Fresenius Usa, Inc. v. Baxter International, Inc.

light of the evidence tion of the facts “clearly established phrase The 1519-20. hold- to the presented. [Court’s] law” “refers Federal at Id. at 120 S.Ct. ings,” not dicta. AFFIRMED. decision state habeas court’s clearly to contrary is established

here not precedent because Supreme Court

U.S. materially not indistin is

Rhode’s case Rompilla. from Williams guishable USA, INC. and Fresenius FRESENIUS cases, Rhode’s in those two counsel Unlike Holdings, Medical Care above, not, explained per counsel did Plaintiffs-Appellants, coun deficiently. Unlike form Williams’ sel, adequately investigate who did not v. evidence, counsel stra mitigating Rhode’s INTERNATIONAL, INC. and BAXTER not to certain tegically decided Corporation, Baxter Healthcare thorough after inves mitigating evidence Appellants. Defendants-Cross Williams, at tigation. 529 U.S. Cf. (“[T]he intro failure to 120 S.Ct. at 1514 2008-1306, Nos. 2008-1331. amount comparatively duce the voluminous of Appeals, United States Court speak in that did Williams’ of evidence Federal Circuit. by justified a tactical deci favor was not voluntary con on Williams’ sion focus 10, 2009. Sept. fession.”). counsel, And, unlike Rompilla’s Rehearing En Banc Denied Rhode’s did not fail to examine counsel 18, 2009. Nov. file would any prosecutor warned used Rompilla, be at trial. 545 U.S. Cf. ... (“holding] at 2460 S.Ct. capital bound to lawyer defendant’s]

[a

make efforts to obtain and re reasonable

view that counsel knows materials evi

prosecutor probably rely will on as sentencing aggravation

dence trial”).

phase is not

The state habeas court’s decision

contrary clearly Su- established U.S.

preme precedent. Court

IV. Conclusion denying

The district court did not err

federal habeas relief as to Rhode’s claim penalty

that counsel rendered ineffective

phase investigation presentation.

Rhode the state has failed show that to, or contrary

habeas decision of, application clearly

an es- unreasonable law,

tablished federal in a deci- resulted

sion based on unreasonable determina- Lee,

William F. Cutler Wilmer Picker- LLP, Boston, MA, Hale and Door argued for appellants. defendants-cross him With on the brief were Bharat R. Ramamurti; William G. McElwain and Cedarbaum, Jonathan G. of Washington, DC. Of counsel on the brief were Michael Abernathy Sanjay J. K. Murthy, K & LLP, L Chicago, Gates IL. NEWMAN, GAJARSA, Before DYK, Judges. Circuit Opinion by for the court filed Circuit Judge Concurring GAJARSA. opinions by Judge filed Circuit NEWMAN and Judge Circuit DYK.

GAJARSA, Judge. Circuit case, In this infringement Plain- USA, tiffs Fresenius Inc. and Fresenius Medical Holdings, Care Inc. (collectively “Fresenius”) appeal and Defendants Bax- International, ter Inc. and Baxter Health- “Baxter”) Corporation (collectively care appeal cross from the final judgment of the United States District Court for the California, District of which was based on findings that infringed claims of patents three asserted Baxter —U.S. (“the 5,247,434 Patent Nos. patent”), '434 (“the 5,744,027 6,284,131 '027 patent”), and (“the patent”) '131 of which disclose —all hemodialysis and claim a integrat- machine ed with a touch screen user interface. Holdings, Fresenius Med. Care Inc. v. Int’l, Baxter No. 03-CV-1431 (N.D.Cal. 2007) (“JMOL Opin- Feb. ”). ion part, We affirm in in part, reverse part, vacate in and remand for further proceedings opinion. consistent with this Brooks, Juanita R. Fish & Richardson P.C., CA, Diego, argued of San plain- BACKGROUND tiffs-appellants. With her on the brief I. Technology The and Patents Florey, were Michael E. Mathias W. Sam- a Reichel, person’s kidneys When fail to uel and Deanna J. function Minneapolis, MN, Hillman, Boston, properly, hemodialysis and Robert E. a machine can func- MA. tion in place kidneys of the to cleanse the (b) a controller to receive non- hemodialysis, operable During toxins.

blood of conductivity concerning particular data a a hemo- through pumped blood is person’s of dialysate selection to be circulated machine, dialy- which contains dialysis expect- calculate data an and to from the toxins formulated to draw solution sate —a conductivity dialysate. reading ed machine, the blood. Inside the out of the dialysate by separated from the blood is Dependent Patent 11.14-21. col.36 that allows tox- semi-permeable membrane only a “data additionally requires claim dialy- into the pass from blood ins “comprises device” that touch input it is to ensure important Because sate. Id. col.36 1.32-33. addi- screen.” inadver- that toxins are removed without limitation of not at tional claim 10 is issue out of tently filtering essential nutrients appeal. in this blood, must machine B. The '131 Patent of nu- monitoring and control facilitate independent Regarding patent, the '131 parameters. merous 2, 3, 13-16, claims claim and which patents from All of the at issue derived on at issue in dependent claim are application filed in parent patent appeal. hemodialy- this Claim 1 A reads: are directed and all of relevant claims apparatus, comprising: sis hemodialysis integrated with to a machine (a) dialysate-delivery system a for sup- user At the time a touch screen interface. plying dialysate hemodialyzer, ato filed, touch parent application was dialysate-delivery system comprising at known been used on screens were and had one unit the group least selected from devices, heart-lung as a other medical such (i) consisting dialysate-preparation of a machine, a touch had not been but screen (n) unit, (iii) unit, dialysate-circulation a a machine. integrated hemodialysis with (iv) unit, and a ultrafiltrate-removal 1000, System pat The which embodies the unit; dialysate-monitoring and issue, ents at was introduced in 1991 and (b) a interface operably user/machine a commercial Fre was success.1 dialysate-delivery sys- connected to the infringing alleged senius introduced the tem, interface com- user/machine device, hemodialysis a machine with a a prising displays touch in- screen 2008K touch screen interface called the setting corresponding formation to a of machine. parameter pertinent operation a to of hemodialysis apparatus, the touch A. The '027 Patent being operable display screen to an indi- only patent '027 at claim issue permitting cium perform, the user to is claim appeal dependent this which is screen, using step the touch at least one dependent on claim which is in turn on procedure of a changing setting for claim 7. Claim reads: parameter, display of the a and to time- kidney dialysis machine, A comprising: profile operational par- variable (a) ameter, dialysate circulating a dia- pump profile being representable for coordinates, lysate dialysate conductivity a a of plot plot being dialysate through including respect a circuit a values with an ordinate of of dialysate compartment dialyzer; operational for a and a parameter time- based abscissa. patent applications patents 1. Althin filed the Althin and at issue relevant chased System pur- and introduced the 1000. Baxter March 2000. Patent col.36 11.1-21. 14 addi- to a rate anticoagulant delivery.” '131 Claim of only Id. at col.4011.61-64. tionally requires that “the touch operable display plurality of screen is Litigation Background II. indicia, corresponding each to a different initially against Fresenius filed suit Bax hemodialysis parameter.” time-variable ter in seeking declaratory judg additionally Id. at col.36 11.64-67.Claim 16 '027, '131, ment that the and '434 requires that “the interface user/machine claims are infringed by invalid and not operable require verify the user to hemodialysis Fresenius’s machines.2 Bax parameter parameter after a value of the counterclaimed, alleging ter that Fresenius selected.” Id. col.37 11.4-6.The addi- 7, 11, infringes claims and 14-16 of the 2, 3, 13, tional limitations recited claims patent; '027 claims 1-3 and 13-16 of the argued appeal. and 15 were not on patent; and claims 26-31 the '434

