Galderma Laboratories LP et al. v. Teva Pharmaceuticals USA, Inc.
Filing
124
MEMORANDUM OPINION providing claim construction for multiple terms in U.S. Patent Nos. 8,815,816, 8,362,069, 9,089,587, 9,233,117, 9,233,118, and 9,782,425. Within five days the parties shall submit a proposed order consistent with this Memorandum Opinion. Signed by Judge Richard G. Andrews on 9/7/2018. (nms)
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
GALDERMA LABO RATORIES
L.P., GALDERMA S.A., and
NESTLE SKIN HEALTH S.A.,
Plaintiffs,
V.
Civil Action No . 1 :17-cv-01783-RGA
TEVA PHARMACEUTICALS USA,
INC. ,
Defendant.
MEMORANDUM OPINION
Jeremy A. Tigan, MORRIS, NICHOLS , ARSHT & TUNNELL LLP, Wilmington, DE; Michael
Wilson (argued), Jamil N. Alibhai (argued), Kelly P. Chen, and Chad Ray, MUNCK WILSON
MANDALA, LLP, Dallas, TX.
Attorneys for Plaintiffs.
Nathan R. Hoeschen, SHAW KELLER LLP, Wilmington, DE; Leora Ben-Ami (argued) and
Justin Bova, KIRKLAND & ELLIS, LLP, New York, NY; Kristen Reichenbach (argued),
KIRKLAND & ELLIS, LLP, San Francisco, CA.
Attorneys for Defendant.
1,
September
2018
A
~ r .~ ISTRlCT ......._..,.,:-;:;~
Presently before the Court is the issue of claim construction of multiple terms in U.S. Patent
Nos. 8,815,816 (the "' 816 Patent"), 8,362,069 (the "' 069 Patent"), 9,089,587 (the '" 587 Patent"),
9,233 ,117 (the '" 117 Patent"), 9,233 ,118 (the '" 118 Patent"), and 9,782,425 (the '" 425 Patent").
(D.I. 110 at 1).
The Court has considered the Parties' Joint Claim Construction Brief. (D.I. 110). The Court
heard oral argument on August 22, 2018. (D.I. 120 ("Tr.")).
I.
LEGAL STANDARD
"It is a bedrock principle of patent law that the claims of a patent define the invention to
which the patentee is entitled the right to exclude." Phillips v. AWH Corp., 415 F.3d 1303, 1312
(Fed. Cir. 2005) (en bane) (citation omitted). "' [T]here is no magic formula or catechism for
conducting claim construction.' Instead, the court is free to attach the appropriate weight to
appropriate sources ' in light of the statutes and policies that inform patent law. '" Soft View LLC v.
Apple Inc., 2013 WL 4758195 , at *1 (D. Del. Sept. 4, 2013) (quoting Phillips, 415 F.3d at 1324)
(alteration in original). When construing patent claims, a court considers the literal language of
the claim, the patent specification, and the prosecution history. Markman v. Westview Instruments,
Inc. , 52 F.3d 967, 979-80 (Fed. Cir. 1995) (en bane), aff'd, 517 U.S. 370 (1996). Of these sources,
"the specification is always highly relevant to the claim construction analysis. Usually, it is
dispositive; it is the single best guide to the meaning of a disputed term." Phillips, 415 F.3d at
1315.
"[T]he words of a claim are generally given their ordinary and customary meaning ....
[This is] the meaning that the term would have to a person of ordinary skill in the art in question
at the time of the invention, i.e., as of the effective filing date of the patent application." Id. at
1312-13. "[T]he ordinary meaning of a claim term is its meaning to [an] ordinary artisan after
reading the entire patent." Id. at 1321. "In some cases, the ordinary meaning of claim language
as understood by a person of skill in the art may be readily apparent even to lay judges and claim
construction in such cases involves little more than the application of the widely accepted meaning
of commonly understood words ." Id. at 1314.
When a court relies solely on the intrinsic evidence-the patent claims, the specification,
and the prosecution history- the court' s construction is a determination oflaw. See Teva Pharm.
USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831 , 841 (2015). The court may also make factual findings
based on consideration of extrinsic evidence, which "consists of all evidence external to the patent
and prosecution history, including expert and inventor testimony, dictionaries, and learned
treatises. " Phillips, 415 F.3d at 1317-19. Extrinsic evidence may assist the court in understanding
the underlying technology, the meaning of terms to one skilled in the art, and how the invention
works . Id. Extrinsic evidence, however, is less reliable and less useful in claim construction than
the patent and its prosecution history. Id.
"A claim construction is persuasive, not because it follows a certain rule, but because it
defines terms in the context of the whole patent." Renishaw PLC v. Marposs Societa ' p er Azioni,
158 F.3d 1243, 1250 (Fed. Cir. 1998). It follows that "a claim interpretation that would exclude
the inventor' s device is rarely the correct interpretation." Osram GMBH v. lnt 'l Trade Comm 'n,
505 F.3d 1351 , 1358 (Fed. Cir. 2007) (citation omitted).
II.
BACKGROUND
Plaintiffs assert six patents from three patent families against Defendant. (D.I. 110 at 1).
The ' 587 Patent, the ' 117 Patent, the ' 118 Patent, and the '425 Patent are members of the Jacovella
2
patent famil y. (Id.). The patents relate generally to methods and compositions for topical treatment
of rosacea with ivermectin.
The parties dispute terms in claims 1 and 7 of the ' 069 Patent. This patent relates to
"pharmaceutical compositions based on a compound of the avermectin family ." (' 069 Patent at
1:22-23). The following claim of the ' 069 Patent is representative:
1. A pharmaceutical/dermatological emulsion which comprises at least one fatty phase,
at least one aqueous phase and at least one avermectin compound, said at least one
fatty phase comprising at least one oily solvent other than a mineral or plant oil, said
avermectin compound being solubilized in said at least one oily solvent to form an
active phase, said active phase being devoid of any solvent for said avermectin
compound distinct from said at least one oily solvent; said emulsion consisting
essentially of:
a first fatty phase which is a solvent for the at least one avermectin compound, in
an amount of from 0.01 % to 25 % by weight, said first fatty phase
consisting essentially of at least one oily solvent selected from the group
consisting of diisopropyl adipate, PPG 15 stearyl ether, octyl dodecanol,
C1 2-C1 s alkyl benzoate and mixtures thereof;
a second fatty phase which is not a solvent for the at least one avermectin
compound, in an amount of up to 20% by weight, said second fatty phase
consisting essentially of at least one member selected from the group
consisting of silicone oils, mineral oils, stearyl alcohol, cetyl alcohol,
waxes, butters and mixtures thereof;
at least one avermectin compound;
at least one emulsifier, in an amount of 1% to 8% by weight;
a gelling agent, in an amount of up to 5% by weight;
an aqueous phase, in an amount of from 50% to 75 % by weight;
and one or more additives selected from the group consisting of humectants,
preservatives, anti-irritants, moisture regulators, pH regulators, osmotic
pressure modifiers, UV-A and UV-B screens and antioxidants.
