RECKITT BENCKISER INC. et al v. TRIS PHARMA, INC.
Filing
220
OPINION filed. Signed by Judge Freda L. Wolfson on 12/21/2011. (mmh)
NOT FOR PUBLICATION [94]
UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY
___________________________________
RECKITT BENCKISER INC. and
:
UCB MANUFACTURING, INC.
:
Plaintiffs,
:
v.
Civil Action No. 09-3125 (FLW)
:
OPINION
:
TRIS PHARMA, INC. and
YU-HSING TU,
:
Defendants.
:
___________________________________
WOLFSON, United States District Judge:
Presently before the Court is a Motion for Summary Judgment of Non-infringement by
Defendants Tris Pharma Inc. (“Tris”) and Yu-Hsing Tu (“Dr. Tu”)(collectively “Defendants”).
The instant motion arises out of a Complaint filed by Plaintiffs Reckitt Benckiser Inc. (“Reckitt”)
and UCB Manufacturing, Inc. (“UCB”) (collectively “Plaintiffs”) alleging, inter alia,
infringement of U.S. Patent No. 5,980,882 (“the ‘882 patent”) by Defendants’ submission of an
Abbreviated New Drug Application (“ANDA”) to market a generic version of the over-thecounter cough syrup Delsym, which is made by Reckitt and allegedly covered by the ‘882 patent
owned by UCB. In this motion, Defendants allege that Plaintiffs have not demonstrated that
Defendants’ use of EDTA results in the claimed 20 percent reduction in degradation over twelve
months of a pharmaceutical composition with EDTA versus an otherwise identical
1
pharmaceutical composition without EDTA, as required by Claims 23, 26 and 36 of the ‘882
patent (the “asserted claims”).1 As a result, Defendants allege that Plaintiffs cannot establish
infringement and, therefore, that summary judgment is warranted. The Court agrees and for the
reasons set forth below, grants Defendants’ motion for summary judgment.
I. BACKGROUND
Because the facts of this case are well known to the parties, and in light of the three Opinions
already issued by this Court in this matter, the Court will only recite the relevant facts herein and
will, instead, incorporate the facts recited in the previous Opinions issued by this Court.
The ‘882 patent, entitled “Drug-Resin Complexes Stabilized by Chelating Agents,” claims
certain pharmaceutical compositions using a drug-resin complex and a chelating agent and
certain methods of making these pharmaceutical compositions. The claims of the ‘882 patent
include Delsym and its method of production. The active ingredient in Delsym is
dextromethorphan, a common cough suppressant that has been on the market for at least 50
years. Delsym contains dextromethorphan in an extended release form so it can be taken less
frequently than a conventional cough syrup. When swallowed, the dextromethorphan is released
over a period of time. The ‘882 patent, the patent at issue here, claims an “improved”
formulation of Delsym to which an extra ingredient – the common preservative or stabilizer
called edtate disodium (“EDTA” or “a salt of EDTA”) has been added.
Importantly, and in relevant part, Claim 23 of the ‘882 patent recites “[a] method for
1
Indeed, the Court notes that in a letter dated November 4, 2011, counsel for Plaintiffs
voluntarily dismissed claims 24 and 25 of the ‘882 patent.
2
improving the stability of a pharmaceutical composition that contains a drug-resin complex
comprising adding a chelating agent in an amount effective to reduce the rate of degradation of
the drug in the drug-resin complex by more than 20 percent over twelve months of storage at
room temperature relative to an otherwise identical pharmaceutical composition without the
chelating agent.” Thus, to prove infringement, Plaintiffs must establish that the accused product
(which contains EDTA) reduces the rate of degradation by more than 20 percent over twelve
months of storage as compared to an otherwise identical product without EDTA. Claims 26 and
36, the remaining claims asserted in this matter, are dependent upon Claim 23.2
In November 2010, this Court issued an Opinion construing various claims of the ‘882
patent. Subsequently, in February 2011, this Court issued an Opinion dismissing a Breach of
Contract count from the amended complaint. Thereafter, in May 2011, the parties met and
conferred regarding certain outstanding discovery issues. As a result, the parties agreed to the
following schedule: the completion of document production on June 10, 2011; the close of fact
discovery on July 8, 2011; that opening expert reports would be due on July 27, 2011; that
rebuttal expert reports would be due on August 24, 2011; and that expert discovery would close
on September 16, 2011. The Magistrate Judge “SO ORDERED” the agreed-upon schedule on
June 3, 2011.
