boston bar association 2002 year in review patent law and litigation robert m. asher erik paul belt...

Boston Bar AssociationBoston Bar Association

20022002YEAR IN REVIEWYEAR IN REVIEW

PATENT LAW and LITIGATIONPATENT LAW and LITIGATIONRobert M. AsherRobert M. Asher

Erik Paul BeltErik Paul BeltBROMBERG & SUNSTEIN LLPBROMBERG & SUNSTEIN LLP

125 Summer Street125 Summer StreetBoston, MA 02110Boston, MA 02110

617-443-9292617-443-9292

January 16, 2003January 16, 2003

TopicsTopicsFestoFesto/Doctrine of Equivalents/Doctrine of EquivalentsPatent ReexaminationPatent Reexamination InherencyInherencyPatent ProsecutionPatent ProsecutionPatent LitigationPatent LitigationGeneric Drug/Hatch-Waxman Generic Drug/Hatch-Waxman

LitigationLitigation..

Copyright © 2003. Robert M. Asher Copyright © 2003. Robert M. Asher and Erik Paul Belt. All rights reservedand Erik Paul Belt. All rights reserved

FestoFesto/Doctrine of /Doctrine of EquivalentsEquivalents

Federal Circuit’s Federal Circuit’s FestoFesto Decision Decision Claims narrowed by amendment Claims narrowed by amendment

create prosecution history estoppel for create prosecution history estoppel for any reason substantially related to any reason substantially related to patentabilitypatentability

Estoppel applies as well to voluntary Estoppel applies as well to voluntary amendmentsamendments

Prosecution history estoppel acts as Prosecution history estoppel acts as an an absolute barabsolute bar against doctrine of against doctrine of equivalentsequivalents


Supreme Court Nibbles Away at the Supreme Court Nibbles Away at the FestoFesto Bar Bar Affirms that estoppel applies even when Affirms that estoppel applies even when

amendment was not for overcoming prior artamendment was not for overcoming prior artAffirms absolute bar when reason for Affirms absolute bar when reason for

amendment is indiscernibleamendment is indiscernibleBut . . .But . . .


Supreme Court Nibbles Away at the Supreme Court Nibbles Away at the FestoFesto Bar Bar Rebuttable presumption replaces Rebuttable presumption replaces

absolute barabsolute barPatentee has burden to show Patentee has burden to show

equivalent was not surrendered – equivalent was not surrendered – FestoFesto 20032003


Plaintiff’s burden to rebut presumptive Plaintiff’s burden to rebut presumptive barbarEquivalent unforeseeable, orEquivalent unforeseeable, orRationale for amendment bears no more than Rationale for amendment bears no more than

tangential relation to equivalent, ortangential relation to equivalent, orPatentee can not reasonably be expected to Patentee can not reasonably be expected to

have described the equivalenthave described the equivalent Impossible Burden?Impossible Burden?

At time of amendment one skilled in the art At time of amendment one skilled in the art could not reasonably be expected to have could not reasonably be expected to have drafted a claim that would have literally drafted a claim that would have literally encompassed the alleged equivalentencompassed the alleged equivalent


Patent Practice Post-Patent Practice Post-FestoFesto Make reasons apparent for all Make reasons apparent for all

amendmentsamendmentsGet claims right the first time – Get claims right the first time –

particularly with respect to Sec. 112particularly with respect to Sec. 112Fight harder to avoid making narrowing Fight harder to avoid making narrowing

amendmentsamendmentsGet the broadest possible literal claimsGet the broadest possible literal claimsConsider using “means for” in Consider using “means for” in

amendmentsamendments

Doctrine of EquivalentsDoctrine of EquivalentsAbbott Labs v. Dey L.P., 287 F.3d 1097 Abbott Labs v. Dey L.P., 287 F.3d 1097

(Fed. Cir. 2002)(Fed. Cir. 2002) Summary judgment of noninfringement Summary judgment of noninfringement

vacated to permit doctrine of equivalentsvacated to permit doctrine of equivalentsClaim 1 requires 68.6%-90.7% Claim 1 requires 68.6%-90.7%

phospholipidphospholipidStatement in prosecution of related patent Statement in prosecution of related patent

application not prosecution estoppel when application not prosecution estoppel when applications are not formally relatedapplications are not formally related

