H. Lundbeck A/S et al v. Lupin Limited, et al
Filing
357
MEMORANDUM OPINION re claim construction. Signed by Judge Leonard P. Stark on 7/16/19. (ntl)
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
H. LUNDBECK A/S, et al. ,
Plaintiffs,
C.A. No. 18-88-LPS
V.
APOTEX INC., et al.,
Defendants.
Jack B. Blumenfeld and Megan E. Dellinger, MORRIS , NICHOLS, ARSHT & TUNNELL LLP,
Wilmington, DE
George F. Pappas, Einar Stole, Christopher N. Sipes, Brianne Bharkhda, Priscilla G. Dodson,
Alaina Whitt, and Allison Schmitt, COVINGTON & BURLING LLP, Washington, DC
Yiye Fu, COVINGTON & BURLING LLP, Palo Alto, CA
Attorneys for Plaintiffs
Kelly E. Farnan and Nicole K. Pedi, RICHARDS , LAYTON & FINGER, P.A., Wilmington, DE
Bradley C. Graveline, SHEPPARD MULLIN RICHTER & HAMPTON LLP, Chicago, IL
Jesse A. Salen, SHEPPARD MULLIN RICHTER & HAMPTON LLP, San Diego, CA
April E. Weisbruch, SHEPPARD MULLIN RICHTER & HAMPTON LLP, Washington, DC
Attorneys for Alembic Pharmaceuticals Limited, Alembic Global Holdings S/ A, and
Alembic Pharmaceuticals, Inc.
Adam W. Poff and Pilar G. Kraman, YOUNG CONAWAY STARGATT & TAYLOR, LLP,
Wilmington, DE
Dennies Varughese, Robert C. Millonig, Daniel J. Ritterbeck, and Stephanie M. Nguyen,
STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C., Washington, DC
Attorneys for Alkem Laboratories Ltd.
Karen L. Pascale and Robert M. Vrana, YOUNG CONAWAY STARGATT & TAYLOR LLP,
Wilmington, DE
William L. Mentlik, Tedd W. Van Burskirk, Aaron S. Eckenthal, LERNER, DAVID,
LITTENBERG, KRUMHOLZ & MENTLIK, LLP, Westfield, NJ
Attorneys for Cipla Limited and Cipla USA Inc.
Kenneth L. Dorsney, MORRIS JAMES LLP, Wilmington, DE
Richard T. Ruzich, Stephen R. Auten, Ian Scott, and Philip Y. Kouyoumdjian,
TAFT STETTINIUS & HOLLISTER LLP, Chicago IL
Attorneys for Apotex Corp., Apotex Inc. and Apotex Research Private Limited.
Kenneth L. Dorsney, MORRIS JAMES LLP, Wilmington, DE
Howard S. Suh and Nicholas P. Chiara, HOLLAND & KNIGHT LLP, New York, NY
Attorneys for Apicore US LLC.
Geoffrey Grivner, BUCHANAN INGERSOLL & ROONEY PC, Wilmington, DE
Matthew L. Fedowitz, Erin M. Dunston, and Mythili Markowski, BUCHANAN INGERSOLL &
ROONEY PC, Alexandria, VA
Phillip L. Hirschhorn, BUCHANAN INGERSOLL & ROONEY PC, New York, NY
Attorneys for MSN Private Laboratories Limited, MSN Pharmaceuticals, Inc., and MSN
Pharmachem Private Limited.
Kelly E. Farnan and Sara M. Metzler, RICHARDS, LAYTON & FINGER, P.A.,
Wilmington, DE
B. Jefferson Boggs, MERCHANT & GOULD PC, Alexandria, VA
Christopher J. Sorenson, MERCHANT & GOULD PC, Minneapolis, MN
Attorneys for Macleods Pharmaceuticals Ltd. and Macleods Pharma USA, Inc.
Dominick T. Gattuso, HEYMAN ENERIO GATTUSO & HIRZEL LLC, Wilmington, DE
Laura A. Lydigsen, Joshua E. Ney, and Judy K. He, BRINKS GILSON & LIONE, Chicago, IL
Attorneys for Sandoz Inc. and Lek Pharmaceuticals d.d.
