ 50; Byrn Dep. Tr. at 117:7-10.)
26 During the Markman hearing, counsel for Otsuka relied upon
select figures and alternative embodiments, each of which rely
upon only two analytical techniques. (See Markman Hr’g Tr. at
127:21-129:17; see also ’615 Patent at 6:49-59, 7:9-18.) The
Court of Appeals for the Federal Circuit, however, discourages
constructions predicated upon figures and alternative
embodiments, see Computer Docking Station Corp. v. Dell, Inc.,
519 F.3d 1366, 1374 (Fed. Cir. 2008), and the embodiments cited
by Otsuka refer only to an “aripiprazole drug substance,” not
“Anhydrous Aripiprazole Crystals B.” For these reasons, the
Court finds that these references have limited relevance to the
construction of “Anhydrous Aripiprazole Crystals B.”
27
Moreover, even in the absence of this consistent language,
the Court finds creditable Defendants’ position that Otsuka has,
on numerous occasions, admitted that “Anhydrous Aripiprazole
Crystals B” should be defined by reference to five analytical
techniques, and not the “one or more” construction it advances
here.
Indeed, in prosecuting the European equivalent of the
’615, ’796, and the ’760 Patents, EP1330249 (hereinafter,
“EP1”), Otsuka repeatedly defined the “Aripiprazole anhydrous
form B” disclosed in the EP1 in terms of its “XRD pattern, the
IR spectrum, the endothermic peak in
thermogravimetric/differential thermo analysis, the endothermic
peak in DSC and, most importantly, the low hygroscopicity.” (Ex.
K to Second Buckton Dec. at 1 (emphasis in original); see also
Second Buckton Dec. at ¶¶ 19-22.)
In other words, Otsuka insisted, in connection with an
indisputably familial patent, that the five crystal
characterization techniques—XRPD, IR, TGA/DTA, DSC, and low
hygroscopicity—together, and not alone, defined “Anhydrous
Aripiprazole Crystals B” from other crystal forms. 27
The EP1 has
substantively similar claims, contains a similar specification,
27
NMR does not, as stated above, identify crystalline forms. As
a result, it comes as little surprise that asserted claims 3 and
4 of the ’615 Patent identify the “Anhydrous Aripiprazole
Crystals B” only by reference to XRPD, IR, TGA/DTA, DSC, and low
hygroscopicity. Nevertheless, because it does not limit claim
scope, the Court will include NMR in its construction of this
disputed term.
28
and proves entirely consistent with the invention described by
the specification of the ’615, ’796, and ’760 Patents.
Therefore, the Court finds that Otsuka’s statements to the EPO
lend even further support for the construction supported by the
specification. 28
See Baxter Healthcare Corp. v. HQ Specialty
Pharma Corp., ___ F. Supp. 3d ____, 2015 WL 5646779, at *9
(D.N.J. Sept. 23, 2015) (citing instructive cases, and holding
the patentee to its clear statements before the EPO).
For all of these reasons, the Court finds that the
specification explicitly teaches that the phrase should be
construed by reference to all of the analytical tests, 29 and will
28
As this Court recently explained, “[t]he Court of Appeals for
the Federal Circuit ‘cautions against indiscriminate reliance on
the prosecution of corresponding foreign applications in the
claim construction analysis,’ particularly if the statements
made during the foreign prosecution arose in response to unique
aspects of foreign patent law.” Baxter, ___ F. Supp. 3d ____,
2015 WL 5646779, at *9 (citations omitted). “Nevertheless, the
Federal Circuit has routinely approved reliance upon statements
in foreign prosecutions where they constituted ‘blatant
admissions’ directed at the relevant art, and where the
statements proved otherwise ‘consistent with the claims and the
invention described in the specification’ at issue.” Id.
Application of these principles to this action provides ample
support for holding Otsuka to its statements during the European
prosecution. See id. (collecting relevant cases).
29 The Court finds Otsuka’s reliance upon Dr. Buckton’s prior
publications and the unrelated aripiprazole patents of Sandoz
AG, Hetero Drugs Limited, and Teva Pharmaceutical Industries
Ltd. unconvincing. (See Markman Hr’g Tr. at 129:24-132:12.)
These extrinsic sources, consisting of non-familial patents and
publications on unrelated compounds, provide further
confirmation for the undisputed industry practice in
characterizing crystal polymorphs, but do little to inform the
special definition analysis in this instance. See Apple Inc. v.
29
understood by a person of ordinary
skill in the art 33
prosecution history, fails to inform,
with reasonable certainty, those
skilled in the art concerning the
scope of the invention)
-or“mean particle size” means to
“analogous to mean equivalent
spherical volume diameter by laser
light diffraction scattering”
-or“mean particle size” refers to “volume
mean particle size”
-or“mean particle size” means “volume
weighted mean”
Otsuka argues, in particular, that the intrinsic record
make “clear that a person of ordinary skill in the art would
readily have understood that ‘mean particle size’ refers to
volume mean particle size,” particularly because the claims
teach that “mean particle size” should be measured using a
“laser diffraction particle size analyzer.”
