United States Court of Appeals
`for the Federal Circuit
`__________________________
`
`SUN PHARMACEUTICAL INDUSTRIES, LTD.,
`Plaintiff-Appellee,
`
`v.
`ELI LILLY AND COMPANY,
`Defendant-Appellant.
`__________________________
`2010-1105
`__________________________
`Appeal from the United States District Court for the
`Eastern District of Michigan in case no. 07-CV-15087,
`Judge George Caram Steeh.
`__________________________
`
`Decided: July 28, 2010
`__________________________
`JAMES F. HURST, Winston & Strawn LLP, of Chicago,
`Illinois, argued for plaintiff-appellee. With him on the
`brief were GAIL J. STANDISH and PETER E. PERKOWSKI, of
`Los Angeles, California.
`
`
`CHARLES E. LIPSEY, Finnegan, Henderson, Farabow,
`Garrett & Dunner, LLP, of Reston, Virginia, argued for
`defendant-appellant. With him on the brief were ROBERT
`D. BAJEFSKY, HOWARD W. LEVINE, ROBERT F. SHAFFER and
`JESSICA R. UNDERWOOD, of Washington, DC. Of counsel
`
`
`for the Federal Circuit
`__________________________
`
`SUN PHARMACEUTICAL INDUSTRIES, LTD.,
`Plaintiff-Appellee,
`
`v.
`ELI LILLY AND COMPANY,
`Defendant-Appellant.
`__________________________
`2010-1105
`__________________________
`Appeal from the United States District Court for the
`Eastern District of Michigan in case no. 07-CV-15087,
`Judge George Caram Steeh.
`__________________________
`
`Decided: July 28, 2010
`__________________________
`JAMES F. HURST, Winston & Strawn LLP, of Chicago,
`Illinois, argued for plaintiff-appellee. With him on the
`brief were GAIL J. STANDISH and PETER E. PERKOWSKI, of
`Los Angeles, California.
`
`
`CHARLES E. LIPSEY, Finnegan, Henderson, Farabow,
`Garrett & Dunner, LLP, of Reston, Virginia, argued for
`defendant-appellant. With him on the brief were ROBERT
`D. BAJEFSKY, HOWARD W. LEVINE, ROBERT F. SHAFFER and
`JESSICA R. UNDERWOOD, of Washington, DC. Of counsel
`
`
`
`SUN PHARMACEUTICAL v. ELI LILLY
`
`2
`
`
`
`on the brief was JAMES P. LEEDS, Eli Lilly and Company,
`of Indianapolis, Indiana.
`__________________________
`Before BRYSON, GAJARSA, and PROST, Circuit Judges.
`PROST, Circuit Judge.
`Appellant Eli Lilly and Company (“Lilly”) appeals
`from a final judgment of the U.S. District Court for the
`Eastern District of Michigan, finding claims 2, 6, and 7 of
`U.S. Patent No. 5,464,826 (“’826 patent”) invalid for
`obviousness-type double patenting over U.S. Patent No.
`4,808,614 (“’614 patent”). Because the district court
`correctly found these claims of the ’826 patent invalid, we
`affirm.
`
`BACKGROUND
`
`Lilly markets the drug Gemzar® for the treatment of
`various forms of cancer. The active ingredient in
`Gemzar® is gemcitabine. Both patents at issue in this
`suit, the ’614 patent and the ’826 patent, cover gemcit-
`abine and are therefore listed in the Food and Drug
`Administration’s (“FDA’s”) Approved Drug Products with
`Therapeutic Equivalence Evaluations (the “Orange Book”)
`with respect to Gemzar®. The ’614 patent claims gemcit-
`abine, as well as a method of using gemcitabine for treat-
`ing viral infections. The ’826 patent, however, claims a
`method of using gemcitabine for treating cancer.
`The ’614 patent, entitled “Difluoro Antivirals and In-
`termediate Therefor,” issued on February 28, 1989 and
`expired on May 15, 2010. The ’614 patent resulted from a
`divisional application, filed December 4, 1984, as a con-
`tinuation-in-part of U.S. Patent Application Serial No.
