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IN RE OMEPRAZOLE PATENT LITIGATION

May 19, 2004.

In re OMEPRAZOLE PATENT LITIGATION


The opinion of the court was delivered by: BARBARA JONES, District Judge

Opinion

I. Introduction *fn1

The consolidated trial in this case addressed claims raising issues of infringement, invalidity, and unenforceability asserted in eight different lawsuits involving four groups of Defendants. On October 16, 2002, this court issued an Opinion and Order that decided the issues raised during Phase I and Phase III of the consolidated trial in this case and involved all parties to this suit. See In re Omeprazole Patent Litig., 222 F. Supp.2d 423 (S.D.N.Y. 2002) (hereinafter Omeprazole I), m naff'd, (Fed. Cir. Dec. 11, 2003) (unpublished decision) (hereinafter Omeprazole II). This decision resolves the issues that were presented in Phase II and Phase IV of the trial and that pertain only to claims pending between Plaintiffs, referred to collectively as "Astra," and Defendant Andrx Pharmaceuticals, Inc. ("Andrx"). Phase II of the trial of this action presented proof on infringement and validity of U.S. Patent Number 6,013,281 (the "`281 patent"), which is owned by Astra. Phase IV of the trial of this action presented proof on Andrx's defenses of inequitable conduct and unclean hands. This case was tried to the court sitting without a jury. The court has considered trial testimony, deposition testimony, exhibits, and pre-trial and post-trial briefing submitted by the parties. The court has made determinations as to the relevance and materiality of the evidence and assessed the credibility of each witness. Upon the record before the court, pursuant to Federal Rule of Civil Procedure 52(a), the court finds the following facts to have been proven by the appropriate standard of proof and sets forth its conclusions of law.

  For the reasons stated below, the court finds the following: Defendant Andrx literally infringes claims 1, 2, 3, 7, 9, 16 and 20-21 of the `281 patent. Claims 1, 2, 3, 7, 16 and 20-21 of the `281 patent are invalid as anticipated. Claim 9 of the `281 patent is invalid as obvious. The asserted claims of the `505 and `230 patents are not unenforceable against Andrx. II. Phase II

  A. Claim Construction of the `281 Patent

  Astra filed the application for the `281 patent based on PCT Application No. PCT/SE96/00161, claiming priority on a Swedish patent application filed on February 9, 1995. The `281 patent addresses methods of making a pharmaceutical dosage form containing proton pump inhibitors, like omeprazole, which are useful for inhibiting gastric acid secretion.*fn2 (See, e.g., P3, col. 4: 41-43; Langer Tr. 5240: 2-11.) Those drugs are susceptible to degradation in acidic reacting and neutral media. (See, e.g., P3, col. 4:58-60.) Therefore, the proton pump inhibitor preferably is protected from contact with acidic reacting gastric juice so that it is transferred intact to the portion of the gastrointestinal tract where the pH is higher and where absorption of the proton pump inhibitor can occur. (See, e.g., id., col. 4: 64 — col. 5 : 4.) Formulation of proton pump inhibitors such as omeprazole is preferably accomplished through the use of a dosage form that has, among other things, a core containing an alkaline reacting compound ("ARC"), an enteric coating, and a separating layer between the core and the enteric coating. (See id., col. 5:5-11.) The `281 patent claims processes for forming a separating layer. (See, e.g., id., col. 5: 44-49.) Specifically, the `281 patent concerns a process for creating a separating layer between the core and the enteric coating by causing an in situ reaction involving the applied enteric-coating material and the ARC in the substrate being coated. (See, e.g., id. ) That reaction creates a salt form of the enteric-coating polymer(s) that is situated between the core and the enteric-coating layer. Thus, the result of the `281 process is to manufacture a formulation for a proton pump inhibitor like that claimed in the `505 and `230 patents, which has three distinct layers. (See id., Ex. C.)

