ALCON RESEARCH, LTD. et al v. APOTEX INC. et al
Filing
180
ENTRY denying Plaintiffs' 162 Motion for Summary Judgment on Defendants' Affirmative Defenses and Counterclaims Alleging Inequitable Conduct. Signed by Judge Richard L. Young on 5/21/2013. (PG)
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF INDIANA
INDIANAPOLIS DIVISION
ALCON RESEARCH, LTD., ALCON
LABORATORIES, INC., ALCON
PHARMACEUTICALS, LTD., and
KYOWA HAKKO KIRIN CO., LTD.
Plaintiffs,
vs.
APOTEX, INC. and APOTEX CORP.
Defendants.
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1:09-cv-102-RLY-TAB
ENTRY ON PLAINTIFFS’ MOTION FOR SUMMARY JUDGMENT ON
DEFENDANTS’ AFFIRMATIVE DEFENSES AND COUNTERCLAIMS
ALLEGING INEQUITABLE CONDUCT
This case arises out of the Abbreviated New Drug Application (“ANDA”) filed by
Apotex, Inc., and Apotex Corp. (collectively “Defendants”), with the United States Food
and Drug Administration. Apotex seeks approval to manufacture and sell a generic
version of Alcon’s1 Pataday™ ophthalmic solution, a prescription eye drop for the
treatment of allergic eye disease. Use of the Pataday product, whose active ingredient is
olopatadine, is protected by, inter alia, U.S. Patent No. 6,995,186 (the “‘186 patent”) and
United States Patent No. 7,402,609 (the “‘609 patent”). After receiving notice of
1
Alcon Pharmaceuticals, Ltd. is the assignee of the ‘186 and ‘609 patents, Alcon Research is the
exclusive licensee of the asserted patents, and Alcon Laboratories, Inc., sells drug products
covered by these patents. (Complaint ¶¶ 30-33, 50-53). The court will refer to the Alcon
plaintiffs collectively as “Plaintiffs” or “Alcon.”
1
Apotex’s ANDA, Alcon filed the present lawsuit2 on February 2, 2009, alleging
infringement of the ‘186 and ‘609 patents.
On September 22, 2010, Apotex filed an Amended Answer, Defenses and
Counterclaims. Apotex’s Fifth affirmative defense and Count V of its Counterclaim
allege that the ‘186 and ‘609 patents are unenforceable because the patents were procured
through inequitable conduct. Plaintiffs now move for summary judgment with respect to
Defendants’ inequitable conduct affirmative defenses and counterclaims. For the reasons
set forth below, Plaintiffs’ motion is DENIED.
I.
Factual Background
A.
Pataday
Pataday™ is an ophthalmic solution developed and sold by Alcon for the
treatment of allergic eye disease. Pataday, which contains olopatadine at a concentration
of 0.2%, is protected by the ‘186 and ‘609 patents.
Before the development of Pataday, Alcon developed and manufactured Patanol®,
a drug remarkably similar to Pataday. Patanol, with an olopatadine concentration of
0.1%, is protected by the ‘805 patent, noted in footnote 1. The primary difference
between these two pharmaceutical drugs is this: Patanol, with a 0.1% concentration of
olopatadine, must be administered to the affected eye at least twice a day; Pataday, with
2
As originally filed, this case included United States Patent No. 5,641,805 (the “‘805 patent”).
Kyowa Hakko Kirin Co. Ltd. is a co-owner of the ‘805 patent, and on that basis, was a plaintiff
in this case. The claims of the ‘805 patent asserted in this litigation have been recently
invalidated by the Federal Circuit. Alcon Research, Ltd., et al. v. Apotex, Inc., et al., 687 F.3d
1362, 1369-70 (Fed. Cir. 2012), cert. denied, 569 U.S. __ (2013). Thus, the patents in dispute
here are the ‘186 and ‘609 patents, and Kyowa Hakko Kirin no longer has an interest in this case.
2
twice the concentration of olopatadine, may be administered just once per day.
