Vectura Limited v. GlaxoSmithKline LLC et al

Filing 254

MEMORANDUM OPINION. Signed by Judge Richard G. Andrews on 3/18/2019. (nms)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE

VECTURA LIMITED,
Plaintiff;
V.

Civil Action No. 16-638-RGA

GLAXOSMITHKLINE LLC and GLAXO
GROUP LIMITED,
Defendants.

MEMORANDUM OPINION
Kelly E. Farnan and Christine D. Haynes, RICHARDS, LAYTON & FINGER, P.A. ,
Wilmington, DE; Dominick A. Conde, Christopher P. Borello (argued), Brendan M. O'Malley
(argued), and Damien N. Dombrowski (argued), VENABLE LLP, New York, NY, attorneys for
Plaintiff.
Jack B. Blumenfeld and Jeremy A. Tigan, MORRIS, NICHOLS , ARSHT & TUNNELL LLP,
Wilmington, DE; Martin J. Black, Kevin M. Flannery (argued), Robert Ashbrook and Sharon K.
Gagliardi, DECHERT LLP, Philadelphia, PA; Blake B. Greene (argued), DECHERT LLP,
Austin, TX, attorneys for Defendants.

March

JK ,

2019

Currently pending before the Court are Plaintiffs motion for partial summary judgment
of no invalidity by anticipation (D.I. 126) and Defendants' motion for summary judgment of
invalidity by lack of enablement. (D.I. 122). The parties have fully briefed the issues. (D.I.
190,195, 208,212, 216,220). The Court heard oral argument on March 4, 2016. (Hr'g
Trans.).
I.

BACKGROUND
PlaintiffVectura Limited sued Defendants GlaxoSmithKline LLC and Glaxo Group

Limited on July 27, 2016 alleging infringement of U.S . Patent Nos. 8,303 ,991 ("the ' 991
patent") and 8,435 ,567 ("the ' 567 patent"). (D.I. 1). Plaintiff has narrowed its infringement
allegations to claim 3 of the ' 991 patent and claim 3 of the ' 567 patent ("the Asserted Claims").
The patents-in-suit "relate to pharmaceutical compositions for inhalation and methods of
making them." (D.I. 82 at 1). The asserted claims are dependent claims which cover only
compositions where the additive is magnesium stearate. (D.I. 195 at 9).
On August 10, 2018, the parties made various motions for summary judgment. Plaintiff
moved for partial summary judgment of no invalidity by anticipation. (D.I. 126). Defendants
moved for summary judgment of non-infringement (D.I. 120) and of invalidity by lack of
enablement (D.I. 122). On October 1, 2018, I issued my claim construction opinion, and
subsequently, the claim construction order. (D.I. 167; D.I. 169). The parties had exchanged
expert reports prior to the opinion, and my constructions of the claim terms differed from that of
either party. I then permitted supplemental expert discovery between the parties and amended
summary judgment briefing. (D.I. 176). The parties have exchanged supplemental expert
discovery and amended their previous summary judgment briefing. At oral argument, I denied
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Defendants' motion for summary judgment of non-infringement. (D.I. 246). I now address the
parties' remaining dispositive motions.

II.

LEGALSTANDARD
A. Summary Judgment
"The court shall grant summary judgment if the movant shows that there is no genuine

dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed.
R. Civ. P. 56(a). The moving party has the initial burden of proving the absence of a genuinely

disputed material fact relative to the claims in question. Celotex Corp. v. Catrett, 477 U.S. 317,
330 (1986). Material facts are those "that could affect the outcome" of the proceeding, and "a
dispute about a material fact is ' genuine' if the evidence is sufficient to permit a reasonable jury
to return a verdict for the nonmoving party." Lamont v. New Jersey, 637 F.3d 177, 181 (3d Cir.
2011) (quoting Anderson v. Liberty Lobby, Inc. , 477 U.S. 242,248 (1986)). The burden on the
moving party may be discharged by pointing out to the district court that there is an absence of
evidence supporting the non-moving party' s case. Celotex, 477 U.S. at 323.
The burden then shifts to the non-movant to demonstrate the existence of a genuine issue
for trial. Matsushita Elec. Indus. Co. v. Zenith Radio Corp. , 475 U.S . 574, 586-87 (1986);
Williams v. Borough of West Chester, Pa., 891 F.2d 458, 460-61 (3d Cir. 1989). A non-moving
party asserting that a fact is genuinely disputed must support such an assertion by: "(A) citing to
particular parts of materials in the record, including depositions, documents, electronically
stored information, affidavits or declarations, stipulations ... , admissions, interrogatory
answers, or other materials; or (B) showing that the materials cited [by the opposing party] do
not establish the absence . . . of a genuine dispute .... " Fed. R. Civ. P. 56(c)(l).