John C. Phillips Jr. , David A Bilson, and Megan C. Haney, PHILLIPS GOLDMAN
MCLAUGHLIN & HALL, P.A., Wilmington, DE
Paul A. Braier, P. Branko Pejic, and Michael J. Fink, GREENBLUM & BERNSTEIN, P.L.C.,
Reston, VA
Attorneys for Unichem Laboratories, Limited.
Arthur G. Conolly III, CONNOLY GALLAGHER LLP, Wilmington, DE
H. Keeto Sabharwal, Ceric C.Y. Tan, and Yun Wei, PILLSBURY WINTRHOP SHAW
PITTMAN LLP, Washington, DC
Attorneys for Torrent Pharmaceuticals Limited and Torrent Pharma Inc.
John C. Phillips Jr, David A. Bilson, and Megan C. Haney, PHILLIPS GOLDMAN
MCLAUGHLIN & HALL, P.A, Wilmington, DE
Marc R. Wezowski, Don J. Mizerk, and David A. Gerasimow, HUSCH BLACKWELL LLP,
Chicago, IL
Thomas P. Heneghan, HUSCH BLACKWELL LLP, Madison, WI
Daisy Manning, HUSCH BLACKWELL LLP, St. Louis, MO
Attorneys for Sigmapharm Laboratories, LLC.
MEMORANDUM OPINION
July 16, 2019
Wilmington, Delaware
STARK, .S.Distrif J~
Plaintiffs brought this suit against Defendants asserting infringement of U.S. Patent Nos.
8,772684 (the '"684 patent"), 8,969,355 (the '"355 patent"), 9,227,946 (the '"946 patent"), and
9,861,630 (the "'630 patent") (the "Crystalline Form Patents"), among others. Presently before
the Court is the issue of claim construction. The parties 1 submitted technology tutorials (D.I.
213,214), objections to such technology tutorials (D.I. 229,231), claim construction briefs (D.I.
200,201,230,232, 251,253), exhibits (D.I. 201-1 , 202-1, 230,232,251 , 253), and expert
declarations (D.I. 203 , 204, 205, 206, 233). The Court held a claim construction hearing on May
29, 2019, at which both sides presented oral argument. (D.I. 263 ("Tr."))
I.
LEGAL ST AND ARDS
The ultimate question of the proper construction of a patent is a question of law. See
Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831 , 837 (2015) (citing Markman v. Westview
Instruments, Inc., 517 U.S. 370, 388-91 (1996)). "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. AWHCorp. , 415 F.3d 1303, 1312 (Fed. Cir. 2005) (citation and internal quotation
marks omitted). "(T]here is no magic formula or catechism for conducting claim construction."
Id. at 1324. Instead, the court is free to attach the appropriate weight to appropriate sources "in
light of the statutes and policies that inform patent law." Id.
1
The following defendants join in the proposed constructions of all disputed terms:
Alembic, Alkem, Apicore, Apotex, Macleods, MSN, Sigmapharrn, Torrent, and Unichem. (See
D.I. 262-1 at 10) The following two defendants join in all proposed constructions, but do not
join the argument that the term "alleviates/alleviating" is indefinite: Cipla and Sandoz. (See id.)
The following four defendants do not join in any of the proposed constructions: Hetero, Lupin,
Prinston, and Zydus. (See id.) Throughout this opinion, the term "Defendants" is intended to
apply to only those defendants that join in the argument being discussed.
1
"[T]he words of a claim are generally given their ordinary and customary meaning ... .
[which 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 (internal citations and quotation marks omitted). " [T]he ordinary meaning of a
claim term is its meaning to the ordinary artisan after reading the entire patent." Id. at 1321
(internal quotation marks omitted). The patent "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." Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996).
While "the claims themselves provide substantial guidance as to the meaning of
particular claim terms," the context of the surrounding words of the claim also must be
considered. Phillips, 415 F.3d at 1314. Furthermore, "[o]ther claims of the patent in question,
both asserted and unasserted, can also be valuable sources of enlightenment .... [b]ecause claim
terms are normally used consistently throughout the patent." Id. (internal citation omitted).
