ASTRAZENECA AB et al v. DR. REDDY'S LABORATORIES INC. et al

Filing 142

OPINION filed. Signed by Judge Joel A. Pisano on 4/30/2013. (eaj)

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY
____________________________________
:
:
ASTRAZENECA AB, et al.
:
:
:
Plaintiffs,
:
Civil Action No. 11-2317 (JAP) (lead case)
:
11-4275 (JAP)
:
11-6348 (JAP)
v.
:
:
OPINION
DR. REDDY’S LABORATORIES INC., :
et al.,
:
:
:
Defendants.
:
____________________________________:
PISANO, District Judge.
Plaintiffs AstraZeneca AB, AstraZeneca LP, KBI-E, Inc. and Pozen, Inc. (“Astra” or
“Plaintiffs”) bring these Hatch-Waxman patent infringement actions against Defendants Dr.
Reddy’s Laboratories Inc., Dr. Reddy’s Laboratories Ltd (together, “Dr. Reddy’s”), Lupin
Ltd., Lupin Pharmaceuticals Inc. (together, “Lupin”), Anchen Pharmaceuticals, Inc.
(“Anchen”) alleging infringement of U.S. Patent No. 6,926,907 (the “ ‘907 patent”), No.
6,369,085 (the “ ‘085 patent”), No. 7,411,070 (the “ ‘070 patent”), No. 7,745,466 (the “ ‘466
patent”), No. 5,714,504 (the “ ‘504 patent”) and 6,875,872 (the “ ‘872 patent”). Presently
before the Court is the parties’ request for claim construction. The Court has held a Markman
hearing and construes the disputed claim terms as set forth below.
I. BACKGROUND
Astra’s pharmaceutical product Vimovo is a combination drug that contains the active
ingredients naproxen, which is a non-steroidal anti-inflammatory drug (“NSAID”), and

esomeprazole magnesium trihydrate, which is a proton pump inhibitor (“PPI”). Vimovo is
used to treat the symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.
The esomeprazole magnesium trihydrate in Vimovo is the same active ingredient in Astra’s
drug product Nexium, an acid inhibitor used to treat gastrointestinal disorders. With the
combination of these two drug products, patients taking Vimovo have a decreased risk of
developing NSAID-associated gastric ulcers.
There are six patents-in-suit. The ‘085 patent, the ‘070 patent and the ‘466 patent
relate to esomeprazole magnesium trihydrate. The relevant claims of the ‘907 patent relate to
a unit dosage form which contains a combination of an NSAID and an acid inhibitor. The
‘504 and ‘872 patents relate to optically pure compositions of certain omeprazole salts. Four
of the patents, specifically, the’504 patent, ‘872 patent, ‘085 patent and ‘070 patent, have been
the subject of other actions before this court involving the drug Nexium and, consequently,
the Court has previously considered and ruled upon the meaning of certain of claim terms at
issue in this case. See AstraZeneca AB v. Dr. Reddy’s Labs., Ltd., Civil Action No. 05-5553
(JAP) (the “Nexium action”). In addition to the claim terms being addressed by this Court for
the first time in the instant actions, Defendants have asked the Court to reconsider some of its
earlier rulings with regard to some of the disputed claim terms.
II. LEGAL STANDARD
In order to prevail in a patent infringement suit, a plaintiff must establish that the
patent claim “covers the alleged infringer’s product or process.” Markman v. Westview
Instrs., Inc., 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (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) (internal

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quotations omitted) (citing Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed.
Cir. 1996) (“we look to the words of the claims themselves ... to define the scope of the
patented invention”). Consequently, the first step in an infringement analysis involves
determining the meaning and the scope of the claims of the patent. Johnson Worldwide
Assocs., Inc. v. Zebco Corp., 175 F.3d 985, 988 (Fed. Cir. 1995). Claim construction is a
matter of law, Markman v. Westview Instrs., Inc., 52 F.3d 967, 979 (Fed. Cir. 1995) aff'd 517
U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996), therefore, it is “[t]he duty of the trial judge
... to determine the meaning of the claims at issue,” Exxon Chem. Patents, Inc. v. Lubrizoil
Corp., 64 F.3d 1553, 1555 (Fed. Cir. 1995).
Generally, the words of a claim are given their “ordinary and customary meaning,”
which is defined as “the meaning that the term would have to a person of ordinary skill in the
art in question at the time of the invention.” Phillips, 415 F.3d at 1312–13 (citations omitted).
In this regard, the Federal Circuit has noted that
It is the person of ordinary skill in the field of the invention through whose
eyes the claims are construed. Such person is deemed to read the words used in
the patent documents with an understanding of their meaning in the field, and
to have knowledge of any special meaning and usage in the field. The
inventor's words that are used to describe the invention—the inventor's
lexicography—must be understood and interpreted by the court as they would
be understood and interpreted by a person in that field of technology. Thus the
court starts the decisionmaking process by reviewing the same resources as
would that person, viz., the patent specification and the prosecution history.
Id. (quoting Multiform Desiccants, Inc. v. Medzam, Ltd., 133 F.3d 1473, 1477 (Fed. Cir.
1998)).
In order to determine the meaning of a claim as understood by a person skilled in the
art, a court may look to various sources from which the proper meaning may be discerned.
These sources include intrinsic evidence, which consists of “the words of the claims

