N OTE : This disposition is nonprecedential. 

# United States **Court of Appeals**  **for the Federal Circuit**

______________________ ASTRAZENECA AB, AKTIEBOLAGET HASSLE, ASTRAZENECA LP, KBI INC. , AND KBI

- E INC., Plaintiffs

- Appellants,

v.

HANMI USA, INC., HAN MI PHARMACEUTICAL CO., LTD., HANMI FINE CHEMICAL CO., LTD.,

AND HANMI HOLDINGS CO., LTD., Defendants

- Appellees.

______________________

2013

- 1490

______________________ Appeal from the Unit ed States District Court for the District of New Jersey in No. 11

- CV

- 0760, Judge Joel A. Pisano.

______________________
Decided: December 19, 2013

______________________

J AY I. A LEXANDER , Covington & Burling LLP, of Washington, DC, argued for plaintiffs

- appellants. With him on the brief were E INAR S TOLE and E RIC R. S ONNENSCHEIN . Of counsel on the brief were H ENRY J. R E NK , B RUCE C. H AAS , and J OSHUA I. R OTHMAN , Fitzpa trick, Cella, Harper & Scinto , of New York, New York.ASTRAZENECA AB v. HANMI USA , INC

. 2

B LAIR M. J ACOBS , McDermott Will & Emery, LLP, of Washington, DC, argued for defendants -appellees. With him on the brief were C HRISTOPHER G. P AULRAJ and P ATRICK J. S TAFFORD . Of counsel on the brief were M ARK B OLAND , M ICHAEL R. D ZWONCZYK , and R ENITA S. R ATHINAM , Sughrue Mion, PLLC, of Washington, DC.

______________________
Before D YK , M OORE , and T ARANTO , Circuit Judges

. T ARANTO , Circuit Judge

. Plaintiffs AstraZeneca AB, Aktiebolaget Hassle, AstraZene ca LP, KBI Inc., and KBI

- E Inc. (collectively, Astra Zeneca) sued Defendants Hanmi USA

, Inc., Hanmi Pharmaceutical Co., Ltd., Hanmi Fine Chemical Co., Ltd.

, and Hanmi Science Co., Ltd., form erly Hanmi Holdings Co., Ltd. (collectively, Hanmi )

. Invoking 35 U.S.C. § 271(e)(2)

, AstraZen eca alleged that a drug Hanmi proposed to market falls within claims of U.S. Patent Nos. 5,714,504 and 5,877, 192

. A fter the district court co nstrued the claim terms “alkaline salt ” in the ’504 patent and “pharmaceutically acceptable salt” in the ’192 pate nt
, the parties consented to the entry of a final judgment of noninfringement based on the constructions

. This appeal presents a single issue: whether the wri tten description limits “alkaline salt” in the ’504 patent to certain specifically named salts. We hold that it does

. T he written description describes the invention clearly and narrowly as including only th os e salts , and Astr aZeneca points to no thing in the intrinsic record that is sufficient to over come that disclaimer

. B ACKGROUND Omeprazole is an “ effective gastric acid secretion i nhibitor[], and [is] useful as [an] antiulcer agent[].” ’504 patent, col. 1, l ines 22

- 23. Two distinct molecules have omeprazole’ s molecular formula and sequence of bondedASTRAZENECA AB v. HANMI USA , INC

. 3

atoms. Th e se “enantiomers” of omeprazole a re mirror

images , which cannot be superimposed on each other. A mixture of the enantiomers in equal amounts is a “ rac emate ” of omeprazole (or “racemic” omeprazole)

. Creating a salt out of omeprazole can enhance stabi lity during storage and transport ation , a useful property in pharmaceutical compounds. See J.A. 5442 (describing the increased stability of certain salts of the racemate). Salts are chemical compounds composed of two opposit ely charged ions: one positive (the cation) and the other negative ( the anion). In an omeprazole salt, the omepr azole molecule is the anion . Several cations have proved suitable for omeprazole , including the metals from Groups IA and II A of the Periodic Table. J.A. 5259.

