ELI LILLY AND COMPANY v. TEVA PARENTERAL MEDICINES, INC. et al
Filing
115
ENTRY ON CLAIM CONSTRUCTION. Signed by Judge Tanya Walton Pratt on 6/20/2012. (JD)
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UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF INDIANA
INDIANAPOLIS DIVISION
ELI LILLY AND COMPANY,
Plaintiff,
v.
TEVA PARENTERAL MEDICINES, INC.,
APP PHARMACEUTICALS, LLC,
PLIVA HRVATSKA D.O.O., TEVA
PHARMACEUTICALS USA, INC. and
BARR LABORATORIES, INC.,
Defendants.
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Case No. 1:10-cv-1376-TWP-DKL
ENTRY ON CLAIM CONSTRUCTION
This patent infringement case is before the Court for construction of patent terms relevant
to methods of administering the compound pemetrexed disodium (“pemetrexed”), the active
pharmaceutical ingredient in the drug ALIMTA®. The Plaintiff in this matter is Eli Lilly and
Company (“Lilly”) and the Defendants are Teva Parenteral Medicines, Inc., App
Pharmaceuticals, LLC, Pliva Hrvatska, D.O.O., Teva Pharmaceuticals USA, Inc., and Barr
Laboratories, Inc. (collectively, “Defendants”). On April 24, 2012, the Court conducted a
Markman hearing at which time the parties presented oral arguments as to the proper
construction of two disputed terms of the patent at issue, U.S. Patent No. 7,772,209 (the “‘209
patent”). The parties submitted thorough and well-crafted briefs and helpful presentations at the
Markman hearing. Jurisdiction is proper under 28 U.S.C. §§ 1331, 1338, 2201 and 2202.
I. FACTUAL BACKGROUND
Lilly and Defendants are companies involved in the formulation and manufacture of
pharmaceuticals. The patent at issue in this infringement suit, the ‘209 patent, relates to Lilly’s
anti-cancer agent ALIMTA®, which is used to treat mesothelioma – the cancer caused by
asbestos exposure – and other forms of lung cancer. Lilly contends that the Abbreviated New
Drug Applications (“ANDAs”) filed by the Defendants with the Food and Drug Administration
(“FDA”) for the manufacture and sale of generic versions of ALIMTA® before the ‘209 patent
expires, infringes upon the ‘209 patent. As a result, Lilly filed this action against Defendants on
October 29, 2010.
ALIMTA’s® active ingredient, pemetrexed, is an antifolate that is known to disrupt the
folic acid pathway which can contribute to the reduction of cancer cells. The ‘209 patent relates
to a method of administering pemetrexed, along with folic acid and vitamin B12, a
methylmalonic acid lowering agent, in order to reduce the toxicities associated with the
administration of pemetrexed. This discovery made by Lilly results in a significant reduction of
certain toxic effects caused by the administration of antifolates, such as pemetrexed, through the
presence of a methylmalonic acid lowering agent without adversely affecting therapeutic
efficacy. Dkt. 1-1, col. 2, ll. 32-37. As a result of ALIMTA® therapy, mesothelioma patients
often live longer and the severity of the disease has been lessened so that patients are able to
have a more normal life.
Originally, Defendants had five claims that they proposed were in dispute, however, the
parties now agree upon the construction of three of those terms. Only two terms remain in
dispute as they relate to the ‘209 patent: 1) the first concerns the proper construction of the term
“patient” and 2) the second concerns the proper construction of the term “vitamin B12.”
Additional facts are added below as needed.
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II. LEGAL STANDARD
Prevailing in a patent infringement suit requires “a finding that the patent claim ‘covers
the alleged infringer’s product or process,’ which in turn necessitates a determination of ‘what
the words in the claim mean.’” Markman v. Westview Instruments, Inc., 517 U.S. 370, 374
(1996) (citation omitted); Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1581-82 (Fed.
Cir. 1996) (“A literal patent infringement analysis involves two steps: the proper construction of
the asserted claim, and a determination as to whether the accused method or product infringes the
asserted claim as properly construed.”). The construction of patent claims, which requires
determining the meaning and scope of the claims, is a matter of law for the court. Markman v.
Westview Instruments, Inc., 52 F.3d 967, 970-71 (Fed. Cir. 1995), aff’d 517 U.S. 370, 116 S.Ct.
1384, 134 L.Ed. 2d 577 (1996). The Federal Circuit has emphasized that “[i]t 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.” Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en
banc) (citations and quotations omitted); see also Vitronics, 90 F.3d at 1582 (“we look to the
words of the claims themselves…to define the scope of the patented invention”).