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When determining whether a genuine issue of material fact exists, the court must view
the evidence in the light most favorable to the non-moving party and draw all reasonable
inferences in that party' s favor. Scott v. Harris, 550 U.S. 372, 380 (2007); Wishkin v. Potter,
476 F.3d 180, 184 (3d Cir. 2007). A dispute is "genuine" only if the evidence is such that a
reasonable jury could return a verdict for the non-moving party. Anderson, 477 U.S. at 247-49.

If the non-moving party fails to make a sufficient showing on an essential element of its case
with respect to which it has the burden of proof, the moving party is entitled to judgment as a
matter of law. See Celotex Corp., 477 U.S. at 322.

B. Anticipation
A patent claim is invalid as anticipated under 35 U.S.C. § 102 if"within the four comers
of a single, prior art document .. . every element of the claimed invention [is described] , either
expressly or inherently, such that a person of ordinary skill in the art could practice the
invention without undue experimentation." Callaway Golf Co. v. Acushnet Co., 576 F.3d 1331 ,
1346 (Fed. Cir. 2009) (alterations in original). As with infringement, the court construes the
claims and compares them against the prior art. See Enzo Biochem, Inc. v. Applera Corp., 599
F.3d 1325, 1332 (Fed. Cir. 2010). Anticipation "may be decided on summary judgment if the
record reveals no genuine dispute of material fact. " Encyclopaedia Britannica, Inc. v. Alpine

Elecs. ofAm. , Inc., 609 F.3d 1345, 1349 (Fed. Cir. 2010).
C. Enablement
The enablement requirement, considered a separate and distinct requirement contained
in 35 U.S.C. § 112, ,r 1, assesses whether "one skilled in the art, after reading the specification,
could practice the claimed invention without undue experimentation." Sitrick v. Dreamworks,
LLC, 516 F.3d 993, 999 (Fed. Cir. 2008). Because the enablement inquiry takes into account
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what is known to one skilled in the art, the Federal Circuit has "repeatedly explained that a
patent applicant does not need to include in the specification that which is already known to and
available to one of ordinary skill in the art. " Koito Mfg. Co. v. Turn-Key-Tech, LLC, 381 F.3d
1142, 1156 (Fed. Cir. 2004). "Enablement is a legal question based on underlying factual
determinations." Vasudevan Software Inc. v. MicroStrategy, Inc , 782 F.3d 671 , 684 (Fed. Cir.
2015). Factors considered in assessing the enablement requirement include:
(1) the quantity of experimentation necessary, (2) the amount of direction or
guidance presented, (3) the presence or absence of working examples, (4) the
nature of the invention, (5) the state of the prior art, (6) the relative skill of those
in the art, (7) the predictability or unpredictability of the art, and (8) the breadth
of the claims.

In re Wands, 858 F.2d 731 , 737 (Fed. Cir. 1988). "A party must prove invalidity for lack of
enablement by clear and convincing evidence." Vasudevan, 782 F.3d at 684.

III.

DISCUSSION
A. Anticipation
Plaintiff moves for summary judgment of no invalidity by anticipation. 1 (D.I. 126).

Plaintiff asserts that no material dispute of fact exists and that the Staniforth and Musa
references 2 do not expressly or inherently anticipate the asserted claims. (D.I. 195 at 11).
Specifically, Plaintiff argues the following: 1) Defendants ' experts did not provide opinions on
anticipation under the Court' s claim construction, 2) Defendants ' experts have not provided
sufficient expert opinion or evidence to conclude that either Staniforth or Musa expressly or
inherently discloses each limitation of the Asserted Claims, and 3) during Dr. Colombo ' s

1
Defendants have mooted part of Plaintiff's motion by agreeing to withdraw Koishi I 984 and Koishi I 988 as
anticipatory references. (D.I. 208 at 6 n.2).
2
The Staniforth reference is WO 96/23485 , an international patent application. (D.I. 208 at 9). The Musa
reference is U.S. Patent No. 6,528,096. (Id.) .