`
`
`
`3
`
`SUN PHARMACEUTICAL v. ELI LILLY
`
`
`
`473,883 (“original ’883 application”), filed on March 10,
`1983.1 ’614 patent at [60], col.1 ll.7-11.
`The specification of the original ’883 application de-
`scribed only gemcitabine’s utility for antiviral purposes.
`The continuation-in-part that resulted in the ’614 patent
`added a description of gemcitabine’s anticancer utility to
`the specification. Specifically, the specification of the ’614
`patent explains:
`In addition to the antiviral utility of the present
`compounds, certain of the compounds of the pre-
`sent invention have also demonstrated excellent
`oncolytic activity in standard cancer screens. A
`particularly preferred compound with this utility
`is [gemcitabine]. This compound demonstrated
`activity in tumor systems L1210V lymphocytic
`leukemia, 6C3HED lymphosarcoma, CA-755 ade-
`nocarcinoma, P1534J lymphatic leukemia and
`X5563 plasma cell myeloma.
`Id. col.17 ll.53-63 (emphases added). Claims 1, 2, and 8 of
`the ’614 patent are directed to a class of nucleosides,
`which includes gemcitabine, whereas dependent claim 12
`is directed solely to gemcitabine. Id. col.19. l.56-col.22
`l.15. Claims 13 and 14 of the ’614 patent recite a method
`of using the claimed nucleosides, including gemcitabine,
`for treating Herpes viral infections. Id. col.22 ll.16-24.
`The ’614 patent does not claim a method of using any of
`the claimed nucleosides for treating cancer.
`
`1 Lilly and Sun Pharmaceutical Industries, Ltd.
`(“Sun”) did not dispute before the district court or on
`appeal that the ’614 patent is entitled to the benefit of the
`filing date of the original ’883 application. See Lilly’s
`Principal Br. 8, 21; Lilly’s Reply Br. 12, 19.
`
`
`
`
`SUN PHARMACEUTICAL v. ELI LILLY
`
`4
`
`
`
`On December 4, 1984, the same day that Lilly filed
`the continuation-in-part that resulted in the ’614 patent,
`Lilly filed another patent application that ultimately
`issued as the ’826 patent. The ’826 patent, titled “Method
`of
`Treating
`Tumors
`in
`Mammals
`with
`2’,2’Difluoronucleosides,” issued on November 7, 1995.
`The ’826 patent expires on November 7, 2012, which is
`two-and-a-half years after the expiration of the ’614
`patent. Lilly did not file a terminal disclaimer with
`respect to the ’826 patent.
`Each claim of the ’826 patent is directed to a method
`of treating cancer with an effective amount of a class of
`nucleosides, which includes gemcitabine. Specifically,
`claim 1 of the ’826 patent recites “[a] method of treating
`susceptible neoplasms[, i.e., cancer,] in mammals com-
`prising administering to a mammal in need of such
`treatment a therapeutically effective amount” of the class
`of nucleosides. ’826 patent col.23 l.41-col.24 l.46. Claim 2
`of the ’826 patent, which depends from claim 1, is specifi-
`cally directed to a method of using gemcitabine “or a
`pharmaceutically acceptable salt thereof” for this purpose.
`Id. col.24 ll.46-48. Dependent claims 6 and 7 are directed
`to treating specific “susceptible neoplasms,” including
`“leukemias, sarcomas, carcinomas, and myelomas,” with
`the entire class of nucleosides and gemcitabine respec-
`tively. Id. col.24 ll.59-64.
`In 2006, Sun, a generic drug manufacturer, filed an
`Abbreviated New Drug Application (“ANDA”) with the
`FDA in which Sun sought approval to market a generic
`version of Lilly’s Gemzar® and certified that both the ’614
`patent and the ’826 patent were invalid or not infringed.
`On November 29, 2007, Sun filed this declaratory judg-
`ment action against Lilly, seeking declaratory relief that
`the ’826 patent is invalid and not infringed. Lilly filed
`
`
`
`5
`
`SUN PHARMACEUTICAL v. ELI LILLY
`
`
`
`counterclaims for infringement of the ’826 patent and the
`’614 patent.