The words in patent claims are “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 question at the
time of the invention.” Phillips, 415 F.3d at 1313; see Home Diagnostics, Inc. v. LifeScan, Inc.,
381 F.3d 1352, 1358 (Fed. Cir. 2004) (“customary meaning” refers to the “customary meaning in
[the] art field”). “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,” in which case claim
construction “involves little more than the application of the widely accepted meaning of the
commonly understood words.” Phillips, 415 F.3d at 1314; see also Renishaw PLC v. Marposs
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Societa’ per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998) (articulating that when there are
several common meanings for a certain term, “the patent disclosure serves to point away from
the improper meanings and toward the proper meaning”). However, there are two exceptions to
the general rule of applying the ordinary meaning to claim terms: 1) when a patentee sets out a
definition and acts as his own lexicographer, or 2) when the patentee disavows the full scope of a
claim term either in the specification or during prosecution. Thorner v. Sony Computer Entm’t
Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012).
To become one’s own lexicographer, a patentee must set forth a definition of the disputed
claim term other than the term’s ordinary and plain meaning. Id. Moreover, “it is not enough for
a patentee to simply disclose a single embodiment or use a word in the same manner in all
embodiments, the patentee must ‘clearly express an intent’ to redefine the term.” See id.; C.R.
Bard, Inc. v. U.S. Surgical Corp., 388 F.3d 858, 862 (Fed. Cir. 2004) (“[T]he inventor’s written
description of the invention, for example is relevant and controlling insofar as it provides clear
lexicography....”) (emphasis added). Additionally, “[t]he patentee may demonstrate an intent to
deviate from the ordinary and accustomed meaning of a claim term by including in the
specification expression of manifest exclusion or restriction, representing a clear disavowal of
claim scope.” Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1325 (Fed. Cir. 2002).
In the absence of an express intent to impart a new meaning to a claim term, the court,
when interpreting claim terms, first reviews the intrinsic evidence, which includes the claims
themselves, the specification, and the prosecution history. See Interactive Gift Express, Inc. v.
Compuserve, Inc., 256 F.3d 1323, 1331 (Fed. Cir. 2001) (“The words used in the claims are
interpreted in light of the intrinsic evidence of record, including the written description, the
drawings, and the prosecution history, if in evidence.”). With respect to the specification, it
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serves an important purpose by providing for a written description of the invention that would
allow a person of ordinary skill in the art to make and use the patented invention.1 See Phillips,
415 F.3d at 1317. Moreover, in reviewing the specification or prosecution history, if these
intrinsic sources define a claim term, that definition shall apply even if it differs from the term’s
ordinary meaning. CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366-67 (Fed. Cir.
2002). However, although claims must be read in light of the specification, the court should not
limit a claim by restricting its scope based on a preferred embodiment within the specification.
Phillips, 415 F.3d at 1323.
Along with the specification, the Court may also review the prosecution history, as part
of the intrinsic record, in determining whether a patentee intended to define a particular term
differently from its ordinary and customary meaning. Teleflex, 299 F.3d at 1326. Further, the
prosecution history can act to “limit[] the interpretation of claims so as to exclude any
interpretation that may have been disclaimed or disavowed during prosecution in order to obtain
claim allowance.” Id. (citing Standard Oil Co. v. Am. Cyanamid Co., 774 F.2d 448, 452 (Fed.
Cir. 1985)).
In addition to relying on intrinsic evidence in ascertaining the scope of an invention’s
claim, the Court also can rely upon extrinsic evidence, which includes evidence outside of the
patent and prosecution history, such as expert testimony, dictionaries, and learned treatises.
Phillips, 415 F.3d at 1317. However, “[C]ourts may rely on dictionary definitions when
construing claim terms, ‘so long as the dictionary definition does not contradict any definition
found in or ascertained by a reading of the patent documents.” (internal citation omitted); see
also Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1308 (Fed. Cir. 1999).
1
Pursuant to 35 U.S.C. § 112, “the 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…to make and use the same….” 35 U.S.C. § 112 ¶ 1.
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Lastly, indefiniteness, like claim construction, “is a legal question.” Young v. Lumenis,
Inc., 492 F.3d 1336, 1344 (Fed. Cir. 2007). To satisfy the definiteness requirement of 35 U.S.C.
§ 1122, “the boundaries of the claim, as construed by the court, must be discernible to a skilled
artisan based on the language of the claim, the specification, and the prosecution history, as well
as her knowledge of the relevant field of art.” Power-One, Inc. v. Artesyn Techs., Inc., 599 F.3d
1343, 1350 (Fed. Cir. 2010) (citation omitted). A claim is indefinite if it is “not amenable to
construction or [is] insolubly ambiguous.” Datamize LLC v. Plumtree Software, Inc., 417 F.3d
1342, 1347 (Fed. Cir. 2005).
III. DISCUSSION
For the purposes of this discussion, the Court will briefly trace the background of the
‘209 patent, resolve the disagreement regarding the person of ordinary skill in the art and then
construe the disputed claim terms at issue.
A.
The ‘209 Patent
The ‘209 patent is directed at administering pemetrexed in combination with folic acid
and a methylmalonic acid lowering agent to reduce the toxicity levels associated with
administration of pemetrexed.
Specifically, the antifolate, pemetrexed, prevents other
compounds, known as reduced folates, from binding to particular enzymes that are essential in
the growth of potentially cancerous tumors. However, certain toxicities are associated with the
administration of pemetrexed disodium. The ‘209 patent discloses a method of administering
pemetrexed in conjunction with certain amounts of folic acid and a methylmalonic acid lowering
agent, such as vitamin B12, to reduce the toxicity levels without affecting the efficacy of the
antifolate.