C. The '434 Patent motion, patent. On Baxter’s the district court granted partial summary judgment Regarding patent, independent the '434 infringes Fresenius claim 1 of the '131 27-31, claim 26 and claims which are de- and claim patent. 26 of the '434 pendent on claim are at issue in this allege Baxter continued to that Fresenius appeal. Claim 26 reads: infringes claims, the other asserted A comprising: machine allege Fresenius continued to that all as (a) means controlling dialysate Following serted claims are invalid. claim parameter selected a group from con- construction, stipulated sisting dialysate temperature and di- infringes Baxter’s remaining asserted concentration, alysate and means for A jury validity followed, claims. trial on delivering dialysate dialysate to a jury and the found claims 7 and 14-16 of compartment hemodialyzer; of a and patent the '027 invalid anticipated and (b) a interface operably user/machine all asserted claims invalid as obvious. means, coupled to dialysate-delivery said The district court determined that sub- interface comprising user/machine support stantial evidence does not adapted display touch screen an indi- jury’s granted obviousness verdict and corresponding parameter cium to a per- judgment Baxter’s motion for as a matter operation tinent to (“JMOL”) of law patent its asserted performing hemodialysis machine for claims are not Namely, invalid as obvious. user, and to permit by touching the district court found Fresenius had indicium, change par- to cause a in the presented not specified evidence that limi- ameter. tations of claim 11 of patent, the '027 '434 Patent col.40 11.29-42. Dependent patent, claims 1 and 14 of the '131 limitations, claims 27-31 include additional claims 26-31 of the '434 pres- were only but the additional limitation in claim ent in Opinion, slip art. JMOL appeal. 30 is relevant to this That limita- 8-13,18-19. addition, op. at the district requires tion a “means delivering for an found that Fresenius did not anticoagulant to a patient wherein the substantial evidence of a motivation to touch provides screen further an indicium combine the elements of the art to soliciting input eorrespond- produce from the user the invention claimed in the '131 original filings appeal. 2. The included two additional patents of which is relevant to this —neither

1294 novo. grant The court or denial of JMOL de Id. at 13-16. patents. and '434 jury’s findings Aspex Eyew Inc. v. Eyewear, not evaluate the Revolution did (Fed.Cir. ear, Inc., 1358, of the '027 claims 7 and 14-16 1370 563 F.3d stating 2009) Promotions, that Baxter anticipated, invalid as Inc. v. (citing Theme anticipation verdict. challenged not FSI, had 991, Mktg. Am. 546 F.3d News at 6 n. 1. Id. (9th Cir.2008)); Mfg. also Koito Co. v. see LLC, 1142, Turn-Key-Tech, 381 F.3d jury damages, the After a trial on (Fed.Cir.2004) (reviewing without defer $14,266,000 in Baxter a total of awarded court in ence JMOL decisions of a district $91,000of which was attributable damages, Circuit). party requesting the Ninth “The disposable products. The unpatented court, ... must show that substantial considering after the four the JMOL district eBay support jury’s factors articulated Inc. v. MercEx evidence did not find L.L.C., 388, 391, 126 change, 547 U.S. S.Ct. evidence is ‘such ings, where substantial (2006), 1837, concluded 164 L.Ed.2d 641 relevant evidence from the record taken as injunctive appropriate relief was by a reason might accepted whole as be enjoined Fresenius. Freseni permanently adequate support able mind as the find ” Holdings, Med. Care Inc. v. Baxter us Koito, ing under review.’ 381 F.3d at Int’l, Inc., 03-CV-1431, op. at slip. No. 8- (quoting Cy Tex. Instruments Inc. v. (N.D.Cal. 2008) (“Injunction March press Corp., Semiconductor Order”). The district court ordered that (Fed.Cir.1996)); see also Revolution injunction January take effect on Eyewear, 563 F.3d 1370-71. 2009, because Fresenius indicated it could explained, As we have “[t]his develop non-infringing machine jury’s court reviews a conclusions on obvi The district court also date. Id. at 8-9. ousness, law, a question of without defer pay ongoing roy ordered Fresenius to ence, fact, underlying findings and the alty price any of 10% of the sales for explicit implicit whether within the ver infringing January machines sold before dict, for LNP substantial evidence.” royalty and a 7% price of the sales Plastics, Mills, Eng’g Inc. v. Miller Waste all in disposable products linked to (Fed.Cir.2001). Inc., 1347, 275 F.3d 1353 fringing machines that were from No sold Where, here, explicit made no 2002, patents expire. vember until the obviousness, findings regarding factual we imposed Id. at 9-10. The district court implicit must determine whether the find royalty explaining rates without necessary ings support bases for the verdict are its calculations. supported by Up substantial evidence. appeals the district court’s john Corp., Co. v. Mova Pharm. 225 F.3d JMOL, grant entry permanent of of a in- (Fed.Cir.2000). 1306, 1310 verdict “[T]he award, junction, royalty and constructions supported by of obviousness must be facts specified claim terms. Baxter cross (1) scope prior and content of the appeals jury’s determination that the (2) art, art, ordinary the level of skill in the patent asserted '027 claims are invalid as (3) the differences between the claimed anticipated. jurisdiction This court has (4) art, any and 1295(a)(1). invention and § pursuant to 28 U.S.C. objective indicia such as commercial suc DISCUSSION or long-felt cess need.” Id.

