Orexo AB et al v. Actavis Elizabeth LLC et al

Filing 127

MEMORANDUM ORDER re: claim construction. Signed by Judge Sue L. Robinson on 10/6/2015. (nmfn)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
OREXO AB and OREXO US, INC.,
Plaintiffs,

v.
ACTAVIS ELIZABETH LLC,
Defendant.

)
)
)
)
)
)
)
)
)

Civ. No. 14-829-SLR

MEMORANDUM ORDER
At Wilmington this ta\"' day of October, 2015, having heard argument on, and
having reviewed the papers submitted in connection with, the parties' proposed claim
construction;
IT IS ORDERED that the disputed claim language of U.S. Patent Nos. 8,454,996
("the '996 patent") and 8,940,330 ("the '330 patent") shall be construed consistent with
the tenets of claim construction set forth by the United States Court of Appeals for the
Federal Circuit in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005), as follows:
1. "Carrier particles:" 1 "Particles comprising one or more pharmaceutically
acceptable substances." 2 The specifications provide that carrier particles "may
comprise" pharmaceutically acceptable substances. 3 ('330 patent, 7:28-30; '996 patent,
4:41-43)

1

Found in claims 1 and 2 of the '996 patent and in claims 1, 3-6, 10 of the '330 patent.
This construction is the portion of the proposed constructions on which the parties
agreed.
3 The parties' additional proposed language seeks to define the way such carrier
particles are used. This is better left to the claim language and the second disputed
limitation addressed below.

2

2. "Presented at the exterior surfaces of the carrier particles" 4 and
"presented upon the surface of carrier particles:" 5 "Positioned at the outside part or

layer of the carrier particles by interactive forces strong enough to keep the adherent
particles at the carrier surface." The parties' central disagreement regarding this
limitation is the "degree" of association between the microparticles and the carrier
particle. The '996 patent describes "[a] pharmaceutical composition ... compris[ing] an
essentially water-free, ordered mixture of at least one pharmaceutically active agent in
the form of microparticles which are adhered to the surfaces of carrier particles which
are substantially larger than the particles of the active agent or agents .... " ('996
patent, abstract; 2:64-67) The '996 patent explains that "a bio/mucoadhesion promoting
agent ... must be positioned at the surfaces of the carrier particles." ('996 patent, 5:5860) In a preferred embodiment, an ordered mixture is made, with finer particles
"adhered to the surfaces of the carrier particles." ('996 patent, 5:62-67)
The '330 specification describes a composition "in the form of a[n] interactive
mixture comprising at least one population of carrier particles upon the surfaces of
which are presented (e.g. adhered) microparticles of buprenorphine or a
pharmaceutically acceptable salt thereof." ('330 patent, 6:66-7:4) The specification
further explains:
The term "interactive" mixture will be understood by those skilled in the art
to include the term "ordered" mixture, and to denote a mixture in which
particles do not appear as single units, as in random mixtures, but rather
where smaller particles (e. g. microparticles of, for example,
buprenorphine) are attached to (i.e. adhered to or associated with) the
4

5

Found in claim 1 of the '996 patent.
Found in claim 1 of the '330 patent.

2

surfaces of larger carrier particles. Such mixtures are characterized by
interactive forces (for example van der Waals forces, electrostatic or
Coulomb forces, and/or hydrogen bonding) between carrier and surfaceassociated particles .... In final mixtures, and compositions comprising
such mixtures, the interactive forces need to be strong enough to keep the
adherent particles at the carrier surface.
('330 patent, 7:5-19) 6 The specification further recites "[b]io/mucoadhesive materials ...
may be presented upon (e.g. adhered to) the surfaces of carrier particles .... " (8:6567)
The specifications do not differentiate between the terms "positioned at,''
"presented upon,'' "adhered to,'' "attached to,'' and "associated with,'' but use them
somewhat interchangeably. 7 The court concludes that, regardless of the language
chosen by either the court or the parties to describe the disputed terms "presented at"
and "presented upon," the focus is properly placed on the specifications' explanation of
the interaction of a carrier particle with other particles in an ordered mixture, that is, "the
interactive forces need to be strong enough to keep the adherent particles at the carrier
surface." ('330 patent, 7:17-19)

3. "Pharmacologically-effective amount:" 8 "An amount that elicits a
therapeutic response." The '330 specification provides:

6

This explanation is the same as the extrinsic evidence relied on by defendants:
"Ordered mixing may be considered to be different from random mixing since it ...
requires particle interaction, i.e. adsorption, chemisorption, surface tension, frictional,
electrostatic or any other form of adhesion." J.A. Hersey, Ordered Mixing: A New
Concept in Powder Mixing Practice, 11 Powder Tech. 41, at 41 (1975).
7
That claim 2 contains the limitation "microparticles adhered to the surfaces of carrier
particles" does not change this conclusion. Moreover, the prosecution history cited by
the parties does not aid in the analysis, as the changes in the limitation are more
complex than plaintiffs' description of replacing "adhered to" with "presented at." (D.I.
89, ex. 6 at JA2022)
8 Found in claim 1 of the '330 patent.

3

The term "pharmacologically effective amount" refers to an amount of an
active ingredient, which is capable of conferring a desired therapeutic
effect on a treated patient, whether administered alone or in combination
with another active ingredient. Such an effect may be objective (i.e.
measurable by some test or marker) or subjective (i.e. the subject gives
an indication of, or feels, an effect).
('330 patent 9:30-36) The court adopts the agreed upon portion of the parties'
construction, finding that plaintiff's additional language 9 further defining "elicit" is
unnecessary.
4. "In contact with:" 10 "Touching at least in part." The specification explains:
In particular, microparticles of buprenorphine or salt thereof and
particles of weakly acidic, weakly-acidic buffer forming, materials are
presented in associative admixture with each other in compositions of the
invention. By "associative admixture" we mean that whether or not
Component (i) is subsequently formulated along with Components (ii) and
(iii) as hereinbefore defined, some form of mixing step (simple mixing,
granulation as described herein before, or otherwise) takes place as
between the buprenorphine/ salt microparticles and particles of weakly
acidic, weakly-acidic buffer forming, materials, rendering them in intimate
contact with each other.
For the avoidance of doubt, by "intimate contact", we include that
micro particles of buprenorphine or salt thereof, and particles of weakly
acidic, weakly-acidic buffer forming, materials, are presented in
compositions of the invention in any form in which they are, at least in
part, in intimate contact with each other. This includes the possibility of the
inclusion of quickly dissolving coatings on one or other, or both, sets of
particles.
('330 patent, 6:46-65) The limitation "in contact with" is sufficiently definite to "inform
those skilled in the art about the scope of the invention with reasonable certainty," when

9

"I.e., is capable of conferring a desired."

° Found in claim 1 of the '330 patent, which recites in part:

1

"Wherein microparticles of
buprenorphine or a pharmacologically-acceptable salt thereof are in contact with
particles comprising citric acid, wherein the buprenorphine or pharmaceutically
acceptable salt thereof and the citric acid are not in the same particle." The parties
agree that the language "are not in the same particle" means "in different." (D.I. 68 at 4)

4

"viewed in light of the specification and prosecution history." Nautilus, Inc. v. Biosig

Instruments, Inc., -

U.S.--, 134 S.Ct. 2120, 2129 (2014).

5. The court has provided a construction in quotes for the claim limitations at
issue. The parties are expected to present the claim construction consistently with any
explanation or clarification herein provided by the court, even if such language is not
included within the quotes

5