Olopatadine at 0.2% is not physically stable, meaning that it will not remain
dissolved in solution. Over time, precipitants such as crystals or other particles will form
in the solution. (Expert Report of Harry Brittain ¶¶ 32-33). The ‘186 and ‘609 patents
claim the use of either of two polymers — polyvinylpyrrolidone (“PVP”) or polystyrene
sulfonic acid (“PSSA”) — to enhance the physical stability of low viscosity3 solution
compositions containing olopatadine. (‘186 patent, col. 16-18; ‘609 patent, col. 16).
B.
The ‘186 Patent Prosecution History
Attorney Patrick Ryan filed United States Patent Application No. 10/175,106 (“the
‘106 application”), entitled Olopatadine Formulations for Topical Administration, which
led to the ‘186 and ‘609 patents. The inventors listed on the application include, inter
alia, Dr. Ernesto J. Castillo, Dr. Huixian Zhang, Haresh G. Bhagat, and Joseph Bullock.
As originally filed, the claims in the ‘106 application did not contain a limitation
regarding the viscosity of the claimed compositions. (‘186 Patent File History (“PH”) at
ALPD0005352-55). On June 29, 2004, the PTO Examiner issued an Office Action
rejecting all pending claims as either anticipated or obvious over the ‘805 patent. In
particular, the Examiner noted that the ‘805 patent disclosed “the use of olopatadine in a
pharmaceutical composition for the treatment of allergic disorders of the eye,” and that
“[t]he addition of [PVP] is also taught by the above reference [‘805 patent].” (Id. at
ALPD0005671).
3
Viscosity is the resistance of a solution to flow, and is measured in centipoise (“cps”). (Id. ¶
31).
3
In response to the Office Action, Ryan met with Bhagat, as well as co-inventors
Dr. Castillo and Bullock, to discuss how to respond to the Examiner’s determination.
(Deposition of Patrick Ryan (“Ryan Dep.”) at 168-70). Ryan needed to distinguish the
use of PVP on the basis that PVP was able to stabilize olopatadine solutions while
maintaining a low viscosity. (Id. at 178-79, 181). To support this argument, the
applicants needed data comparing the viscosities of stable olopatadine formulations
containing PVP with formulations using other polymers such as polyvinyl alcohol (or
“PVA”). Ryan asked Bhagat to generate viscosity data for the three formulations listed
in Tables 3 and 4 of the ‘106 patent application, listed as Formulation H (with HPMC),
Formulation I (with Carbopol 974P), and Formulation J (with PVA). (Id. at 183).
Bhagat, in turn, requested Dr. Zhang to conduct the testing for the three requested
formulations because she was more familiar with viscosity measurements than he.
(Deposition of Haresh Bhagat (“Bhagat Dep.”) at 143, 145, 149; Deposition of Huixian
Zhang (“Zhang Dep.”) at 111).
On July 13, 2004, Ryan requested an interview with the Examiner. (PH at
ALPD0005684). In the request form, Ryan noted that he planned to offer arguments of
“superior results not disclosed or predicted by the prior art.” (Id.).
On August 11, 2004, Dr. Zhang conducted the testing as requested by Bhagat for
PVA. (See Zhang Laboratory Notebook at ALPD0079674 (“Zhang Lab. Ntbk.”)). The
results showed three different viscosity data points for Formulation J (polyvinyl alcohol
or PVA), which was comprised of 0.2% olopatadine formulation containing 1.8% PVA.
(Id.; Bhagat Dep. at 168-69). As specified in the examples of the ‘106 application, Dr.
4
Zhang measured the viscosity of Formulation J with a Brookfield DV-1+ Viscometer
using a CP42 spindle. (Zhang Lab. Ntbk.). The Brookfield viscometer has a variation of
experimental data, or error rate, of 5%. (Zhang Dep. at 83-84). Dr. Zhang conducted the
test at three different rotation speeds: 12 rpm, 30 rpm, and 60 rpm, and recorded the
results in her laboratory notebook.
Formulation J (PVA)
RPM
12
30
60
Viscosity
2.05 cps
2.10 cps
2.00 cps
Torque
4.0%
10.5%
20%
(Zhang Lab. Ntbk.). Dr. Zhang believed that the 2.10 cps measured at 30 rpm and the
2.00 cps measured at 60 rpm were scientifically valid measurements of the viscosity of
Formulation J. (Zhang Dep. at 113-14).
