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Takeda Pharmaceutical Co., Ltd., et al v. Sandoz

May 16, 2013

TAKEDA PHARMACEUTICAL CO., LTD., ET AL., PLAINTIFFS,
v.
SANDOZ, INC.,
DEFENDANT.



The opinion of the court was delivered by: United States District Court Northern District of California United States Magistrate Judge Joseph C. Spero

CLAIM CONSTRUCTION ORDER

I.INTRODUCTION

Takeda Pharmaceutical Co., Ltd., Takeda Pharmaceuticals U.S.A., Inc. (formerly known as Takeda Pharmaceuticals North America, Inc.), Takeda Pharmaceuticals LLC, and Takeda 16 Pharmaceuticals America, Inc. (hereinafter, referred to collectively as "Takeda") initiated this 17 patent infringement action under 35 U.S.C. § 271(e)(2), a provision of the Hatch-Waxman Act, 18 and the Declaratory Judgment Act, 28 U.S.C. §§ 2201, 2202, in response to Abbreviated New 19 Drug Applications ("ANDA") No. 203-504, submitted to the U.S. Food and Drug Administration 20 ("FDA") by Sandoz, Inc. ("Sandoz"). In its ANDA, Sandoz seeks FDA approval to manufacture 21 and sell a generic version of Takeda‟s drug DEXILANT (dexlansoprazole), a prescription drug 22 used to treat acid reflux disease. 23 Takeda owns several patents related to dexlansoprazole that it asserts are infringed by Sandoz‟s ANDA product, including U.S. Patent No. 7,790,755 ("the ‟755 Patent"). In this Order, 25 the Court construes the claim term "said polymeric substance" in claim 1 of the "755 Patent. 26 Pursuant to the parties‟ stipulation, the hearing set for May 9, 2013 at 1:30 p.m. was vacated. 27

II.BACKGROUND

The ‟755 Patent relates to controlled-release compositions for imidazoles, a class of compounds of which dexlansoprazole is a member. The asserted claims of the ‟755 Patent are 2 specifically directed at a capsule that uses a dual-delayed release mechanism with two different 3 types of "tablets, granules, or fine granules" (hereinafter referred to as "granules"), each with a 4 different type of enteric coating. Claim 1 describes the compositions and enteric coatings as 5 follows:

A capsule comprising: composition (i) comprising a tablet, granule or fine granule in which a release of an active ingredient is controlled; said tablet, granule or fine granule comprising a core particle containing an imidazole compound [having a chemical formula specified in the claim] and a pH-dependently soluble release-controlled coating-layer which comprises one kind of polymeric substance or a mixture of two or more kinds of polymeric substances having different release properties selected from the group consisting of hydroxypropylmethyl cellulose phthalate, cellulose acetate phthalate, carboxymethylethyl cellulose, methyl methacrylatemethacrylic acid copolymer, methacrylic acid-ethyl acrylate copolymer, methacrylic acid-methyl acrylate-methyl methacrylate copolymer, hydroxypropyl cellulose acetate succinate, polyvinyl acetate phthalate and shellac; said polymeric substance is soluble in the pH range of 6.0 to 7.5, and composition (ii) comprising a tablet, granule or fine granule comprising a core particle containing the active ingredient and enteric coat such that the active ingredient is released in the pH range of no less than 5.0 to no more than 6.0.

‟755 Patent, claim 1 (emphasis added). The Court refers to composition (i) as the "high-pH 19 granule" and composition (ii) as the "low-pH granule" based on the pH ranges specified in the 20 claim for the two compositions. 21

The parties dispute the meaning of the claim term "said polymeric substance" (in bold). In 22 its opening brief, Takeda contends it refers to the phrase that precedes it in claim 1 (also in bold) 23 and thus means "said polymeric substance or mixture of two or more kinds of polymeric 24 substances." Takeda‟s Opening Claim Construction Brief ("Takeda Opening Brief") at 11-12 25 (citing Baldwin Graphic Systems, Inc. v. Siebert, Inc., 512 F.3d 1338, 1340 (Fed. Cir. 2008)). 26

According to Takeda, Baldwin stands for the proposition that where a claim term using "said" 27 refers back to an antecedent phrase that "carries no definitive numerosity," the claim term also is 28 not limited as to numerosity. Id. Here, Takeda asserts, the case is even stronger than Baldwin for finding that "said polymeric substance" may encompass either a single polymeric substance or a 2 mixture of two polymeric substances because the antecedent phrase makes this clear rather than 3 simply leaving the numerosity undefined. Id. at 13. 4

Takeda also cites the following passage in the specification that it contends supports its 5 position that "said polymeric substance" can be a single substance or a combination of the two: 6 methylcellulose phthalate (HP-55, HP-50 manufactured by Shin- Etsu Chemical Co., Ltd.), cellulose acetate phthalate, carboxymethyl ethylcellulose (CMEC manufactured by Freund Industrial Co., Ltd.), methyl methacrylate-methacrylic acid copolymer (Eudragit L100 (methacrylic acid copolymer L) or Eudragit S100 (methacrylic acid copolymer S); manufactured by Rohm Co.), methacrylic acid-ethyl acrylate copolymer (Eudragit L100-55 (dried methacrylic acid copolymer LD) or Eudragit L30D- 55 (methacrylic acid copolymer LD); manufactured by Rohm Co.), methacrylic acid-methyl acrylate-methyl methacrylate copolymer manufactured by Rohm Co.), hydroxypropyl cellulose acetate succinate (HPMCAS manufactured by Shin-Etsu Chemical Co., Ltd.), polyvinyl acetate phthalate and shellac are used. . . . The polymer as the above-mentioned coating material may be used alone or at least 2 or more kinds of the polymers may be used to coat in combination, or at least 2 or more kinds of the polymers may be coated sequentially to prepare multi-layers.

As a coating material for controlling pH-dependently the release of medical active ingredient, polymers such as hydroxypropyl (Eudragit FS30D

Takeda Opening Brief at 13 (quoting "755 Patent, col. 9, ll. 42-65) (emphasis in Takeda Opening 17 Brief ). Takeda argues that the word "polymer" in this passage is used in the same way as the 18 term "polymeric substance" in claim 1 and shows that the inventors used that word to refer to a 19 single substance or a mixture of two substances. Id. at 13. 20

In its responsive brief, Sandoz argues that the claim term is insolubly ambiguous because a 21 person skilled in the art would not know if it refers only to "one kind of polymeric substance" or 22 also to the "mixture of two or more kinds of polymeric substances." Defendant Sandoz, Inc.‟s 23

Responding Claim Construction Brief ("Sandoz Responsive Brief") at 4. Thus, according to 24 Sandoz, to the extent claim 1 identifies a pH range at which "said polymeric substance" is soluble 25 (that is, between pH 6.0 and 7.5), a person skilled in the art would not know if the claim requires 26 that: 1) one kind of polymeric substance be soluble in this range; 2) the mixture of two or more 27 polymeric substances having different release properties be soluble in this range; 3) each of the 28 constituent polymers in the mixture of polymers be ...


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