Roxane Laboratories, Inc. v. Camber Pharmaceuticals, Inc. et al
OPINION & ORDER denying as moot 188 Motion to Preclude; denying as moot 207 Motion to Strike, that, in U.S. Patent No. 8,563,032, the term size 00 or less means precisely size 00 or less, and flowable granules means flowable granules. Signed by Judge Stanley R. Chesler on 7/15/15. (cm )
UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY
ROXANE LABORATORIES, INC.,
CAMBER PHARMACEUTICALS INC.
Civil Action No. 14-4042 (SRC)
OPINION & ORDER
This matter comes before the Court on the application for claim construction by
Plaintiff Roxane Laboratories, Inc. (“Roxane”) and Defendants Camber Pharmaceuticals Inc. and
InvaGen Pharmaceuticals Inc. (collectively, “Defendants”). In this patent infringement suit
involving a pharmaceutical patent, the parties seeks construction of claims in U.S. Patent No.
8,563,032 (“the ’032 patent”).
The law of claim construction
A court’s determination “of patent infringement requires a two-step process: first, the
court determines the meaning of the disputed claim terms, then the accused device is compared
to the claims as construed to determine infringement.” Acumed LLC v. Stryker Corp., 483 F.3d
800, 804 (Fed. Cir. 2007). “[W]hen the district court reviews only evidence intrinsic to the
patent (the patent claims and specifications, along with the patent’s prosecution history), the
judge’s determination will amount solely to a determination of law.” Teva Pharms. USA, Inc. v.
Sandoz, Inc., 135 S. Ct. 831, 841 (2015).
The focus of claim construction is the claim language itself:
It is a bedrock principle of patent law that the claims of a patent define the
invention to which the patentee is entitled the right to exclude. Attending this
principle, a claim construction analysis must begin and remain centered on the
claim language itself, for that is the language the patentee has chosen to
‘particularly point out and distinctly claim the subject matter which the
patentee regards as his invention.’
Innova/Pure Water, Inc. v. Safari Water Filtration Sys., 381 F.3d 1111, 1115-1116 (Fed. Cir.
2004) (citations omitted).
The Federal Circuit has established this framework for the construction of claim
We have frequently stated that the words of a claim ‘are generally given their
ordinary and customary meaning.’ We have made clear, moreover, that the
ordinary and customary meaning of a claim term is the meaning that the term
would have to a person of ordinary skill in the art in question at the time of the
invention, i.e., as of the effective filing date of the patent application.
The inquiry into how a person of ordinary skill in the art understands a claim term
provides an objective baseline from which to begin claim interpretation. . .
In some cases, the ordinary meaning of claim language as understood by a person
of skill in the art may be readily apparent even to lay judges, and claim
construction in such cases involves little more than the application of the widely
accepted meaning of commonly understood words. In such circumstances,
general purpose dictionaries may be helpful. In many cases that give rise to
litigation, however, determining the ordinary and customary meaning of the claim
requires examination of terms that have a particular meaning in a field of art.
Because the meaning of a claim term as understood by persons of skill in the art is
often not immediately apparent, and because patentees frequently use terms
idiosyncratically, the court looks to those sources available to the public that
show what a person of skill in the art would have understood disputed claim
language to mean. Those sources include the words of the claims themselves, the
remainder of the specification, the prosecution history, and extrinsic evidence
concerning relevant scientific principles, the meaning of technical terms, and the
state of the art.
Phillips v. AWH Corp., 415 F.3d 1303, 1312-1314 (Fed. Cir. 2005) (citations omitted).
Claim construction of the disputed terms
“Size 00 or less”
Claim 1 states:
A calcium acetate capsule formulation comprising flowable granules comprised
of a pharmaceutically acceptable amount of calcium acetate along with other
pharmaceutically acceptable adjuvants, wherein said granules are filled into and
contained within a pharmaceutically acceptable capsule such that 667 mg of said
calcium acetate on an anhydrous basis are present in said capsule that is size 00 or
The parties dispute the meaning of the phrase, “size 00 or less.” Defendants contend that “size
00” means “precisely size 00,” and excludes capsules of size 00el. Roxane contends that
“pharmaceutically acceptable capsule . . . that is size 00 or less” means “a capsule suitable for
oral consumption by a human having the diameter of any capsule designated size ‘00’ or less.”
