Reckitt Benckiser LLC v. Aurobindo Pharma Limited et al

Filing 134

MEMORANDUM OPINION re claim construction. Signed by Judge Leonard P. Stark on 11/3/16. (ntl)

IN THE UNITED STATES DISTRICT,COURT
. FOR THE DISTRICT OF DELAWARE
RECKITT BENCKISER LLC,
Plaintiff,
C.A. No. 14-1203-LPS

v.

AUROBINDOPHARMA LIMITED and
AUROBINDO PHARMA USA, INC.,
Defendants.

James M. Lennon andPilarG. Kraman, YOUNG CONAWAY STARGATT &TAYLOR, LLP,
Wilmington, DE .
John T. Gutkoski, Douglas J. Nash, M. Eric Galvez, Bella S. Satra, and-F. Paul Vellano, III,
BARCLAY DAMON, LLP, Boston, MA
Attorneys for Plaintiff

Mary B. Matterer and Richard K. Herrmann, MORRIS JAMES, LLP, Wilmington, DE .
Timothy H. Krafa, George J. Barry III, Meghan M. :Rachford, and Michael F. Nullet,
MCGUIREWOODS LLP,Atlanta, GA
Attorneys for Defendants

·MEMORANDUM OPINION

November3, 2016
Wilmington, Delaware

On September 17, 2014, Plaintiff Reckitt Benckiser LLC ("Reckitt" or "Plaintiff') filed
suit against Defendants Aurobindo Pharma Limited and Aurobindo Pharma USA, Ille.
("Aurobindo'' or "Defendants") alleging infringement of U.S. Patent Nos. 6,372,252 (the "'252
patent"), 6,955,821 (the "'821 patent"), and 7;838,032 (the· "'032 patent"). 1 The patents are
directed- to controlled-release formulations of the drug guaifenesin.
The parties submitted claim construction briefs (D.I. 50, 51, 59, 61) and Aurobindo
submitted a technology tutorial (D.I. 49). The Court held a claim construction hearing on August
. 8, 2016. (See D.I. 102 ("Tr."))

I.

LEGAL STANDARDS
The ultimate question of the proper construction of a patent is a question oflaw. See Teva

Phann. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 837 (2015) (citing Markman v. Westview
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Instruments, Inc., 517 U.S~ 370, 388-91 (1996)). "It is a bedrock principle of patent law that the
claims ofa patent define the invention to which the patentee is entitled the right to exclude."

Phillips v. AWHCorp., 415 F.3d 1303, 1312 (Fed. Cir.2005) (internal quotation marks omitted).
"[T]here is no magic formula or catechism for conducting claim construction." Id. at 1324.
Instead, the court is free to attach the appropriate weight to appropriate sources "in light of the
statutes and policies that inform patent law."· Id. ·
"[T]he words of a claim are generaHy given their ordinary and customary meaning ...
[which is] -the meaning that the term would have to a person of ordinary skill in the art in

After the claim construction hearing, Reckitt dropped its claims related t~ the '252
patent. (See D.l. 111).
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question at the time of the invention, i.e., as of the effective filing date of the patent application."

Id. at 1312-13 (internal citations and quotation marks omitted). "[T]he ordinary meaning of a
claim term is its meaning to the ordinary artisan after reading the entire patent." Id. at 13 21
(internal quotation marks omitted). The patent specification "is always highly relevant to the
claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of
a disputed term." Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996).
While "the claims themselves provide substantial guidance as to the meaning of particular
claim terms," the context of the surrounding words of the claim also must be considered.

