Case 3:11-cv-02317-JAP-DEA Document 142 Filed 05/01/13 Page 1 of 20 PageiD: 5511
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`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
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`ASTRAZENECA AB, et al.
`
`Plaintiffs,
`
`v .
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`DR. REDDY'S LABORATORIES INC.,
`et al.,
`
`Defendants.
`
`PISANO, District Judge.
`
`Civil Action No. 11-23 17 (JAP) (lead case)
`11-4275 (JAP)
`11-6348 (JAP)
`
`OPINION
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`Plaintiffs AstraZeneca AB, AstraZeneca LP, KBI-E, Inc. and Pozen, Inc. ("Astra" or
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`"Plaintiffs") bring these Hatch-Waxman patent infringement actions against Defendants Dr.
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`Reddy's Laboratories Inc., Dr. Reddy's Laboratories Ltd (together, "Dr. Reddy's"), Lupin
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`Ltd., Lupin Pharmaceuticals Inc. (together, "Lupin"), Anchen Pharmaceuticals, Inc.
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`("Anchen") alleging infringement of U.S. Patent No. 6,926,907 (the" '907 patent"), No.
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`6,369,085 (the " '085 patent"), No. 7,411,070 (the" '070 patent"), No. 7,745,466 (the " ' 466
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`patent"), No. 5,714,504 (the" '504 patent") and 6,875,872 (the" '872 patent"). Presently
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`before the Court is the parties' request for claim construction. The Court has held a Markman
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`hearing and construes the disputed claim terms as set forth below.
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`I. BACKGROUND
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`Astra's pharmaceutical product Vimovo is a combination drug that contains the active
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`ingredients naproxen, which is a non-steroidal anti-inflammatory drug ("NSAID"), andl
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`esomeprazole magnesium trihydrate, which is a proton pump inhibitor ("PPI"). Vimovo is
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`used to treat the symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.
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`The esomeprazole magnesium trihydrate in Vimovo is the same active ingredient in Astra's
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`drug product Nexium, an acid inhibitor used to treat gastrointestinal disorders. With the
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`combination of these two drug products, patients taking Vimovo have a decreased risk of
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`developing NSAID-associated gastric ulcers.
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`There are six patents-in-suit. The '085 patent, the '070 patent and the '466 patent
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`relate to esomeprazole magnesium trihydrate. The relevant claims of the '907 patent relate to
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`a unit dosage form which contains a combination of an NSAID and an acid inhibitor. The
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`' 504 and ' 872 patents relate to optically pure compositions of certain omeprazole salts. Four
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`of the patents, specifically, the'504 patent, ' 872 patent, '085 patent and '070 patent, have been
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`the subject of other actions before this court involving the dmg Nexium and, consequently,
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`the Court has previously considered and ruled upon the meaning of certain of claim terms at
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`issue in this case. See AstraZeneca AB v. Dr. Reddy's Labs., Ltd. , Civil Action No. 05-5553
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`(JAP) (the "Nexium action"). In addition to the claim terms being addressed by this Court for
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`the first time in the instant actions, Defendants have asked the Court to reconsider some of its
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`earlier rulings with regard to some of the disputed claim terms.
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`II. LEGALSTANDARD
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`In order to prevail in a patent infringement suit, a plaintiff must establish that the
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`patent claim "covers the alleged infringer's product or process." Markman v. Westview
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`Instrs., Inc., 517 U.S. 3 70, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). "It is a bedrock principle
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`of patent law that the claims of a patent define the invention to which the patentee is entitled
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`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.
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`Cir. 1996) ("we look to the words of the claims themselves ... to define the scope of the
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`patented invention"). Consequently, the first step in an infringement analysis involves
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`determining the meaning and the scope ofthe claims of the patent. Johnson Worldwide
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`Assocs., Inc. v. Zebco Corp., 175 F.3d 985, 988 (Fed. Cir. 1995). Claim construction is a
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`matter of law, Markman v. Westview Instrs., Inc. , 52 F.3d 967, 979 (Fed. Cir. 1995) ajj'd 517
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`U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996), therefore, it is "[t]he duty of the trial judge
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`... to determine the meaning of the claims at issue," Exxon Chern. Patents, Inc. v. Lubrizoil
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`Cmp., 64 F.3d 1553, 1555 (Fed. Cir. 1995).
