United States District Court, D. Delaware
PERNIX IRELAND PAIN LTD and PERNIX THERAPEUTICS, LLC, Plaintiffs,
ACTAVIS LABORATORIES FL, INC., Defendant. PERNIX IRELAND PAIN LTD and PERNIX THERAPEUTICS, LLC, Plaintiffs,
ALVOGEN MALTA OPERATIONS LTD., Defendant.
ORDER CONSTRUING THE TERMS OF U.S. PATENT NOS. 9,
265, 760, 9, 326, 982. 9, 333, 201, 9, 339, 499, 9, 421, 200,
and 9, 433, 619
having considered the submissions of the parties and hearing
oral argument on the matter, IT IS HEREBY ORDERED, ADJUDGED,
and DECREED that, as used in the asserted claims of U.S.
Patent Nos. 9, 265, 760 (the '"760 Patent"), 9,
326, 982 (the '"982 Patent"), 9, 333, 201 (the
'"201 Patent"), 9, 339, 499 (the '"499
Patent"), 9, 421, 200 (the '"200 Patent"),
and 9, 433, 619 (the "'619 Patent"):
term "administering" is construed to mean
"delivering into the body."
phrase "starting dose is not adjusted relative to a
patient without hepatic impairment" is construed to mean
"[t]he dose prescribed to a patient with mild or
moderate hepatic impairment when initiating treatment is not
reduced due to that hepatic impairment relative to the dose
prescribed to a patient without hepatic impairment when
terms "subject" and "average [or mean]"
in the phrases "[average/mean] hydrocodone
[AUCo-inf/Cmax] . . . [in/dosed to] subjects . .. ., "
and "[average/mean] hydrocodone [AUCO-inf/Cmax] . ..
[in/dosed to] subjects ... relative to subjects, " are
construed to have their plain and ordinary
 Plaintiffs ask the court to construe
"administering" as "prescribing, dispensing,
giving or taking (such that what is prescribed, dispensed,
given or taken is actually taken into the patient's
body)." (D.I. 60 at 7). Plaintiffs argue that the plain
meaning, the specification, and prior case law clearly
counsel in favor of a broad construction. (D.I. 60 at 7). The
The patentees explicitly use the term
"prescribing" elsewhere within the patent:
"[C]hanges in pharmacokinetic parameters . .. can lead
to many problems, including . . . complications for
physicians in prescribing." '760 patent, col. 4 11.
30-34. If the term "administering" was meant to
encompass the physician "prescribing" the drug to
the patient, then the patentees' would not have
differentiated between the two terms in the
Further, Defendants' proposed construction of
"administering" is consistent with the patent. The
patent describes how "[t]he drug seeps out over a period
of time starting at about 1 hour after administration and
continues until about 10-12 hours after administration."
Id. col. 7 11. 50-52. The patent also explains that
"Zohydro ER capsules exhibit peak plasma concentrations
occurring approximately 5 hours after dose
administration." Id. col. 18 11. 22-23. In
fact, the specification is replete with such examples. On the
contrary, there are only two instances where substituting the
plaintiffs' construction of either
"prescribing" or "dispensing" for
administration would make contextual sense: (1) "[ER]
morphine sulfate . .. should be administered with caution,
and in reduced dosages in . .. patients with severe ...
hepatic insufficiency, " Id. col. 4 11. 27-29;
and (2) "[t]he blood levels of the drug do not become
dangerously high to a patient even when the patient is
hepatically impaired and a government approved label packaged
with the drug indicated the dosage can be administered to
patients with and without hepatic impairment."
Id. col. 7 11. 52-57. Defendants first citation to
the specification is found in the part of the patent
discussing a prior art drug, KADIAN®. The court,
therefore, does not find that evidence to be relevant to the
construction of "administering" in the context of
the '760 invention. As for the second citation, the court
does not see how such a disclosure undermines Defendants'
construction. Thus, the patent does not support Plaintiffs
Plaintiffs argue that Defendants cite to parts of the
specification that use the term "administration, "
instead of the claim term, "administering." (D.I.
