NUVO PHARMACEUTICALS (IRELAND) DESIGNATED ACTIVITY COMPANY, HORIZON MEDICINES LLC, Plaintiffs-Cross-Appellants
DR. REDDY'S LABORATORIES INC., DR. REDDY'S LABORATORIES, LTD., MYLAN, INC., MYLAN PHARMACEUTICALS INC., MYLAN LABORATORIES LIMITED, Defendants-Appellants
Appeals from the United States District Court for the
District of New Jersey in Nos. 3:11-cv-02317-MLC-DEA,
3:13-cv-00091-MLC-DEA, 3:13-cv-04022-MLC-DEA, Judge Mary L.
B. Monroe, Finnegan, Henderson, Farabow, Garrett &
Dunner, LLP, Washington, DC, argued for
Horizon Medicines LLC also represented by Charles
Stephen M. Hash, Baker Botts, LLP, Austin, TX, for
plaintiff-cross-appellant Nuvo Pharmaceuticals (Ireland)
Designated Activity Company. Also represented by Jeffrey Sean
Henry Pollack, Windels Marx Lane & Mittendorf LLP,
Madison, NJ, argued for all defendants-appellants.
Defendants-appellants Dr. Reddy's Laboratories Inc., Dr.
Reddy's Laboratories, Ltd. also represented by Stuart D.
Dufresne, Perkins Coie LLP, Madison, WI, argued for all
defendants-appellants. Defendants-appellants Mylan, Inc.,
Mylan Pharmaceuticals Inc., Mylan Laboratories Limited also
represented by Autumn N. Nero; Dan L. Bagatell, Hanover, NH;
Shannon Bloodworth, Washington, DC.
Sailesh K. Patel, Schiff Hardin LLP, Chicago, IL, for
defendants-appellees Lupin Ltd., Lupin Pharmaceuticals, Inc.
Prost, Chief Judge, Clevenger and Wallach, Circuit Judges.
CLEVENGER, CIRCUIT JUDGE.
Reddy's Laboratories, Inc., Mylan Pharmaceuticals, and
Lupin Pharmaceuticals (collectively, "the
Generics") appeal from the final judgment of the United
States District Court for the District of New Jersey
following a bench trial upholding the asserted claims of U.S.
Patent Nos. 6, 926, 907 ("the '907 patent") and
8, 557, 285 ("the '285 patent") as nonobvious
under 35 U.S.C. § 103, enabled under 35 U.S.C. §
112, and adequately described under § 112. Nuvo
Pharmaceuticals, Inc. and Horizon Pharma (collectively,
"Nuvo") cross-appeal from the district court's
grant of summary judgment of noninfringement to Dr.
Reddy's, concluding that one of its drug products will
not infringe the claims of the '907 patent. For the
reasons set forth below, we reverse the appeal and dismiss
anti-inflammatory drugs, also known as NSAIDs, control pain.
Common NSAIDs include, among others, aspirin and naproxen.
While NSAIDs control pain, they also have the undesirable
side effect of causing gastrointestinal problems such as
ulcers, erosions, and other lesions in the stomach and upper
small intestine. Some theorize that the undesirable side
effect is tied to the combination of NSAID with the presence
of acid in the stomach and upper small intestine. So, to
treat the side effect, some practitioners began prescribing
acid inhibitors to be taken by a patient along with the
NSAID. The NSAID treats the pain while the acid inhibitor
reduces the acidity in the gastrointestinal tract, which is
achieved by increasing the pH level in the tract. Common acid
inhibitors include, among others, proton pump inhibitors
("PPIs") like omeprazole and esomeprazole.
combination therapy had complications. First, stomach acid
degraded the PPI before it could reach the small intestine.
To fix that issue, an enteric coating that wears off after a
certain amount of time has elapsed was placed around the PPI.
Second, if the NSAID was released before the acid inhibitor
had enough time to raise the pH level in the tract, patients
would continue to suffer gastrointestinal damage. To address
those complications, Dr. John Plachetka invented a new drug
form that coordinated the release of an acid inhibitor and an
NSAID in a single tablet. The tablet contained a core of an
NSAID like naproxen in an amount effective to treat pain, an
enteric coating around the NSAID that prevents its release
before the pH increases to a certain desired level, and an
acid inhibitor like PPI around the outside of the enteric
coating that actively works to increase the pH to the desired
level. Dr. Plachetka's invention contemplates using some
amount of uncoated PPI to allow for its immediate release
into a patient's stomach and upper small intestine. Dr.
Plachetka recognized problems associated with uncoated PPI,
namely that without a coating, the PPI is at risk of
destruction by stomach acid-thereby undermining the
therapeutic effectiveness of the PPI.
Plachetka received the '907 patent on his invention,
which he assigned to Pozen Inc. He also received the '285
patent, which is a division of an abandoned application that
was a division of another application that itself was a
continuation-in-part of the application that resulted in the
'907 patent. The '285 patent is also assigned to
Pozen. The two patents bear the same title,
"Pharmaceutical Compositions for the Coordinated
Delivery of NSAIDs," and have nearly identical
of the '907 patent and claim 1 of the '285 patent are
representative. They read as follows:
1. A pharmaceutical composition in unit dosage form suitable
for oral administration to a patient, comprising:
(a) an acid inhibitor present in an amount effective to raise
the gastric pH of said patient to at least 3.5 upon the
administration of one or more of said unit dosage forms;
(b) a non-steroidal anti-inflammatory drug (NSAID) in an
amount effective to reduce or eliminate pain or inflammation
in said patient upon administration of one or more of said
unit dosage forms;
and wherein said unit dosage form provides for coordinated
release such that:
i) said NSAID is surrounded by a coating that, upon ingestion
of said unit dosage form by said patient, prevents the
release of essentially any NSAID from said dosage form unless
the pH of the surrounding medium is 3.5 or higher;
ii) at least a portion of said acid inhibitor is not
surrounded by an enteric coating and, upon ingestion of said
unit dosage form by said patient, is released regardless of
whether the pH of the surrounding medium is below 3.5 or
'907 patent col. 20 ll. 9-32.
1. A pharmaceutical composition in unit dosage form
comprising therapeutically effective amounts of:
(a) esomeprazole, wherein at least a portion of said
esomeprazole is not surrounded by an enteric coating; and
(b) naproxen surrounded by a coating that inhibits its
release from said unit dosage form unless said dosage form is
in a medium with a pH of 3.5 or higher;
wherein said unit dosage form provides for release of said
esomeprazole such that upon introduction of said unit dosage
form into a medium, at least a portion of said esomeprazole