United States District Court, D. Delaware
Michael P. Kelly, Daniel M. Silver, and Benjamin A. Smyth,
McCARTER & ENGLISH, LLP, Wilmington, DE, Jane M. Love,
Robert Trenchard, and Paul E. Torchia, GIBSON, DUNN &
CRUTCHER LLP, New York, NY Andrew P. Blythe, GIBSON, DUNN
& CRUTCHER LLP, Los Angeles, CA Attorneys for Plaintiff
C. Phillips, Jr. and Megan C. Haney, PHILLIPS, GOLDMAN,
MCLAUGHLIN & HALL, P.A., Wilmington, DE Michael J.
Gaertner, David B. Abramowitz, Carolyn A. Blessing, Emily L.
Savas, and Jonathan B. Turpin, LOCKE LORD LLP, Chicago, IL
Attorneys for Attorneys for Zydus Pharmaceuticals (USA),
Cadila Healthcare Limited
Belgam and Eve H. Ormerod, SMITH, KATZENSTEIN & JENKINS
LLP, Wilmington, DE Alan Pollack and Louis H. Weinstein, BUDD
LARNER, P.C, Short Hills, N.J. Attorneys for Accord
Healthcare, Inc., Dr. Reddy's Laboratories, Inc., Dr.
Reddy's Laboratories, Ltd., Torrent Pharmaceuticals Ltd.,
and Torrent Pharma Inc.
Kenneth L. Dorsney, MORRIS JAMES LLP, Wilmington, DE Timothy
H. Kratz and George J. Barry III, KRATZ & BARRY LLP,
Atlanta, GA Attorneys for Aurobindo Pharma Limited, Aurobindo
Pharma USA, Inc.
Kenneth L. Dorsney, MORRIS JAMES LLP, Wilmington, DE Howard
S. Sun, HOLLAND & KNIGHT LLP, Attorneys for Hetero USA
Inc., Hetero Labs Limited, Hetero Labs Limited Unit-V,
Prinston Pharmaceutical Inc.
E. Farnan and Sara M. Metzler, RICHARDS, LAYTON & FINGER,
PA., Wilmington, DE Attorneys for Breckenridge
Pharmaceutical, Inc., Standard Chemical & Pharmaceutical
Stamatios Stamoulis and Richard C. Weinblatt, STAMOULIS &
WEINBLATT, LLP, Wilmington, DE Mieke Malmberg, SKIERMONT
DERBY LLP, Los Angeles, CA Paul Skiermont, Sarah Spires, and
Steven J. Udick, SKIERMONT DERBY LLP, Dallas, TX Attorneys
for HEC Pharm Co. and HEC Pharm USA Inc.
Fredrick L. Cottrell, III, Jason J. Rawnsley, and Alexandra
M. Ewing, RICHARDS, LAYTON & FINGER, PA., Wilmington, DE
Shannon M. Bloodworm and Brandon M. White, PERKINS COIE LLP,
Washington, DC Bryan D. Beel, PERKINS COIE LLP, Portland, OR
Michael R. Laing, PERKINS COIE LLP, Madison, WI Attorneys for
Mylan Pharmaceuticals Inc.
Kenneth L. Dorsney, MORRIS JAMES LLP, Wilmington, DE Stephen
R. Auten, Richard T. Ruzich, Roshan P. Shrestha, TAFT
STETTINIUS & HOLLISTER LLP, Chicago, IL Attorneys for
Alkem Laboratories, Ltd.
U.S. District Judge
Novartis Pharmaceuticals Corp. ("Novartis" or
"Plaintiff') filed suit against 25 generic
pharmaceutical companies ("Defendants") on June 16,
2018, alleging infringement of U.S. Patent No. 9, 187, 405
("the '405 patent"). (D.I. 1) The '405
patent "relates [to] uses of an SIP receptor modulator
... for the treatment or prevention of neo-angiogenesis
associated with a demyelinating disease, e.g. multiple
sclerosis." ('405 patent at Abstract) The parties
dispute the significance of the preambles to the three
independent claims of the '405 patent, as well as the
meaning of the term "daily dosage." The Patent
Trial and Appeal Board ("PTAB") issued a final
written decision on a petition for inter par tes
review ("IPR") challenging the validity of claims
1-6 of the '405 patent, on July 11, 2018. (D.I. 430-17
Ex. 43) The PTAB's decision construed the disputed terms
using the standard of "broadest reasonable
interpretation" ("BRI"). The parties completed
claim construction briefing on April 16, 2019 (D.I. 426, 429,
479, 484) and the Court held a claim construction hearing on
April 23, 2019 (D.I. 498) ("Tr.").
ultimate question of the proper construction of a patent is a
question of law. See TevaPharm. USA, Inc. v. Sandoz,
Inc., 135 S.Ct. 831, 837 (2015) (citing Markman v.
Westview Instruments, Inc., 517 U.S. 370, 388-91
(1996)). "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)
(citation and internal quotation marks omitted).
"[T]here is no magic formula or catechism for conducting
claim construction." Id. 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.
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 (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." Id. 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
of a disputed term." Vitronics Corp. v.
Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996).
"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 of the patent in question, both asserted
and unasserted, can also be valuable sources of
enlightenment.... [b]ecause claim terms are ...