I. Standard of Review presumed Each claim is val id, contending that the party and as the Following procedural law of the Circuit, invalid, Ninth we review the district asserted claims are Fresenius was

1295 underlying findings.”); Sage fact invalidity of each claim evidence required prove Prods., Indus., convincing evidence. See 35 Inc. v. Devon 126 by clear and Co., (Fed.Cir.1997) 282; Corp. Mfg. (declining § Lisle v. A.J. U.S.C. F.3d (Fed.Cir.2005). Thus, 1306, 1316 infringement argument 398 F.3d a novel to consider verdict, “we must reviewing jury’s raised on appeal). jury had substan- whether the determine 50(a) In motion for Baxter’s Rule JMOL to conclude that upon tial evidence which 50(b) JMOL, and Rule renewed motion for invalidity] met its bur- party alleging [the only briefly jury’s Baxter mentioned the invalidity by clear and showing den of verdict, motion, anticipation and in each Koito, at convincing evidence.” 381 F.3d relegated Baxter its discussion of that ver- 1149. 50(a) In single dict to a footnote. its Rule motion, also consider appeal, merely this we Baxter stated that “[t]o entry permanent of a the district court’s rights, moves for preserve its Baxter also injunction royalty award. We review that the JMOL on Fresenius’ defense Ser- grant permanent of a the district System anticipates atron the asserted Inno injunction for abuse of discretion. claims of the '027 because Freseni- Labs., 512 F.3d genetics, N.V. v. Abbott System prove us has failed to (Fed.Cir.2008); eBay, see also corroborating art with sufficient evidence.” Regard 547 U.S. S.Ct. provided J.A. 21588. Baxter no further award, royalty the district court’s “we 50(a) explanation the Rule motion and review the trial court’s determinations develop anticipation argu- did little to law, clearly erro erroneous conclusions of 50(b) Rule motion. In that ment its findings, factual and clear errors of neous motion, footnote, in a also Baxter stated amounting to an abuse of discre judgment it “renews its JMOL on Fresenius’ v. Purchas Mitutoyo Corp. tion.” Cent. System defense that the Seratron antici- (Fed.Cir. LLC, ing, pates renders obvious the remain- and/or 2007). Patent,” ing asserted claims of the '027 provided explanation and then a minimal Appeal Regarding II. Baxter’s Cross regarding prove how “Fresenius failed to Anticipation of Claim of the convincing clear evidence that that '027 Patent System prior art with suffi- Seratron appeal, issue in its cross As sole corroborating evidence.” cient Baxter asserts that substantial evidence argues Baxter appeal, On finding that support jury’s does not System required Seratron lacks two of the 7 is invalid as claim of the '027 opera “it claim limitations because is not By failing properly to raise anticipated. non-conductivity ble to receive data con court, argument that before the district cerning dialysate, selection of particular it, has waived and we decline to Baxter non-conductivity and it does not use data Tech., Bridge Inc. consider it. See Golden expected conductivity to calculate an read (Fed. Nokia, Inc., 1318, v. 527 F.3d 1323 Rep. Br. at 5-6. ing.” Appellant’s Cross Cir.2008) (declining to consider a new ar Baxter asserts that its limited statements party could have raised before gument preserved argu to the district court those court); Software, Inc. v. Sw. the district (Fed. appeal, disagree. ments for but we Before 1280, 1290 Harlequin 226 F.3d court, argued Baxter that it is Cir.2000) the trial (“Failing properly to move for to because Fresenius failed entitled JMOL pre at the of the evidence JMOL close System prior is sufficiency prove to Seratron challenge cludes a presented should have been to the district argue that the Sera art —Baxter did not claim limita in- System specified lacked in the first tron court for its consideration assertions, to Baxter’s Contrary tions. stance. anticipation to an challenge specific one reasons, conclude foregoing For the we chal preserve possible all finding does not properly present that not its Baxter did If a fails to finding. party to that

