Alcon Research Ltd. v. Barr Laboratories Inc.
Filing
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OPINION- the effective date of any FDA approval of Barrs BAC-free ANDA product shall be a date which is not earlier than the date of the expiration of the last to expire of the '497 and '253 patents. ***Civil Case Terminated. Signed by Judge Legrome D. Davis on 12/13/2011. (lih)
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
ALCON RESEARCH LTD.,
Plaintiff,
v.
BARR LABORATORIES INC. et al.,
Defendants.
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CIVIL ACTION
NO. 09-CV-0318-LDD
OPINION
Legrome D. Davis, J.
I.
December 13, 2011
Introduction
Plaintiff Alcon Research, Ltd. (“Alcon”) brought this patent infringement action in
response to Defendants’ Par Pharmaceutical, Inc. (“Par”) and Barr Laboratories Inc. (“Barr”)
filing of Abbreviated New Drug Applications (ANDAs)1 for FDA approval to market generic
versions of Alcon’s Travatan® and Travatan Z® products. Travatan® and Travatan Z® are
topical prescription eye drops used to treat glaucoma and ocular hypertension, a condition
associated with glaucoma. Although both Travatan® and Travatan Z® contain the same active
ingredient, i.e., the prostaglandin Travoprost in a concentration of 0.004% w/v, Travatan®
contains benzalkonium chloride (“BAC” or “BAK”), a conventional antimicrobial agent, while
Travatan Z® does not.
1
Par submitted ANDA Nos. 91-340 and 91-341 seeking FDA approval to market generic
versions of Alcon’s Travatan® and Travatan Z® products, respectively. Barr submitted ANDA
No. 91-411 seeking FDA approval to market a generic version of Alcon’s Travatan Z® product.
Barr also submitted, but subsequently withdrew, an ANDA for Travatan®.
1
Leading up to trial, Alcon asserted four (4) patents against the Defendants. Two (2) of
the patents-in-suit – U.S. Patent Nos. 5,631,287 (“the ‘287 patent”) and 6,011,062 (“the ‘062
patent”), collectively the “Schneider patents” or the “castor oil patents” – relate to methods of
enhancing the chemical stability of prostaglandin-containing compositions by adding
polyethoxylated castor oil (“PECO”) to the compositions. The other two (2) patents – U.S.
Patent Nos. 6,503,497 (“the ‘497 patent”) and 6,849,253 (“the ‘253 patent”), collectively the
“Chowhan patents” or the “borate-polyol patents” – describe aqueous ophthalmic compositions
containing a water soluble borate-polyol complex to enhance the antimicrobial activity of the
compositions. Following a Markman hearing, we issued an Order on September 6, 2011,
construing several disputed claim terms of the four (4) aforementioned patents-in-suit. (Doc.
Nos. 213, 214).
We conducted a bench trial on the issues of infringement and validity from November 2,
2011, through November 8, 2011. As indicated above, trial began with four (4) patents and two
(2) Defendants. However, following the first day of testimony, which focused on the Chowhan
patents, Alcon and Par, the first ANDA filer, agreed to settle their dispute, leaving Barr as the
only remaining Defendant. (Doc. No. 242). Barr then stipulated that it infringed the two (2)
Chowhan patents and that those patents are not invalid (Doc. No. 243), leaving only the two (2)
castor oil patents in contention. We then heard testimony from Alcon and Barr on the castor oil
patents, and both Alcon and Barr fully briefed the salient issues post-trial. Having considered
the documentary evidence and testimony, we make the following findings of fact and
conclusions of law pursuant to Federal Rule of Civil Procedure 52(a).
2
II.
Findings of Fact
A.
The Castor Oil Patents (U.S. Patent Nos. 5,631,287 and 6,011,062)
1.
Alcon contends that the manufacture of Barr’s ANDA product, i.e., Barr’s
generic version of Travatan Z®, infringes Claim 12 of the ‘287 patent and
Claim 19 of the ‘062 patent. (Tr. 471:3-21).
2.
Claim 12 of the ‘287 patent depends from Claim 1 of the ‘287 patent (‘287
patent, 10:53-54).
3.
As such, Claim 12 of the ‘287 patent covers a method of enhancing the
chemical stability of an aqueous composition comprising a
therapeutically-effective amount of a prostaglandin, wherein the method
comprises adding a chemically-stabilizing amount of a polyethoxylated
castor oil to the composition, and wherein the composition is a topically
administrable ophthalmic composition. (‘287 patent, 8:57-61; 10:53-54).
4.
Claim 19 of the ‘062 patent depends from Claim 12 of the ‘062 patent
(‘062 patent, 14:15-16).
5.
As such, Claim 19 of the ‘062 patent covers a method of enhancing the
chemical stability of an aqueous composition comprising a
therapeutically-effective amount of a prostaglandin, wherein the method
comprises adding a chemically-stabilizing amount of a polyethoxylated
castor oil selected from the group of PEG-5 to PEG-200 hydrogenated
castor oils to the composition, and wherein the composition is a topically
administrable ophthalmic composition. (‘062 patent, 11:65-12:3; 14:15-
3
16).
6.
As should be readily apparent, the two (2) claims-in-suit are identical
except that Claim 12 of the ‘287 patent is open to any PECO, while Claim
19 of the ‘062 patent limits the PECO to one selected from the group of
PEG-5 to PEG-200 hydrogenated castor oils.
B.
A Person of Ordinary Skill in the Art (“PHOSITA”)
1.
We agree with Dr. Kent, Barr’s expert, that the hypothetical PHOSITA
with respect to the technical field of the castor oil patents would have a
Ph.D. in chemistry or a related field with limited experience (0 to 3 years),
or a B.S. or M.S. with more practical experience (5 or more years) in the
fields of pharmacy, analytical chemistry, organic chemistry, or chemical
engineering. (Tr. 684:8-21).
2.
Specifically, we believe that a PHOSITA would have a background in
chemistry because the claimed invention is drawn to chemicallystabilizing a prostaglandin-containing composition using PECO.
Therefore, the PHOSITA here should have significant chemistry-related
knowledge and/or experience to understand and practice the claimed
methods. (Tr. 685:3-20).
3.
However, all of our factual findings and legal conclusions would remain
the same if we were to adopt the PHOSITA definition espoused by Alcon
in its pretrial proposed findings of fact and conclusions of law, i.e., that a
PHOSITA in the art of pharmaceutical formulations and compositions
4
would have at least a master’s degree in pharmacy, pharmaceutics, or a
related field, and have at least two (2) years experience working on the
development of pharmaceutical formulations and/or compositions
involving varying dosage forms. (Doc. No. 220, at 14). In other words,
the relatively minor differences in the PHOSITA definitions propounded
by Plaintiff Alcon and Defendant Barr have no material effect on our
analysis and ultimate conclusions in this matter.
C.
Infringement
1.
The only disputed issue regarding infringement of Claim 12 of the ‘287
patent and Claim 19 of the ‘062 patent, i.e., the asserted castor oil patent
claims, is whether or not the amount of PECO in the composition of
Barr’s ANDA product is a “chemically-stabilizing amount” such that
Barr’s method of manufacturing its ANDA product enhances the chemical
stability of the composition. (Tr. 843:8-12).
2.
As set forth in our claim construction Order, the phrase “enhance /
enhancing the chemical stability” in the castor oil patent claims means “to
increase or increasing the ability of the prostaglandin to resist chemical
change (as distinguished from merely increasing the physical stability of
the prostaglandin or composition.)” (Doc. No. 214). Travoprost is the
prostaglandin in Barr’s ANDA product. (Tr. 412:21-25).
3.
One enhances the chemical stability of an ophthalmic composition such as
Barr’s ANDA product by reducing or decreasing the degradation of the
5
active ingredient, here, the prostaglandin Travoprost. (Tr. 412:1-25). As
distinguished from chemical stability, physical stability refers to physical
phenomena such as absorption, adsorption, and precipitation. (Tr. 320:20322:23). If the PECO in Barr’s ANDA product merely enhances the
physical stability of Travoprost, as opposed to enhancing its chemical
stability, at least in part, then Barr does not infringe Claim 12 of the ‘287
patent and Claim 19 of the ‘062 patent, i.e., the asserted castor oil patent
claims.
4.
Alcon failed to prove by a preponderance of the evidence that Barr
manufactures its ANDA product, i.e., its generic version of Travatan Z®,
by a method that comprises adding a chemically-stabilizing amount of
PECO to its composition to enhance the chemical stability of the
composition.
5.
Given Barr’s stipulation of infringement, Alcon proved by a
preponderance of the evidence that Barr’s ANDA product falls within the
scope of Claims 7, 21, 41, and 43 of the ‘497 patent and Claim 18 of the
‘253 patent, i.e., the borate-polyol patents. (Doc. No. 243).
D.
Enablement and Written Description Under 35 U.S.C. § 112, First Paragraph
1.
The asserted castor oil patent claims are extremely broad. (Tr. 800-11).
2.
The castor oil patent disclosures provide relatively limited information
and guidance to a person skilled in the art regarding how to practice the
claimed invention (Tr. 795-800).
6
3.
The art of chemically stabilizing prostaglandins is quite unpredictable.
(Tr. 417:3-20; 420:13-25; 417:21-23; 418:22-419:4; 419:13-25; 692:11693:9; 698-704; 708; 809-11; ‘287 patent, 6:23-26).
4.
Given the breadth of the asserted claims, the relatively limited disclosure,
and the unpredictability of the art, Barr proved by clear and convincing
evidence that one skilled in the art could not carry out the full scope of the
asserted castor oil patent claims without undue experimentation, and a
person skilled in the art would not recognize that the inventors of the
castor oil patents were in possession of the claimed invention at the time
the castor oil patent applications were filed.