(Otsuka’s
Responsive Claim Constr. Br. at 12 (citation omitted).)
Defendants, by contrast, take the position that the term proves
“indefinite” (or, incapable of construction), because it’s
amenable to multiple meanings.
(Defs.’ Opening Claim Constr.
Br. at 12-15; Defs.’ Responsive Claim Constr. Br. at 11-16.)
Defendants specifically argue that the ordinary artisan would,
in reviewing the disclosures, confront a number of unresolved
33
Because all parties substantively agree that the phrase “mean
particle size” has multiple meanings, the Court rejects at the
outset Otsuka’s position that the phrase has any “plain”
meaning, and therefore requires no construction. (See, e.g.,
Otsuka’s Opening Claim Constr. Br. at 18.)
31
issues that “directly affect the output of the particle size
analysis,” particularly given the array of possible
interpretations for the terms “‘means’ and ‘sizes.’” 34
(Defs.’
Opening Claim Constr. Br. at 14-15.)
The parties’ construction positions hinge upon issues of
indefiniteness, an area of law that has undergone fundamental
changes following Nautilus, Inc. v. Biosig Instruments, Inc.,
___ U.S. ____, 134 S. Ct. 2120 (2014), which is next addressed.
1. Standard for Indefiniteness
“A patent must ‘conclude with one or more claims
particularly pointing out and distinctly claiming the subject
matter which the applicant regards as [the] invention.’”
Media
Rights Techs., Inc. v. Capital One Fin. Corp., ___ F.3d ____,
No. 2014-1218, 2015 WL 5166358, at *3 (Fed. Cir. Sept. 4, 2015)
(citing 35 U.S.C. § 112).
A claim fails to satisfy this
statutory requirement and proves “invalid for indefiniteness if
its language, when read in light of the specification and the
prosecution history, ‘fail[s] to inform, with reasonable
certainty, those skilled in the art about the scope of the
34
Defendants further claim that Otsuka’s “many conflicting
constructions,” namely, “plain and ordinary meaning,” “analogous
to mean equivalent spherical volume diameter by laser light
diffraction scattering,” “volume mean particle size,” and
“volume weighted mean,” prove indefiniteness. (See Markman Hr’g
Tr. at 180:17-185:5.)
32
invention.’”
35
Media Rights Techs., Inc., ___ F.3d ____, 2015
WL 5166358, at *3 (quoting Nautilus, ___ U.S. ____, 134 S. Ct.
at 2124).
A claim may, for example, prove indefinite if its language
“might mean several different things” and the patent itself
identifies “no informed and confident choice ... among the
contending definitions.”
2130 n.8.
Nautilus, ___ U.S. ____, 135 S. Ct. at
Stated differently, in order to overcome an
indefiniteness challenge, “the patent and prosecution history
must disclose a single known approach or establish that, where
multiple known approaches exist, a person having ordinary skill
in the art would know which approach to select.” 36
Dow Chemical
Co. v. Nova Chemicals Corp (Canada), ___ F.3d ____, 2015 WL
5060947, at *6 (Fed. Cir. Aug. 28, 2015) (citation omitted); see
35
In articulating this standard, Nautilus fundamentally “changed
the law of indefiniteness.” Dow Chem. Co., ___ F.3d ____, 2015
WL 5060947, at *6.
36 For that reason alone, the Court rejects Otsuka’s position
that “mean particle size” should be found definite, simply
because “other courts have readily construed the term ‘mean
particle size.’” (Otsuka’s Opening Claim Constr. Br. at 15
(citing Eli Lilly & Co. v. Teva Pharm. USA, Inc., No. 06-1017,
2008 WL 2410420, at *1 (S.D. Ind. June 11, 2008).) In reality,
Otsuka cites to only one case that construed the term, prior to
the Supreme Court’s articulation of a new indefiniteness test
under Nautilus, and where neither party actually advanced an
indefiniteness argument. See Eli Lilly & Co., 2008 WL 2410420,
at *4-*5. Beyond these clearly distinguishing features, the
indefiniteness inquiry focuses upon whether the relevant patent
record discloses a single meaning among multiple possibilities,
not whether an unrelated patent contained such disclosures. See
Nautilus, Inc., ___ U.S. ____, 134 S. Ct. at 2124 (describing
the standard for indefiniteness).
33
also Teva Pharms. USA, Inc. v. Sandoz, Inc., 789 F.3d 1335 (Fed.
Cir. 2015) (same).