(' 069 Patent, claim 1) (disputed terms italicized).
The parties dispute terms in claims 1, 2, and 11 of the '816 Patent. This patent relates to
"formulation of ivermectin into topical pharmaceutical compositions useful for the treatment of
rosacea." ('816 Patent at 1:50-53). The following claim of the ' 816 Patent is representative:
1. A method for treating rosacea, common acne, seborrheic dermatitis, perioral
dermatitis, an acneform rash, transient acantholytic dermatitis or acne necrotica
3
milliaris, comprising topically applying onto the affected skin area of an individual in
need of such treatment, a topical pharmaceutical emulsion which comprises: a thus
effective amount of ivermectin; an oily phase; at least one surfactant-emulsifier
selected from the group consisting of polyoxyethylenated fatty acid esters and
sorbitan esters; a mixture of solvents and/or propenetrating agents for the ivermectin,
said solvents and/or propenetrating agents being selected from the group consisting
ofpropylene glycol, ethanol, isopropanol, butanol, N-methyl-2-pyrrolidone, DMSO,
polysorbate 80, phenoxyethanol, glyceryl triacetate and oleyl alcohol; one or more
gelling agents but excluding aluminum magnesium silicate/titanium dioxide/silica;
and water; said emulsion having lamellar layers of liquid crystals and being
chemically stable over a period of 8 weeks.
(' 816 Patent, claim 1) (disputed terms italicized).
The parties dispute terms in claims 1, 2, 7, 8, 10, 15, 23 , and 29 of the ' 587 Patent. This
patent relates to "a method of treating inflammatory lesions of papulopustular rosacea." (' 587
Patent at 2:38-40). The following claim of the ' 587 Patent is representative:
1. A method of treating papulopustular rosacea or inflammatory lesions of rosacea in a
subject in need thereof, comprising topically administering, once daily, to a skin area
affected by the papulopustular rosacea or the inflammatory lesions of rosacea a
therapeutically effective amount of a pharmaceutical composition comprising about 0.1%
to about 1% by weight ivermectin and a pharmaceutically acceptable carrier to thereby
obtain an onset of a significant reduction in inflammatory lesion count in the subject 2
weeks after the initial administration of the pharmaceutical composition without coadministration of another active ingredient, wherein the subject has moderate to severe
papulopustular rosacea or 10 or more of the inflammatory lesions before the treatment.
(' 587 Patent, claim 1) (disputed terms italicized).
The parties dispute terms in claims 1, 5, and 6 of the ' 118 Patent. This patent relates to "a
method of treating inflammatory lesions ofpapulopustular rosacea. " (' 118 Patent at 2:38-40).
The following claim of the ' 118 Patent is representative:
1. A method of treatingpapulopustular rosacea in a subject in need thereof, comprising
topically administering, once daily, to a skin area affected by the papulopustular rosacea
a therapeutically effective amount of a pharmaceutical composition comprising about 1%
by weight ivermectin and a pharmaceutically acceptable carrier to thereby obtain a
significant reduction in inflammatory lesion count in the subject.
(' 118 Patent, claim 1) ( disputed terms italicized).
4
The parties dispute terms in claims 1, 2, 3, 4, 9, 10, 11 , 13, and 17 of the ' 425 Patent. The
' 425 Patents relates to "a method of treating inflammatory lesions of papulopustular rosacea. "
('425 Patent at 2:50-52). The following claim of the ' 425 Patent is representative:
1. A method oftreatingpapulopustular rosacea in a subject in need thereof, comprising
topically administering, once daily, to a skin area affected by the papulopustular rosacea
a therapeutically effective amount of a pharmaceutical composition comprising
ivermectin and a pharmaceutically acceptable carrier without co-administration of
another active pharmaceutical ingredient, wherein the pharmaceutical composition
comprises 0.5% to 1.5% by weight ivermectin.
(' 425 Patent, claim 1) (disputed terms italicized).
The parties agree on a construction for five additional terms. (D.I. 110 at 7-8).
III.
CONSTRUCTION OF DISPUTED TERMS
1.
"oily solvent"
a.
Plaintiffs ' proposed construction:
Plain and ordinary meaning, "an oil or oil-like compound that can dissolve
ivermectin"
b.
Defendant 's proposed construction:
"an organic solvent not miscible with water and excluding alcohols or glycols"
c.
Court 's construction:
"organic solvent not miscible with water that can dissolve ivermectin excluding
alcohols or glycols except octyl dodecanol"
This term appears in claims 1 and 7 of the ' 069 Patent. The parties agree that "the ' 069
Patent' s ' oily solvent' is a solvent for the avermectin compound that is part of an oily or fatty
phase of the composition." (D.I. 110 at 11 , 15). The parties further agree that a POSA would
understand an "oily solvent" to be "organic" and "not miscible with water." (Tr. at 15-16, 28).
5
However, the parties disagree on (1) the proper characteristics of an "oily solvent" to include in a
construction and (2) whether alcohols and glycols were disclaimed during prosecution.
Focusing on the first point of disagreement, Defendant argues that its definition including
"organic" and "not miscible with water" is consistent with the ' 069 Patent' s specification' s
description of an oily solvent. (D.I. 110 at 11-12). Defendant asserts that "the ' 069 Patent uses
[the concept of miscibility] when describing the two phases of an oil-in-water emulsion" and "the
POSA would have understood ' oily solvent' to refer to a ' solvent not miscible with water. "' (Id.
at 12). Defendant also notes that "miscibility (or immiscibility) with water is readily discemable
based on chemical structure." (Id. at 19). Plaintiffs broadly reject Defendant' s characterization of
"oily solvents," saying, "Teva' s two qualifiers are unnecessary .... " (Id. at 16). Considering
"organic," Plaintiffs argue that this "connotes any carbon-based solvent, not just oils or oil-like
compounds" and "is so broad . .. that it does nothing to clarify the term' s scope." (Id. at 9, 1516). Plaintiffs further argue that "not miscible with water" creates ambiguity. (Id. at 16).
