United States District Court, D. New Jersey
MEMORANDUM AND ORDER
G. SHERIDAN, U.S.D.J.
matter comes before the Court on a Second Amended Joint Claim
Construction and Prehearing Statement (hereinafter
“Joint Claim Construction”) regarding U.S. Patent
No. 5, 661, 151 (“the '151 patent”),
submitted by Merck Sharp & Dohme Corp.
(“Merck” or “Plaintiffs”) and Actavis
Laboratories FL, Inc., Andrx Corporation, Actavis Pharma,
Inc. and Actavis, Inc. (collectively, “Actavis”)
pursuant to L. Pat. R. 4.3. (See D.I. 128).
'151 patent is directed to the synthesis and clinical use
of antifungal compound posaconazole, which is used for
treating or preventing fungal infections.
Noxafil®, a brand name pharmaceutical drug for
treating or preventing fungal infections, especially in
people with weak immune systems, includes the active
order to market and sell Noxafil®, Merck
listed the '151 patent in the Food and Drug
Association's (“FDA”) Approved Drug Products
with Therapeutic Equivalence Applications, commonly known as
the Orange Book. See 21 U.S.C. § 355(B)(1).
Thereafter, Actavis filed an Abbreviated New Drug Application
(“ANDA”) with the FDA in order to seek approval
to market a generic version of Noxafil®.
See 21 U.S.C. § 355(j)(1). Accordingly,
pursuant to 21 U.S.C. § 355(j)(5)(B)(iii), Merck
initiated this suit against Actavis because Actavis'
request to market the generic version of
Noxafil® is done prior to the expiration of
the '151 patent.
noted in the Joint Claim Construction, the parties dispute
the meaning of the following claim terms recited in claim 12
of the '151 patent -“pharmaceutical composition,
” and “pharmaceutically acceptable carrier”
(collectively “disputed claim terms”).
2, 2017, pursuant to L. Pat. R. 4.6, the Court held a
Markman hearing to define the aforementioned two
claim terms. These terms are construed below.
'151 patent is generally directed to the synthesis and
clinical use of antifungal compound posaconazole, which is
used for treating and/or preventing fungal infections.
(See Abstract of the '151 patent). The '151
patent filed on June 2, 1995, as Application No. 460, 752, is
a continuation-in-part of an application filed under the
Patent Cooperation Treaty (“PCT”). The PCT
application is a continuation-in-part of another application
filed on December 21, 1993. As such, the potential effective
filing date of the '151 patent is December 21, 1993. The
'151 patent discloses antifungal compounds of formula I
and pharmaceutical compositions, which are expected to
exhibit anti-allergic, anti-inflammatory and immunomodulating
activities. The pharmaceutical composition contains a
fungicidally effective amount of other antifungal compounds
such as cell wall active compound. (Id. at col. 56,
'151 patent further discloses that pharmaceutical
compositions are formulated by combining the compound of
formula I or an equivalent amount of a pharmaceutically
acceptable salt of compound I with a suitable,
inert, pharmaceutically acceptable carrier or diluent.
Examples of suitable pharmaceutical compositions include
solid or liquid compositions for oral administration such as
tablets, capsules, pills, powders, granules, solutions,
suppositories, troches, lozenges, suspensions or emulsions.
(Id. at col. 57, ll. 40-50).
the '151 patent discloses that a solid carrier can be one
or more substances which may act as diluents, flavoring
agents, solubilizers, lubricants, suspending agents, binders
or tablet disintegrating agents, or as an encapsulating
material. The carrier can also be a finely divided solid
which is in admixture with the finely divided active
compound. In a tablet form, for example, the active compound
is mixed with the carrier that has the necessary binding
properties. The carrier is added in suitable proportions such
that the tablet is compacted in the desired shape and size.
(Id. at col. 57, ll. 45-55).
prosecution of the patent application of the '151 patent,
the examiner rejected the claimed subject matter. Applicant
amended the then pending claims to include claim term
“in vivo” to differentiate over the cited art.
(See Image File Wrapper of the '151 patent,
Applicant's Arguments/Remarks Made in an Amendment, filed
May 24, 1996). This amendment was made in response to patent
examiner's rejection mailed on November 22, 1995.
Additionally, arguments against the obviousness rejection
under 35 U.S.C. § 103 were also made. (Id.)
mailing a final rejection on August 21, 1996, the examiner
conducted a personal interview with the Applicant's
representative. During the personal interview, the enablement
rejection under pre-AIA (“America Invents Act”)
35 U.S.C. § 112, first paragraph, was discussed, and the
Applicants agreed to provide an affidavit demonstrating that
enablement exists for use of “in vivo” esters.