In conceptualizing this framework, the Court
finds two recent Federal Circuit decisions—both of which concern
the indefiniteness of measurements—instructive.
In Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., 789 F.3d
1335 (Fed. Cir. 2015), the Federal Circuit applied the legal
standards set forth in Teva Pharmaceuticals USA, Inc. v. Sandoz,
Inc., ___ U.S. ____, 135 S.Ct. 831 (2015) and Nautilus, Inc. v.
Biosig Instruments, Inc., ___ U.S. ____, 134 S. Ct. 2120, 2124
(2014), in order to resolve the question of indefiniteness
regarding a claim limitation of U.S. Patent No. 5,800,808 (the
“’808 patent”)—“molecular weight of about 5 to 9 kilodaltons.”
789 F.3d at 1338.
The Teva parties agreed that “molecular
weight” could refer to peak average molecular weight (Mp), number
average molecular weight (Mn), and weight average molecular
weight (Mw), and that each of those measures required a different
calculation and would typically yield “a different result for a
given polymer sample.”
Id. at 1338.
The ′808 patent
specification, however, did not expressly define “molecular
weight,” nor did it use the terms Mp, Mn, or Mw.
Id.
Even more,
the prosecution history contained inconsistent statements, with
the patentee stating in one instance that “molecular weight”
referred to Mw, and in another than it meant Mp.
Id. at 1345.
As a result, the Teva court found the term indefinite, despite
34
testimony from the patentee’s expert that someone skilled in the
art could, despite any ambiguity, have determined the intended
measure.
Id. at 1338, 1341, 1344-45.
Most recently, in Dow Chemical Co. v. Nova Chemicals Corp.
(Canada), ___ F.3d ____, 2015 WL 5060947 (Fed. Cir. Aug. 28,
2015), the Federal Circuit again applied the recent Supreme
Court decisions (as well as its own decision in Teva) to resolve
the question of indefiniteness regarding a claim limitation of
U.S. Patent Nos. 5,847,054 (the “’053 Patent”) and 6,111,023
(the “’023 Patent”)—“a slope of strain hardening coefficient
greater than or equal to 1.3.”
Id. at *2.
Similar to Teva, the
phrase “slope of strain hardening” proved testable by at least
“four methods,” each of which would “produce different results,
i.e., a different slope.”
Id. at *9.
The intrinsic records,
however, provided no guidance about “which method should be
used.”
Id.
As a result, the Federal Circuit found the claim
limitations indefinite, despite the testimony from the
patentee’s expert that one of ordinary skill, in reviewing the
specification, would have known to select the method the expert
himself developed.
Id. at *10.
Commenting further on its
earlier decision in the Teva case, the Federal Circuit noted in
Dow that particularly “where difference approaches to
measurements are involved,” id. at *6 (citing Teva, 789 F.3d at
1341, 1344-45), the post-Nautilus standard requires that “‘[t]he
35
claims, when read in light of the specification and the
prosecution history, must provide objective boundaries for those
of skill in the art.’”
Dow Chemical Co., 2015 WL 5060947, at *6
(quoting Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364,
1371 (Fed. Cir. 2010) (citing Nautilus, 134 S. Ct. at 2130 &
n.8))).
2. The ’615 Patent fails to inform, with reasonable
certainty, the meaning of the phrase “mean particle
size”
In applying this standard here, the Court finds that the
facts of Teva and Dow closely resemble the claim limitation at
issue here—“mean particle size.”
Indeed, even a cursory
inspection of the intrinsic record demonstrates that the ’615
Patent fails to provide the required guidance.
Indeed, Otsuka readily acknowledges the susceptibility of
“mean particle size” to multiple measurements, each of which
could yield varied results.
(See Otsuka’s Opening Claim Constr.
Br. at 16-17; Otsuka’s Responsive Claim Constr. Br. at 12-18.)
Nevertheless, Otsuka submits that the ’615 Patent, when viewed
through the eyes of the person of ordinary skill in the art,
reveals that “mean particle size” refers to “volume mean
particle size.”
(Otsuka’s Opening Claim Constr. Br. at 16.)
support of this position, Otsuka points to a narrow portion of
In
the specification that identifies a laser diffraction particle
36
size analyzer, 37 and then to asserted dependent claims 15 and 16,
both of which contain the limitation that the “mean particle
size [be] measured using a laser diffraction particle size
analyzer.”
(’615 Patent at 48:1-6.)
Otsuka then argues that an
ordinary artisan would, based upon industry literature,
understand the reference to “particle size analysis via laser
diffraction methods” as an instruction to construe “mean
particle size” as “volume mean particle size.” 38
(Otsuka’s
Opening Claim Constr. Br. at 16.)
The Court notes that only the asserted dependent claims of
the ’615 Patent, claims 15 and 16, limit particle size
measurement to the laser diffraction technique.