In accordance with the schedule, on July 27, 2011, Plaintiffs timely served the opening expert
report of Dr. Stephen R. Byrn (“Opening Report”). Indeed, in relevant part, in the Opening
2
Claim 26 recites, “[a] method according to claim 23, wherein the composition is a
suspension.” Similarly, Claim 36 recites, “A method according to claim 23, wherein the drug in
the drug-resin complex is dextromethorphan.”
3
Report, Dr. Byrn made the following reference to an independent laboratory’s manufacture of
Tris’s product:
I understand that Counsel for Reckitt Benckiser and UCB requested an
independent laboratory to manufacture Tris’s Proposed ANDA product with and
without the EDTA-washed resin and conduct stability testing at room temperature
over twelve months. The data available after nine months establishes that the
EDTA-washed resin in Tris’s proposed ANDA product reduces the rate of
degradation by 57.3% over nine months and meets this part of the claim
limitation. Following normal linear degradation, a similar reduction in
degradation would occur after twelve months. I summarize the available data
below. I reserve the right to supplement this report as additional data becomes
available.
Opening Report ¶ 67.
On August 24, 2011, Plaintiffs timely served Dr. Byrn’s rebuttal expert report (“Rebuttal
Report”). Thereafter, on August 26, 2011, Defendants filed the instant motion for summary
judgment based, in part, on the opening and rebuttal reports of Dr. Stephen R. Byrn. In their
opening brief, Defendants argued that summary judgment was warranted because Plaintiffs failed
to meet the requirements of Claim 23 since they did not demonstrate that the accused product
(which contains EDTA) reduces the rate of degradation by more than 20 percent over twelve
months of storage as compared to an otherwise identical product without EDTA. Specifically,
Defendants contend that Plaintiffs could not establish infringement by merely: (1) comparing the
stability of the accused product to the stability of Plaintiffs’ product, Delsym; (2) pointing to the
stability of an experimental Tris product; or (3) relying on a statement by Dr. Byrn concerning an
independent laboratory’s “manufacture of Tris’s Proposed ANDA product with and without the
EDTA-washed resin” over a nine month period that was wholly unsupported by any reasonable
basis.
4
On September 13, 2011, after receiving Defendants’ summary judgment motion, but prior to
filing any Opposition thereto, and without seeking permission of the Court, Plaintiffs served a
supplemental expert report of Dr. Byrn (“Supplemental Report”). Importantly, and in relevant
part, the Supplemental Report analyzed, for the first time, the independent laboratory tests
conducted between August 2010 and September 2011 of the samples manufactured by Plaintiffs
that allegedly replicate Defendants’ accused product.
Thereafter, on September 21, 2011, Plaintiffs filed a Brief in Opposition to Defendants’
summary judgment motion. Specifically, Plaintiffs argue that they have multiple sets of data
showing that Defendants’ product infringes the Improved Stability Limitation set forth in Claim
23 and that such data are sufficient to defeat the instant motion for summary judgment. In
support of their Opposition, Plaintiffs attached the Supplemental Report of Dr. Byrn and,
additionally, included a declaration from Dr. Byrn containing information from the Supplemental
Report.
As a result, on September 21, 2011, Defendants immediately filed an informal motion to
strike the Supplemental Report. In the motion, Defendants alleged that they were unduly
prejudiced by the late and unauthorized submission of the Supplemental Report, which contained
substantial new data and information that went well beyond the scope of Dr. Byrn’s opening
report. Specifically, Defendants argued that “the new report is the first time that Dr. Byrn
expresses any opinion on the manufacturing and testing methods used by Aptuit, despite the fact
that this information was available in August 2010, almost a full year before opening expert
reports were due. . . .This is also the first time that Dr. Byrn renders opinions on the reliability of
Aptuit’s alleged results, including statistical analysis and kinetic modeling.” Defs’ Mot. to Strike
5
(Sept. 21, 2011)(“Def’s Sept. 21 Letter”) at 3. Moreover, Defendants contended that they were
additionally prejudiced by “[P]laintiffs’ concealment that samples were being manufactured and
tested by Aptuit throughout fact discovery. Underlying data from third party laboratories. . .were
requested by [D]efendants yet never produced.” Id.