Numeric ranges do not preclude DOENumeric ranges do not preclude DOE

Doctrine of EquivalentsDoctrine of Equivalents Johnson & Johnston v. R.E. ServiceJohnson & Johnston v. R.E. Service, 285 , 285

F.3d 1046 (Fed. Cir. 2002)F.3d 1046 (Fed. Cir. 2002)Steel disclosed in Specification:Steel disclosed in Specification:

While aluminum is currently the preferred While aluminum is currently the preferred material for the substrate, other metals, such material for the substrate, other metals, such as stainless steel or nickel alloys, may be used. as stainless steel or nickel alloys, may be used.

But not recited in the claims:But not recited in the claims: a sheet of aluminum which constitutes…a sheet of aluminum which constitutes…

Jury found copper-steel and copper-aluminum Jury found copper-steel and copper-aluminum laminates to be equivalentlaminates to be equivalent

Reversed on grounds that use of steel was Reversed on grounds that use of steel was dedicated to the publicdedicated to the public

Doctrine of EquivalentsDoctrine of Equivalents Cooper Cameron v. Kvaerner Cooper Cameron v. Kvaerner

OilfieldOilfield, 291 F. 3d 1317 (Fed. , 291 F. 3d 1317 (Fed. Cir. 2002)Cir. 2002) Claim 10: “a workover port Claim 10: “a workover port

extending laterally . . . from extending laterally . . . from between the two plugs”between the two plugs”

All Elements RuleAll Elements Rule What is an element – each word!!What is an element – each word!!

Defendant had a “workover Defendant had a “workover port” but not “between” the port” but not “between” the two plugstwo plugs

Infringement by equivalents Infringement by equivalents barred because “between” barred because “between” could not be ignoredcould not be ignored

Patent Reexamination Patent Reexamination Becomes More Appealing Becomes More Appealing

Inter PartesInter Partes Reexamination may be Reexamination may be appealed to Federal Circuit by third appealed to Federal Circuit by third party requestorparty requestor

May now be based on previously May now be based on previously cited reference - cited reference - In re Portola In re Portola PackagingPackaging overruled by 2002 Justice overruled by 2002 Justice Department Authorization ActDepartment Authorization Act

Patent ReexaminationPatent ReexaminationMuch less expensive than litigationMuch less expensive than litigationNo presumption of validityNo presumption of validityBroadest reasonable interpretation Broadest reasonable interpretation

of claimsof claimsCan weaken patent by cancelling or Can weaken patent by cancelling or

amending claimsamending claimsCan strengthen patent by providing Can strengthen patent by providing

USPTO second stamp of approvalUSPTO second stamp of approval

Inter PartesInter Partes ReexaminationReexamination

Available only for patents filed after Available only for patents filed after November 29, 1999November 29, 1999

Requestor estopped from asserting Requestor estopped from asserting invalidity over prior art documents in invalidity over prior art documents in litigationlitigation

No interviews with Examiner on the No interviews with Examiner on the meritsmerits

May be used to obtain a stay of May be used to obtain a stay of litigationlitigation

InherencyInherency Inherency tough sell, except when it Inherency tough sell, except when it

comes to broccolicomes to broccoli Crown Operations Int’l v. SolutiaCrown Operations Int’l v. Solutia, 289 F.3d , 289 F.3d

1367 (Fed. Cir. 2002) - ‘511 patent not 1367 (Fed. Cir. 2002) - ‘511 patent not invalidinvalid

Rosco v. Mirror LiteRosco v. Mirror Lite, 304 F.3d 1373 (Fed. Cir. , 304 F.3d 1373 (Fed. Cir. 2002) – anticipation reversed2002) – anticipation reversed

In re Cruciferous Sprout LitigationIn re Cruciferous Sprout Litigation, 301 F.3d , 301 F.3d 1343 (Fed. Cir. 2002) – invalidity upheld1343 (Fed. Cir. 2002) – invalidity upheld

Elan Pharmaceuticals v. Mayo Found., Elan Pharmaceuticals v. Mayo Found., 304 304 F.3d 1221 (Fed. Cir. 2002) – anticipation F.3d 1221 (Fed. Cir. 2002) – anticipation reversedreversed

