## United States Court of Appeals for the Federal Circuit

05-1313

IMPAX LABORATORIES, INC., Plaintiff-Appellant,

v.
AVENTIS PHARMACEUTICALS INC., Defendant-Appellee.

C. Kyle Musgrove , Kenyon & Kenyon, of Washingt on, DC, argued for plaintiffappellant. With him on the brief were Philip J. McCabe , of San Jose, California; Michael M. Shen , of Washington, DC; and Steven J. Lee , of New York, New York . Paul H. Berghoff , McDonnell, Boehnen, Hulbert, & Berghoff LLP, of Chicago, Illinois, argued for defendant-appellee. With him on the brief were Curt J. Whitenack , James C. Gumina , Jeremy E. Noe , and Paul S. Tully . Of counsel on the brief was Joseph Kirk, Jr. , Aventis Pharmaceuticals Inc., of Bridgewater, New Jersey. Appealed from: United States District Court for the District of Delaware Judge Joseph J. Farnan, Jr.

## United States Court of Appeals for the Federal Circuit

05-1313 IMPAX LABORATORIES, INC., Plaintiff-Appellant,

v.
AVENTIS PHARMACEUTICALS INC., Defendant-Appellee.

__________________________ DECIDED: November 20, 2006

__________________________ Before RADER, SCHALL, and PROST, Circuit Judges

. Opinion for the court filed by Circuit Judge SCHALL. Concurring-in-part opinion filed by Circuit Judge RADER. SCHALL, Circuit Judge

. Impax Laboratories, Inc. (“Impax”) sued Aventis Pharma ceuticals Inc. (“Aventis”) in the United States District Court for the District of Delawa re for a declaratory judgment that Impax did not infr inge, induce infringement of, or contribute to the infringement of, U.S. Patent No. 5,527,814 (“the ’814 patent”) under 35 U.S.C. § 271(e)(2) by filing an Abbreviated New Drug Applicat ion (“ANDA”). In its suit, Impax alleged, inter alia , that the ’814 patent was invalid and unenforceable. Impax filed its ANDA under the provisions of the Patent Laws and Drug Price Competiti on and Patent Term RestorationAct of 1984, Pub. L. No. 98- 417, 98 Stat. 1585 (198 4), codifi ed at 21 U.S. C. §§ 355, 360(c) (2000), 35 U. S.C. §§ 15 6, 271, and 282 (2000) (commonly referred to as the “Hatch-Waxman Act”). In its ANDA, Impa x sought the approv al of the United States Food and Drug Administration (“FDA”) to engage in the commercial manufacture and/or sale of rilu zole tablet s for the treatment of patients with amyotrophic lateral sclerosis (“ALS”). Impax now appeals from the decision of the district court, following a bench trial, that it failed to prove (1) t hat the ’814 patent is unenforceable due to inequitable conduct and (2) that claims 1-5 of the ’814 pat ent are invalid as anticipated. See Impax La bs ., Inc. v. Av entis Pharms., Inc. , 333 F. Supp. 2d 265 (D. De l. 2004) (“Validity and Enforceability Order ”). We see no error in the decis ion of the district court on the inequitable conduct is sue. However, as far as the anticipation is sue is concerned, we conclude that the court erred in its determination that one of the alleged two items of invalidating prior art did no t enable a method of us ing ri luzole to treat ALS and, therefore, could not serve as an anticipatory reference under 35 U.S.C. § 102(b). Accordingly, we affirm-in-par t, vacate-in-part, and remand. BACKGROUND I. A. Impax is a Dela ware c o rpor ation with its princi pal plac e of busin ess in Hayward, California. Aventis is a Dela wa re corporat ion with its princip a l place of business in Bridge wate r, New Jersey. Aventis was fo rmed in 1999 as part of a merger between

05-1313 2Rhone-Poulenc, S.A., (“RP”) and Hoechst, AG. 1 Aventis owns the ’814 pat ent, which involv es the use of riluzole to treat ALS. Aventis sells riluzole under the trade name Rilutek. B. ALS, commonly referred to as Lou Gehrig’s disease, is a dis eas e of the central
nervous sy stem. It i n volves the progress i ve degeneration of th e nerves that carry impulses to muscles. ALS is characterized by the death of the nerves that control motor function (also called motor neurons). This occurs after the motor neuron cell bodies shrivel and harden, a process called sc lerosis. The clinical symptoms of ALS may first appear in t he skeletal muscles, referred to as “ limb onset” ALS, or in the bulbar muscles of the throat, tongue, and resp iratory system, referred to as “bulbar onset” ALS. Riluzole is the chemical compound 6-trifluoromethoxy- 2-benzothiazolamine. In 1993 and 1994, Aventis conducted co mparative testing of r iluzole and s e ven other compounds, Pharm 1001 through 1007, on dissoc i ated rat spinal cord cells. The purpose of the testing was to det ermine whet her the compounds woul d be effective in treating ALS. Dr. Louvel s ent riluzole and the other s e ven compounds to a research facility in Uruguay for analys is. The effects of riluzole and the other compounds on th e rat spinal c o rds were analyzed based on the following criteria: (1 ) number of neurons in the cells (used to screen for extraneous e ffects of the compound); (2) number of neurites per neuron 2 (thought to indic a te effectiveness in treating ALS) ; and (3)

1 At the time the ’814 pa tent was prosecuted, Dr. Er ic Louvel, the inventor, worked for Rhone Poulenc Rorer, S.A. (“RPR”). RP was the par ent compa n y of RPR. For simplic ity, during the discus s ion of the prosecution history of the ’814 patent, we refer to Aventis as the prosecuting party. 2 A neurite is a projection from a neuron.

05-1313 3neuronal diameter (thought to indicate neur onal health an d to be pertinent to treating ALS). The 1993 tests compared riluzole to c o mpounds identified as Pharm 1001 through Pharm 1004 (“the 1993 comparative test data”). The 1993 study concluded: None of PHARM com pounds s h owed the s a me pattern of effects than [sic] Riluzole. PHARM 1001 and 1003 were toxic for motoneurons, while PHARM 1003 also decreased the num ber of neurites per neuron. PHARM 1002 was observed to stimulate t he growth of the cultures and to increase the size of neurons. PHAR M 1004 showed no relevant effects. The 1994 set of tests com pared riluz o le to compound s identified as Pharm 1005 through Pharm 1007 (“the 1994 comparative test data”). The 1994 study conclud ed: “None of PHARM compounds tested showed the same pattern of effects than [sic] Riluzole: PHARM 1005 and PH ARM 1006 induced an impor tant decrease in neuronal cell number (including mot oneurons) and prevented the develop ment and differentiation of neurons . The effects of PHARM 1007 were not s i gnific antly different from control conditions.” C. In due c o urse, the ’814 patent issued from U.S. Patent Applic ation Serial No. 08/327,343 (“the ’343 application ”), filed October 21, 1994, wh ic h claimed priority to U.S. Patent Applic ation Serial No. 07/945, 789 (“the ’789 applicat ion ”), filed September 16, 1992. The ’343 a pplic ation and the ’789 ap plic ation both were directed to treating ALS with riluzole. On November 19, 1993, the examiner issued a final rejection of the claims of the ’789 applic ation based on obviousness in light of certain prior art. The examiner asserted that the prior art disclos ed that AL S “is a motor neuron di sease or disorder

