Sunovion wins appeal from DNJ at CAFC in eszopiclone [Lunesta] case

Sunovion v. Teva and Dr. Reddy's

The CAFC reversed:


Sunovion Pharmaceuticals, Inc. (“Sunovion”) appeals
from the decision of the United States District Court for
the District of New Jersey granting summary judgment
that Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s
Laboratories, Inc. (collectively “Reddy”) do not infringe
claims 1, 2, and 8 of Sunovion’s U.S. Patent 6,444,673 (the
“’673 patent”). Sunovion Pharm., Inc. v. Teva Pharm.
USA, Inc., No. 09-1302, 2013 WL 211289 (D.N.J. Jan. 17,
2013). Because we conclude that, although the district
court did not err in construing the asserted claims,
Sunovion was entitled to a judgment of infringement as a
matter of law under 35 U.S.C. § 271(e)(2)(A), we reverse.




This case involved enantiomers:


Stereoisomers are molecules that have the same
molecular formula or atomic composition, but which are
arranged differently in space. Enantiomers are a pair of
stereoisomers that are non-superimposable mirror images
of each other and often have distinct physical properties.
In organic chemistry, enantiomeric pairs include
compounds that have one or more stereogenic centers, i.e.,
carbon atoms with four different substituent atoms or
groups of atoms. Those compounds are thus said to be
chiral.
To distinguish between different enantiomers of the
same compound, chemists use various naming conventions.
Enantiomers are sometimes called optical isomers
because a pure enantiomer rotates plane-polarized light
in a particular direction. If the light rotates clockwise,
then that enantiomer is labeled as dextrorotatory; its
counterpart will rotate the light counterclockwise and is
labeled levorotatory. A different nomenclature system
labels each stereogenic center “(R)” or “(S)” according to a
set of scientific rules. A racemate (or racemic mixture) is
an equal mixture of two enantiomers and therefore is not
optically active (i.e., will not rotate plane-polarized light
in either direction because its constituent enantiomers
cancel each other out).




A declaration was involved:


Following a Markman hearing, the district court
construed the claim term “essentially free” to mean “less
than 0.25% of [the] levorotatory isomer.” Sunovion
Pharm., Inc. v. Teva Pharm. USA, Inc., No. 09-1302
(D.N.J. Apr. 10, 2012), ECF No. 417 (“Markman Opinion”).
The court found that there was no plain meaning
for the disputed term and thus focused on intrinsic evidence,
including the prosecution history of the patent,
because it was undisputed that neither the claims nor the
written description defined what degree of enantiomeric
purity of the dextrorotatory isomer was “essentially free”
of the levorotatory isomer. Id. at 5–6. The court held that
Sunovion was bound by its own definition of the invention
as containing less than 0.25% of the levorotatory enantiomer
through a declaration submitted by named coinventor
Roussel and through amendments and arguments
made during prosecution.



The issue


The district court accordingly granted Reddy’s renewed
motion for summary judgment of noninfringement.
Sunovion, 2013 WL 211289, at *6. The court found that
the eszopiclone products that Reddy presumes to market
would likely be “outside the infringing range of less than
0.25% of levorotatory isomer” because of Reddy’s internal
manufacturing guidelines and the Cappuccino certification
in which it pledged to constrain the amount of levorotatory
isomer to not less than 0.3%, despite the contrary
representations made to the FDA in Reddy’s amended
ANDA specification.



The CAFC affirmed the district court on claim construction:


The term “essentially free” appears only in the claims
of the ’673 patent and does not appear anywhere in the
written description. Except for the claims, the specification
is devoid of any reference to the degree of enantiopurity
of the claimed dextrorotatory isomer of zopiclone.
The written description refers to the subject of the
claimed invention merely as the dextrorotatory isomer of
zopiclone, distinguished from the racemate, which is by
definition a 50/50 mixture of the two enantiomers. ’673
patent col. 1 ll. 24–35. However, the prosecution history
of the application that matured into the ’673 patent
demonstrates that the applicants repeatedly and consistently
defined their claimed invention to be as exhibited by
Example 1. The only other example in the patent, Example
2, briefly describes a pharmaceutical formulation of
the active product, id. col. 4 ll. 5–15, not another example
of the dextrorotatory isomer. (...)

The applicants’ repeated and consistent attribution of
the purity level of less than 0.25% levorotatory isomer to
“the invention” and “the instant invention” thus gives
meaning to the term “essentially free.” Verizon Servs.
Corp. v. Vonage Holdings Corp., 503 F.3d 1295, 1308
(Fed. Cir. 2007) (“describ[ing] the features of the ‘present
invention’ as a whole . . . limits the scope of the
invention”); Microsoft Corp. v. Multi-Tech Sys., Inc., 357
F.3d 1340, 1348 (Fed. Cir. 2004) (limiting claim terms to
an embodiment that was “repeatedly and consistently
describe[d]”).



As to infringement


Sunovion argues that Reddy’s amended ANDA
specification itself controls the issue of infringement
because it expressly defines Reddy’s product in a way that
directly addresses the infringement question (i.e., eszopiclone
with 0.0–0.6% levorotatory isomer), which includes
the “less than 0.25%” purity range that would allow
Reddy to sell infringing products. Appellant Br. 53–54.
(...)
We agree with Sunovion. Although no traditional patent
infringement has occurred until a patented product is
made, used, or sold, under the Hatch-Waxman framework,
the filing of an ANDA itself constitutes a technical
infringement for jurisdictional purposes. 35 U.S.C.
§ 271(e)(2)(A); Eli Lilly & Co. v. Medtronic, Inc., 496 U.S.
661, 676 (1990). But the ultimate infringement question
is determined by traditional patent law principles and, if
a product that an ANDA applicant is asking the FDA to
approve for sale falls within the scope of an issued patent,
a judgment of infringement must necessarily ensue. See
Abbott Labs. v. TorPharm, Inc., 300 F.3d 1367, 1373 (Fed.
Cir. 2002).
What Reddy has asked the FDA to approve as a regulatory
matter is the subject matter that determines
whether infringement will occur, and the fact that Reddy
either tells the court that its manufacturing guidelines
will keep it outside the scope of the claims or has even
filed a declaration in the court stating that it will stay
outside the scope of the claims does not overcome the
basic fact that it has asked the FDA to approve, and hopes
to receive from the FDA, approval to market a product
within the scope of the issued claims.