Teva Pharmaceuticals USA Inc. et al v. Forest Laboratories Inc.

Filing 70

ORDER CONSTRUING THE TERMS OF U.S. PATENT NO. 6,194,000. Signed by Judge Gregory M. Sleet on 7/9/2015. (mdb)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE

TEVA PHARMACEUTICALS USA, INC.
and MAYNE PHARMA INTERNATIONAL
PTYLTD.,
Plaintiffs,
v.
FOREST LABORATORIES, INC.,
Defendant.

)
)
)
)
)
)
)
)
)
)
)
)

Civil Action No. 13-2002-GMS

ORDER CONSTRUING THE TERMS OF U.S. PATENT NO. 6,194,000
The court having considered the submissions of the parties and having heard oral argument
on the matter-IT IS HEREBY ORDERED, ADJUDGED, and DECREED that, as used in the
asserted claims of U.S. Patent No. 6,194,000 ("the '000 Patent"):
1. The term "wind-up" is construed to mean "an increase in output to a repeated or
constant input, resulting in an exaggerated pain response." 1

1

The parties' dispute concerns whether wind-up should be defined by a particular physiological mechanism
or a more generalized understanding of the condition. The confusion stems essentially from a single passage in the
specification:
[l]t is believed that the NMDA receptor complex plays only a minor role in routine
synaptic transmission. However, the receptor complex may be activated following
repeated afferent stimuli as occurs during trauma such as surgery. Repeated
stimuli cause a temporal summation ofC-fibre-mediated responses of dorsal horn
nociceptive neurones; this phenomenon, increased output to a constant input, is
known as wind-up.
'000 Patent, col. 1 11. 20-30. Despite failing to provide the court with a clear proposal, the defendant seeks a
construction incorporating these specific physiological elements: temporal summation ofC-fibre-mediated responses
of dorsal horn nociceptive neurons.
The whole of the intrinsic evidence, however, does not support such a narrow interpretation. Indeed, even
the above-quoted passage supports the court's ultimate construction. The final clause-"this phenomenon, increased
output to a constant input, is known as wind-up"-is an effective definition of wind-up. After going through a
complex, lengthy description of the physiology at play, the patentee elected to include a more simplified description
in the form of an appositive to describe the "phenomenon" of wind-up: "increased output to a constant input."

2. The term "to diminish or abolish wind-up" is construed to mean "to diminish or abolish
wind-up in the human or animal subject of the administration."2

See Apposition, MERRIAM-WEBSTER: DICTIONARY & THESAURUS, http://www.merriam-webster.com/
dictionary/apposition (last visited July 9, 2015) ("an arrangement of words in which a noun or noun phrase is followed
by another noun or noun phrase that refers to the same thing" (emphasis added)). Subsequent disclosures explain
what the patentee meant by this: "These neural mechanisms may be expressed physically as hyperalgesia (increased
pain sensation) and allodynia (pain arising from a stimulus that is not normally painful)." Id. col. 111. 34-37. Thus,
it is the painful expression of the underlying neural mechanisms that constitutes wind-up.
The prosecution history supports this view. In overcoming an indefiniteness rejection, the applicant stated:
The term "wind up" relates to an increase in output to a repeated constant input
or stimulus. The output is manifested as pain and is measured in experiments as
the nerve's response. Wind up results in an exaggerated pain response to a
stimulus which normally would not be painful ....
(D.I. 60 at JA0159.) The Examiner accepted this explanation and in the Notice of Allowance concluded:
The method of preparing the novel combination and method of treatment provides
dissolution profiles which result in serum blood levels of the NMDA receptor
antagonist in sufficient amounts to diminish or abolish wind-up. Wind-up being
an increase in output to a repeated constant input or stimulus. The output
manifested as pain in the case of wind-up results in an exaggerated pain
response to a stimulus which normally would not be painful.
(Id. at JA0207 (emphasis added).) Again, it is the manifestation, or expression, of the nerve response that causes pain.
This pain is called wind-up.
Both prosecution statements refer to wind-up as an "exaggerated pain response to a stimulus which normally
would not be painful"-allodynia. But the patent specification makes clear that hyperalgesia-a more generalized
increased pain sensation-also falls under the umbrella of wind-up. '000 Patent, col. 1 11. 34-37. thus, a definition
simply requiring an exaggerated pain response-regardless of whether the input is normally painful-adequately
captures the patent's teaching.
2

Claim 1 claims:
A method of preparing an analgesic pharmaceutical compos1t10n for the
administration of an NMDA receptor antagonist to a human or animal subject for
the treatment of pain, comprising:

the immediate release form and sustained release form being present in
sufficient amounts to diminish or abolish wind-up.
'000 Patent, claim 1. "Claim construction is a matter of resolution of disputed meanings and technical scope, to clarify
and when necessary to explain what the patentee covered by the claims, for use in the determination of infringement.
It is not an obligatory exercise in redundancy." US. Surgical Corp. v. Ethicon, Inc., 103 F.3d 1554, 1568 (Fed. Cir.
1997). The plaintiffs appear to oppose construction not because it would improperly narrow the scope of the claims
but, rather, because it is redundant-it restates what is already understood by the plain language. (D.I. 69 at 43-44.)
The court, however, agrees with the defendant that the construction does indeed clarify an ambiguity in the claims.
Specifically, the construction makes clear that the amounts "sufficient" to diminish or abolish wind-up are not merely
theoretically sufficient. The immediate and sustained release forms are present in sufficient amounts to diminish
wind-up in the subject actually receiving the treatment. Thus, the court is comfortable erring on the side of
redundancy, as opposed to risking confusion at a later stage oflitigation.