It is likewise true that " [d]ifferences among claims can also be a useful guide .... For
example, the presence of a dependent claim that adds a particular limitation gives rise to a
presumption that the limitation in question is not present in the independent claim." Id. at 131415 (internal citation omitted). This "presumption is especially strong when the limitation in
dispute is the only meaningful difference between an independent and dependent claim, and one
party is urging that the limitation in the dependent claim should be read into the independent
claim." SunRace Roots Enter. Co., Ltd. v. SRAM Corp., 336 F.3d 1298, 1303 (Fed. Cir. 2003).
It is also possible that "the specification may reveal a special definition given to a claim
term by the patentee that differs from the meaning it would otherwise possess. In such cases, the
inventor's lexicography governs." Phillips, 415 F.3d at 1316. It bears emphasis that " [e]ven
2
when the specification describes only a single embodiment, the claims of the patent will not be
read restrictively unless the patentee has demonstrated a clear intention to limit the claim scope
using words or expressions of manifest exclusion or restriction." Hill-Rom Servs. , Inc. v. Stryker
Corp., 755 F.3d 1367, 1372 (Fed. Cir. 2014) (quoting Liebel-Flarsheim Co. v. Medrad, Inc., 358
F.3d 898, 906 (Fed. Cir. 2004)) (alteration in original) (internal quotation marks omitted).
In addition to the specification, a court "should also consider the patent's prosecution
history, if it is in evidence." Markman v. Westview Instruments, Inc., 52 F.3d 967,980 (Fed. Cir.
1995), aff'd, 517 U.S. 370 (1996). The prosecution history, which is "intrinsic evidence,"
"consists of the complete record of the proceedings before the [Patent and Trademark Office]
and includes the prior art cited during the examination of the patent." Phillips, 415 F.3d at 1317.
" [T]he prosecution history can often inform the meaning of the claim language by demonstrating
how the inventor understood the invention and whether the inventor limited the invention in the
course of prosecution, making the claim scope narrower than it would otherwise be." Id
"In some cases, ... the district court will need to look beyond the patent's intrinsic
evidence and to consult extrinsic evidence in order to understand, for example, the background
science or the meaning of a term in the relevant art during the relevant time period." Teva, 135
S. Ct. at 841 . "Extrinsic evidence consists of all evidence external to the patent and prosecution
history, including expert and inventor testimony, dictionaries, and learned treatises." Markman,
52 F.3d at 980. For instance, technical dictionaries can assist the court in determining the
meaning of a term to those of skill in the relevant art because such dictionaries "endeavor to
collect the accepted meanings of terms used in various fields of science and technology."
Phillips, 415 F.3d at 1318. In addition, expert testimony can be useful "to ensure that the court' s
understanding of the technical aspects of the patent is consistent with that of a person of skill in
3
the art, or to establish that a particular term in the patent or the prior art has a particular meaning
in the pertinent field. " Id. Nonetheless, courts must not lose sight of the fact that "expert reports
and testimony [are] generated at the time of and for the purpose of litigation and thus can suffer
from bias that is not present in intrinsic evidence." Id. Overall, while extrinsic evidence "may
be useful to the court," it is "less reliable" than intrinsic evidence, and its consideration "is
unlikely to result in a reliable interpretation of patent claim scope unless considered in the
context of the intrinsic evidence." Id. at 1318-19. Where the intrinsic record unambiguously
describes the scope of the patented invention, reliance on any extrinsic evidence is improper.
See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1308 (Fed. Cir. 1999) (citing
Vitronics , 90 F.3d at 1583).
Finally, "[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."
Renishaw PLC v. Marposs Societa ' per 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. Int '! Trade Comm 'n, 505 F.3d 1351 , 1358 (Fed. Cir. 2007)
(quoting Modine Mfg. Co. v. US. Int '! Trade Comm 'n, 75 F.3d 1545, 1550 (Fed. Cir. 1996)).