44:40-45:22.)
(See id. at
The specification, however, specifically refers
to a laser diffraction particle analyzer, and for that reason,
the Court will presume that the ’615 Patent overall instructs
that particle size be measured by such technique.
37
The cited portion of the specification reads:
(6) Particle Size Measurement
0.1g of the particles to be measured were suspended in
a 20 ml n-hexane solution of 0.5 g soy lecithin, and
particle size was measured using a size distribution
meter (Microtrack HRA, Microtrack Co.).
(’615 Patent at 22:51-55.)
38 As referenced above, Otsuka’s proposed construction of “mean
particle size” has been a moving target, ranging from “plain and
ordinary meaning” to “analogous to mean equivalent spherical
volume diameter by laser light diffraction scattering” to
“volume mean particle size” and finally to “volume weighted
mean”
37
Nevertheless, it remains undisputed that the laser
diffraction measurement technique generates two “mean” measures:
a volume weighted mean and a surface area weighted mean.
(See,
e.g., Second Buckton Dec. at ¶¶ 30-34, 40-41; Byrn Dep. at 20001; Markman Hr’g Tr. at 76:19-22.)
Despite these alternate
measures, the parties’ experts appear to agree, at least
superficially, that the volume weighted mean constitutes one of
the more frequently used measures for particle size analysis.
(See, e.g., Markman Hr’g Tr. at 77:9-12; Byrn Dec. at ¶ 58
(arguing that secondary sources reflect the understanding a
person of ordinary skill in the art would have had at the time
of filing that “mean particle size” refers to the volume mean
particle size).)
A closer inspection of their various
submissions, however, reveals the lack of uniform understanding
in the relevant scientific community.
Specifically, Otsuka’s expert, Dr. Byrn, states in his
declaration that “volume mean particle size” constitutes the
default meaning of “mean particle size” to one of ordinary
skill.
(See Byrn Dec. at ¶¶ 55-58; but see Byrn Dep. at 200:5-
209 (discussing d(0.5) or the median distribution).)
In
reviewing a typical laser diffraction results analysis report
during his deposition, however, Dr. Byrn took the position that
“mean particle size” refers to the median volume distribution,
or d(0.5), not the “volume weighted mean” or the “surface
38
weighted mean,” and that such approach comported with the
ordinary understanding.
(Byrn Dep. at 200:5-209)
Defendants’
expert, Dr. Buckton, then testified that the “median is the most
frequently used” measurement for particle size analysis (Markman
Hr’g Tr. at 77:9-12 (emphasis added)), but acknowledges that
“the volume-weighted mean” serves as the “the most frequently”
presented mean.
(Buckton Dep. at 424:4-9; see also Second
Buckton Dec. at ¶ 39 (stating that volume weighted mean “is the
most frequently used mean value, in [his] experience”).)
Even more, the ’615 Patent makes no connection between
“mean particle size” and volumetric measures (although it speaks
in terms of volume in unrelated contexts), and therefore
provides no information from which to divine, with reasonable
certainty, the appropriate measure of the “mean” for purposes of
the ’615 Patent.
(See generally ’615 Patent at 19:38-40.)
Nor does the ’615 Patent instruct on the manner in which to
characterize the “size” of the particle (see generally ’615
Patent at 22:51-55), which can be defined by reference to any
one of the following measures:
39
Fig. 3.04-1
Commonly used measurements of particle size
(Ex. S to Second Buckton Dec.) 39
In other words, a person of
ordinary skill would be left to guess on how best to
characterize particle size, among the array of possible
descriptions.
In order to fill these gaps in the intrinsic record, Otsuka
resorts entirely to the opinion of its own expert, Dr. Byrn.
(See generally Byrn Dec. at ¶ 58; see also Otsuka’s Responsive
Claim Constr. Br. at 13 (arguing that “[n]one of Defendants’
allegations prove Dr. Byrn wrong”).)
Nevertheless “a claim term
is indefinite if it ‘leave[s] the skilled artisan to consult the
39
As explained by Dr. Buckton, the measurement of particle size
varies in complexity based upon the shape of particle (spherical
or irregular) and the number of measured particles. (See Second
Buckton Dec. at ¶ 43.) Figure 3.04-1, in turn, depicts the “at
least five types of optical microscopy” particle size
determinations. (Second Buckton Dec. at ¶ 43 n.5.) These types
specifically include length, width, Feret’s diameter, Martin’s
diameter, and the maximum horizontal intercept. For that reason,
particle size determination requires information on both the
type of diameter measured and on the particle shape. The ’615
Patent, however, provides no such disclosure.
40
‘unpredictable vagaries of any one person’s opinion,’” Dow Chem.
Co., ___ F.3d ____, 2015 WL 5060947, at *10 (quoting Interval
Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1371 (Fed. Cir.