E.
Indefiniteness Under 35 U.S.C. § 112, Second Paragraph
1.
Barr failed to prove by clear and convincing evidence that the claim term
“enhancing the chemical stability” is insolubly ambiguous, despite the
lack of an explicit comparator in the patent disclosure or claims
(“enhanced with respect to what?”). Specifically, one skilled in the art
would understand the “enhancing the chemical stability” limitation in the
asserted castor oil patent claims to mean that using PECO in the
formulation must provide increased chemical stability as compared to not
using PECO. Stated differently, using the claimed invention (adding a
chemically stabilizing amount of PECO) must increase the chemical
stability of the prostaglandin as compared to not using the invention.
2.
The claim term “therapeutically effective amount” is not insolubly
7
ambiguous. As we suggested in our claim construction memorandum, a
“therapeutically effective amount” is an amount necessary to achieve an
intended, expected, or desired result. Relatedly, a specific amount of a
drug can produce a therapeutic effect without being therapeutically
effective. (Doc. No. 213, at 30). Here, Barr has not proven by clear and
convincing evidence that one of ordinary skill in the art would have to
engage in undue experimentation to determine a “therapeutically effective
amount” of prostaglandin in the context of the asserted castor oil patent
claims, which are limited to topically administrable ophthalmic
compositions.
F.
Anticipation Under 35 U.S.C. § 102
1.
Barr’s expert Dr. Kent identified only one (1) potentially anticipatory
reference, namely U.S. Patent No. 5,721,273, which was filed on Dec. 15,
1993 and issued on Feb. 24, 1998. (Tr. 825:6-828:18; 923:5-924:2; DTX
806). The ‘273 patent names Alcon as the assignee but does not have any
overlapping inventorship with the castor oil patents-in-suit. (DTX 806).
2.
L. Wayne Schneider, an inventor named on the castor oil patents,
conceived and reduced to practice enough of his claimed invention prior
to Dec. 15, 1993, the filing date of the ‘273 patent, such that the ‘273
patent does not constitute prior art with respect to the castor oil patent
claims in suit. (Tr. 340-62).
G.
Obviousness under 35 U.S.C. § 103
8
1.
Other than the ‘273 patent, Barr’s expert Dr. Kent relied on six (6) prior
art references to conclude that Claim 12 of the ‘287 patent and Claim 19
of the ‘062 patent, i.e., the castor oil patent claims-in-suit, are obvious
under 35 U.S.C. § 103: (1) U.S. Patent No. 4,684,633; (2) Japanese Patent
Application S53-148518; (3) U.S. Patent No. 4,430,340; (4) U.S. Patent
No. 5,296,504; (5) U.S. Patent No. 5,091,417; and (6) U.S. Patent No.
5,185,372. (Tr. 820-36).
2.
Dr. Kent’s testimony boils down to simply identifying the individual
elements of the claimed invention in various prior art references. (Tr.
818-36). A PHOSITA would have had no reason or motivation to
combine the teachings of the six (6) aforementioned prior art references
absent impermissible hindsight. Therefore, Barr failed to prove by clear
and convincing evidence that the prior art rendered the asserted castor oil
patent claims obvious to a PHOSITA at the time the invention was made.
H.
Alcon’s Un-Litigated U.S. Patent Nos. 5,510,383 and 5,889,052
1.
Alcon’s original complaint initially asserted U.S. Patent Nos. 5,510,383
and 5,889,052 against Barr. (Doc. No. 1 ¶¶ 9-22, 50-63). However, Alcon
did not assert these two patents in its pretrial filings or at trial, and Alcon
did not present any evidence whatsoever on these patents at trial, although
Alcon never formally withdrew its claims based on the patents.
2.
At the close of Alcon’s case-in-chief, Barr moved for judgment as a matter
of law of non-infringement of the ‘383 and ‘052 patents, noting that Alcon
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presented no evidence on these two patents and therefore cannot meet its
burden of proving infringement by a preponderance of the evidence. (Tr.
563:2-15).
3.
We recognize that the pleadings in this matter are not in complete
harmony with the issues that were actually litigated and adjudicated. In
situations such as this, we conform the pleadings to the judgment, not vice
versa. As such, Barr is not entitled to a judgment of non-infringement
with respect to the ‘383 and ‘052 patents, which were not actually
litigated.
III.
Conclusions of Law
A.
Choice of Law
1.
In this patent infringement action, we are bound by, and seek guidance
from, the body of law developed by the United States Court of Appeals for
the Federal Circuit, as well as its predecessor, the Court of Customs and
Patent Appeals. See South Corp. v. United States, 690 F.2d 1368,
1370-71 (Fed. Cir. 1982) (adopting the body of law represented by the
holdings of the Court of Claims and the Court of Customs and Patent
Appeals).
2.
Additionally, we apply Federal Circuit law to resolve issues pertaining to
or unique to patent law, while we apply Third Circuit law to resolve all
other issues. See Molins PLC v. Quigg, 837 F.2d 1064, 1066 (Fed. Cir.
1988) (noting that “we apply the law of that circuit to which district court
10
appeals normally lie, unless the issue pertains to or is unique to patent
law.”) (citation omitted).
3.
Here, all the issues we address in this Opinion either pertain to, or are
unique to, patent law, so we look to Federal Circuit law to shape the
resolution of this matter.
4.
Of course, the Supreme Court’s patent-related jurisprudence also binds us,
to the extent the Court has spoken on topics relevant to the issues facing
us here.
B.
Infringement
1.
“To show literal infringement of a patent, a patentee must supply
sufficient evidence to prove that the accused product or process meets
every element or limitation of a claim.” Rohm & Haas Co. v. Brotech
Corp., 127 F.3d 1089, 1092 (Fed. Cir. 1997). Regarding the burden of
proof, “[i]nfringement requires proof by a preponderance of the evidence.”
Id.
2.
“An infringement analysis requires two separate steps. First, the court
must construe the claims asserted to be infringed as a matter of law in
order to establish their meaning and scope. Second, the claims as
construed are compared to the allegedly infringing device or process.”
Texas Instruments Inc. v. Cypress Semiconductor Corp., 90 F.3d 1558,
1563 (Fed. Cir. 1996) (internal citation omitted).
3.
In ANDA litigation such as this, our infringement inquiry is the same as in
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any other patent suit. Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562,
1569 (Fed. Cir. 1997). Specifically, we must evaluate “whether the patent
in question is invalid or will not be infringed by the manufacture, use, or
sale of the drug for which the [ANDA] is submitted. 21 U.S.C. §
355(j)(2)(A)(vii)(IV). The only difference in actions brought under §
271(e)(2) is that the allegedly infringing drug has not yet been marketed
and therefore the question of infringement must focus on what the ANDA
applicant will likely market if its application is approved, an act that has
not yet occurred.” Id. As such, “the patentee’s burden of proving ultimate
infringement is not met by the filing of the ANDA. The relevant inquiry is
whether the patentee has proven by a preponderance of the evidence that
the alleged infringer will likely market an infringing product.” Id. at
1570.
4.
Before turning to the castor oil patents, the heart of the parties’ dispute,
we first briefly address the borate-polyol patents. As mentioned supra,
Alcon and Par settled after the first day of testimony, which focused on
the borate-polyol patents. Barr, the lone remaining Defendant, then
stipulated that it infringed the two (2) borate-polyol patents-in-suit and
that those patents are not invalid (Doc. No. 243).
5.
Notwithstanding Barr’s concessions, insofar as Alcon bears the burden of
proof on infringement, we will briefly recite Alcon’s infringement
evidence adduced at trial. Alcon’s expert Dr. George Zhanel testified that
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the borate-polyol complex in Barr’s BAC-free ANDA composition, i.e.,
its proposed generic version of Travatan Z®, enhances the antimicrobial
activity of the composition, as required by the asserted borate-polyol
claims, i.e., Claims 7, 21, 41, and 43 of the ‘497 patent and Claim 18 of
the ‘253 patent. (Tr. 166-95). Additionally, another Alcon expert, Dr.
Soumyajit Majumdar, testified that Barr’s BAC-free ANDA product meets
all the other limitations of the asserted claims, e.g., the specificallyclaimed polyols, the ratios and weight percentages of various components,
and the fact that Barr’s ANDA product is “unpreserved.” (Tr. 256-89).
6.
The testimony of Alcon’s two experts, viewed in light of Barr’s
concession of infringement, convinces us that Alcon proved by a
preponderance of the evidence that Barr’s BAC-free ANDA product
infringes the asserted borate-polyol claims, i.e., Claims 7, 21, 41, and 43
of the ‘497 patent and Claim 18 of the ‘253 patent.
7.
As such, the effective date of any FDA approval of Barr’s BAC-free
ANDA product shall be a date which is not earlier than the date of the
expiration of the last to expire of the ‘497 and ‘253 patents.
8.
We now come to the castor oil patents. At the outset, we note that
determining infringement (or lack thereof) of the asserted castor oil patent
claims in this matter is needlessly complex. As mentioned supra, the only
contested issue with respect to infringement of the castor oil patent claims
is whether or not the amount of PECO in Barr’s ANDA product is a
13
“chemically-stabilizing amount.” (Tr. 843:8-12). If the PECO in Barr’s
ANDA product chemically stabilizes the Travoprost, i.e., the active
prostaglandin ingredient, then Barr infringes. If the PECO does not
chemically stabilize the Travoprost, then Barr does not infringe.
9.