05-1313 4which may be treatable in huma ns with antiglutamate agents” and that “riluzole is known to be a glut amate antagonist usef ul for the tr eatment of motor neurons in ma mmals.” (It had been t heorized that exc i tatory amino acids, such as glut amates, may be involved in ALS.) On that basis, the examin er conclud ed that “[o]ne of ordinary skill in the art would have been motivated . . . to employ riluzole in the treatment of any form of the motor neuron dis ease, ALS, since riluz o le was know n in the art as an antiglutam a te agent, and antiglutamate agents were known in t he art for the treatment of ALS.” Responding on May 24, 1994, Aventis re lied on the 1994 comp arative test dat a relating to Pharm 1006 (6-pentafluoroethoxy -2- benzothiazolamine) and Pharm 1007 (6- (1,1,2,2-tetrafluoroethoxy)-2- benzothiazolamine). Both ar e c o mpounds disclosed in U.S. Patent No. 5,236,940 (“t he ’940 patent”), which the examiner referred to as “pertinent to the applicant’s disclosure.” A v entis stated that Pharm 1006 and Pharm 1007 const i tuted “evidence of the non-obviousne ss of the instant clai ms” ov er the prior art relied upon by the examiner . Aventis explained that riluz o le, Pharm 1006, and Pharm 1007 were c o mpared in two tests on disso c i at ed spinal c o rd cell cultures as to the number of neurites per neur on and neuron diam eter. Avent is stated that positiv e results were shown for riluzole: The most striking effects are: 1) increased number of neurites per neuron; and 2) increased number of large neurons. These results are urged to be unex pected and not predictable from the prior art. The Examiner should note that the compound Pharm 1006 presents an opposite ac tion and compound Pharm 1007 is inactiv e . The effects shown for Riluzole per mit the use of this compound for the treatment of motor neuron diseas es, in particular, ALS. A May 24, 1994 declaration from Dr. Louvel accompanied the res ponse and discussed the testing methodology and 1 994 comparative test data obtained for riluzole and

05-1313 5Pharm 1006 and Pharm 1007. The same decla ration was subm itted on February 6, 1995, during prosecution of the c ontinuing ’343 applic ation, an applic ation t hat claime d priority to the later abandoned ’789 application. On February 21, 1995, the examiner reje cted the claims of the ’ 3 43 applic ation as obvious based on several prior art refe rences, including a prior art reference authored by Dr. Theodore Munsat. The ex aminer challenged th e testing procedure resulting in the 1994 comparat ive test and described in the February 6, 1995 Louv el declaration as providing unexpected results: “Applic ant has not demonstrated that the testing procedure dis c ussed in the declarat i on wo uld be accepted by one of ordinary skill in the art as showin g the activity of compoun ds in the claimed m e thods of treatment.” The examiner t hen explained that the F ebr uary 6, 1995 dec laration had been considered but was “deemed not persuasive to overcome the rejection under 35 U.S.C. 103.” In April 5, 1995, June 6, 1995, and Sept ember 20, 1995 interviews with the examiner and in a June 19, 1995 response, Aventis as sert ed that the 1994 c o mparative test data on Pharm 1006 and Pharm 1007 a nd other evidence indicat ed that th e invention had unexpected resu lts. A June 22, 1995 dec laration from Dr. Louvel asserted that the testing procedure that was used to compare the Pharm 1006 and Pharm 1007 compounds to riluzole was well-established

. Thereafter, on September 27, 1995, Aven tis obtained new patent prosecution counsel and stated to the examiner t hat the June 19, 1995 response was “fully responsive” to the February 21, 1995 Office Ac tion. Aventis then withdrew “reliance on all previous arguments and declarations.” Avent is also s ubmitted a declaration from Dr.

05-1313 6Munsat (as noted, the author of one of the prior art referenc es cit ed by the examiner) that stated that by the priority date of t he ’814 patent one of ordinary skill in the art would hav e had no r easonable expe ctation of succes s in us in g riluzole to treat ALS because of the failure of ot her glutamate antagonists to e ffectively treat ALS. On March 1, 1996, the exami ner issued a Notice of Allowability specific ally referencing amendments and remarks from t he June 19, 1995 response, the Muns at declaration, and the September 27, 1995 res pons e. The applicant s responded that they viewed the application as “allowed sole ly becaus e of the September 27, 1995, Amendment and Declaration of Dr. Munsat.” The ’814 patent is sued on June 18, 1996, and names Dr. Louvel as the sole inventor. D. Claims 1-5 are the only claims of the ’814 patent that are at iss u e in this c a se. Independent claim 1 claims “[ a] method for treating a ma mmal with [ALS], c o mprising the step of administering to said mammal in recognized need of said treatment an effective amount of [ri l uzole] or a pharmaceutic ally acc eptable salt t hereof.” ’814 patent , claim 1. Claims 2 through 4 each depend on claim 1. Id. , claims 2-4. Claim 2 adds the limitation t hat the form of AL S being treated inv o lves “early bulbar inv o lv ement.” Id. , claim 2. Claim 3 adds the lim itation that the form of ALS being treated “is the bulbar form.” Id

. , claim 3. Claim 4 adds the limitation t hat the effective amount of compound being administered comprises 25 to 200 mg of riluzole. Id. , claim 4. Claim 5 depends from claim 4 and claims the administration of riluzole in an amount of 50 mg. Id. , claim
5.

05-1313 7II. A. Pursuant to the Hatc h-Waxman Act, sect ion 505 of the Federal Food, Drug , and Cosmetic Act, codified at 21 U.S.C. § 355, was amended to authorize the filing of ANDAs. 21 U.S.C. § 355; see also Warner-Lambert Co. v. Apotex Corp. , 316 F.3d 1348, 1358 (Fed. Cir. 2003). Under 35 U.S.C. § 271(e)(2), it is an act of infringement to submit an ANDA under 21 U.S. C. § 355(j) for a drug clai med in a patent before the patent’s expiration: It shall be an act of infringement to submit—(A) an application under section 505(j) of the F ederal Food, Drug, and Cosmetic Act . . . for a drug claimed in a patent or the use of whic h is c l aimed in a patent, . . . if the purpose of such submission is to obtain approval under such Act [i.e., Title 21 of the United States Code] to eng age in the com m ercial manufacture, use, or sale of a drug . . . claim ed in a patent or t he use of which is claimed in a patent before t he expiration of such patent. 35 U.S.C. § 271(e)(2) (2000). On March 16, 2001, I m pax fi led an ANDA with the F D A und er 21 U.S.C. § 355(j), seeking approval to market and sell generic riluzole tablets f o r the treatment of ALS. The FDA approved Impax’s ANDA on January 29, 2003. At the ti me t hat Impax filed its ANDA, there was no patent listed with resp ect to riluz o le in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”), which list s patents that claim an approved or pending use of a new dr ug. 3 Howe ver, Impax became aware of the ’ 814 patent while preparing its ANDA. On June 25, 2002, Impax filed a declarato ry judgment action in the District of Delaware. In its suit, Impax sought a declara tion that it had not infringed the ’814 patent

3 See 21 C.F

. R. § 314.53; Warner-Lambert , 316 F.3d at 1361 n.6.