lenges anticipa- claim 7 argument regarding the court, argument an the trial or raise before thus, court, tion verdict to district only undeveloped presents a skeletal argument. Baxter has waived that court, may to the trial we deem argument appeal, on and we argument waived III. Obviousness W., v. Inc. Hum do so here. See CBOCS — The district court determined that Fre- 1951, U.S. -, 128 S.Ct. phries, present evi- senius failed substantial (2008) (declining to n. 170 L.Ed.2d 864 limita- dence that various non-touch-screen noting appellate consider a claim while present claims were tions of asserted that claim waived be court had deemed “only a skeletal presented prior cause it was in the art. The district court also court) argument” (citing to the district present did not found that Fresenius sub- W., Inc., v. 474 F.3d Humphries CBOCS stantial evidence of a motivation to com- (7th Cir.2007)); Bridge Golden the elements of the art bine (“This Tech., an appel 527 F.3d at 1323 achieve the invention claimed in the '131 we late court and as such abide patents. argues and '434 arguments will not general rule that new the non-touch-screen limitations the as- ap be decided the first instance on serted claims were standard in art peal.”); Corp. Beecham v. SmithKline present- machines and that it (Fed. Apotex Corp., 439 F.3d jury. ed substantial evidence of such to the Cir.2006) argument (deeming an waived Baxter contends the asserted claims are presented because was not as a devel minimum, nonobvious, or at a that Fresen- brief); oped argument opening Sage in the proving ius failed to meet its burden of (“With Prods., few invalidity by convincing clear and evidence. exceptions, jurisdic notable such as some reasons, following For the we reverse the matters, appellate tional courts do not con grant district Baxter’s JMOL theories, party’s lodged sider new first motion, except as to claims 26-31 of the If appeal. litigant on seeks to show patent. overlooking argu error a trial court’s ment, argument it must first A. 11 of the '027 Claim Patent court.”). to the trial claim 11 dependent Because on Moreover, anticipation argu- the new claim it all includes limitations recited presents appeal ment Baxter on includes claim 7. The district determined regarding factual assertions the informa- presented any Fresenius had not testimo tion in the manual. contained Seratron ny regarding the obviousness of claim Rep. Br. at Appellant’s See Cross 7-15. and thus concluded Fresenius neces Fresenius contests those factual asser- sarily failed to demonstrate that all limita tions, arguing that the technical state- 11 in art. prior tions of claim were the in manual ments the Seratron cannot be Opinion, slip op. Specifical JMOL 19. interpreted proposed by the manner that ly, the district court determined be Appellant’s Rep. Baxter. Br. at See 18-20. only ex Thus, Causey cause Mr. parties present the a new factual —Fresenius’s dispute testify a that claim 11 is appeal. dispute pert on Such factual witness to Co., Upjohn not discuss the claim 7 limita- stantial evidence. 225 F.3d at obvious—did tions, Here, had failed to meet its jury implicitly Fresenius 1310. the found that convincing proving by clear and burden present all limitations of claim 7 were that claim 11 is obvious. Id. We evidence art, above, prior the explained and as sub- disagree. finding. stantial evidence that supports Thus, a jury reasonable could conclude notes, although Mr.

As Fresenius Cau- that the non-touch-screen limitations of limitations, claim 7 sey not discuss the did prior claim 11 in the art consider- were Ragsdale, expert Mr. another witness for Fresenius, Causey’s testimony Mr. in combination discussed those previously had testimony he testified that claim 7 is with Mr. Ragsdale’s limitations when and the anticipated. determining invalid as manual. Seratron Because substantial evi- presented Fresenius substantial whether supports jury’s implicit finding, dence jury’s support evidence to verdict inappropriate. JMOL was obvious, we must consider all claim is B. and 13-16 jury that was before the and Claims 1-3

evidence draw all reasonable inferences from that of the '131 Patent light evidence most favorable to appeal, parties On limit their argu- Koito, at 1149. Fresenius. See (a) ments to element of claim 1 speci- and testimony, a Ragsdale’s From Mr. reason- fied additional limitations of claims 14 and jury able could conclude that all limitations 16. in the art. present prior of claim 7 were (a) into elements and Claim is divided (a) Element of Claim (b), Ragsdale separately and Mr. testified (a) requires: Element of claim 1 element, how each explaining about each dialysate-delivery system for supply- art ma- prior was Seratron ing dialysate hemodialyzer, to a the dia- also chine. J.A. 14342-43. Fresenius lysate-delivery system comprising at operating the Seratron’s manual. offered least one unit selected from the group Thus, assessing was when the (i) consisting dialysate-preparation dependent obviousness of claim it could (ii) (iii) unit, unit, dialysate-circulation reasonably that all limitations of conclude (iv) unit, an ultrafiltrate-removal claim 7 in the art based on Mr. were dialysate-monitoring unit. Ragsdale’s testimony. '131 Patent col.36 11.1-8. The district argues Baxter Fresenius failed concluded substantial evidence carry it its burden because did not support jury’s not does verdict be- properly connect all of the evidence re Causey, expert cause Mr. Fresenius’s who garding of claim the obviousness name obvious, testified that claim 1 is did not ly Causey Mr. because never referred to (a). specifically analyze Because element Ragsdale’s testimony. Appel Mr. Cross Causey’s “testimony analyze Mr. not did argument Br. at 40. That fails. Al lant’s explain language the claim and which

though would have been advisable for components art embodied Causey that Mr. Fresenius to ensure dis claim,” each element of the asserted all limitations of claim 11 when he cussed district court determined that Fresenius regarding testified the obviousness of proving had not met its burden of claim, required was not to do so. here, Opinion, slip claim is invalid. JMOL When, question of obviousness at 13. all the claims jury, op. Because asserted is submitted to we must review (a) factual for sub- of the '131 contain the element jury’s implicit findings (a) limitation, granted clude that the limitations of element the district claims. We for all of the asserted in art. prior Specifically, JMOL were known the court. disagree with the district jury prior- art the could conclude the hemodialysis contained a machine with a (a) in written Markush Element is dialysate-delivery system supplies dia- form, element is dis such that the entire lysate hemodialyzer comprises a a in art if one alternative by prior closed the dialysate-circulation in art. unit. Because sub- group prior the Markush the See Pharms., Schering Corp. v. supports jury’s Geneva the find- stantial evidence (hold (Fed.Cir.2003) 339 F.3d ing, inappropriate. JMOL was ing anticipated a claim invalid as when compounds in Markush form and a claimed 2. Claim