InherencyInherency Crown Operations Int’l v. SolutiaCrown Operations Int’l v. Solutia

Claim 1. Solar/safety film for Claim 1. Solar/safety film for use in laminated window use in laminated window assemblyassembly Flexible, transparent plastic Flexible, transparent plastic

layerlayer Multilayer solar control Multilayer solar control

coatingcoating Flexible, transparent, energy Flexible, transparent, energy

absorbing plastic safety layerabsorbing plastic safety layer Wherein said solar control Wherein said solar control

film contributes no more film contributes no more than about 2% visible than about 2% visible reflectancereflectance

2% limitation not necessarily 2% limitation not necessarily presentpresent

InherencyInherency Rosco, Inc. v. Mirror Lite Co.Rosco, Inc. v. Mirror Lite Co.

Claim 1: a convex ellipsoid mirror lens “Claim 1: a convex ellipsoid mirror lens “having a having a varying radius of curvaturevarying radius of curvature” along the major ” along the major axisaxis

Defendant argued the vacuum thermoforming Defendant argued the vacuum thermoforming process necessarily yields mirror with varying process necessarily yields mirror with varying radius of curvature, even though it prefers a radius of curvature, even though it prefers a constant curvatureconstant curvature

Prior art patent does not specify vacuum processPrior art patent does not specify vacuum process

InherencyInherency In re Cruciferous Sprout LitigationIn re Cruciferous Sprout Litigation: :

Broccoli Patent LosesBroccoli Patent Loses

Claim 1. a method of preparing a Claim 1. a method of preparing a food product rich in glucosinolatesfood product rich in glucosinolates

Identifying seeds which Identifying seeds which produce cruciferous sprouts . . . produce cruciferous sprouts . . . containing high Phase 2 containing high Phase 2 enzyme-inducing potentialenzyme-inducing potential

Invalid over prior art eating of Invalid over prior art eating of broccoli sprouts even though broccoli sprouts even though properties were not knownproperties were not known

InherencyInherency Elan Pharmaceuticals v. Mayo Found.Elan Pharmaceuticals v. Mayo Found.

Claim 1: A transgenic rodentClaim 1: A transgenic rodent A transgene encoding a heterologous APP A transgene encoding a heterologous APP

polypeptide having the Swedish mutationpolypeptide having the Swedish mutation The transgene is expressed to produce a human The transgene is expressed to produce a human

APP polypeptide having the Swedish mutationAPP polypeptide having the Swedish mutation Said polypeptide is processed to Said polypeptide is processed to ATF-betaAPPATF-betaAPP in in

a sufficient amount to be detectable in a brain a sufficient amount to be detectable in a brain homogenate of said transgenic rodenthomogenate of said transgenic rodent

InherencyInherency Elan Pharmaceuticals v. Mayo Found.Elan Pharmaceuticals v. Mayo Found.

ATF-betaAPP not disclosed in humans until after ATF-betaAPP not disclosed in humans until after prior art Mullan patent was filedprior art Mullan patent was filed

Dyk dissent argues Mullan disclosed Swedish form Dyk dissent argues Mullan disclosed Swedish form APP and that ATF-betaAPP would necessarily resultAPP and that ATF-betaAPP would necessarily result

Later, Federal Circuit vacates decision and agrees to Later, Federal Circuit vacates decision and agrees to rehearing rehearing en bancen banc rehearing. rehearing. Watch for it in 2003Watch for it in 2003

PatentPatent ProsecutionProsecutionProvisional Application TrapProvisional Application Trap

Specification requirements are the same Specification requirements are the same for regular and provisional applicationsfor regular and provisional applications

Provisional must satisfy written Provisional must satisfy written description, enablement, and best mode description, enablement, and best mode requirements to provide effective priority requirements to provide effective priority or invention datesor invention dates

PatentPatent ProsecutionProsecutionProvisional Application TrapProvisional Application Trap

New Railhead Mfg. v. Vermeer Mfg.,New Railhead Mfg. v. Vermeer Mfg., 298 298 F.3d 1290 (Fed. Cir. 2002)F.3d 1290 (Fed. Cir. 2002) Patent invalidated when it could not benefit Patent invalidated when it could not benefit

from provisional application filing datefrom provisional application filing date

Patent ProsecutionPatent Prosecution Prosecution Laches (the Lemelson Defense)Prosecution Laches (the Lemelson Defense) Symbol Technologies v. Lemelson Med. Found.,Symbol Technologies v. Lemelson Med. Found.,