4
II.
CONSTRUCTION OF DISPUTED TERMS
A.
"characterized by an XRPD [pattern] as shown in [any of] FIG[S] ... "2
Plaintiffs
No construction necessary
Alternatively, "identifiable by reference to an x-ray powder diffraction pattern as shown in
rany ofl FIGrSl ... "
Defendants
"having an XRPD pattern with all the peaks and corresponding relative intensities shown in
the recited Figure[ s]"
Alternatively, the claim is indefinite
Court
"identifiable by reference to an x-ray powder diffraction pattern as shown in [any of]
FIG[Sl . .. "
Claim 1 of the ' 684 patent is representative and claims a compound "in a crystalline form
characterized by an XRPD pattern as shown in any of FIGS . 1-17." It is undisputed that each of
Figures 1-1 7 in the ' 684 patent shows an XRPD pattern for a particular crystalline form, which
corresponds to the specific examples set forth in the specification. (See D.I. 200 at 5; D.I. 232 at
4; see also '684 patent at 2:46-65) It also appears to be undisputed that it is scientifically
impossible to consistently obtain identical XRPD patterns even for the same crystalline form,
and that the specification and claims allow for experimental error. 3 (See D.I. 201 at 10; D.I. 230
at 4; D.I. 253 at 1; Tr. at 28-31) In fact, the specification expressly provides the maximum
2
This term appears in claims 1 and 3 of the ' 684 patent, claims 2, 5, and 7 of the ' 355
patent, claim 2 of the '946 patent, and claims 3 and 6 of the ' 630 patent.
3
While Defendants stated at oral argument that "experimental error is [not] part of the
claims," Defendants also repeatedly argued that experimental error is specified in the claims and
specification. (See Tr. at 28-31 )
5
amount of experimental error permitted for the four major peak positions; claims 2 and 3 also
specify a margin of experimental error. (See D.I. 230 at 4; ' 684 patent at 4:50-67 & els. 2-3)4
Even though it appears that Defendants ultimately agree that experimental error is
permitted, their proposed construction, which requires "all the peaks and corresponding relative
intensities" shown in the Figures, suggests that an exact match to an XRPD pattern in the Figures
is necessary for there to be infringement. (See D.I. 201 at 10; Tr. at 31-32) Defendants also fail
to present any evidence supporting the relative intensities limitation in their proposed
construction. (See Tr. at 46-48) As Plaintiffs note, the patents never mention relative intensities,
and focus on peak positions. (See D.I. 201 at 10) As Plaintiffs' expert, Dr. Myerson, opines,
there is considerable variability as to peak intensity, so a POSA 5 would commonly characterize
crystalline forms without regard to relative intensity. (See D.I. 205 (Myerson Deel.) at 28) Dr.
Myerson' s opinion is consistent with the ' 684 patent and relevant literature, which also
characterize XRPD patterns of the crystalline forms only by their peak positions. (See D.I. 201
at 9; ' 684 patent at 2:46-65)
Plaintiffs' construction is consistent with prior decisions in this Court and others. In
Eisai Co., Ltd. v. Glenmark Pharm., Ltd. , 2015 WL 1228958, at *8-9 (D. Del. Mar. 17, 2015),
where the claims and specification were silent on the matter of measurement error, the Court
construed "characterized by" as "identifiable by reference to," relying on the agreement among
4
The Court is not persuaded that dependent claim 3 would end up being broader than
claim 2 if Plaintiffs' construction is adopted, because claim 2 only refers to four specific peak
positions whereas claim 3 refers to a corresponding XRPD graph that contains more
characteristics than just the four identified peak positions. (See D.I. 200 at 4-5)
5
Defendants do not challenge Plaintiffs ' definition of a POSA and both parties agree that
it does not impact claim construction. (See Tr. at 44-46)
6
the parties' experts that "XRPD was universally known at the pertinent time to be subject to
measurement error." Id. (finding defendants ' construction, which required an exact match, "too
rigid"); see also Kawa Co. , Ltd. v. Amneal Pharm. , LLC, 2017 WL 10667089, at *38 (S.D.N.Y.