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`Generally, the words of a claim are given their "ordinary and customary meaning,"
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`which is defmed as "the meaning that tbe tenn would have to a person of ordinary skill in the
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`art in question at the time ofthe invention." Phillips, 415 F.3d at 1312- 13 (citations omitted).
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`In this regard, the Federal Circuit has noted that
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`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 u sage 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.
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`!d. (quoting Multiform Desiccants, Inc. v. Medzam, Ltd. , 133 F.3d 1473, 1477 (Fed. Cir.
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`1998)).
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`In order to determine the meaning of a claim as understood by a person skilled in the
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`art, a court may look to various sources from which the proper meaning may be discerned.
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`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
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`extrinsic evidence "concerning relevant scientific principles, the meaning of technical terms,
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`and the state of the art," id.
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`When considering the intrinsic evidence, the court's focus must begin and remain on
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`the language of the claims, "for it is that language that the patentee chose to 'particularly
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`point[ ] out and distinctly claim[ ] the subject matter which the patentee regards as his
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`invention.' " Interactive Gift Express, Inc. v. Compuserve, Inc., 256 F.3d 1323, 1331
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`(Fed.Cir.2001) (quoting 35 U.S. C.§ 112, ~ 2). The specification is often the best guide to the
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`meaning of a disputed tem1. Honeywelllnt'l v. ITT Indus., 452 F.3d 1312, 1318
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`(Fed.Cir.2006). It is improper, however, to import limitations from the specification into the
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`claims. Seachange Int'l v. C- COR Inc., 413 F.3d 1361, 1377 (Fed. Cir. 2005). The court may
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`also consider as intrinsic evidence a patent's prosecution history, which is evidence of"how
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`the inventor understood the invention and whether the inventor limited the invention in the
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`course of prosecution, making the claim scope narrower than it would otherwise be."
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`Phillips, 415 F.3d at 13 17.
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`While a court is permitted to turn to extrinsic evidence, such evidence is generally of
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`less significance and less value in the claim construction process. I d. at 1317. Extrinsic
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`evidence is evidence that is outside the patent and prosecution history, and may include expert
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`testimony, dictionaries, and treatises. Id. The Federal Circuit has noted that caution must be
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`exercised in the use of extrinsic evidence, as this type of evidence may suffer from inherent
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`flaws affecting its reliability in the claim construction analysis. Id. at 1319 ("We have viewed
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`extrinsic evidence in general as less reliable than the patent and its prosecution history in
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`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
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`considered in the context of the intrinsic evidence." Extrinsic evidence may never be used to
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`contradict intrinsic evidence. Id. at 1322-23.
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`III. CONSTRUCTION OF THE DISPUTED CLAIM TERMS
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`The '907 Patent
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`The '907 patent is
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`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 bas been raised to a safe level. The invention also encompasses
`methods of treating patients by administering tbis 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.
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`'907 Patent, Abstract. All of the disputed terms of the '907 patent are found in claim ] . This
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`claim is set forth below, and discussion oftbe disputed claim language follows.
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`Claim 1 ofthe ' 907 patent reads:
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`A pharmaceutical composition in unit dosage form suitable for oral
`administration to a patient, comprising:
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`(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;
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`(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:
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`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.
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`'907 patent, claim I.
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`The parties dispute the construction of the following portions of the claim:
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`1. "an acid inhibitor present in an amount effective to raise the gastric pH of said patient to
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`at least 3. 5 upon the administration of one or more of said unit dosage forms"
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`Plaintiffs contend that this term should be construed as "an acid inhibitor present in an
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`amount capable of raising the gastric pH of said patient to at least 3.5 upon the administration
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`of one or more single entities for drug administration over a period oftime." Defendants
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`argue that this term means "an acid inhibitor present in the unit dosage form in an amount
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`effective to raise gastric pH to at least 3.5 at the time the unit dosage form is administered."