Dr. Byrn was deposed on October 3, 2011. During his deposition, Dr. Byrn appears to admit
that he did not analyze the data about which he opined in paragraph 67 of his Opening Report,
and, moreover, that his only understanding that the third party data replicated Defendants’
products and method was based on what Plaintiffs’ attorneys told him. Defs’ Reply in Support of
Motion to Strike (Oct. 7, 2011)(“Defs’ Oct. 7 Letter.”)3
3
In support of their assertion, Defendants cite to the following deposition testimony:
Q.
Now, when you say you understand that counsel for Reckitt Benckiser UCB
requested the independent laboratory and you put the data here in paragraph 67,
what other information did you have at the time about how the tests were done?
A.
The understanding I had was that they had repeated the process, the Tris process,
using the Tris batch records and the Tris contents and the procedure that Tris had
used.
Q.
And what understanding was that based – on what was that understanding based?
A.
What I was told.
Q.
By whom?
A.
By the attorneys.
***
At the time you prepared this expert report, you did not know that the work that
was told to you by the attorneys for plaintiffs had been done by Aptuit; true?
A.
I don’t think I knew that.
Q.
You had not audited the Aptuit methods; correct?
A.
I understood that it was a replication of the Tris method.
Q.
Because that’s what the lawyers told you; correct?
A.
Correct.
Q.
You didn’t independently verify that?
A.
Correct.
Defs’ Oct. 7, Letter, at 2-3.
Q.
6
On October 21, 2011, the Magistrate Judge held oral argument on Defendants Motion to
Strike the Supplemental Report and, on that same date, issued an Order striking the
Supplemental Report. Plaintiffs appealed the Magistrate Judge’s October 21, 2011 Order. In an
opinion dated, December 21, 2011, I affirmed the Magistrate’s Order in its entirety. As a result,
this Court will not consider the Supplemental Report, nor any information contained within Dr.
Byrn’s declaration that stems from the Supplemental Report, in deciding the instant motion for
summary judgment.
II. LEGAL STANDARD
Summary judgment serves to “isolate and dispose of factually unsupported claims.” Celtex
Corp. v. Catrett, 477 U.S. 317, 323-24 (1986). It “shall be rendered forthwith if the pleadings,
depositions, answers to interrogatories, and admissions on file, together with affidavits, if any,
show that there is no genuine issue as to any material fact and that the moving party is entitled to
judgment as matter of law.” Fed. R. Civ. P. 56(c); see Anderson v. Liberty Lobby, Inc., 477 U.S.
242, 248-50 (1986). Summary judgment is just as appropriate in a patent case as in any other
civil case. Paragon Podiatry Lab. v. KLM Labs., Inc., 984 F.2d 1182, 1190 (Fed.Cir.1993). In
addition, in deciding a motion for summary judgment, “[t]he evidence of the nonmovant is to be
believed, and all justifiable inferences are to be drawn in his favor.” Anderson v. Liberty Lobby,
Inc., 477 U.S. 242, 255 (1986).
The patentee must prove infringement by a preponderance of the evidence. Mannesmann
Demag Corp. v. Enginerred Metal Prods. Co. Inc., 793 F.2d 1279, 1282 (Fed. Cir.1986). To
prove infringement of a patent claim to a method, the patentee must prove that every step in the
7
method is performed by the accused process, either literally or under the doctrine of equivalents.
Canton Bio-Medical, Inc. v. Integrated Liner Techs., Inc., 216 F.3d 1367, 1370 (Fed. Cir.2000).
The absence of any one limitation of a claim in the accused process precludes a finding of literal
infringement of that claim. Kahn v. GMC, 135 F.3d 1472, 1477 (Fed. Cir.1998). Summary
judgment of non-infringement is, therefore, appropriate where no reasonable jury could find that
the accused process carries out each and every step of the claim or its equivalent. Goldenberg v.
Cytogen, Inc., 373 F.3d 1158, 1163-64 (Fed. Cir.2004). On the other hand, summary judgment
of infringement is proper when “no reasonable jury could find that any limitation in a properly
construed claim is missing from an accused device.” PC Connector Solutions LLC v. SmartDisk
Corp., 406 F.3d 1359, 1364 (Fed. Cir.2005).
Specifically, for literal infringement, the accused product or process must “contain each
limitation of the claim exactly” and there cannot be “any deviation from the claim.” Litton Sys.
v. Honeywell, 140 F.3d 1449, 1454 (Fed.Cir.1998); see also Telemac Cellular Corp. v. Topp
Telecom, Inc., 247 F.3d 1316, 1330 (Fed.Cir.2001). If each limitation is not satisfied exactly,
infringement may still be found under the doctrine of equivalents, but only if the difference
between the claim limitation not present literally and the corresponding element in the accused
device or process is “insubstantial.” Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S.