With respect to Plaintiffs' proposed construction, Defendant argues that the term "oil-like"
is not contained in the specification and is inconsistent with the ' 069 Patent' s preferred solvent.
(Id. at 12). Plaintiffs respond that "oil-like" encompasses "fatty alcohols and esters preferred by
the inventors." (Id. at 15). At oral argument, Plaintiffs suggested that "oil-like" might mean
"[f]atty, oily, lipophilic, or just .. . that it's going to be part of the oily phase of this emulsion."
(Tr. at 14).
On the characterization of an "oily solvent," I largely agree with Defendant. As agreed by
the parties, Defendant's construction accurately characterizes an "oily solvent." Plaintiffs do not
provide a persuasive reason the agreed accurate construction is unhelpful. Furthermore, adopting
6
Plaintiffs' suggested "oil-like" construction, a term Plaintiffs admit is synonymous with "oily,"
does not clarify the term.
Regarding the second point of disagreement, Defendant argues that the patentees
disavowed alcohols and glycols to overcome an obviousness rejection based on the Manetta prior
art reference. (D.I. 110 at 13 (citing '069 Patent File History: Amendment (May 4, 2012) at 9-14
(D.I. 112 at App. 77-82)); see also U.S. Pat. Pub. No. 2006/0100165 ("Manetta")). Defendant
argues the disclaimer is evidenced by Applicants "attribut[ing] the ' surprisingly good physical and
chemical stability properties' of the claimed emulsions to a lack of alcohol or glycol." (D.I. 110
at 13 (citing ' 069 Patent File History: Amendment (May 4, 2012) at 12-13 (D.I. 112 at App. 7879))).
Plaintiffs argue that the inclusion of an alcohol as a solvent in the claims of the ' 069 Patent
precludes a finding of disclaimer. (Id. at 10). Defendant admits that "octyl dodecanol, a fatty
alcohol" is identified "as a solvent for avermectin" in the claims and specification of the ' 069
Patent. (Id. at 14). To overcome this apparent inconsistency, Defendant states that the inclusion
of octyl dodecanol "merely suggests that the patentees did not intend 'alcohol-type solvent' to
include the particular fatty alcohol octyl dodecanol." (Id.). Defendant argues that I should find
disclaimer of alcohols, except for octyl dodecanol, because the ' 069 Patent characterizes certain
alcohols as inferior and because a fatty alcohol, oleyl alcohol, "is one of the alcohols used by the
Manetta prior art." (Id.).
Additionally, Plaintiffs assert that "Manetta ... describe[s] formulations using certain
alcohols or glycols to solubilize ivermectin as part of the aqueous phase of an emulsion, whereas
all claims of the ' 069 Patent (proposed and issued) used oily solvents that dissolved the active
within the oily phase." (Id. at 17-18 (emphasis in original)). In response, Defendant points to the
7
argument made by the Applicants during prosecution that focuses on the solvent and makes no
mention of the aqueous/oily phase distinction. (Se e id. at 18-19). For example, when directly
addressing Manetta, Applicants argued, "Manetta repeatedly defines emulsions wherein an
avermectin compound (ivermectin) is required to be solubilized in [an] alcohol or glycol solvent
or the like." ('069 Patent File History: Amendment (May 4, 2012) at 10 (D.I. 112 at 78)).
Defendant asserts this contrasts with "the ' 069 Patent's claims requir[ing] solubilizing avermectin
in an ' oily solvent. "' (D.I. 110 at 19).
I agree that Applicants disclaimed alcohols and glycols during prosecution. "[A] patentee
may limit the meaning of a claim term by making a clear and unmistakable disavowal of scope
during prosecution. This may occur, for example, when the patentee explicitly characterizes an
aspect of his invention in a specific manner to overcome prior art." Purdue Pharma L.P. v. Endo
Pharm. Inc. , 438 F.3d 1123, 1136 (Fed. Cir. 2006) (citation omitted). The use of an "i.e." phrase
is strong evidence of an Applicant's characterization or definition of her invention.
See
SkinMedica, Inc. v. Histogen Inc. , 727 F.3d 1187, 1200 (Fed. Cir. 2013) ("[A] patentee's use of
'i.e. ' signals an intent to define the word to which it refers." (citation omitted)). Furthermore,
"there is no principle of patent law that the scope of a surrender of subject matter during
prosecution is limited to what is absolutely necessary to avoid a prior art reference that was the
basis for an examiner's rejection." Norian Corp. v. Stryker Corp. , 432 F.3d 1356, 1361 (Fed. Cir.
2005). During prosecution the Applicants argued, "Manetta repeatedly defines emulsions wherein
an avermectin compound (ivermectin) is required to be solubilized in [an] alcohol or glycol solvent
... " and that "there is clearly no appreciation in Manetta of the surprisingly good physical and
chemical stability properties resulting from solubilization . . . in ... at least one oily solvent .. . ."
('069 Patent File History: Amendment (May 4, 2012) at 10-13 (D.I. 112 at App. 78-81)).
8
Furthermore, Applicants explicitly characterized the invention as distinct from Manetta in this
way, stating, "Manetta provides neither a suggestion nor an expectation of success in doing what
the inventors have done (i.e. solubilizing [an] avermectin compound in said at least one oily solvent
to form an active phase as opposed to using [an] alcohol or glycol solvent, as required by
Manetta .[)]. " (Id. at 12 (D.I. 112 at App. 80)). Because Manetta discloses "oleyl alcohol" (a fatty
alcohol) as a solvent for ivermectin, the Applicants' statements characterizing their invention and
distinguishing Manetta must be read to disclaim this class of alcohols. (See Manetta at [48]).
Additionally, during prosecution Applicants amended claim 1 to include a limitation that
the invention was "devoid of alcohol and glycol solvent" to avoid an obviousness rejection based
on Manetta. ('069 Patent File History: Amendment (Sept. 15, 2011) at 2-13 (D.I. 112 at App. 4657)). Applicants ' effort to overcome Manetta with this amendment failed.
('069 Patent File
History: Office Action (Jan. 6, 2012) at 2-3 (D.I. 112 at App. 60-61)). Applicants subsequently
"cancelled Claim 1 without prejudice to or disclaimer of the subject matter thereof. " ('069 Patent
File History: Amendment (May 4, 2012) at 9 (D.I. 112 at App . 77)). However, the Applicants '
suggested limitation, in combination with the rest of the prosecution history, supports my
conclusions that Applicants understood the invention as devoid of alcohols and glycols and
overcame Manetta by disclaiming these compounds.