prior art reference disclosed one of the Skoll, compounds); In re 523 F.2d patent claimed Claim 14 of the '131 de (CCPA 1975); 1392, 1397 see also Titani from claim 1 and addition pends adds one Banner, Corp. um Metals v. al limitation: “wherein the touch screen is (Fed.Cir.1985) (“It also an elementa indicia, operable display plurality a of when, ry principle of law that each to a time- corresponding different otherwise, ranges a of a claim recitation hemodialysis parameter.” variable '131 the claim is compositions, covers several Patent Although col.3611.64-67. the district in ‘anticipated’ prior if one of them is court noted that the manual for the Cobe art.”). Thus, a art prior device discloses prior art machine—which was in evi C3 (a) dialysate-deliv if it a element contains dence and had been submitted to the ery system supplying dialysate for to a jury correspond “an indicium —disclosed hemodialyzer comprising only dialysate a hemodialysis a param to time-variable (or any circulation unit one of the other eter,” the district court concluded alternatives). three listed present any Fresenius failed to evidence prior It is clear that the art disclosed a “plurality of indicia” limitation of hemodialysis containing dialy- machine present prior claim 14 in art. was Kelly, sate-circulation unit. Mr. Baxter’s Opinion, slip op. JMOL at 8-9. We dis witness, agreed admitted and that all he- agree. modialysis jury machines—which the could testified, Causey Mr. using explana- reasonably presume include would those demonstrative, tory that the inventors prior way art —must have “some prior provid- art machine had Cobe C3 circulating dialysate through dialy- param- ed for more than one time-variable addition, sate circuit.” J.A. at 14399. In eter. The indicated that Ragsdale opinion, Mr. testified that in his demonstrative system dialysate prior “the Seratron includes a art machine allowed for multiple pump circulating dialysate through indicia, ... corresponding each different dialysate a circuit including compartment hemodialysis time-variable parameter. dialyzer.” Finally, for a J.A. at 14342. jury reasonably have could credited Causey Mr. testified that the limitations of Causey’s testimony Mr. and concluded that (a) element of the present the relevant limitation was the CMS 08 art ma- prior art Cobe C3 machine. Because sub- chine. jury’s im- supports stantial evidence plicit finding plurality of indicia totality testimony

Based on the art, limitation existed JMOL presented by Kelly, Ragsdale, Messrs. Causey, reasonably inappropriate. could con- was

1299 only functional, mony 3. 16 ‘based on a not a Claim ” structural, analysis.’ (quoting Alpex Com additionally asserts that Fresen- Baxter Co., Corp. v. puter Nintendo 102 F.3d failed to demonstrate follow- ius (Fed.Cir.1996))). 1222 pat as a Just 16 in the ing limitation of claim existed prove infringement entee who seeks to art: “the interface is prior user/machine a provide analysis by must structural dem verify the user to a operable require to onstrating that the accused device has the parameter after a value of the parameter corresponding identified structure or an Patent col.37 11.4-6. is selected.” '131 structure, equivalent challenger a who argument unpersuasive. That Freseni- that a means-plus- seeks demonstrate expert prior us’s testified that the CMS 08 function limitation in present prior was art machine contains the limitation de- prove art corresponding must claim, referring in the specifically scribed an equivalent present structure —or page to a of the CMS 08 manual that —was Co., in prior art. See In re Donaldson testimony. supports the J.A. at (Fed.Cir.1994) (en 16 F.3d Thus, sup- substantial evidence banc) (“[W]e paragraph hold that six ap ports jury’s implicit finding that the plies regardless of the context in which the claim limitation at issue in the existed interpretation of means-plus-function lan prior art. arises, i.e.,

guage whether as part of a C. Claims 26-31 of the '434 Patent patentability determination in the PTO or part validity of a infringement deter contain means-plus-