277 F.3d 1361 (Fed. Cir. 2002) 277 F.3d 1361 (Fed. Cir. 2002) Patents-in-suit claim benefit of filing dates as early as Patents-in-suit claim benefit of filing dates as early as

19541954Customers began receiving notices of infringement in Customers began receiving notices of infringement in

19981998Patent applicant complied with USPTO statutes and rulesPatent applicant complied with USPTO statutes and rulesDefense of prosecution laches may be assertedDefense of prosecution laches may be asserted

Patent ProsecutionPatent Prosecution In re Bogese, In re Bogese, 303 F.3d 1362 (Fed. 303 F.3d 1362 (Fed.

Cir. 2002)Cir. 2002)USPTO may apply laches to reject a USPTO may apply laches to reject a

patent applicationpatent application

Patent LitigationPatent LitigationYear of the PlaintiffYear of the Plaintiff

FestoFesto saves Doctrine of Equivalents saves Doctrine of EquivalentsClaim construction: Harder to narrow Claim construction: Harder to narrow

scope of claims.scope of claims. Invalidity becomes even harder to Invalidity becomes even harder to

proveprove

Patent LitigationPatent LitigationJurisdictionJurisdiction

Holmes Group Inc. v. Vornado Air Circulation Holmes Group Inc. v. Vornado Air Circulation Systems Inc.,Systems Inc., 535 U.S. 826 (2002) (Scalia, J.) 535 U.S. 826 (2002) (Scalia, J.)

Held: Federal Circuit has no Held: Federal Circuit has no jurisdiction over appeal in which jurisdiction over appeal in which the only patent law issue is the only patent law issue is asserted in the counterclaim.asserted in the counterclaim.

Result: Regional circuits could Result: Regional circuits could decide some patent law issuesdecide some patent law issues


Holmes v. VornadoHolmes v. Vornado facts: facts: Holmes sued Vornado in District of Holmes sued Vornado in District of

Kansas seeking a declaratory judgment Kansas seeking a declaratory judgment that it does not infringe Vornado’s trade that it does not infringe Vornado’s trade dress for spiral grill design fans. dress for spiral grill design fans.

Vornado counterclaimed for patent Vornado counterclaimed for patent infringement.infringement.

Declaratory judgment granted. Declaratory judgment granted. Patent infringement counterclaim Patent infringement counterclaim

stayed.stayed.


Holmes v. VornadoHolmes v. Vornado facts (cont’d): facts (cont’d): Vornado bypasses 10Vornado bypasses 10thth Circuit and Circuit and

appeals directly to Federal Circuitappeals directly to Federal CircuitFederal Circuit accepts jurisdiction and Federal Circuit accepts jurisdiction and

vacates judgment.vacates judgment.Holmes petitions Supreme Court, which Holmes petitions Supreme Court, which

grants grants certcert..


Holmes v. VornadoHolmes v. Vornado Legal Reasoning: Legal Reasoning:Key question: whether action is one Key question: whether action is one

“arising under” federal patent law. § § “arising under” federal patent law. § § 1338(a) and 1295(a). 1338(a) and 1295(a).

Answer turns on “well-pleaded Answer turns on “well-pleaded complaint” rulecomplaint” rule

Complaint did not allege patent Complaint did not allege patent infringementinfringement

Counterclaim cannot serve as basis for Counterclaim cannot serve as basis for “arising under” jurisdiction“arising under” jurisdiction


Back to 1981?Back to 1981?Federal Circuit formed in 1982 with the Federal Circuit formed in 1982 with the

mission of unifying patent law and mission of unifying patent law and eliminating forum shoppingeliminating forum shopping

Supreme Court sidesteps Congress’s goal Supreme Court sidesteps Congress’s goal in establishing Federal Circuit. in establishing Federal Circuit.