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themselves, the remainder of the specification, [and] the prosecution history,” id. at 1314, and
extrinsic evidence “concerning relevant scientific principles, the meaning of technical terms,
and the state of the art,” id.
When considering the intrinsic evidence, the court’s focus must begin and remain on
the language of the claims, “for it is that language that the patentee chose to ‘particularly
point[ ] out and distinctly claim[ ] the subject matter which the patentee regards as his
invention.’ ” Interactive Gift Express, Inc. v. Compuserve, Inc., 256 F.3d 1323, 1331
(Fed.Cir.2001) (quoting 35 U.S.C. § 112, ¶ 2). The specification is often the best guide to the
meaning of a disputed term. Honeywell Int'l v. ITT Indus., 452 F.3d 1312, 1318
(Fed.Cir.2006). It is improper, however, to import limitations from the specification into the
claims. Seachange Int'l v. C–COR Inc., 413 F.3d 1361, 1377 (Fed. Cir. 2005). The court may
also consider as intrinsic evidence a patent’s prosecution history, which is evidence of “how
the inventor understood the invention and whether the inventor limited the invention in the
course of prosecution, making the claim scope narrower than it would otherwise be.”
Phillips, 415 F.3d at 1317.
While a court is permitted to turn to extrinsic evidence, such evidence is generally of
less significance and less value in the claim construction process. Id. at 1317. Extrinsic
evidence is evidence that is outside the patent and prosecution history, and may include expert
testimony, dictionaries, and treatises. Id. The Federal Circuit has noted that caution must be
exercised in the use of extrinsic evidence, as this type of evidence may suffer from inherent
flaws affecting its reliability in the claim construction analysis. Id. at 1319 (“We have viewed
extrinsic evidence in general as less reliable than the patent and its prosecution history in
determining how to read claim terms.”). While “extrinsic evidence may be useful to the

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court, ... it is unlikely to result in a reliable interpretation of patent claim scope unless
considered in the context of the intrinsic evidence.” Extrinsic evidence may never be used to
contradict intrinsic evidence. Id. at 1322–23.
III. CONSTRUCTION OF THE DISPUTED CLAIM TERMS
The ‘907 Patent
The ‘907 patent is
directed to a drug dosage forms that release an agent that raises the pH of a
patent’s gastrointestinal tract, followed by a non-steroidal anti-inflammatory
drug. The dosage form is designed so that the NSAID is not released until the
intragastric pH has been raised to a safe level. The invention also encompasses
methods of treating patients by administering this coordinated release,
gastroprotective, antiarthritic/analgesic combination unit dosage form to
achieve pain and symptom relief with a reduced risk of developing
gastrointestional damage such as ulcers, erosions and hemorrhages.
‘907 Patent, Abstract. All of the disputed terms of the ‘907 patent are found in claim 1. This
claim is set forth below, and discussion of the disputed claim language follows.
Claim 1 of the ‘907 patent reads:
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;