2
35 U.S.C. § 112 ¶ 2 sets forth the definite requirement, which provides that specification of a patent must
“conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the
applicant regards as his invention.” 35 U.S.C. § 112 ¶ 2.
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B.
Person of Ordinary Skill in the Art
Claim terms are construed from the perspective of the person of ordinary skill in the art to
whom the patent is addressed. Phillips, 415 F.3d at 1313 (“The descriptions in patents are not
addressed to the public generally, to lawyers or to judges, but, as section 112 [of title 35] says, to
those skilled in the art to which the invention pertains or with which it is most nearly
connected.”). Although the determination of whom the person in the ordinary skill in the art is
not dispositive of the claims construction in this case, the resolution of this issue is helpful to the
Court.
Lilly suggests that “the person of ordinary skill in the art for the’209 patent would have
the skills of a medical oncologist, with the knowledge and experience regarding the use of
antifolates in the treatment of cancer, as well as knowledge and experience regarding the use of
antifolates in the treatment of cancer, as well as knowledge and experience regarding the
management of toxicities….” Pl. Claim Const. Br., Dkt. 94 at 9. Defendants argue that a person
of ordinary skill in the art “would have a medical degree and additional qualifications or
experience in the field of nutritional sciences and/or oncology, as well as practical experience in
a clinical setting and/or academia.” Def. Resp. Br., Dkt. 97 at 6. In addition, Defendants
contend that the person of ordinary skill in the art would collaborate with other medical
professionals in certain fields, including oncology. Id. The parties agreed at the Markman
hearing that the person of ordinary skill in the art would be a medical doctor, Dkt. 114, Tr. at p.
25, ll. 16-19, but disagreed on whether the person of ordinary skill in the art can be only a
medical oncologist or whether he or she could be a medical doctor with expertise in nutritional
sciences.3
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Both parties reiterated during oral arguments that the issue of determining who is the person of ordinary skill in the
art as it applies to the ‘209 patent is not dispositive with respect to the Court’s resolution of the parties’ proposed
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In the Court’s view, neither party’s proposal is incorrect. Based on the ‘209 patent and
the representations of the parties and their experts, the Court finds that the person of ordinary
skill in the art, for purposes of this claim construction order, can be a medical doctor who
specializes in oncology or a medical doctor with extensive experience in the areas of nutritional
sciences involving vitamin deficiencies. However, as to the latter person, this individual would
need to have collaborated with medical oncologists who have knowledge and experience in the
treatment of cancer through the use of antifolates.
C.
The Disputed Terms
The parties dispute two terms in the ‘209 patent for the purposes of claim construction.
Each disputed term is addressed in turn.
Claim 1:
A method of administering pemetrexed disodium to a patient in need thereof
comprising administering an effective amount of folic acid and an effective
amount of folic acid and an effective amount of a methylmalonic acid
lowering agent followed by administering an effective amount of pemetrexed
disodium, wherein
the methylmalonic acid lowering agent is selected from the group
consisting of vitamin B12, hydroxocobalamin, cyano-10chlorocobalamin,
aquocobalamin
perchlorate,
aquo-10chlorocobalamin
perchlorate,
azidocobalamin,
cobalamin,
cyanocobalamin, or chlorocobalamin.4
constructions of the disputed claim terms. See Tr. at p.25, ll. 10-15. However, for purposes of this claim
construction order the Court finds it necessary to resolve the dispute. See Candela Corp. v. Palomar Medical Techs.
Inc., 2008 WL 3285255, at *2-*3 (E.D. Tex. Aug. 6, 2008) (resolving the parties’ dispute concerning who is the
person of ordinary skill in the art before construing the disputed claim terms); Black & Decker Inc. v. Robert Bosch
Tool Corp., 389 F. Supp.2d 1010, 1017 (N.D. Ill.) aff’d in part, vacated in part for other reasons, 260 Fed. Appx.
284 (Fed. Cir. 2008) (citing Phillips, 415 F.3d at 1313) (“The Court must construe the claims from the vantage point
of a person of ordinary skill in art…therefore, [the Court] must determine the level of ordinary skill in the art for
purposes of this [claim construction] motion.”).
4
The term “hydroxycobalamin” in claim 1 has been corrected to read “hydroxocobalamin.” Additionally, there is a
typographical error in claim 1: “aquo-10-cobalamin perchlorate” should read “aquo-10-chlorocobalamin
perchlorate.” Dkt. 95-2 at 21, ¶7 n.4; Dkt. 99-1at 21, ¶54 n.6.
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Claim 12:
An improved method for administering pemetrexed disodium to a patient in
need of chemotherapeutic treatment, wherein the improvement comprises:
a) administration of between about 350 µg and about 1000 µg of folic
acid prior to the first administration of pemetrexed disodium;
b) administration of about 500 µg to about 1500 µg of vitamin B12,
prior to the first administration of pemetrexed disodium; and
c) administration of pemetrexed disodium.