This Court considered this question when it heard the motion for a preliminary injunction
in this case, and made a preliminary claim construction ruling in favor of Defendants. Having
reexamined the issue, this Court concludes that its original reasoning was sound, and
incorporates those reasons into this Opinion.
It appears that the meaning of “size 00” in the context of fillable pharmaceutical capsules
is fairly clear. In the “Other Publications” section of the patent specification, there is a reference
to a pharmaceutical capsule size chart: “Torpac,
http://www.erowid.org/archive/rhodium/pdf/gelcap.sizechart.pdf, 1-3.*” This reference contains
various statistics about various capsule sizes. It contains information about size 00 capsules,
which are said to have a height of 23.3 mm and a volume of .95 ml. It appears that, in the
context of fillable pharmaceutical capsules, “size 00” refers to a capsule of approximately this
size, and this is its common and ordinary meaning. It also appears that there is an elongated
version of this capsule which is generally referred to as “size 00el,” which has the same diameter
but a greater length and volume. The parties do not disagree that, within the context of the
pharmaceutical art, “size 00” and “size 00el” refer to particular standard gelatin capsule sizes,
and there is no material dispute over what those sizes are. This Court concludes that the claim
term at issue, “size 00 or less,” refers to size 00 and excludes size 00el.
Roxane has made a concerted effort to inject confusion into this fairly simple and
straightforward matter. Roxane contends that “size 00 or less” is “a technical term of art whose
ordinary meaning is not plainly apparent to a layperson.” (Pl.’s Reply Br. 5 n.5.) As the
following discussion will show, this Court disagrees. Furthermore, Roxane points to a variety of
pieces of extrinsic evidence which, it contends, support its argument that the skilled artisan
would understand “size 00” to include size 00el. Roxane even urges this Court that, given the
Supreme Court’s recent decision in Teva, it has an obligation to “to look beyond the patent’s
intrinsic evidence and to consult extrinsic evidence . . .”1 135 S. Ct. at 841.
Roxane cites no post-Teva decision by the Federal Circuit that stands for the proposition
that the Teva decision altered the established roles of intrinsic and extrinsic evidence in claim
construction. In terms of the issues raised by Roxane, it is worth noting that the Federal Circuit,
hearing the Teva case on remand from the Supreme Court, held:
Roxane here both misreads and misquotes the Supreme Court, which stated: “In some
cases, however, the district court will need to look beyond the patent’s intrinsic evidence and to
consult extrinsic evidence in order to understand, for example, the background science or the
meaning of a term in the relevant art during the relevant time period.” Id. Roxane has not
shown that this is such a case. Roxane has not persuaded this Court that a greater understanding
of the background science is needed to construe the term at issue, nor that the meaning of the
term has changed over time such than an investigation into the usage during another time period
would be helpful.
To the extent that Teva argues that the meaning of “molecular weight” in the
context of patents-in-suit is itself a question of fact, it is wrong. See Teva, 135 S.
Ct. at 841-42. A party cannot transform into a factual matter the internal
coherence and context assessment of the patent simply by having an expert offer
an opinion on it. The internal coherence and context assessment of the patent,
and whether it conveys claim meaning with reasonable certainty, are questions of
law. The meaning one of skill in the art would attribute to the term molecular
weight in light of its use in the claims, the disclosure in the specification, and the
discussion of this term in the prosecution history is a question of law. The district
court should not defer to Dr. Grant’s ultimate conclusion about claim meaning in
the context of this patent nor do we defer to the district court on this legal
question. To the extent that Teva argues that this ultimate determination deserves
deference, it is in error. To the extent that Teva or the dissent suggests that the
specification’s disclosure of SEC would “infer” that this claim term, molecular
weight, in this patent refers to Mp, such an inference is part of the legal analysis,
not a fact finding to be given deference. Determining the meaning or significance
to ascribe to the legal writings which constitute the intrinsic record is legal
analysis. The Supreme Court made clear that the factual components include “the
background science or the meaning of a term in the relevant art during the
relevant time period.” Id. at 841. Teva cannot transform legal analysis about the
meaning or significance of the intrinsic evidence into a factual question simply by
having an expert testify on it. Id. at 841 (“experts may be examined to explain
terms of art, and the state of the art, at any given time, but they cannot be used to
prove the proper or legal construction of any instrument of writing” (citation
omitted)). Determining the significance of disclosures in the specification or
prosecution history is also part of the legal analysis.