Alcon could have determined, rather definitively, whether the PECO in
Barr’s ANDA product (or the PECO in Travatan Z®, its own product,
which is extremely similar, if not functionally identical, to Barr’s ANDA
product) enhances the chemical stability of the Travoprost in the
composition by running the appropriate chemical stability tests. (Tr.
680:4-18; 726-37). For whatever reason, Alcon did not perform this
testing.2 Therefore, instead of having a relatively clear answer to the
infringement question, we are left drawing inferences and making
educated guesses.
10.
Of course, Alcon is free to prove its case as it sees fit. See Moleculon
Research Corp. v. CBS, Inc., 793 F.2d 1261, 1272 (Fed. Cir. 1986)
(patentee can prove infringement through direct or circumstantial
evidence). Unfortunately for Alcon, the method of proof it chose merely
invites us to speculate that the PECO in Barr’s ANDA product chemically
stabilizes the Travoprost, and Alcon did not prove infringement by a
preponderance of the evidence. See Lucent Tech., Inc. v. Gateway, Inc.,
2
As far as we know, Barr did not perform this testing either. Of course, as the accused
infringer, Barr does not bear the burden of proof on infringement.
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543 F.3d 710, 722-24 (Fed. Cir. 2008) (recognizing that overly speculative
circumstantial evidence will not suffice to prove infringement).
11.
Speaking broadly, Alcon rests its infringement contentions on the
testimony of (1) its expert Dr. Levinson and (2) L. Wayne Schneider, an
inventor of the castor oil patents. We address each in turn.
12.
Dr. Levinson relied primarily on a single document – an Alcon technical
report entitled “Solubility of Travoprost in HCO-40 and Soaking Study of
Polypropylene Material in Prototype Formulations” (the “Solubility
Study”) – to reach his conclusion that Barr’s ANDA product infringes the
castor oil patents. (Tr. 549:3-550:7; PTX 45; DTX 1012). In particular,
Levinson relies on the data in Table 7 of the Solubility Study to conclude
that the PECO in Barr’s ANDA product chemically stabilizes the
Travoprost. (Tr. 492-504). To draw this conclusion, Levinson compares
sample 92941, which contains no HCO-40 (a particular PECO), with
sample 92957, an identical solution that contains 0.50% HCO-40. After
eight (8) weeks at an elevated temperature, the sample without HCO-40
lost 12% of its Travoprost, while the sample with 0.50% of HCO-40 lost
8% of its Travoprost3. (PTX 45, Table 7).
13.
Dr. Levinson’s infringement analysis fails to persuade us for a number of
reasons. First, the Solubility Study on which Levinson relies mentions
3
Table 7 shows an 8% decrease at eight (8) weeks for both samples, but as Dr. Levinson
correctly points out, the authors of the Solubility Study did not normalize the data in Table 7
before reporting it. (Tr. 499:17-502:25).
15
nothing at all about chemical stability, and the study was designed to test
something entirely different, i.e., the solubility of Travoprost and its
compatibility with polypropylene packaging material in varying HCO-40
concentrations. (PTX 45, Summary). In other words, the authors of the
study drew no conclusions about the effect of HCO-40 on the chemical
stability of Travoprost; rather, Levinson drew that conclusion on his own
based on the control sample data provided by the authors in Table 7.
While it is certainly possible to analyze another’s data in a new light and
draw valid conclusions, we believe such conclusions must withstand
careful scrutiny. Levinson’s do not.
14.
As mentioned supra, in his analysis, Levinson relied on two discrete data
points in Table 7: sample 92941 (0% HCO-40) at eight (8) weeks and
sample 92957 (0.50% HCO-40) at eight (8) weeks. We think it more
analytically sound to evaluate the data in its entirety. In doing so, several
things become clear to us. First, the Travoprost in the tested composition
has good stability even without any PECO / HCO-40. In sample 92941,
which contains absolutely no PECO, 88% of the Travoprost remains after
eight (8) weeks at an elevated temperature. (PTX 45, Table 7).
15.
Second, the data in Table 7 is subject to at least some experimental error
or uncertainty. For example, according to Table 7, the Travoprost
concentration actually increases slightly over some period of time in some
of the samples. (PTX 45, Table 7, sample 92956 between weeks 2 and 4;
16
sample 92954 between weeks 0 and 1). No one has suggested to us that
the PECO actually generates Travoprost over time, so experimental error
or uncertainty most likely explains the anomalous data.
16.
Third, even small variations in the composition of a Travoprost-containing
solution can, and do, have a noticeable effect on the stability of the
Travoprost (chemical or physical stability, we do not know). For
example, consider samples 92940 and 92941 in Table 7. Neither sample
contains PECO, and the samples are identical in all respects except that
92940 contains 0.02% of BAC, while 92941 contains 0.01% of BAC.
This minuscule change in BAC concentration apparently alters the
stability of the composition such that the 0.02% BAC sample loses 15% of
its Travoprost at eight (8) weeks while the 0.01% BAC sample loses only
12%.4 Relatively speaking, this is on the same order of magnitude as the
4% difference that Dr. Levinson finds so compelling in comparing the “no
PECO” sample to the “0.50% PECO” sample. Additionally, the fact that
BAC concentration appears to affect Travoprost stability to about the
same extent as PECO concentration does is particularly instructive in
evaluating the probative value of the Table 7 data because all of the
samples in Table 7 contain BAC, while Barr’s ANDA product does not.
17.
This observation comports with Alcon’s and Mr. Schneider’s own
4
Like Dr. Levinson, we normalized this data for effective comparison. For example, in
sample 92940, [(76-64.5) / (76)] x 100 = 15%.
17
recognition that various parameters including pH, buffer, buffer
concentration, preservatives, chelating agents, and other excipients may
affect the chemical stability of prostaglandins in ophthalmic formulations
(Tr. 383:9-384:4; 417:3-20; 420:13-25; 790-92).
18.
Fourth, with respect to Figures 1-3 of the castor oil patents, Dr. Levinson
opined that the data in the aforementioned Figures shows chemical
stability, not physical stability, because the data plotted linearly on a log
scale, which indicates a first-order chemical reaction. (Tr. 479:2-481:20).
Of course, the prostaglandin Mr. Schneider tested in the castor oil patents
was not Travoprost, so it does little to inform our analysis of whether
PECO chemically stabilizes Travoprost in Barr’s ANDA product.
Additionally, the data in Table 7 of the Solubility Study on which Dr.
Levinson so heavily relies, and which does test Travoprost, is decidedly
un-linear. In all the samples, very little Travoprost disappears in the first
four (4) weeks, and then the Travoprost concentration drops off between
four (4) and eight (8) weeks. (PTX 45, Table 7). If we believe Dr.
Levinson’s testimony on this topic, then the Table 7 data is not indicative
of a first-order chemical reaction, unlike the data in the castor oil patents.
This highlights the point we have already made: different prostaglandincontaining ophthalmic formulations have different stability profiles, which
depend on a variety of factors.
19.
Dr. Levinson also surmises that the decrease in Travoprost concentration
18
must result from chemical instability as opposed to physical loss
(absorption, adsorption, precipitation) because (1) the loss occurs over
time, while adsorption is rapid (Tr. 480:18-23), and (2) absorption does
not occur in glass, and the tests resulting in the Table 7 data were carried
out in glass ampules (Tr. 482:1-3; PTX 45, Table 7). However, Levinson
does admit that some adsorption onto glass could occur. (Tr. 492:10-17).
Notably, Levinson provides no authority or documentary evidence to
support his assertion that adsorption would occur rapidly. (Tr. 539:11540:2).
20.
Additionally, one of Alcon’s own patents, U.S. Patent No. 6,235,781 (“the
‘781 patent”), undercuts Dr. Levinson’s conclusions regarding physical
loss of prostaglandins. (DTX 183). The ‘781 patent discloses that PECO,
including HCO-40, inhibits the adsorption of prostaglandin onto container
walls. (‘781 patent, 4:39-63). The ‘781 patent says nothing about
chemical stability, but rather deals with prostaglandin loss to different
packaging materials, i.e., physical loss. The graphs depicted in Figures 14 of the ‘781 patent show that, in fact, a substantial amount of
prostaglandin physical loss may occur, even in glass containers. Second,
the ‘781 patent inventors waited four (4) weeks before measuring
prostaglandin loss. (‘781 patent, Figures 1-4). If physical loss occurs so
rapidly (mere hours or days, as Dr. Levinson opined), why wait four (4)
weeks to test for it? Finally, the ‘781 patent inventors apparently believed
19
that physical loss occurs rather steadily over time (‘781 patent, Figures 14, which depict a linear decrease in prostaglandin concentration over a
four (4) week period). This is in tension with Dr. Levinson’s opinion that
adsorption occurs rapidly and then stops, or at least equilibrates.
21.
In the end, the difference in missing Travoprost between the “no PECO”
sample and the “0.50% PECO” sample is 4% – after eight (8) weeks, 92%
of the Travoprost remains in the PECO-containing sample, while 88% of
the Travoprost remains in the sample without PECO. We do not know for
sure where the missing Travoprost went in either sample. However, this is
an extremely small difference which could be attributed to a number of
factors other than PECO enhancing the chemical stability of the
Travoprost, e.g., experimental error or uncertainty, adsorption,
precipitation, or other physical loss. These factors take on particular
importance here because the Travoprost concentration is so low – 0.005%
w/v in the Table 7 samples and 0.004% in Travatan Z® and Barr’s generic
version of the same. (PTX 45, Table 2). Therefore, even a small absolute
amount of experimental error or physical instability (adsorption, etc.)
would lead to a relatively large variation, percentage-wise, in Travoprost
concentration.