AstraZeneca discovered that certain salts of an omeprazole enantiomer, as opposed to the racemate

, ha ve “improved pharmacokinetic and metabolic properties which will give an improved therapeutic profile such as a lower degree of interindividual variation.” ’504 patent, col. 1, l ines 51- 54

. Its original application for the ’504 patent, filed in 1995 as a continuation

- in

- part of a 1994 application, described and claimed particular salts

, defined by six identified cations : Na + , Mg 2+ , Li + , K + , Ca 2+
, or N + (R) 4 , where R is an alkyl with one to fo ur carbons. Id. col. 1, line 1, to col. 6, line 35; J.A. 82

- 85. (The last form ula denotes a class of ammonium cations, but for present purposes we may refer to it with the singular “cation ”— making six cations in all. ) During prosecution, AstraZeneca conducted exper iments that led it to conclude that one of the two enanti omers gave particularly good results. J.A. 312

- 25. The preferred enantiomer is known as “( -)- omeprazole” or “(S) omeprazole,” sometimes written as “esomeprazole.” In early 1997, in response to the E xaminer ’s rejection of original claims, AstraZeneca filed amended claims to focus on that enantiomer. J.A. 121, 296

- 309; see also ’192ASTRAZENECA AB v. HANMI USA , INC

. 4

patent, col. 2, l ines 28

- 34 ( continuation

- in

- part filed in April 1997, stating: “ [O] ne of the enantiome rs of omepr azole .

. . is hereby claimed to be an improved alternative to omeprazole in the treatment of gastric acid related di seases resulting in higher dose efficiency and in less inte rindividual variation in plasma levels .”)

. The new claims

, now at is sue , are all limited to pharmaceutical compounds that contain certain esomeprazole salt s as an active ingredient ; but the independent claims no longer expres sly refer to the originally identified six cations , instead claiming an “alkaline salt” or “pharmaceutically accept able salt.” See ’ 504 patent, col. 1 4 , l ines 5-49 ; ’ 192 patent, col. 7 , l ine 1 7, to col. 8, line 54

. Ast raZeneca sells Nexium®

, a product whose active i ngredient is the magnesium (Mg 2+ ) salt of esomeprazole

, magnesium being one Astr aZeneca’s original six cations

. In December 2010, Han m i filed an application with the F ood and Drug Administration under 21 U.S.C. § 355(b)(2) seeking appr oval to sell a product that co ntains the strontium (Sr 2+ ) salt of esomeprazole , strontium not being one of AstraZeneca’s original six cations

. The application certified that the ’ 504 and ’ 192 patents are invalid or would not be infringed by Hanmi’s proposed product. On February 9, 2011, AstraZeneca filed suit, alleging that Han m i’s proposed product infringed the claims of the ’504 and ’192 patents under 35 U.S.C. § 271(e)(2)(A)

. On December 12, 2012, the district cou r t constru ed the term “alkaline salt ” in the ’504 patent and “ p harm aceutically acceptable salt” in the ’ 192 patent . AstraZeneca argued that both terms have the same broad meaning:

a ny “ basic ” salt of esomepra zole that is suitable for use i n a pharmaceutical formulation. Han m i argued that both
terms are limited to the disclosed “ Na + , Mg 2+ , Li + , K + , Ca 2+ or N + (R) 4 salts of the single enantiomers of omepra zole

. ” ’504 patent, col. 2, l ines 42

- 44. T he district court agreed with Han mi

, concluding that the written descriptionASTRAZENECA AB v. HANMI USA , INC

. 5

define s the invention as limited to the disclosed salts. AstraZeneca AB v. Hanmi USA, Inc.

, No. 11

- CV

- 0760
, 2012 WL 6203602 , at *3 -4 (D. N.J. Dec. 12, 2012)

. And because the court held that the ’192 patent incorporates the ’504 patent’ s disclosure

, it construed “pharmaceutica lly acceptable salt” the same way. Id . at *6 -7.

After the district court denied AstraZeneca’ s motion for reconsider ation, the parties consented to the entry of a final judgment that the Han m i product does not infringe under the district court’s claim construction . Consent Order and Final Judgment, AstraZeneca AB v . Hanmi USA, Inc. , No. 11

- CV

- 0760 , Dkt. No. 338 (D. N.J. June 3, 2013). Han m i stipulated that both patents are valid and enforceable. Id . AstraZeneca timely appealed , and w e have jurisdiction under 28 U.S.C. § 1295(a)(1).

D ISCUSSION The only issue on app eal is the proper construction o f the claim term “alkaline salt

, ” a question that we decide de novo. E.g., Cybor Corp. v. FAS Techs., Inc.

, 138 F.3d 1448, 1454

- 56 (Fed. Cir. 1998)

. Because the written description of the ’504 patent contains a clear disclaimer of any salt except those using six enumerated cations, we agree with the district court that “alkaline salt” i s limited to the Na + , Mg 2+ , Li + , K + , Ca 2+ , and N + (R) 4 salts of the

now

- claimed enantiomer of omeprazole

. 1 Independent claim 1 of the ’504 patent claims
[a] pharmaceutical formulation for oral admi nistration comprising a pure solid state alkaline

1 AstraZeneca agrees that the salt limitations in both patents should be construed the same way

. Br. of Appellant at 8. Like the district court, therefore, we focus on the ’504 patent.ASTRAZENECA AB v. HANMI USA , INC

. 6

salt of the ( -)- enantiomer of [omeprazole] and a pharmaceutically acceptable carrier.

