Acorda Therapeutics Inc. v. Actavis Laboratories FL Inc.
MEMORANDUM OPINION re claim construction. Signed by Judge Leonard P. Stark on 3/16/16. (ntl)
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
ACORDA THERAPEUTICS, et al. ,
C.A. No. 14-882-LPS
ALKEM LABORATORIES LTD ., et.
Jack B. Blumenfeld, Maryellen Noreika, and Jeremy A. Tigan, MORRIS , NICHOLS , ARSHT &
TUNNELL LLP, Wilmington, DE
Aaron Stiefel, Daniel P. DiNapoli, and Jeffrey Martin, KAYE SCHOLER LLP , New York, NY
Sylvia M. Becker, KAYE SCHOLER LLP, Washington, DC
Soumitra Deka, KAYE SCHOLER LLP, Palo Alto, CA
Anthony Michael, ACORDA THERAPEUTICS, INC., Ardsley, NY
Attorneys for Plaintiffs Acorda Therapeutics, Inc. and Alkermes Pharma Ireland Limited.
John C. Phillips, Jr., David A. Bilson, and Megan C. Haney, PHILLIPS, GOLDMAN &
SPENCE, P.A., Wilmington, DE
Attorneys for Defendants Actavis Laboratories FL, Inc. , Aurobindo Pharma Ltd,
Aurobindo Pharma USA, Inc., Alkem Laboratories, Ltd. , Accord Healthcare, Inc. , Teva
Pharmaceuticals USA, Inc. , Apotex Corp., and Apotex, Inc.
George C. Lombardi, Maureen Rurka, and Samuel S. Park, WINSTON & STRAWN LLP ,
Attorneys for Defendants Apotex Corp., Apotex Inc. , and Teva Pharmaceuticals, USA.
Inuon T. Aly, Sailesh K. Patel, and A. Taylor Corbitt, SCHIFF HARDIN LLP, Chicago, IL
Allison L. Maddeford, SCHIFF HARDIN LLP, San Francisco, CA
Attorneys for Defendants Aurobindo Pharma Ltd., Aurobindo Phanna USA, Inc., Accord
Healthcare, Inc., and Alkem Laboratories Ltd.
Richard K. Herrmann and Mary B. Matterer, MORRIS JAMES LLP, Wilmington, DE
Timothy H. Kratz, MCGUIREWOODS LLP, Atlanta, GA
Cedric C.Y. Tan, MCGUIREWOODS LLP, Washington, DC
Attorneys for Defendant Mylan Pharmaceuticals, Inc.
Neal C. Belgam and Eve H. Ormerod, SMITH, KATZENSTEIN & JENKINS LLP, Wilmington,
Joseph R. Robinson and Grace Yang, TROUTMAN SANDERS LLP, New York, NY
Attorneys for Defendant Roxane Laboratories.
March 16, 2016
This is a patent infringement action brought by Acorda Therapeutics, Inc. and Alkermes
Pharma Ireland Limited ("Plaintiffs") under the Hatch-Waxman Act. Plaintiffs filed suit against
Defendants Aurobindo Pharma Ltd., Aurobindo Pharma USA, Inc. , Alkem Laboratories Limited,
Accord Healthcare, Inc., Mylan Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc. , Roxane
Laboratories, Inc., Apotex Corp., and Apotex, Inc ("Defendants"). Each defendant submitted an
Abbreviated New Drug Application ("ANDA") to market a generic version of Amypra, a drug
containing the active pharmaceutical ingredient 4-aminopyridine ("4-AP"). Plaintiffs assert five
Orange Book-listed patents: U.S. Patent Nos. 5,540,938 (the '" 938 patent"), 8,007,826 (the '" 826
patent"), 8,354,437 (the '"437 patent"), 8,440,703 (the '" 703 patent"), and 8,663, 685 (the '" 685
patent"). The asserted patents relate generally to the use of a sustained release formulation of 4AP .
The parties submitted claim construction briefs (D.I. 125, 127, 172, and 173) and the
Court held a claim construction hearing on March 7, 2016 ("Tr.").