22.
Further, even assuming the data in Table 7 shows that PECO enhances the
chemical stability of Travoprost in the tested formulations, which we have
concluded it does not, the tested formulations differ significantly from
20
Barr’s ANDA product. In particular, the Travoprost concentrations and
pH’s are slightly different; the Solubility Study formulations contain
tromethamine, mannitol, EDTA, and BAC, and Barr’s ANDA product
does not; and Barr’s ANDA product contains propylene glycol, sorbitol,
and zinc chloride, while the Solubility Study formulations do not. (PTX
45, Table 2; Barr’s ANDA 91-411; Tr. 740:2-742:4). Since variables such
as pH, buffer, buffer concentration, preservatives, chelating agents, and
other excipients can affect the chemical stability of prostaglandins in
ophthalmic formulations (see ¶¶ 16-17 supra), the compositional
differences between the Solubility Study formulations and Barr’s ANDA
product preclude us from relying on the Solubility Study data to draw any
reliable inferences with respect to the stability of Barr’s ANDA product.
In other words, even if Table 7 of the Solubility Study shows that HCO-40
chemically stabilizes Travoprost in the tested samples, which is unclear,
we have little reason to believe that HCO-40 would act similarly in Barr’s
ANDA product.
23.
Finally, we note that Dr. Levinson admitted numerous times that he is not
an expert in prostaglandin chemistry or chemical changes in
prostaglandins. (Tr. 527:22-528:12; 529:9-14; 534:7-15; 532:11-18;
536:4-19; 542:24-543:2). To some extent, this undermines our faith in his
ability to reliably assess whether or not the PECO in Barr’s ANDA
product chemically stabilizes Travoprost, the prostaglandin at issue.
21
24.
We now turn to Mr. Schneider’s testimony. Mr. Schneider is the sole
inventor named on the ‘287 patent and one of three joint inventors named
on the ‘062 patent, i.e., the castor oil patents in suit. We begin by noting
that Mr. Schneider was not held out as an expert in this matter and did not
submit any expert reports. (Tr. 330:5-15; 406:8-10). At trial, Alcon’s
counsel stated that Schneider would testify about the work he did to
develop his invention and not draw any expert conclusions. (Tr. 330:515). With that stipulation, and over Defense counsel’s objection, we gave
Schneider wide latitude to tell his invention story. (Tr. 329:22-330:15).
25.
Nonetheless, in its post-trial brief, Alcon relies on Schneider’s testimony
to support its infringement contentions. (Doc. No. 247, at 8-10).
Therefore, we feel obliged to briefly discuss our reasons for finding
Schneider’s testimony unpersuasive as far as infringement is concerned.
26.
First, Schneider never tested Barr’s ANDA product, and he candidly
admitted that he has no idea whether Barr’s ANDA product has any
chemical degradation products under any conditions. (Tr. 440:23-25).
27.
Second, we find that Mr. Schneider lacks credibility on the critical
“chemical stability / loss v. physical stability / loss” issue in this case. For
one thing, Schneider flip-flopped on whether or not he believes that
anything other than pH would have an appreciable influence on the
chemical stability of prostaglandin compositions. (Tr. 436-37).
Specifically, he said “No” to the USPTO during the prosecution of his
22
castor oil patent application; “Yes” in his deposition; and “No” in an
errata to his deposition. (Tr. 436-37).
28.
In addition, Mr. Schneider, the inventor of the patents-in-suit, appears
confused about whether PECO enhances the chemical stability of
prostaglandins or merely enhances their physical stability. In his
deposition, Schneider was asked whether the data in his patents might
indicate that the PECO enhances the physical stability of the prostaglandin
compositions. He answered: “Might. Yes, it might. I can’t deny that.
But my feeling is that it indicates the chemical stability because the
polyethoxylated castor oil affords solubility and prevents loss of physical
absorption or physical -- the polyethoxylated castor oil prevents the
physical loss of the prostaglandin from the solution.” (Tr. 416:3-17).
This suggests to us that, at least at the time of Schneider’s deposition, he
did not have a clear understanding of how PECO works to stabilize
prostaglandins.
29.
Third, many of the experiments and associated data about which Mr.
Schneider testified, including all the castor oil patent data, involved
prostaglandins other than Travoprost, the active ingredient in Travatan Z®
and Barr’s ANDA product. (Tr. 340-62). This data has limited probative
value with respect to the chemical stability of Travoprost in Barr’s ANDA
product because even small differences in a prostaglandin’s chemical
structure can significantly influence its stability. (Tr. 417:21-23; 418:22-
23
419:4 (isopropyl ester considerably more stable than butyl ester); 419:1325).
30.
Fourth, much of Schneider’s current testimony regarding chemical
stability, including his interpretation of HPLC graphs, finds very little
support from the contemporaneous observations Schneider made during
his invention process, e.g., in his lab notebooks and patent applications.
For example, in the evidence we saw, Schneider only explicitly labeled
prostaglandin degradation products (“Deg 1” and “Deg 2”) on an HPLC
graph on one single occasion, i.e., in a 1993 experiment involving AL6045, a prostaglandin that is not Travoprost, and the surfactant
Polysorbate 80, not PECO. (Tr. 340:5-343:22; 344:2-13). Additionally,
Schneider did not include any HPLC graphs in the castor oil patents, much
less explain the significance of any of the HPLC data he collected. (See
‘287 and ‘062 patents).
31.
Despite the absence of contemporaneously-recorded observations, and
despite the fact that Alcon never sought to qualify Schneider as an HPLC
expert (Tr. 330:5-15; 406:15-16), at trial Schneider saw fit to offer
relatively detailed and complex explanations of how he knew that certain
HPLC data showed prostaglandin chemical stability or degradation as
opposed to physical loss, or surfactant degradation, or impurities, or some
other explanation for the HPLC results. (Tr. 361:14-362:11; 396-400;
441:17-445:18; 456-57; 459). This post hoc analysis of undoubtedly
24
cherry-picked data fails to convince us that PECO chemically stabilizes
prostaglandins in ophthalmic compositions. Further, even if select HPLC
data presented by Mr. Schneider supports the proposition that PECO
chemically stabilizes prostaglandins in some instances, we could not
reliably infer that the PECO would exhibit a similar chemically-stabilizing
effect in Barr’s ANDA formulation, which differs from all the
formulations that Schneider tested. (See ¶¶ 16, 17, 29 supra, discussing
how prostaglandin composition stability depends on a host of variables).
32.
Fifth, similar to Dr. Levinson, Schneider opines that the prostaglandin
concentration he measured, recorded, and submitted to the USPTO in
Figures 1-3 of the ‘287 patent decreased linearly over a period of time,
which indicates chemical loss as opposed to physical loss because
physical loss occurs rapidly. (Tr. 375:24-376:17; 428:15-429:22).
Relatedly, the ‘287 patent specification suggests that the patent data shows
degradation occurring via a first-order chemical reaction. (‘287 patent,
8:19-26). However, Schneider did not produce any documentary support
for his hypothesis (Tr. 429:22 (“It’s intuitively obvious to one skilled in
the art”)).
33.
In addition, we reiterate that the prostaglandin Schneider tested in the
castor oil patents is not Travoprost, and the prostaglandin composition
Schneider tested differs markedly from Barr’s ANDA product (‘287
patent, 7:25-47). Therefore, the patent data says little about whether
25
PECO would enhance the chemical stability of Travoprost in Barr’s
Travatan Z® generic. For example, while the prostaglandin concentration
decreases linearly in Figures 1-3 of the castor oil patents, the Travoprost
concentration in Table 7 of the Solubility Study does not. With this kind
of variability, we cannot simply take data collected on one prostaglandin
formulation and assume that it would translate to another.
34.
Finally, we agree with Dr. Kent, Barr’s expert, that Alcon’s own internal
documents demonstrate Alcon’s belief that PECO works by physically
stabilizing Travoprost, not by chemically stabilizing it. (Tr. 780:1-15).
35.
For example, an Alcon memo from 1997, three (3) years after Schneider
filed the ‘287 patent application, states that “[l]ess than 7% change of the
stability profile of AL06221 [Travoprost] and no change of the stability
profile of AL12419 (~1.5%) [a Travoprost degradation product] was
discovered after 8 weeks at 55o C. No or trace amount of AL09584 and
AL05848 [other degradation products] can be detected.” (DTX 1283, at
8786:11). In other words, 7% of the Travoprost went missing, but it was
not due to chemical degradation.
36.
In its post-trial brief, Alcon attempts to explain this data by noting that the
referenced study tested a formulation comprising PECO, so the study
merely confirms that PECO prevents the chemical degradation of
Travoprost. (Doc. No. 247, at 7). In other words, Alcon apparently
argues that PECO works so well to chemically stabilize Travoprost that
26
absolutely no chemical degradation occurs. This position contradicts
Alcon’s own expert’s testimony regarding the data in Table 7 of the
Solubility Study. Specifically, the formulations tested to generate the data
in Table 7 also included PECO, yet 8% of the Travoprost went missing in
the “0.50% PECO” sample. (PTX 45, Table 7). And according to Dr.
Levinson, Table 7 shows “immutable data that there’s chemical
degradation going on.” (Tr. 499:10-11). In other words, Travoprost
chemical degradation occurs even in PECO-containing compositions,
contrary to what Alcon’s post-trial brief would have us believe.
37.