Dr. Zhang noted in her laboratory notebook, without any explanation, that only the
2.10 cps measured at 30 rpm should be reported, marking that data point with an arrow
and a note that stated, “Report data.” (See Zhang Lab. Ntbk.). At her deposition, Dr.
Zhang did not recall why she singled out the 2.10 cps measurement at the time, could not
explain why she chose to report the 2.10 cps measurement over the 2.00 cps
measurement, or why she did not report both “valid” values. (Zhang Dep. at 116-18).
The day after Dr. Zhang obtained the viscosity data for PVA, she sent an email
with an attachment to Bhagat, replying to an email chain that included an email from
Ryan to Bhagat discussing the prosecution of the ‘106 application. (See Pls.’ Privilege
Log at 26, Entry ALPD0102227-28, at 56, Entry ALPD0107973-74 at 56-57, Entry
5
ALPD0107975-76). Bhagat, in turn, forwarded Dr. Zhang’s email with the attachment to
Ryan. (Id.). Dr. Zhang postponed signing her laboratory notebook until the day after she
emailed Bhagat. (See Zhang Lab. Ntbk.). The substance of these emails was ruled to be
protected by the attorney-client privilege by order of Magistrate Judge Baker. (See
Docket # 182).
Relying on the viscosity data Dr. Zhang collected for PVA, Ryan asked Bhagat to
submit a declaration to the PTO. (Ryan Dep. at 179-80). Ryan prepared the initial draft
of Bhagat’s declaration “after talking with [Bhagat] . . . to understand what he did and
what the results were.” (Id. at 181). Ryan then provided Bhagat with the 2004 Office
Action, which set forth the lack of unexpected results as a reason for the rejection, and
the initial draft of his declaration “for him to review and mark up and edit.” (Id. at 181,
183). Bhagat added his personal information to the declaration and the technical
information regarding olopatadine formulations – including the viscosity data for
Formulations H, I, and J — found in paragraphs 6-9 of his declaration. (Bhagat Dep. at
134-35; PH at ALPD0005696-97). Bhagat and Dr. Zhang then exchanged emails. (See
Pls.’ Privilege Log at 26, Entry ALPD0102227-28, Entry at ALPD0102233-36).
On September 8, 2004, Bhagat reviewed and verified Dr. Zhang’s laboratory
notebook that contained the viscosity data for Formulation J (PVA). (See Zhang Lab.
Ntbk.; Bhagat Dep. at 155, 169). In paragraph 6 of his declaration submitted to the PTO,
Bhagat included only the 2.10 cps measurement, and omitted the 2.0 cps measurement
and information on the error rate associated with the Brookfield viscometer. (PH at
ALPD0005695-97).
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On September 9, 2004, Ryan met with the PTO to discuss responding to the 2004
Office Action. According to the Examiner’s notes, Ryan agreed to consider “amending
the claims to the Jepson format and inserting specific viscosity, and the Office will
consider the amendments favorably.” (See PH at ALPD0005685). Ryan interpreted the
Examiner’s remarks as “a nonbinding indication . . . that at least as of that moment, if you
provided those things [listed in the Interview Summary], [the PTO] wouldn’t have any
other basis for rejecting the case and would likely to [sic] give you an allowance.” (Ryan
Dep. at 166-67). The day after meeting with the Examiner, he and Bhagat exchanged
emails. (See Pls.’ Privilege Log at 26-27, Entry ALPD0102237-38, at 57, Entry
ALPD0107977).
On September 10, 2004, Ryan responded to the June 29, 2004 Office Action by
submitting an amendment to the pending claims to specify a viscosity of 1-2 cps. The
amendment to claim 1 reads as follows:
In a topically administrable solution composition for treating allergic or
inflammatory disorders of the eye and nose comprising olopatadine and a
polymeric ingredient, the improvement wherein the amount of olopatadine
in the solution is 0.17-0.62% (w/v), the polymeric ingredient is a polymeric
physical stability-enhancing ingredient consisting essentially of
polyvinylpyrrolidone [PVP] or polystyrene sulfonic acid [PSSA] in an
amount sufficient to enhance the physical stability of the solution, and
wherein the composition has a viscosity of 1-2 cps and does not contain
polyvinyl alcohol [PVA] . . . .