Phillips, 415 F.3d at 1314. Furthermore, "[o]ther claims of the patent in question, both asserted
and mi.asserted, can also be valuable sources of enlightenment ... [b] ecause claim terms are
normally used consistently throughout the patent .... " Id. (internal citation omitted).
It is likewise true that"[ d]ifferences among claims can also be a useful guide .... For
- example, the presence of a dependent claim that adds a particular limitation gives rise to, a
presumption that the limitation in question is not present in the independent claim." Id. at 131415 (internal citation omitted). This "presumption is especially strong when the limitation in
dispute is the only meaningful difference between an independent and dependent claim, and one
party is urging that the limitation in the dependent claim should be read into the independent
claim." SunRace Roots Enter. Co., Ltd. v. SRAM Corp., 336 F.3d 1298, 1303 (Fed. Cir. 2003).
It is also possible that "the specification may reveal a special definition given to a claim
term by the patentee that differs from the meaning it would otherwise possess. In such cases, the
inventor's lexicography governs." Phillips, 415 F.3d at 1316. It bears emphasis that "[e]ven
when the specification describes only a single embodiment, the claims of the patent will not be

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read restrictively unless the patentee has demonstrated a clear intention to limit the claim scope
using words or expressions of manifest exclusion or restriction." Hill-Rom Servs., Inc.· v. Stryker
Corp., 755 F.3d 1367, 1372 (Fed. Cir. 2014) (quotingLiebel-Flarsheim Co. v. Medrad, Inc., 358

F.3d 898, 906 (Fed. Cir. 2004)) (internal quotation marks omitted).
In addition to the specification, a court "should also consider the patent's prosecution

history, if it is in evidence." Markman v. Westview Instruments, Inc., 52 F.3d 967, 980 (Fed. Cir.
1995), ajf'd, 517 U.S. 370 (1996). The prosecution history, which is "intrinsic evidence,~'
"consists of the complete record of the proceedings before the PTO [Patent andTrademark
Office] and includes the prior art cited during the examination of the patent." Phillips, 415 F.3d
at 1317. "[T]he prosecution history can often inform the meaning of the claim language by
demonstrating how the inventor understood the invention and whether the inventor limited the
invention in the course of prosecution, making the claim scope narrower than it would otherwise
be." Id.
In some cases, "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." Teva, 135 S. Ct. at
841. Extrinsic evidence "consists of all evidence external to the patent artd prosecution history,
including expert and inventor testimony, dictionaries, and learned treatises." Markman, 52 F.3d
at 980. For instance, technical dictionaries can assist the court in determining the meaning of a
term to those of skill in the relevant art because such dictionaries ''endeavor to collect the
accepted meanings of terms used in various fields of science and technology." Phillips, 415 F.3d
at 1318. In addition, expert testimony can be useful "to ensure that the court's understanding of
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the technical aspects of the patent is consistent with that of a person of skill in the art, or to
establish that a particular term in the patent or the prior art _has a particular meaning in the
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pertinent field." Id. Nonetheless, cotirts must not lose sight of the fact that "expert reports and
testimony [are] generated at the time of and for the purpose of litigation and thus can suffer from
bias that is not present in intrinsic evidence." Id. Overall, while extrinsic evidence "may be
useful" to the court, it is "less reliable" than intrinsic evidence, and its consideration "is unlikely
to result in a reliable interpretation of patent claim scope unless considered in the context of the
intrinsic evidence." Id. at 1318-19. Where the intrinsic record unambiguously describes the
scope of the patented invention, reliance on any extrinsic evidence is improper.. See Pitney

Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1308 (Fed. Cir. 1999) (citing Vitronics, 90
F.3d at 1583) ..
Finally, "[t]he construction that stays true to the claim language and most naturally aligns
with the patent's description of the invention will be, in the end, the correct construction."

Renishaw PLC v. Marposs Societa 'per Azioni, 158F.3d1243, 1250 (Fed. Cir. 1998). It follows
that "a claim interpretation that would exclude the inventor's device is rarely the correct
interpretation." Osram GmbH v. Int'l Trade Comm 'n, 505 F.3d 1351, 1358 (Fed. ·cir. 2007)
(quoting Modine Mfg. Co. v. U.S. Int'l Trade Comm 'n, 75 F.3d 1545, 1550 (Fed. Cir. 1996)).

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II.

CONSTRUCTION OF DISPUTED TERMS
A.