60 at 9). Plaintiffs believe that because
"administering" and "administration" are
different parts of speech, the use of
"administration" cannot influence the construction
of "administering." Id. The court does not
find that argument persuasive because there exists no
plausible reason- and Plaintiffs do not offer one-to give the
noun form a different meaning than the verb form.
The court also does not find Plaintiffs' citations
to case law persuasive. "[T]he determination of the
meaning of a particular term in one patent will not
necessarily bear on the interpretation of the same term in a
cases Plaintiffs cite to construe the term
"administering" in the context of completely
different patents. This is not a situation where the patents
in the other cases all derive from the same parent
application. See Omega Eng'g, Inc, v. Raytek
Corp., 334 F.3d 1314, 1334 (Fed. Cir. 2003) ("[W]e
presume, unless otherwise compelled, that the same claim term
in the same patent or related patents carries the same
construed meaning."). Accordingly, the court declines to
adopt Plaintiffs' broad construction, which finds no
support in the patent.
 The phrase "starting dose is not
adjusted relative to a patient without hepatic
impairment" appears in the wherein clause of claim 1 of
the '760 patent. The parties dispute whether the phrase
is a claim limitation. The court finds that the disputed
phase is a limitation, and, therefore, adopts Plaintiffs'
To support their contention that the disputed phrase
is not a limitation, Defendants cite to caselaw evidencing
that statements of purpose and result cannot be considered
limitations. (D.I. 74 at 14); Bristol-Myers
subsequent patent" Phillips v. AWHCorp, 415
F.3d 1303, 1333 (Fed. Cir. 2005) (Mayer, J., dissenting). The
Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368,
1375-77 (Fed. Cir. 2001). Defendants also argue that claim
phrases producing no manipulative difference in how the steps
of the claims are carried out cannot be considered
limitations. (D.I. 74 at 14); Minton v. Nat'l
Ass'n of Sec. Dealers, Inc., 336 F.3d 1373, 1380-81
(Fed. Cir. 2003) (finding that the phrase "whereby the
security is traded efficiently" did not inform the
"mechanics" of how the trade was executed, but
instead, characterized the result of the claim step,
"executing a trade of the security"). The court is
not persuaded by Defendants' citations because it finds
that adjusting the starting dose relative to a patient
without hepatic impairment is, in fact, a manipulative
difference over the prior art, not merely a statement of
purpose or result.
The Background of the Invention describes the
treatment of hepatic impairment with opioids prior to the
invention of the patents-in-suit. It states that opioids
"generally require reduced dosing in patients with
hepatic impairment, because the liver is the source of most
opioid metabolism." '760 patent, col. 2 1.
A2-AA. Because the liver regulates the effects of
opioids in the body, a hepatic impairment makes it difficult
for the liver to sufficiently control the effects of opioids.
As a result, if patients with a hepatic impairment are not
given a controlled, reduced dose of opioids that their liver
can manage, there is a risk of "excessive or persistent
sedation, coma or death." Id. col. 2 I. 47.
Receiving a reduced dose of the opioids, however, diminishes
some of the benefits of the drug. Therefore, there was a need
in the prior art for an opioid that could safely, yet
effectively, manage the pain of those with hepatic
impairments. For that reason, the ability of a patient with a
hepatic impairment to gain the same benefits from the opioid
that a non-hepatically impaired patient receives in just one
dose differs from the prior art. This is not a situation
where a "whereby clause in a method claim . . . simply
expresse[s] the intended result of a process step positively
recited." Minton, 336 F.3d at 1381. The
disputed phrase does have an effect on how the administering
step is performed-contrary to Defendants'
argument-because patients with hepatic impairment ingest a
different dose than they normally would, given the prior art.
As such, the claim phrase explaining that hepatically and