Sept. 19, 2017) (finding that claim language "characteristic [XRPD] pattern with characteristic
peaks" does not require exact match of all peaks and relative intensities); AstraZeneca AB v. Dr.
Reddy 's Labs., Inc., 2013 WL 1847639, at *9 (D.N.J. May 1, 2013) (rejecting requirement for
"exact match" of XRPD patterns as "too rigid" and construing "characterized by the following"
as "identifiable by reference to"). Notably, Defendants agree that "identifiable by reference to"
is synonymous with "characterized by" and that they have not pointed to any cases where the
Court adopted their view. (See Tr. at 20, 33-34, 45) 6
The Court is also not persuaded by Defendants' alternative view that the claim term is
indefinite. A POSA would be able to assess the crystalline form and exemplary XRPD patterns
provided in the patent and discern with reasonable certainty whether a particular crystalline form
is characterized by a particular XRPD pattern. (See D.I. 205 (Myerson Deel. at 27))
Accordingly, the Court will adopt Plaintiffs' proposed construction. 7
6
The Court is also not persuaded that the patent examiner already rejected such a
construction. (See D.I. 200 at 7-8) During prosecution, the examiner rejected the word
"approximately" in claims 2 and 3, because it has no accepted definition related to XRPD
patterns, so it was replaced with experimental error measures to reflect the parameters of claims
2 and 3. (See D.I. 202 Ex. 2 at 3) The term at issue here does not raise the same concerns.
7
Plaintiffs agreed not to object if Defendants' expert testifies at trial that "identifiable by
reference to" requires an exact match. (See Tr. at 26)
7
B.
"1-[2 [(2,4-dimethylphenylsulfanyl)-phenyl]piperazine hydro bromide salt
[alpha form, beta form, gamma form]" 8
Plaintiffs
a crystalline form of vortioxetine hydro bromide, referred to in the patent specification as
r"alpha" /"beta" / "gamma"l, that can be distinguished from other forms
Defendants
vortioxetine hydrobromide salt crystalline form described in the specification as the [alpha /
beta / gamma] form and having all characteristics assigned to the [alpha / beta / gamma] form
in the specification
Court
vortioxetine hydrobromide salt crystalline form described in the specification as the [alpha /
beta / gamma] form and being identifiable by reference to the [alpha / beta / gamma] form in
the specification
The parties dispute whether the claims require use of a particular set of analytical data
from the patent's examples in order to identify each crystalline form of vortioxetine
hydrobromide (i.e., alpha, beta, and gamma). Plaintiffs' proposed construction points to the
specification' s general references to each form, while Defendants propose that the forms are
defined by the characteristics described in Examples 4b, 4d, 4f, 4h, and 4j of the '630 patent as
well as Figures 2-5. (See D.I. 251 at 4; D.I. 253 at 6 n.6)
The Court agrees with Defendants that in the context of this patent "a POSA must look to
the specification in order to identify and understand the scope of the claimed crystal form" (D.I.
230 at 13), but disagrees with Defendants regarding where a POSA would look. The examples
in the patent on which Defendants rely are non-limiting examples of measurements that may
result from specific analytical tests described in Examples 4a, 4c, 4e, 4g, and 4i. (See D.I. 232 at
9) For instance, Example 4b describes the alpha form "as prepared in example 4a," and Example
4a describes one analytical test that was performed on a sample, but both parties' experts agree
that many different analytical tests may be performed to identify the same crystalline form (as
8
This term appears in claims 1-7 of the ' 630 patent.