2014)), and Otsuka’s reliance upon Dr. Byrn requires just that.
In this case, the wording of the claim term “mean” and
specification may be construed as designating an instrument by
which to conduct a measurement of “mean particle size,” but
nothing therein guides the skilled practitioner whether to
utilize the “volume weighted mean” or the “surface weighted
mean” that such a device reports as measurements.
The choice of
“volume” or “surface” matters because each type lends to a
different result.
Looking then to extrinsic evidence, Otsuka
has not demonstrated that “volume weighted mean” is the default
measurement that the ordinary skilled practitioner would select,
given the clear absence of a convergence upon that convention in
the field; this is the hallmark of an indefinite term.
Similarly, as discussed above, the words “particle size” are
likewise indefinite, as there are multiple accepted aspects of
“size,” each yielding a different result, and the intrinsic and
extrinsic evidence does not narrow the field to the one aspect
meant to establish the boundary of the invention, as discussed
above.
For these reasons, the Court finds the term “mean particle
size” indefinite.
See Teva Pharms. USA, Inc., 789 F.3d at 134441
45 (finding the term “molecular weight” indefinite); Dow
Chemical Co., ___ F.3d ____, 2015 WL 5060947, at *10 (finding
the claim term including the phrase “slope of strain”
indefinite).
“wherein said low hygroscopicity is defined as a
moisture content of [0.40%/0.10%] or less after
placing said substance/Crystals for 24 hours in a
desiccator maintained at a temperature of 60° C and a
humidity level of 100%” 40
Exemplar claims 3 and 4 of the ’615 Patent disclose “A
pharmaceutical solid oral preparation comprising Anhydrous
Aripiprazole Crystals B having low hygroscopicity and one or
more pharmaceutically acceptable carriers, wherein said low
hygroscopicity is a moisture content of [0.40%/0.10%] or less
after placing said Crystals for 24 hours in a desiccator
maintained at a temperature of 60 º C and a humidity level of
100%...” 41 (’615 Patent at 44:40-45:22 (emphasis added).)
With
respect to the meaning of this phrase, the parties advance the
following competing constructions:
40
As stated above, this disputed phrase appears in asserted
claims 3, 4, 15, and 16 of the ’615 Patent, claims 1 and 2 of
the ’796 Patent, and claims 1 and 2 of the ’760 Patent.
41 The asserted claims of the ’796 and the ’760 Patents, in turn,
claim Anhydrous Aripiprazole Crystals B and/or Aripiprazole drug
substance “of low hygroscopicity wherein said low hygroscopicity
is defined as a moisture content of [0.40%/0.10%] or less after
placing said substance/Crystals for 24 hours in a desiccator
maintained at a temperature of 60° C and a humidity level of
100%.” (’796 Patent at 44:21-31; ’760 Patent at 44:22—32.)
42
(water/dessicator). 24 hours later, the weighing
bottle was removed, transferred to an environment of a
room temperature and about 30% RH (magnesium chloride
hexahydrate saturated water solution/dessicator) and
left to rest for 24 hours and the water content of the
sample was measured by the Karl Fischer method.
(See ’615 Patent at 22:56-64 (emphasis added); ’796 Patent at
22:59-67; ’760 Patent at 22:56-64.)
More specifically, these parties agree that because the
disputed claim phrase defines the novelty of reduced
hygroscopicity, it necessarily incorporates the “HygroscopicityTest Method” described by the specification.
These parties
diverge, however, on whether the specification should be read to
account for “‘reasonable variations’ in the ‘Hygroscopicity-Test
Method’” (as argued by Otsuka), or whether the specification
should be read as the strict definition of the disclosed test
method (as argued by Defendants). 44 Teva, Prinston, Zydus,
Aurobindo, and Amneal (hereinafter, the “indefinite
Defendants”), by contrast, argue that the phrase defines itself,
and therefore requires no construction, much less the
importation of a claim limitation from the specification (i.e.,
any incorporation of the “Hygroscopicity-Test Method”).
(Defs.’
Responsive Claim Constr. Br. at 19-23.)
44
These Defendants additionally challenge Otsuka’s construction
to the extent it states that “wherein said low
hygroscopicity...” has a plain and ordinary meaning. (Defs.’
Responsive Claim Constr. Br. at 17.)
44
the context of the particular claim in which the disputed term
appears, but in the context of the entire patent, including the
specification.”).
In that way, the specification simply
explains, in greater detail and under a heading entitled
“Hygroscopicity Test Method,” the actual steps involved in
testing the hygroscopicity of the claimed invention. 46
(See also
Buckton Dec. at ¶¶ 25-26; Byrn Dep. at 182:6.)