`On August 17, 2009, the district court granted Sun’s
`motion for partial summary judgment that the asserted
`claims, namely claims 2, 6, and 7, of the later ’826 patent
`are invalid for obviousness-type double patenting over the
`earlier ’614 patent. Sun Pharm. Indus., Ltd. v. Eli Lilly
`& Co., 647 F. Supp. 2d 820 (E.D. Mich. 2009) (“Summary
`Judgment Order”). Relying primarily on our decisions in
`Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC,
`349 F.3d 1373 (Fed. Cir. 2003), and Pfizer, Inc. v. Teva
`Pharmaceuticals USA, Inc., 518 F.3d 1353 (Fed. Cir.
`2008), the district court concluded that, given the ’614
`patent’s disclosure of gemcitabine’s anticancer use, claim
`12 of the earlier ’614 patent, which claims gemcitabine,
`and claims 2, 6, and 7 of the later ’826 patent, which
`claim a method of using gemcitabine for cancer treatment,
`are not patentably distinct as a matter of law. Summary
`Judgment Order, 647 F. Supp. 2d at 824-25.
`Upon motion by Lilly, the district court, pursuant to
`Federal Rule of Civil Procedure 54(b), entered final judg-
`ment that the ’826 patent is invalid. Lilly timely ap-
`pealed to this court. We have jurisdiction under 28 U.S.C.
`§ 1295(a)(1).
`
`DISCUSSION
`
`“Double patenting is a question of law, which we re-
`view without deference.” Pfizer, 518 F.3d at 1363. Simi-
`larly, we review “a district court’s grant of summary
`judgment without deference.”
` Perricone v. Medicis
`Pharm. Corp., 432 F.3d 1368, 1372 (Fed. Cir. 2005). “A
`court considering summary judgment must draw all
`
`
`
`SUN PHARMACEUTICAL v. ELI LILLY
`
`6
`
`
`
`reasonable inferences in favor of the nonmovant.” Ge-
`neva, 349 F.3d at 1379.
`“The doctrine of double patenting is intended to pre-
`vent a patentee from obtaining a timewise extension of [a]
`patent for the same invention or an obvious modification
`thereof.” In re Basell Poliolefine Italia S.P.A., 547 F.3d
`1371, 1375 (Fed. Cir. 2008). The proscription against
`double patenting takes two forms: (1) statutory double
`patenting, which stems from 35 U.S.C. § 101 and prohib-
`its a later patent from covering the same invention, i.e.,
`identical subject matter, as an earlier patent, and (2)
`obviousness-type double patenting, which is a judicially
`created doctrine that prevents a later patent from cover-
`ing a slight variation of an earlier patented invention.
`Perricone, 432 F.3d at 1372-73; see Geneva, 349 F.3d at
`1377-78.
`The second type of double patenting, obviousness-type
`double patenting, prohibits “claims in a later patent that
`are not patentably distinct from claims in a commonly
`owned earlier patent.” In re Basell, 547 F.3d at 1375. An
`obviousness-type double patenting analysis, which “com-
`pares claims in an earlier patent to claims in a later
`patent or application,” Geneva, 349 F.3d at 1378 n.1,
`consists of two steps, Pfizer, 518 F.3d at 1363. First, the
`court “construes the claim[s] in the earlier patent and the
`claim[s] in the later patent and determines the differ-
`ences.” Id. Second, the court “determines whether those
`differences render the claims patentably distinct.” Id. “A
`later claim that is not patentably distinct from,” i.e., “is
`obvious over[] or anticipated by,” an earlier claim is
`invalid for obviousness-type double patenting. Eli Lilly &
`Co. v. Barr Labs., Inc., 251 F.3d 955, 968 (Fed. Cir. 2001).
`
`
`
`7
`
`SUN PHARMACEUTICAL v. ELI LILLY
`
`
`
`Our prior obviousness-type double patenting decisions
`in Geneva and Pfizer, which addressed factual situations
`closely resembling that presently before the court, control
`this case. In both cases, we found claims of a later patent
`invalid for obviousness-type double patenting where an
`earlier patent claimed a compound, disclosing its utility in
`the specification, and a later patent claimed a method of
`using the compound for a use described in the specifica-
`tion of the earlier patent. See Pfizer, 518 F.3d at 1363;
`Geneva, 349 F.3d at 1385-86. We held that a “claim to a
`method of using a composition is not patentably distinct
`from an earlier claim to the identical composition in a
`patent disclosing the identical use.” Pfizer, 518 F.3d at
`1363; Geneva, 349 F.3d at 1385-86.