Claims 26-31 court.”); in mination McGinley see also limitations, function all require Sports, v. Franklin 262 F.3d delivering dialysate “means for to a (Fed.Cir.2001) (Michel, J., dissenting) dialysate compartment hemodialyzer.” of a (“Of course, in the context of a means-plus- '434 Patent col.40 11.33-35. The district claim, function the invalidating prior art granted Baxter’s motion for JMOL simply must disclose not a means for invalidity part of no based on its conclu function, achieving the desired prove sion that failed but rather particular structure delivering dialysate means for recited the writ limitation description ten present prior agree, corresponding was in the art. to that func We thereof.”). tion, equivalent or an though for somewhat different reasons than those articulated the district court. Here, Fresenius neither identified the Namely, present any Fresenius failed to specification structure that corre- evidence—let alone substantial evidence— sponds delivering dialy- to the means for corresponding the structure to the nor compared sate it to the structures limitation, delivering dialysate means for present in the art. CytoLogix, See thereof, or an equivalent existed in the (“Here, CytoLogix F.3d failed art. identify the structure in specifica- tion that ‘temperature is the controller firmly It is established our compare means’ and it to the structure of precedent analysis that a structural is re the accused device. Accordingly, because quired means-plus-function when limita CytoLogix failed to substantial ev- issue; analysis tions functional infringement idence of See, of claim 13 of the e.g., CytoLogix alone will not suffice. patent, verdict of Corp. infringe- Sys., v. Ventana Med. (Fed.Cir.2005) reversed.”). (“To ment of claim 13 must be in At establish ¶ most, 112, 6, fringement § under the evidence of supports is insuffi record cient for the holder to present finding testi- that some structures that could above, evidentiary proof the burden of can- claimed function existed the perform the our it is clear prior precedent, clearly identifying art. Under not be carried without Thus, finding that such a is insufficient. corresponding prior structure in the CytoLogix, jury’s as in verdict as to Thus, art. substantial evidence does not claims 26-31 cannot stand. support jury’s implicit finding that the prior stepper art contained a motor means that there is an addi We note also anticoagulant, and the delivering an affirming the district tional reason for correctly granted district court JMOL. grant regarding depen of JMOL 30, requires a “means for dent claim which reasons, we affirm the foregoing For the delivering anticoagulant patient.” an to a grant district court’s of JMOL as to claims jury instructed the district court patent. 26-31 of the '434 corresponding micropro structure is stepper cessor and motor. Fresenius D. Motivation to Combine USA, Int’l, Inc., Inc. v. Baxter No. 03- All appeal of the claims on 2006) (Dkt. (N.D.Cal. July at 21 hemodialysis directed to a machine inte 825) ”). (“Jury No. Because Instructions interface, grated with a touch screen user present any Fresenius failed to evidence which Baxter contends was novel and non- required stepper that the motor structure patent obvious at the time the relevant art, prior existed in the the district court applications were filed. Fresenius con correctly granted JMOL. Fresenius has tends touch screens were well— testimony any cited no wherein witness known in the art and had been wide “stepper discussed motor.” Fresenius ly employed-even on other medical de manual, contends that the which Cobe C3 vices—such that Baxter’s addition of a jury, was submitted to the discloses the touch screen interface to an otherwise con structure, necessary notably, but Freseni ventional machine would have pages us has cited no manual that refer unpatentable. been obvious and thus a “stepper indepen ence motor.” After record, dently reviewing the this court The district court conducted the trial briefly notes that the CMS 08 manual opinion and issued its JMOL before the “stepper mentions a motor” but does not Supreme Court decided KSR Internation- discuss structure the context of the al Co. v. U.S. Teleflex delivering anticoagu claimed an (2007). Thus, S.Ct. 167 L.Ed.2d 705 function— Moreover, lant. if even the CMS 08 manu applied teaching-sug- the district court stepper delivering al disclosed a motor for gestion-motivation test for obviousness as it anticoagulant, was Fresenius’s bur by it existed it was before modified KSR. disclose, discuss, clearly den to and identi granted The district court JMOL and fy jury supporting for the evidence jury’s overturned the that all verdict as- upon relying prove which it was patents serted claims of the '131 and '434 claim limitation was in the are invalid it as obvious because deter- Koito, art. (holding See 381 F.3d at 1151 mined Fresenius had failed to demon- challenger that a failed to meet its burden required strate the motivation to combine. proving prior anticipated art reference ap We first note that it remains provide claims when “failed to propriate post-ASA considering for a any testimony other evidence that obviousness “to determine whether there would demonstrate to the how that apparent was an reason to combine the reference met the limitations of claims”). Here, known elements in the fashion claimed as with the means for KSR, delivering dialysate limitation discussed issue.” U.S. witness, Thus, jury’s prevalence obvi described the ease and 127 S.Ct. to our verdict remains relevant “integrating ousness touch screen into some not overturn the review because we will a computer-controlled kind of machine” findings underlying factual implicit opined filing as of the relevant they sup jury’s long verdict so date, it would not have been difficult for LNP by substantial evidence. See ported integrate one to a touch screen interface Plastics, 275 F.3d at 1353. As ex Eng’g into a hemodialysis machine. J.A. at below, sub plained presented Fresenius 14321-22. jury’s im support stantial evidence to the KSR, “if technique Under has finding prior factual the art plicit device, improve been used to one and a of a touch suggested the combination in person ordinary of skill the art would screen user interface with known elements recognize that it improve would similar Thus, prior hemodialysis of art machines.3 in way, using devices the same the tech grant of we reverse the district nique applica is obvious unless its actual the claims in the JMOL as to asserted '131 beyond tion is his or her skill.” 550 U.S. patent. addition, at In S.Ct. 1727. “[t]he present- Baxter concedes that Fresenius familiar combination of according elements prior publication ed a art that disclosed the likely to known methods be obvious use of a touch screen interface on a medi- yield predicta when it does no more than an specifically cal anesthesia-deliv- device— ble results.” Id. at 127 S.Ct. 1727. system. publication That noted hemo- ery Here, jury implicitly the found that dialysis rapidly advancing as one area of prior art suggested combining a touch medicine, complex technologies stated that screen with known elements of a hemodial advances, rapid have fueled such and then ysis finding supported machine. That necessary to equipment disclosed that the by substantial evidence because a reason technologies could practice complex those jury able could conclude that Dr. Rau’s improved an user interface. benefit from an publication explicit sugges contained publication specif- then J.A. tion to combine the disclosed benefits of a ically integration described the of touch hemodialysis touch screen interface with a screen interface with anesthesia-deliv- addition, jury machine. could rea Rau, Dr. ery system. the author of the conclude, sonably Dr. based on Phares’s jury publication, explained where testimony, ordinarily that an skilled arti publication hemodialysis his mentioned san would have known how to make that pointed publi- and to other sections of the Thus, combination. substantial evidence that, opinion, suggested cation his jury’s findings supports the limita hemodialy- addition of a touch screen to a tions of '131 claims were known Specifical- sis machine. J.A. 14373-75. art, prior prior suggest art ly, publication Dr. Rau testified that his combining ed those elements to arrive at “gave examples you numerous of where invention, the claimed and that the ordi technology] can use screen benefi- [touch narily skilled artisan would have known cially” stated that “one of the exam- and Therefore, how to make that combination. hemodialysis I ples which mentioned was KSR, inappropriate JMOL is under and a machine.” J.A. at Phares, grant 14373-75. Dr. another Fresenius we reverse the district court’s of ordinary derstanding person of skill in "[t]he 3. The was instructed that claimed suggest was the field that would the claimed in- invention is not obvious unless there Jury something at 26. in the art or within un- vention.” Instructions the district court did not err hold that all asserted claims regarding JMOL above, However, injunctive it relief is as discussed when determined patent. '131 evidence that present injunction failed to appropriate, we vacate the in claims 26-31 of present limitations all to revise or remand for the district court in the were injunction light of our reconsider thus, the district court’s we affirm likewise vacate the reversal of JMOL. We art — to those claims. grant of JMOL as royalty award and remand for district court to reconsider that award view objective evi- argues presented Baxter opinion. this its to demonstrate dence sufficient However, it invention was not obvious. Injunction A. The Permanent jury to assess proper role of the was the weight of Baxter’s evi- credibility the and injunction, permanent To obtain a integrat- of regarding the difficulties dence must demonstrate: prevailing patentee the machine with a touch hemodialysis a (1) an irreparable that it has suffered and the commercial suc- screen interface (2) at injury; that remedies available patents. an cess of embodiment law, in- monetary damages, as such jury was instructed that it must con- The adequate compensate injury; to for that Jury Instructions at that sider evidence. (3) that, of hard- considering the balance Therefore, to render its verdict on 26-27. and ships plaintiff between the defen- obviousness, jury necessarily the deter- warranted; dant, remedy equity is mined that Baxter’s evidence was insuffi- (4) public and that the interest would showing to overcome Fresenius’s cient by injunc- permanent not be disserved claims are invalid as obvious. We will the tion. implicit finding not disturb that factual eBay, 391, 126 at 547 U.S. S.Ct. by it evi- supported because substantial performed appro The district court the dence. eBay. by It priate analysis required Injunction IV. The Permanent explained all of the factors and weighed Royalty and Award why ultimately injunc determined Injunction Or appropriate. tive relief is argues Fresenius that the district court der, Contrary slip op. at 3-8. to Freseni permanently abused its discretion when it assertion, us’s the district court did not enjoined Fresenius and awarded Baxter a injunction permanent to be consider royalty on machines sold be- 1, 2009, following infringe “all but January inevitable” disposables fore and Although we ment Fresenius linked to those machines. determination.4 asserts burden, injunction 4. The district court did discuss an because is Fresenius’s and not "[i]t inevitable,” Baxter's, as "all but but it did so in the to taste the bitter fruit of its own context, balancing hardships context of the relative inaction.” Id. Read in the "all but parties legal le- and did not commit error. inevitable” statement does not amount to error, gal particularly light The district court noted that it was "some- of the fact that that, applied bewildering having court correct four- what admitted district infringing analysis. patents nearly years ago explained and two factor test its merely having year likely acknowl- known for least district court was inevitable, injunction eBay, edging, all did Chief Roberts in was but Fresenius Justice apparently nothing implement granted injunctive relief has done that "courts have any infringing upon finding infringement the vast alternative to the de- [accused Order, (em- Injunction slip op. majority eBay, at 7 cases.” 547 U.S. vice].” C.J., added). (Roberts, phasis The district court then found 126 S.Ct. 1837 concur- hardships ring). that the balance of favored Baxter Instead, royalty we vacate the award and challenges to the district additional several legal it cites no error analysis, but court’s court to remand for district consider that the district fails to demonstrate previous proper whether the award is clearly erroneous factual any made court light of this court’s modification of the example, For determinations. In judgment. particular, court’s district “ignored” court the district asserts may that our reversal of JMOL we note 50-52, evidence, Br. at but Appellant’s see the district court’s consideration of affect requirement that the district there is no putative royalty rate that would result every single fact opinion discuss court’s hypothetical negotiation from a between addition, the rec- alleged by Fresenius. analysis That Baxter and Fresenius. support ord contains district factors, Georgia influenced determinations; Pacific the district court factual Indus., see Minks v. Polaris Thus, we conclude clearly did not err. (Fed.Cir.2008), not abuse its and our decision the district court did in- granted permanent when it discretion may affect how the district here Nonetheless, vacate junctive relief. we factors, weighs one of more of those see injunction and remand for the district Georgia-Pac. Corp. Plywood Corp., v. U.S. injunction or reconsider the court to revise (S.D.N.Y.1970). 1116, 1120 F.Supp. 318 reversal of the district light of our regarding the '027 grant court’s of JMOL that argues Fresenius also the patents. and '131 a imposing royalty district court erred post-verdict disposables on sales of linked Royalty B. The Award pre-verdict. to machines that were sold court ordered Fresenius to The district Fresenius, According portion that royalty of 10% of the sales pay ongoing an royalty jury the inappropriate because any infringing machines sold be- price for already damages had awarded Baxter 2009, 1, royalty January and a of 7% fore pre-verdict. based on machines sold We all price disposable prod- of the sales for disagree the district court acted infringing ucts linked to machines because 7, 2002, from November until were sold A damages within its discretion. award Order, Injunction slip patents expire. the pre-verdict infringing prod for sales of the argues the district op. at 9-10. Fresenius fully compensate patentee uct does not the by imposing its discretion court abused post-verdict account for because it fails to royalty explaining ongoing without repair parts. See Carborundum sales royalty rate determinations. bases for its Innovations, Equip. Co. v. Molten Metal Toyota Corp., Motor 504 See Paice LLC v. (Fed.Cir.1995). 872, 72 F.3d 881-82 (Fed.Cir.2007) (remanding F.3d Although jury damages had awarded because, of the se- explanation absent pre-verdict sales of ma Fresenius’s rate, royalty this court can- lection of the products, disposable chines and Fresenius whether the district court not determine indicating cites no evidence discretion) (citing Hensley v. abused its post-verdict sales of dis also considered Eckerhart, 103 S.Ct. U.S. linked machines sold posable products (“It (1983) impor- L.Ed.2d 40 [is] court was within pre-verdict. The district provide tant ... for the district court to explanation concise but clear of its reasons royalty on those impose its discretion to award.”)). for the fee disposable products order to sales of fully infringe Baxter for the compensate today do not decide whether We royalty proper. award was ment. district court’s thus, arguments claim construction are Arguments

