Sunovion Pharmaceuticals Inc. v. Watson Pharmaceuticals Inc. et al

Filing 184

MEMORANDUM OPINION regarding claim construction. Signed by Judge Leonard P. Stark on 3/21/2014. (rpg)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE

SUNOVION PHARMACEUTICALS,
INC.,
Plaintiff,
v.

C.A. No. 12-993-LPS

ACTA VIS, INC. (F/K/A WATSON
PHARMACEUTICALS, INC.)
Defendants.

Thomas H. Beck, Esq., Todd L. Krause, Esq., Jesselyn C. Pe, Esq., SIDLEY AUSTIN LLP,
New York, NY.
Andrew Lin, Esq., SIDLEY AUSTIN LLP, Dallas, TX.
Geoffrey R. Beatty, Esq. SIDLEY AUSTIN LLP, Los Angeles, CA.
Jack B. Blumenfeld, Esq., Karen Jacobs, Esq., Regina Murphy, Esq., MORRIS, NICHOLS,
ARSHT & TUNNELL LLP, Wilmington, DE.
Attorneys for Plaintiff Sunovion Pharmaceuticals, Inc.

Melanie K. Sharp, Esq., James L. Higgins, Esq., Robert M. Vrana, Esq., YOUNG CONAWAY
STARGATT & TAYLOR LLP, Wilmington, DE.
E. Anthony Figg, Esq., Joseph A. Hynds, Esq., Brett A. Postal, Esq., Jennifer. P. Nock, Esq.,
ROTHWELL, FIGG, ERNST & MANBECK, P.C., Washington, DC.
Attorneys for Defendant Actavis, Inc.

MEMORANDUM OPINION

March 21,2014
Wilmington, Delaware

Presently before the Court is the issue of claim construction of two disputed terms of
U.S. Pat. No. 7,256,310 B2 (filed Dec. 8, 2003) ("the '310 patent").
I.

BACKGROUND
Plaintiff Sunovion Pharmaceuticals, Inc. (hereinafter "Sunovion" or "Plaintiff') filed this

patent infringement action against Defendant Actavis Pharmaceuticals, Inc. (formerly known as
Watson Pharmaceuticals, Inc., hereinafter "Actavis" or "Defendant") on July 27, 2012. This
case arises from Defendant's filing of an Abbreviated New Drug Application ("ANDA'') with
the United States Food and Drug Administration ("FDA") seeking approval to market a generic
version of the Plaintiffs Xopenex HFA® Inhalation Aerosol drug product. (D.I. 1)

II.

LEGALSTANDARDS
"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. AWH Corp., 415 F.3d 1303,
1312 (Fed. Cir. 2005) (internal quotation marks omitted). Construing the claims of a patent
presents a question oflaw. See Markman v. Westview Instruments, Inc., 52 F.3d 967, 977-78
(Fed. Cir. 1995), aff'd, 517 U.S. 370, 388-90 (1996). "[T]here is no magic formula or catechism
for conducting claim construction." Phillips, 415 F.3d 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 ofthe invention, i.e., as of the effective filing date of the patent application."

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!d. 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." !d. 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
ofadisputed 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 ofthe 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 .... " !d. (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." !d. 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

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using words or expressions of manifest exclusion or restriction." Liebel-Flarsheim Co. v.
Medrad, Inc., 358 F.3d 898, 906 (Fed. Cir. 2004) (internal quotation marks omitted), aff'd, 481
F.3d 1371 (Fed. Cir. 2007).
In addition to the specification, a court "should also consider the patent's prosecution
history, if it is in evidence." Markman, 52 F.3d at 980. 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 ofthe 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." !d.
A court also may rely on "extrinsic evidence," which "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 ofthe patent is consistent with that
of a person of ordinary 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." !d. 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." !d.

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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." I d. at 1318-19.
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 GmbHv. fTC, 505 F.3d 1351, 1358 (Fed. Cir. 2007).

III.

CONSTRUCTION OF DISPUTED TERMS
A.

"levalbuterol" [all claims]

Plaintifrs Proposed
Construction

"substantially optically pure levalbuterol"

Defendant's Proposed
Construction

The claim term 'levalbuterol' refers to the R-enantiomer of
albuterol. Claim 1, which recites 'levalbuterol L-tartrate,' reads
on levalbuterol tartrate in any form, including crystalline form,
alone (pure) or in combination with any amount of any other
substance or substances.
"substantially optically pure levalbuterol"

Court's Construction

Plaintiff proposes to construe the term "levalbuterol" as "substantially optically pure
levalbuterol." Defendant proposes that "levalbuterol" in the context of Plaintiffs patent claims
refers to levalbuterol in combination with any amount of any other substance or substances,
including, most importantly in this case, in combination with any amount of the corresponding
enantiomer S-albuterol. (D.I. 152 at 4) That is, Defendant's construction would include racemic
albuterol. (See D.I. 175 ("Tr.") at 13) However, as the patent makes clear, racemic albuterol
was known in the prior art. (See D.I. 151 Ex. A at col.3, 1.43-47) In addition to the general