`In Geneva, the earlier patent claimed a compound, po-
`tassium clavulanate, and the specification disclosed its
`effectiveness in inhibiting β-lactamase in humans. 349
`F.3d at 1384-86. The later patent then claimed a method
`of using the compound to effect β-lactamase inhibition in
`humans or animals. Id. In our obviousness-type double
`patenting analysis, we determined that to ascertain the
`scope of the earlier patent’s claim to the compound itself,
`we had to examine the specification of the earlier patent,
`including the compound’s disclosed utility. Id. at 1385.
`Upon reviewing this disclosure, we concluded that the
`claims of the two patents were not “patentably distinct”
`and thus the later patent was invalid for obviousness-type
`double patenting, because the later patent “claim[ed]
`nothing more than [the earlier patent’s] disclosed utility
`as a method of using the . . . compound.” Id. at 1385-86.
`Similarly, in Pfizer, the earlier patent claimed several
`compounds and the specification disclosed their use in
`treating
`inflammation and
`inflammation-associated
`disorders. 518 F.3d at 1363 & n.9; see U.S. Patent No.
`
`
`
`SUN PHARMACEUTICAL v. ELI LILLY
`
`8
`
`
`
`5,563,165 (“’165 patent”), at [57], col.1 ll.11-14, col.3 ll.3-
`27. The later patent then claimed a method of using
`these compounds for treating inflammation, inflamma-
`tion-associated disorders, and specific
`inflammation-
`associated disorders, including arthritis, pain, and fever.
`Pfizer, 518 F.3d at 1363 & n.9; see U.S. Patent No.
`5,760,068 (“’068 patent”) col.97 l.49-col.108 l.29. After
`rejecting the patentee’s objection to our consideration of
`the specification of the earlier patent, we determined that
`the later patent “merely claims a particular use described
`in the [earlier] patent of the claimed compositions of the
`[earlier] patent.” Pfizer, 518 F.3d at 1363 & n.8. As such,
`we concluded that the asserted claims of the later patent
`were not “patentably distinct” from the claims of the
`earlier patent, and thus the later patent was invalid for
`obviousness-type double patenting. Id. at 1368.
`Lilly attempts to distinguish Geneva and Pfizer from
`this case, arguing that the holding of these cases should
`be limited to their facts. Lilly contends that in both cases,
`the specification of the earlier patent disclosed a single
`use for the claimed compound, which was an essential
`part of the patented invention and thus necessary to
`patentability. Lilly argues that the double-patenting
`analysis of Geneva and Pfizer does not apply to the later
`’826 patent claims reciting a method of using gemcitabine
`for cancer treatment because, though the specification of
`the earlier ’614 patent disclosed gemcitabine’s use in
`treating both viral infections and cancer, the antiviral use
`provided the essential utility necessary to the patentabil-
`ity of the ’614 patent’s claim to gemcitabine. Lilly objects
`to what it characterizes as the district court’s extension of
`the obviousness-type double patenting analysis of Geneva
`and Pfizer to any utility disclosed in the specification of
`an earlier patent. We reject Lilly’s argument.
`
`
`
`9
`
`SUN PHARMACEUTICAL v. ELI LILLY
`
`
`
`It is true that, as the Geneva court recognized, the
`earlier patent in Geneva disclosed a “single use” for the
`claimed compound, namely inhibition of β-lactamase. 349
`F.3d at 1384-86. However, the reasoning and holding of
`Geneva are not so limited. Id. Our later decision in Pfizer
`demonstrates this point. We disagree with Lilly’s attempt
`to characterize Pfizer as involving a single disclosed
`utility, as well as with its argument that the decision’s
`rationale turned on this alleged single utility.