V. Other validity. moot as to the issue parties’ have considered the We unpersua and find them arguments other Baxter asserts that it is entitled to example, For Fresenius asserts sive. new trial if this court determines construing two court erred district grant court’s of JMOL was errone- district controlling the “means for claim terms: disagree. We have decided the ous. We in claim 26 of dialysate term parameter” law, no invalidity issues as a matter of and the “time variable '434 trial warranted. new in all claims of the profile” term asserted patent. '131 We decline to consider those VI. CONCLUSION First, arguments. failed to Fresenius failed to demonstrate Because if clearly what result would occur explain to cer- corresponding that the structures adopted proposed this court Fresenius’s means-plus-function tain claim limitations gave this claim constructions. Fresenius art, we affirm were guidance and cited no record little judgment the district court’s Freseni- support regarding why a modified claim prove us failed to that claims 26-31 of the infringement construction would affect reverse the invalid. We judgment, validity judgment, or both. grant of JMOL as to all district alone, may For that reason we decline to addition, other asserted claims. al- consider Fresenius’s claim construction ar though we hold the district court did v. Jang Corp., See Boston Sci. guments. perma- not abuse its discretion when it (Fed.Cir.2008) (“The Fresenius, enjoined nently we vacate the Supreme explicitly has held that Court injunction and remand so III permit Article does not the courts to injunction may revise or reconsider the in resolve issues when it is not clear that the light only the fact that claims of 26-31 of question resolution of the will resolve a infringed. the '434 remain valid and controversy concrete between interested Breeze, Finally, royalty vacate the award en- we v. parties.” (citing Coffman by 316, 322-24, tered the district court and remand for U.S. 65 S.Ct. 89 L.Ed. (1945))). addition, proceedings further with to the extent consistent this opinion. Fresenius contends a claim con modified may infringement struction affect AFFIRMED-IN-PART, REVERSED-