For that reason, the Court will adopt Defendants’
construction. 47
46
The indefinite Defendants argue that the disputed phrase fails
on indefiniteness grounds, as evidenced by the fact that
Otsuka’s contention that “when considering the claimed low
hygroscopicity test, a POSA would look to the Hygroscopicity
Test Method in the specification and consider ‘reasonable
variations’ to account for ‘practical realties.’” (Defs.’
Responsive Claim Constr. Br. at 23 (emphasis in original).)
Nevertheless, because the Court will not adopted Otsuka’s
“reasonable variations” construction, as explained below, it
need not reach the issue of indefiniteness. However, even if it
did, the disputed claims provide more than enough information to
disclose the scope of the claims (or, the meaning of low
hygroscopicity) with reasonable certainty. (See Buckton Dep. at
167:15-18, 392:14-393:1 (setting forth Dr. Buckton’s opinion
that the term, when viewed through the lens of the
specification, is reasonable clear).)
47 The Court will not, however, incorporate the “reasonable
variations” proposed by Otsuka. In advancing a construction
that includes “reasonable variations in the test method,” Dr.
Byrn appears to envision a construction that accounts for
“practical laboratory realities” (Byrn Dec. at ¶ 65), e.g.,
laboratory variations, or “[s]omething as simple as a truck
driving by the building or power fluctuations.” (Markman Hr’g
Tr. at 30:24-31:3.) These sorts of laboratory conditions,
however, have no place in the Court’s construction, nor any
actual rooting in the intrinsic record. (See Byrn Dep. at 256:67 (stating that the Court need not adopt “reasonable variations”
as part of its construction).)
46
Nevertheless, the Court finds that “aripiprazole drug
substance” requires no elaborate interpretation.
Indeed, claims
1 and 2 of the ’760 Patent identify the claimed invention as
“Aripiprazole drug substance of low hygroscopicity wherein said
low hygroscopicity is a moisture content of [0.40%/0.10%] or
less after placing said Crystals for 24 hours in a desiccator
maintained at a temperature of 60 º C and a humidity level of
100%.”
(’760 Patent at 44:23-32.)
In that way, the language
makes clear that the “Aripiprazole drug substance” claimed in
the ’760 Patent broadly describes aripiprazole as the active
ingredient of the finalized formulation. 49
The formulation
examples, in turn, teach that “[t]he following examples used
aripiprazole drug substance made by first milling or pulverizing
the conventional hydrate of aripiprazole and then heating it to
form the anhydrous form (anhydrous aripiprazole crystals b).”
(Id. at 40:43-46.)
The specification therefore makes clear that
“aripiprazole drug substance” also refers, more broadly, to the
aripiprazole compound prior to incorporation into its final
formulations.
As a result, the Court finds that a person of ordinary
skill in the art would, upon reviewing the language of the ’760
Patent in its entirety, conclude that “aripiprazole drug
49
Nearly every relevant embodiment of the specification contains
a similar disclosure. (See, e.g., ’760 Patent at 5:64-7:62.)
48
substance” means a drug substance that consists of aripiprazole,
either in pure chemical form or as the active chemical
ingredient in finalized form.
(See Byrn Dep. at 92:10-19.) 50
“a/the pharmaceutical composition” / “in combination
with” 51
In its TRO Opinion, the Court addressed, at great length,
the appropriate construction of the phrase “pharmaceutical
composition,” as recited in the asserted claims of the ’350
Patent.
See Otsuka, ___ F. Supp. 3d ____, 2015 WL 1782653, at
*9-*13.
In connection with the pending Markman submissions,
Otsuka, in essence, requests that the Court revisit its
“preliminary” TRO construction, but largely reiterates positions
this Court previously rejected, and again ignores the explicit
teachings of its own specification. 52
(See generally Otsuka’s
Opening Claim Constr. Br. at 21-26; Otsuka’s Responsive Claim
Constr. Br. at 26-34.)
Defendants, by contrast, urge the Court
to maintain its previous construction.
(See, e.g., Defs.’
Opening Claim Constr. Br. at 30-33
50
Only Otsuka presented expert testimony in support of its
proposed construction of “aripiprazole drug substance.”
51 As stated above, this disputed phrase appears in claims 1
through 18 of the ’315 Patent.
52 Indeed, Otsuka has only augmented its position on this
disputed claim phrase through its submission of additional
extrinsic evidence, namely, the expert declarations of Dr.
Correll and Dr. Byrn. Otsuka no longer relies upon Dr. Bryan L.
Roth, the expert Otsuka relied upon in connection with the TRO
proceedings.
49
aripiprazole in combination with (b) at least one
serotonin reuptake inhibitor selected from the group
consisting of citalopram, escitalopram and salts
thereof.