(See PH at ALPD0005689) (emphasis added). Ryan distinguished the ‘106 application
from the ‘805 patent by noting that the ‘805 patent “provides no basis for selecting
polyvinylpyrrolidone [PVP] over the other named viscosity-enhancing agents.” (Id. at
ALPD0005692). Unlike the ‘805 patent, the ‘106 application “is based on the finding
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that [PVP] . . ., unlike polyvinyl alcohol [PVA] and the polyacrylic acid carbomer 974P,
enhance the physical stability of solutions containing 0.17-0.62% olopatadine when the
solutions have a viscosity of 1-2 cps.” (Id. at ALPD0005693). In addition, Bhagat
signed a declaration reporting that Formulations H, I, and J [PVA] have viscosities
greater than 1-2 cps. (Id. at ALPD0005695-97).
Ryan relied on Bhagat’s declaration to overcome the PTO’s rejection and to
support the patentee’s argument that PVP provided superior results over other polymers,
such as PVA, in enhancing the physical stability of a 0.2% olopatadine solution while
maintaining a low viscosity. (Ryan Dep. at 179). The declaration reported the following
viscosity data as measured by the Brookfield DV-I+ Viscometer:
Formulation
Viscosity Spindle RPM
Formulation H
1502 cps CP53
6 rpm
(HPMC)
Formulation I
45.4 cps
CP42
6 rpm
(Carbolpol 974P)
Formulation J (PVA) 2.1 cps
CP42 30 rpm
(PH at ALPD0005696).
Based on Plaintiffs’ September 10, 2004 response to the 2004 Office Action, the
PTO issued a Notice of Allowance on December 22, 2004, and the ‘186 patent issued
from the ‘106 application on February 7, 2006. (See PH at ALPD0005700-03).
C.
The ‘609 Patent Prosecution History
On March 15, 2005, Ryan filed United States Patent Application No. 11/079,996
(“the ‘996 application”), entitled “Olopatadine Formulations for Topical Administration,”
naming, inter alia, Dr. Castillo, Dr. Zhang, Bhagat, and Bullock, as the co-inventors.
8
(‘609 Patent File History at ALPD0005742-79). The ‘996 application is a continuation of
the ‘106 application and, among other things, shares the same specification as the ‘106
application, which resulted in the ‘186 patent. (See id. at ALPD0005902). After several
exchanges between the PTO and Ryan, on February 9, 2007, the PTO issued an Office
Action rejecting the only pending claim (“2007 Office Action”). Citing Formulations H
(HPMC) and J (PVA) in Table 3, the PTO found that although “Applicant alleges
criticality of the advantages of adding [PVP] to olopatadine in comparison with the other
polymers used with olopatadine . . . Applicant has presented no evidence that the addition
of PVP is advantages [sic] over the other polymers used with olopatadine . . . .” (See id.
at ALPD0006235-36).
In an effort to overcome the Examiner’s rejection, Ryan submitted: (1) an
amendment to the pending claims to recite a solution having “a viscosity of 1-2 cps”; (2)
remarks representing that “[i]n contrast to the 1-2 cps solution compositions recited in
Applicants’ claims (as currently amended), none of the compositions shown in Table 3
[including Formulation J] has a viscosity of 1-2 cps”; and (3) Bhagat’s declaration,
previously submitted during the prosecution of the ‘106 application, reporting that
Formulations H, I, and J have viscosities greater than 1-2 cps. (See id. at ALPD000624250). The PTO eventually issued a Notice of Allowance on July 2, 2008, and the ‘609
patent issued from the ‘996 application on July 22, 2008. (See id. at ALPD0006345-48).
All other facts necessary to a fair determination of this motion will be addressed in
the Discussion Section.
9
II.