05-1313 8under 35 U.S.C. § 271(e)(2) by filing its ANDA, a nd that it woul d not contribute to or induce infringement of any valid c l aim of t he ’814 patent by engagi ng in the m anufacture and sale of its riluzole product for the treatment of ALS. Impax as se rted that the claims of the ’814 patent were invalid over the prior art and inva lid by reason of incorrect inventorship. Impax later amended its comp laint to add alle gations of inequitable conduct. On December 12, 2002, the dis t rict court entered a pre liminary injunction against Impax, barring it from marketing its riluzole product. Impax Labs., Inc. v. Aventis Pharms., Inc

. , 235 F. Supp. 2d 390 (D. Del. 2002). On April 29, 2003, the parties entered into a sti pulation whereby Impax conc eded that its ANDA product infringed claims 1, 4, and 5 of the ’814 patent. B. From October 28 to 30, 2003, t he district court conducted a bench trial on the issues of (1) whether claims 1-5 of the ’814 patent were unenforceable due to inequitable conduct, (2) whet her claims 1-5 of t he ’814 patent were invalid as anticipated, as obvious, or by reason of in correct inventorship, and (3) whether Impax infringed claims 2-3 of the ’814 patent or induced suc h infringem ent. See V a l i di ty and Enforceability Order , 333 F. Supp. 2d at 268. On August 30, 2004, the district court issued a Memorandum Opinion and Order, concl uding that Impax ha d not proven that the ’814 patent was unenforceable due to inequitable conduct or demonstrated that claims 1-5 were invalid as anticipated by the prior art cited by Im pax. Id. at 265. The court also rejected Impax’s assertion that clai ms 1-5 of the ’814 pa tent were invalid by reason of obvious nes s or for incorrect inventorship. Id. at 276. With respect to obvious nes s, the court held that Impax had not proven, by clear and convinc i ng

05-1313 9evidenc e, that the prior art upon which Impax relied rendered the claims obv i ous. Id. at 274-76. With respect to inventorship, the court found that the allegation was “unduly speculativ e and not supported by evidence suffici ent to support a finding of invalidity.” Id. at 276. Finally, in a footnote, the court decline d to address whether Impax’s proposed marketing of riluzole would induce infringe ment of claims 2 and 3 of the ’814 patent bec ause “Impax may not engage in t he manufacture or sale of riluzole regardles s of whether its proposed actions would induc e infringem ent of claims 2 and 3 of the ’814 patent.” 4 Id. at 284 n.5. On March 16, 2005, the district court ent ered final judgment against Impax, to the effect that claims 1-5 of the ’814 patent were neither unenforceable nor invalid, that Impax’s pr oposed manufacture or sale of riluzo le would induce infringe ment of claims 1, 4, and 5 of the ’814 patent, and that lmpax’s propos ed marketing of rilu zole t o treat ALS would induce infringement of clai ms 2 and 3 of the ’814 patent. On March 21, 2005, Impax filed a timely notice of appeal. We have jurisdic tion pursuant to 28 U.S.C. § 1295(a)(1). DISCUSSI ON Impax appeals the district court’s determinat ion that it failed to pr ove (1) that the ’814 patent is unenforceable due to inequitable conduc t and (2) that the ’814 patent is invalid as anticipated. We address these contentions in turn.

4 This was because Impax had conceded infr ingement of claims 1, 4, and 5.

05-1313 10I. A. To prove that a patent is unenforceable due to inequitable conduct, the al leged infringer must provide clear and convinc i ng evidenc e of (1) affirmati v e misrepresentations of a material fact, fail ure to disclose material information, or submission of false material inf o rmation and (2) an intent to deceive. Alz a Corp. v. Mylan Labs ., Inc. , 391 F.3d 1365, 1373 (Fed. Cir. 2004). The materiality aspec t of inequitable c ondu ct was rec e ntly disc ussed in Digital Control Inc. v. Charles Machine Works , 437 F.3d 1309 (Fed. Cir. 2006). In that case, we considered the standard for ma teriality set forth in the pres ent version of U.S. Patent and Trademark Office (“PTO”) Rule 56, see 37 C.F.R. § 1.56(b) (2 004), as well as th e previous version of the rule, that was in effect through 1992. Digit a l Control , 437 F.3d at 1314. We explained that “if a misstatement or omission is material under the new Rule 56 standard, it is material. Similarly, if a misstatement or omission is materi al under the ‘reasonable examiner ’ standard or under the older three tests, 5 i t i s a l s o m a t e r i a l

. ” I d

. at 1316. The present Rule 56 standard is as follows: Information is materi al to patentabili ty when it is not cumulative to information already of record or being made of record in the application, and (1) It establishes, by itself or in combination with other information, a prima facie case of unpatentability of a claim; or

5 The “older three tests” inc l ude (1) the objective “but for” standard, “where the misrepresentation was so ma terial that the patent shoul d not have issued,” (2) the subjective “but for” te st, “w here the misrepresentat ion actually caused the ex ami n er to approve the patent application when he would not otherwise hav e done so,” and (3) the “but it may have” standard, “where the mi srepresentation may have influenced the patent examiner in the course of prosecution.” Digital Control , 437 F.3d at 1315.