The regional circuits may again hear The regional circuits may again hear patent appeals in some casespatent appeals in some cases

May lead to circuit conflict and forum May lead to circuit conflict and forum shoppingshopping


Bailey v. Dart Container Corp. of Michigan et Bailey v. Dart Container Corp. of Michigan et al., 292 F.3d 1360 (Fed.Cir. 2002)al., 292 F.3d 1360 (Fed.Cir. 2002) Judgment winner may not file cross-appeal merely Judgment winner may not file cross-appeal merely

to argue alternative grounds for affirming the to argue alternative grounds for affirming the judgmentjudgment

May file cross-appeal only to seek reversal or May file cross-appeal only to seek reversal or modification of judgmentmodification of judgment

Patent LitigationPatent LitigationClaim ConstructionClaim Construction

Trend: Ordinary Meaning Rules. Trend: Ordinary Meaning Rules. Trend: Terms given broader scope. Trend: Terms given broader scope. Federal Circuit appears fed up with Federal Circuit appears fed up with

defense gimmicks and wordplay. defense gimmicks and wordplay. Comeback for “extrinsic” evidence, Comeback for “extrinsic” evidence,

particularly dictionariesparticularly dictionaries


CCS Fitness, Inc. v. Brunswick Corp.,CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359 (Fed. Cir. 2002)288 F.3d 1359 (Fed. Cir. 2002)

Disputed term: “reciprocating member”Disputed term: “reciprocating member”

Defendant says it must be limited to Defendant says it must be limited to drawing showing the member (432) to be drawing showing the member (432) to be a single-component, straight-bar structure.a single-component, straight-bar structure.

Plaintiff says nothing in claim limits the Plaintiff says nothing in claim limits the member to a particular shape. Term member to a particular shape. Term covers multi-component, curved bar.covers multi-component, curved bar.


CCS FitnessCCS Fitness: Ordinary Meaning : Ordinary Meaning TriumphsTriumphs

““Heavy presumption” that claim has Heavy presumption” that claim has its ordinary meaning.its ordinary meaning.

Claim term will cover any size or shape Claim term will cover any size or shape structure unless expressly limited.structure unless expressly limited.

Inventor need not describe every Inventor need not describe every conceivable and future embodimentconceivable and future embodiment


CCS FitnessCCS Fitness: Hard to Beat Presumption. : Hard to Beat Presumption. Only four ways to narrow ordinary Only four ways to narrow ordinary meaning:meaning:Patentee as lexicographerPatentee as lexicographer

clear “definition” in specification or file historyclear “definition” in specification or file historyClear disavowal of claim scopeClear disavowal of claim scope

Patentee distinguishes prior art based on Patentee distinguishes prior art based on particular embodiment particular embodiment

Means-plus-function termMeans-plus-function termClaim is so unclear that intrinsic Claim is so unclear that intrinsic

evidence is needed to understand it.evidence is needed to understand it.


Teleflex, Inc. v. Ficosa North America Teleflex, Inc. v. Ficosa North America CorpCorp., 299 F.3d 1313 (Fed. Cir. 2002)., 299 F.3d 1313 (Fed. Cir. 2002) TheThe CCS Fitness CCS Fitness presumption gets presumption gets

heavier.heavier.Claim not limited to single disclosed Claim not limited to single disclosed

embodimentembodimentClaim narrowed only if specification or Claim narrowed only if specification or

file history showsfile history shows ““words or expressions of manifest words or expressions of manifest

exclusion or restriction” andexclusion or restriction” and ““clear disavowal of claim scope”clear disavowal of claim scope”


CCS FitnessCCS Fitness and and Teleflex Teleflex RulesRulesKey inquiry is whether the patent Key inquiry is whether the patent

expressly describes alleged narrow expressly describes alleged narrow embodiment as “embodiment as “important”important” to the to the invention.invention.

Can’t use intrinsic evidence’s silence Can’t use intrinsic evidence’s silence to narrow the meaning of the termto narrow the meaning of the term

Can’t confine claim to single disclosed Can’t confine claim to single disclosed embodiment unless there is clear embodiment unless there is clear disavowal of claim scope.disavowal of claim scope.


