Novartis Pharmaceuticals Corporation et al v. Par Pharmaceutical Inc.
Filing
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MEMORANDUM OPINION providing claim construction of a term in U.S. Patent Nos. 7,297,703 and 7,741,338. Within five days the parties shall submit a proposed order consistent with this Memorandum Opinion. Signed by Judge Richard G. Andrews on 10/16/2015. Associated Cases: 1:14-cv-01494-RGA, 1:14-cv-01508-RGA, 1:15-cv-00078-RGA, 1:15-cv-00128-RGA(nms)
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
NOVARTIS PHARMACEUTICALS
. CORPORATION and NOVARTIS AG,
Plaintiffs,
Civil Action No. 14-1494-RGA
V.
Civil Action No. 15-78-RGA
PAR PHARMACEUTICAL, INC.,
Defendant.
NOVARTIS PHARMACEUTICALS
CORPORATION and NOVARTIS AG,
Plaintiffs,
Civil Action No. 14-1508-RGA
v.
Civil Action No. 15-128-RGA
ROXANE LABORATORIES, INC.,
Defendant.
MEMORANDUM OPINION
Daniel M. Silver, Esq., McCARTER & ENGLISH, LLP, Wilmington, DE; Nicholas N. Kallas,
Esq., Christopher E. Loh, Esq. (argued), Charlotte Jacobsen, Esq., Christina Schwarz, Esq,,
LauraK. Fishwick, Esq., FITZPATRICK, CELLA, HARPER & SCINTO, New York, NY,
attorneys for Plaintiffs.
Steven J. Fineman, Esq., Katharine C. Lester, Esq., RICHARDS LAYTON & FINGER, P.A.,
Wilmington, DE; Daniel G. Brown, Esq., LATHAM & WATKINS LLP, New York, NY; Roger
J. Chin, Esq., LATHAM & WATKINS LLP, San Francisco, CA; Marc N. Zubick, Esq., Brenda
L. Danek, Esq., LATHAM & WATKINS LLP, Chicago, IL; Parker M. Tresemer, Esq.,
LATHAM & WATKINS LLP, Los Angeles, CA, attorneys for Defendant Par Pharmaceutical,
Inc.
Richard L. Horwitz, Esq., David E. Moore, Esq., Bindu A. Palapura, Esq., POTTER
ANDERSON & CORROON LLP, Wilmington, DE; Marta E. Gross, Esq., Keith A. Zullow,
Esq., Michael B. Cottier, Esq. (argued), Steven J. Bernstein, Esq., GOODWIN PROCTER LLP,
New York, NY, attorneys for Defendant Roxane Laboratories, Inc.
October
J./;l., 2015
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Presently before the Court is the issue of claim construction of a term in U.S. Patent Nos.
7,297,703 ("the '703 patent") and 7,741,338 ("the '338 patent"). Plaintiffs Novartis
Pharmaceuticals Corporation and Novartis AG assert claims of the '703 patent, the '338 patent,
and U.S. Patent No. 5,665,772 against Defendants Par Pharmaceutical, Inc. and Roxane
Laboratories, Inc. in the above-captioned cases.' The Court has considered the parties' Joint
Claim Construction Brief. (D.I. 72). 2 The Court heard oral argument on October 14, 2015.
I. LEGAL STAND ARD
"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) (en bane) (internal quotation marks omitted). "'[T]here is no magic formula or
catechism for conducting claim construction.' Instead, the court is free to attach the appropriate
weight to appropriate sources 'in light of the statutes and policies that inform patent law."'
Soft View LLC v. Apple Inc., 2013 WL 4758195, at *1 (D. Del. Sept. 4, 2013) (quoting Phillips,
415 F.3d at 1324). When construing patent claims, a court considers the literal language of the
claim, the patent specification, and the prosecution history. Markman v. Westview Instruments,
Inc., 52 F.3d 967, 977-80 (Fed. Cir. 1995) (en bane), aff'd, 517 U.S. 370 (1996). Of these
sources, "the 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." Phillips, 415 F .3d
at 1315 (internal quotation marks and citations omitted).
"[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
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2
The claim terms ofU.S. Patent No. 5,665,772 are not at issue in this proceeding.
Citations to "D.I. "are citations to the docket in C.A. No. 14-1494.
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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 quotation marks and citations omitted). "[T]he ordinary meaning of a
claim term is its meaning to [an] ordinary artisan after reading the entire patent." Id. at 1321
(internal quotation marks omitted). "In some cases, the ordinary meaning of claim language as
understood by a person of skill in the art may be readily apparent even to lay judges, and claim
construction in such cases involves little more than the application of the widely accepted
meaning of commonly understood words." Id. at 1314 (internal citations omitted).