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`The key difference in the parties' constructions centers on whether the acid inhibitor
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`contained in the unit dosage form must be in an amount sufficient to raise gastric pH to 3.5
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`upon administration of a single dose. As can be seen from the proposed constructions,
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`Plaintiffs contend that the disputed claim language encompasses pharmaceutical compositions
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`that rna y require multiple administrations before the acid inhibitor is effective to raise the
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`gastric pH to the desired level, while Defendants contend that the acid inhibitor must obtain
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`the desired effectiveness in a single dose. Contrary to Defendants' arguments, the Court finds
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`that the relevant evidence supports the conclusion that the claim language encompasses an
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`acid inhibitor that may require more than one dose to achieve the desired effectiveness.
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`Significantly, the claim language itself states that achieving the goal of raising gastric
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`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" tmjt dosage forms to a single administration.
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`Defendants' construction, while focusing on the words «upon the administration," improperly
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`reads out the "or more, portion of the claim language. Bicon, Inc. v. Straumann Co., 441
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`F.3d 945, 950 (Fed. Cir. 2006) (noting courts must construe claims with an eye toward giving
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`effect to all the terms in the claim). The "or more" language appears to be specifically
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`designed takes into account the fact that, as acknowledged in the patent, the effect of certain
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`types of acid inhibitors "may be delayed for several hours and may not take full effect for
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`several days." '907 patent, col.l, lines 62- 63. Overall, taking into account all ofthe relevant
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`evidence cited by the parties and, in particular, the language of the patent itself, the Court
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`ftnds that the evidence does not support Defendants' construction.
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`Plaintiffs' proposed construction, while a more accurate construction than
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`Defendants', seems to unnecessarily complicate the issue by swapping certain words in the
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`claim with various synonyms. For example, Plaintiffs' construction swaps "effective to raise''
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`with "capable of raising" and "administration of one or more of said unit dosage forms" with
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`"admimstration of one or more single entities." The Court, however, sees no reason to depart
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`from the clear claim language, and will adopt a construction similar to that proposed by
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`Plaintiffs but whlch modilles the claim language less so than Plaintiffs' proposed
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`construction. The Court ftnds that a person of skill in the art would understand the term "an
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`acid inhibitor present in an amount effective to raise the gastric pH of said patient to at least
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`3.5 upon the administration of one or more of said unit dosage forms" to mean "an acid
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`inhibitor present in an amount effective to raise the gastric pH of said patient to at least 3.5
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`upon the administration of one or more of said unit dosage forms over a period of time" and,
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`consequently, construes the term accordingly.
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`2. "wherein said unit dosage form provides for coordinated release"
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`Plaintiffs argue that the Court should construe this term to mean "wherein the single
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`entity for drug administration provides for the sequential release of acid inhibitor followed by
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`NSAID." Defendants, on the other hand, contend that the proper constmction is "release of
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`the NSAID in the unit dosage form is prevented until the acid inhibitor in the unit dosage
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`form increases gastric pH to at least 3.5." The relevant evidence supports Plaintiffs'
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`construction.
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`As an initial matter, the specification itself defines "coordinated release" as being
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`sequential, namely, the release of an acid inhibitor followed by the release of an NSAID.
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`Specifically, the specification states that "[a]ll of the dosage forms are designed for oral
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`delivery and provide for the coordinated release of therapeutic agents, i.e., for the sequential
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`release of acid inhibitor followed by analgesic." '907 patent, col. 5, lines 16-19. Further, the
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`claim itself describes a sequential release -- the acid inhibitor is first released and the release
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`of the NSAID is delayed until the pH in the "surrounding medium," is 3.5 or higher. This is
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`also described in the specification, which indicates that the dosage form "provides for
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`coordinated release . . . i.e., the acid inhibitor is released first and the release ofNSAID is
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`delayed until after the pH in the GI tract bas risen." '907 patent, col3. line 63 to col4. line 2.
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`During prosecution, the applicant similarly characterized the claimed release as sequential in
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`nature, i.e., the release of the acid inhibitor followed later by the NSAID release. See, e.g.,
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`Andersen Decl. Ex. 5. Overall, the claim language, the specification, and the prosecution
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`history describe a sequential release of drugs, the first of which is the release of the acid
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`inhibitor, which is then followed by the release of the NSAID once the pH of the surrounding
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`environment reaches the appropriate pH.