05-1313 11(2) It refutes, o r is inconsistent with, a position the applicant takes in: (i) Opposing an argume n t of unpa tentability r e lie d on b y the Office, or (ii) Asserting an argum ent of patentability. A prima facie case of unpatentability is est ablis hed when the inf o rmation compels a conclus i on that a cl aim is unpatentable under the preponderance of ev idence, burden-of-proof standard, giving eac h term in the claim its broadest reasonable co nstruction consistent with the specification, and before any c onsi deration is g i ven to evidence whic h may be submitted in an attempt to establis h a contrary conclusion of patentability. 37 C.F.R. § 1.56(b) (2006). Under the prior “reasonable examiner” standard, an omission or misstatement was material if “a reasonable ex aminer would hav e considered such prior art impor tant in deciding whet her to allow the parent applic ation.” Dig ital Con t rol , 437 F.3d at 1314 (citations omitted). As seen, inequitable conduct also requires an intent to deceive . To satisfy the intent to deceive element of inequitable c onduct, “the involv ed conduct, viewed in light of all the evidence, in cluding ev idence indicative of good faith, must indic a te sufficient culpability to require a finding of intent to deceive.” King sdown Med. Cons ultants, Ltd. v. Hollister, Inc. , 863 F.2d 867, 876 (Fed. Cir. 1988) (en banc in relevant part). “Intent need not, and rarely can, be proven by direct evidence.” Merck & Co. v. Danbury Pharmacal, Inc. , 873 F.2d 1418, 1422 (Fed. Cir. 1989). Ra ther, intent to deceive is generally inferred from the facts and circumst ances surrounding the applicant’s overall conduct. Id. If the court finds materiality and intent, it “must balanc e the equities to determine whether the patentee has committed inequi table conduct that warrants holding the

05-1313 12patent unenforceable. ” Monsanto Co. v. Bayer BioSc i ence N.V. , 363 F.3d 1235, 1239 (Fed. Cir. 2004). The more material the omi ssion or misrepresentation, the less intent that must be shown to elicit a finding of inequitable conduct. Br i s tol-Myers Squibb Co. v. Rhone-Poulenc Rorer, Inc. , 326 F.3d 1226, 1234 (Fed. Cir. 2003). If inequitable conduct oc curred with respect to one or mor e cl aims of an applicati on, the entire patent is unenforceable. Kingsdown Med. Consultants , 863 F.2d at 877. We review a district court’ s ultimate decision on a claim of inequitable con d uc t for an abuse of discretion and its threshold findings on materiality and intent for clear error. Alza , 391 F.3d at 1369-70. An abuse of discretion occurs when (1) the court’s decision is clearly unreasonable, arbitrary, or fancif ul, (2) the court’s decision is bas ed on an erroneous construction of the la w, (3) the court’s factual findings are clear l y erroneous, or (4) the record contains no evidence upon which the court rationally could have bas ed its decision. See, e.g. , Cybor Corp. v

. FAS Techs., Inc

. , 138 F.3d 1448, 1460 (Fed. Cir. 1998) (en banc). Under the clear error st andard, the court’s findings will not be overturned in the abs ence of a “ definite and firm conviction” that a mistake has been made. Hoffmann-La Roche, Inc

. v. Promega Corp. , 323 F.3d 1354, 1359 (Fed. Cir. 2003) (quoting Molins PL C v. Textron, Inc. , 48 F.3d 1172, 1180 (Fed. Cir. 1995)). B. Before the district court, Impax’s main contention in suppor t of its claim of inequitable conduct— and the c o ntent ion that is relev ant on appeal—was that, during prosecution of the ’789 applic ation and the c ontinuing ’343 ap plic ation, Aven tis withheld from the examiner the 1993 comp arative test data relating to the testing of Pharm 1001 through Pharm 1004, and the 1994 co m parative test data relating to the testing of

05-1313 13Pharm 1005. According to Impax, the wit hheld dat a was material because it was incons istent with an argument advanced by Av entis in support of patenta bility during prosecution. Aventis res ponded that the information that was not provided to the examiner was immaterial, superfluous, or le ss pertinent than the disclosed information. The district court ruled that under either the materiality standar d of the current version of Rule 56 or equitable principles (i.e., the rule s based on the pre-1992 version of Rule 56) Impax had not proven inequ itable conduct. Validity and Enforceability Order , 333 F. Supp. 2d at 277. Consideri ng the alleged withholdin g of the 1993 comparative test data, the court concluded that “Aventis’s partial disc losure of the comparative test results was not inappr opriate.” Id. at 279-81. The court found that the withheld 1993 and 1994 comparative te st data was not material because (1) the results for Pharm 1002, 6 Phar m 1003, and Pharm 1005 were not inc ons istent with the representation to the examiner that riluzole was better than Pharm 1006 and Pharm 1007, whic h were the subject of the 1994 comparativ e test data; (2) “the withheld c o mparative testing did not produce results that indicated effectiveness in treating ALS, ” because while Pharm 1002 produced increases in neuron diameter and neurites per neuron, it only produced “significant” increases in neuron diameter; (3) the “patent examiner explicitly excluded the submitted testing [Pharm 1006 and Pharm 1007] from her decision” bec ause “‘the applicant has not dem onstrated t hat the testing procedures discus s ed in the declaration would be accepted by one of ordinary skill in the ar t as showing the activity of compounds in the claimed met hod of treatment’”; and (4) “the comparative test results were not as valuable as the re su lts of huma n clinica l trials which were subm itted to the

6 Pharm 1002 is disc los ed in U.S. Patent No. 5,026,717, whic h for m ed the basis for an initial obv iousness re jection by the examiner.

05-1313 14PTO.” Id. at 280-81. The district c ourt suggested that even if it did find a “minimal level of materiality” there was an absenc e of intent to deceive. Id. Thus, the district court concluded that there wa s no inequitable conduct in the prosecution of the ’814 patent. Id. C. On appeal, Impax repeats its claim that Aventis committed inequitable conduct by withholding the 1993 comparative test data and the 1994 comparative test data relating to Pharm 1005. According to Impax , that data was inconsistent with a position that Aventis took in its Ma y 24, 1994 response. In it s re sponse, which relied on Dr. Louvel’s May 24, 1994 declaration pursuant to 37 C.F.R. § 1.132, Aventis a r gued that the invention was pat entable be cause it s h owed unexpected res u lts over Pharm 1006 and Pharm 1007. Impax argues that Dr. Louvel’s declarati on withheld data for certain prior art compounds (Pharm 1002 and Pha rm 1003, inc l uded in the 1993 comparative test dat a , and Pharm 1005, inc l uded in the 1994 c o mparative test data) that had positive result s for key criteria. Specifically, Impax ar gues that the 1993 com parative test data demonstrates that Pharm 1002 and Pharm 1003, along with riluzole, had the highest increase of neurites per neuron and that P harm 1002 had the gr eatest absolute values in increas ed diameter of neuron cells. Impax c ontends that Pharm 1002 presented positive results in two of the same parameter s in which riluzo le tested positive, while Pharm 1006 and Phar m 1007 did not, so Pharm 1002 is “superior” to Pharm 1006 and Pharm 1007. Thus, Impax conc ludes, Dr. Louvel failed to disclose positive test data for Pharm 1002, which data under mined the argum ent Aventis was making in prosecution