1.
Term 1: “patient”
Claim Term/Phrase
Plaintiff’s Proposed
Construction
Defendants’ Proposed
Construction
“patient”
“human undergoing medical
treatment”
“mammal”
The parties dispute the meaning of the term “patient” as it is referred to in the claims of
the ‘209 patent. Lilly argues that “patient” should have its ordinary and customary meaning,
which is: a human undergoing medical treatment.
Pl. Claim Const. Br., Dkt. 94 at 27.
Defendants counter that the intrinsic record establishes that the term “patient” means mammal
for two reasons: 1) Lilly implicitly redefined the term “patient” in the specification when it used
it interchangeably with mammal, and 2) the proposed construction of “patient” is supported by
the ‘209 patent’s prosecution history. After reviewing the ‘209 patent, the Court agrees with
Lilly’s construction that the ordinary and customary meaning of “patient” should apply over the
construction proposed by Defendants.
There is a presumption that the claim terms chosen by the patentee “mean what they say
and have the ordinary meaning that would be attributed to those words by persons skilled in the
relevant art.” ACTV, Inc. v. Walt Disney Co., 346 F.3d 1082, 1088 (Fed. Cir. 2003). However,
determining the ordinary and customary meaning of a claim term, in certain fields of art, requires
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a further examination of “those sources available to the public that show what a person of skill in
the art would have understood the disputed claim language to mean.” Phillips, 415 F.3d at 1314
(quoting Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1116 (Fed.
Cir. 2004)). These sources include the claims themselves, the specification, the prosecution
history and extrinsic evidence. Id.
a.
The ‘209 Patent Claims
The Federal Circuit has articulated that the courts should also consider the context of the
surrounding words of the claims in an effort to determine the ordinary and customary meaning of
a disputed term. ACTV, 346 F.3d at 1088. In addition, claim terms are usually understood to
carry their ordinary and customary meaning. Phillips, 415 F.3d at 1312 (citing Vitronics, 90
F.3d at 1582). In this case, the claims of the ‘209 patent describe that a “patient” is to be
administered effective amounts of methylmalonic acid lowering agent, folic acid, and
pemetrexed disodium. Lilly contends that “patient” should be construed to have its ordinary and
customary meaning – a human being undergoing medical treatment – however, the Court must
review the specification to determine if Lilly has used the term “patient” in a manner that is
inconsistent with its ordinary meaning. Vitronics, 90 F.3d at 1582.
b.
The ‘209 Patent Specification
In their briefing and oral argument, the parties agreed that the words “patient” and
mammal are used in the specification. Defendants argue that the plain and ordinary meaning of
the term “patient” cannot be adopted when it was implicitly redefined in the specification
because the patentee used the word mammal and “patient” interchangeably in the ‘209 patents
specification, therefore they must have the same meaning. And, Defendants argue that this
interchange shows that “patient” was redefined to mean mammal. Pursuant to Phillips, the Court
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will give “patient” it’s ordinary and customary meaning unless Lilly has redefined the term by
acting as its own lexicographer or disavowed the full scope of the claim term. See Thorner, 669
F.3d at 1365 (setting forth the exceptions to the general rule of applying the plain and ordinary
meaning of a claim term). Defendants argue that Lilly redefined the term “patient” by using that
term in conjunction with the word mammal in the following section of the specification:
As used herein, the term “in combination with” refers to the administration of the
methylmalonic acid lowering agent, the antifolate drug, and optionally the folic
acid; in any order such that sufficient levels of methylmalonic acid lowering agent
and optionally folic acid are present to reduce the toxicity of an antifolate in a
mammal. The administration of the compounds maybe simultaneous as a single
composition or as two separate compositions or can be administered sequentially
as separate compositions such that an effective amount of the agent first
administered is in the patient’s body when the second and/or third agent is
administered. The antifolate drug may be administered to the mammal first,
followed by treatment with the methylmalonic acid lowering agent. Alternatively,
the mammal may be administered the antifolate drug simultaneously with the
methylmalonic acid lowering agent. Preferably, the mammal is pretreated with
the methylmalonic acid lowering agent and then treated with the antifolate. If
folic acid is to be administered in addition to the methylmalonic acid lowering
agent, the folic acid may be administered at any time prior, post, or
simultaneously to the administration of either the methylmalonic acid lowering
agent or the antifolate. Preferably, the mammal is pretreated with the
methylmalonic acid, and then treated with folic acid, followed by treatment with
the antifolate compound.
Dkt. 1-1, col. 4, 11. 4-27. Defendants also emphasized the interchangeable use of the two terms
in the following description of a preferred embodiment:
In the especially preferred embodiment of this invention, about 0.1 mg to about
30 mg, most preferably about 0.3 mg to about 5 mg, of folic acid is administered
orally to a mammal about 1 to 3 weeks post administration of the methylmalonic
acid lowering agent and about 1 to 24 hours prior to the parenteral administration
of the amount of an antifolate. However, it will be understood that the amount of
the methylmalonic acid lowering agent actually administered will be determined
by a physician, in light of the relevant circumstances, including the condition to
be treated, the chosen route of administration, the actual agent administered, the
age, weight, and response of the individual patient, and the severity of the
patient’s symptoms, and therefore the above dosage range are not intended to
limit the scope of the invention in any way.