A method of treating a mood disorder ... [through]
administration of an effective amount of a
pharmaceutical composition comprising aripiprazole in
combination with at least one serotonin reuptake
inhibitor selected from the group consisting of
citalopram, and salts thereof.
10
A method of treating a mood disorder ... [through]
administration of an effective amount of a
pharmaceutical composition comprising aripiprazole in
combination with at least one serotonin reuptake
inhibitor selected from the group consisting of
escitalopram, and salts thereof.
11
12-16
The method of any one of claims 9 to 11, wherein the
pharmaceutical composition further comprises at least
one pharmaceutically acceptable carrier.
13
14-16
17
18
The method of any one of claims 9 to 11...
The method of any one of claims 9 to 11...
The composition of claim 5...
The composition of claim 1...
(’350 Patent at 28:64-30:48.)
Several features critically relevant to construction
immediately emerge from even a cursory inspection of the plain
intended the “(s)” to be “(a).” Any other interpretation proves
wholly inconsistent with the remaining claims, particular
dependent claim 13. (Compare ’350 Patent at 29:37-38, with
30:23-25.) Even more critically, Otsuka has not requested that
the Court construe the term “comprise(s),” and the opportunity
to do so has long since expired. For these reasons, the Court
finds that claim 9 provides no support for Otsuka’s
construction.
51
claim language, namely, the consistent inclusion of “a
pharmaceutical composition” in the singular, followed by
grammatically uninterrupted identification of the composition’s
at least two component parts.
See Credle v. Bond, 25 F.3d 1566,
1571 (Fed. Cir. 1994) (stating that “grammatical structure and
syntax” of the claim can be important evidence for claim
construction).
Indeed, taken together, the phrases “a
pharmaceutical composition” and “in combination with,” when
followed by an unequivocal delineation of the required parts,
provide a clear indication that the asserted claims of the ’350
Patent refer to a single pharmaceutical composition or dosage
comprised of multiple active pharmaceutical ingredients.
See,
e.g., Research Plastics, Inc. v. Fed. Packaging Corp., 421 F.3d
1290, 1295 (Fed. Cir. 2005) (“[C]laim terms are presumed to be
used consistently throughout the patent, such that the usage of
a term in one claim can often illuminate the meaning of the same
term in other claims.”); see also Phillips, 415 F.3d at 1314
(noting that “the use of a term within the claim [can] provide a
firm basis for construing the term”).
The overall structure of the ’350 Patent, throughout its
various sequential components, then consistently and repeatedly
teaches that the claimed invention concerns a single dosage
form, comprised of two active ingredients.
52
Indeed, the ’350 patent describes the invention at the
outset in its abstract as a “pharmaceutical composition”
comprised of “(1) a carbostyril derivative,” either
“aripiprazole or a metabolite,” together with “(2) a serotonin
reuptake inhibitor,” e.g., citalopram and/or escitalopram, “in a
[single] pharmaceutically acceptable carrier.”
at Abstract (emphasis added).)
(See ’350 Patent
In the disclosure of the
invention, the ’350 patent then reiterates that the claimed
invention consists of at least two ingredients “in a
pharmaceutically acceptable carrier.”
(Id. at 2:66-6:17.)
Identical disclosures appear in the Detailed Description,
which describes in detail the “first” and “second” ingredients,
“contained,” “combined,” or “mixed” in the single
“pharmaceutical composition.” (See, e.g., id. at 6:47-55, 10:5257, 11:47-48 (“Combination of the First Ingredient with the
Second Ingredient”), 13:56-62 (“the amounts of the first
ingredient and the second ingredient to be contained in the
pharmaceutical composition of the present invention...”), and
20:27-41 (describing aripiprazole in a combined administration
with citalopram and/or escitalopram).)
Indeed, the introduction
of the Detailed Description states that, “[t]he pharmaceutical
composition of the present invention comprises a first
ingredient comprising a carbostyil derivative active as a
dopamine-serotonin system stabilizer and a second ingredient
53
comprising a serotonin reuptake inhibitor, in a pharmaceutically
acceptable carrier.”
(Id. at 6:47-51 (emphasis added).)
In
that regard, the syntax of the introduction alone indicates that
the single “pharmaceutically acceptable carrier” describes and
limits the preceding composition to a carrier, or dosage,
comprised of two ingredients.
Even more, however, the Detailed
Description contains the following illustrative subheadings:
“The Pharmaceutical Composition: The First Ingredient,” i.e.,
aripiprazole, “The Pharmaceutical Composition: The Second
Ingredient,” i.e., a serotonin reuptake inhibitor, and
“Combination of the First Ingredient with the Second
Ingredient,” i.e., a combination of aripiprazole and an SRI, and
preferably “a combination of aripiprazole/citalopram.”