05-1313 15that its riluzole compound showed unexpect ed results in the treatment of ALS (as compared to Pharm 1006 and Pharm 1007). As fa r as the 1994 comparative test data is concerned, Impax argues that the data demonstrates that Pharm 1005 and riluzole had the largest increase in neuron cell diameter. Impax reject s the district court’s three reasons for finding the information immaterial. First, Impax assert s that the withheld information is incons is tent because Dr. Louvel assert ed in prosec ution that riluzole had unexpected results. Ther efore, it was inconsis tent to withhold test results that exhibit e d better results for other compounds. Second, Im pax argues that it is irrelevant that the withheld data does not indicate effectiveness in treating ALS b e cause it was “clearly better than the data that Dr. Louvel supplied” and thus material. Aventis res ponds that Impax mis r epresent s the comparative test data becaus e, while Phar m 1002 and Pharm 1005 were positiv e in neuron diameter, they were not signific antly different from the control in neurites per neuron, while Pharm 1001 and 1003 were toxic for motoneurons, and only rilu zole was posit ive in all parameter s tested. Further, Aventis asse rts that the report ed data was consistent with Aventis’s statements to the examiner because t he 1994 comparative te st data on Pharm 1006 and Pharm 1007 serv ed to distinguish the ’ 814 patent from the ’940 patent , while the unreported 1993 comparative test data was related to compound s that were not in the ’940 patent

. D. We see no error in the ruling of the dist rict court that the 1993 comparative test data and the 1994 comparative te st data on Pharm 1005 were not material under either Rule 56 standard. There is no evidenc e that the withheld com parative test data

05-1313 16establish e s by itself or in com b ination with other informa tion a prima facie case of unpatentab ility of a claim. In ou r view, the di strict co urt correctl y recogniz ed that the comparative test data did not pr oduce results that indicat ed that any of Pharm 1002, 1003, or 1005 was effective in treating ALS. As the district court recognized, [a]lthough some of the Pharm c o m pounds produced significant positiv e results in one of the t w o relev a nt par ameters—an incr ease in neurites per neuron or an increase in neur on diameter—none of the Pharm compounds from the withhe ld t e sts produced results signific a nt in bot h parameters. For example, Phar m 1002 pr oduced inc r eases in neuron diameter and neurites per neuron, but only produced s i gnific a nt increases in neuron diameter. Validity and Enforceability Order , 333 F. Supp. 2d at 280. Further, there is no evidence that the with held c o mparative test data refutes or is incons istent with a position Av entis took dur ing pros ec ution. Av entis submit ted correct information, and Impax does not argue that the submitted co mparative testing data wa s false. We see no error in t he district court’ s determinati on that the results for Pharm 1002, Phar m 1003, and Pharm 1005 were not inc ons istent with the representation to the examiner that ri luzole was bette r than Pharm 1006 and Pharm 1007. The comparative test data in this case was submitted to demonstrate unexpected results based on compositions in the ’940 patent—namely Pharm 1006 and Pharm 1007. Aventis never suggested that this was the only testing dat a or that another compound, such as Pharm 1002, was not tested. Finally, there is no evidenc e that a reasonable examiner “would have conside r ed such prior art important in deciding whether to allow t h e parent application. ” Digital Control , 437 F.3d at 1314. As discussed above, the 1993 comparative test data and the

05-1313 171994 com parative test data on Pharm 1005 di d not produce results that indicated effectiveness in treating ALS. Reviewing the district court’s finding on materiality fo r clear error, we are not left with a definite and firm conviction t hat a mistake has been committed. Nor did the district c ourt clearly err in its intent findings. The district c ourt concluded after a bench trial that there was an “absence” of intent. V a lidity and Enforceability Order , 333 F. Supp. 2d at 281. As far as intent is concerned, Impax asserts that the 1993 and 1994 com parative test data were withheld with an intent to deceive. F i rst, Impax argues that misrepresent ations and omissions in a dec laration are presumptively intentional. Next, Impax asserts that the circumstances surrounding prosecution demonstrate an in tent to deceive bec ause of the submis sion of the declaration and the materiality of the withheld information. Finally , Impax ar gues that Dr. Louvel, who was involved in t he preparat ion and prosecution of the ’814 patent, was aware of the 1993 comparative test data and the comparative test data on Pharm 1005, but he chose to disclose only the 1994 c o mparative test data on Pharm 1006 and Pharm 1007. Aventis responds that ther e is no c l ear and convincing evidence of intent to deceive. It argues that Impax’s citations to internal Aventis doc uments suggesting th at Aventis did not hav e faith in the strength of the application do not dem onstrate an inten t to deceive. It distinguishes Impax’s relian ce on cas e s involving false statements in declarations, arguing that there w a s no fals e information in the Louvel declarat i on. We cannot say that the distri ct court’s finding that ther e was no intent amounts to clear error. Dr. Louvel was involved in both the 1993 and 1994 testin g and the

05-1313 18prosecution of the ’814 patent. He did dis c lose the data relevant to distinguishing the ’940 patent—the 1994 comparative test data on Pharm 1006 and Pharm 1007—but he did not dis c lose the c o mparative test data that would be irrelevant to distinguishing the ’940 patent. We agree with the district court that these fa cts, standing alone, are not enough to establish an intent to deceive. As the district court recognized, there was no evidenc e that Impax intended to deceive the PTO when it did not disclos e the 1993 comparative test data or the comparative test data on Pharm 1005. We thus affirm the district court’s ruling that the ’814 pa tent is not unenforceable by reason of inequitable conduct

. II. A. An issued patent is presumed to be va lid, and the burden of establis hing invalidity as to any claim of a patent rests upon the party asserti ng such invalid ity. 35 U.S.C. § 282. Clear and c o nvincing evidence is requi red to invalidat e a patent. Typeright Keyboard Corp. v. Microsoft Corp. , 374 F.3d 1151, 1157 (Fed. Cir. 2004). When the prior art was before th e examiner during prosecuti on of the applic ation, there is a particularly heav y burden in establishing inva lidity. See Hewlett-Pac k ard Co. v

. Bausch & Lomb Inc. , 909 F.2d 1464, 1467 (Fed. Cir. 1990). In the district court Impax c l aimed that claims 1-5 of t he ’814 patent were anticipated by the ’940 patent 7 and French Application No. 2,640,624 (“the ’624 application” ), from which the ’940 patent claims priorit y

. The pertinent facts are as follows:

7 As noted above, during prosecution of the ’789 applic ation, the examiner cited the ’940 patent as pertinent prior art.