Moreover, Applicants did not reference the aqueous/oily phase distinction on which
Plaintiffs now rely. In fact, the intrinsic record shows that Applicants broadly differentiated the
alcohols and glycols of Manetta from the "oily solvents" described by the claims and ascribed the
positive characteristics of the invention to the non-alcohol or non-glycol nature of the solvent.
Although alcohols and glycols were disclaimed as a general matter, the patentee's inclusion
of octyl dodecanol in the claims of the ' 069 Patent provides some evidence that octyl dodecanol
9
was retained. Because Applicants unmistakably disavowed alcohols and glycols, while claiming
octyl dodecanol, I will include this limitation in the construction. 1
Therefore, I will construe "oily solvent" to mean "organic solvent not miscible with water
that can dissolve ivermectin excluding alcohols or glycols except octyl dodecanol. "
2.
"plant oil"
a.
Plaintiffs ' proposed construction:
Plain and ordinary meaning, "an oil obtained from a plant"
b.
Def endant 's proposed construction:
Indefinite or "oily substance or mixture that exists in a plant, including diisopropyl adipate"
c.
Court 's construction :
Plain and ordinary meaning, "oil obtained from a plant as differentiated from
mineral, animal, or synthetically obtained oils"
This term appears in claim 1 of the ' 069 Patent. The parties agree that a POSA would
understand that "di-isopropyl adipate" is not an oil. (Tr. at 56-57). The parties disagree as to (1 )
whether a POSA would understand "oil" to mean "oily," (2) whether a plant oil must be derived
from a plant, and (3) whether the patentee intended to classify di-isopropyl adipate as a "plant oil"
in the context of the ' 069 Patent.
As to the first point of disagreement, Defendant argues, " [T]he POSA would have
understood ' plant oil ' to refer to ' oily substance[s] or mixture[s] that exist[] in a plant. "' (D.I.
110 at 22). Plaintiffs respond, "Teva' s proposed construction ... expands the term ' oil ' to include
' oily substances ' that are not oils." (Id. at 24 (emphasis in original)). Plaintiffs also point out that
1
I gather that it does not matter to the parties whether octyl dodecanol was disclaimed.
10
the patentee used "oily" in the claims "when referring to claimed solvents like fatty alcohols and
esters that are not oils, but the narrower term ' oil' for the excluded plant oils." (Id. at 25). I agree
with Plaintiffs' position that "oil" and "oily" are distinct in the context of the claims. Therefore, I
will not adopt Defendant' s "oily" construction.
On the second point of disagreement, Defendant contends that the distinction between
"plant oils" and other oils is the "technical dichotomy between substances that can only be derived
in the lab and those that may also be found in nature." (Id. at 22). Defendant claims, "The POSA
would consider the compound itself, not the source, when classifying a substance as a 'plant oil'
or not." (Id. ). Plaintiffs respond, "[A] POSA would understand the term 'plant oil ' to refer to oils
extracted from plants supplied commercially as excipients." (Id. at 25). I agree with Plaintiffs.
The plain and ordinary meaning of "plant oil" refers to oils obtained from plants.
Regarding the third point of disagreement, Defendant argues, "[T]he patentee intended to
classify di-isopropyl adipate as a 'plant oil ' in the context of the ' 069 Patent." (Id. at 22-23 ).
Defendant admits that di-isopropyl adipate is not an oil. (Tr. 56-57). Despite the technical
inaccuracy of Defendant's proposed classification of di-isopropyl adipate, Defendant asserts that
"the ' 069 Patent incorporates by reference the entirety of WO 2005/089806 ("WO ' 806")." (Id.
at 23). 2 WO ' 806 lists di-isopropyl adipate among examples of "plant oils." (Id.). Plaintiffs
respond that the patentee did not consider "plant oil" to include di-isopropyl adipate. (Id. at 2021 ). Plaintiffs note, "[T]he specification and claims explicitly recite diisopropyl adipate as a
2
"Each patent, patent application, publication, text and literature article/report cited or indicated
herein is hereby expressly incorporated by reference in its entirety." ('069 Patent at 19:53-55).
There are at least seven references incorporated, including 1,930 pages of THE EXTRA
PHARMACOPOEIA (Martindale, 29 th ed. 1989). (' 069 Patent at 1:46-48). I doubt that such
wholesale incorporation by reference is a good practice.
11
preferred oily solvent." (Id. at 21 , 26; see also Tr. at 58). I agree with Plaintiffs. By its plain
language, the claim' s inclusion of diisopropyl adipate as an example of an oily solvent negates
Defendant' s construction, which is solely based on one statement incorporated by reference into
the specification. A POSA would understand that the specification is a better guide to the Patent's
scope than an incorporated reference.
In the alternative, Defendant argues that the ' 069 Patent' s incorporation ofreferences with
conflicting characterizations of "di-isopropyl adipate" renders the claims indefinite. 3 (D.I. 110 at
23). Defendant asserts, "If the POSA would have been uncertain as to whether di-isopropyl adipate
was excluded from the ' active phase' in claim 1 because of inconsistent information regarding
whether di-isopropyl adipate is a 'plant oil,' then the POSA would not have been reasonably certain
as to the scope of these claims." (Id.) . Plaintiffs respond that the POSA' s understanding of diisopropyl adipate combined with the teachings of the claims and specification overcome any doubt
cast by WO ' 806. (Id. at 27). I agree with Plaintiffs. The ' 069 Patent' s claims and specification
overwhelmingly characterize "di-isopropyl adipate" as a preferred solvent, and, therefore, not a
plant oil. Given this information, a POSA would understand "di-isopropyl adipate" is not a plant
oil.
Therefore, I will construe "plant oil" according to its plain and ordinary meaning: "an oil
obtained from a plant as differentiated from mineral, animal, or synthetically obtained oils."
3
Indefiniteness must be shown by clear and convincing evidence. See Sonix Tech. Co. v.
Publ 'ns Int '! Ltd, 844 F.3d 1370, 1377 (Fed. Cir. 2017).
12
3.
"a first fatty phase which is a solvent" and "a second fatty phase which is not a
solvent"
a.
Plaintiffs ' proposed construction:
A first fatty phase [which is a solvent] : one or more lipophilic compounds [which
is a solvent]
A second fatty phase [which is not a solvent]: one or more lipophilic compounds
[which is not a solvent]
b.
Defendant 's proposed construction:
"a first fatty phase" and "a second fatty phase" are indefinite.
Alternatively, "a first fatty phase" means "an immiscible liquid component[] of a
system that is separate from the aqueous and second fatty phase, into which the
avermectin is solubilized;" and
"a second fatty phase" means "an immiscible component of a system that is
separate from the aqueous and first fatty phases"
c.