"portion"2

Plaintiff
"a part of a Whole, either separated or integrated with it"
Defendants
"a discrete part of the product"

Court
"a distinct formulation"
The Federal Circuit previously construed "portion" in the context of the (now nonasserted) '252 patent. See Reckitt Benckiser Inc. v. Watson Laboratories, Inc., 430 Fed. App'x
87l(Fed. Cir. 2011). The '252 patent issued from U.S. Application Serial No. 09/559,542 ("the
'542 application"). Defendants urge the.Court to adopt the same construction of "portion".in the
context of the '032 patent-in-suit, because the '032 patent issued from an application that is a
continuation-in-part of the '542 application.
"It is settled that prosecution disclaimer attaches to progeny continuation in part

applications where the same claim limitation is at issue." Omega Eng'g, Inc, v. Raytek Corp.,
334 F.3d 1314, 1335 (Fed. Cir. 2003). When evaluating whether two claim limitations are the
same, the "appropriate focus is on the scope of the claim element, not the meaning of particular
words in isolation." Regents of Univ. ofMinnesota v. AGA Med. Corp., 717 F.3d 929, 943 (Fed .
. Cir. 2013).
Defendants argue that the portion limitations of the claims of the '252 patent that were
construed by the Federal Circuit are the same as the portion limitations of the asserted claims of

2

This term appears in claim 1 of the '032 patent.
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the '032 patent because both appear in the context of a claim to a product "having two portions":
an "immediate release form" ("IR") and a "sustained release form" ("SR"). Moreover, the claims
in both patents have similar structure. After setting out the. "two-portion" limitation, both
patents' claims describe the concentrations of guaifenesin the claimed product must deliver to the
body.
· The nearly-identical language and structure of the "portion"-containing limitations in the
'252 and '032 patents suggest that the "portion" limitation should be construed the same in both
patents. That is, as the Federal Circuit explained in its discussion of the term, the two-portion
limitation distinguishes the claimed products, which contain distinct IR and SR formulations,
. from products that contain a single formulation. 3 See Watson, 430 Fed. App'x at 876. While not
limiting the claims to embodiments in which the sustained and immediate release portions of the
drug have a particular spatial relationship, the Federal Circuit's construction does require that the.
sustained and immediate release "portions" of the product comprise two distinct formulations. 4
This distinction is consistent with the description of the invention of the '032 patent as set forth
in its specification. See '032 pat. col. 3:66-4:6 (explaining that invention may relate to

3

In Watson, the issue was whether during prosecution the patentees had "disavowed claim
coverage' of sustained release tablets," even if those tablets "release some guaifenesin
immediately upon ingestion." Watson, 430 Fed. App'x at 876.
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The Federal Circuit affirmed the lower court's "discrete part" construction on the basis
that it "excludes single-formulatibn SR tablets." Watson, 430 Fed. App'x at 877. The Court also
noted that the ''discrete part" construction "accurately encompass[ ed] the three embodiments of
two-portion tablets and capsules disclosed in the specification" of the '252 patent, but did not
suggest that the construction was meant to limit the claims to those embodiments or others like
them. Id.; see also '252 pat. col. 3:57-60, 9:46-56 (describing three disclosed embodiments:
bilayer tablets having an IR portion on one face and an SR portion on the other; bilayer tablets
having an SR portion in the center that is coated and surrounded by an IR portion; and
guaifenesin capsules containing beads of the IR formulation and beads of the SR formulation). ·
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preparations "in the form of capsules having beads or granules of both immediate release
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formulation and beads or granules of sustained tel ease formulation ... [in which] beads may
, comprise a mixture of discrete beads each having only one of the SR or IR formulations or may
comprise be_ads containing both SR aJ?-d IR formulations associated in a single bead,

or

combinations of the forgoing"). Thus, the Court will construe "portion" as a "distinct
formulation. " 5

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·"modified release drug product" 6

Plaintiff
"a dosage form comprising a sustained release quantity and an immediate release quantity,
and having both immediate release and sustained release properties"
Defendants
"a dosage form comprising a sustained_ release portion and an immediate release portion, and
having both immediate release and sustained release properties''

Court
"a dosage form comprising a sustained release quantity and an immediate release quantity, and
having both immediate release and sustained release properties"
Each of the disputed cla.im terms is directed to a "modified release drug product"