Beckson Marine, Inc. v. NFM, IncBeckson Marine, Inc. v. NFM, Inc., 292 F.3d ., 292 F.3d 718 (Fed. Cir. 2002) 718 (Fed. Cir. 2002) Term not limited to specific shape or dimensions Term not limited to specific shape or dimensions

shown in patent drawingsshown in patent drawings

Inverness Medical Switzerland GmbH v. Inverness Medical Switzerland GmbH v. Warner Lambert Co.,Warner Lambert Co., 309 F3d 1373 (Fed. Cir. 309 F3d 1373 (Fed. Cir. 2002)2002) Term (“on” and “onto”) having two possible Term (“on” and “onto”) having two possible

meanings is construed to cover both meanings, meanings is construed to cover both meanings, unless otherwise limited.unless otherwise limited.

Ambiguous prosecution history does not limit Ambiguous prosecution history does not limit termterm


Dictionary DefinitionsDictionary DefinitionsDictionaries make comebackDictionaries make comebackBut which dictionary to use?But which dictionary to use?


Texas Digital Systems, Inc. v. Texas Digital Systems, Inc. v. Telegenix, Inc.,Telegenix, Inc., 308 F.3d 1193 (Fed. Cir. 308 F.3d 1193 (Fed. Cir. 2002)2002)““Dictionaries are always available” for helping Dictionaries are always available” for helping define disputed termdefine disputed term““Most meaningful” source for claim constructionMost meaningful” source for claim construction

Court may consult dictionary Court may consult dictionary at any stage of litigationat any stage of litigation, even if , even if no party has offered it into no party has offered it into evidence evidence


Texas DigitalTexas Digital: Dictionaries in Twilight : Dictionaries in Twilight ZoneZoneDictionaries are not really “extrinsic” Dictionaries are not really “extrinsic”

evidence evidence If all dictionary definitions are consistent If all dictionary definitions are consistent

with the patent, claim will be construed with the patent, claim will be construed to cover all such definitionsto cover all such definitions

Must consult dictionary that was Must consult dictionary that was available “at the time the patent issued.”available “at the time the patent issued.”


Transclean Corp. v. Bridgewood Services, Transclean Corp. v. Bridgewood Services, Inc.,Inc., 290 F.3d 1364 (Fed. Cir. 2002) 290 F.3d 1364 (Fed. Cir. 2002)Disputed term is “resilient” Disputed term is “resilient” Technical dictionary or standard English Technical dictionary or standard English

dictionary?dictionary?

Technical dictionary is better Technical dictionary is better source when term is used in a source when term is used in a technical context to describe technical context to describe component of a mechanical component of a mechanical devicedevice


Inverness Medical Switzerland GmbH v. Inverness Medical Switzerland GmbH v. Princeton Biomeditech Corp.,Princeton Biomeditech Corp., 309 F.3d 309 F.3d 1365 (Fed. Cir. 2002).1365 (Fed. Cir. 2002).Disputed term is “mobility” Disputed term is “mobility” Technical or standard English dictionary?Technical or standard English dictionary?

Standard English dictionary Standard English dictionary will provide proper definition in will provide proper definition in most cases. most cases. Especially if no established Especially if no established meaning in technical treatisemeaning in technical treatise


What does “book” mean?What does “book” mean?Person of ordinary skill would Person of ordinary skill would

not turn to a dictionary to not turn to a dictionary to determine its meaning.determine its meaning.

Patent is better than Patent is better than dictionary for defining dictionary for defining common words in context of common words in context of the inventionthe invention

General Creation LLC v. LeapFrog Enterprises, Inc.,General Creation LLC v. LeapFrog Enterprises, Inc., 2002 WL 31548117 (W.D. Va., Nov. 18, 2002)2002 WL 31548117 (W.D. Va., Nov. 18, 2002)

Patent LitigationPatent LitigationExtrinsic EvidenceExtrinsic Evidence

MarkmanMarkman and and VitronicsVitronics (1995-96) discredited (1995-96) discredited extrinsic evidence. Showed lack of faith in extrinsic evidence. Showed lack of faith in juries.juries.

2002 saw comeback for extrinsic evidence. 2002 saw comeback for extrinsic evidence. Could mean more use of witnesses at Could mean more use of witnesses at MarkmanMarkman hearingshearings

Verve, LLC v. Crane Cams, Inc.,Verve, LLC v. Crane Cams, Inc., 311 F.3d 1116 311 F.3d 1116 (Fed. Cir. 2002)(Fed. Cir. 2002)Judge erred in excluding all extrinsic evidenceJudge erred in excluding all extrinsic evidencePatents written for skilled artisans and must be read Patents written for skilled artisans and must be read

through their eyes. Extrinsic evidence aids that view.through their eyes. Extrinsic evidence aids that view.