05-1313 19On December 13, 1989, the application t hat matured into the ’940 patent was filed. The ’940 patent, which is owned by Av entis, is directed to a class of compound s disclos ed in formula I below:

’940 patent, col.1, ll.10- 66. The ’940 pat ent explains that formula I inc l udes many different compounds, but it exempts 6-trif luoromethoxy-2-benzothiazolamin e . Id. , col.1. ll.10-37. That is, 6-tri f luor omethoxy-2-benz othiazol amine, also known as riluzole, is a compound that could f a ll within the literal s c ope of formula I but is e x plicitly exempted from formula I by the specific ation of the ’940 patent. The ’940 patent explains that 6

- trifluoromethoxy-2-benzothiaz olamine is not new, and thus does not form part of the invention. Id. , col.1. ll.41-47. The ’940 patent goes on to state that t he compounds of formul a I are useful in treating medical condit ions associated with the effects of glutam ate such as ALS: The compounds of formula (I) and their salts pos sess advantageous pharmacological properties. These com pounds are us eful in the t r eatment of medical conditions associated with the effects of glutamate in which it is desirable to inhibit such effects at least partially. They are active with respect to glutamate-induced convul sions, and are hence useful in the treatment and prevention of conv uls i ve phenomena, schizo p hrenic disorders, and in part i cular the defic iency forms of schizophrenia, sleep disorders, phenomena linked to cerebral is chaemia and also neurologic a l conditions in which glutamate may be im plicated, s u ch as Alzheimer’s disease, Huntington’s chorea, [ALS] and oliv opontocerebellar atrophy. ’940 patent , col.2. l.63 to col.3, l.8 (emphases added).

05-1313 20The ’940 patent claim s priority from the ’624 application, whic h has a disc losure similar to that of the ’940 patent . Howe ver, the ’624 application does not exempt 6- trifluoromethoxy-2-benzothiaz olamine from the family of formula I compounds as a claimed compound. B. Before the district court, Impax argued that ever y limitation of claims 1-5 of the ’814 patent was disclosed by the ’940 pat ent. Impax asserted that the ’ 9 40 patent disclos ed a class of compounds generally enco mpassed by formula I, including riluzole, and that the ’940 pat ent taught t hat riluzole is useful in treating ALS and also taught effective administration. Because the ’9 40 patent claims priority from the ’62 4 application and contains similar disclos ur es, Impax ass e rted virtually identical arguments with respec t to the ’624 applicatio n. Aventis responded t hat the ’940 patent

exc l uded riluzole from the co mpounds in formula I. Aventis as serted in addition that even if the ’940 patent inclu ded riluzole, it did not antici pate the ’814 pat ent because it failed to disclose the inventio n in the ’814 patent and was not enabling because it did not provide specific instruction for using riluzole and actually taught away from riluzole. It asserted similar arguments with res pect to the ’624 application. The district court agreed with Impax that formula I of the ’940 patent included riluzole, but concluded that the ’814 paten t was not anticipated because “formula I entails suc h a large n u mber of compounds . . . [that] one of ordin a ry skill in the art would not have recogniz ed that riluzole was effective in treating ALS wit hout additiona l det ail or guidance that is not found in the disclosure of the ’940 patent.” V a lidity and

05-1313 21Enforceability Order , 333 F. Supp. 2d at 272 (emphasis added). 8 The court reasoned that riluzole was not listed as one of the “especially advant ageous” compounds, that riluzole was not meaningfully dis c ussed in the ’940 pat ent, and that the language of the ’940 patent demonstrated that there was “substantial unc e rtainty regarding the effectiveness of treating ALS with glutam ate inhibiting compounds.” Id. (emphasis added). The district court concluded t hat the language in t he ’940 p a tent which indic a ted that formula I compounds will treat “neurological conditions in whic h glutamate may be implicated” amounted to speculation t hat those compounds w ould be useful in treating ALS. Id. The court stated: “[ O]ne of ordinary skill in the art would not have recognized riluzole’s effectiveness in treating ALS, and theref ore, the Court finds that the ’940 patent does not antic ipat e the ’814 patent.” Id. (emphasis added). Thus, the court apparently determined that even though formula I of the ’940 patent includes riluzole, the formula did not anticipate the ’8 14 patent because it did not disclose riluzole as being effective in treating ALS. Therefore, the court reasoned, formula I was not enabling. The district court explained that the ’624 application, from which t he ’940 pat ent claims priority, contained a disc losure simi lar to the ’940 patent and that the parties asserted virtually identical arguments with respect to the two disclosures. Id. T h u s , i t concluded that there were no material di fferences between the two references that persuaded the court to reach a conclus i on different from the one it had r e ached wit h respect to the ’940 patent. Id. Having decided that the ’940 patent and the ’62 4

8 The district court’s statements about r iluzole in the prior art being effective in treating ALS are unrelated to the words “effective amount” in the cla i ms of the ’814 patent.

05-1313 22application were not enabling, t he district court did not addr ess whether they anticipated claims 1-5 of the ’814 patent. C. On appeal, Impax argues that the ’940 patent enables tr eating ALS with riluz o le because it provides sufficient guidanc e to al low one of ordin a ry skill in t h e art to determine riluzole’s ac tual effectiveness aga inst ALS wit hout undue experimentation, as the ’940 patent indic a tes t hat the compounds of formula I are active against ALS and specifies the dosage r anges to be giv en. I m pax also argues that the ’624 applic ation anticipates the ’814 patent, but acknowledges that the ’ 624 applic ation does not exc l ud e riluzole from the compounds inc l uded in formula I. Aventis res ponds that the ’940 patent—whi c h was cons idered during prosecution but was not viewed by the exam iner as su pporting a rejection of the pending claims— does not enable a method of using riluzole to treat ALS, as the ’940 p a tent disclos e s hundreds of possible c o mpounds, does not meaningfu lly discuss riluzole or identify it as a medication, indicates that the compounds of formula I may be useful in treating “a laundry list of diseas es,” and offers only “s peculation” that the formula I compound s might treat ALS. Aven tis furt her argues that there was n o evidence that a person of skill in the art would find the ’940 patent “to indicate efficacy agains t ALS,” that the district court correctly found that ther e was uncertainty as to whether riluzole would work to treat ALS, and that th e gaps in t he ’940 patent cannot be filled by extrins i c k nowledge because no such extrinsic knowledge exist ed. Av entis contends that Impax’s expert, Dr. Jeffery Rothstein, was unabl e to identify any spec ific teac hing in the ’940 patent that would hav e led one to riluzole , while its expert, Dr. Benjamin Br ooks, testified that one

05-1313 23skilled in t he art would not hav e had a reasonab le expectation of success in treating ALS based on the disclos ure of the ’940 patent. Aventis posits that the dec i sion regarding the ’940 pat ent would be applic able to the ’624 applic ation. D. An invention is anticip ated if it “was . . . described in a printed public ation in this

. . . country . . . more than one year prior to the date of application for patent in the United States.” 35 U. S. C. § 102(b) (2000). A patent clai m is inv a lid as anticipated if every limit ation in a claim is found in a single prior art refere nce, either ex plic itly or inherently. See MEHL/Bioph ile I n t’l Corp. v. Milgraum , 192 F.3d 1362, 1365 (Fed. Cir. 1999). “Anticipation is a factual matter, wh ich we review under the clearly erroneous standard.” Glaxo v. Novopharm , 52 F.3d 1043, 1047 (Fed. Cir. 1995). In order to be anticipating, a prior art reference must be enabling so that the claimed s u bject matter may be made or used by one skilled in t he art. Amgen Inc. v. Hoechst Marion Rous sel, Inc. , 314 F.3d 1313, 1354 (Fed. Cir . 2003); Helifix, Ltd. v. Blok-Lok, Ltd. , 208 F.3d 1339, 1346 (Fed. Cir. 2000); Akzo N.V. v. U.S. Int’l Trade Comm’n , 808 F.2d 1471, 1479 ( F ed. Cir . 1986). Prior art is not enab ling s o as to be anticipating if it does not enabl e a person of ordinary skill in th e art to carry out the invention. See Elan Pharms., Inc. v. Mayo Found. , 346 F.3d 1051, 105 7 (Fed. Cir. 2003) (remanding the case to the district c ourt for a determination of whether the prior art reference enab led persons o f ordinary sk ill to ma ke the inv ention without undue experimentation); In re Donohue , 766 F.2d 531, 533 (Fed. Cir. 1985) (“[P]rior art .