17, 39-40 (1997); Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d
1139, 1351 (Fed. Cir.2003). An accused device may infringe under the doctrine of equivalents
only if it possesses all of the limitations of the relevant claim either literally or equivalently. See
Warner-Jenkinson Co., 520 U.S. at 40-41.
Thus, a determination of infringement requires a two-step analysis. “First, the court
8
determines the scope and meaning of the patent claims asserted.... [Second,] the properly
construed claims are compared to the allegedly infringing device.” Cybor Corp. v. FAS Techs.,
Inc., 138 F.3d 1448, 1454 (Fed.Cir.1998) (en banc) (citations omitted). Step one, claim
construction, is an issue of law. Markman v. Westview Instruments, Inc., 52 F.3d 967, 970-71
(Fed. Cir.1995) (en banc), aff'd, 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). Step
two, comparison of the claim to the accused device, requires a determination that every claim
limitation or its equivalent be found in the accused device. See Warner-Jenkinson Co. v. Hilton
Davis Chem. Co., 520 U.S. 17, 29 (1997). Those determinations are questions of fact, and on
summary judgment, the issue is whether there is no genuine issue of material fact regarding
infringement. Bai v. L & L Wings, Inc., 160 F.3d 1350, 1353 (Fed. Cir.1998). Summary
judgment of noninfringement may only be granted if, after viewing the alleged facts in the light
most favorable to the nonmovant and drawing all justifiable inferences in the nonmovant's favor,
there is no genuine issue whether the accused device is encompassed by the patent claims. Pitney
Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1304(Fed. Cir.1999).
III. DISCUSSION
In the instant matter, each of the asserted claims – 23, 26 and 36 – requires a comparison over
twelve months between a product with EDTA and an otherwise identical product without EDTA
resulting in a greater than 20 percent reduction in degradation of the drug when EDTA is added.
In this regard, Defendants argue, that because Plaintiffs have not set forth any evidence of the
required comparison between the accused product and an otherwise identical product made
9
without EDTA over a twelve month period, summary judgment is warranted.
Defendants assert three separate bases for their motion. First, Defendants contend that
Plaintiffs cannot rely on third-party test data provided by Aptuit to demonstrate infringement.
Next, Defendants argue that because Plaintiffs only compared the accused Tris product to
Delsym, they did not meet the specifications of Claim 23 which require a comparison of the
accused product with “an otherwise identical pharmaceutical composition without” EDTA.
Finally, Defendants argue that Plaintiffs compared an experimental Tris product to the Claims
rather than comparing the accused Tris product to the Claims. For the reasons set forth below,
the Court grants Defendants’ motion for summary judgment of non-infringement.
A. Third Party Laboratory Test Data
In his Opening Report, Dr. Byrn relies on third party test data provided by Aptuit, an
independent laboratory, to demonstrate that Defendants’ product infringed the ‘882 patent.
Specifically, and in relevant part, Dr. Byrn opined that:
I understand that Counsel for Reckitt Benckiser and UCB requested an
independent laboratory to manufacture Tris’s Proposed ANDA product with and
without the EDTA-washed resin and conduct stability testing at room temperature
over twelve months. The data available after nine months establishes that the
EDTA-washed resin in Tris’s proposed ANDA product reduces the rate of
degradation by 57.3% over nine months and meets this part of the claim
limitation. Following normal linear degradation, a similar reduction in
degradation would occur after twelve months.
Opening Report ¶ 67.
In the instant motion, Defendants contend that Plaintiffs cannot rely on the third-party test
data provided by Aptuit to demonstrate infringement. Specifically, Defendants argue that: (1)
10
Plaintiffs have not shown that the Aptuit product is the same as Tris’s ANDA product; and (2)
Dr. Byrn’s opinions are not shown to be based on reliable and scientific methods.4 The Court
agrees.