`First, Lilly’s classification of Pfizer is factually erro-
`neous because the earlier patent’s specification unambi-
`guously disclosed more than one utility for the claimed
`compound. Specifically, the specification of the earlier
`patent described the compound’s use in treating both
`inflammation and inflammation-associated disorders.2
`The specification also enumerated nearly fifty different
`inflammation-associated disorders, including pain, head-
`aches, fever, arthritis, asthma, bronchitis, skin-related
`conditions, and gastrointestinal conditions, for which the
`claimed compounds “would be useful.” ’165 patent col.3
`ll.3-27. The specification’s discussion of the compounds’
`use for both inflammation and inflammation-associated
`disorders, as well as the diverse range of ailments ex-
`pressly included in the “inflammation-associated disor-
`ders” category, shows that the specification disclosed
`
`
`2 See, e.g., ’165 patent, at [57] (“A class of . . . com-
`pounds is described for use in treating inflammation and
`inflammation-related disorders.”) (emphasis added); id.
`col.1 ll.11-14 (“This invention . . . specifically relates to
`compounds . . . for treating inflammation and inflamma-
`tion-associated disorders, such as arthritis.”) (emphasis
`added); id. col.3 ll.3-27 (“Compounds of Formula I would
`be useful for the treatment of inflammation in a subject,
`and for treatment of other
`inflammation-associated
`disorders.”) (emphasis added).
`
`
`
`SUN PHARMACEUTICAL v. ELI LILLY
`
`10
`
`
`
`more than one use for the claimed compounds. The later
`patent even claimed the compounds’ use for inflamma-
`tion,
`inflammation-associated disorders, and specific
`inflammation-associated disorders, including arthritis,
`pain, and fever, in separate dependent claims, further
`evidencing that the utilities disclosed in the specification
`of the earlier patent are distinct. See ’068 patent col.108
`ll.18-27. Therefore, we do not agree that Pfizer involved a
`single disclosed utility that was alone essential to the
`patentability of the claimed compounds.
`Moreover, the analysis in the Pfizer decision shows
`that obviousness-type double patenting encompasses any
`use for a compound that is disclosed in the specification of
`an earlier patent claiming the compound and is later
`claimed as a method of using that compound. Pfizer
`never implies that its reasoning depends in any way on
`the number of uses disclosed in the specification of the
`earlier patent. See 518 F.3d at 1363. Instead, its broad
`analysis reflects that the court considered the multiple
`uses for the compound that were discussed in the specifi-
`cation of the earlier patent. Indeed, the Pfizer decision
`ultimately invalidated claims in the later patent that
`were separately directed to these multiple uses, including
`inflammation, inflammation-associated disorders, and the
`specific inflammation-associated disorders of arthritis,
`pain, and fever. Id. at 1363 & n.9; see ’068 patent col.108
`ll.18-27.
`Thus, the holding of Geneva and Pfizer, that a “claim
`to a method of using a composition is not patentably
`distinct from an earlier claim to the identical composition
`in a patent disclosing the identical use,” extends to any
`and all such uses disclosed in the specification of the
`
`
`
`11
`
`SUN PHARMACEUTICAL v. ELI LILLY
`
`
`
`earlier patent.3 Pfizer, 518 F.3d at 1363; Geneva, 349
`F.3d at 1385-86. Indeed, as both cases recognized,
`[i]t would shock one’s sense of justice if an inven-
`tor could receive a patent upon a composition of
`matter, setting out at length in the specification
`the useful purposes of such composition, . . . and
`then prevent the public from making any benefi-
`cial use of such product by securing patents upon
`each of the uses to which it may be adapted.
`Pfizer, 518 F.3d at 1363 n.8 (emphases added); Geneva,
`349 F.3d at 1386 (quoting In re Byck, 48 F.2d 665, 666
`(CCPA 1931)).