Id

., col. 14, l ines 6- 10; see also id.

, col. 14 , l ines 21

- 26 (independent claim 6, a method of administering “a pure solid s tate alkaline salt of the ( -)- enantiomer of [omepr azole] ”); id

., col. 14, l ines 27

- 34 (independent claim 7). It is undisputed that the term “alkaline salt,” on its face and outside the context of the ’504 patent, would not be li mited to the six cations named in the district court’s claim construction. But we agree with the district court that this is a patent in which the written description , by clear disclaimer, limits the claim scope to those cations.

T he first sentence of the Detailed Description declares : The present invention refers to the new Na +
, Mg 2+ , Li + , K + , Ca 2+ or N + (R) 4 salts of the single e nantiomer s of omeprazole, where R is an alkyl with 1- 4 carbon atoms, i.e. Na + , Mg 2+ , Li + , K + , Ca 2+ or N + (R) 4 salts of (+) -[omeprazole] and (-)- [omeprazole], where R is an alkyl with 1

- 4 ca rbon atoms.

Id

., col. 2, l ines 42

- 49. That language clearly defines “the present invention” not as salts of omeprazole, or salts of single enantiomers of omeprazole, but as a particular set of “ new” salts of enantiomers of omeprazole , limited to the six named cations

. The Abstract , though not grammat ically a sente nce, confirms th e limit ing disclaimer by identifying what AstraZeneca said was “novel”: “The novel optically pure compounds Na + , Mg 2+ , Li + , K + , Ca 2+ or N + (R) 4 salts of (+ )- [omeprazole] or ( -)- [omeprazole], in particular sodium and magnesium salt form there of .

. .” Id

., Abstract.

Tho se statements clearly confine the invention to the six identified cations, disclaiming anything else. See, e.g.

, Verizon Servs. Corp. v. Vonage Holdings Corp. , 503 F.3dASTRAZENECA AB v. HANMI USA , INC

. 7

1295, 1308 (Fed. Cir. 2007); Honeywell Int’l, Inc. v. ITT Indus. , 452 F.3d 1312, 1318

- 19 (Fed. Cir. 2006); SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc. , 242 F.3d 1337, 1340

- 45 (Fed. Cir. 2001). The very specificity and origin of the list of cations for salts confirm the plain meaning of th e disclaimer language. AstraZ eneca ’s expert attested that a skilled artisan would presumptively understand that all of the metals of Periodic Table Groups IA and II A , plus ammonium as an “honorary” member of those Groups for th ese purposes, would be suita ble for forming a salt with the negatively charged enantiomer

. J.A. 5354. AstraZeneca chose only certain members of that presumptively suitable class : the first five of the six cations are metals in Groups IA and IIA

, and the sixth is ammonium. By c onspicuously c hoosing only certain members of the class, and using the language it did, AstraZeneca conveyed a clear and definitive meaning that it was disclaiming other members of the class

— like Hanmi’s chosen strontium, another metal from Group IIA, imme diately below calcium in the Periodic Table

. AstraZeneca advances three arguments for concluding otherwise. These arguments do not suffice to overcome the clear disclaimer language of the written description.
First, AstraZeneca asserts that one passage in the written description shows an intent to cover salts other than those of the listed six cations. The sentence Astr aZeneca relies on reads: “Alkaline salts of the single ena ntiomers of the invention are, as mentioned above, beside the sodium salts

. . . and the magnesium salts

. . . , exe mplified by their salts with Li + , K + , Ca 2+ or N + (R) 4 , where R is an alkyl with 1

- 4 C

- atoms.” ’504 patent , col. 5, lines 7

- 11. Astra Z eneca reads the “exemplified” language to mean that all six of the cations identified in column 2 are just examples of a broader group that is the invention. But the sentence does not say that. T he “exemplified” language applies directly to only four of the six cationsASTRAZENECA AB v. HANMI USA , INC

. 8

and is not preceded by the word “also” or any other la nguage that might have more affirmatively suggested an intent to treat all six identified cations as merely exe mplary. The context is also important: the sentence comes after two paragraphs describing the salts from Periodic Table Group IA (involving sodium) and the salt s from Group IIA (involving magnesium) and says that it is just repeating information that was “mentioned above.” In
context
, we think that th e AstraZeneca

- highlighted
sentence is best read as summarizing the two preceding paragraphs, neither of which sug gests that the invention is a broader class of salts than the group identified in column 2

. This sentence does not negate the clear di sclaimer language quoted above.