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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 above 3.5.
‘907 patent, claim 1.
The parties dispute the construction of the following portions of the claim:
1. “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”
Plaintiffs contend that this term should be construed as “an acid inhibitor present in an
amount capable of raising the gastric pH of said patient to at least 3.5 upon the administration
of one or more single entities for drug administration over a period of time.” Defendants
argue that this term means “an acid inhibitor present in the unit dosage form in an amount
effective to raise gastric pH to at least 3.5 at the time the unit dosage form is administered.”
The key difference in the parties’ constructions centers on whether the acid inhibitor
contained in the unit dosage form must be in an amount sufficient to raise gastric pH to 3.5
upon administration of a single dose. As can be seen from the proposed constructions,
Plaintiffs contend that the disputed claim language encompasses pharmaceutical compositions
that may require multiple administrations before the acid inhibitor is effective to raise the
gastric pH to the desired level, while Defendants contend that the acid inhibitor must obtain
the desired effectiveness in a single dose. Contrary to Defendants’ arguments, the Court finds
that the relevant evidence supports the conclusion that the claim language encompasses an
acid inhibitor that may require more than one dose to achieve the desired effectiveness.
Significantly, the claim language itself states that achieving the goal of raising gastric
pH to 3.5 may occur upon administration of “one or more” unit dosage forms. There is no

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language limiting the “one or more” unit dosage forms to a single administration.
Defendants’ construction, while focusing on the words “upon the administration,” improperly
reads out the “or more” portion of the claim language. Bicon, Inc. v. Straumann Co., 441
F.3d 945, 950 (Fed. Cir. 2006) (noting courts must construe claims with an eye toward giving
effect to all the terms in the claim). The “or more” language appears to be specifically
designed takes into account the fact that, as acknowledged in the patent, the effect of certain
types of acid inhibitors “may be delayed for several hours and may not take full effect for
several days.” ‘907 patent, col.1, lines 62–63. Overall, taking into account all of the relevant
evidence cited by the parties and, in particular, the language of the patent itself, the Court
finds that the evidence does not support Defendants’ construction.
Plaintiffs’ proposed construction, while a more accurate construction than
Defendants’, seems to unnecessarily complicate the issue by swapping certain words in the
claim with various synonyms. For example, Plaintiffs’ construction swaps “effective to raise”
with “capable of raising” and “administration of one or more of said unit dosage forms” with
“administration of one or more single entities.” The Court, however, sees no reason to depart
from the clear claim language, and will adopt a construction similar to that proposed by
Plaintiffs but which modifies the claim language less so than Plaintiffs’ proposed
construction. The Court finds that a person of skill in the art would understand the term “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” to mean “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 over a period of time” and,
consequently, construes the term accordingly.

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2. “wherein said unit dosage form provides for coordinated release”
Plaintiffs argue that the Court should construe this term to mean “wherein the single
entity for drug administration provides for the sequential release of acid inhibitor followed by
NSAID.” Defendants, on the other hand, contend that the proper construction is “release of
the NSAID in the unit dosage form is prevented until the acid inhibitor in the unit dosage
form increases gastric pH to at least 3.5.” The relevant evidence supports Plaintiffs’
construction.
As an initial matter, the specification itself defines “coordinated release” as being
sequential, namely, the release of an acid inhibitor followed by the release of an NSAID.
Specifically, the specification states that “[a]ll of the dosage forms are designed for oral
delivery and provide for the coordinated release of therapeutic agents, i.e., for the sequential
release of acid inhibitor followed by analgesic.” ‘907 patent, col. 5, lines 16-19. Further, the
claim itself describes a sequential release -- the acid inhibitor is first released and the release
of the NSAID is delayed until the pH in the “surrounding medium,” is 3.5 or higher. This is
also described in the specification, which indicates that the dosage form “provides for
coordinated release . . . i.e., the acid inhibitor is released first and the release of NSAID is
delayed until after the pH in the GI tract has risen.” ‘907 patent, col 3. line 63 to col 4. line 2.
During prosecution, the applicant similarly characterized the claimed release as sequential in
nature, i.e., the release of the acid inhibitor followed later by the NSAID release. See, e.g.,
Andersen Decl. Ex. 5. Overall, the claim language, the specification, and the prosecution
history describe a sequential release of drugs, the first of which is the release of the acid
inhibitor, which is then followed by the release of the NSAID once the pH of the surrounding
environment reaches the appropriate pH.