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Id. at col. 6, ll. 35-54.
The Court is not persuaded by Defendants’ argument. Here, Defendants conceded in
their claim construction response brief that the term “patient” is not explicitly defined in the ‘209
patent specification. See Def. Resp. Br., Dkt. 97 at 26. Thus, their argument is narrowed to
whether Lilly implicitly redefined the term “patient.” In order for a term to be redefined
implicitly, “the redefinition must be so clear that it equates to an explicit one.” Thorner, 669
F.3d at 1368. Thorner further states that “a person of ordinary skill in the art would have to read
the specification and conclude that the applicant has clearly disavowed claim scope or has acted
as its own lexicographer.” Id. The Court finds that Lilly has not acted as its own lexicographer
or disavowed the full scope of the claim term “patient.” Even though the two terms appeared in
the specification, there is nothing problematic with Lilly’s use of the term “patient” in describing
that a human undergoing medical treatment will be administered the methylmalonic acid
lowering agent, folic acid, and antifolate. See id. (“Simply referring to two terms as alternatives
or disclosing embodiments that all use the term the same way is not sufficient to redefine a claim
term.”).
Moreover, Defendants proposed construction of the term “patient” is not consistent with
how the term is interpreted in light of the specification. As the Defendants conceded, the
specification did not explicitly define the term “patient.” In addition, the Federal Circuit has
emphasized that courts cannot rewrite claims, but instead should give effect to the claim terms
chosen by the patentee. K-2 Corp. v. Salomon S.A., 191 F.3d 1356, 1364 (Fed. Cir. 1999).
Additionally, the Court finds that the specification does not support the Defendants’
proposed construction of the term “patient” to encompass mammals. Specifically, a person of
ordinary skill in the art reading the specification would not associate the administration of
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pemetrexed disodium and methylmalonic acid lowering agent to mammals. The fact that the
specification sets forth the administration of methylmalonic acid lowering agents and folic acid
to mammals in pre-clinical trials does not mean that the claim term “patient” must be construed
to encompass all potential functions outlined in the specification. See Phillips, 415 F.3d at 1327
(“We have held that ‘the fact that a patent asserts that an invention achieves several objectives
does not require that each of the claims be construed as limited to structures that are capable of
achieving all of the objectives.’”) (internal citation omitted).
When the ‘209 patent specification discussed pre-clinical trials, it disclosed tests
involving mice and referred to them as animals. See Dkt. 1-1, col. 6, l. 56 – col. 8, l. 38. When
the specification discussed clinical trials, on the other hand, it used the term “patient” in
association with the treatment of cancer through the administration of an antifolate.
For
example, following the discussion of mice involved in a pre-clinical study, the specification
discussed the administration of an antifolate “[i]n a typical clinical evaluation involving cancer
patients.” Dkt. 1-1, col. 8, ll. 39-42. A person of ordinary skill in the art would understand the
term patient when discussed in the context of a clinical trial to involve a human undergoing
medical treatment and not a mammal. Accordingly, the Court finds that the specification of the
‘209 patent supports Lilly’s proposed construction of the claim term “patient.”
c.
The Prosecution History of the ‘209 Patent
In addition to consulting the specification, courts should also consult the prosecution
history, which consists of the complete record of the proceedings before the United States Patent
and Trademark Office (“PTO”).
Phillips, 415 F.3d at 1317 (“Like the specification, the
prosecution history provides evidence of how the PTO and the inventor understood the patent.”).
The ‘209 patent was issued from the U.S. Patent Application No. 11/776,329 (“the ‘329
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application”), which was filed as a division of U.S. Patent Application No. 11/288,807 (“the ‘807
application). In addition, the ‘807 application was filed as a division of U.S. Patent Application
No. 10/297,821 (“the ‘821 application”). In support of their position, Defendants cite to two
draft claims originating from the ‘807 application and the ‘329 application, respectively.
Amended claim 3 of the ‘807 application stated the following: “A method of inhibiting tumor
growth in humans comprising….” Dkt. 98-10 at 3 (emphasis added). Amended claim 29 of the
‘329 application stated the following: “an improved method for administering pemetrexed
disodium to a patient in need of chemotherapeutic treatment, wherein the improvement
comprises….” Dkt. 98-14 at 3 (emphasis added). Based on these amendments, Defendants
contend that the change from the word “human” to the word “patient” had a broadening effect so
that the amended claim included non-humans. See Def. Resp. Br., Dkt. 97 at 29.
The Court disagrees. Defendants emphasis on the prosecution history related to the
issuance of the ‘209 patent to show that the claim term “patient” was broadened is misplaced; the
claim scope was actually narrowed – not broadened – by the use of the term “patient” instead of
human. Unlike the word human, “patient” encompasses a human undergoing medical treatment,
whereas the word human, by itself, does not refer to a human receiving any additional treatment.