The ultimate question of the proper construction of a patent is a question of law. See Teva
Pharm. USA, Inc. v. Sandoz, Inc. , 135 S. Ct. 831 , 837 (2015) (citing Markman v. Westview
Instruments, Inc., 517 U. S. 370, 388-91 (1996)). "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."
Phillips v. A WH Corp., 415 F.3d 1303 , 1312 (Fed. Cir. 2005) (internal quotation marks omitted).
" [T]here is no magic formul a 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 generally 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, 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 1321
(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 unasserted, 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
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) (quoting Liebel-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), afj"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 and Trademark
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
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 and 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
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
pertinent field." Id. Nonetheless, courts 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, 158 F.3d 1243, 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. US Int 'l Trade Comm 'n, 75 F.3d 1545, 1550 (Fed. Cir. 1996)).
CONSTRUCTION OF DISPUTED TERMS '
"therapeutically effective concentration" 2
Plain and ordinary meaning. Alternatively: "blood plasma level of drug that ameliorates a
"an amount sufficient to decrease or prevent the symptoms associated with a medical condition
or infirmity or to normalize body functions in disease or disorders that result in impairment of
specific bodily functions"
"blood plasma level of drug that ameliorates a symptom"
The parties agree that the term "concentration" refers to "blood plasma levels." They also
agree that the preambles of the asserted claims, each of which describes maintaining a
"therapeutically effective concentration" of 4-AP in order to "improve walking in a human with
multiple sclerosis," are limiting. (Tr. at 25 , 31) They disagree, however, about which of two
descriptions of "therapeutically effective amount" found in the ' 826 patent the Court should
adopt as the construction of this term.
The specification contains a list of defined terms, including that "therapeutically effective
amount" means "an amount sufficient to decrease or prevent the symptoms associated with a
medical condition or infirmity or to normalize body functions in disease or disorders that result in
impairment of specific body functions ." '826 patent col. 5:51-61. In the next column of the
specification, the patent states that a "therapeutically effective amount" of drug provided by the
The parties have stipulated to the construction of certain terms discussed in their
briefing. (See D.I. 187, 193) Accordingly, the Court will not construe them, nor include their
construction in its written order.
This term appears in claims 1, 2, 5-7, 10, 11 , 14-16, 18-22, and 24-29 of the ' 826 patent.
sustained-release pharmaceutical compositions is "an amount ... that when administered to a
patient or subject ameliorates a symptom of a neurological disease." Id. at 6:5-19. Given that, as
the parties agree, the claims at issue are limited by preambles that refer to improving a particular
category of symptoms (those related to walking) of a particular neurological disease (multiple
sclerosis), the Court finds that the latter construction is more pertinent in the context of the
asserted claims. Therefore, the Court adopts Plaintiffs ' proposed construction. 3
"therapeutically effective blood levels" 4
Plain and ordinary meaning. Alternatively: "blood levels sufficient to produce the desired
"an amount present in the patient's blood sufficient to decrease or prevent the symptoms
associated with a medical condition or infirmity"
"blood levels sufficient to produce a therapeutic effect"
The parties ' dispute again centers on the meaning of "therapeutically effective," this time
in the context of the ' 938 patent. Defendants contend that a drug is present in the body in a
"therapeutically effective" amount if the amount is sufficient to "decrease or prevent symptoms"
of the medical condition it is meant to treat. Plaintiffs argue that this construction would
inappropriately limit the claims, because a drug can have therapeutic effects without actually
Plaintiffs would most prefer that the Court not construe the term at all and instead give it
its "plain and ordinary meaning." However, the Court finds that the parties have presented an
actual dispute regarding the scope of the claim term. It is the Court' s duty to resolve this dispute
by providing a construction. See 02 Micro Int'! Ltd. v. Beyond Innovation Tech. Co. , Ltd. , 521
F.3d 1351 , 1361-62 (Fed. Cir. 2008).