Since the burden of proving infringement rests with the patentee, an accused infringer
seeking summary judgment may “meet its initial responsibility either by providing evidence that
would preclude a finding of infringement, or by showing that the evidence on file fails to
establish a material issue of fact essential to the patentee’s case.” Novartis Corp. V. Ben Venue
Labs., Inc., 271 F. 3d 1043, 1046 (Fed. Cir. 2001). In the context of a summary judgment
motion, the Federal Circuit has explained, “[u]nder modern summary judgment law, a patentee
who fails to provide probative evidence of infringement runs the risk of being peremptorily
nonsuited . . . Evidence from which a reasonable fact-finder could find infringement will forestall
this possibility. However, a party does not meet this evidentiary threshold merely by submitting
the affidavit of an expert who opines that the accused device meets the claim limitations.” Id. at
1050-1051(citations omitted). Instead, the Federal Circuit requires “that the factual predicate of
an expert’s opinion must find some support in the record, and has emphasized that mere
‘theoretical speculations’ lacking a basis in the record will not create a genuine issue of fact. . .
Moreover, where an expert’s opinion is predicated on factual assumptions, those assumptions
must also find some support in the record.” Id. at 1051.
4
In addition, Defendants argue that Dr. Byrn’s supplemental reports are inadmissible; for
the reasons set forth in the Magistrate Judge’s October 21, 2011 Order striking the Supplemental
Report, as well as this Court’s December 21, 2011 Opinion affirming the Magistrate Judge’s
October 21, 2011 Order, this Court will not consider this argument nor will the Court consider
the Supplemental Report.
11
For example, in Novartis v. Ben Venue Laboratories, Inc., 271 F. 3d 1043 (Fed. Cir. 2001),
the Federal Circuit affirmed a district court’s grant of summary judgment of non-infringement
where the patentee failed to present sufficient evidence to raise a fact issue regarding
infringement. Specifically, in an attempt to defeat the accused infringer’s motion for summary
judgment, the patentee introduced an expert’s opinion that, based on a computer model, the
accused product formed the necessary crystalline structure during the manufacturing process.
However, the expert did not provide any supporting evidence to show how its model accurately
approximated the accused infringer’s manufacturing process. There, the Federal Circuit faulted
the expert declaration for failing to explain the basis for his model, and, specifically, failing to
explain what facts of record the expert based his model upon or the assumptions he employed in
making the model. Indeed, the court explained that “every simulation of a physical process
embodies at least some simplifying assumptions, and requires both a solid theoretical foundation
and realistic input parameters to yield meaningful results. Without knowing these foundations, a
court cannot evaluate whether the simulation is probative, and it would be unfair to render an
expert’s opinion immune to challenge because its methodology is hidden in an uncommented
computer model . . . under our law and the law of the Third Circuit it was [plaintiff’s] obligation
to set forth detailed basis of its evidence such that the district court could evaluate whether it
could support a finding of infringement by a reasonable fact-finder. Without such basis . . . we
must regard [the expert’s] opinion] as no more than theoretical speculation raising, at best, a
‘metaphysical doubt as to the material facts.’” Id. at 1054 (citations omitted).
Conversely, in Dow Chemical Co., v. Nova Chemicals Co., Civ. A. No. 05-737, 2010 WL
2044931 (D.Del. May 20, 2010), defendants argued that summary judgment based on non12
infringement was proper because plaintiff could not establish the elements of infringement.
There, defendant argued that plaintiff could not show that the accused polymer met the limitation
requirements based on the method by which plaintiff tested the product. Specifically, defendant
argued that “because [plaintiff] ran tests on a version of the accused product it created and did so
under different polymerization conditions and with a different co-catalyst than [defendant] uses,
there is no valid evidence of infringement.” Id. at *4. In denying defendant’s motion for
summary judgment, the court explained that “the first argument presented by [defendant] was
that the accused product has not been shown to have [a qualifying component] because Dow
tested on fabrications of the accused product it made and not on the actual product.” Id.
However, the court went on to explain that plaintiff had sustained its burden to defeat summary
judgment because plaintiff “has produced sufficient evidence that the testing procedures it carried
out were scientifically acceptable and based on the accused product. There was testing by a
qualified expert in an appropriate setting and the expert also offered substantial explanation for
his actions.” Id. at *5. In contrast, the facts extant before this Court fall short in these respects.
In the instant matter, the entirety of the evidence in the record before me concerning the thirdparty testing consists of three sentences in Dr. Byrn’s Opening Report and pertains to tests that
Dr. Byrn did not supervise, design or conduct.5 Specifically, Dr. Byrn opines, in relevant part,
5
Importantly, the Court notes that it is well-established that “an expert need not have
obtained the basis for his opinion from personal perception . . . Likewise, numerous courts have
held that reliance on scientific test results prepared by others may constitute the type of evidence
that is reasonably relied upon by experts for purposes” of the Federal Rules. Monsanto Co. v.