A second Alcon document from 1996, two (2) years after Schneider filed
his castor oil patent application, also supports the proposition that
Travoprost loss occurs through physical means, not chemical degradation
(DTX 104). In particular, the 1996 document states that Travoprost loss
“is now known to be related to the packaging interaction. Chemistry data
shows no concurrent increase in degradation products which supports this
conclusion.” (DTX 104; Tr. 773:17-774:14). Again, no mention that
PECO chemically stabilizes Travoprost, or even that the chemical stability
of Travoprost is a concern.
38.
Finally, Alcon’s ‘781 patent, filed a mere two weeks after the second
castor oil patent issued and containing much of the same disclosure,
discloses that PECO, including HCO-40, inhibits the adsorption of
prostaglandin onto container walls. (DTX 183; ‘781 patent, 4:39-63).
27
Other than briefly mentioning the ‘287 castor oil patent in the
“Background of the Invention” section, the ‘781 patent says nothing about
chemical stability, but rather deals with prostaglandin loss to different
packaging materials, i.e., physical loss. Although the ‘781 patent does not
negate the possibility that PECO might chemically stabilize prostaglandins
such as Travoprost, the patent’s exclusive focus on physical stability
weakens that inference.
39.
For the aforementioned reasons, we hold that Alcon failed to prove by a
preponderance of the evidence that the PECO in Barr’s ANDA product
chemically stabilizes the composition. Stated differently, Alcon has not
shown that Barr manufactures its Travatan Z® generic by “adding a
chemically stabilizing amount of polyethoxylated castor oil” to the
composition to “enhance the chemical stability” of the composition, as
required by the asserted castor oil patent claims. Therefore, Barr does not
infringe any of the asserted castor oil patent claims, i.e., Claim 12 of the
‘287 patent and Claim 19 of the ‘062 patent.
C.
Enablement Under 35 U.S.C. § 112, First Paragraph
1.
The first paragraph of 35 U.S.C. § 112 sets out the enablement
requirement: “[t]he specification shall contain a written description of the
invention, and of the manner and process of making and using it, in such
full, clear, concise, and exact terms as to enable any person skilled in the
art to which it pertains, or with which it is most nearly connected, to make
28
and use the same...” (emphasis added).
2.
“The full scope of the claimed invention must be enabled. The rationale
for this statutory requirement is straightforward. Enabling the full scope
of each claim is part of the quid pro quo of the patent bargain. A patentee
who chooses broad claim language must make sure the broad claims are
fully enabled. The scope of the claims must be less than or equal to the
scope of the enablement to ensure that the public knowledge is enriched
by the patent specification to a degree at least commensurate with the
scope of the claims.” Sitrick v. Dreamworks, LLC, 516 F.3d 993, 999
(Fed. Cir. 2008) (internal citations and quotations omitted). In layman’s
terms, a patentee must give a lot to get a lot. With that in mind, the
Federal Circuit has emphasized that “[p]atent protection is granted in
return for an enabling disclosure of an invention, not for vague intimations
of general ideas that may or may not be workable.” Genentech, Inc. v.
Novo Nordisk A/S, 108 F.3d 1361, 1366 (Fed. Cir. 1997).
3.
In In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988), the Federal Circuit
laid out eight (8) factors to consider in evaluating enablement: “(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.”
29
4.
In accordance with these Wands factors, in unpredictable technologies, the
Federal Circuit “has refused to find broad generic claims enabled by
specifications that demonstrate the enablement of only one or a few
embodiments and do not demonstrate with reasonable specificity how to
make and use other potential embodiments across the full scope of the
claim.” PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 1564
(Fed. Cir. 1996). For example, the court recently held that a particular
patent (1) having extraordinarily broad claims but (2) providing only
minimal guidance (three working examples) in (3) a highly unpredictable
art failed the enablement requirement as a matter of law. Pharm. Res.,
Inc. v. Roxane Labs., Inc., 253 Fed. App’x 26, 27-31 (Fed. Cir. 2007).
5.
Of course, as with all invalidity defenses, the accused infringer must prove
lack of enablement by clear and convincing evidence. See Sitrick, 516
F.3d at 1000 (“[w]e are mindful that Defendants have the evidentiary
burden to show facts supporting a conclusion of invalidity by clear and
convincing evidence.”).
6.
Here, we find that the asserted castor oil patent claims are extremely
broad; the technology of stabilizing prostaglandins is highly
unpredictable; and the castor oil patent disclosures, which provide
experimental data on only one (1) prostaglandin compound and two (2)
PECO compounds, provide minimal guidance to one skilled in the art
regarding how to practice the full scope of the claimed invention.
30
Additionally, the chemical stability v. physical stability conundrum (see
“Infringement” section, supra) adds another layer of complexity to the
task facing one skilled in the art who wishes to carry-out the claimed
method. Therefore, one skilled in the art would have to perform undue
experimentation to practice the full scope of the asserted castor oil patent
claims, and Barr has proven lack of enablement by clear and convincing
evidence.
7.
Beginning with Wands factors (2) and (3) (the amount of direction or
guidance presented, and the presence or absence of working examples),
the castor oil patents provide very little guidance to one skilled in the art.
The working examples are limited to a single prostaglandin compound
(“Compound No. 2”) (‘287 patent, Figures 1-3). Additionally, Schneider
tested only two (2) PECO compounds, i.e., Cremophor® EL and Alkamuls
® EL-620 (‘287 patent, Figures 1-3), and the two (2) PECO compounds
he tested have similar chemical structures (Tr. 364:10-19 (“Alkamuls is a
polyoxyl 30 castor oil, the Cremophor is a polyoxyl 35 castor oil”)).
Additionally, while the castor oil patents baldly assert that PECOs
chemically stabilize prostaglandins, the patents do not disclose how. For
example, the patents do not discuss how PECOs might inhibit or prevent
prostaglandins from chemically degrading. This is particularly
problematic in light of the apparent difficulty in distinguishing between
the chemical stability / loss and physical stability / loss of prostaglandins
31
in ophthalmic compositions. (See “Infringement” section, supra).
8.
Turning next to Wands factors (4) and (7) (the nature of the invention and
the predictability or unpredictability of the art), the technology at issue
here is highly unpredictable. As discussed supra, even small variations in
the composition of a prostaglandin-containing solution can, and do, have a
noticeable effect on the stability of the prostaglandin. (See
“Infringement” section ¶ 16). Various parameters including pH, buffer,
buffer concentration, preservatives, chelating agents, and other excipients
may affect the chemical stability of prostaglandins in ophthalmic
formulations (Tr. 383:9-384:4; 417:3-20; 420:13-25; 790-92; 809-11).
Minor differences in a prostaglandin’s chemical structure can significantly
influence its stability. (Tr. 417:21-23; 418:22-419:4 (isopropyl ester
considerably more stable than butyl ester); 419:13-25; 698-704). The
‘287 patent mentions that too much PECO may adversely affect a
prostaglandin’s pharmacologic activity. (‘287 patent, 6:23-26). All of
this convinces us of the unpredictability of prostaglandin stability in
ophthalmic formulations.
9.
Regarding Wands factor (5) (the state of the prior art), as discussed in
detail below, the prior art teaches very little about chemically stabilizing
prostaglandins, much less by using PECO in ophthalmic formulations.
This gives us all the more reason to insist on an adequate disclosure in the
castor oil patents.
32
10.
Regarding Wands factor (6) (the relative skill of those in the art), we
expect a PHOSITA in this technology to possess a relatively high level of
skill. However, even a highly-skilled PHOSITA would have to undertake
undue experimentation to practice the claimed invention, given the
unpredictable technology, limited disclosure, and broad claims of the
castor oil patents.
11.
Finally, with respect to Wands factor (8) (the breadth of the claims), the
asserted castor oil patent claims are extremely broad. Although our claim
construction Order narrowed the galaxy of prostaglandin compounds
covered by the claims somewhat5, we agree with Dr. Kent that the claims
encompass a “rather inordinately large number of potential compounds.”
(Tr. 677:23-678:7). Additionally, the asserted claims are open to a myriad
of other components typically present in ophthalmic compositions (any
buffer, any preservative, any excipient, etc.), in any concentration or ratio,
and at any pH. (See Claim 12 of the ‘287 patent and Claim 19 of the ‘062
patent). Additionally, Claim 12 of the ‘287 patent is open to any PECO,
and Claim 19 of the ‘062 patent is open to a wide variety of PECOs. In
the context of the castor oil patent claims, this compositional breadth
5
Per our claim construction Order, the claim term “prostaglandin” means “the natural
compounds PGE1, PGE2, PGE3, PGF1á, PGF2á, PGF3á, PGD2, and PGI2 (prostacylcin), as well as
analogues and derivatives of such natural compounds (including the pharmaceutically acceptable
esters and salts of such natural compounds and their analogues and derivatives), which have
similar biological activities of either greater or lesser potencies.” (Doc. No. 214).
33
poses a huge challenge to one skilled in the art because, as previously
discussed numerous times, these variables may affect the stability of a
prostaglandin-containing composition. As Dr. Kent correctly observed,
when “you have a lot of variables on top of one another, the
experimentation gets out of control quickly.” (Tr. 812:1-5).
12.
To conclude, we find the enablement issue here to be analogous to that in
Pharmaceutical Resources, Inc. v. Roxane Laboratories, Inc., 253 Fed.
App’x 26 (Fed. Cir. 2007). In a highly unpredictable art, Schneider
claimed his invention broadly but disclosed relatively little. He claimed
that PECO chemically stabilizes prostaglandins, but did not disclose how.
He apparently failed to recognize, or at least did not disclose, that his data
may reflect enhanced physical stability instead of, or in addition to,
enhanced chemical stability. In other words, Schneider did not hold up his
end of the patent bargain. After conducting the appropriate analysis under
Wands, we conclude that one skilled in the art could not practice the
invention claimed in the castor oil patents without undue experimentation.