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The Federal Circuit construed "portion" as "a discrete part of the product." Watson, 430
Fed. App'x at 876. :r1aintiff in this case argues that adopting the Federal Circuit's claim
construction of "portion" in the context of the '032 patent would violate the doctrine of claim
differentiation because it would render claim 1 identical to claim 3, which is directed to "[t]he
drug product according to claim 1, wherein the first and second portions are discrete." See
Phillips, 415 F .3d at 1315 ("[T]he presence of a dependent claim that adds a particular limitation
gives ·rise to a presumption that the limitation in question is not present in the independent
claim."). ·The parties have not asked the court to construe the term "discrete" in the context of·
claim 3 of the '032 patent, so the Court does not reach the ·issue of whether the meaning of
"discrete" in that claim is .the same as the meaning of the term "discrete" in the context of the
Federal Circuit's construction of the "portion" term of the '252 patent. In order to avoid
confusion, however, the Court has (non-substantively) modified the Federal Circuit's
construction of "portion" by substituting "distinct formulation" for "discrete part of the product."
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This term appears in claims l, 2, 6-12, 17, 29-30, and-41-42 of the '821 patent.
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including at least "a first quantity of guaifenesin in an immediate release formulation ... [and] a
second quantity of guaifenesin" in either a "sustained release form" or a "release-delaying
matrix." See '821 pat. col. 30:11-16, 32:23-27. The parties agree that the term "quantity" means
"amount." (D.I. 50 at 8; D.I. 51 at 16) Defendants argue that this claim term also imposes
"important structural limits on the claimed invention." (D .I. 51 at 16) Specifically, Defendants
ask the Court to construe "quantity" as "portion," where "portion" refers to a quantity of
guaifenesin located in a "physically separate, discrete formulation[]." (See id.)
Defendants' argument that the claims are limited to embodiments having physically
separate IR and SR formulations is predicated on the patentee's tacit acknowledgment that the
claimed products have two "portions," just like the claimed formulations of the '252 patent.
(D.I. 51 at 16-18; D.I. 59 at 5-10) During proseyution, the examiner issued an obviousness-t)rpe
double patenting rejection based on the '252 patent, because both the pending claims and those
of the '252 patent "claim modified release tablets having two portions containing guaifenesin in
both portions." (See D.I. 59 at 6)- The patentee did not directly dispute this characterization,
acknowledging that both sets of claims "are directed to guaifenesin in immediate release and
sustained release formulation." (Id.) Defendants argue that the patentees thereby accepted of the
examiner's characterization of their invention as having two "portions," and that this acceptance,
along with the patentee's subsequent use of the term "portions" to describe its product, indicates
that the patentee intended to impose the "portion" limitation from the '252 patent upon the
claims of the '821 patent. Plaintiff responds that the patentee could not have intended to impose
such a limitation, because the patentee ultimately amended the claims to exclude the word
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"portion" and distinguished the claims from the prior art by adding a requirement that the

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claimed products include "at least one additional drug" besides guaifenesin. (D.I. 50 at 8)
The plain language of the disputed claims imposes a requirement that the modified release
drug product includes two, distinct formulations: an IR formulation and an SR formulation (or
release-delaying matrix). Because these formulations are_distinct, they are, inherently, physically
"separate" to some extent. This is identical to the requirement imposed by the "portion"
limitation as construed by the Federal Circuit. (See supra Section A} Thus, it is not completely
clear what additional limitation Defendants would impose by substituting the word "quantity" for
"portion."
To the extent the parties' dispute centers on whether the IR and SR formulations must be
"physically separate," as in, for example, a bi-layered tablet (see D.I. 61 at 8-10), the Court finds
thatthe claims do not impose limitations regarding the spatial orientation of the two. The Court
recognizes that the two different formulations of guaifenesih in the claimed products are·
inherently physically "separate" because they are distinct formulations. However, the intrinsic
record does not support additional structural or spatial limitations being imposed by the word
"portion." Given this lack of evidence, the Court adopts Plaintiffs proposed construction.