Patent LitigationPatent LitigationInfringement DefensesInfringement Defenses

Tate Access Floors, Inc. v. Interface Architectural Tate Access Floors, Inc. v. Interface Architectural Resources, Inc.,Resources, Inc., 279 F.3d 1357 (Fed. Cir. 2002). 279 F.3d 1357 (Fed. Cir. 2002).

Held: No “practicing the Held: No “practicing the prior art” defense to patent prior art” defense to patent infringementinfringementCan’t avoid presumption Can’t avoid presumption of validity and burden of of validity and burden of proof by raising prior art as proof by raising prior art as infringement defenseinfringement defense

Patent LitigationPatent LitigationValidity DefensesValidity Defenses

Proof of Prior Public Proof of Prior Public Use -- Use -- §102(b)§102(b)

Juicy Whip, Inc. v. Juicy Whip, Inc. v. Orange Bang, Inc.,Orange Bang, Inc., 292 F.3d 728 (Fed. 292 F.3d 728 (Fed. Cir. 2002)Cir. 2002)““post-mix” post-mix”

beverage dispenser beverage dispenser with simulated with simulated displaydisplay


Juicy WhipJuicy Whip: G*d is my witness – and : G*d is my witness – and that’s not enoughthat’s not enoughSix witnesses testified that they Six witnesses testified that they

saw or used an anticipatory beverage saw or used an anticipatory beverage dispenser years before the patent dispenser years before the patent application date.application date.

Not enough.Not enough.Testimony must be corroborated by Testimony must be corroborated by

physical evidence to be clear and physical evidence to be clear and convincingconvincing


Juicy WhipJuicy Whip: : What do Barbed Wire What do Barbed Wire and Drink Dispensers have in and Drink Dispensers have in common?common? Uncorroborated testimony of Uncorroborated testimony of

witnesses recalling long-past events is witnesses recalling long-past events is not clear and convincingnot clear and convincing

Rules applies no matter whether Rules applies no matter whether witness is interested or independent. witness is interested or independent. Witness’s credibility not an issue.Witness’s credibility not an issue.

Preferred proof: contemporaneous Preferred proof: contemporaneous records, photos, modelsrecords, photos, models


Rosco, Inc. v. Mirror Lite Co.,Rosco, Inc. v. Mirror Lite Co., 304 F.3d 304 F.3d 1373 (Fed. Cir. 2002)1373 (Fed. Cir. 2002)Must corroborate testimony of prior Must corroborate testimony of prior

invention under § 102(g). invention under § 102(g). Juicy WhipJuicy Whip déjà déjà vu.vu.

Testimony alone is not clear and Testimony alone is not clear and convincingconvincing

Alleged prior inventor must also show Alleged prior inventor must also show that, at the time, he recognized and that, at the time, he recognized and appreciated the features of the inventionappreciated the features of the invention


Written description. The Federal Circuit Written description. The Federal Circuit takes a mulligan.takes a mulligan.Enzo Biochem, Inc. v. Gen-Probe Inc.,Enzo Biochem, Inc. v. Gen-Probe Inc., 285 285

F.3d 1013 (Fed. Cir., April 2, 2002) (affirms F.3d 1013 (Fed. Cir., April 2, 2002) (affirms summary judgment of invalidity)summary judgment of invalidity)

Enzo Biochem, Inc. v. Gen-Probe Inc.,Enzo Biochem, Inc. v. Gen-Probe Inc., 63 63 USPQ.2d 1618 (Fed. Cir., July 15, 2002) USPQ.2d 1618 (Fed. Cir., July 15, 2002) (court grants panel rehearing)(court grants panel rehearing)

Enzo Biochem, Inc. v. Gen-Probe Inc., Enzo Biochem, Inc. v. Gen-Probe Inc., 296 296 F.3d 1316 (Fed. Cir., July 15, 2002)(reverses F.3d 1316 (Fed. Cir., July 15, 2002)(reverses summary judgment)summary judgment)


Enzo Biochem: Enzo Biochem: FactsFactsPatent directed to nucleic acid probes Patent directed to nucleic acid probes

used in tests for gonorrheaused in tests for gonorrheaInventors deposited biological samples Inventors deposited biological samples

at the American Type Culture Collectionat the American Type Culture CollectionSpecification describes the claimed Specification describes the claimed

“composition of matter” only by its “composition of matter” only by its biological activity or function—biological activity or function—i.ei.e., its ., its ability to hybridize to ability to hybridize to N. gonorrhoeaeN. gonorrhoeae at at a certain ratio.a certain ratio.