Barr has proven lack of enablement by clear and convincing evidence.
D.
Written Description Under 35 U.S.C. § 112, First Paragraph
1.
As with enablement, 35 U.S.C. § 112, first paragraph, provides the basis
for the written description requirement: “[t]he specification shall contain
a written description of the invention, and of the manner and process of
making and using it, in such full, clear, concise, and exact terms as to
34
enable any person skilled in the art to which it pertains, or with which it is
most nearly connected, to make and use the same...” (emphasis added).
2.
The “test for written description is whether the disclosure of the
application reasonably conveys to those skilled in the art that the inventor
had possession of the claimed subject matter as of the filing date.” Eli
Lilly & Co. v. Teva Pharms. USA, Inc., 619 F.3d 1329, 1345 (Fed. Cir.
2010) (quoting Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336,
1351 (Fed. Cir. 2010) (en banc)).
3.
As the en banc Federal Circuit recently reaffirmed, Section 112 “contains
a written description requirement separate from enablement.” Ariad, 598
F.3d at 1351. However, the purpose of the written description
requirement, or at least one of its purposes, mirrors that of the enablement
requirement: “[a]s this court has repeatedly stated, the purpose of the
written description requirement is to ensure that the scope of the right to
exclude, as set forth in the claims, does not overreach the scope of the
inventor’s contribution to the field of art as described in the patent
specification. It is part of the quid pro quo of the patent grant and ensures
that the public receives a meaningful disclosure in exchange for being
excluded from practicing an invention for a period of time.” Id. at 135354 (internal citations and quotations omitted).
4.
Additionally, the factors relevant to the written description inquiry are
similar to the Wands factors we use to analyze enablement: “the nature
35
and scope of the invention at issue,” “the existing knowledge in the
particular field, the extent and content of the prior art, the maturity of the
science or technology, [and] the predictability of the aspect at issue.”
Boston Scientific Corp. v. Johnson & Johnson, 647 F.3d 1353, 1363 (Fed.
Cir. 2011).
5.
Here, we have already set forth in detail our reasons for concluding that
the asserted castor oil patent claims do not meet Section 112's enablement
requirement. (See “Enablement” section, supra). Indeed, we believe that
the Section 112, first paragraph, analysis in this case proceeds more
cleanly through the enablement framework than through a written
description-type inquiry.6 Nonetheless, given the current state of written
description jurisprudence, we find that the castor oil patent claims also fail
the written description requirement for essentially the same reasons that
they fail the enablement requirement: the art in question is highly
unpredictable and the claims are extremely broad, but the written
description is relatively limited. (See “Enablement” section, supra). Barr
has proven that Alcon’s castor oil patents lack an adequate written
6
In this respect, we agree with Judge Gajarsa that “[t]he enablement requirement of 35
U.S.C. § 112 ¶ 1 is the appropriate tool for invalidating claims that are broader than their
disclosure,” and in cases such as this, “the enablement analysis is simpler and more appropriate.”
Boston Scientific, 647 F.3d at 1369-70 (Gajarsa, J., concurring-in-part). We certainly see the
value in maintaining a separate written description requirement, e.g., “in curtailing claims that do
not require undue experimentation to make and use, and thus satisfy enablement, but that have
not been invented, and thus cannot be described.” Ariad, 598 F.3d at 1352. However, when a
patentee discloses a little but claims a lot, it seems to us that lack of enablement, not lack of an
adequate written description, is the primary concern.
36
description by clear and convincing evidence.
E.
Indefiniteness Under 35 U.S.C. § 112, Second Paragraph
1.
35 U.S.C. § 112, second paragraph, requires a patent specification to
“conclude with one or more claims particularly pointing out and distinctly
claiming the subject matter which the applicant regards as his invention.”
“The purpose of the definiteness requirement is to ensure that the claims
delineate the scope of the invention using language that adequately
notifies the public of the patentee’s right to exclude.” Young v. Lumenis,
Inc., 492 F.3d 1336, 1346 (Fed. Cir. 2007) (citation omitted). In other
words, members of the public should be able to read the claims and
understand whether or not they infringe the patent. As with any invalidity
defense, an accused infringer must prove indefiniteness by clear and
convincing evidence. Spansion, Inc. v. Int’l Trade Comm’n, 629 F.3d
1331, 1344 (Fed. Cir. 2010) (“Because a patent is presumed to be valid,
the evidentiary burden to show facts supporting a conclusion of invalidity
is one of clear and convincing evidence.”) (citation omitted).
2.
The Defendant bears a heavy burden in challenging claims as indefinite.
“Claims are considered indefinite when they are not amenable to
construction or are insolubly ambiguous.... Thus, the definiteness of claim
terms depends on whether those terms can be given any reasonable
meaning.” Young v. Lumenis, 492 F.3d at 1346 (internal citation and
quotation omitted). Relatedly, “close questions of indefiniteness in
37
litigation involving issued patents are properly resolved in favor of the
patentee.” Exxon Research & Eng’g Co. v. United States, 265 F.3d 1371,
1380 (Fed. Cir. 2001).
3.
Additionally, “the fact that some experimentation may be necessary to
determine the scope of the claims does not render the claims indefinite.”
Id. at 1379 (citation omitted). More specifically, the term “‘effective
amount’ is a common and generally acceptable term for pharmaceutical
claims and is not ambiguous or indefinite, provided that a person of
ordinary skill in the art could determine the specific amounts without
undue experimentation.” Geneva Pharms., Inc. v. GlaxoSmithKline PLC,
349 F.3d 1373, 1383-84 (Fed. Cir. 2003).
4.
Barr submits that two (2) terms in the castor oil patent claims render the
claims indefinite: “therapeutically-effective amount” and “enhancing the
chemical stability.” We disagree. The aforementioned phrases are
amenable to construction, so Barr failed to prove indefiniteness by clear
and convincing evidence.
5.
Regarding the “therapeutically-effective amount” limitation, Barr’s
experts Dr. Stern and Dr. Kent essentially opine that the term is indefinite
because it covers a broad range of prostaglandin concentrations. (Tr.
618:22-619:6; 628:10-629:24; 682). Perhaps it does, but that is not the
appropriate test. A functional limitation like “therapeutically-effective
amount” is not indefinite as long as a PHOSITA could determine the
38
claimed amounts without undue experimentation. Geneva, 349 F.3d at
1383-84.
6.
Here, the castor oil patent claims are limited to topically administrable
ophthalmic compositions. Barr’s expert Dr. Stern identified only two (2)
potential uses for prostaglandins in such compositions: (1) treating
glaucoma / ocular hypertension, and (2) growing longer eyelashes. (Tr.
626:4-628:9). This cabins the amount of experimentation necessary to
determine a “therapeutically-effective amount” of prostaglandin in the
castor oil patent claims. Additionally, the prior art disclosed prostaglandin
dosages effective to treat glaucoma. (Tr. 886-88; 893:7-10; 895:16-19).
This makes it even easier for one skilled in the art to determine the metesand-bounds of the asserted claims.
7.
Moreover, Dr. Stern seeks to hold patentees to an overly stringent
definiteness standard. According to Dr. Stern’s testimony, for a claim to
be definite, the patentee must disclose enough information to design a
drug “as close to ideal as possible.” (Tr. 636:14-23). Section 112 does
not mandate such precision. For the aforementioned reasons, we are
persuaded that the limitation “therapeutically-effective amount”
adequately puts the public on notice of the scope of the asserted claims.
Given that the claims are confined to topically administrable ophthalmic
compositions, one skilled in the art could determine through routine
experimentation what amounts of prostaglandin are “therapeutically-
39
effective,” especially in light of the prior art disclosures on the topic.
8.
Turning now to the phrase “enhancing the chemical stability,” Dr. Kent
believes this limitation is indefinite because neither the castor oil patent
specification nor the claims disclose an appropriate comparator. (Tr. 682;
814:17-23). He asks, “enhanced [chemical stability] over what?” (Tr.
682:11). We agree that the castor oil patents do not explicitly answer the
question, “enhanced over what?”. However, we do not believe this
disposes of the indefiniteness question.
9.
First, we have already construed the aforementioned limitation to mean
“to increase or increasing the ability of the prostaglandin to resist
chemical change (as distinguished from merely increasing the physical
stability of the prostaglandin or composition.)” (Doc. No. 214). Of
course, this still does not answer the “enhanced over what?” question.
However, the castor oil patents do not manifest any intent to either (1)
give the term “enhancing” any particular art-specific meaning, or (2) limit
the claims to those methods in which PECO enhances the chemical
stability over a particular alternative surfactant, e.g., Polysorbate 80. As
such, we interpret “enhancing” to have its ordinary, customary meaning in
the context of the claims. See Abbott Labs. v. Baxter Pharm. Prods., Inc.,
334 F.3d 1274, 1278 (Fed. Cir. 2003) (noting that claim term is given its
ordinary and customary meaning as long as patentee does not “deviate
from the accustomed meaning of the disputed claim term.”).
40
10.
Given the above, one of ordinary skill in the art would understand that the
asserted castor oil patent claims require that using PECO in the
formulation must provide increased chemical stability as compared to not
using PECO. In other words, using the invention must increase the
chemical stability of the prostaglandin as compared to not using the
invention. Although somewhat shakily, Schneider confirmed this
interpretation during his testimony. (Tr. 448:16-449:16 (Answering
“[e]nhanced chemical stability in the presence of polyethoxylated castor
oil compared to the same vehicles without polyethoxylated castor oils” to
the question “[e]nhanced compared to what?”).
