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Astrazeneca Ab, et al. v. Hanmi Usa

December 10, 2012


The opinion of the court was delivered by: Pisano, District Judge.


Plaintiffs AstraZeneca AB, Aktiebolaget Hassle, AstraZeneca LP, KBI Inc. and KBI-E Inc. (collectively, "AstraZeneca" or "Plaintiffs") bring this patent infringement against defendants Hanmi, Inc., Hanmi Pharmaceutical Co., Ltd., Hanmi Fine Chemical Co., Ltd. and Hanmi Holdings Co., Ltd. (collectively, "Hanmi" or "Defendants") alleging that Hanmi infringed two of AstraZeneca's patents by filing with the U.S. Food and Drug Administration ("FDA") a New Drug Application ("NDA") seeking approval to market their esomeprazole strontium products prior the expiration of certain patents held by AstraZeneca. The patents at issue are U.S Patent No. 5,714,504 (the " '504 patent") and U.S. Patent No. 5,877,192 (the " '192 patent") (together, the "patents-in-suit"), which cover pharmaceutical compositions containing alkaline salts of esomeprazole and methods of the use of such compositions to treat gastric acid related diseases. Presently before the Court is the parties' request for claim construction.


AstraZeneca manufactures and markets Nexium, a capsule drug product containing an esomeprazole salt as the active ingredient. Hanmi is seeking approval from the United States Food and Drug Administration to manufacture esomeprazole strontium capsules in the United States. As part of its NDA, Hanmi submitted a Paragraph IV certification asserting that the '504 patent and the '192 patent are invalid or will not be infringed by their NDA product. Hanmi provided notice to AstraZeneca of its filing by letter dated December 29, 2010, and this lawsuit followed.

The '504 and '192 patents relate to, inter alia, pharmaceutical compounds containing esomeprazole salt active ingredients and methods to treat gastric acid related diseases by administering them. More specifically, the asserted claims of the '504 patent (claims 1--7 and 10) are directed to "pharmaceutical formulation[s]" containing an "alkaline salt" of esomeprazole and methods of use thereof for "inhibiting gastric acid secretion" and "treatment of gastrointestinal inflammatory disease." The asserted claims of the '192 patent (1--7, 10--19 and 21--23) are directed to methods for the "treatment of gastric acid related diseases" with esomeprazole "or a pharmaceutically acceptable salt thereof" and to methods for the "production of a medicament for treating gastric acid related diseases" containing the same.

The parties have requested that the Court construe certain disputed terms in each of the patents-in-suit.*fn1 The Court having held a claim construction hearing on the relevant issues, this Opinion addresses the proper construction of the disputed terms.


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 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 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 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.


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