Court 's construction:
A first fatty phase which is a solvent: "one or more lipophilic compounds which is
a solvent"
A second fatty phase which is not a solvent: "one or more lipophilic compounds
which is not a solvent"
This term appears in claim 1 of the ' 069 Patent.
Both parties agree that "the patent
describes oil-in-water emulsions consisting of two ' immiscible' phases-a fatty (oily) phase and
an aqueous phase." (Id. at 36). The parties disagree (1) whether a POSA would understand the
claim to require that the two fatty phases that make up the oily phase be immiscible as to each
other and (2) whether the two fatty phases render the claim indefinite.
As to the first point of disagreement, Defendant argues that "phase" means " [a]n entity of
a material system which is uniform in chemical composition and physical state." (Id. at 31 ).
Defendant describes "phase" in the context of an oil-in-water emulsion as "droplets of oil [that]
13
are separate and recognizable in the emulsion relative to the aqueous liquid in which those droplets
are dispersed. " (Id. at 30). Defendant asserts that a POSA understands this phenomenon to
encompass the concept of miscibility and proposes a definition of "phase" requiring complete
miscibility from the rest of a solution. (Id. at 31 ). Such a construction, Defendant concludes,
would require a product covered by claim 1 of the ' 069 Patent to be a complex multi-phase
emulsion. (Id. at 32, 40).
Plaintiffs counter that, as shown by many examples, the ' 069 Patent "uses the term ' phase'
more broadly to describe various components of the fatty and aqueous phases."
(Id. at 36
(emphasis in original)). According to Plaintiffs, the intrinsic record is clear on the meaning of
"phase" and superior to Defendant' s "abstract definition of the term ' phase ' in a general chemistry
dictionary. " (Id. at 39). Plaintiffs also respond that the ' 069 Patent' s specification provides an
understanding of the " second fatty phase" consistent with its proposed construction when it
"describes how to distinguish between compounds comprising each fatty phase, stating that the
second fatty phase ' means a lipophilic phase which comprises one or more lipophilic compounds
which are not solvents for the active agent."' (Id. at 28 (quoting ' 069 Patent at 3 :66-4:2)).
Plaintiffs further note that "nothing in the specification supports Teva' s position that the ' first ' and
' second' fatty phases must be ' separate' and immiscible with respect to each other." (Id. at 29
(emphasis in original)). Rather, "the specification describes mixing the fatty phases together and
' incorporating ' or ' introducing ' the blended fatty phase into the aqueous phase to form an
emulsion." (Id.) .
I agree with Plaintiffs because the quoted portion of the specification is lexicography. The
intrinsic evidence does not support Defendant' s contention that the "first" and "second" fatty
phases must be separate "entities" within the final emulsion. Rather, the intrinsic record is clear
14
that the "phases" refer to two components of the fatty phase - a component that is a solvent and a
component that is not.
On the second point of disagreement, Defendant argues that, regardless of the construction
I adopt, the "first" and "second" fatty phases are indefinite. (Id. at 33). Defendant asserts, " It is
unclear whether the patentees intended to claim an ' oil-in-water emulsion' or a multi-phase
composition, or whether the claim requires the emulsion to be made in a particular way. " (Id.).
The crux of Defendant's argument focuses on its assessment that "claim 1 on its face clearly
describes multi-phase emulsions," and that this would be inconsistent with a POSA' s
understanding as well as the examples provided in the specification. (Id.) . Plaintiffs respond that
Defendant' s expert agrees that a POSA would understand the final emulsion to contain a single
oily phase. (Id. at 37). In view of Defendant's expert' s agreement, Plaintiffs assert that a POSA
would have "no confusion that, in the context of the ' 069 Patent, ' phase' refers to components of
the composition having distinct functions or characteristics." (Id. at 37).
Defendant also supports its view of the claim and specification by identifying a patent
office rejection of a similar claim during the prosecution of a different, related patent. (Id. at 34).
Specifically, Defendant argues that because the patent examiner of U.S. Patent No. 9,592,249 (the
'" 249 Patent") required that the applicants clarify that the "'first' and ' second' ' fatty phases ' [are]
part of the ' active phase, "' this precludes construing the phrase to have such a requirement in the
'069 Patent. (Id. at 42). Plaintiffs respond that the '249 Patent' s "prosecution actually shows that
Galderma is correct." (Id. at 3 8). According to Plaintiffs, "It is clear from such prosecution history
that both the examiner and inventors understood and agreed that the specification discloses, and
the claims relate to, emulsions in which the two-recited fatty ' phases' are not separate and
imm[i}scible in the final emulsion." (Id. (emphasis in original)). That is, Plaintiffs' stance is that
15
the amendment adding a "comprising" limitation was simply making express an already inherent
limitation. (Id.).
I agree with Plaintiffs. The ' 069 Patent describes an active phase that is made up of "one
oily phase which is a solvent for the active agent" and "one fatty phase which is not a solvent for
the active agent." ('069 Patent at 3:54-65). A POSA provided with the specification and claim
would understand the invention to contain a fatty phase which is a solvent for the active ingredient
and a fatty phase which is not a solvent for the active ingredient. Furthermore, the prosecution
history of the '249 Patent, a patent extrinsic to the ' 069 Patent, provides at least some support for
Plaintiffs' stance that a POSA' s understanding of the claimed emulsion as having two distinct
phases is reflected in claim 1. Because a POSA would readily understand what the claimed
emulsion would look like, the language does not render the claim indefinite.
Therefore, I construe "a first fatty phase which is a solvent" to mean "one or more lipophilic
compounds which is a solvent" and "a second fatty phase which is not a solvent" to mean "one or
more lipophilic compounds which is not a solvent."
4.
"said emulsion having lamellar layers of liquid crystals"
a.
Plaintiffs ' proposed construction:
Plain and ordinary meaning
b.
Defendant 's proposed construction:
Indefinite or "where the liquid crystals formed in the emulsion are arranged in
layers/sheets that exhibit a long-range translational order along one direction, and
those lamellae layers exist in sufficient concentration and number to cause the
emulsion to be stable for at least 8 weeks"
c.
Court 's construction:
Plain and ordinary meaning
16
This term appears in the asserted claims of the ' 816 Patent. The parties agree "that a POSA
understands both the terms ' lamellar' and ' liquid crystal. "' (D.I. 110 at 48 ; Tr. at 78-79). The
parties dispute (1) whether the term is indefinite because it does not require a certain structure in
a particular amount and (2) whether "said emulsion having lamellar layers of liquid crystals" must
be present in sufficient quantities to stabilize the oil/water interface.