11.
For these reasons, the claim term “enhancing the chemical stability” can
be construed and is not insolubly ambiguous. In fact, if we could not
construe the term, then we would not have performed the infringement
analysis in this matter, supra. See Amgen Inc. v. Hoechst Marion
Roussel, Inc., 314 F.3d 1313, 1342 (Fed. Cir. 2003) (recognizing that
“[o]ne cannot logically determine whether an accused product comes
within the bounds of a claim of unascertainable scope.”).
12.
For the aforementioned reasons, neither “therapeutically-effective
amount” nor “enhancing the chemical stability” render the asserted claims
insolubly ambiguous, and Barr failed to prove by clear and convincing
evidence that the claims lack definiteness under 35 U.S.C. § 112, second
paragraph.
41
F.
Anticipation Under 35 U.S.C. § 102
1.
Anticipation requires proof that all of the elements in a patent claim are
described within the four corners of a single prior art reference. See
Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1335 (Fed. Cir.
2002). Additionally, to establish that a patent is prior art under Section
102(e), it must be filed before the invention by the applicant for patent.
Power Integrations, Inc. v. Fairchild Semiconductor Int’l, Inc., 585 F.
Supp. 2d 568, 574-75 (D. Del. 2008).
2.
Here, Alcon and Barr dispute whether a particular reference qualifies as
prior art. In this regard, Alcon has the initial burden of offering evidence
that Mr. Schneider invented the subject matter of his patent prior to the
critical date of the reference. Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572,
1576-77 (Fed. Cir. 1996). However, once Alcon adduces such evidence,
Barr must prove by clear and convincing evidence that the critical date of
the reference precedes Schneider’s invention date. Id. at 1578.
Otherwise, the reference does not constitute prior art.
3.
But what constitutes “invention”? “Conception is the touchstone of
inventorship...It is the formation in the mind of the inventor, of a definite
and permanent idea of the complete and operative invention, as it is
hereafter to be applied in practice. The test for conception is whether the
inventor had an idea that was definite and permanent enough that one
skilled in the art could understand the invention; the inventor must prove
42
his conception by corroborating evidence, preferably by showing
contemporaneous disclosures.” Univ. of Pittsburgh of Commonwealth
Sys. of Higher Educ. v. Hedrick, 573 F.3d 1290, 1297-98 (Fed. Cir. 2009)
(internal citations and quotations omitted).
4.
However, reduction of the invention to practice also matters, in that
“priority of invention goes to the first party to reduce an invention to
practice unless the other party can show that it was the first to conceive
the invention and that it exercised reasonable diligence in later reducing
that invention to practice.” Mahurkar, 79 F.3d at 1577 (citation omitted).
“To show actual reduction to practice, an inventor must demonstrate that
the invention is suitable for its intended purpose.” Id. at 1578.
5.
Importantly, a patentee need not show prior inventorship of the entire
scope of the claimed invention if the allegedly anticipatory reference
discloses only a little. In In re Stempel, 241 F.2d 755, 759 (C.C.P.A.
1957), the court held that in a priority contest, “all the applicant can be
required to show is priority with respect to so much of the claimed
invention as the reference happens to show. When he has done that he has
disposed of the reference.” See also Eli Lilly & Co. v. Sicor Pharms., Inc.,
705 F. Supp. 2d 971, 994-95 (S.D. Ind. 2010) (applying Stempel to a
Section 102 analysis).
6.
Here, Barr’s expert Dr. Kent identified only one (1) potentially
anticipatory reference, namely U.S. Patent No. 5,721,273, which was filed
43
on Dec. 15, 1993 and issued on Feb. 24, 1998. (Tr. 825:6-828:18; 923:5924:2; DTX 806). However, as discussed below, this reference is not
prior art because Schneider conceived and reduced to practice enough of
his claimed invention prior to Dec. 15, 1993, the filing date of the ‘273
patent, such that the ‘273 patent does not constitute prior art with respect
to the castor oil patent claims in suit. (Tr. 340-62).
7.
Specifically, Schneider testified, and his lab notebooks confirm, that prior
to December 15, 1993, Schneider performed experiments to study the
stability of AL-6534, a particular prostaglandin, in various vehicles
employing different surfactants. (Tr. 350:6-21; 358:22-24). Two (2) of
the surfactants Schneider studied were Cremophor® EL and Alkamuls®
EL 620, both of which are PECOs. (Tr. 355:22-356:8). In fact, these are
the same two PECOs tested in the castor oil patents. (‘273 patent, Figures
2-3). Using HPLC, Schneider analyzed samples of the various
formulations to determine and compare prostaglandin loss over time. (Tr.
357-61). Schneider found that the tested PECOs prevented prostaglandin
loss much more effectively than Polysorbate 80, a widely-used surfactant
in ophthalmic formulations, and Schneider attributed these results to
PECO chemically stabilizing the prostaglandin. (Tr. 358-62).
8.
The allegedly-anticipatory ‘273 patent (DTX 806) focuses not on chemical
stability, but rather on the efficacy of certain prostaglandin compounds in
treating glaucoma. (‘273 patent, 1:30-37). One of the disclosed
44
prostaglandin compositions includes Cremophor® EL (‘273 patent, 15:936), but the reference does not mention that Cremophor® EL might have a
chemically stabilizing effect on the prostaglandin.
9.
For the aforementioned reasons, we hold that Schneider conceived and
reduced to practice enough of his claimed invention prior to December 15,
1993, the filing date of the ‘273 patent reference, such that this reference
is not prior art with respect to the asserted castor oil patent claims. Stated
another way, prior to the ‘273 patent’s filing date, Schneider demonstrated
conception and reduction to practice of at least as much of his invention as
the ‘273 patent showed. See Stempel, 241 F.2d at 759. Since the
reference is not prior art, it cannot anticipate the claims.
10.
Some might perceive a tension between this conclusion, in which we
found that Schneider did invent a method of chemically stabilizing
prostaglandins using PECO, and our finding of non-infringement that
rested largely on the lack of evidence showing that PECO chemically
stabilizes prostaglandins. There is no such tension. The different (1)
burdens of proof and (2) relevant formulations dictate the different results.
To prevail on infringement, Alcon had to prove that the PECO in Barr’s
ANDA product formulation chemically stabilizes the prostaglandin
Travoprost. Alcon failed to clear this hurdle. On the other hand, in the
Section 102 analysis, Barr had to prove by clear and convincing evidence
that the PECO does not chemically stabilize the prostaglandin in the
45
formulations in the patent, i.e., that Schneider did not invent the claimed
method prior to the critical reference date. Barr failed to meet this burden.
G.
Obviousness Under 35 U.S.C. § 103
1.
Under 35 U.S.C. § 103(a), “[a] patent may not be obtained...if the
differences between the subject matter sought to be patented and the prior
art are such that the subject matter as a whole would have been obvious at
the time the invention was made to a person having ordinary skill in the
art to which said subject matter pertains.”
2.
The Supreme Court’s seminal decision in Graham v. John Deere Co. of
Kan. City, 383 U.S. 1, 17-19 (1966) sets forth the basic obviousness
framework: in analyzing obviousness, “the scope and content of the prior
art are to be determined; differences between the prior art and the claims
at issue are to be ascertained; and the level of ordinary skill in the
pertinent art resolved. Against this background, the obviousness or
nonobviousness of the subject matter is determined. Such secondary
considerations as commercial success, long felt but unsolved needs, failure
of others, etc., might be utilized to give light to the circumstances
surrounding the origin of the subject matter sought to be patented. As
indicia of obviousness or nonobviousness, these inquiries may have
relevancy.”
3.
The Court most recently revisited the subject of obviousness in KSR
International Co. v. Teleflex Inc., 550 U.S. 398 (2007). In KSR, the Court
46
endorsed “an expansive and flexible approach” to the obviousness inquiry,
rejecting the purportedly “rigid approach” of the Federal Circuit. Id. at
415. More specifically, the Court declined to hold that a claim is invalid
under Section 103 only if the prior art itself contained a “teaching,
suggestion, or motivation” (TSM) to combine the elements of various
references in a way that rendered the claimed invention obvious. Instead,
the obviousness “analysis need not seek out precise teachings directed to
the specific subject matter of the challenged claim, for a court can take
account of the inferences and creative steps that a person of ordinary skill
in the art would employ.” Id. at 418. According to KSR, “[t]he
combination of familiar elements according to known methods is likely to
be obvious when it does no more than yield predictable results.” Id. at
416.
4.
However, post-KSR, “a flexible TSM test remains the primary guarantor
against a non-statutory hindsight analysis.” Ortho-McNeil Pharma., Inc. v.
Mylan Labs., Inc., 520 F.3d 1358, 1364 (Fed. Cir. 2008). Of course,
“those teachings, suggestions, or motivations need not always be written
references but may be found within the knowledge and creativity of
ordinarily skilled artisans.” Id. at 1365. The mere fact that it may be
“obvious to try” a certain combination does not necessarily render a
combination claim obvious. See Abbott Labs. v. Sandoz, Inc., 544 F.3d
1341, 1352 (Fed. Cir. 2008) (“The Court in KSR did not create a
47
presumption that all experimentation in fields where there is already a
background of useful knowledge is ‘obvious to try,’ without considering
the nature of the science or technology....Each case must be decided in its
particular context...”).
5.
Additionally, unexpected results support a finding of non-obviousness.