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deposition, he admitted that Staniforth and Musa do not expressly anticipate and do not
necessarily result in the claimed invention. (D.I. 195 at 11-12, 16). Defendants assert that there
is a material factual dispute regarding whether Staniforth and Musa anticipate the claims and
that Defendants' experts have put forth enough evidence that a reasonable jury could find in
their favor on anticipation. 3 (D.I. 208 at 7-8).
While the Federal Circuit has declined to state a "per se rule" that expert testimony is
required to prove anticipation, see Carrier Corp. v. Goodman Global, Inc. , 64 F. Supp. 3d 602,
615 (D. Del. 2014) (citing cases), " [t]ypically, testimony concerning anticipation must be
testimony from one skilled in the art and must identify each claim element, state the witnesses'
interpretation of the claim element, and explain in detail how each element is disclosed in the
prior art reference." Schumer v. Lab. Comput. Sys. , Inc., 308 F.3d 1304, 1315 (Fed. Cir. 2002).
Defendants assert that their experts have met this requirement. (D.I. 208 at 14).
I disagree. I do not need to consider Plaintiffs first and third arguments because
Defendants' expert opinions, taken in the light most favorable to Defendants, as required, do not
satisfy the requirements to prove anticipation. Dr. Colombo's various reports do not "identify
each claim element, state [his] interpretation of the claim element, and explain in detail how
each element is disclosed in" either Staniforth or Musa. Schumer, 308 F.3d at 1315. Neither
does Dr. Russell's SEM-EDX4 analysis. (See D.I. 142-1 at 44-45). Claim 3 of the '991 patent
reads as follows :

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Defendants note that these assertions are based upon Defendants ' belief that Plaintiffs experts rely on an
incorrect interpretation of my claim construction, mirroring Plaintiff's initial proposed constructions. (D.I. 208 at
7). As Defendants unequivocally state, " it is [Defendants '] position that under the proper interpretation of the
Court's constructions of the composite active particle terms, [Plaintiff] has not shown that [Defendants' ] accused
products infringe the asserted claims and the Staniforth and Musa references do not anticipate the claims." Id.
4
SEM-EDX is Scanning Electron Microscopy with Energy Dispersive X-ray spectroscopy. (D.I. 208 at 3). It is
"an analytical technique that can measure the topography of particles and, with certain limitations, the components
thereof." (Id.).

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3. Composite active particles as claimed in claim 2, wherein the additive material
includes magnesium stearate.
('991 patent, cl. 3). It depends from claims 1 and 2, which read as follows:
1. Composite active particles for use in a pharmaceutical composition for
pulmonary administration, each composite active particle comprising a particle of
active material and particulate additive material on the surface of that particle of
active material, wherein the composite active particles have a mass median
aerodynamic diameter of not more than 10 µm , and wherein the additive material
promotes the dispersion of the composite active particles upon actuation of a
delivery device.
2. Composite active particles as claimed in claim 1, wherein the additive material
includes one or more of: an amino acid or derivative thereof; a peptide or
derivative thereof, a phospholipid or derivative thereof, a surface active material;
or a metal stearate and derivative thereof.
('991 patent, els. 1-2). The asserted claims of the ' 567 patent are similar.
Dr. Colombo's expert reports focus solely on the Staniforth and Musa references'
disclosure of a single claim limitation-composite active particles-and whether the disclosure
satisfied Plaintiffs proposed claim construction of the term. 5 (D.I. 125-1 , Ex. 2 at ,r,r 71 , 79,
110-14 (opening report), Ex. 4 at ,r,r 7-13 (reply report); D.I. 192-1 , Ex. 6 ,r,r 67-68
(supplemental rebuttal report)). 6 While Dr. Colombo ' s expert report states that he believes the
Staniforth and Musa references anticipate all claims of the asserted patents, he provides no
accompanying analysis to support his conclusion. (D.I. 125-1 , Ex. 2 at ,r 71). For example, Dr.
Colombo' s analysis of the Staniforth or Musa references makes no mention of whether they

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The term "microparticle[s]" which appears only in the '567 patent, has the same meaning as the term "composite
active particle[s]" in the context of the claims. Plaintiff's proposed claim construction for this term was: "[a] single
particulate entit[y/ies] made up of a particle of active material to which one or more particles of additive material
are fused. " (D.l. 167 at 5).
6
I construed "composite active particle[ s]" to mean " [a] single particulate entit[y/ies] made up of a particle of
active material to which one or more particles of additive material are fixed such that the active and additive
particles do not separate in the airstream." (D.l. 169 at 1). Dr. Colombo 's supplemental report focuses on this
construction.