AstraZeneca next turns to the prosecution history , but it too does not overcome the clear disclaimer language in the patent. When AstraZeneca filed the application that issued as the ’504 patent , t he language of the claims aligned perfectly with the written description’s clear language about the scope of the “present invention” : the broadest of the claims were limited in terms to salts using the six identified cations

, combined with either one of the
two omeprazole enantiomers . J.A. 82. After the Exami ner rejected those claims for anticipat ion and obvious ness , J.A. 117

- 18, AstraZeneca shifte d the focus to unexpected benefits achieved by using the ( -)- enantiomer rather than the (+) -enantiomer . Whereas the original claims and written description treated the two enantiomers with parity

, AstraZeneca now distinguished the prior art by amending th e claims to cover only esomeprazole , which it argued “unexpectedly exhibits a different and more a dvantageous pharmacokinetic profile than the racemic mixture or the (+)

- enantiomer of omeprazole.” J.A. 300. To support that assertion, AstraZeneca submitte d clinical studies that , it explained to the Examiner, “involved both the monovalent sodium salt and the divalent magnesium salt of the ( -)- enantiomer of omeprazole, thus supportingASTRAZENECA AB v. HANMI USA , INC

. 9

the full scope of the genus of alkaline salts disclosed in the application and as claimed herein .” Id . (emphasis added).

AstraZeneca relies on the italicized language to argue for a broadening that overc ame the disclaimer in the patent itself. B ut we think that AstraZeneca is making more of this passage than the language support s. In the context of an amendment that otherwise narrowed the rejected claims, and a written description that so clearly limited the invention to the identified salts, the statement on which AstraZeneca relies is, at a minimum, not clear enough to overcome the limitation. Neither this statement nor anything else in the pros ecution history state s that there is a substantial expansion being undertaken

. T he prosecution history does not mention, or include data for, any salt beyond th e salts identifi ed in the written description. And contrary to AstraZeneca’s contention, the reference to “the full scope of the genus of alkaline salts .

. . as claimed” does not establish a disclaimer

- overriding expansion to a wide class of alkaline salts beyond the al kaline salts identified in column 2. For one thing, the term “genus” can refer simply to an enumerated collection, without an ind ependently unifying characteristic of the collection’ s me mbers

— as when “genus” is used for a Markush

- type claim that recite s a group whose members may have nothing in

common but their membership in the group

. See

, e.g. , Eli Lilly & Co. v. Teva Parenteral Meds

. , Inc. , 689 F.3d 1368, 1 373 (Fed. Cir. 2012) (“generic, Markush

- style claims”); Merck & Co. v. Mylan Pharm s ., Inc. , 190 F.3d 1335, 1340 (Fed. Cir. 1999) (“Markush genus”); Abbott Labs. v. Baxter Pharm. Prods

. , Inc. , 334 F.3d 1274, 128 0 (Fed. Cir. 2003) (“ ‘ A Markush group is a sort of homemade generic expre ssion . . .’ ”). In any event, the full language at issue refers to the “ genus of alkaline salts disclosed in the application and as claimed herein .” (Emphasis added.) That la nguage is naturally understood to limit the genus being described to the particular salts “disclosed in the applic a-ASTRAZENECA AB v. HANMI USA , INC

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tion,” i.e.

, those based on the six enumerated cations. It certainly is not clear in conveying a broader meaning. Finally

, AstraZeneca presses a n argument based on claim differentiation , noting that each independent claim recit ing an “alkaline salt” has a dependent claim that differs only by the addi tion of “wherein the alkaline salt is

a Na + , Mg 2+ , Li + , K + , Ca 2+ or N + (R) 4 salt.” See ’504 patent, col. 14, l ines 14

- 15; id.

, col. 14, l ines 48

- 49. But “t he doctrine of claim differentiation does not .

. . override clear statements of scope in the specification.” The Toro Co. v. White Consol. Indus., Inc. , 199 F.3d 1295, 1302 (Fed. Cir. 1999). Here, what otherwise might be an inference from differences in claim language cannot override the unmistakable l imitation of “alkaline salt” set out in the written description

. C ONCLUSION

T he written description of the ’504 patent contains a clear disclaimer of claim scope, and no other aspect of the intrinsic record clearly points the other way. We ther efore conclude that the district court’s construction of “alkaline salt” was correct , and we affirm the judgment of noninfringement based on that construction

. AFFIRMED