After all, some humans go decades without visiting the doctor. Accordingly, the prosecution
history does not support the Defendants’ proposed construction.
d.
Extrinsic Evidence
Finally, in construing the meaning of claim terms a court can turn to the extrinsic
evidence, such as dictionaries, treaties, and expert testimony in determining patent claim scope.
See Phillips, 415 F.3d at 1317-18. On their own, the claims do not provide sufficient aid in
defining the term “patient” because “patient” is not explicitly defined in the specification or in
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the prosecution history. Thus, the Court looks to the extrinsic evidence to provide context in an
effort to arrive at the ordinary and customary meaning of the term. See Phillips, 415 F.3d at
1317 (articulating that courts may refer to extrinsic evidence if they deem it useful in
determining a claim term’s true meaning).
The first source describes “patient” as “[a] person receiving or registered to receive
medical treatment; a sick person, esp. one staying in a hospital.” New Shorter Oxford English
Dictionary 2123 (1993). The second source describes “patient” as “a person who is under
medical care or treatment.” Random House Unabridged Dictionary (2d revised ed. 1993). The
third source describes “patient” as “an individual awaiting or under medical care and
treatment…” Merriam-Webster’s Collegiate Dictionary (10th ed. 1993). In addition to these
dictionary definitions, Lilly provided an expert report from Dr. Peter O’ Dwyer, a medical
oncologist who has treated numerous patients with ALIMTA®. In Dr. O’Dwyer’s expert report,
he opined that a person of ordinary skill in the art would understand the term “patient” to mean a
human undergoing medical treatment. Dkt. 95-1 at 9-10.
In short, the Court finds that the extrinsic evidence reinforces the Court’s view that
Lilly’s proposed construction is correct from the extrinsic evidence. It is clear that the word
“patient” involves a human’s receipt of medical treatment or care. Moreover, Lilly’s expert’s
opinion on the understanding of the term “patient” by a person of ordinary skill in the art does
not contradict the meaning supported by the intrinsic evidence. Importantly, Defendants have
not presented any other extrinsic evidence, in the form of expert reports, to support their
proposed construction.
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Because neither the intrinsic record nor extrinsic record supports the Defendants’
proposed construction, the Court rejects it. For these reasons, the Court adopts Lilly’s proposed
construction, as it aligns with the ordinary and customary meaning of the claim term.
2.
Term 2: “vitamin B12”
Claim Term/Phrase
“vitamin B12”
Plaintiff’s Proposed
Construction
“cyanocobalamin”
Defendants’ Proposed
Construction
“indefinite”
The parties disagree on the construction of the term vitamin B12 as it is used in the claim
language of the ‘209 patent.
Specifically, Lilly contends that there are two ordinary and
customary meanings of the claim term “vitamin B12” – one narrow and one broad depending on
the context in which it is used. Lilly argues that the Court should adopt the narrower ordinary
meaning of “vitamin B12,” which is “cyanocobalamin,” over its broader plain meaning, “vitamin
B12 and its pharmaceutical derivatives.” Defendants counter by arguing that Lilly explicitly
defined the term “vitamin B12” in the ‘209 patent’s specification. In addition, Defendants argue
that both the ‘209 patent’s explicit definition and Lilly’s proposed construction of the term
“vitamin B12” are unreasonable and unworkable; therefore, the term is indefinite. Finally,
Defendants ask the Court to rule that, because the term “vitamin B12” is indefinite, it necessarily
follows that the claims containing this term are invalid. See Def. Resp. Br., Dkt. 97 at 25. The
Court will address the parties’ claim construction arguments in turn.
A.
Construing the meaning of “vitamin B12”
Claim construction starts with the language of the claim itself. See Vitronics, 90 F.3d at
1582. In the ‘209 patent, claim 1 provides for a method of administering pemetrexed disodium
along with folic acid and a methylmalonic acid lowering agent, wherein “the methylmalonic acid
lowering agent is selected from the group consisting of vitamin B12, hydroxocobalamin, cyano-
16
10-chlorocobalamin,
aquocobalamin
perchlorate,
aquo-10-chlorocobalamin
perchlorate,
azidocobalamin, cobalamin, cyanocobalamin, or chlorocobalamin.” Dkt. 1-1, col. 10, ll. 60-65.
In addition, claim 2 provides for “[t]he method of claim 1, wherein the methylmalonic acid
lowering agent is vitamin B12.” Id. at col. 10, ll. 66-67. When analyzing claim 1, the terms
“vitamin B12” and “cyanocobalamin” are both used in the claim language.
Lilly contends that a person of ordinary skill in the art would understand “vitamin B12”
to have two plain and ordinary meanings in the context of the patent: 1) cyanocobalamin and 2)
vitamin B12 and its pharmaceutical derivatives. In support of its contention, Lilly presents
testimony from its expert, Dr. O’Dwyer, stating that when vitamin B12 is prescribed in the
medical field, the particular vitamin supplement is referred to as cyanocobalamin, whereas
vitamin B12 deficiency would commonly refer to vitamin B12 and its pharmaceutical
derivatives. See Dkt. 95-2 at 2, ¶5; Dkt. 96-5 at 81: 6-9; see also Phillips, 415 F.3d at 1318.