`Furthermore, we reject Lilly’s argument that the dis-
`trict court erred in consulting the specification of the
`issued ’614 patent, as opposed to the specification of an
`earlier application, to ascertain the relevant disclosed
`uses of the compound gemcitabine for its obviousness-type
`
`3
`In rejecting Lilly’s proposed single, essential util-
`ity test, we also note that such a test would be unwork-
`able. Where an earlier patent specification describes
`multiple uses for a compound, a court would be unable to
`identify the one use that was “essential” or “necessary” to
`patentability. Indeed, Lilly’s counsel repeatedly conceded
`at oral argument that “many times [a court] may not able
`to tell” which use was essential to patentability, as would
`be required under Lilly’s test. Oral Arg. at 3:39-6:03,
`available at http://oralarguments.cafc.uscourts.gov/mp3/2010-
`1105.mp3; see id. at 9:48-10:42 (“In many cases, we con-
`cede th[is] could be a difficult inquiry.”); id. at 13:20-
`13:58. Additionally, the characterization of the single
`essential utility might be arbitrary in application. For
`example, a broadly defined “single” utility might in actu-
`ality encompass multiple utilities, leading to significant
`problems in applying Lilly’s proposed standard.
`
`
`
`
`SUN PHARMACEUTICAL v. ELI LILLY
`
`12
`
`
`
`double patenting analysis. Both Geneva and Pfizer make
`clear that, where a patent features a claim directed to a
`compound, a court must consider the specification because
`the disclosed uses of the compound affect the scope of the
`claim for obviousness-type double patenting purposes. In
`Geneva, we acknowledged the general rule that an earlier
`patent’s specification is not available to show obviousness-
`type double patenting. 349 F.3d at 1385. We have held,
`however, that there are “certain instances” where the
`specification of an earlier patent may be used in the
`obviousness-type double patenting analysis. In re Basell,
`547 F.3d at 1378. Specifically, the specification’s disclo-
`sure may be used to determine whether a claim “merely
`define[s] an obvious variation of what is earlier disclosed
`and claimed,” “to learn the meaning of [claim] terms,” and
`to “interpret[] the coverage of [a] claim.” Id. As we
`recognized in Geneva, a court considering a claim to a
`compound must examine the patent’s specification to
`ascertain the coverage of the claim, because a claim to a
`compound “[s]tanding alone . . . does not adequately
`disclose the patentable bounds of the invention.” 349 F.3d
`at 1385. In examining the specification of the earlier
`patent, the court must consider “the compound’s disclosed
`utility.” Id.
`We affirmed this holding in Pfizer by rejecting the
`patentee’s objection to our reliance on the specification of
`the earlier patent that claimed the compounds at issue
`and explaining that “[t]here is nothing that prevents us
`from looking to the specification to determine the proper
`scope of the claims.” Pfizer, 518 F.3d at 1363 (citing
`Geneva, 349 F.3d at 1386). Thus, we have expressly held
`that, where a patent claims a compound, a court perform-
`ing an obviousness-type double patenting analysis should
`examine the specification to ascertain the coverage of the
`claim.
`
`
`
`13
`
`SUN PHARMACEUTICAL v. ELI LILLY
`
`
`
`In response to Lilly’s arguments, we determine that
`where such examination of the specification is appropri-
`ate in an obviousness-type double patenting analysis, the
`specification that must be considered is that of the issued
`patent. Lilly contends that the district court should have
`evaluated the ’614 patent’s claim to gemcitabine based on
`the specification that existed as of the undisputed effec-
`tive filing date of the ’614 patent, namely the specification
`of the original ’883 application. The original ’883 applica-
`tion disclosed only gemcitabine’s antiviral use, not its
`anticancer use; Lilly added a description of gemcitabine’s
`anticancer use to the specification in a continuation-in-
`part application that eventually resulted in the ’614
`patent. Lilly therefore asks this court to ignore the ’614
`patent’s description of gemcitabine’s use in cancer treat-
`ment, because this disclosure was not part of the original
`’883 application.
`To support this argument, Lilly cites only the basic
`tenet of claim construction, as stated in Phillips v. AWH
`Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005), that claim
`terms should be given their ordinary and customary
`meaning and this meaning is the one that “the term
`would have to a person of ordinary skill in the art in
`question at the time of the invention, i.e., as of the effec-
`tive filing date of the patent application.” Phillips, how-
`ever, does not support the proposition that a court should
`ignore portions of the patent specification in construing
`claims. Instead, Phillips makes clear that claim terms
`must be construed in light of the entirety of the patent,
`including its specification, and that the specification to be
`consulted is that of the issued patent, not an earlier
`application.