Teva Pharms. USA, Inc. v. Sandoz, Inc., 2015 U.S. App. LEXIS 10229, *15-*16 (Fed. Cir. June
18, 2015). Similarly, Roxane “cannot transform legal analysis about the meaning or significance
of the intrinsic evidence into a factual question simply by having an expert testify on it.” Id. at
Roxane contends otherwise:
The Supreme Court explained that when parties dispute how a POSITA
understands the ordinary meaning of a claim term (especially a technical term of
art), the district court “will need” to analyze extrinsic evidence, including
pertinent references and expert declarations, and resolve those disputes.
(Pl.’s Resp. Br. 3-4.) This is incorrect. Phillips is still good law, and it stands for the proposition
that extrinsic evidence may not be “used to contradict claim meaning that is unambiguous in
light of the intrinsic evidence.” Phillips, 415 F.3d at 1324. As the following analysis will
demonstrate, this Court finds that the meaning of the claim term “size 00 or less” is unambiguous
in light of the intrinsic evidence. There is no need to resolve ambiguities of meaning by
examining extrinsic evidence.2
“Claim construction analysis begins with the intrinsic evidence.” Irdeto Access, Inc. v.
Echostar Satellite Corp., 383 F.3d 1295, 1299 (Fed. Cir. 2004). It is very difficult to reconcile
Roxane’s proposed construction with the plain language in the patent itself. There is nothing in
the patent that even suggests that the applicants understood “size 00” to mean a family of capsule
sizes. To the contrary, the usage of “size 00” in the patent is inconsistent with the family
definition that Roxane has proposed. The strongest piece of evidence is the first appearance of
the phrase in the specification: “According to one embodiment of the invention, the capsule is a
size 00 capsule containing 667 mg of calcium acetate.” ’032 patent, col.3 ll.29-31. Note the use
of the singular in that sentence, which refers to “one embodiment,” “the capsule,” and “a size 00
capsule.” If size 00 is understood to mean a family of two sizes, this sentence makes little sense.
If the applicants intended the family definition, the sentence should read: “According to some
embodiments of the invention, the capsules are size 00 capsules containing 667 mg of calcium
acetate.” In other words, the singular forms in the sentence ought to be plural. The use of the
Roxane asserts that “[t]he claim construction issue in Teva, itself, is instructive.” (Pl.’s
Br. 5.) This is correct, but this Court understands the Teva case differently. In Teva, the
intrinsic evidence alone was insufficient to resolve ambiguities in the meaning of the claim term
– so much so that the Federal Circuit, on remand, found Claim 1 invalid for indefiniteness. 2015
U.S. App. LEXIS 10229 at *23-*24. In the instant case, examination of the intrinsic evidence
does not leave unsolved questions about the meaning of “size 00 or less.”
phrase “one embodiment” is particularly difficult to square with the family theory: it strongly
indicates that “size 00” is a set which contains only one element, not two.3
The next appearance of “size 00” in the patent is in Example 1: “The final blend was then
filled into size 00 capsules using an IMA capsule filling machine wherein the resulting filled
capsules had a weight of 880 mg and contained 760 mg of the final blend, including a 667 mg
dose of calcium acetate.” ‘032 patent, col.5 ll.53-57. In this instance, “capsules” is a plural
form, and yet the capsules are said to have “a weight of 880 mg.” Again, this is very difficult to
square with the family definition, since, using that definition, it would mean that both a size 00
capsule filled with 760 mg of final blend and a size 00el capsule filled with 760 mg of final
blend have the same weight of 880 mg. Presumably, an empty size 00 capsule and an empty size
00el capsule, which share a common diameter but have different heights, have different weights.
It would not make sense to assert that capsules with varying weights, when empty, yield capsules
with a single weight, when filled with a single amount of final blend.
The only other place in the patent in which “size 00” appears is claim 1.
A similar analysis may be performed on the Uraizee declaration. Dr. Uraizee’s main
point in the declaration was that granules prepared by the Nakai process did not fit in a size 00
capsule. There appears to be no dispute that a size 00 capsule and a size 00el capsule have
different fill capacities.4 There is nothing in the writing of the declaration that suggests that Dr.
If Roxane’s proposed construction is correct, we are left with a patent specification that
says “one embodiment” when it means “two embodiments.”
Roxane’s opening brief presents a table which generally demonstrates this. (Pl.’s Br. 8.)