KSR, 550 U.S. at 416 (“The fact that the elements worked together in an
unexpected and fruitful manner supported the conclusion that Adams’
design was not obvious to those skilled in the art.”). See also
Ortho-McNeil, 520 F.3d at 1365 (declaring that “powerful unexpected
results” have “particular importance” to the obviousness inquiry).
6.
Here, other than the ‘273 patent, which is not prior art (see “Anticipation”
section, supra), Barr’s expert Dr. Kent relied on six (6) prior art references
to conclude that the castor oil patent claims-in-suit are obvious under
Section 103: (1) U.S. Patent No. 4,684,633; (2) Japanese Patent
Application S53-148518; (3) U.S. Patent No. 4,430,340; (4) U.S. Patent
No. 5,296,504; (5) U.S. Patent No. 5,091,417; and (6) U.S. Patent No.
5,185,372. (Tr. 820-36). However, Dr. Kent’s testimony boils down to
simply identifying the individual elements of the claimed invention in
various prior art references. (Tr. 818-36). A PHOSITA would have had
no reason or motivation to combine the teachings of the six (6)
aforementioned prior art references absent impermissible hindsight.
Therefore, Barr failed to prove by clear and convincing evidence that the
48
prior art rendered the asserted castor oil patent claims obvious to a
PHOSITA at the time the invention was made.
7.
Although a detailed description of each and every prior art reference Barr
cited is unwarranted, we will briefly discuss each reference and how it
differs from the claimed invention. The ‘633 patent (DTX 801) is drawn
to a prostaglandin emulsion suitable for IV administration. (Abstract).
The patent does not concern topical ophthalmic compositions; merely
discloses that any of a long list of surfactants, including PECO, may
optionally be added to the emulsion as a “high molecular weight
compound;” gives no indication that PECO is a preferred surfactant; and
does not discuss chemical stabilization of the prostaglandin by PECO.
8.
The ‘518 Japanese patent application (DTX 797) discusses chemically
stabilizing PGE prostaglandins (p. 68) with non-ionic surfactants,
including “POE castor oil or cured castor oil derivatives,” but gives no
reason for one skilled in the art to choose PECO from the long list of
disclosed surfactants. (p. 68). Although the compositions in ‘518 may be
liquid or solid, i.e., freeze-dried, the only example given containing PECO
is freeze-dried. (p. 70).
9.
The ‘340 patent (DTX 796) discloses stabilizing aqueous solutions of PGI2
compounds with surfactants. (Abstract). However, the patent discloses
both cationic and neutral surfactants, and does not even name PECO or
castor oil as a potential surfactant. Rather, the surfactant may include
49
“polyoxyethylated vegetable oils,” (6:40-49), a broad genus that at least
arguably includes PECO. Additionally, the ‘340 patent does not mention
topically administrable ophthalmic compositions; on the contrary, the
disclosed solution is administered via injection. (Tr. 906:10-16).
10.
The ‘504 patent (DTX 804) discloses prostaglandin-containing ophthalmic
compositions for topically treating glaucoma (Abstract). However, the
‘504 patent does not mention PECO at all. Instead, it discloses that the
composition may contain surfactants such as “polysorbate 80, liposomes
or polymers, for example methyl cellulose, polyvinyl alcohol, polyvinyl
pyrrolidone and hyaluronic acid.” (5:30-42). Additionally, the ‘504
patent does not disclose that the surfactant chemically stabilizes the
prostaglandin; rather, the surfactant is added “for increasing the
viscosity.” (5:42).
11.
The ‘417 patent (DTX 807) concerns a PGE emulsion used to treat
hepatitis. (Abstract). The emulsion may contain a nonionic surfactant
selected from a list including, among other things, PECO. (3:10-24).
Like other previously discussed references, the ‘417 patent does not
mention chemical stabilization at all, much less using PECO to chemically
stabilize the PGE; provides no reason to choose PECO over the other
disclosed nonionic surfactants; and has nothing to do with topically
administrable ophthalmic compositions.
12.
Finally, the ‘372 patent (DTX 803) is drawn to a “stable aqueous
50
preparation for ophthalmic topical administration containing vitamin A.”
(Abstract). The reference discloses stabilizing vitamin A by emulsifying
it in water with a nonionic surfactant. (2:65-3:1). Specifically, “[i]n the
aqueous preparation of the present invention, a non-ionic surfactant is
used in order to form an emulsion by dispersing vitamin A in the aqueous
medium. For a non-ionic surfactant, any of the non-ionic surfactants
which are conventionally used as constituents of eye drops may be
conveniently used. For example, either of polysorbate 80 and
polyoxyethylenehydrogenated castor oil may advantageously be used.”
(3:32-40) (emphasis added). However, as previously mentioned, the ‘372
patent deals with vitamin A, not prostaglandins.
13.
The combination of references that comes the closest to rendering the
castor oil patent claims obvious is (1) the ‘504 patent, and (2) the justdiscussed ‘372 patent. However, at best, these patents together suggest
substituting PECO for polysorbate 80 in the ‘504 patent’s prostaglandincontaining formulations with the expectation of obtaining similar results.
After all, the ‘372 patent expresses no preference for either
“conventionally-used” surfactant and certainly does not mention that
PECO may enhance the chemical stability of prostaglandins (or vitamin A,
for that matter). This is not enough to prove obviousness in this case
because the castor oil patents show that PECO and Polysorbate 80 are not
equivalently effective in stabilizing prostaglandins. Instead, PECO
51
unexpectedly prevents prostaglandin loss much more effectively than
Polysorbate 80 does, at least in the tested formulations. (‘287 patent,
Figures 2-3). These results, unexpected by the prior art, support a finding
of non-obviousness. See KSR, 550 U.S. at 416; Ortho-McNeil, 520 F.3d
at 1365.
14.
At bottom, Barr failed to prove obviousness by clear and convincing
evidence. It seems to us that Dr. Kent utilized the castor oil patents as a
template and recreated the claimed invention by picking-and-choosing
select portions of various references through impermissible hindsight.
Even post-KSR, this kind of hindsight reasoning does not suffice to prove
obviousness. See Ortho-McNeil, 520 F.3d at 1364 (“a flexible TSM test
remains the primary guarantor against a non-statutory hindsight
analysis.”). In Dr. Kent’s opinion, combining bits and pieces of the
references here is not “an impossible reach.” (Tr. 891:12-17).
Respectfully, the obviousness standard has not gotten so lax, even after
KSR. If it ever does, then virtually nothing could be patented.
H.
Alcon’s Un-Litigated U.S. Patent Nos. 5,510,383 and 5,889,052
1.
“Pleadings do not suffice to support a judgment when the subject matter
was not litigated, or fairly placed in issue, during the trial....There must be
sufficient and explicit notice of the claims at risk. When the pleadings are
not in complete harmony with the issues that were litigated and
adjudicated, it is the pleadings that may be conformed to the judgment, not
52
vice versa.” Tol-O-Matic, Inc. v. Proma Produkt-Und Marketing
Gesellschaft m.b.H., 945 F.2d 1546, 1554-55 (Fed. Cir. 1991), abrogated
on other grounds, Markman v. Westview Instruments, Inc., 52 F.3d 967
(Fed. Cir. 1995).
2.
Relatedly, a reference to particular claims in a complaint is not enough to
support a judgment with respect to claims not at issue during trial and not
actually litigated by the parties. 800 Adept, Inc. v. Murex Sec., Ltd., 539
F.3d 1354, 1367-68 (Fed. Cir. 2008). In fact, passing judgment on patent
claims that were never litigated or placed at issue during trial constitutes
reversible error. See id. at 1368 (reversing trial court’s judgment of
invalidity with respect to unasserted claims).
3.
Here, Alcon initially asserted U.S. Patent Nos. 5,510,383 and 5,889,052
against Barr. (Doc. No. 1 ¶¶ 9-22, 50-63). However, Alcon did not assert
these two patents in its pretrial filings or at trial, and Alcon did not present
any evidence whatsoever on these patents at trial, although Alcon never
formally withdrew its claims based on the patents. At the close of Alcon’s
case-in-chief, Barr moved for judgment as a matter of law of noninfringement of the ‘383 and ‘052 patents, noting that Alcon presented no
evidence on these two patents and therefore cannot meet its burden of
proving infringement by a preponderance of the evidence. (Tr. 563:2-15).
4.
Since these patents were not at issue during trial and not actually litigated
by the parties, Barr is not entitled to a judgment of non-infringement of
53
these patents. 800 Adept, 539 F.3d at 1367-68. As neither party
presented any evidence on the ‘383 and ‘052 patents at trial, we decline to
make any findings or draw any conclusions about the infringement or
validity of the patents.
IV.
Conclusion
A.
For the aforementioned reasons, we find and declare that (1) Barr’s ANDA
product, i.e., its generic version of Travatan Z®, does not infringe the asserted
castor oil patent claims; (2) the asserted castor oil patent claims are not enabled
and lack an adequate written description under 35 U.S.C. § 112, first paragraph;
(3) the asserted castor oil patent claims are sufficiently definite under 35 U.S.C. §
112, second paragraph; (4) the prior art does not either anticipate under Section
102 or render obvious under Section 103 the asserted castor oil patent claims; and
(5) given Barr’s stipulation of infringement, Barr’s ANDA product infringes
Claims 7, 21, 41, and 43 of the ‘497 patent and Claim 18 of the ‘253 patent (the
borate-polyol patents). As such, it is hereby ORDERED that the effective date of
any FDA approval of Barr’s BAC-free ANDA product shall be a date which is
not earlier than the date of the expiration of the last to expire of the ‘497 and ‘253
patents.
BY THE COURT:
/s/ Legrome D. Davis
Legrome D. Davis, J.
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