`Specifically, Phillips, as well as the rest of our claim
`construction precedent, expounds that a “person of ordi-
`
`
`
`SUN PHARMACEUTICAL v. ELI LILLY
`
`14
`
`
`
`nary skill in the art is deemed to read the claim term not
`only in the context of the particular claim in which the
`disputed term appears, but in the context of the entire
`patent, including the specification.” ICU Med., Inc. v.
`Alaris Med. Sys., Inc., 558 F.3d 1368, 1374 (Fed. Cir.
`2009) (emphasis added); Aquatex Indus., Inc. v. Techniche
`Solutions, 419 F.3d 1374, 1380 (Fed. Cir. 2005); Phillips,
`415 F.3d at 1313. In other words, “the ‘ordinary meaning’
`of a claim term is its meaning to the ordinary artisan
`after reading the entire patent.” ICU Med., 558 F.3d at
`1375 (emphasis added); Phillips, 415 F.3d at 1321. Phil-
`lips further explains the “fundamental rule” that claim
`terms “are construed with the meaning with which they
`are presented in the patent document.” 415 F.3d at 1316
`(emphasis added). As such, “[t]he construction that stays
`true to the claim language and most naturally aligns with
`the patent’s description of the invention will be . . . the
`correct construction.” Id. (emphasis added).
`In sum, our claim construction precedent establishes
`that claim terms must be construed in light of the entire
`issued patent. This precedent leaves no room for debate
`that the relevant specification for claim construction
`purposes is that of the issued patent, not an early version
`of the specification that may have been substantially
`altered throughout prosecution. There is no support for
`Lilly’s argument that the district court should have
`consulted the specification of the original ’883 application,
`which was changed before the ’614 patent issued, to
`construe the issued patent claims. Lilly cannot avoid
`portions of the specification of the ’614 patent by resorting
`to the specification as originally filed.
`We note that, where necessary in the obviousness-
`type double patenting analysis, consulting the specifica-
`tion of the issued patent, as opposed to an earlier version
`
`
`
`15
`
`SUN PHARMACEUTICAL v. ELI LILLY
`
`
`
`of the specification, is consistent with the policy behind
`double patenting. As we stated in In re Kaplan, 789 F.2d
`1574, 1579-80 (Fed. Cir. 1986), “[a]ll proper double pat-
`enting rejections, of either type, rest on the fact that a
`patent has been issued and later issuance of a second
`patent will continue protection, beyond the date of expira-
`tion of the first patent” of the same invention or an obvi-
`ous variation thereof. In other words, the double
`patenting doctrine is concerned with the issued patent
`and the invention disclosed in that issued patent, not
`earlier drafts of the patent disclosure and claims.
`In conclusion, the district court correctly followed the
`double patenting analysis of the Geneva line of cases,
`which address the situation in which an earlier patent
`claims a compound, disclosing the utility of that com-
`pound in the specification, and a later patent claims a
`method of using that compound for a particular use
`described in the specification of the earlier patent. As the
`district court recognized, claim 12 of the earlier ’614
`patent claims the compound gemcitabine. Following our
`precedent in Geneva, the district court properly consid-
`ered the uses for gemcitabine disclosed in the specifica-
`tion of the issued ’614 patent, specifically its use in
`treating viral infections and cancer, to determine the
`scope of this claim. See Geneva, 349 F.3d at 1385; Sum-
`mary Judgment Order, 647 F. Supp. 2d at 824-25. In
`light of the earlier ’614 patent’s description of gemcit-
`abine’s use in treating cancer, the asserted claims of the
`later ’826 patent, which recite a method of using gemcit-
`abine to treat cancer, are not patentably distinct from the
`’614 patent’s claim to gemcitabine. The asserted claims of
`the later ’826 patent simply claim the anticancer use
`disclosed in the specification of the ’614 patent as a
`method of use claim. See Pfizer, 518 F.3d at 1363; Ge-
`neva, 349 F.3d at 1385. Therefore, we affirm the district
`
`
`
`SUN PHARMACEUTICAL v. ELI LILLY
`
`16
`
`
`
`court’s judgment that the asserted claims, claims 2, 6, and
`7, of the ’826 patent are invalid for obviousness-type
`double patenting over the ’614 patent.
`AFFIRMED
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