The Lightfoot reference cited in the Uraizee declaration also presents a table which demonstrates
this. (Uraizee Decl. at 2 n.1, INVAGEN0003652.)
Uraizee understood the term “size 00 capsule” to encompass a set with two elements with
differing fill capacities. The declaration appears to be written from the perspective that a size 00
capsule has a single fill capacity, and that this single fill capacity is insufficient to hold 710 mg
of calcium acetate granules prepared by the Nakai process. In particular, Dr. Uraizee states:
“Due to the lower bulk density and lower tapped density (0.65 g/cc) of the granules by the Nakai
et al. process, only about 592 mg of granules can be comfortably filled into the capsule.”
(Uraizee Decl. at 2, INVAGEN0003652.) Note that this implies that a size 00 capsule has one
fill capacity; there is no suggestion that a size 00 capsule has a range of fill capacities. If Dr.
Uraizee understood “size 00” to refer to a set containing two capsules of different volumes, she
might have written this sentence differently, such as by using a range, e.g., “about 592 mg to 610
mg can be comfortably filled into size 00 capsules.”5
Roxane contends that documents relating to the applicants’ appeal to the Patent Trial and
Appeal Board (“PTAB”), the transcript of which was not included in the record when this Court
heard the motion for a preliminary injunction, provide intrinsic evidence which supports
Plaintiff’s construction. Roxane first points to this statement in the appeal reply brief:
[It] is apparent to one of ordinary skill that the claimed capsules are administrable
to humans for treating hyperphosphatemia, whereas larger capsules of size
number 000 are not normally administered to humans.
(Long Dec. Ex. 17 at 4, ROX_CA00000276). Roxane contends that this statement “clearly
expressed” that the claim term “size 00” excludes only size 000. (Pl.’s Br. 17.) This is
Roxane has conceded that, in connection to the declaration, Dr. Uraizee tested only the
size 00 capsule, and not size 00el, and so that explains why her declaration appears to reflect a
single fill capacity. (Pl.’s Resp. Br. 2.) Thus, Roxane takes the position that Dr. Uraizee tested
only one size capsule, but wrote a declaration using a term that she understood to refer to two
capsules of different volumes, but did not attempt to clarify the matter. This is difficult to credit.
unpersuasive; this sentence says nothing about the scope of the claim term “size 00.” Roxane
argues that “[t]he Applicants expressly stated that only the ‘larger capsules of size number 000'
are outside the scope of the ‘claimed capsules,’” but this is not supported by the plain language
Roxane has quoted. (Id.) There is no “only” in the original sentence, so it was not expressly
stated, nor is “only” implied.6
Roxane also attempts to make use of the applicant’s correction of a small mistake made
by the examiner. According to statements made in the appeal reply brief, in the appeal answer
brief submitted by the examiner to the PTAB, the examiner mistakenly asserted that claim 1
covers capsules of size 00 or larger, instead of smaller. (Long Dec. Ex. 17 at 4,
ROX_CA00000276). The statements made by the applicants in pointing out and correcting that
error do not speak to the issue of whether the applicants used “size 00” to refer to a family.7
The appeal reply brief actually provides evidence that works against Roxane’s position.
It contains the statement: “[t]he Uraizee Declaration only tested size 00 capsules . . .” (Long
Dec. Ex. 17 at 5, ROX_CA00000277). There is no dispute that, in the experiment described in
that declaration, Dr. Uraizee tested only capsules of size 00, and did not test capsules of size
00el.8 It is quite clear that, in this appeal reply brief sentence, “size 00” was used to refer to size
Roxane also cites the transcript for the hearing before the PTAB and claims, once again,
that the applicant explicitly stated that only size 000 capsules are larger capsules. The transcript
does not say that. (Long Dec. Ex. 18 at 9:14-20, ROX_CA00050020).
Similarly, Roxane finds support for its position in a statement to the PTAB that a size 0
capsule was one size smaller, rather than two sizes smaller, than the claimed invention. (Pl.’s
Resp. Br. 1.) The problem with this argument is that at issue is the meaning of the claim term
“size 00,” not the word “size.” The parties have not asked for claim construction of the word
“size,” and the use of “size” outside the context of the claim term at issue does not reliably
illuminate the meaning of the claim term.
“Roxane can now confirm that she used a non-elongated version.” (Pl.’s Resp. Br. 2.)
00 capsules only, rather than the set of size 00 and size 00el capsules. This is consistent with the
usage throughout the intrinsic record.