When a court relies solely upon the intrinsic evidence-the patent claims, the
specification, and the prosecution history-the court's construction is a determination of law.
See Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 841 (2015). The court may also
make factual findings based upon consideration of extrinsic evidence, which "consists of all
evidence external to the patent and prosecution history, including expert and inventor testimony,
dictionaries, and learned treatises." Phillips, 415 F.3d at 1317-19 (internal quotation marks and
citations omitted). Extrinsic evidence may assist the court in understanding the underlying
technology, the meaning of terms to one skilled in the art, and how the invention works. Id.
Extrinsic evidence, however, is less reliable and less useful in claim construction than the patent
and its prosecution history. Id. "A claim construction is persuasive, not because it follows a
certain rule, but because it defines terms in the context of the whole patent." Renishaw PLC v.
Marposs Societa 'per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998).
II. CONSTRUCTION OF DISPUTED TERM
The disputed claim term "catalytic amount" appears in claim 1 of the '703 patent and
claim 2 of the '338 patent. (D.I. 72 at 8). The '338 patent is a continuation of the '703 patent
and the '703 and '338 patents share the same specification. (D.I. 73-1 at 13; D.I. 72 at 8). The
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parties agree that the term should be construed to have the same meaning in the claims of the
'703 and '338 patents. (D.I. 72 at 8).
1.
"catalytic amount"
a.
Plaintiffs' proposed construction: small amount as compared to the amount of the
poly-ene macrolide
b.
Defendants' proposed construction: an amount up to 1% based on the weight of the
poly-ene macrolide
c.
Court's construction: small amount as compared to the amount of the poly-ene
macrolide
The parties agree that the term "catalytic amount" refers to an amount of antioxidant that
is relative to the amount of the claimed poly-ene macrolide. (D.I. 72 at 9-10, 26). The dispute
concerns how much antioxidant is a "catalytic amount" as that term is used in the asserted
claims.
Plaintiffs argue that their construction is proper under principles of claim differentiation,
relying on claims 1 and 2 of the '703 patent. (Id. at 12). Claims 1 and 2 of the '703 patent read:
1. A solid mixture comprising a poly-ene macrolide and an antioxidant wherein
the poly-ene macrolide is selected from the group consisting of rapamycin, a
16-0-substituted rapamycin, and a 40-0-substituted rapamycin and wherein
the antioxidant is present in a catalytic amount.
2. A mixture according to claim 1, wherein the antioxidant is present in an
amount of up to 1% based on the poly-ene macrolide weight.
('703 patent, col. 8, 11. 37-44). Plaintiffs contend that "catalytic amount" in claim 1 of the '703
patent should be construed to encompass amounts greater than the amount disclosed in
dependent claim 2 of that patent, "up to 1% based on the poly-ene macrolide weight," because
the scope of an independent claim is presumed to be different from and broader than the scope of
a claim that depends from the independent claim. (D.I. 72 at 12-14). Plaintiffs further contend
that a claim terin expressed in general descriptive terms typically should "not be limited to a
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numerical range that may appear in the written description as referring to a preferred
embodiment or in other, narrower claims." (Id. at 14 (quoting RF Del., Inc. v. Pac. Keystone
Techs., Inc., 326 F.3d 1255, 1263 (Fed. Cir. 2003) (internal quotation marks omitted))).
Plaintiffs maintain that their construction can be applied to the'338 patent consistent with the
doctrine of claim differentiation. (Id. at 15). Claims 1 and 2 of the '338 patent read:
1. A solid mixture comprising 40-0-(2-hydroxy)ethyl:.rapamycin and 2,6-di-tertbutyl-methylphenol (BHT).
2. A mixture according to claim 1, wherein said 2,6-di-tert-butyl-4-methylphenol
(BHT) is present in a catalytic amount.
('338 patent, col. 10, 11. 12-15). Plaintiffs argue th_at the scope of independent claim 1 of the
'338 patent remains broader than the scope of dependent claim 2 under its proposed construction
of "catalytic amount" because the amount of BHT in claim 1 is not limited, while the amount of
BHT in claim 2 is limited to a catalytic amount. (D.I. 72 at 15).
Defendants argue that the specification defines the disputed term and that that definition
must govern construction of the claim term in spite of Plaintiffs' claim differentiation arguments.
(Id. at 28, 30). Defendants maintain that the term "catalytic amount" is defined in the
specification language that follows:
According to the invention, there is provided
1.
A process for stabilizing a poly-ene macrolide comprising adding an
antioxidant to the purified macrolide, preferably at the commencement of its
isolation step. This process is particularly useful for the production of a
stabilized poly-ene macrolide in bulk. The amount of antioxidant may
conveniently be up to 1%, more preferably from 0.01 to 0.5% (based on the
weight of the macrolide). Such a small amount is referred to hereinafter as a
catalytic amount.