. . must sufficiently describe t he claimed invention to have placed the public in possession of it. Such possessio n is effected if one of ordinary skill in the art could hav e combine d

05-1313 24the publication’s desc r iption of the invent ion with his own knowledge to make the claimed inv ention.”) (ci t ation omitted). The enablement requirement fo r prior art to antic ipate under section 102 doe s not require utility, unlike the ena blement requirement for patents under section 112. 9
Rasmusson v. Smith K line Beec ham Corp. , 413 F.3d 1318, 1325-26 (Fed. Cir. 2005) (“[A] prior art reference nee d not demonstrate ut ility in order to se rve as an a n ticipatin g reference under section 102.” (citing In re Sc hoenwald , 964 F.2d 1122, 1 124 (Fed. Cir. 1992); In re Donohue , 632 F.2d 123, 126 n.6 (C.C.P.A. 1980)); see also In re Samour , 571 F.2d 559, 563-64 (C.C.P.A. 1978); In re Hafner , 410 F.2d 1403, 1405 (C.C.P.A. 1969). In Rasmusson , we held that the B oard of Pa tent Appeals and Interferences (“Board”) erred in determining that a prior ar t reference was not ena bling and thus not anticipatory

. 413 F.3d at 1325-26. The patent application in Rasmusson cl ai med a method of treating prostate cancer by us ing a chemic al called finasteride. Id. at 1320. The prior art reference disclos ed a method of treating prostate cancer by using finasteride, but the Board found that the prior art reference was not enabling because it failed to demonstrate that finasteride was “effe ctive” in treating prostate cancer. Id. at 1325-26. We reversed the Board’s determinati on that the prior art was not enabling and remanded the case for consideration of anticipat ion, holding that proof of efficacy is not required for a prior art reference to be enabling under section 102. Id. ; see also Nov o

9 Section 112, paragraph 1 states: The spec ification shall contain a written description of the in vention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same . . . . 35 U.S.C. § 112, ¶ 1 (2000).

05-1313 25Nordisk Pharms., Inc. v. Bio-Tec h . Gen. Corp. , 424 F.3d 1347, 1355 (Fed. Cir. 2005) (“The standard for enablement of a prior art re ference for purposes of anticipation under section 102 differs from the enablement s t andard under 35 U.S.C. § 112. . . . While section 112 ‘provides that the specificati on must enable one skilled in the art to “use” the invention,’ . . . ‘section 102 makes no such requirement as to an anticipatory disclos ure,’ . . . . Significantly, we have stat ed that ‘ant icipation do es not require actual performance of suggestions in a disclosur e. Rather, anticipation only requires that those sugg estions be enable d to one of skill in the art.’” (citations omitted)); BristolMyers Squibb Co. v. Ben Venue Labs., Inc. , 246 F.3d 1368, 1378 (Fed. Cir. 2001) (holding that prior art that suggested a drug was ineffect ive nev ertheless anticipated a patent on t hat drug); Celeritas T e chs. v. Rockwell Int’l Corp. , 150 F.3d 1354, 1361 (Fed. Cir. 1998) (“A reference is no less anticipatory if, after di sclos ing the inv ention, the reference then dis par ages it. T hus, the q uestion whether a reference ‘teaches away’ from the invention is inapplicable to an ant icipation analysis.”). “Whether a prior art reference is enabl ing is a question of law based upon underlying factual findings.” Minn. Mining & Mfg. Co. v. Chemque, Inc. , 303 F

. 3d 1294, 1301 (Fed. Cir. 2002). In Amgen , we stated that, when, as here, an accused infringer asserts that either claimed or unc laimed material in a pr io r art patent anticipat es patent claims ass e rted against it, the infringer is ent itled to a presumpti on that the allege dly anticipating material is enabled. 314 F.3d at 1355 (“[A] court cannot ignore an asserted prior art patent in evaluating a defense of invalidity for ant icipation, just because the accused infringer has not pr oven it enabled.”). However, “[i]f a patente e presents evidenc e of nonenablement that a court finds persuasive, the tr ial court must then

05-1313 26exc l ude the particular prior art patent in any anticipat ion inquiry, for then the presumption has been overcome.” Id. In this case, the iss ue is whether the prior art enables the treatment of a specific disease with a specific compound. E. We turn first to the question of whether the ’940 patent is an enabling prior art reference. Riluzole is a com pound of formula I in the ’940 pa tent. At the same time, the ’940 patent recognizes that the compounds of formula I of the ’940 patent possess “advantageous pharmacological properties” and “are active with respect to glutamate induced convulsions, and are hence usef ul in the treatment and prevent ion of . . . neurologic al conditions in whic h glutamate may be im plicated, such as . . . [ALS] . . . .” ’940 patent col.2, l.63 to co l.3, l.8. The ’940 patent explains that the dosages of the compounds in formula I “depend on the effe ct sought, the treatment, period and the administration route used,” but that they are “generally between 30 and 300 m g per day in oral administration for an adult , with unit doses ranging from 10 to 100 mg of active substance.” Howev e r, “the doctor will det er mine appropriate dosage in accor dance with the age and weight and all other factors characteristic of t he subject to be treated.” While the ’940 patent includes riluzole as a formula I compound, suggests that formula I compounds may be used to treat ALS, and provides some dosage infor m ation, the district court found that the ’940 patent did not antic ipate the ’814 patent because the disclos ure of the ’940 patent was not enabling at leas t in part because the r e was no evidenc e that it would be “effective. ” Validity and Enf o rceability Order , 333 F. Supp. 2d at 272. However, as we recognized in Ras m usson , proof of efficacy is not r equired for a prior art reference to be enabling for purpo ses of ant icipation. 413 F.3d 1326. That

05-1313 27is, a section 102 prior art reference does no t have to be “effective” to be enabling and thus anticipating. Id. Under Rasmusson , the effectiveness of the prior art is not relevant. Id. Rather, the proper iss ue is whether the ’940 pat ent is enabling in th e sense that it describes the claim ed inventio n sufficiently to enable a person of ordinary skill in the art to carry out the invention. As seen above, howev er, the district cour t focused only on the former question. Thus, we remand to allow the district court to make the proper factual determinations and t hen reach its own legal conc lusion as to whether the ’940 patent is enabled. We reach a different conclus i on, however, with respect to the ’624 applic ation. The ’624 applic ation does not ident ify riluzole by name. As found by the district court, riluzole is just one of hundreds of compounds included in formula I. When a reference disclos es a class of compounds, i.e. , a genus, a person of ordinar y skill in the art should be able to “at once envisage each member of th[e] .