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`The Court, consequently, finds Plaintiffs' construction to be more consistent with the
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`intrinsic evidence and rejects Defendants' proposed construction. Defendants' construction
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`reads the disputed claim language too narrowly, as the «surrounding medium" is not limited to
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`the stomach as Defendants' construction would require. The specification explains that where
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`gastric pH has not reached the requisite pH the NSAID would not release until it "reaches an
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`environment where the pH is above about 4," which would be in the small intestine. '907
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`patent, col. 14, lines 59- 65; see also, col. 13, lines 12- 18. Having considered all of the
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`relevant evidence, the Court concludes that a person of skill in the art would understand the
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`disputed term to mean "'wherein said unit dosage form provides for coordinated release" to
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`mean "wherein the single entity for drug administration provides for the sequential release of
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`acid inhibitor followed by NSAID."
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`3. "a coating that, upon ingestion of said unit dosage form by said patient, prevents the
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`release of essentially any NSAID from said dosage form unless the pH of the surrounding
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`medium is 3.5 or higher"
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`The parties' dispute over this term relates to the manner in which the specified coating
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`controls the release of the NSAID. Defendants seek a construction that specifies that the
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`means by which the coating controls the release includes both by time and by pH. They
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`propose the following construction: "a coating that, upon ingestion of said unit dosage form
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`by said patient, controls the release ofNSAID by time or pH and thereby prevents the release
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`of essentially any NSAID form said dosage form unless the pH of the surrounding medium is
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`3.5 or higher." Plaintiffs, on the other hand, contend that the plain and ordinary meaning of
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`the phrase should apply, and, further, that the plain and ordinary meaning requires that the
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`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
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`this phrase, which states that the form of control for NSAID release is pH, should apply. The
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`language ofthe claim itself is clear. The coating prevents the release of the NSAID '\mless"
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`the pH of the surrounding medium is 3.5. The term "unless" as it is used here is conditional,
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`not temporal. There is nothing in the claim language itself directed toward controlling the
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`release of the NSAID by time. The Court's conclusion is further supported by the fact that
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`the prosecution history shows that during prosecution the applicant replaced "said NSAID is
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`not released until the gastric pH of said patient is 3.5 or higher" with the language that states
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`NSAID release is prevented "unless the pH of the surrounding medium is 3.5 or higher". See
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`Andersen Dec I. Ex. 3 (emphasis added).
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`Defendants' have not convinced the Court that departure from the plain language of
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`the claim is appropriate and their arguments in support of their proposed construction are
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`unavailing. While it is true that the specification describes two alternative types of coatings,
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`namely, one that controls release by pH and one that controls by time, the time release coating
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`is covered elsewhere in the claims. See, e.g. , claim 37; see also Intamin Ltd. v. Magnetar
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`Techs. , Corp. , 483 F.3d 1328, 1337 (Fed. Cir. 2007) ("A patentee may draft different claims
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`to cover different embodiments."). Defendants also point to claims 19 and 20-- which
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`depend on claim l and are directed to a "barrier coating" that dissolves at a certain rate -- m
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`arguing that that clain1 1 must encompass time-dependent coating. In doing so, however,
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`Defendants ignore that claims 19 and 20 refer to a different coating than claim 1.
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`Consequently, the Court rejects Defendlants proposed construction and fmds that the plain and
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`ordinary meaning of the disputed phrase shall apply. Under the plain and ordinary meaning,
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`the coating controls the release of the NSAID by pH only.
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`4. "enteric coating"
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`The term enteric coating is not expressly defined in the patent. It appears that the
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`parties generally agree that an enteric coating is a delayed-release coating that does not
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`dissolve in the stomach but, rather, dissolves after passing through the stomach to permit
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`release of a drug further down in the digestive tract. Indeed, this is consistent with the
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`specification of the '907 patent, which makes clear that an enteric coating delays release of a
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`drug until after it has passed through the stomach. '907 patent, col 1 line 64 to col. 2 line 2
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`("[T]his class of drugs is enteric coated to avoid destruction by stomach acid."); col. 9 lines
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`50-57 ("The function of the enteric coat is to delay the release ofnaproxen . ... The coating
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`does not dissolve in the harshly acidic pH of the unprotected stomach.").