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The Court, consequently, finds Plaintiffs’ construction to be more consistent with the
intrinsic evidence and rejects Defendants’ proposed construction. Defendants’ construction
reads the disputed claim language too narrowly, as the “surrounding medium” is not limited to
the stomach as Defendants’ construction would require. The specification explains that where
gastric pH has not reached the requisite pH the NSAID would not release until it “reaches an
environment where the pH is above about 4,” which would be in the small intestine. ‘907
patent, col. 14, lines 59–65; see also, col. 13, lines 12–18. Having considered all of the
relevant evidence, the Court concludes that a person of skill in the art would understand the
disputed term to mean “wherein said unit dosage form provides for coordinated release” to
mean “wherein the single entity for drug administration provides for the sequential release of
acid inhibitor followed by NSAID.”
3. “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”
The parties’ dispute over this term relates to the manner in which the specified coating
controls the release of the NSAID. Defendants seek a construction that specifies that the
means by which the coating controls the release includes both by time and by pH. They
propose the following construction: “a coating that, upon ingestion of said unit dosage form
by said patient, controls the release of NSAID by time or pH and thereby prevents the release
of essentially any NSAID form said dosage form unless the pH of the surrounding medium is
3.5 or higher.” Plaintiffs, on the other hand, contend that the plain and ordinary meaning of
the phrase should apply, and, further, that the plain and ordinary meaning requires that the
coating control the release of the NSAID by pH only and not by time.

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The Court agrees with Plaintiffs, and concludes that the plain and ordinary meaning of
this phrase, which states that the form of control for NSAID release is pH, should apply. The
language of the claim itself is clear. The coating prevents the release of the NSAID “unless”
the pH of the surrounding medium is 3.5. The term “unless” as it is used here is conditional,
not temporal. There is nothing in the claim language itself directed toward controlling the
release of the NSAID by time. The Court’s conclusion is further supported by the fact that
the prosecution history shows that during prosecution the applicant replaced “said NSAID is
not released until the gastric pH of said patient is 3.5 or higher” with the language that states
NSAID release is prevented “unless the pH of the surrounding medium is 3.5 or higher”. See
Andersen Decl. Ex. 3 (emphasis added).
Defendants’ have not convinced the Court that departure from the plain language of
the claim is appropriate and their arguments in support of their proposed construction are
unavailing. While it is true that the specification describes two alternative types of coatings,
namely, one that controls release by pH and one that controls by time, the time release coating
is covered elsewhere in the claims. See, e.g., claim 37; see also Intamin Ltd. v. Magnetar
Techs., Corp., 483 F.3d 1328, 1337 (Fed. Cir. 2007) (“A patentee may draft different claims
to cover different embodiments.”). Defendants also point to claims 19 and 20 -- which
depend on claim 1 and are directed to a “barrier coating” that dissolves at a certain rate -- in
arguing that that claim 1 must encompass time-dependent coating. In doing so, however,
Defendants ignore that claims 19 and 20 refer to a different coating than claim 1.
Consequently, the Court rejects Defendants proposed construction and finds that the plain and
ordinary meaning of the disputed phrase shall apply. Under the plain and ordinary meaning,
the coating controls the release of the NSAID by pH only.

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4. “enteric coating”
The term enteric coating is not expressly defined in the patent. It appears that the
parties generally agree that an enteric coating is a delayed-release coating that does not
dissolve in the stomach but, rather, dissolves after passing through the stomach to permit
release of a drug further down in the digestive tract. Indeed, this is consistent with the
specification of the ‘907 patent, which makes clear that an enteric coating delays release of a
drug until after it has passed through the stomach. ‘907 patent, col 1 line 64 to col. 2 line 2
(“[T]his class of drugs is enteric coated to avoid destruction by stomach acid.”); col. 9 lines
50–57 (“The function of the enteric coat is to delay the release of naproxen . . . . The coating
does not dissolve in the harshly acidic pH of the unprotected stomach.”).
Where the parties’ constructions diverge with regard to this term is related to the
breadth of the construction. Plaintiffs propose that the term “enteric coating” be construed
more generally to mean “a delayed release coating.” Defendants seek a more specific
construction of the term, i.e., “a coating that controls the release of an active agent from a unit
dosage form by pH.” In support of their construction, Plaintiffs argue that the term “enteric”
would be understood by one that is skilled in the art as a coating that delays dissolution of the
coating and release of the drug further in the digestive tract, but it does not limit the manner in
which the drug release is delayed. Defendants counter that persons skilled in the art generally
understand an “enteric coating” to be pH dependent.
There is limited intrinsic evidence that sheds light on the question of the proper
construction of the term. Plaintiffs point out that the background section of the specification
at one point mentions a “pH sensitive enteric coating,” which Plaintiffs claim would be
redundant if the Defendants’ construction were correct. This weighs somewhat in favor of