  According to the claims of the `281 patent, one prerequisite for forming the in situ layer is the concentration of the ARC in the substrate, which must be more than 0.1 mmol/g dry ingredients in the alkaline-containing part of the core. (See, e.g., id., claim 1 and Certificate of Correction.) In addition, the specification of the `281 patent teaches that process variables used during the enteric-coating process must be adjusted to take into account the particular enteric coatings and equipment. (Langer Tr. 5240:16-5241:11.) The `281 patent states that "process parameters such as inlet air temperature, air flow, atomizer air flow and spraying rate are adjusted with respect to the equipment used for the process as well as the specific enteric coating polymer(s)." (P3, col. 8:51-55.) For example, the `281 patent teaches that when using hydroxypropyl methylcellulose acetate succinate LF ("HPMCAS LF"), the following process information is included for applying the enteric coating to a tablet: 100 grams of core material was coated at a rate of 3.8 grams per minute, inlet air temperature was 42° Celsius and flow was set to 40 Nm3/hr, atomizer airflow was 2.1 Nm 3/hr obtained with a pressure of 1.7 bar. In addition, after enteric coating, the inlet air temperature was raised to 60° Celsius, and the product was kept at that temperature for approximately five minutes. (See id., col. 11:41-65.) The `281 patent also explains that the in situ layer has certain characteristics: it shows intense fluorescence when analyzed by confocal laser scanning microscopy ("CLSM") (see id., col. 5:60 — col. 6:3; see also Lovgren Tr. 1763:19-1764:1), and the salt of the enteric-coating polymer that forms the separating layer is not soluble in acetone (see P3, col. 9:42-48).

  The `281 patent contains 21 claims. Astra asserts claims I, 2, 3, 7, 9, 16 and 20-21 of the `281 patent against Andrx. Claim 1, an independent process claim, is the only independent claim contained in the `281 patent. The remaining asserted claims of the `281 patent are process claims that depend on claim 1, but then add other features or specify requirements applicable to particular aspects of or ingredients used in the process. The first claim of the `281 patent requires the following process:
A process for preparing an oral pharmaceutical formulation comprising the steps of: forming a core material comprising a proton pump inhibitor and at least one alkaline reacting compound, wherein the concentration of the alkaline reacting compound is more than 0.1 mmol/g dry ingredients in the alkaline containing part of the core material, and applying an enteric coating polymer so as to surround the core material thereby forming in situ a separating layer as a water soluble salt product between the alkaline compound and the enteric coating polymer.
  (P3, col. 15:65 — col. 16:9, Certificate of Correction.) The only terms in dispute for the purposes of claim construction appear in the first claim. Claim construction disputes exist with regard to the following two terms found in the claims of the `281 patent: "in situ " and "separating layer." For a detailed description of the legal standards applicable to the court's interpretation of the claim terms at issue in this case, see Omeprazole I, at 441-44.

  1. The Term "In Situ "

  According to the claim language itself, the core material lies on one side of the separating layer, while the enteric coating lies on the other side: "thereby forming in situ a separating layer as a water soluble salt product between the alkaline compound and the enteric coating polymer." (P3, col. 16:7-9 (emphasis added).) "In situ" is a scientific or technical term of Latin origin that literally means "in place." or, in the original location. (Astra's Cl. Constr. Mem. of 11/5/01, Ex. 31, McGraw Hill Dictionary of Scientific and Technical Terms, 5th ed. at 1023 (1994).) A person of ordinary skill in the art would understand the term "in situ " to have that meaning. (See Langer Tr. 5245:19-5246:1.)

  "In situ" in the context of claim 1 of the `281 patent refers to the formation of the separating layer within the formulation, as compared to its separate application, a process covered by the claims of the `505 and `230 patents. This construction of "in situ " is supported by the specification:
According to a second aspect [,] the present invention provides a process for the manufacture of two functionally different layers in one manufacturing step. By such a process a separating layer comprising a water soluble salt of an enteric coating polymer is obtained, as well as the enteric coating layer itself.
According to said process the separating layer is formed by an in situ reaction between the enteric coating polymer and the alkaline core material comprising the pharmaceutically active substance.
(P3, col. 5:44-58.) Thus, the separating layer is created within the formulation-in place-by the chemical reaction of an alkaline reacting compound and the enteric coating.