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`Where the parties' constructions diverge with regard to this term is related to the
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`breadth of the construction. Plaintiffs propose that the term "enteric coating" be constm ed
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`more generally to mean "a delayed release coating." Defendants seek a more specific
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`construction of the term, i.e. , "a coating that controls the release of an active agent from a unit
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`dosage form by pH." In support of their constmction, Plaintiffs argue that the term "enteric"
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`would be understood by one that is skilled in the art as a coating that delays dissolution of the
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`coating and release of the drug further in the digestive tract, but it does not limit the manner in
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`which the drug release is delayed. Defendants counter that persons skilled in the art generally
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`understand an "enteric coating" to be pH dependent.
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`There is limited intrinsic evidence that sheds light on the question of the proper
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`construction of the term. Plaintiffs point out that the background section of the specification
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`at one point mentions a "pH sensitive enteric coating," which Plaintiffs claim would be
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`redundant if the Defendants' constmction 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
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`extrinsic evidence. Not surprisingly, the parties offer conflicting expert opinions. Plaintiffs'
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`expert opines that a person of ordinary skill in the art would understand the term "enteric
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`coating" to mean a delayed release coating, one typically used to delay release of the drug
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`until it reaches the intestines. Williams Decl. ~ 42-46. Plaintiffs' expert bases his opinion in
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`part on the FDA's Guidance for Industry SUPAC-MR: Modified Release Solid Oral Dosage
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`Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In
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`Vitro Dissolution Testing and In Vivo Bioequivalence Documentation (September 1997),
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`which defines "enteric coated" as "[i)ntended to delay the release ofthe drug (or drugs) until
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`the dosage form has passed through the stomach. Enteric coated products are delayed release
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`dosage forms." Williams Decl. Ex. C. Plaintiffs' expert also relies upon a textbook on
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`pharmaceutical dosage forms which describe enteric coatings that can be either pH(cid:173)
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`dependent, enzyme-dependent or time-dependent. Defendants' expert takes a contrary view,
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`and points to certain scientific literature describing pH-dependent enteric coatings.
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`Considering the relevant extrinsic evidence, the Court concludes that one skilled in the
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`relevant art would understand the term «enteric coating" to be a delayed release coating.
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`While the evidence shows that an enteric coating is commonly and perhaps frequently pH(cid:173)
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`dependent, the evidence shows that other types of enteric coatings are utilized in the field.
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`There is nothing in the patent or otherwise that directs a construction that limits the term
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`"enteric coating" in claim 1 of the '907 patent to strictly a pH-dependent form. The Court,
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`therefore, will construe the term consistent with Plaintiffs' proposed construction.
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`5. "at least a portion of said acid inhibitor is no! surrounded by an enteric coating and, upon
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`ingestion of said unit dosage form by said patient, is released regardless of whether the pH of
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`the surrounding medium is below 3.5 or above 3.5"
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`The parties both contend that this phrase shouldl be given its plain and ordinary
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`meaning but, unfortunately, disagree on what the plain and ordinary meaning is. Plaintiffs
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`argue that this phrase means "at least a portion of said proton pump inhibitor is immediately
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`released." Defendants contend that this phrase means "at least some amount of acid inhibitor
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`is not surrounded by an enteric coating and, upon ingestion of said unit dosage form by said
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`patient, is released regardless of whether the pH of the surrounding medium is below 3.5 or
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`above 3.5." Defendants' explain that their constmction, however, incorporates their proposed
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`construction of"enteric coating," which requires the enteric coating specifically to be a pH
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`dependent coating. Thus, under Defendants' proposed constmction of the instant phrase, the
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`claim would exclude only the use of a pH-dependent coating on a portion of the acid inhibitor,
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`but not the use of other delayed release coatings, such as those coatings that are time(cid:173)
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`dependent. However, the Court rejected of Defendants' proposed construction for "enteric
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`coating," finding that the term "enteric coating" was not limited to pH-dependent coatings
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`only. The Court, therefore, rejects Defendants' proposed constmction here.
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`The claims themselves as well as the specification make clear that the acid inhibitor of
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`the invention releases '"immediately" upon ingestion due to the absence of a delayed release
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`coating. See, e.g., '907 patent, col. 8, hnes 47-49 (stating that the acid inhibitor in Example 1
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`is "released from the dosage foml immediately after aru:ninistration"); col. 9, lines 60-62
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`(same for Example 2); see also Example 3 and Example 4. This is consistent with the "'plain
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`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
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`of said acid inhibitor is not surrounded by an enteric coating and, upon ingestion of said unit
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`dosage form by said patient, is immediately released regardless of whether the pH of the
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`surrounding medium is below 3 _5 or above 3 .5."