Summary Judgment Standard
Summary judgment is appropriate if the record “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). A factual dispute is genuine “if the evidence is such that a
reasonable jury could return a verdict for the non-moving party.” Anderson v. Liberty
Lobby, Inc., 477 U.S. 242, 248 (1986). A factual dispute is material if, under the
substantive law, it could affect the outcome of the suit. Id.; see also Payne v. Pauley, 337
F.3d 767, 770 (7th Cir. 2003) (noting that summary judgment is not appropriate if a
reasonable jury could return a verdict in favor of the nonmoving party).
In determining whether a genuine issue of material fact exists, the court construes
the facts in the light most favorable to the non-moving party and draws all reasonable
inferences in favor of that party. Heft v. Moore, 351 F.3d 278, 282 (7th Cir. 2003) (citing
Anderson, 477 U.S. at 255). The moving party bears the burden of demonstrating the
“absence of evidence on an essential element of the non-moving party’s case.” Celotex
Corp. v. Catrett, 477 U.S. 317, 325 (1986). If the moving party meets its burden, the
non-moving party may not respond by simply resting on the pleadings, but must
demonstrate by specific factual allegations that a genuine issue of material fact exists for
trial. Green v. Whiteco Industries, Inc., 17 F.3d 199, 201 (7th Cir. 1994) (citing Celotex,
477 U.S. at 322).
III.
Inequitable Conduct Standard
“Patent Applicants are required to prosecute patent applications with candor, good
faith, and honesty.” Semiconductor Energy Lab. Co. v. Samsung Elecs. Co., 204 F.3d
10
1368, 1373 (Fed. Cir. 2000); see also Molins PLC v. Textron, Inc., 48 F.3d 1172, 1178
(Fed. Cir. 1995). Attorneys, agents, and applicants who have applications pending before
the PTO have an uncompromising duty to report all facts concerning possible fraud or
inequitable conduct underlying the application. See Precision Instrument Mfg. Co. v.
Auto. Maint. Mach. Co., 324 U.S. 806, 818 (1945); see also 37 C.F.R. § 1.56(a) (2012)
(stating that the duty of candor extends to “[e]ach individual associated with the filing
and prosecution of a patent application”). If a patent applicant violates these duties, the
entire patent may be held unenforceable due to inequitable conduct. Therasense, Inc. v .
Becton, Dickinson & Co., 649 F.3d 1276, 1288 (Fed. Cir. 2011) (characterizing the
remedy for inequitable conduct as the “atomic bomb” of patent law).
“Inequitable conduct includes affirmative misrepresentations of material fact,
failure to disclose material information, or submission of false material information,
coupled with an intent to deceive.” Novo Nordisk Pharms., Inc. v. Bio-Tech. Gen. Corp.,
424 F.3d 1347, 1359 (Fed. Cir. 2005) (internal quotations and citations omitted). To
prevail on a claim alleging the nondisclosure of information, as in this case, “the accused
infringer must prove by clear and convincing evidence that the applicant knew of the
reference, knew that it was material, and made a deliberate decision to withhold it.”
Therasense, 649 F.3d at 1290. Materiality and intent are separate elements that must be
proven independently of the other. Id.
Undisclosed information is material if “the PTO would not have allowed a claim
had it been aware of the undisclosed [information].” Id. at 1291 (explaining that “the
materiality required to establish inequitable conduct is “but-for” materiality). In addition,
11
the accused infringer must prove not only that the applicant knew of the material nature
of the withheld information, but acted with the specific intent to deceive the PTO. Id. at
1290. “A finding that the misrepresentation or omission amounts to gross negligence or
negligence under a ‘should have known’ standard does not satisfy [the] intent
requirement.” Id. (citing Kingsdown Med. Consultants, Ltd. v. Hollister, Inc., 863 F.2d
867, 876 (Fed. Cir. 1988)). Instead, the specific intent to deceive “‘must be the single
most reasonable inference able to be drawn from the evidence.’” Id. (quoting Star
Scientific, Inc. v. R.J. Reynolds Tobacco Co., 537 F.3d 1357, 1366 (Fed. Cir. 2008)).
Because evidence of intent to deceive is rarely available, such intent may be inferred
from indirect and circumstantial evidence. Id. (citation omitted).
IV.