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Plaintiffs’ construction, but alone it is not sufficient and, therefore, it is appropriate to turn to
extrinsic evidence. Not surprisingly, the parties offer conflicting expert opinions. Plaintiffs’
expert opines that a person of ordinary skill in the art would understand the term “enteric
coating” to mean a delayed release coating, one typically used to delay release of the drug
until it reaches the intestines. Williams Decl. ¶ 42-46. Plaintiffs’ expert bases his opinion in
part on the FDA’s Guidance for Industry SUPAC-MR: Modified Release Solid Oral Dosage
Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In
Vitro Dissolution Testing and In Vivo Bioequivalence Documentation (September 1997),
which defines “enteric coated” as “[i]ntended to delay the release of the drug (or drugs) until
the dosage form has passed through the stomach. Enteric coated products are delayed release
dosage forms.” Williams Decl. Ex. C. Plaintiffs’ expert also relies upon a textbook on
pharmaceutical dosage forms which describe enteric coatings that can be either pHdependent, enzyme-dependent or time-dependent. Defendants’ expert takes a contrary view,
and points to certain scientific literature describing pH-dependent enteric coatings.
Considering the relevant extrinsic evidence, the Court concludes that one skilled in the
relevant art would understand the term “enteric coating” to be a delayed release coating.
While the evidence shows that an enteric coating is commonly and perhaps frequently pHdependent, the evidence shows that other types of enteric coatings are utilized in the field.
There is nothing in the patent or otherwise that directs a construction that limits the term
“enteric coating” in claim 1 of the ‘907 patent to strictly a pH-dependent form. The Court,
therefore, will construe the term consistent with Plaintiffs’ proposed construction.

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5. “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 above 3.5”
The parties both contend that this phrase should be given its plain and ordinary
meaning but, unfortunately, disagree on what the plain and ordinary meaning is. Plaintiffs
argue that this phrase means “at least a portion of said proton pump inhibitor is immediately
released.” Defendants contend that this phrase means “at least some amount of 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
above 3.5.” Defendants’ explain that their construction, however, incorporates their proposed
construction of “enteric coating,” which requires the enteric coating specifically to be a pH
dependent coating. Thus, under Defendants’ proposed construction of the instant phrase, the
claim would exclude only the use of a pH-dependent coating on a portion of the acid inhibitor,
but not the use of other delayed release coatings, such as those coatings that are timedependent. However, the Court rejected of Defendants’ proposed construction for “enteric
coating,” finding that the term “enteric coating” was not limited to pH-dependent coatings
only. The Court, therefore, rejects Defendants’ proposed construction here.
The claims themselves as well as the specification make clear that the acid inhibitor of
the invention releases “immediately” upon ingestion due to the absence of a delayed release
coating. See, e.g., ‘907 patent, col. 8, lines 47-49 (stating that the acid inhibitor in Example 1
is “released from the dosage form immediately after administration”); col. 9, lines 60-62
(same for Example 2); see also Example 3 and Example 4. This is consistent with the “plain
and ordinary” meaning of the term advanced by Plaintiffs. Keeping its construction as close

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as the claim language as possible, the Court construes this term as follows: “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 immediately released regardless of whether the pH of the
surrounding medium is below 3.5 or above 3.5.”
The ‘085 patent, ‘070 patent, ‘466 patent
As stated earlier, Vimovo contains an NSAID, naproxen, and a proton pump inhibitor,
the trihydrate form of esomeprazole magnesium. The ’085 and ’070 patents relate to
esomeprazole magnesium trihydrate; and the ’466 patent relates to the combination of
esomeprazole magnesium trihydrate and a second active ingredient selected from a specified
group. These three patents have the same inventors and the same specification, but their
claims differ. The ’085 patent is limited to a specific form of “the magnesium salt of Someprazole trihydrate” characterized by certain x-ray diffraction “d-values.” ‘085 patent,
col.10 lines 5–34. The ’070 patent later issued claiming a form of esomeprazole magnesium
trihydrate and certain preparation processes. The ’466 patent claims pharmaceutical
compositions and methods of treatment comprising esomeprazole magnesium trihydrate and a
second active ingredient.
1. “magnesium salt of S-omeprazole trihydrate”
This term appears in the claims of the ‘085 patent (claims 1-5, 7-14, 16), ‘070 patent
(claim 1-4), ‘466 patent (claims 1-4, 12). Plaintiffs offer the following proposed construction:
“magnesium salt of S-omeprazole having approximately three molecules of bound water per
molecule of S-omeprazole magnesium.” 1 Defendants proposed construction is as follows: “a
trihydrate of a magnesium salt of S-omeprazole containing three molecules of water per
1

This is not the same proposed construction that appears in the parties’ Joint Claim Construction and Prehearing
Statement. Plaintiffs submitted this “streamlined” proposed construction shortly before the Markman hearing.