On the first point of disagreement, Defendant argues that the term is indefinite because
"the ' 816 Patent provides no guidance as to how to detect or measure these structures" and does
not "disclose a required concentration or otherwise instruct as to how to determine whether a
particular emulsion has ' lamellar layers of liquid crystals."'
(D.I. 110 at 46). Moreover,
attributing stabilization of the emulsion to the structures, Defendant argues, "The POSA would be
uncertain how much is needed to infringe these claims, since small amounts may be present and
undetectable, or else detectable without contributing substantially to the emulsion' s stability." (Id.
at 47). Plaintiffs respond, "The ' 816 Patent . . . require[s] . . . only that the emulsion has lamellar
layers of liquid crystals," not that they stabilize the emulsion or be present in a specific amount.
(Id. at 49). Furthermore, Plaintiffs argue, "[T]he POSA is aware of tools for detecting lamellar
liquid crystals within an emulsion." (Id.).
On this point I agree with Plaintiffs. A POSA would understand what it means to have
"lamellar layers of liquid crystals." The POSA is in possession of tools that can measure such
structures in an emulsion. The specification need not teach a technique for measuring the presence
of a structure if the technique is known in the art. Therefore, I find the term does not render the
asserted claims of the ' 816 Patent indefinite.
On the second point of disagreement, Defendant advocates for a construction requiring
"layers or sheets of liquid crystals that exhibit a long-range translational order along one direction
17
(i.e., in order to form each of the layers)" and that such structures provide stability to the emulsion.
(Id. at 47). In support of imposing a stability limitation, Defendant argues that "the example
compositions in the specification achieved stability for 8 to 12 weeks, and there is no other
mechanism identified in the specification as providing this stability." (Id. at 48). Plaintiffs respond
that there is no support in the specification for importing a "layers or sheets" limitation or a
"causing the emulsion to be stable for 8 weeks" limitation. (Id. at 44-45). Plaintiffs admit ,"[A]
POSA would expect the lamellar liquid crystals to contribute to the chemical stability disclosed
for the inventive emulsions," but note, "the specification does not state that the lamellar liquid
crystals are the sole reason that the disclosed chemical stability is achieved." (Id. at 51 ).
On this point I agree with Plaintiffs. The ' 816 Patent' s specification does not provide
support for either of Defendant's proposed limitations.
Thus, a POSA, considering the
specification, would not understand the crystal formations of the '816 Patent to be limited to layers
or sheets extending in a single direction. Furthermore, although "lamellar layers ofliquid crystals"
stabilize the emulsion, the specification does not attribute the stability of the emulsion exclusively
to such structures.
Therefore, I will construe "said emulsion having lamellar layers of liquid crystals" as
having its plain and ordinary meaning.
5.
"rosacea"
a.
Plaintiffs ' proposed construction:
"a chronic cutaneous disorder primarily of the convexities of the central face
(cheeks, chin, nose, and central forehead), encompassing various combinations of
such cutaneous signs as flushing, erythema, telangiectasia, edema, papules,
pustules, ocular lesions, and rhinophyma"
18
b.
Defendant 's proposed construction:
"a chronic inflammatory skin condition, which includes symptoms of erythema,
papules, pustules, nodules, or inflammatory lesions"
c.
Court 's construction:4
"chronic inflammatory eruption of the nose and adjoining flush areas of the face
characterized by erythema, papules, pustules, and telangiectasia"
This term appears in the asserted claims of the ' 816 Patent. The parties agree that the
' 816 Patent does not expressly define "rosacea." (Id. at 52-53 , 55). The parties disagree whether
the intrinsic record provides a definition of "rosacea."
Defendant argues for a construction drawn from U.S . Patent No . 6,133,310 ("Parks"),
which is incorporated by reference into the ' 816 Patent. Plaintiffs argue that Defendant's
construction excludes several symptoms that Parks describes such as '" telangiectasia,' ' eruption
of the nose,' affected ' eye or eyelids,' and ' flushing ."' (Id. at 58).
Plaintiffs advocate a construction drawn from a 2002 expert committee report (" Wilkin").
(Id. at 53 ; D.I. 112 at App. 578-82). Defendant notes that Plaintiffs ' draws its definition from
extrinsic evidence. (D.I. 110 at 55). Defendant also argues that Plaintiffs' construction adds
unnecessary complexity by including ocular symptoms. (Id. at 55).
I largely agree with Defendant. Parks, as part of the intrinsic record, provides the best
evidence of what the patentee meant by "rosacea. " (See ' 816 Patent at 2:26-40). Wilkin is
4
"Rosacea" and "papulopustular rosacea" (the next term) are terms of art. Both sides have
proposed constructions. I am uncertain whether there is a real dispute here, as I doubt that there
would be debate among medical doctors over whether a patient did or did not have rosacea or
papulopustular rosacea. I am not sure there is any benefit achieved by adopting the constructions
I am adopting.
19
extrinsic evidence and I will not consider it because the intrinsic evidence provides a clear
definition. Drawing my construction directly from Parks, I construe "rosacea" as "a chronic
inflammatory eruption of the nose and adjoining flush areas of the face characterized by
erythema, papules, pustules, and telangiectasia." (Se e Parks at 1 :4-8).
6.
"papulopustular rosacea" ("PPR")
a.
Plaintiffs' proposed construction:
"rosacea subtype 2, a chronic inflammatory disorder characterized by facial
papules, pustules, and erythema"
b.
Defendant 's proposed construction:
"chronic inflammatory disorder characterized by facial papules, pustules,
persistent erythema, and the presence of inflammatory infiltrates that accompany
flares"
c.
Court's construction:
"chronic inflammatory disorder characterized by facial papules, pustules,
persistent erythema, and the presence of inflammatory infiltrates that accompany
flares"
This term appears in the asserted claims of the ' 587, ' 118, and ' 425 Patents. The parties
disagree (1) whether the construction should include "subtype 2" and (2) whether "inflammatory
infiltrate that accompany flares" is helpful.
On the first point of disagreement, Plaintiffs argue that "all of the Jacovella Patents cite to
and rely on the 2002 Wilkin report describing PPR as a subtype of rosacea. " (D.I. 110 at 53).