(See Examiner Interview Summary Record mailed on
December 19, 1996).
the Applicant filed a response to the outstanding Office
action with a declaration from Dr. Ashit K. Ganguly, a
co-inventor of the '151 patent. In its response, the
Applicant essentially argued that based on the specification
one skilled in the art would be able to readily determine
which of the ester compounds would be soluble or suspendible
in a pharmaceutically acceptable aqueous media. (See
Applicant's Arguments/Remarks filed on January 29, 1997;
citing Declaration of Dr. Ganguly at ¶ 17).
Applicants noted that they are “amending claim 17 of
this application to cover a preferred embodiment, and to
recite that such esters of the compounds of the claimed
invention have a solubility in a pharmaceutically acceptable
media of at least about 1 to about 50 mg/ml.”
(Id. at 6). Thereafter, on February 7, 1997, a
notice of allowance was mailed by the patent examiner, which
was later followed by a corrected notice of allowance on
February 27, 1997. No reasons for allowance in-particular
were provided by the patent examiner when issuing the notice
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) (quoting Innova/Pure Water Inc. v.
Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1115
(Fed. Cir. 2004)). Claim construction determines the correct
claim scope, and is a determination exclusively for the court
as a matter of law. Markman v. Westview Instruments,
Inc., 52 F.3d 967, 978-79 (Fed. Cir. 1995) (en banc),
aff'd, 517 U.S. 370 (1996). The focus in
construing disputed terms in claim language “is on the
objective test of what one of ordinary skill in the art at
the time of the invention would have understood the term[s]
to mean.” Id. at 986.
determine the meaning of the claims, courts start by
considering the intrinsic evidence. Phillips, 415
F.3d at 1313; C.R. Bard, Inc. v. U.S. Surgical
Corp., 388 F.3d 858, 861 (Fed. Cir. 2004); Bell Atl.
Network Servs., Inc. v. Covad Comms. Group, Inc., 262
F.3d 1258, 1267 (Fed. Cir. 2001). The intrinsic evidence
includes the claims themselves, the specification, and the
prosecution history. Phillips, 415 F.3d at 1314;
C.R. Bard, Inc., 388 F.3d at 861.
claims themselves provide substantial guidance in determining
the meaning of particular claim terms. Phillips, 415
F.3d at 1314. First, the context in which a term is used in
the asserted claim can be very instructive. Id.
Other asserted or non-asserted claims can aid in determining
the claim's meaning because claim terms are normally used
consistently throughout a patent. Id. Differences
among claims can also assist in understanding a term's
meaning. Id. For example, when a dependent claim
adds a limitation, there is a presumption that the
independent claim does not include that limitation.
Id. at 1314-15.
‘must be read in view of the specification of which
they are a part.'” Id. at 1315 (quoting
Markman, 52 F.3d at 979). “[T]he 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.'”
Id. (quoting Vitronics Corp. v. Conceptronic,
Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). This is true
because a patentee may define his own terms, give a claim
term a different meaning than the term would otherwise
possess, or disclaim or disavow the claim scope. Id.
at 1316. In these circumstances, the inventor's
lexicography governs. Id. The specification may also
resolve the meaning of ambiguous claim terms “where the
ordinary and accustomed meaning of the words used in the
claims lack sufficient clarity to permit the scope of the
claim to be ascertained from the words alone.”
Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d
1313, 1325 (Fed. Cir. 2002). But, “[a]lthough the
specification may aid the court in interpreting the meaning
of disputed claim language, particular embodiments and
examples appearing in the specification will not generally be
read into the claims.” Comark Commc'ns, Inc. v.
Harris Corp., 156 F.3d 1182, 1187 (Fed. Cir. 1998)
(quoting Constant v. Advanced Micro-Devices, Inc.,
848 F.2d 1560, 1571 (Fed. Cir. 1988)); also see
Phillips, 415 F.3d at 1323 (“although the
specification often describes very specific embodiments of
the invention, we have repeatedly warned against confining
the claims to those embodiments.”).
prosecution history is another tool to supply the proper
context for claim construction. It “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 that it would otherwise be.”
Phillips, 415 F.3d at 1317.
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. Although extrinsic evidence can be useful, it
is “less significant than the intrinsic record in
determining ‘the legally operative meaning of claim
language.'” Phillips, 415 F.3d at 1317
(quoting C.R. Bard, Inc., 388 F.3d at 862).
and treatises may aid a court in understanding the underlying
technology and the manner in which one skilled in the art
might use claim terms, but dictionaries and treatises may
provide definitions that are too broad or may not be
indicative of how the term is used in the patent.
Id. at 1318. Similarly, expert testimony may aid a
court in understanding the underlying technology and
determining the particular meaning of a term in the pertinent