8
the same form may take on slightly varying characteristics depending on the preparation
method). (See D.I. 232 at 9-10) Claims should not be limited to a patent' s examples, unless the
patentee demonstrated a clear intent to do so, see Aria Diagnostics, Inc. v. Sequenom, Inc., 726
F.3d 1296, 1301 (Fed. Cir. 2013), and no such intent is evident here. Indeed, portions of the
specification (such as a table) other than the examples on which Defendants rely also contain
information a POSA could use to characterize and distinguish a given form. (See Tr. at 52-53 ,
68-69; '630 patent at 4:63-5:15) Defendants' construction would render superfluous the
dependent claims, which add limitations with more specific characteristics (i.e., a particular
XRPD pattern or particular XRPD peak positions). (See D.I. 201 at 15 ; D.I. 232 at 10; Tr. at 5152; see also, e.g., ' 630 patent, els. 2-3)
The Court rejects Defendants' argument that the patentee' s terminal disclaimer
demonstrates that Plaintiffs acquiesced in the patent examiner' s double-patenting rejection. (See
D.I. 200 at 15-16; D.I. 232 at 11-12) See Quad Envtl. Techs. Corp. v. Union Sanitary Dist., 946
F.2d 870,874 (Fed. Cir. 1991) (" [T]he filing ofa terminal disclaimer simply serves the statutory
function of removing the rejection of double patenting, and raises neither presumption nor
estoppel on the merits of the rejection."). Rather, the Court concludes, as did the patent
examiner, that the claims at issue here are not identical to those of the prior patent, as the prior
patent expressly incorporates limitations referring to particular XRPD characteristics while claim
1 of the '630 patent does not. (See D.I. 232 at 11 )
The Court agrees with Plaintiffs that the claims are referring to the different forms as
discussed in the patent rather than the forms with the specific characteristics in the examples.
However, the Court finds that Plaintiffs' proposed "distinguished from other forms" language
unhelpful. Accordingly, the Court will modify the construction (in a manner agreed-to by
9
Plaintiff at oral argument, see Tr. at 54-56), and consistent with the Court's resolution of the first
dispute (i.e., "being identifiable by reference to"). The parties' dispute as to whether all of the
characteristics must be met in order to qualify as a particular crystalline form is a factual dispute
that will be addressed at the infringement stage.
C.
"mixtures thereoP' 9
Plaintiffs
No construction necessary
Alternatively, "mixtures including vortioxetine hydrobromide salt alpha form, vortioxetine
hydrobromide salt beta form, vortioxetine hydrobromide salt gamma form, vortioxetine
hvdrobromide salt hemihydrate, and vortioxetine hydrobromide salt ethyl acetate solvate"
Defendants
"mixtures of only the foregoing listed forms"
Court
"mixtures of only the foregoing listed forms"
The parties agree that claim 1 of the ' 630 patent recites a Markush group (see Tr. at 74,
77), as it lists specified alternatives in the form of: "selected from the group consisting of [A, B,
C, D, E], and mixtures thereof." See Multilayer Stretch Cling Film Holdings, Inc. v. Berry
Plastics Corp., 831 F.3d 1350, 1357 (Fed. Cir. 2016). The Court agrees with Defendants that
this language limits the components of the claimed mixtures. The claimed mixtures may not
contain polymorphic forms not listed in the claim.
"Use of the transitional phrase ' consisting of to set off a patent claim element creates a
very strong presumption that that claim element is ' closed' and therefore ' excludes any elements,
steps, or ingredients not specified in the claim." Id. at 1358 (quoting AFG Indus. , Inc. v.
Cardinal JG Co., Inc., 239 F.3d 1239, 1245 (Fed. Cir. 2001)). Here, the Court agrees with
Defendants that the term "consisting of' means that the Markush group "contains only what is
9
This term appears in claim 1 of the ' 630 patent.
10
expressly set forth in the claim." Id. One of the items set forth in the group is "mixtures
thereof." While the term "mixture" is often open-ended and "does not exclude additional,
unnamed ingredients," Mars, Inc. v. HJ Heinz Co., L.P., 377 F.3d 1369, 1376 (Fed. Cir. 2004),
in a Markush group - e.g. , "A, B, and C, and mixtures thereof' - district courts have held that
"mixtures thereof' allows "for mixtures of the listed Markush members" but prohibits other
types of listed agents that are not in the Markush group, see Galderma Labs. L.P. v. Teva Pharm.
USA, Inc., 2018 WL 4290390, at *13 (D. Del. Sept. 7, 2018); see also AstraZeneca Pharm. LP v.