. . cl ass” for th e individual compounds, i.e. , species, to be enabled. In re Petering , 301 F. 2d 676, 681 (C.C.P.A. 1962). If the members cannot be env isioned, the reference does not disclos e the species and the reference is not enabling. Here, with the large num ber of compounds included in formula I and no spec ific identific a tion of riluzole by the ’624 app lication, the ’624 applic ation does not di sclose riluz o le, and therefor e, cannot enable treatment of ALS with riluzole. The ’624 application cannot anticipate any of clai ms 1-5 of the ’814 patent. In sum, we do not dis t urb the ruling of t he district court that the ’624 applic ation does not anticipate. Howev e r, we vacate the ruling of the di strict court with respect to the ’940 patent and remand the case to the dist rict court for further proceedings. O n

05-1313 28remand, the district c ourt should determine whether t he ’940 patent is en abling, usin g the proper legal st andard. That has not y e t been done beca u se, as seen, the district court stopped its analysis after concluding t hat the ’940 patent did not disc lose that the compounds of formula I were effective in treat ing ALS. What the district court must determine on remand is whether t he disc los u re of formula I in the ’940 patent enables a person of ordinary skill in the art to carry out the invention claim ed in cla i ms 1-5 of the ’814 patent . See Ela n Pharms. , 346 F.3d at 1057. Specifically , the district court must determine whether the ’940 pat ent enable s a pers on of ordinary skill in the art to treat ALS with riluzole. Effectiveness in treating ALS does not have to be established. See Rasmusson , 413 F.3d at 1325-26. If the district court determines that what is disclosed in formula I of the ’940 patent is e nabling in that a perso n of ordina ry skill in th e art can carry out the invention, then it will be for t he district court to determine whether that disclos ure anticipates claims 1-5 of the ’ 814 patent. If, however, the di strict court determines that what is disclos ed in formula I of the ’940 patent is not enabling in that a person of ordinary skill in the ar t could not carry out the invent ion, t h en the dis t rict court should again hold that claims 1-5 of the ’ 814 patent are not anticip ated by the disclosure of the ’940 patent and t hat therefore claims 1-5 are not i n valid. CONCLUS ION In sum, (1) We affirm the district court’s dete rmination that there was no inequitable conduct.

05-1313 29(2) We vacate the district court’s d e termination that claims 1-5 of the ’814 patent are not invalid by reason of anticipation. We rem and the case to the district court for further proceedings consistent with this opinion, as set forth above. COSTS Each party shall bear its own costs.

AFFIRMED-IN-PART, VACATED -IN-PART, and REMANDED

05-1313 30

## United States Court of Appeals for the Federal Circuit

05-1313 IMPAX LABORATORIES, INC., Plaintiff-Appellant,

v. AVENTIS PHARMACEUTICALS INC., Defendant-Appellee. RADER, Circuit Judge , concurring in part. I join the majority opinion on a ll points except the anticipation determination. Examining the record in th is case, I think the district court did make a proper finding regarding anticipati on. Therefore, in my view, the case does not require a remand. This court’s opi nion states that the reason the district court determined that the ‘ 814 patent was not anticipated by the ‘940 patent was because “the [district] court apparently det ermined that even though formula I of the ‘940 patent disclosed riluzole, the formula did not anticipate the ‘814 patent because it did not disclose riluzole as be ing effective for treating ALS.” Majority Opinion , 22. Thus, citing Rasmussen v. SmithKline Beecham Corp. , 766 F.2d 531, 533 (Fed. Cir. 1985), the majority op inion remands because a “reference need not demonstrate utility” for anticipation. Majority Opinion , 25. While the trial court referred to e ffectiveness, its findings go beyond that narrow ruling and suffice to uphold its judgmen t. For example, t he district court noted first that formula I encompasses a par ticularly large number of compounds. Impax Labs., Inc. v. Aventis Pharms., Inc., 333 F. Supp. 2d 265, 271-72 (D. Del.2004). In addition, the distri ct court examined the specif ication of the ‘940 patent and determined that riluzole was not meani ngfully discussed in the treatment of medical c onditions associated with the effects of glutamate. Id. at 272. Moreover, the court determined that the l anguage of the ‘940 patent itself created “substantial uncertainty” regarding use of glutamate inhibiting compounds in the treatment of ALS. Id. The c o urt determined that t he language in the patent discussing conditions implic ating glutamate to be speculativ e, at best. Id. Thus, I read the district court to have f ound that the ‘940 disc losure did not put one of sk ill in the art in possess ion of the invention at all. Elan Pharms., Inc. v. Mayo Found. , 346 F.3d 1051, 1057 (Fed. Cir. 2003) . When it found that the disclos ure leaves “substantial unc ertainty,” the trial court suffi ciently supported its holding. Id. The ‘940 disclosure does not make it a potential tr eatment in any
way. Further, th e majority opinion provides even more evidence that the ‘940 patent is not an enabling reference for the purpos es of antic ipating the ‘81 4 patent. For example, the opinion notes that the ‘940 patent was consider ed by the examiner during prosecution and not considered a prior art reference to support a rejection of the cl aims. Majority Opinion , 23. In addition, the opinion points out that Impax’s own expert “was unable to identify any specific teaching in the ‘940 patent that would hav e led one to riluzole.” Id. Further, Aventis’ expert found that the disclosure of the ‘9 40 patent would not hav e given a person a reasonable expectation of succ ess in treating ALS. Id. at 24. Once again, the record – even beyond the parts ci ted by the trial judge – show no anticipation.

05-1313 2Anticipation does not require proof of “u tility,” or (in other words) “actual performance of suggestions in a disclos ur e,” Bristol-Myers Squibb Co. v. Ben Venue Labs., 246 F.3d 1368, 1378 (Fed. Cir. 2001), but in this case, the district court has found that the dis c losure does not m a ke even a suggestion of disclos ure to one of skill in the art. Be yond t he efficacy question, the ‘9 40 pat ent does not even disclos e the necessary sugges tion to enable one of ordinary skill in the art to look to riluzole for the treat ment of ALS in the first place. Thus, I would affirm the district court’s determi nation of anticipation without requiring a remand in this case.

05-1313 3