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`The '085 patent, '070 patent, '466 patent
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`As stated earlier, Vimovo contains an NSAID, naproxen, and a proton pump inhibitor,
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`the trihydrate form of esomeprazole magnesium. The '085 and '070 patents relate to
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`esomeprazole magnesium trihydrate; and the '466 patent relates to the combination of
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`esomeprazole magnesium trihydrate and a second active ingredient selected from a specified
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`group. These three patents have the same inventors and! the same specification, but their
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`claims differ. The '085 patent is limited to a specific form of"the magnesium salt of S-
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`omeprazole trihydrate" characterized by certain x-ray d iffraction "d-values." '085 patent,
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`coLlO lines 5- 34. The '070 patent later issued claiming a form of esomeprazole magnesium
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`trihydrate and certain preparation processes. The '466 patent claims pharmaceutical
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`compositions and methods of treatment comprising esomeprazole magnesium trihydrate and a
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`second active ingredient
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`1. "magnesium salt of S-omeprazole trihydrate"
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`This term appears in the claims ofthe '085 patent (claims 1-5, 7-14, 16), '070 patent
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`(claim 1-4), '466 patent (claims 1-4, 12). Plaintiffs offer the following proposed construction:
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`"magnesium salt of S-omeprazole having approximate! y three molecules of bound water per
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`molecule ofS-omeprazole magnesium." 1 Defendants proposed construction is as follows: "a
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`trihydrate of a magnesium salt of S-omeprazole containing three molecules of water per
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`1 This is not the same proposed construction that appears in the pMties' 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
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`substantially free from magnesium salts ofR-omeprazole and other prior art forms of
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`magnesium salts of S-omeprazole including S-omeprazole dihydrate and amorphous forms. "
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`This disputed term appears in the asserted claims of the three trihydrate patents.
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`Claim 1 of the '070 patent, which reads in its entirety, "[t]he magnesium salt of S-omeprazole
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`trihydrate," is a simple compound claim, while the other asserted claims address preferred
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`embodiments and processes and pharmaceutical compositions. The Court finds that it is clear
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`from a comparison ofthe claims themselves that the term ""[t]he magnesium salt of S(cid:173)
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`omeprazole trihydrate" is intended to have a broad constmction. Having considered the
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`relevant evidence, the Court simply finds no basis to import the limitations sought by
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`Defendants into the claim language.
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`The Court, however, agrees with Defendants that Plaintiffs' constmction is flawed to
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`the extent that it seeks to defme the trihydrate as having "approximately" three molecules of
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`water. This simply is not consistent with the plain and ordinary meaning of the term
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`trihydrate. Consequently, the Court shall constme "magnesium salt of S-omeprazole
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`trihydrate" as "a trihydrate of a magnesium salt of S-omeprazole containing three molecules
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`of water per molecule of magnesium salt of S-omeprazole."
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`2. "characterized by the following major peaks in its X-ray diffractogram"
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`This term appears in the '085 patent (claims 1-4, 12) and the '466 patent (claims 3,
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`11). Plaintiffs contend this phrase means "identifiable by reference to an X-ray diffractogram
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`that includes the major peaks below." Defendants, on the other hand, offer this proposed
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`construction: "having all ofthe 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,
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`wherein the compound is characterized by the following major peaks in its X-ray
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`diffractogram:"
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`d-vnlue r .A
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`Relative Intensity
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`2.67
`2.79
`3.27
`3.52
`3.82
`3.96
`4.14
`5.2
`5.6
`6.7
`6.9
`8.3
`16.6
`
`In
`m
`m
`s
`:s
`VS
`m
`Ill
`m
`vs
`s
`w
`\ ' S
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`The numbers in the left column indicate a position on the x-axis of a peak in an X-ray
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`diffractogram of the material in question and the letters in the right column indicate a relative
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`intensity ofthe corresponding peak.2 The difference between the parties' proposed
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`construction centers on whether the S-omeprazole trihydrate at issue must have all of the
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`referenced peaks without exception.
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`The Court concludes that Defendants' construction, which would require an exact
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`match, is too rigid. The claim language requires o