judgment, disagree. we uncon IN-PART, VACATED-IN-PART, and ditionally in stipulated its accused REMANDED COSTS fringing every device contains each and No costs. claims, element of the and J.A. proceeded argue invalidity then to at trial. NEWMAN, Judge, concurring. Circuit stipulation way That in no or indi stated join I I opinion, the court’s but write upon cated that it was conditioned separately respond Judge Dyk’s sep- to construction, district claim and in thus, opinion, proposes arate which he infringement judgment cannot be stay completion the district court should of by a altered modified claim construction. in litigation, pending this view of the reex- Finally, to the extent proffered Fresenius’s proceeding. Although pro- in amination this support claim constructions would its validity posal adopted response, is not it warrants arguments, we note we have in stage protracted litiga- not relied on the contested claim terms for for at this this Fresenius, tion, any full in holdings adverse to and after trial and decision 1988). court, stay full A appeal ruling finality, district after and of after the issues only court and with appellate validity of the of and infringement have been liti- remand, remedy remaining on gated modified and decided the district court and inappropriate. an action would be Circuit, such appealed to the Federal is a dis- Further, has question this been neither of tortion the role of reexamination. sponte pres- nor debated. Its sua briefed I strong supporter prin- remain a stage irreg- entment as available at this ciple of reexamination. It can a useful be ular. powerful and tool for the benefit of both began Only in litigation This patentees and those interested in restrict- adjustment damages of a mod issue of and eliminating adversely patents. held permanent injunction ification of the to However, if routinely delay available to of reflect our reversal JMOL remain on judicial disputes, resolution of proce- Meanwhile, remand. the reexamination subject dure is if inequity, manipu- not PTO, finally yet has to be decided abuse, lation and through delays review, subject judicial and remains on are activity. inherent PTO The statisti- validity the same issues of as have been cal data of the Patent and Trademark Of- litigated. proposal The would entail sever relief, place aspect fice this in sharp years’ delay, al if additional the court were the number of requests reexamination stay now to the action at this final stage.1 increasing, as is the completion time for of relationship PTO, between reexamination reexamination appeal courts, litigation right judicial is not new to the and well as the of review. In its variety responses summaries, precedent reflects recent statistical the PTO re- situations, particular in ports filing as summarized a 54% increase in parte ex Lite, (from Slip Systems, Track Inc. v. Metal reexaminations since 2004 441 in (Fed.Cir.1998) 2004 to 680 and with filings 2009). respect proceedings USPTO, with to concurrent in- through June See Reex- (June cluding PTO reexamination and PTO inter- amination Operational Statistics 2009), It proceedings. ference is established that http://www.uspto.gov/ available at required stay judicial web/patents/documents/reexam_ a “court is not to operations_06-09.pdf. resolution of the reexaminations.” filings view Of these Co., Corp. Viskase v. American Nat’l reported litigation. Can 31% were to be in Id. (Fed.Cir.2001). 1316,1328 partes The Inter reexaminations increasing are corollary rapidly, rule is the PTO has no au- from filings 2008 to 195 thority stay pending through to reexamination the of reported June with 66% litigation. litigation. outcome of district court Ethi- to be in Id. The PTO also re- (Fed.Cir. con, Quigg, Inc. v. 849 F.2d 1422 that as ports quarter of third of colleague appears partes 1. Our in concurrence to Once an order for inter reexamina- believe that a PTO decision on reexamination patent tion of a has been issued under sec- judicial will override a decision reached after patent may stay tion owner obtain a appeal. trial and That All is incorrect. any pending litigation of which involves an accomplished delay. exercising can be is In patentability any issue of of claims of the deny grant stay pending its discretion to patent subject which are the of inter reexamination, a district court should consid- order, partes reexamination unless the delay upon patentee. er the effect of With litigation pend- court before which such is reexamination, respect partes to inter stay determines that a would not serve grant stay § U.S.C. 318 commits the of a justice. the interests of special the district court’s discretion with added). patentee: (emphasis heed to the concerns of the parte for ex reexam- average pendency TRIBE OF EASTERN SHAWNEE months, from an increase ination is 36.1 OKLAHOMA, Plaintiff- 2008. Id. the 34.6 months December Appellant, partes inter reexamina- pendency of average 41.7 months. reported tion is v. Id. STATES, Defendant-Appellee. UNITED ap- on reexamination can be Decisions No. 2008-5102. subject pealed to the Board and judicial reports review. The PTO of Appeals, United States Court heavy in- experiencing Board is still Federal Circuit. backlog ap- appeals crease in and the of Sept. contrast, case is peals. remedy of the on

over but review that the district suggestion

remand. The stay proceedings,

court should now stage, contrary precepts final to the

this just resolution of dis- expeditious

putes.

DYK, Judge, concurring. Circuit join majority opinion

I on the under- not

standing does foreclose staying

district court its discretion from proceedings pending

further the outcome Pat- the reexamination before U.S.

ent and Trademark Office. While Fresen- invalidity

ius did not establish the of claims patent in the

26-31 '434 district proceeding, those claims on their validity light

face are of dubious of our

holding that claims 1-3 and 13-16 of the and claim 11 of the '027 entirely possible It

are invalid. Patent and Trademark will fi-

U.S. Office

nally conclude that claims 26-31 also invalid.

Case Details

Case Name: Fresenius Usa, Inc. v. Baxter International, Inc.

Court Name: Court of Appeals for the Federal Circuit

Date Published: Sep 10, 2009

Citation: 582 F.3d 1288

Docket Number: 2008-1306, 2008-1331

Court Abbreviation: Fed. Cir.