Furthermore, "the ' 117 Patent describes PPR as one of four rosacea subtypes." (Id.). Plaintiffs
argue that because "the' 117, '587, '425, and' 118 Patents all derive from the same priority
application and share many common terms, the Court ' must interpret the claims consistently
across all asserted patents. "' (Id. at 59 (citing SightSound Techs., LLC v. Apple Inc., 809 F.3d
1307, 1316 (Fed. Cir. 2015)). Defendant responds that the content of the '587 Patent's
20
specification controls over Wilkin because the Applicants did not incorporate Wilkin into the
patent's definitions. (Id. at 57). Additionally, Defendant asserts, "Although the ' 117 patent
shares a priority claim with the ' 587, '425, or ' 118 patents, these patents are not related." (Id. at
56).
The proper characterization of PPR symptoms presents a second point of disagreement.
Defendant advocates for a construction derived fully from the specification of the ' 587 Patent.
(Id. at 56). Plaintiffs respond that Defendant' s "definition describes the clinical characterization
of PPR (e.g., the 'presence of inflammatory infiltrates that accompany flares ') and does not assist
a POSA in understanding the claim term." (Id. at 59).
I agree with Defendant' s construction. The parties agree that Defendant's proposed
construction is an accurate clinical characterization of PPR. (Id. at 59). Furthermore, the ' 587
Patent's specification provides the best evidence of what the patentee meant by "papulopustular
rosacea. " The fact that the ' 117 Patent mentions PPR as a subtype of rosacea does not overcome
the strength of a construction drawn directly from the ' 587 Patent' s specification, does not
establish that "subtype 2" is helpful, and does not mean that the Court is construing terms
inconsistently across related patents. Drawing my construction directly from the ' 587 Patent, I
construe "papulopustular rosacea" to mean "a chronic inflammatory disorder characterized by
facial papules, pustules, persistent erythema, and the presence of inflammatory infiltrates that
accompany flares. "
21
7.
a mixture of solvents and/or propenetrating agents for the ivermectin, said solvents
and/or propenetrating agents being selected from the group consisting of propylene
glycol, ethanol, isopropanol, butanol, N-methyl-2-pyrrolidone, DMSO, polysorbate
80, phenoxyethanol, glyceryl triacetate and oleyl alcohol
a.
Plaintiffs ' proposed construction:
Plain and ordinary meaning
b.
Defendant 's proposed construction:
"a mixture of solvents and/or propenetrating agents in the emulsion that must be a
mixture of at least two of propylene glycol, ethanol, isopropanol, butanol, Nmethyl-2-pyrrolidone, DMSO, polysorbate 80, phenoxyethanol, glyceryl triacetate
and oleyl alcohol or mixtures thereof, but cannot include any other solvents
and/or propenetrating agents"
c. Court 's construction:
"a mixture of solvents and/or propenetrating agents in the emulsion that must be a
mixture of at least two of propylene glycol, ethanol, isopropanol, butanol, Nmethyl-2-pyrrolidone, DMSO, polysorbate 80, phenoxyethanol, glyceryl triacetate
and oleyl alcohol or mixtures thereof, but cannot include any other solvents
and/or propenetrating agents"
This term appears in the asserted claims of the ' 816 Patent. The parties agree that this phrase
contains a Markush group. (Id. at 65, 67). The parties dispute whether the claimed "mixture of
solvents" can include solvents other than those recited in the claim.
Plaintiffs argue that the claim language overcomes the "presumption that a Markush group is
closed to mixtures or combinations of the recited elements." (Id. at 60). "If a patentee desires
mixtures or combinations of the members of the Markush group, the patentee [needs] to add
qualifying language while drafting the claim." Abbott Labs. v. Baxter Pharm. Prods., Inc., 334
F.3d 1274, 1281 (Fed. Cir. 2003). Plaintiffs submit that "mixtures" is such qualifying language.
(D.I. 110 at 60). Specifically, Plaintiffs argue that "mixtures" allows emulsions that include the
named solvents plus other unnamed solvents. (D.I. 110 at 60-61). In support of this contention,
22
Plaintiffs cite a case construing "mixtures" outside of the context of a Markush group. (Id. at 61
(citing Mars, Inc. v. HJ Heinz Co., 377 F.3d 1369, 1376 (Fed. Cir. 2004))). Plaintiffs argue that
Mars stands for the general proposition that "mixtures" are never closed to unnamed ingredients.
(Id.).
Defendant appears to agree that the Markush presumption was overcome to a degree, but not
to the extent argued by Plaintiffs. Defendant argues, "The patentees' use of the language
' selected from the group consisting of in claims 1, 2 and 11 of the ' 816 Patent indicates clear
intent to apply the legal effect of that phrase, which is to close the group to additional members,
i.e., additional ' solvents and/or propenetrating agents. "' (Id. at 62). In response to Plaintiffs'
argument that "mixtures" vitiates a Markush group, Defendant asserts, "[T]he word ' mixtures '
inside the Markush group allows for mixtures of the listed Markush members, which Teva does
not dispute. Plaintiffs' proposal, however, would open the claim to mixtures with solvents
and/or propenetrating agents not listed in the Markush group ... ." (Id at 64-65 (emphasis in
original)). This, Defendant argues, "improperly changes the ' consisting of language into
' comprising' language." (Id. at 65).
Plaintiffs also argue that construing the Markush group to exclude other solvents contradicts
the specification. (Id. at 61 ). Specifically, Plaintiffs note that the specification describes
diisopropyl adipate, a solvent for ivermectin, as "part of the ' oily phase' that may also be a
solvent for ivermectin-despite not being listed in the Markush group of a ' mixture of
solvents."' (Id.) . Defendant responds that its construction is not inconsistent with the
specification. (Id. at 65). Rather, the specification lists diisopropyl adipate as a part of the oily
phase, a different part of the mixture than the active phase described by the Markush group.
(Id.).
23
I agree with Defendant. " [I]f a patent claim recites ' a member selected from the group
consisting of A, B, and C,' the ' member' is presumed to be closed to alternative ingredients D, E,
and F." Multilayer Stretch Cling Film Holdings, Inc. v. Berry Plastics Corp., 831 F.3d 1350,
1358 (Fed. Cir. 2016). Defendant' s construction gives "mixtures" its proper legal effect by
limiting the solvents and/or propenetrating agents but allowing additional non-solvents and/or
propenetrating agents elements to be included. The "mixtures" language requires that the
solvents and/or propenetrating agents contain two or more of the listed solvents and/or
propenetrating agents. It therefore serves a purpose in the phrase being construed, without
converting the Markush group into a comprising claim.