David, No.2007–1104, 2008 WL 304751 (Fed.Cir. Feb.5, 2008) (citing Ratliff v. Schiber Truck
Co., 150 F.3d 949, 955 (8th Cir.1998) (holding that expert testimony regarding a report prepared
by a third party was properly allowed); Gussack Realty Co. v. Xerox Corp., 224 F.3d 85, 94, 95
(2d Cir.2000) (finding that testimony was properly admitted from an expert who did not conduct
13
that “ [t]he data available after nine months establishes that the EDTA-washed resin in Tris’s
proposed ANDA product reduces the rate of degradation by 57.3% over nine months and meets
this part of the claim limitation. Following normal linear degradation, a similar reduction in
degradation would occur after twelve months.” Opening Report ¶ 67. As evidenced by Dr.
Byrn’s terse and conclusory statement, Dr. Byrn does not provide any explanation or “factual
predicate” concerning the third party testing. See, e.g., Novartis, 271 F.3d at 1051. Indeed,
nothing in Dr. Byrn’s opinion suggests, let alone establishes, that the third party testing was
scientifically acceptable, that Aptuit was qualified to perform the testing or that the product
manufactured and tested by Aptuit was the same as Tris’s ANDA product. Moreover, Dr. Byrn’s
opinion appears to be based, entirely, on information he was told by counsel and not based on
first hand review or knowledge. See supra n. 3. Indeed, not only did Dr. Byrn not supervise,
design or conduct the experiments about which he opined, but at the time of his Opening Report,
Dr. Byrn had not independently reviewed any of the third party data and was, instead, relying
solely upon information he was told by Plaintiffs’ counsel. See id. Thus, unlike Dow Chemical,
there is no evidence whatsoever to support Dr. Byrn’s Opinion regarding the third party
laboratory results. Because Plaintiffs have not set forth any basis for Dr. Byrn’s opinion
concerning the third party testing, let alone demonstrated that the product manufactured and
his own tests).” That said, an expert's “unsupported conclusion on the ultimate issue of
infringement is insufficient to raise a genuine issue of material fact.” Arthur A. Collins v.
Northern Telecom Ltd., 216 F.3d 1042, 1046 (Fed.Cir.2000). Instead the expert must include the
facts upon which his conclusions were reached. See id.; Zelinski v. Brunswick Corp., 185 F.3d
1311, 1317 (Fed.Cir.1999). Here, Dr. Byrn did not independently evaluate the third party testing,
nor the samples created by Aptuit, and thus, could not comment upon the reliability of the testing
and whether it definitely supports his conclusions.
14
tested by Aptuit was the same as Tris’s accused product, the Court finds that Dr. Byrn is unable
to opine regarding the manufacture and testing of the third party data. Since there is no
independent basis for relying on the third party test results, the record is devoid of any reliable
analysis of those results; thus, the Court finds that the third party data is insufficient to defeat
Defendants’ motion for summary judgment.
B. Plaintiffs’ Comparison of the Accused Tris product to Delsym
Next, Plaintiffs attempt to prove that Tris’s ANDA product infringes the ‘882 patent by
comparing the accused product to Delsym. In this motion, Defendants argue that because
Plaintiffs have only compared Tris to Delsym, and have not compared Tris’s product with EDTA
to an identical pharmaceutical product without EDTA as required by Claim 23, Plaintiffs have
failed to demonstrate infringement.
As discussed above, Claim 23 requires a comparison of “a drug-resin complex comprising
adding a chelating agent” to “an otherwise identical pharmaceutical composition without the
chelating agent.” Thus, Claim 23 expressly requires a comparison between the accused product
(with EDTA) and an “identical” pharmaceutical composition without EDTA. In that regard,
Defendants initially argue that although Dr. Byrn compares Delsym to Tris’s ANDA product,
Plaintiffs have not demonstrated that Delsym is an identical pharmaceutical product for purposes
of Claim 23.6 In support of this argument, Defendants note that Dr. Byrn has not opined that
Tris’s product and Delsym are identical as required by Claim 23. Indeed, Defendants point to a
chart contained in Dr. Byrn’s Opening Report demonstrating that the Delsym and Tris products
6
In addition, the Court notes that as discussed infra, because Delsym and Tris’s ANDA
product both contain EDTA, Plaintiffs have not met the requirements of Claim 23.