C.

"release-delaying matrix" 7

Plaintiff
"pharmaceutical preparation that incorporates the active pharmaceutical ingredient· dispersed ·
within a dosage form and releases the active pharmaceutical ingredient in a controlled fashion"
Defendants
"a combination of hydrophilic and water insoluble polymers ofthe sustained.release
formulation which gels when exposed to a media of low pH"

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This term appears in claim 1 of the '821 ·patent.
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Court
"a combination of hydrophilic and water insoluble polymers of the sustained release
formulation which gels in the stomach"

The parties agree that the claimed "release-delaying matrix" comprises a combination of
hydrophilic and water insoluble polymers. They disagree, however, about whether those
polymers must "gel when exposed to a media of low pH." Defendants contend ~hat the patentee
added this limitation by being its own lexicographer. (D.I. 59 at 20)
The specifications of both patents unambiguously state that the polymers of the claimed
inventions gel when placed in "aqueous acidic· media." See, e.g. '252 pat. col. 3:34-31, 5:656:23; '821 pat. col. 7:18-39. This tendency to gel is described as an inherent property of the
claimed polymers: diffusion of guaifenesin from the gelled polymers is the mechanism by which
the claimed invention achieves a sustained release. For this reason, the claims are limited to
combinations of polymers that gel at low pH. However, the specification does not

spec~fy the

meaning of"low pH' or "acidic," but instead only defines the pH level at which the polymers gel
by reference to the pH of the stomach. See, e.g., '252 pat. col. 3:34-37; '821 pat. col. 3:47-51
("When a tablet comprising the sustained release formulation is exposed to an aqueous medium
of low pH, such as that found in the stomach, the polymer combination gels causing _guaifenesin
and the drug ingredient to diffuse from the gel."). Hence, the Court will construe the term to
specify that the formulation gels "in the stomach."

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n.

·"immediate release formulation wherein the guaifenesin becomes
bioavailable in .a subject's stomach" 8

.Plaintiff
"a form intended to rapidly release in the stomach guaifenesin for absorption"
Defendants
"a form intended to rapidly release in the stomach substantially all of the guaifenesin for
absorption"
Court
"a form intended to rapidly release in the stomach guaifenesili for absorption"
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The parties disagree about whether this term requires that "substantially all" of the
guaifenesin in the immediate release formulation must become bioavailable in a subject's
stomach. Defendants find such a requirement in the disputed term. Plaintiff counters that this
cannot be correct because other claims in the patent refer to immediate release formulations in
which the guaifenesin becomes "fully bioavailable" in the stomach. (D.I. 50 at 18-19) Indeed, in
prior litigation over the '252 patent, the Federal Circuit construed the term "an immediate release
formulation which becomes fully

bioav~ilable

in a subject's stomach" as a formulation in which

"substantially all". of the formulation becomes bioavailable in the stomach. See Adams
.Respiratory Therapeutics, Inc. v. Perrigo Co., 616 F.3d 1283, 1290 (Fed. Cir. 2010).

Defendants argue that the specification limits the claims to embodiments that have an
immediate release formulation in which "substantially all" of the guaifenesin quickly becomes
bioavailable in the stomach, because the claims require the guaifenesin to reach a concentration
profile identical to that of a standard immediate release formulation. (D.f 59 at 22-23)
Defendants have not, however, pointed to intrinsic or extrinsic evidence to substantiate this

8

This term appears in claims 1 and 29 of the '821 patent.
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contention. Defendants also note that the parties have stipulated that the rel~vant portion of the
concentration profile outlined in the '821 patent is identical to the concentration profile created.
by embodiments of claims in the '252 patent, which refer to guaifenesin becoming "fully
bioavailable." However, Defendants have not explained why this necessarily means that the
embodiments of the '821 patent must achieve that profile by making "substantially all" of their
guaifenesin available in the stomach (as opposed to, for example, having a larger amount of
guaifenesin in the immediateTelease formulation, and releasing only some of it).

III.

CONCLUSION
The Court construes the disputed terms as explained above. An appropriate Order

follows.

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