Handa Pharm. , LLC, 2010 WL4941431 , at *4 (D.N.J. Nov. 30, 2010) (construing "mixtures
thereof' to mean "a blend of two or more of the [types] recited in [the claim]").
Plaintiffs have not identified anything in the specification or prosecution history that
"unmistakably manifest[s] an alternative meaning." Multilayer, 831 F.3d at 1359. The
specification's discussion of polymorphic forms generally (beyond the five listed) does not
demonstrate that the claims must include mixtures including forms other than the five listed.
(See D.l. 200 at 16; D.I. 251 at 6) Nor has the Court been presented with extrinsic evidence
supporting a conclusion that mixtures limited to the five forms recited would not make scientific
sense.
Defendants concede that under their construction the mixture may contain excipients so
long as the mixture does not include any unlisted forms of vortioxetine hydro bromide. (See Tr.
at 87) The Court agrees.
11
D.
"alleviates/ alleviating" 10
Plaintiffs
No construction necessary
Alternatively, "mitigates/ mitigating"
Defendants
Indefinite
Court
"mitigates / mitigating"
Pursuant to 35 U.S.C. ยง 112, "a patent' s claims, viewed in light of the specification and
prosecution history, [must] inform those skilled in the art about the scope of the invention with
reasonable certainty." Nautilus, Inc. v. Biosig Instruments, Inc. , 134 S. Ct. 2120, 2129 (2014);
see also Cox Commc 'ns, Inc. v. Sprint Commc 'n Co. LP, 838 F.3d 1224, 1231 (Fed. Cir. 2016)
(noting relevant inquiry is "whether the ' claims,' not particular claim terms," inform one of
scope with reasonable certainty). "Indefiniteness must be proven by clear and convincing
evidence." Sonix Tech. Co., Ltd. v. Publications Int '!, Ltd. , 844 F.3d 1370, 1377 (Fed. Cir.
2017). Defendants have not met their burden.
Instead, the Court agrees with Plaintiffs that the plain and ordinary meaning of
"alleviates" in the medical context is reducing the severity of symptoms. (See D.I. 232 at 16)
This plain and ordinary meaning is used in the specification, which describes "alleviating" as
"partially arrest[ing] the clinical manifestations" of MDD and "reliev[ing]" a symptom ofMDD.
(D.I. 201 at 18; '630 patent at 9:48-50, 9:66-10:1) Defendants' concern that a POSA would not
know whether symptoms should be reduced or eliminated is without merit. The specification
distinguishes "alleviate or relie[ve]" from "cure or eliminate." ('630 patent at 9:66-10:1)
10
This term appears in claims 1, 2, 4, and 5 of the ' 946 patent and claims 1-7 of the ' 630
patent.
12
Dictionaries also clearly define the term as reducing symptoms, not requiring eliminating them
entirely. (See D.I. 200 at 18-19; D.I. 201 at 19; D.I. 232 at 18-19)
Although there are several diagnostic scales that list differing symptoms for MDD,
Defendants have not proven by clear and convincing evidence that a POSA' s conclusion as to
whether a patient's MDD symptoms were alleviated could actually come to a different
conclusion based on which scale the POSA was reviewing. (See Tr. at 93-96, 99) Since
"absolute precision" is not required, see Nautilus, 134 S. Ct. at 2129, quantitative measurements,
temporal limitations, or specific methods of testing are not always required to render a claim notindefinite. (See D.I. 200 at 19; D.I. 232 at 17-18) Rather, the record shows that " [c]linicians
understand [MDD] symptoms and know how to evaluate whether the severity of one or more
symptoms has been reduced in their patients." (D .I. 23 2 at 17-18 (citing evidence); see also D .I.
233 (Mattingly Declaration) at 7-10)
The Court will adopt Plaintiffs' proposed construction ("mitigates / mitigating") to clarify
that the term requires only a reduction of symptoms.
III.
CONCLUSION
The Court will construe the disputed terms as explained above. An appropriate Order
follows .
13
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