('703 and '338 patents, col. 1, 11. 27-36 (emphasis added); D.I. 72 at 28). Relying on
Sinorgchem Co., Shandongv. International Trade Commission, 511F.3d1132, 1136 (Fed. Cir.
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2007), Defendants argue that the presence of the words "is referred to" indicates that the
patentees acted as their own lexicographers and that the term "catalytic amount" is defined in the
specification as an amount up to 1% based on weight of the macrolide. (D.I. 72 at 28).
Plaintiffs respond that the specification does not limit the claim term "catalytic amount"
to the specific numeric ranges disclosed because the specification makes clear that the numeric
ranges are merely "convenient" and "preferable" examples of catalytic amounts. (Id. at 17-18).
Plaintiffs also respond that, to control construction of a claim term, a definition in the
specification must be set forth with "reasonable clarity, deliberateness, and precision." (D.I. 72
at 41 (quoting Abbott Labs. v. Syntron Bioresearch, Inc., 334 F.3d 1343, 1354 (Fed. Cir. 2003)).
Plaintiffs argue that the specification does not clearly express an intent to define the term
"catalytic amount" because the specification does not state that "catalytic amount" "is" or "refers
to" a certain amount and the claim term is not set off in quotation marks. (Id. at 41-42).
Regarding extrinsic evidence, Plaintiffs argue that the term "catalytic amount" is used by
persons having ordinary skill in the art to encompass small anlounts relative to the weight of
reactants, which is a broader meaning than "up to 1%"of the weight ofreactants. (Id. at 21-25).
Defendants argue that Plaintiffs' reliance on extrinsic evidence is unavailing because: (1)
extrinsic evidence is irrelevant when an analysis of intrinsic evidence alone resolves the
ambiguity in a claim term; (2) the prior art on which Plaintiffs rely is inapposite; and (3)
Plaintiffs' expert's declaration improperly argues legal issues. (Id. at 33-35).
Defendants also contend that Plaintiffs' proposed construction frustrates the purpose of
claim construction because it does not clarify the meaning of the claim term and itself requires
construction. (Id. at 36). Plaintiffs respond that a proper construction can be provided in
descriptive terms and need not set forth an exact numeric bound. (Id. at 49-50). Plaintiffs
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maintain that their construction does not introduce additional vagueness into the claim term. (Id.
at 49).
Here, the patentee did not "clearly set forth a definition of the disputed claim term[] and
clearly express an intent to define the term." GE Lighting Solutions, LLC v. AgiLight, Inc., 750
F.3d 1304, 1309 (Fed. Cir. 2014) (internal quotation marks omitted). The language identified by
Defendants does not express an intent to define "catalytic amount" as an amount of antioxidant
"up to 1%"for several reasons. First, the numerical percentage recited in the specification is
preceded by the non-limiting phrase "may conveniently be," which weighs against adopting a
claim construction that is limited to what follows the phrase. See Glaxo Group LTD v. Teva
Pharm. USA, Inc., 2009 WL 1220544, at *3 (D. Del. Apr. 30, 2009). Second, although the
presence of the phrase "is referred to" is one factor that may indicate that the patentee acted as
his own lexicographer, see In re Imes, 778 F.3d 1250, 1252-53 (Fed. Cir. 2015), Linear Tech.
Corp. v. Int'! Trade Comm 'n, 566 F.3d 1049, 1054 (Fed. Cir. 2009), here the phrase does not
connect the term and its alleged definition. Rather, it connects the term with an intervening
phrase, "[s]uch a small amount," which, in tum, refers to the previous sentence containing
Defendants' proposed construction. Third, there are no quotation marks around "catalytic
amount." Although the absence of quotation marks around a supposedly defined term does not
. necessarily mean that the patentee did not act as his own lexicographer, it is one factor tending to
show that the description is not definitional. See France Telecom, S.A. v. Marvell
Semiconductor, Inc., 2014 WL 1007449, at *4 (N.D. Cal. Mar. 12, 2014).
Analysis of Plaintiffs' extrinsic evidence is unnecessary because the intrinsic evidence
resolves the dispute. See Vitronics Corp. v. Conceptronic Inc., 90 F.3d 1576, 1583 (Fed. Cir.
1996). Because I conclude that the specification does not define the term "catalytic amount,'' I
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construe the term as Plaintiffs propose, in accordance with the doctrine of claim differentiation.
This construction does not introduce additional vagueness by failing to import a numerical
limitation.
III.
CONCLUSION
Within five days the parties shall submit a proposed order consistent with this
Memorandum Opinion.
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