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unlikelihood that the patentee would attempt to patent a claim that was plainly anticipated, the
fact that the examiner never suggested an anticipation rejection weighs heavily against
Defendant's proposal. 1
The Court finds that a person of ordinary skill in the art ("POSA"), having read the
entire '31 0 patent, would understand the meaning of "levalbuterol" to be optically active,
substantially pure R-albuterol. The patent cites a process for obtaining optically pure (R)benzylalbuterol, a precursor compound for the production oflevalbuterol, as disclosed in U.S.
Patent No. 5,545,745 (the "'745 patent") entitled "Enantioselective Preparation of Optically Pure
Albuterol." (See D.I. 151 Ex. A at col.1, 1.19-21) Moreover, the patent specification identifies
and distinguishes racemic albuterol sulfate in the drug product Proventil HF A™. (!d. at col.3
1.43-47)
Defendant argues that the prosecution history of the '31 0 patent supports a claim scope
for levalbuterol L-tartrate broadly encompassing (S)-albuterol. (D.I. 152 at 4-5) Defendant
focuses on language in the patent applicant's response to an office action: "The claim reads on
levalbuterol L-tartrate in any form, including any crystalline form, alone (pure) or in
combination with any amount of any other substance or substances." (D.I.151 Ex.D, at SUN
123) In context, however, it is clear the applicant intended to claim substantially optically pure
levalbuterol even when it was mixed with other compounds. See id. ("In real life, it is
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During prosecution, the examiner rejected the claims based on 35 U.S.C. § 103, stating that
enantiomers were prima facie obvious absent unexpected results. (D.I.151 Ex. D at SUN 111)
Plaintiff emphasizes, and the Court agrees, that had the examiner believed the applicant was
claiming the racemate, the rejection would instead have been made for anticipation. (See D.l.
151 at 7) These facts parallel the facts of In re May, where claims to enantiomers were rejected
for obviousness rather than anticipation. See 574 F.2d 1082, 1089, 1095 (CCPA 1978) (holding
that claims to enantiomers, rejected by the PTO as prima facie obvious, were ultimately
nonobvious based on unexpected results).
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impossible to obtain a chemical substance in a form totally free of other substances . . . . Any
real product containing levalbuterol L-tartrate will in fact contain levalbuterol L-tartrate in a
form that is a combination of levalbuterol L-tartrate and some other substance or substances.").
The patentee was not stating that the claims encompassed a racemic mixture of levalbuterol and
the corresponding enantiomer S-albuterol. As Defendant conceded during the hearing, the '31 0
patent does not expressly claim, nor does its prosecution history indicate a desire to claim,
racemic albuterol. (Tr. at 20, 22)
Defendant cites several cases for the general proposition that reciting a compound
encompasses that compound in any surrounding. See, e.g., In re Williams, 171 F.2d 319, 320
(CCP A 1948) ("The existence of a compound as an ingredient of another substance does not
negative novelty in a claim to the pure compound."); Smithkline Beecham Corp. v. Apotex Corp.,
403 F. 3d 1331, 1346 (Fed. Cir. 2005) (holding that presence of claimed compound as minor
contaminant in prior art drug was sufficient to invalidate claim by inherent disclosure); Schering

Corp. v. Geneva Pharmaceuticals, 339 F. 3d 1373, 1381 (Fed. Cir. 2003) (holding that
"compound claims are inherently anticipated by a prior art disclosure of a drug that metabolizes
into the claimed compound"). However, it is well understood that "there is no indication that ...
a plain-English purity limitation is the only way to distinguish the prior art." Ortho-McNeil

Pharm., Inc. v. Mylan Labs., Inc., 348 F. Supp. 2d 713, 725 (N.D.W. Va. 2004). There is
substantial intrinsic evidence manifesting the clear intent of the applicant to claim substantially
optically pure levalbuterol, not levalbuterol in racemic albuterol. Thus, the Court finds the cases
cited by Defendant distinguishable and unpersuasive.

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B. "a solution of levalbuterol" [all claims]

Plaintiff's Proposed
Construction

"a solution containing substantially optically pure levalbuterol"

Defendants' Proposed
Construction

The phrase 'a solution of levalbuterol' in Claim 18 reads on
levalbuterol dissolved in one or more solvents, alone (pure) or in
combination with any amount of any other substance or
substances.

Court's Construction

"a solution containing substantially optically pure levalbuterol"

For the same reasons already discussed, the Court will construe the term "a solution of
levalbuterol" as "a solution containing substantially optically pure levalbuterol."

IV.

CONCLUSION
For the foregoing reasons, the Court will construe the disputed claim terms of the '31 0

patent consistent with this Memorandum Opinion. An appropriate Order follows.

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