Lilly proposes that the Court adopt the narrower construction of the term and construe “vitamin
B12” to mean cyanocobalamin.
Because the claim language, standing alone, does not fully alleviate the ambiguity
surrounding the meaning of “vitamin B12,” the Court turns to the specification because “it is the
single best guide to the meaning of a disputed term.” Phillips, 415 F.3d at 1315 (quoting
Vitronics, 90 F.3d at 1582). The ‘209 patent specification provides in relevant part:
The term “vitamin B12” refers to vitamin B12 and its pharmaceutical derivatives,
such as hydroxocobalamin, cyano-10-chlorocobalamin, aquocobalamin
perchlorate,
aquo-10-chlorocobalamin
perchlorate,
azidocobalamin,
chlorocobalamin, and cobalamin. Preferably the term refers to vitamin B12,
cobalamin, and chlorocobalamin.
Dkt. 1-1, col. 5., ll. 5-10. From this language, Defendants assert that “vitamin B12” was
explicitly defined by Lilly, and because that definition cannot be applied to the claim term
17
consistently throughout the patent, “vitamin B12” is indefinite.
See generally, Digital
Biometrics v. Identix, Inc., 149 F.3d 1335, 1345 (Fed. Cir. 1998) (“[T]he same word appearing in
the same claim should be interpreted consistently.”). The Court disagrees.
First, the Court finds that the relevant language quoted above referring to “vitamin B12”
is not an explicit definition of the claim term in the written description. Significantly, there is
evidence to establish that Lilly does not provide an explicit definition for “vitamin B12.” See
Abbott Labs. v. Andrx Pharm., Inc., 473 F.3d 1196, 1210-11 (Fed. Cir. 2007) (holding that the
district court erred in determining a claim term was explicitly defined when there was evidence
that the patentee did not provide a definition for the disputed term in the written description). In
Abbott, the Federal Circuit concluded that a term definition within a patent’s specification that
contained words such as “means” or “as used herein” could be interpreted as redefinitions of
those terms from their ordinary and customary meanings. Id. at 1210. Like the patent at issue in
Abbott, the ‘209 patent provides for definitions of certain terms by using particular words, such
as “means” or “as used herein,” in the process of defining the term. See, e.g., Dkt. 1-1, col. 3, ll.
53-55 (“As used herein, the term ‘effective amount’ refers to…”), Dkt. 1-1, col. 3, ll. 59-60 (“As
used herein the term ‘toxicity’ refers to…”), Dkt. 1-1, col. 4, ll. 1-3 (“As used herein, the term
‘nonhematolgic event’ refers to…”), Dkt. 1-1, col. 4, ll. 4-9 (“As used herein, the term ‘in
combination with’ refers to…”), Dkt. 1-1, col. 5, ll. 51-55 (“The term ‘FBP binding agent’ as
used herein refers to…”), Dkt. 1-1, col. 6, ll. 53-54 (“The term ‘pharmaceutical’ when used as an
adjective means…”).
Notably, the ‘209 patent does not use those types of words and phrases with respect to the
term “vitamin B12”: “‘vitamin B12’ refers to….” Dkt. 1-1, col. 5., l. 5. This particular phrasing,
when viewed in the context with the other additional terms located in the ‘209 patent, does not
18
signify an intent by Lilly to redefine the term “vitamin B12” under the rationale of Abbott. See
Abbott, 473 F.3d at 1210 (concluding the phrase “‘pharmaceutically acceptable polymer is…’
[did] not…unambiguously signify that the description provided [was] definitional”). Moreover,
neither Lilly nor Defendants have proposed that the Court adopt the so-called explicit definition
of “vitamin B12” as the proper construction of the term. Therefore, the Court concludes that the
term “vitamin B12” is not explicitly defined in the ‘209 patent.
Second, Defendants reliance on the principle that a single term should be construed
consistently throughout a patent is misplaced in this case when the specification “puts the reader
on notice of the different uses of a term.” Pitney Bowes, 182 F.3d at 1311. “[W]here the
language of the written description is sufficient to put a reader on notice of the different uses of a
term, and where those uses are further apparent from publicly-available documents referenced in
the patent file, it is appropriate to depart from the normal rule of construing seemingly identical
terms in the same manner.” Id. (emphasis added). Moreover, as discussed in more detail below,
the prosecution history is consistent with the conclusion that the term “vitamin B12” can mean
cyanocobalamin in the context of the ‘209 patent. Thus by analyzing the written description, in
the context of the prosecution history, it is apparent that a person of ordinary skill in the art
would understand “vitamin B12” to mean “cyanocobalamin” when it is used.