15
are, in fact, different. Further, Defendants argue that Plaintiffs’ reliance on the alleged
bioequivalence of Delsym and Tris is inapposite. For the reasons set forth below, the Court
agrees.
Initially, the Court notes that nothing in the record demonstrates that Delsym and Tris are
identical pharmaceutical products for purposes of Claim 23. Indeed, nowhere does Dr. Byrn
opine that Delsym and Tris are identical products for purposes of the asserted claims. Moreover,
a chart contained in Dr. Byrn’s Opening Report expressly demonstrates that eight of seventeen
ingredients in the Delsym and Tris products are different. Opening Report ¶ 64. At best, Dr.
Byrn states that “Tris’s proposed ANDA product’s formulation show[s][sic] remarkable
similarity to Delsym.” Opening Report ¶ 64. However, the plain language of Claim 23 requires
that the products be identical and not “remarkably similar” for purposes of demonstrating that the
accused product infringes.
Moreover, to the extent that Plaintiffs rely on the bioequivalence of Delsym and Tris in order
to satisfy the “identical” requirement of Claim 23, the Court finds that such reliance is misplaced.
Indeed, as the Federal Circuit has explained:
Bioequivalency and equivalent infringement are different inquiries.
Bioequivalency is a regulatory and medical concern aimed at establishing that two
compounds are effectively the same for pharmaceutical purposes. In contrast,
equivalency for purposes of patent infringement requires an element-by-element
comparison of the patent claim and the accused product, requiring not only
equivalent function but also equivalent way and result. Different attributes of a
given product may thus be relevant to bioequivalency but not equivalent
infringement, and vice versa. As the Northern District of Illinois observed in the
Sandoz case, “[i]f bioequivalency meant per se infringement, no alternative to a
patented medicine could ever be offered to the public during the life of a patent.”
Sandoz PI Order, 486 F.Supp.2d at 776. Thus, while potentially relevant, the
bioequivalency of an accused product with a product produced from the patent at
issue is not sufficient to establish infringement by equivalents.
16
Abbott Labs. v. Sandoz, Inc., 566 F.3d 1282, 1298 (Fed. Cir. 2009).
Applied here, although Plaintiffs argue that Delsym and Tris’s ANDA product are similar
and, moreover, that the bioequivalence data demonstrates “the similarity between an innovator
product and an accused product,” nothing in the record demonstrates that Delsym and Tris’s
ANDA product are identical as required for the comparison in Claim 23. For these reasons, the
Court finds that Plaintiffs have failed to establish that Delsym and Tris’s ANDA product are
identical for purposes of the asserted claims.
However, even assuming that this Court were to find that Delsym and Tris’s ANDA product
are identical for purposes of Claim 23, the Court finds that the record is barren of a comparison
between the accused product (with EDTA) and an identical product without EDTA. Importantly,
in their opening brief, Defendants argue that “[t]he purported similarity in stability between Tris
Pharma’s product and Delsym asserted by Dr. Byrn is also inapt because both products use
EDTA. This says nothing about the relative stability of the Tris Pharma product when compared
to an otherwise identical product made without EDTA, which is the comparison required by the
patent claims.” Defs’ Br. at 5 (emphasis in original). Indeed, Plaintiffs have not disputed
Defendants’ assertion. In fact, Plaintiffs’ Opposition Brief appears to focus solely on a
comparison of Tris (with EDTA) to Delsym (with EDTA), Pls’ Opp. 11-14, and Plaintiffs do not
dispute Defendants’ contention that the record does not demonstrate a comparison of Tris’s
ANDA product (with EDTA) to an identical pharmaceutical product without EDTA.
Moreover, in their responsive fact statement, Plaintiffs state that “Dr. Byrn considers the
comparison of Tris Pharma’s ANDA product (which uses EDTA) to Delsym with EDTA in
17
conjunction with, among other evidence, twelve month stability data conducted by Aptuit, a third
party laboratory, that demonstrates that Tris Pharma’s ANDA product has a more than 20%
reduction . . .to an otherwise identical pharmaceutical composition without EDTA.” Pls’ Resp.