(Id. at
6:56, 10:52, 11:47-59.) Imbedded within these six columns, the
Patent uniformly treats the claimed invention as a single
“combination” dosage, and specifically delineates the preferred
weight ratio “of the first ingredient to the second ingredient”
as generally, “about 1 to 70 parts by weight, preferably about 1
to 30 parts by weight of the first ingredient and the second
ingredient in the total amount on the basis of the
pharmaceutical composition.”
(See id. at 11:58-59, 12:61-63,
13:59-61.)
The eighteen “non-limiting formulation examples of
aripiprazole” then uniformly disclose formulations for “the
54
[claimed] tablet” that contain multiple active pharmaceutical
ingredients, namely aripiprazole combined with at least one SRI,
together in a single “tablet.”
(Id. at 20:46-25:17 (emphases
added); see also 11:54-58 (setting forth a non-exhaustive list
of the relevant SRIs).)
Otsuka does not genuinely dispute the volume and
pervasiveness of these consistent intrinsic references to a
composition in a single dosage form. 55
Rather, it submits that
the Court’s construction must take into account the undisputed
extrinsic reality that psychiatrists do not, as a practical
matter, prescribe single dosage forms of antipsychotics and
antidepressants.
(See, e.g., Markman Hr’g Tr. at 36:6-18,
55
The Court rejects Otsuka’s reliance upon isolated portions of
the specification for the same reasons set forth in the TRO
Opinion. See Otsuka, ___ F. Supp. 3d ____, 2015 WL 1782653, at
*12-*13. Critically, these portions of the specification all
identify alternative embodiments involving separate dosage
forms, not the single composition otherwise disclosed in the
plain claim language and throughout the remainder of the
specification. (See, e.g., ’350 Patent at 3:52-67, 14:10-21.)
The Court need not credit alternative embodiments, particularly
those that, as here, “contradict” the relevant claim language.
TIP Sys., LLC v. Phillips & Brooks/Gladwin, Inc., 529 F.3d 1364,
1373 (Fed. Cir. 2008) (declining to include alternatively
disclosed embodiment because it “would contradict the language
of the claims”); see also Rolls-Royce, PLC v. United Techs.
Corp., 603 F.3d 1325, 1334-35 (Fed. Cir. 2010) (omitting certain
disclosed embodiments to avoid a construction that “outweighs
the language of the claim.”). Moreover, even if the Court
accepted Otsuka’s interpretation of these specific portions of
the specification, the specification itself cannot be “a
substitute for, nor can [it] be used to rewrite, the chosen
claim language.” SuperGuide Corp. v. DirectTV Enters., Inc., 358
F.3d 870, 875 (Fed. Cir. 2004) (“[s]pecifications teach,”
“[c]laims claim”).
55
104:9-105:7; Correll Dec. at ¶ 22.)
Rather, psychiatrists
prefer to engage in combination therapy, i.e., to prescribe an
antipsychotic in a separate dosage form from the antidepressant,
in order to have the ability to titrate the dosages based upon
the individual reactions of certain patients.
(See, e.g.,
Markman Hr’g Tr. at 36:6-37:11, 104:9-105:7.)
Indeed,
combination therapy appears to be the predominant method of
treating mood disorders.
(See Markman Hr’g Tr. at 104:18-20;
Correll Dep. at 44:17-24 (“Combination therapy is more the rule
than the exception in psychiatry, as it is in many areas of
medicine, where one medication alone is not good enough.”).)
Nevertheless, the disputed claim phrase need not be construed in
accordance with its most successful commercial form, and it
remains true that there is at least one other commerciallysuccessful product, Symbyax®, that combines “an atypical
antipsychotic” with a “serotonin reuptake inhibitor,” all while
providing physicians the ability to titrate.
200.]
[See Docket Item
See also Chef Am., Inc. v. Lamb-Weston, Inc., 358 F.3d
1371, 1373 (Fed. Cir. 2004) (“[E]ven if, ... construing the
patent ... produces a nonsensical result, the court cannot
rewrite the claims.
Plaintiff’s patent could have easily been
written to reflect the construction plaintiff attempts to give
it today.”)
56
The amount of intrinsic evidence that consistently
discloses a single dosage form can hardly be described as
anything less than substantial, and the Court again finds no
support for Otsuka’s position that the “pharmaceutical
composition” identified by the ’350 Patent should be construed
to teach that aripiprazole and the at least one SRI (namely,
escitalopram and/or citalopram) may be presented in separate
and/or multiple dosage forms.
For all of these reasons, the
Court construes the phrase to refer to a single dosage form, or
“pharmaceutical composition,” containing at least two active
ingredients: aripiprazole and at least one of citalopram,
escitalopram and salt thereof.
CONCLUSION
An accompanying Order will be entered.
November 16, 2015
Date
s/ Jerome B. Simandle
JEROME B. SIMANDLE
Chief U.S. District Judge
57
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