United States District Court, D. Delaware
NOVARTIS PHARMACEUTICALS CORPORATIONS and NOVARTIS AG, Plaintiffs/Counterclaim Defendants
MYLAN PHARMACEUTICALS INC., Defendant/Counterclaim Plaintiff.
M. Silver, MCCARTER & ENGLISH LLP, Wilmington, DE;
Christina Schwarz (argued), Nicholas N. Kallas, Christopher
E. Loh, Charlotte Jacobsen, Jared Stringham (argued),
FITZPATRICK, CELLA, HARPER & SCINTO, New York, NY.
Attorneys for Plaintiffs and Counterclaim Defendants.
M. Lennon, DEVLIN LAW FIRM LLC, Wilmington, DE; Shannon M.
Bloodworm, Brandon M. White, PERKINS COIE LLP, Washington,
DE; Bryan D. Beel (argued), David Anstaett, PERKINS COIE LLP,
Portland, OR. Attorneys for Defendant and Counterclaim
ANDREWS, U.S. DISTRICT JUDGE.
before me is the issue of claim construction of multiple
terms in U.S. Patent Nos. 8, 778, 962 ("the '962
patent"), 8, 617, 598 ("the '598 patent"),
and 7, 297, 703 ("the '703 patent"). I held
oral argument on June 14, 2018. (D.I. 71
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) (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)
(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, 977-80 (Fed.
Cir. 1995) (en banc), aff'd, 5\l 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 omitted).
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 (citations and internal quotation
marks 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.
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. 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)
asserts the '962 and '598 patents against Mylan.
(D.I. 1). Mylan seeks declaratory judgments of
non-infringement and invalidity of the '962, '598,
and '703 patents. (D.I. 15). The '962 patent
"claims methods of inhibiting growth of non-malignant
solid tumors of the brain ... by administering
therapeutically effective amounts of the active compound
everolimus." (D.I. 59 at 1). The '598 patent
"claims novel pharmaceutical compositions of everolimus
in the form of dispersible tablets, which tablets are
dispersed in an ingestible liquid before consumption."
(Id. at 32). The '703 patent "discloses and
describes mixtures of stabilized pharmaceutical active
ingredients, and methods for stabilizing the
ingredients," where the "active ingredient is
preferably a poly-ene macrolide (a compound with a particular
type of ringed structure) having immunosuppressant
properties." (Id. at 60).
asserted claims of the '962 patent read as follows:
1. A method for inhibiting growth of non-malignant
solid tumors of the brain in a subject, said method
consisting of administering to said subject a
therapeutically effective amount of a compound of
R1 is CH3,
R2 is -CH2-CH2-OH, and
2. The method of claim 1 wherein the compound of formula I
is administered at a daily dose range of from about 0.1 to
25 mg, as a single dose or in divided doses.
3. The method of claim 1 wherein the compound of formula I
is administered in a unit dosage form of from about 0.05 to
4. The method of claim 1 wherein the compound of formula I
is administered in a unit dosage form of from about ...