Discussion
Although this motion was filed by the Plaintiffs, the court will begin its discussion
with the theory underlying Defendants’ inequitable conduct affirmative defenses and
counterclaims, which the court will refer to, for simplicity’s sake, as Defendants’
inequitable conduct claims.
According to Defendants, the testing performed by Dr. Zhang reflected no
significant difference between the viscosity of PVP as compared to PVA; therefore, PVP
was not “unexpectedly superior” to PVA in stabilizing olopatadine in 0.17-0.62%
solution. At this juncture, the language of claim 1 bears repeating:
In a topically administrable solution composition for treating allergic or
inflammatory disorders of the eye and nose comprising olopatadine and a
polymeric ingredient, the improvement wherein the amount of olopatadine
in the solution is 0.17-0.62% (w/v), the polymeric ingredient is a polymeric
physical stability-enhancing ingredient consisting essentially of
12
polyvinylpyrrolidone [PVP] or polystyrene sulfonic acid [PSSA] in an
amount sufficient to enhance the physical stability of the solution, and
wherein the composition has a viscosity of 1-2 cps and does not contain
polyvinyl alcohol [PVA] . . . .
(See PH at ALPD0005689)
Defendants’ claims are premised on the omission of two key pieces of information
during prosecution of the asserted patents. First, Defendants contend that the Applicants
(Ryan, Dr. Zhang, and Bhagat) only reported the viscosity data for Formulation J (PVA)
that was favorable to patentability (2.1 cps), and intentionally failed to disclose the
viscosity data for Formulation J that was unfavorable to patentability (2.0 cps). Second,
Defendants contend that the Applicants intentionally failed to disclose that the specific
error rate for a Brookfield viscometer is 5%. Had the Applicants done so, say the
Defendants, Formulation J (PVA at 2.0 cps) would have fallen within the statistically
valid viscosity range of between 1.995 and 2.205 cps — overlapping with the claimed
viscosity range in the asserted patents (between 1-2 cps). (See ‘186 patent, col. 16, ll:3031; ‘609 patent, col. 16, ll:4-5).
For purposes of this motion, the parties agree that the viscosity value for
Formulation J (PVA) at 2.1 cps was material to patentability. Thus, the merits of
Defendants’ inequitable conduct claims hinge on intent. On this point, Plaintiffs note that
“a district court may not infer intent solely from materiality.” Therasense, 649 F.3d at
1290.
In support of their motion, Plaintiffs argue the Applicants worked in isolation,
unaware of what the other was doing or why. This is best exemplified by the following:
13
(1) Dr. Zhang, a named inventor of the ‘186 and ‘609 patents, claims she did not know
why she was asked to conduct the viscosity test of Formulation J (PVA), (Zhang Dep. at
116); (2) Dr. Zhang claims she does not know why she provided the 2.1 cps data point for
Formulation J to Bhagat, instead of the 2.0 data point, even though both values were
scientifically valid, (id. at 116); (3) Bhagat, a named inventor of the ‘186 and ‘609
patents, who was also involved in prosecuting the patents, claims that the purpose of
verifying Dr. Zhang’s test results was simply to verify that the experiments were
conducted in the manner described in Dr. Zhang’s laboratory notebook page, (Bhagat
Dep. at 165-66); (4) Ryan, who on behalf of Alcon was prosecuting the patent, claims the
only data he received regarding the viscosity of Formulation J was the 2.10 cps data point
provided by Bhagat, (Ryan Dep. at 190-92); (5) Plaintiffs claim there is no evidence that
Bhagat and Dr. Zhang had knowledge that Ryan was adding the limitation “wherein the
composition has a viscosity of 1-2cps” to the patent claims; and (6) Bhagat claims he did
not mention the statistical error rate of 5% in his declaration to the PTO, because such
information is “understood” by those “knowledgeable about using the instrument and
dealing with viscosity measurements,” (Bhagat Dep. at 161). Relying principally on the
Federal Circuit’s en banc decision in Therasense, Plaintiffs argue that the only reasonable
inference to be gleaned from these facts is that the Applicants did not fail to disclose the
viscosity data of Formulation J [PVA] with the specific intent to deceive.