Defendants’ argument that “vitamin B12” is indefinite because it violates the principles
of claim construction is flawed because that is not the standard of indefiniteness. A claim is
indefinite if it is “not amenable to construction or [is] insolubly ambiguous.” Datamize, 417
F.3d 1347. The Court accepts Lilly’s expert’s (Dr. O’Dwyer) representation that a person of
ordinary skill in the art would understand “vitamin B12” to mean cyanocobalamin. See Dkt. 95-2
at 4-5, ¶ 5; see also Phillips, 415 F.3d at 1318 (explaining that “extrinsic evidence in the form of
19
expert testimony can be useful to a court for a variety of purposes, such as…to ensure that the
court’s understanding of the technical aspects of the patent is consistent with that of a person of
skill in the art”) (citations omitted). Furthermore, both parties’ experts agreed that if “vitamin
B12” means cyanocobalamin it would comport with the doctrine of claim differentiation by
making claim 2 narrower in scope than claim 1. See Dkt. 95-2 at 6, ¶ 8; see also A.K. Steel Corp.
v. Sollac & Ugine, 344 F.3d 1234, 1242 (Fed. Cir. 2003). This lends further support to the
notion that Lilly’s proposed construction is “reasonable,” and if a claim term “can be given any
reasonable meaning,” the claim cannot be indefinite. Ultimax Cement Mfg. Corp. v. CTS Cement
Mfg. Corp., 587 F.3d 1339, 1352 (Fed. Cir. 2009). The Court finds that “vitamin B12” is
amenable to construction and the specification supports Lilly’s proposed claim construction of
“vitamin B12.”
Lastly, the Court will consider the prosecution history in construing the term “vitamin
B12.” See Phillips, 415 F.3d at 1317. Lilly presented a draft claim (claim 3 of the ‘807
application) to the PTO referring to administering a “methylmalonic acid lowering agent selected
from the group consisting of vitamin B12, hydroxocobalamin, cyano-10-chlorocobalamin,
aquocobalamin
perchlorate,
aquo-10-chlorocobalamin
perchlorate,
azidocobalamin,
chlorocobalamin, cobalamin, and cyanocobalamin….” Dkt. 96-17 at 10. During the prosecution
of the ‘807 application, the examiner rejected claim 3 of the ‘807 application which listed
“vitamin B12” and “cyanocobalamin” separately within the same claim because the examiner
stated the two agents were the same. Dkt. 96-19 at 15.5 Following the rejection, Lilly continued
to file new draft claims as part of the ‘329 application (which issued as the ‘209 patent), that
were based on the understanding that the definition of “vitamin B12” was “cyanocobalamin.”
5
The examiner after previously rejecting a claim containing both the terms vitamin B12 and cyanocobalamin,
allowed such a claim to be issued. See Dkt. 1-1, col. 10, ll. 56-60.
20
See Dkt. 98-14 at 4.
In light of the prosecution history between Lilly and the PTO, it
demonstrates Lilly’s understanding of the term “vitamin B12” to mean “cyanocobalamin.” The
Court finds that the prosecution history, along with the rest of the intrinsic record, supports
Lilly’s proposed construction of the term “vitamin B12.”
IV. CONCLUSION
For these reasons set forth above, the disputed claim terms have the following meanings:
CLAIM TERM
MEANING
patient
human undergoing medical treatment
vitamin B12
cyanocobalamin
SO ORDERED.
06/20/2012
Date: ________________
________________________
Hon. Tanya Walton Pratt, Judge
United States District Court
Southern District of Indiana
21
DISTRIBUTION:
Jan M. Carroll
BARNES & THORNBURG LLP
jan.carroll@btlaw.com
Emily L. Rapalino
GOODWIN PROCTER, LLP
erapalino@goodwinprocter.com
Michael B. Cottler
GOODWIN PROCTER, LLP
mcottler@goodwinprocter.com
David O. Tittle
BINGHAM GREENEBAUM DOLL LLP
dtittle@bgdlegal.com
Anne N. DePrez
BARNES & THORNBURG LLP
adeprez@btlaw.com
Daryl L. Wiesen
GOODWIN PROCTER, LLP
dwiesen@goodwinprocter.com
Bruce Roger Genderson
WILLIAMS & CONNOLLY LLP
bgenderson@wc.com
Eric H. Yecies
GOODWIN PROCTER, LLP
eyecies@goodwinprocter.com
Dov P. Grossman
WILLIAMS & CONNOLLY, LLP
dgrossman@wc.com
Jonathan E. Grossman
GOODWIN PROCTER, LLP
jgrossman@goodwinprocter.com
Kandi Kilkelly Hidde
BINGHAM GREENEBAUM DOLL LLP
khidde@bgdlegal.com
Megan A. Hughes
WILLIAMS & CONNOLLY, LLP
mhughes@wc.com
David M. Krinsky
WILLIAMS & CONNOLLY, LLP
dkrinsky@wc.com
Ellen E. Oberwetter
WILLIAMS & CONNOLLY, LLP
eoberwetter@wc.com
Adam L. Perlman
WILLIAMS & CONNOLLY LLP
aperlman@wc.com
22
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