  The patent specifications repeatedly describe the separating layer as forming "spontaneously" during the enteric-coating process. (See id., col. 9:49-50 ("separating layer is spontaneously formed in situ during the process"), col. 10:32-33, col. 11:2-3, col. 12:6-7, col. 13:46-47, col. 14:45-46.) Citing the testimony of its expert Dr. Banakar concerning that language in the specification, Andrx argues that a person of ordinary skill in the art of pharmaceutical formulation would have understood the term "forming in situ " to mean forming immediately during the enteric-coating process. (See Banakar Tr. 5217:16-17 ("The plain meaning of the word `spontaneous' is right away, immediately.").) However, there is no temporal requirement in either the claims or the specification for when the separating layer must form. The fact that the specification refers to the separating layer forming spontaneously means that it forms without additional human effort. (Langer Tr. 5251:14-23.)

  2. The Term "Separating Layer"

  Andrx argues that the terms "subcoating" and "separating layer" are used interchangeably throughout the `505, `230 and `281 patents, so that both terms should be accorded the same definition throughout. (See Andrx Cl. Constr. Mem. of 11/5/01, at 22.) In fact, the terms "subcoating" and "separating layer" are not used interchangeably in the `505 and `230 patents. The court has analyzed the ordinary meaning of the terms "subcoating" and "separating layer" in detail in the context of construing the term "subcoating" as used in the claims of the `505 and `230 patents. See Omeprazole I, at 464-68. The court defined the term "subcoating" to mean "a layer that is physically on and conforms to the contours of a core and is underneath another layer-the enteric coating." Id. at 464. The court also found that the specifications of the `505 and `230 patents make clear that the subcoating required by the claims of the `505 and `230 patent is a type of separating layer, as that term is used in the specifications of the `505 and `230 patents. Id. at M465. Thus, the subcoating required by the claims of the `505 and `230 patents is a species of the more generic term "separating layer" as used in the `505 and "230 patents, id., and the terms "subcoating" and "separating layer" do not have the same definition in the `505 and `230 patents.

  Like its use in the `505 and `230 patents, the term "separating layer" as used in the `281 patent is a generic term, which includes different species like subcoatings and capsules. As the `281 patent explains, there are different kinds of separating layers:
The discoloration can be avoided by applying some type of separating layer between the core material. . . .
Thus, there are a lot of patent applications describing such a separating layer between a core material comprising the pharmaceutically active substance and an enteric coating layer. See for instance, U.S. Pat. No. 4,786,505. . . .
(P3, col. 5:18-25 (emphasis added).) The `505 patent identifies gelatin capsules as one kind of separating layer and subcoatings as another. See Omeprazole I, at 465-66. (See also Pl, col. 4:8-11.) The difference then, is not the definition that the patents ascribe to the term `'separating layer," which has the same meaning in all three patents. Rather, the difference is in the choice of claim language. The `505 and `230 patents claim only the species of separating layer that is a subcoating, while the `281 patent contains broader claim language that covers not only subcoatings but all species of separating layers.*fn3

  Like the definition Andrx proposed for the term "subcoating" in the claims of the `505 and `230 patents, the definition Andrx proposes for the term "separating layer" in the claims of the `281 patent would impose numerous additional requirements on the separating layer that are not stated in the claims. See Omeprazole I, at 470-71. For example, Andrx's construction of the term "separating layer" would require that the layer be continuous so that the core and the enteric coat do not come into contact with each other. (See Andrx Cl. Constr. Mem. of 11/5/01, at 21-22; Andrx Cl. Constr. Reply Mem. of 11/12/01, at 8.) Andrx argues that if the separating layer is not continuous, then it cannot perform its intended function, which is to keep the omeprazole in the core from coming into contact with the enteric coating. (Andrx Cl. Constr. Mem. of 11/5/01, at 22.) The court has already decided that, as understood by a person of ordinary ...


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