In Therasense, the Federal Circuit “tighten[ed] the standard for finding both intent
and materiality in order to redirect a doctrine that has been overused to the detriment of
the public.” Id. at 1288-90 (noting that, for example, “the inequitable conduct doctrine
14
has plagued not only the courts but also the entire patent system”). “Proving that the
applicant knew of a reference, should have known of its materiality, and decided not to
submit it to the PTO does not prove specific intent to deceive.” Id. at 1290. Instead, to
meeting the clear and convincing evidence standard, “the specific intent to deceive must
be “‘the single most reasonable inference able to be drawn from the evidence.’” Id.
(quoting Star Scientific, 537 F.3d at 1366) (emphasis added). Therasense, however, was
an appeal from a bench trial, and sets forth the standard for proving inequitable conduct
at trial. Indeed, the opinion is replete with references to “the evidence,” to “the burden of
proof,” and to what is necessary to “prevail on a claim.” The court’s function in that
instance is to determine the facts and apply the law to those facts.
In marked contrast, this case is before the court on Plaintiffs’ motion for summary
judgment. To prevail, Plaintiffs have the burden of establishing the absence of an
essential element of Defendants’ case in accordance with the applicable standard of
review. Celotex Corp., 477 U.S. at 325; Optium Corp. v. Emcore Corp., 603 F.3d 1313,
1319-20 (Fed. Cir. 2010). In other words, the inquiry is whether, viewing the evidence in
the light most favorable to the Defendants, no reasonable trier of fact could find the
Applicants acted with the specific intent to deceive the PTO. “‘Intent to deceive cannot
be inferred simply from the decision to withhold [information] where the reasons given
for the withholding are plausible.’” Astrazeneca Pharm. v. Teva Pharm., 583 F.3d 766,
777 (Fed. Cir. 2009) (granting summary judgment where threshold facts did not establish
materiality and intent) (quoting Dayco Products, Inc. v. Total Containment, Inc., 329
F.3d 1358, 1367 (Fed. Cir. 2003)). See also Morningware, Inc. v. Hearthware Home
15
Products, Inc., 898 F.Supp.2d 1018, 1043 (finding disputed issue of fact existed “with
respect to the intent prong of the Therasense analysis, which is a fact-sensitive inquiry”);
see also Mitsubishi Heavy Indus., Ltd. v. General Elec. Co., 2012 WL 4336208, at * 4
(M.D. Fla., Sept. 21, 2012) (finding disputed issue of fact on the issue of intent, and
citing Therasense).
In light of the standard on summary judgment, the court finds a reasonable trier of
fact could conclude the testimony of Ryan, Bhagat, and Dr. Zhang is not plausible in light
of their roles in the prosecution of the patent, the email traffic amongst the three of them
during the relevant time frame, and by the simple fact that neither Ryan, Dr. Zhang, nor
Bhagat can explain why the 2.1 cps viscosity value for Formulation J was chosen over the
2.0 viscosity value, even though Dr. Zhang opined that both values were scientifically
valid, nor why the Examiner was not informed of the potential error rate of 5%. Bhagat
claims that the error rate was not reported because, to those knowledgeable and wellversed in the science of viscosity testing, it is just “understood” that there is an error rate.
There is no evidence in this record, though, establishing that a PTO Examiner would be
such a person well-versed in viscosity testing. A reasonable trier of fact could therefore
conclude that in order to gain allowance of the asserted patents, Ryan, Dr. Zhang, and
Bhagat, individually or in concert with one another, made a deliberate decision to
withhold the 2.0 viscosity data of Formulation J from the Examiner, and/or made the
deliberate decision to withhold the Brookfield viscometer error rate of 5%. Accordingly,
Plaintiffs’ motion for summary judgment is DENIED.
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V.
Conclusion
For the reasons set forth above, Plaintiffs’ Motion for Summary Judgment (Docket
# 162) is DENIED.
SO ORDERED this 21st day of May 2013.
________________________________
__________________________________
RICHARD L. YOUNG, CHIEF JUDGE
RICHARD L. YOUNG, CHIEF JUDGE
United States District Court
United States District Court
Southern District of Indiana
Southern District of Indiana
Distributed Electronically to Registered Counsel of Record.
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