Roxane has proposed a construction that conflicts with the intrinsic evidence; Defendants
have proposed a construction that is consistent with the intrinsic evidence. The intrinsic
evidence uniformly demonstrates that “size 00 or less” does exclude capsules of size 00el, and so
means “precisely size 00 or less.”
Defendants contend that the claim term “flowable granules” in Claim 1 excludes any
granule produced by a wet granulation process. Roxane contends that there is no such exclusion.
Defendants first point to the fact that the specification describes only a dry granulation
production method. It is well-settled that the Federal Circuit “has expressly rejected the
contention that if a patent describes only a single embodiment, the claims of the patent must be
construed as being limited to that embodiment.” Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d
898, 906 (Fed. Cir. 2004).
Defendants next point to a statement in the appeal decision from the PTAB, observing
that the specification describes a dry granulation method. (PTAB decision at 3,
ROX_CA00000304). This is a simple statement of fact. The PTAB made no legal conclusions
limiting claim scope to granules produced by dry granulation methods.
Lastly, Defendants contend that the applicants disclaimed granules produced by a wet
granulation process during prosecution. There is no dispute that the applicants used the Uraizee
declaration to overcome an obviousness rejection, and that they distinguished the flowable
granules made by the dry granulation process disclosed in the ’032 patent specification from the
granules produced by the wet granulation process described in Nakai. As Defendants state,
under Federal Circuit law, “where the patentee has unequivocally disavowed a certain meaning
to obtain his patent, the doctrine of prosecution disclaimer attaches and narrows the ordinary
meaning of the claim congruent with the scope of the surrender.” Omega Eng’g, Inc. v. Raytek
Corp., 334 F.3d 1314, 1324 (Fed. Cir. 2003).
The key to the analysis is that the applicant must unequivocally disavow a certain
meaning of a claim term, and Defendants have not explained what meaning of “flowable
granules” has been disavowed. The statements distinguishing the Nakai process do not rise to
the level of an unequivocal disavowal of some meaning of “flowable granules.” In the
declaration, Dr. Uraizee states that, using the granules she produced using the Nakai process,
“[t]he capsule fill was part slug and part granules.” (Uraizee Decl. at 2, INVAGEN0003652).
Defendants have not explained what a slug is, nor what the appearance of slug in the capsule fill
has to do with being flowable, nor why this Court should conclude that wet granulation is to
blame for the slug.9 Defendants have failed to persuade this Court that the applicants used
“words or expressions of manifest exclusion or restriction, representing a clear disavowal of
claim scope.” Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1327 (Fed. Cir. 2002).
It is not at all clear that Dr. Uraizee even relied on the wet/dry granulation distinction to
distinguish Nakai. Her main point appears to be about granule density: the inventive process
produced granules with a much higher bulk density than did the Nakai process. (Uraizee Decl. at
4, INVAGEN0003654). While she does refer at points to the issue of whether the granules were
flowable, as already stated, she makes no clear statement about how the wet/dry production
distinction affects granule flowability.
Furthermore, the transcript from the PTAB hearing shows that counsel for the applicants argued:
“[The examiner] ignores the declaration evidence that Nakai wasn’t able to consistently produce
flowable granules as claimed.” (Long Decl. Ex. 18 at 7:11-12, ROX_CA00050018) (italics
added). This appears to concede that the Nakai wet granulation process sometimes produced
The Court agrees with Roxane and concludes that “flowable granules” means “flowable
Also before the Court are two motions seeking to exclude certain extrinsic evidence from
consideration during claim construction. This Court has determined that the meaning of the
claim terms at issue is unambiguous in light of the intrinsic evidence. It has not needed to rely
on extrinsic evidence in claim construction, and these motions will be denied as moot.
For these reasons,
IT IS on this 15th day of July, 2015 hereby
ORDERED that, in U.S. Patent No. 8,563,032, the term “size 00 or less” means
“precisely size 00 or less,” and “flowable granules” means “flowable granules;” and it is further
ORDERED that Defendants’ motion to preclude the testimony of Stuart Silverman
(Docket Entry No. 188) is DENIED as moot; and it is further
ORDERED that Defendants’ motion to strike the declaration of Larry L. Augsburger
(Docket Entry No. 207) is DENIED as moot.
s/ Stanley R. Chesler
Stanley R. Chesler, U.S.D.J.
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