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molecule of magnesium salt of S-omeprazole in a unit cell of the crystal lattice that is
substantially free from magnesium salts of R-omeprazole and other prior art forms of
magnesium salts of S-omeprazole including S-omeprazole dihydrate and amorphous forms.”
This disputed term appears in the asserted claims of the three trihydrate patents.
Claim 1 of the ‘070 patent, which reads in its entirety, “[t]he magnesium salt of S-omeprazole
trihydrate,” is a simple compound claim, while the other asserted claims address preferred
embodiments and processes and pharmaceutical compositions. The Court finds that it is clear
from a comparison of the claims themselves that the term ““[t]he magnesium salt of Someprazole trihydrate” is intended to have a broad construction. Having considered the
relevant evidence, the Court simply finds no basis to import the limitations sought by
Defendants into the claim language.
The Court, however, agrees with Defendants that Plaintiffs’ construction is flawed to
the extent that it seeks to define the trihydrate as having “approximately” three molecules of
water. This simply is not consistent with the plain and ordinary meaning of the term
trihydrate. Consequently, the Court shall construe “magnesium salt of S-omeprazole
trihydrate” as “a trihydrate of a magnesium salt of S-omeprazole containing three molecules
of water per molecule of magnesium salt of S-omeprazole.”
2. “characterized by the following major peaks in its X-ray diffractogram”
This term appears in the ‘085 patent (claims 1-4, 12) and the ‘466 patent (claims 3,
11). Plaintiffs contend this phrase means “identifiable by reference to an X-ray diffractogram
that includes the major peaks below.” Defendants, on the other hand, offer this proposed
construction: “having all of the referenced major peaks in its X-ray diffractogram.”

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Claim 1 of the ’085 patent reads: “The magnesium salt of S-omeprazole trihydrate,
wherein the compound is characterized by the following major peaks in its X-ray
diffractogram:”

The numbers in the left column indicate a position on the x-axis of a peak in an X-ray
diffractogram of the material in question and the letters in the right column indicate a relative
intensity of the corresponding peak. 2 The difference between the parties’ proposed
construction centers on whether the S-omeprazole trihydrate at issue must have all of the
referenced peaks without exception.
The Court concludes that Defendants’ construction, which would require an exact
match, is too rigid. The claim language requires only that the S-omeprazole trihydrate be
“characterized” by the peaks in the table, not necessarily that it have a perfect one-to-one
relationship. Even Defendants’ expert concedes that although the X-ray diffraction of a
compound will have the same “general appearance,” the positions of the peaks may differ
somewhat because of slight experimental errors. Plaintiffs’ construction accounts for such
differences, while Defendants’ would not. Consequently, the Court will construe

2

As noted in the ‘085 patent, the definitions of the abbreviations used in the right column are as follows: vs
(very strong), s (strong), m (medium), w (weak), vw (very weak).

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“characterized by the following major peaks in its X-ray diffractogram” to mean “identifiable
by reference to an X-ray diffractogram that includes the major peaks below.”
3. “represented by FIG. 1”
This term appears in the ‘070 patent (claims 2, 4) and the ‘466 patent (claims 2, 10).
The claim language refers to the following graph designated as Figure 1 in these patents:

The diffractogram of Figure 1 shows position (x axis) plotted against intensity (y axis),
obtained when a powder sample is irradiated with X-rays at various angles indicated by the
values on the x axis.
According to Plaintiffs, the disputed term “represented by FIG. 1” means “represented
by Figure 1 of the ‘070 patent (or ‘466 patent).” Defendants contend that this term means
“having an X-ray diffractogram the same as FIG. 1.” As with the previously discussed term
“characterized by the following major peaks in its X-ray diffractogram”, here again difference
the parties’ proposed construction boils down to whether “represented by FIG. 1” requires
that the S-omeprazole trihydrate at issue must have an X-ray diffractogram that is perfectly