This term appears in claims 3 and 8 of the '938 patent.
decreasing or preventing symptoms of a disease. (D .I. 125 at 11 )5
The Court agrees with Plaintiffs that it would be improper to equate therapeutic
effectiveness with "decreas[ing] or prevent[ing] symptoms." The '826, '437, ' 703, and '685
patents, which are part of the same family as the ' 938 patent, demonstrate that a drug may have
desirable effects besides decreasing or preventing symptoms. For example, the ' 703 patent
describes a drug as therapeutically effective if it "decrease[ s] or prevent[ s] the symptoms
associated with a medical condition or infirmity, . .. normalize[s] body functions in disease or
disorders that result in impairment of specific bodily functions, or . .. provide[s] improvement in
one or more of the clinically measured parameters of the disease." '703 patent col. 6:33-38. The
intrinsic record of the ' 938 patent does not suggest that the claims are limited to just one of these
therapeutic effects. Instead, the prosecution history of the '938 patent indicates that a drug is
therapeutically effective if it "ameliorate[ s]" a neurological disease - with no requirement that
the drug benefit the afflicted patient in a particular way. (D.I. 138-1 at 3) Though Defendants'
expert declares that a person of ordinary skill in the art would understand both "therapeutically
effective" and "ameliorate" to require improvement in the symptoms of a disease, his statements
are conclusory and unsupported by the intrinsic record. (D.I. 130-32) Thus, the disputed term
will be given its plain and ordinary meaning of "blood levels sufficient to produce a therapeutic
Plaintiffs would again prefer that the Court not construe the term at all, and instead give
it its "plain and ordinary meaning." However, the Court finds that the parties have presented an
actual dispute regarding the scope of the claim term, and the Court has resolved that dispute by
providing a construction.
Plaintiffs agreed at the claim construction hearing that this construction was an
acceptable variation of their proposed construction. (Tr. at 4 7)
"a sustained release composition" 7
Plain and ordinary meaning. Alternatively: "Composition that provides slower release of the
active agent over an extended period of time compared to an immediate release formulation. "
"a formulation designed to release a therapeutically effective amount of drug or other active
agent such as polypeptide or synthetic compound over an extended period of time, with a
result being a reduction in the number of treatments necessary to achieve desired therapeutic
"a formulation designed to release a therapeutically effective amount of drug or other active
agent such as polypeptide or synthetic compound over an extended period of time"
The parties agreed at the claim construction hearing that a sustained release composition
is a composition that is designed to release an active agent over an extended period of time, but
disagree about whether the Court' s construction should compare such compositions to immediate
release compositions. (Tr. 54 and 59) Because the parties agree that a person of ordinary skill in
the art at the time of the invention would have understood that the words "extended period of
time" distinguish sustained release compositions from immediate release compositions (Id. at 55
and 61 ), the Court sees no need to include words requiring such a comparison in its construction.
The Court thus adopts the definition of the term "sustained release formulation" set forth in the
patent specifications : "a formulation designed to release a therapeutically effective amount of
drug or other active ingredient such as a polypeptide or a synthetic compound over an extended
period oftime" 8 ;826 patent col. 5:33-38 ; ' 685 patent col. 5:37-42.
This term appears in the asserted claims of the ' 826, ' 703, and ' 685 patents.
Defendants' proposed construction includes an additional clause from the specification.
Both Plaintiff and Defendant agreed at the claim construction hearing that it is not inappropriate
to strike this clause from the Court' s construction. (Tr. 54-55, 63) Because the Court finds that
"a sustained release tablet" 9
Plain and ordinary meaning. Alternatively: "tablet that provides slower release of the active
ingredient over an extended period of time compared to an immediate release formulation"
"a tablet designed to release a therapeutically effective amount of drug or other active agent
such as a polypeptide or synthetic compound over an extended period of time, with the result
being a reduction in the number of treatments necessary to achieve therapeutic effect"
"a tablet designed to release a therapeutically effective amount of drug or other active agent
such as a polypeptide or synthetic compound over an extended period of time"
The parties agree that the term "sustained release" has an identical meaning in this term as
in the term "sustained release composition" in the ' 826 patent. The parties also agree that
disputed term "sustained release tablet" simply requires that the sustained release composition be
formulated as a tablet. The Court thus adopts the same construction of "sustained release" as for
the ' 826 patent claims, but specifies that in this context that the composition is a tablet.
The Court construes the disputed terms as explained above. An appropriate Order
the clause confuses rather than clarifies the construction, the Court has excluded the clause from
This term appears in claims 32, 33, 36, and 37 of the ' 437 patent.
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