I
t

2

I

3. The preamble phrase "for the administration ... to a human or animal subject for the
treatment of pain" is construed not to be limiting. 3
4. The terms "immediate release form" and "immediate release" are construed to mean
"pharmaceutical form in which the release of the active ingredient is not delayed and/or
extended" and "release that is not delayed and/or extended," respectively. 4
5. The terms "sustained release form" and "sustained release" are construed to mean
"pharmaceutical form in which the release of the active ingredient is delayed and/or
extended" and "release that is delayed and/or extended," respectively. 5
3

"In general, a preamble limits the invention if it recites essential structure or steps, or if it is necessary to
give life, meaning, and vitality to the claim. Conversely, a preamble is not limiting where a patentee defines a
structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for
the invention." Catalina Mktg. Int'!, Inc. v. Coo/savings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (internal
citation and quotation marks omitted). The preamble phrase does not recite essential structure or steps and does not
serve as an antecedent basis for subsequent elements in the claim body. See id. The court is satisfied that the disputed
portion of the preamble is not limiting because it merely states an intended purpose of the invention.
4

The court's construction is consistent with a plain and ordinary understanding of the word "immediate."
The plaintiffs point to a statement in the specification perhaps suggesting that immediate release is achieved
"promptly." '000 Patent, col. 3 11. 55-60 ("[D]elayed release dosage forms ... release the drug at a time other than
promptly after administration."). But the specification did not unambiguously redefine "immediate" to mean
"prompt," and the court is reluctant to inject ambiguity into the claims with a word like "prompt," which has no
ascertainable boundaries.
The specification is consistent with the view that immediate release forms of the NMDA receptor antagonist
are not altered to extend or delay release. "A suitable immediate release (IR) form of the NMDA receptor antagonist
may simply be particles of the antagonist or particles of the antagonist admixed with [various different components]."
Id. col. 3 11. 30-45. The patent does not teach that the combination of the active ingredient with these different
components---even insoluble components-affects the release profile. But it does describe other functions: "A core
used herein the description contains the active ingredient and other carriers and excipients, fillers, stablising agents,
binders, core seeds or colorants." Id. col. 3 11. 61-63. Moreover, the patent teaches that coatings can be used on
immediate release cores but only "for aesthetic, handling, or stability purposes." Id. col. 6 11. 11-13. Thus, there is
nothing in the intrinsic record to suggest a different understanding of "immediate" should be applied-it means
without delay and/or extension.
The plaintiffs' contention that constructions in the form of negative limitations-such as that proposed by
the defendant-are disfavored or face a more exacting standard is a misunderstanding of Federal Circuit case law.
See Omega Eng'g, Inc, v. Raytek Corp., 334 F.3d 1314, 1322 (Fed. Cir. 2003).
5

Whereas immediate release is not delayed and/or extended, supra note 4, sustained release is just the
opposite. The specification supports this view. See '000 Patent, col. 3 11. 53-54 ("The controlled release may be a
sustained release or delayed/modified release." (emphasis added)); col. 4 ll. 6-7 ("Preferably, the controlled release
component is a sustained (or extended) release form." (emphasis added)).
The plaintiffs argue that the sustained release form releases the active ingredient over a longer period than
that of the immediate release form. This relative construction-dependent entirely on immediate release-is simply
not how the specification treats the claim term.

3

~.

I
I

6. The term "immediate release form and sustained release form being present in
sufficient amounts" is construed to mean "immediate release form and sustained release
form together being present in sufficient amounts."6

Dated: July~' 2015

6

The defendant seeks to construe the claim term as requiring independently sufficient amounts of both the
immediate release form and the sustained release form to diminish or abolish wind-up. In other words, either form,
standing alone, would serve to treat wind-up. But such a construction is neither required by the language of the
claims nor supported by the teachings of the specification.
In particular, the defendant emphasizes the claims' use of the plural "amounts" rather than a single "amount"
capable of diminishing or abolishing wind-up. See, e.g., '000 Patent, claim I. The claim drafters perhaps could have
framed the claims to require a single unified amount capable of treating wind-up. But the usage of "amounts" does
not automatically require a different understanding. The combination of the immediate release form and the sustained
release form will indeed result in two "amounts" of active ingredient, even if only the combined total is relevant.
Thus, the plaintiffs' understanding is not an improper revision of the claims.
Moreover, "[ c]laim language must be viewed in light of the specification, which is 'the single best guide to
the meaning of a disputed term."' Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364 (Fed. Cir. 2014) (quoting
Phillips v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005)). The specification always refers to the combined
amount(s) as having the therapeutic effect, rather than the individual amount of each. "We have found that a
particularly effective composition for the administration of an NMDA receptor antagonist to diminish or abolish wind
up is one providing both immediate release of an NMDA receptor antagonist and controlled or sustained release of
an NMDA receptor antagonist." Id. col. 1 11. 52-56 (emphasis added); see also id. col. 5 11. 6--10 ("The IR
[intermediate release] and SR [sustained release] forms of the NMDA receptor antagonist are then combined into a
single dosage such that the amount ofNMDA receptor antagonist in the composition of the invention is in the range
of about 1-5000 mg typically."). Never does the patent teach that each form is present in a sufficient amount to treat
wind-up on its own. The court adjusts the construction to mirror the original claim language as closely as possible
but largely adopts the plaintiffs' reasoning.

4