United States District Court, D. Delaware
IBSA INSTITUT BIOCHIMIQUE, S.A., ALTERGON, S A., and IBSA PHARMA INC., Plaintiffs,
TEVA PHARMACEUTICALS USA, INC., Defendant.
B. Blumenfeld and Brian P. Egan, MORRIS, NICHOLS, ARSHT &
TUNNELL LLP, Wilmington, DE; Jeffrey J. Oelke (argued), Ryan
P. Johnson (argued), Laura T. Moran, and Eric M. Majchrzak,
FENWICK & WEST LLP, New York, NY; Erica R. Sutter,
FENWICK & WEST LLP, Mountain View, CA. Attorneys for
W. Shaw, Karen E. Keller, and Nathan R. Hoeschen, SHAW KELLER
LLP, Wilmington, DE; J.C. Rozendaal (argued), Kristina
Caggiano Kelly (argued), Michael Joffre, and Deirdre M.
Wells, STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C,
Washington, DC. Attorneys for Defendant.
ANDREWS, U.S. DISTRICT JUDGE.
before me is the issue of claim construction of multiple
terms in U.S. Patent No. 7, 723, 390 ('"390
Patent"). (D.I. 70). I have considered the Parties'
Joint Claim Construction Brief and supplemental submissions.
(Id; D.I. 97, 98). I heard oral argument on June 27,
2019. (D.I. 94 ("Tr.")).
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) (citation
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.'" SoftView LLC v. Apple Inc., 2013 WL
4758195, at *1 (D. Del. Sept. 4, 2013) (quoting
Phillips, 415 F.3d at 1324) (alteration in
original). 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, 979-80 (Fed.
Cir. 1995) (en banc), 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
words of a claim are generally given their ordinary and
customary meaning. . . . [This 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. "[T]he ordinary meaning of a
claim term is its meaning to [an] ordinary artisan after
reading the entire patent." Id. at 1321.
"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.
court relies solely on 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 on
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. 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.
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). 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)
patent is invalid for indefiniteness if its claims, read in
light of the specification delineating the patent, and the
prosecution history, fail to inform, with reasonable
certainty, those skilled in the art about the scope of the
invention." Nautilus, Inc. v. Biosig Instruments,
Inc., 572 U.S. 898, 901 (2014); see also 35
U.S.C. § 112 ("The specification shall conclude
with one or more claims particularly pointing out and
distinctly claiming the subject matter which the inventor ...
regards as the invention.")- A patent claim is
sufficiently definite if it is "precise enough to afford
clear notice of what is claimed, thereby apprising the public
of what is still open to them." Nautilus, 572
U.S. at 909 (cleaned up).
is a question of law" to which the general principles of
claim construction apply. Eli Lilly & Co. v. Teva
Parenteral Meds., Inc., 845 F.3d 1357, 1370 (Fed. Cir.
2017). A claim term "is indefinite if its language
'might mean several different things and no informed and
confident choice is available among the contending
definitions.'" Media Rights Techs., Inc. v.
Capital One Fin. Corp., 800 F.3d 1366, 1371 (Fed Cir.
2015) (quoting Nautilus, 572 U.S. at 911 n.8).
patent-in-suit relates generally to pharmaceutical
compositions for thyroid hormones. ('390 Patent at
1:6-7). The patent descends from an Italian priority
application. (See D.I. 71-1, Exh. O (Italian
application); see also D.I. 71-1, Exh. P (February
11, 2019 translation of Italian application)).
specification discusses only the T3 and T4 thyroid hormones.
(See '390 Patent at 1:11-16). The body also
produces Tl and T2 thyroid hormones. (Tr. at 13:15-20). The
numbers (one through four) refer to the number of iodine
atoms attached to the base molecule, thyronine.
Parties dispute the proper construction of terms in claims 1,
7, and 8:
1. A pharmaceutical composition comprising thyroid
hormones or their sodium salts in the form of either:
a) a soft elastic capsule consisting of a shell of gelatin
material containing a liquid or half-liquid inner
phase comprising said thyroid hormones or their
salts in a range between 0.001 and 1% by weight of said
inner phase, dissolved in gelatin and/or glycerol, and
optionally ethanol, said liquid or half-liquid inner
phase being in direct contact with said shell without any
interposed layers, or
b) a swallowable uniform soft-gel matrix comprising
glycerol and said thyroid hormones or their salts in
a range between 0.001 and 1% by weight of said matrix.
7. The pharmaceutical composition according to claim 1,
having an outer coating which simplifies ingestion.
8. The pharmaceutical composition according to claim 1,
wherein the material of the capsule contents or the
swallowable uniform soft-gel matrix includes a plasticizer to
control its hardness.
('390 Patent, claims 1, 7, 8 (disputed terms
CONSTRUCTION OF DISPUTED TERMS
hormones or their [sodium] salts"
Plaintiffs' proposed construction:
Plain and ordinary meaning: "one or more thyroid
hormones or their [sodium] salts"
Defendant's proposed construction:
Plain and ordinary meaning: multiple thyroid hormones or
sodium salts of multiple thyroid hormones
"one or more thyroid hormones or their [sodium]
Parties agree that this claim covers compositions that
contain more than one type of thyroid hormone. (See
D.I. 70 at 3-20). They disagree, however, whether the claim