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disclose an "additive material [that] promotes the dispersion of the composite active particles."
(' 991 patent, cl. 1; D.I. 125-1 , Ex. 2 at ilil 71 , 79, Ex. 4 at ilil 7-13 , D.I. 192-1 , Ex. 6 ilil 67-68).
Dr. Russell ' s reports also focus solely on the "composite active particle" claim element
and whether the Staniforth and Musa references disclose a blend with the requisite level of
association between active and additive particles. (D.I. 142-1 at 44-45, 129-31). She provides
no analysis of whether the references disclose an "additive material [that] promotes the
dispersion of the composite active particles." ('991 patent, cl. 1; D.I. 142-1 (no reference to
dispersion)). The evidence of the experts, taken in the light most favorable to Defendants, is
insufficient to show anticipation. Therefore, Plaintiff has demonstrated that Defendants failed
to make a sufficient showing on an essential element of their case with respect to which they
have the burden of proof. See Celotex Corp., 477 U.S. at 322. Thus, I grant Plaintiffs motion
for partial summary judgment of no invalidity by anticipation.

B. Enablement
Defendants move for summary judgment of invalidity for lack of enablement. (D.I.
122). Defendants assert that there is no material dispute of fact that making the full scope of the
asserted claims requires undue experimentation. (D.1. 190 at 7-8). More specifically,
Defendants assert that the scope of the composite active particles covered by the asserted claims
is unduly broad and enablement would require a person of ordinary skill in the art to 1) make
each composite active particle, 2) test the particle to ensure that it is a composite active particle,
3) test the particle for dispersion, and 4) in connection with the ' 567 patent only, test the particle
for dissolution. (Id.). Plaintiff argues that the asserted claims are enabled and that Defendants
have not met the clear and convincing evidence threshold to succeed on an invalidity defense at
summary judgment. (D.1. 212 at 4). The parties' briefing identifies material disputes of fact as
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to 1) the quantity of experimentation necessary and 2) the predictability or unpredictability of
the art. As there are material disputes as to the facts underlying the enablement analysis, I deny
Defendants' motion for summary judgment.
First, the parties dispute whether the art is predictable or unpredictable. (DJ. 190 at 17;

DJ. 212 at 21; Hr' g Trans. at 22:16-19; 44:18-20; 46:4-10; 47:22-48:2). Defendants argue that
"the dispersion properties of a particular composition are unpredictable owing to . . . the
complexity of particle-particle interactions." (DJ. 190 at 17-18). Plaintiff asserts that there is
no evidence "suggesting that the properties of magnesium stearate could change .. . such that
magnesium stearate somehow becomes unsuitable for promoting dispersion and delaying
dissolution." (DJ. 212 at 22). Plaintiff also disputes whether the PowderHale report shows an
inoperative embodiment. (Id. at 18-19).
Second, the parties dispute the quantity of experimentation necessary for a person of

ordinary skill in the art ("POSA") to make the full scope of the claims. (DJ. 190 at 16-17; DJ.
212 at 20). Defendants assert that a POSA would need to engage in trial and error testing of the
individual composite active particles within the scope of the claims to make the full scope of the
claims. (DJ. 190 at 16-17). More specifically, Defendants argue that a POSA would have to
engage in undue experimentation to determine which iterations of a composite active particle
actually promote dispersion. (Id. at 17). Plaintiff argues that a POSA would be able to make
the full scope of the claims with little experimentation for the following reasons: (1) " [t]here is
no dispute that a POSA would know how to make composite active particles with magnesium
stearate" (DJ. 212 at 5); (2) " [t]he specifications provide [] guidance on an ' optimum amount'
of additive material to use" (id. at 11 ); (3) a POSA would understand from the specifications
that SEM is an appropriate method to confirm that particles are composite active particles (id. at
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15); (4) a POSA would understand from the prior art how to conduct SEM testing (id.); and (5)
a POSA would understand how to adjust the myriad variables for dispersion (id. at 20-21 , Hr'g
Trans. at 42:11-20; 44:18-20; 49:14-18).
Given these material disputes of fact, a reasonable jury could determine that the art is
predictable and that minimal experimentation is needed to make the full scope of the claims.
Therefore, I deny Defendants' motion for summary judgment of invalidity.

IV.

CONCLUSION
For the foregoing reasons, Plaintiffs motion for partial summary judgment is

GRANTED and Defendants' motion for summary judgment of invalidity is DENIED.
An accompanying order will be entered.

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