Therefore, I construe "a mixture of solvents and/or propenetrating agents for the ivermectin,
said solvents and/or propenetrating agents being selected from the group consisting of propylene
glycol, ethanol, isopropanol, butanol, N-methyl-2-pyrrolidone, DMSO, polysorbate 80,
phenoxyethanol, glyceryl triacetate and oleyl alcohol" to mean "a mixture of solvents and/or
propenetrating agents in the emulsion that must be a mixture of at least two of propylene glycol,
ethanol, isopropanol, butanol, N-methyl-2-pyrrolidone, DMSO, polysorbate 80, phenoxyethanol,
glyceryl triacetate and oleyl alcohol or mixtures thereof, but cannot include any other solvents
and/or propenetrating agents. "
8.
"to thereby obtain an onset of a significant reduction in inflammatory lesion count
in the subject 2 weeks after the initial administration of the pharmaceutical
composition"
a.
Plaintiffs ' proposed construction:
Plain and ordinary meaning
b.
Defendant 's proposed construction:
24
Indefinite
c.
Court's construction:
"to thereby obtain a statistically significant reduction in inflammatory lesion
count at or before two weeks" 5
This term appears in asserted claims of the ' 587 and ' 425 Patents. 6 The parties agree that
"significant reduction" means "reduction/improvement that is statistically significant, not due to
chance alone, which has a p-value of 0.05 or less." (D.I. 110 at 7). The parties dispute whether
"onset" is amenable to construction in the context of the claims.
Defendant argues, " [I]nconsistent use of the word ' onset' coupled with an unclear and
subjective plain meaning render asserted claims 1, 10, 15, and 29 of the '587 Patent and claims 4
and 13 of the ' 425 Patent invalid as indefinite." (Id. at 70). First, Defendant notes that coupling
dictionary definitions of "onset" with the agreed construction of "significant reduction" "leads to
a nonsensical result. " (Id. at 71). In Defendant's view, such a dictionary-based construction
would be "directed to obtaining or observing the ' beginning ' of a statistically significant belief,
based on past experimental results, that reduction of inflammatory lesion count will occur in
another, future patient." (Id. at 71-72). Defendant further argues, "Ignoring the statistical nature
of this phrase would . .. not save these claims" because '" onset' must still correspond to the
' beginning or start' of something." (Id. at 72 (emphasis omitted)). According to Defendant, the
5
The somewhat different phrase, "wherein an onset of a significant reduction in inflammatory
lesion count in the subject is observed 2 weeks after the initial administration," should be
construed similarly. ('425 Patent, claims 4, 13; ' 587 Patent, claims 10, 29).
6
This is the full term in claims 1 and 15 of the ' 587 patent. The language that is consistent in all
the asserted claims of the ' 587 and ' 425 Patents is "an onset of a significant reduction in
inflammatory lesion count in the subject." I think the analysis is the same regardless of the
varying language in the remaining claims.
25
potential "something" that might represent a "beginning or start" is subjective much like "the
onset of a cold." (Id.). Plaintiffs respond, "A POSA would understand that the term ' onset'
means the beginning or start of a detectable clinical improvement." (Id. at 75).
Defendant asserts, " It is also incorrect to equate the claimed 'onset' with the ' significant
reduction' itself." (Id. at 73). This is true, Defendant argues, because, "The prosecution history
and the language of the claims themselves demonstrate that the patentees intended an ' onset of a
significant reduction in inflammatory lesion count' to be something different and distinct from ' a
significant reduction."' (Id.) . As evidence, Defendant points to the relationship between
independent claim 8 and dependent claim 10 where an "onset" must be "something different and
discrete." (Id.). Additionally, Defendant urges that the prosecution history requires the
distinction because Applicants added the "onset" limitation to overcome prior art. (Id. at 74).
Plaintiffs respond that the claims were amended to add not only "onset," but also "2 weeks after
initial administration." (Id. at 76). The patent office allowed the claims because of the
unexpected nature of the early onset. (Id.) .
I agree with Plaintiffs that the phrase does not render the claims indefinite. The ' 857
Patent' s specification discusses how "[t]his early onset of significant effectiveness is unexpected
and surprising in comparison with the conventional treatments." (' 587 Patent 4:62-64). "This
early onset" refers to "at two weeks after the initial treatment, about 30% (p<0.001) and 27.3 %
(p<0.01) median reduction of the inflammatory lesion counts . . .. " (Id. at 4:55-57). A POSA
considering the specification, would understand that "onset ... 2 weeks after initial
administration" refers to the timing of an observable, statistically significant, clinical
improvement.
26
Therefore, I construe "to thereby obtain an onset of a significant reduction in
inflammatory lesion count in the subject 2 weeks after the initial administration of the
pharmaceutical composition" to mean "to thereby obtain a statistically significant reduction in
inflammatory lesion count at or before two weeks."
9.
"without co-administration of another active ingredient"
a.
Plaintiffs ' proposed construction:
Plain and ordinary meaning
b.
Defendant 's proposed construction:
"without treating with any other active ingredient at any time throughout the
course of therapy"
c.
Court 's construction:
"without co-administration of another active ingredient as part of the therapy"
This term appears in the asserted claims of the ' 587 and ' 425 Patents. The parties dispute
whether "co-administration of another active ingredient" extends to treatment of a patient with
any other active ingredient for any reason.
Defendant argues that this negative limitation should be construed to foreclose a patient
taking any other medication for any reason. (See D.I. 110 at 82). As support for this sweeping
limitation, Defendant points to clinical studies cited in the ' 587 Patent' s specification and a
dictionary describing '" coadministration' as ' giving of two or more therapeutic agents at the
same time."' (Id. at 81-82). Plaintiffs respond that Defendant' s "construction is overly
restrictive because it improperly limits the use of any active ingredient even if the active
ingredient is for something other than the PPR treatment, e.g., a headache or high blood
27
pressure." (Id. at 83). Plaintiffs argue, "[T]he construction should make clear that the claims
require no other treatment/or PPR during the ivermectin regimen. " (Id. (emphasis in original)).
I agree with Plaintiffs that the "without co-administration" negative limitation is not so
broad as to cover all medication taken by a patient for any reason. The fact that clinical studies
limit unrelated medications, as a matter of course, is not persuasive evidence of the patentee' s
intent regarding "without co-administration." Therefore, the term is properly construed to
exclude therapeutic treatment of PPR with any other active ingredient, but not use of active
ingredients for other, unrelated ailments.
Therefore, I construe "without co-administration of another active ingredient" to mean
"without co-administration of another active ingredient as part of the therapy. "
IV.
CONCLUSION
Within five days the parties shall submit a proposed order consistent with this
Memorandum Opinion.
28
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