Fact Statement (“Pls’ Resp. FS”) ¶ 1 (emphasis added). Initially, the Court notes that the
responsive fact statement is internally inconsistent; Dr. Byrn’s comparison of Tris’s ANDA
product to Delsym – two products with EDTA – is an entirely separate inquiry, and based on
entirely separate data, than Dr. Byrn’s opinion regarding the third party data. Thus, Plaintiffs’
attempt to conflate the two is not helpful to this Court nor is it helpful to the analysis required
under Claim 23. Moreover, based on the above statement the Court finds that Plaintiffs have
expressly averred that Dr. Byrn compared two pharmaceutical products with EDTA, as opposed
to two pharmaceutical products one of which contains EDTA and one which does not. Indeed, to
the extent that Plaintiffs argue that Dr. Byrn considered the two drugs with EDTA “in
conjunction” with the twelve month stability data, the Court notes that the Supplemental Report
containing an analysis of the third party data has been struck from the record. Moreover, to the
extent that Plaintiffs suggest that Dr. Byrn could rely on nine-months of stability testing
conducted by Aptuit, I have already ruled that the record contains no factual predicate to support
a proper consideration of this testing. Thus, at this point, there is nothing in the record to
demonstrate that Plaintiffs compared Tris’s ANDA product with EDTA to an identical product
without EDTA as required by Claim 23. Thus, Plaintiffs cannot rely on this evidence to defeat
Defendants’ motion for summary judgment.
C. Experimental Tris product
Finally, Plaintiffs attempt to demonstrate infringement of the ‘882 patent by relying on
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internal Tris data regarding an experimental Tris ANDA product made with Purolite C100MR
resin. In this motion, Defendants argue that because Plaintiffs compared an experimental Tris
product manufactured with a different resin than that utilized in the manufacture of the ANDA
product, Plaintiffs have not demonstrated infringement. In addition, Defendants argue that
because the experimental data upon which Plaintiffs rely encompasses only three months of
testing (as opposed to the 12 months recited by Claim 23), such data fails to meet the
requirements of the asserted claims. In response, Plaintiffs argue that although the experimental
Tris product and the accused product are different, the addition of EDTA will have the same
effect in both products. In addition, Plaintiffs argue that Dr. Byrn properly opined by
extrapolating the three month data out to twelve months.
It is well-established that “[l]iteral infringement requires the patentee to prove that the
accused device contains each limitation of the asserted claim(s). . . . If any claim limitation is
absent from the accused device, there is no literal infringement as a matter of law.” Bayer AG v.
Elan Pharmaceutical Research Corp., 212 F.3d 1241, 1248 (Fed. Cir. 2000). Thus, it is beyond
question that in order to demonstrate infringement, Plaintiffs bear the burden of showing that the
accused Tris ANDA product meets the asserted claims of the ‘882 patent.
Here, in an attempt to show that Defendants infringed the ‘882 patent, Plaintiffs rely on
internal Tris data regarding an experimental Tris ANDA product made with Purolite C100MR
resin that shows a more than 20 percent reduction in rate of degradation over three months
compared to the same formulation without EDTA. Opening Report ¶ 68; Byrn Decl., Ex. D., 10.
Importantly, however, unlike the experimental Tris product, Tris’s ANDA product does not
contain C100MR, but instead, uses Amberlite IRP69, a different resin. Thus, there is no
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evidence in the record showing that the accused product meets the asserted claims of the ‘882
patent.
In addition, the Court notes that the asserted claims require a comparison over twelve months
to determine whether the addition of EDTA results in a 20 percent reduction in degradation.
However, the data upon which Plaintiffs rely to demonstrate infringement comprise just three
months worth of testing. In his Opening Report, Dr. Byrn opines that “[a]ssuming a normal
linear degradation rate,” the three month data “suggests that over twelve months the formulation
with the EDTA-washed resin would continue to show decreased degradation compared with the
formulation without EDTA-washed resin, supporting. . .this part of the claim.” Opening Report
¶ 68. Thus, at best, Dr. Byrn has opined that an experimental Tris product that uses a different
resin than that used in the accused product would show the requisite degradation if the three
month data were extrapolated over a 12 months period. This, however, is not sufficient to meet
Plaintiffs’ burden of establishing that the accused Tris product shows a more than 20 percent
degradation over a twelve month period as required by the asserted claims. For these reasons,
Plaintiffs cannot rely on the evidence concerning Tris’s experimental product to defeat the instant
motion for summary judgment.
IV. CONCLUSION
For the foregoing reasons, Defendants’ Motion for Summary Judgment is GRANTED.
Dated: December 20, 2011
/s/ Freda L. Wolfson
Freda L. Wolfson, U.S.D.J.
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