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identical to Figure 1. For reasons similar to those with respect to the previous term, the Court
again finds Defendants’ construction too rigid. Accordingly, the term “represented by FIG.
1” shall be construed consistent with Plaintiffs’ proposed construction, namely, “represented
by Figure 1 of the ‘070 patent (or ‘466 patent).”
‘504 and ‘872 Patents
The ’872 patent claims the magnesium salts of the (–)-enantiomer of omeprazole
exhibiting high or very high optical purities of “at least about”: 94% (claim 1), 98.4% (claim
4), 99.8% (claim 7), and 99.9% (claim 10), measured by enantiomeric excess. Claims 5, 8,
and 11 are parallel to claims 4, 7, and 10, only the “about” language is removed. Claims 3, 6,
and 9 limit the independent claims to those containing esomeprazole magnesium compounds
“in crystalline form.”
The ’504 patent claims pharmaceutical formulations (and treatment methods)
comprising solid, chemically pure alkaline salts of the (–)-enantiomer of omeprazole and a
pharmaceutically acceptable carrier. This claim is further limited to “optically pure” alkaline
salts of (–)-omeprazole (claim 2); specific alkaline salts, such as magnesium or sodium
(claims 3 and 5); and salts in a “substantially crystalline form” (claim 4). Claims 6 and 10 are
directed to methods of using the claimed formulation.
1. “(-)-enantiomer of 5-metholy-2[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1Hbenzimidazole” and “optically pure”
These terms appear in the claims of the ‘504 patent. The Court previously construed
“(–)-enantiomer of 5-methoxy-2[[(4-methoxy-3,5- dimethyl-2-pyridinyl)met-hyl]sulfinyl]1H-benzimidazole” (claims 1-6 and 10) in the Nexium action to mean “(–)-omeprazole of
high optical purity, also referred to as (S)-omeprazole, the (S)-enantiomer of omeprazole”

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wherein “high optical purity” means at least 94% enantiomeric excess and, when modified by
“optically pure,” (claim 2) in at least 98% enantiomeric excess. Dr. Reddy’s, 2010 WL
1981790 at *6-8. Plaintiffs ask the Court to adopt its previous construction here, while
Defendants urge the Court to adopt an alternative construction that the Court previously
rejected. The Court has carefully considered Defendants’ arguments, but finds no basis to
alter its earlier construction. For the same reasons in its decision in the Nexium action, the
Court shall construe “(–)-enantiomer of 5-methoxy-2[[(4-methoxy-3,5- dimethyl-2pyridinyl)met-hyl]sulfinyl]-1H-benzimidazole” to mean “(–)-omeprazole of high optical
purity, also referred to as (S)-omeprazole, the (S)-enantiomer of omeprazole” wherein “high
optical purity” means at least 94% enantiomeric excess and, when modified by “optically
pure,” (claim 2) in at least 98% enantiomeric excess.
2. “in substantially crystalline form”
This term appears in claim 4 of the ‘504 patent. The Court previously construed this
term in the Nexium action to mean “sufficient crystallinity present to permit further optical
purification of the enantiomer if required.” Dr. Reddy’s, 2010 WL 1981790 at *8. Plaintiffs
ask the Court to adopt its previous construction here, while Defendants urge the Court to
adopt an alternative construction based upon arguments that the Court previously rejected.
The Court has carefully considered Defendants’ arguments, but finds no basis to alter its
earlier construction. For the same reasons in its decision in the Nexium action, the Court shall
construe “in substantially crystalline form” to mean “sufficient crystallinity present to permit
further optical purification of the enantiomer if required.”

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3. “in crystalline form”
This term appears in claims 3, 6 and 9 of the ‘872 patent. The Court previously
construed this term in the Nexium action to mean “at least some of the magnesium salt of
esomeprazole present is in a solid with a repeating pattern of atoms or molecules of the
constituent chemical species.” Dr. Reddy’s, 2010 WL 1981790 at *3. Plaintiffs ask the Court
to adopt its previous construction here, while Defendants urge the Court to adopt an
alternative construction that the Court previously rejected. The Court has carefully
considered Defendants’ arguments, but finds no basis to alter its earlier construction. For the
same reasons in its decision in the Nexium action, the Court shall construe “in crystalline
form” to mean “at least some of the magnesium salt of esomeprazole present is in a solid with
a repeating pattern of atoms or molecules of the constituent chemical species.”
IV. CONCLUSION
For the reasons set forth above, the disputed claim terms will be construed as
indicated. An appropriate Order shall accompany this Opinion.

/s/ Joel A. Pisano
JOEL A. PISANO, U.S.D.J.

Dated: April 30, 2013

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