Enzo BiochemEnzo Biochem: The Holding: The HoldingDeposit of biological materials in a public Deposit of biological materials in a public

depository can satisfy written description depository can satisfy written description requirement. requirement.

Departs from Departs from Regents of Univ. of Calif. v.Regents of Univ. of Calif. v. Eli Eli Lilly, Lilly, 119 F.3d 1559 (Fed. Cir. 1997), which 119 F.3d 1559 (Fed. Cir. 1997), which held that description of a gene’s function is held that description of a gene’s function is not enough to meet the requirement.not enough to meet the requirement.

Now, some functional descriptions of Now, some functional descriptions of genetic material can satisfy description genetic material can satisfy description requirement.requirement.


Enzo BiochemEnzo Biochem (cont’d) (cont’d) Adopts MPEP GuidelinesAdopts MPEP Guidelines Holding comports with Holding comports with Festo’s Festo’s recognition recognition

that words cannot always fully describe an that words cannot always fully describe an inventioninvention

Liberalizes written description requirementLiberalizes written description requirement Complete about-face from court’s original Complete about-face from court’s original

holding that “deposit is not a substitute for holding that “deposit is not a substitute for a written description of the claimed a written description of the claimed invention”invention”


All Dental Prodx, LLC v. Advantage Dental All Dental Prodx, LLC v. Advantage Dental Prods., IncProds., Inc., 309 F.3d 774 (Fed. Cir. 2002)., 309 F.3d 774 (Fed. Cir. 2002)Further liberalization of written description Further liberalization of written description

requirementrequirementHeld: specification need not mention a Held: specification need not mention a

limitation introduced by amendment, so long limitation introduced by amendment, so long as one of ordinary skill would recognize that as one of ordinary skill would recognize that the new limitation reflects the invention the new limitation reflects the invention shown in the specificationshown in the specification

My Prediction: written description disputes My Prediction: written description disputes will depend on battle of the expertswill depend on battle of the experts

Generic Drug/Hatch-Generic Drug/Hatch-WaxmanWaxman

Exception to Year of the PlaintiffException to Year of the PlaintiffRulings favor Defendant Generic Rulings favor Defendant Generic

Drug makersDrug makers


Pending Legislation. All bark, little bite.Pending Legislation. All bark, little bite. McCain-Schumer bill passes SenateMcCain-Schumer bill passes Senate

Limits situation in which pioneer drug Limits situation in which pioneer drug company can seek automatic 30-month stay company can seek automatic 30-month stay against generic drug makeragainst generic drug maker

Generic drug makers can file suit to de-list Generic drug makers can file suit to de-list patents from the FDA’s “Orange Book”patents from the FDA’s “Orange Book”

Proposed New FDA RegulationsProposed New FDA RegulationsPermit only one automatic 30-month stay Permit only one automatic 30-month stay

per generic drug applicationper generic drug application


““Scare-the-pants off you” Scare-the-pants off you” JurisdictionJurisdictionDr. Reddy’s Labs Ltd v. Dr. Reddy’s Labs Ltd v.

aaiPharma IncaaiPharma Inc., 2002 WL ., 2002 WL 31059289 (S.D.N.Y., Sept. 31059289 (S.D.N.Y., Sept. 13, 2002)13, 2002)

Prilosec patent owner’s Prilosec patent owner’s vague threats to the generic vague threats to the generic drug industry as a whole, drug industry as a whole, made in made in Wall Street JournalWall Street Journal article, supported article, supported declaratory judgment action declaratory judgment action by one generic drug makerby one generic drug maker


Abbott Labs v. TorPharm, IncAbbott Labs v. TorPharm, Inc., 300 F.3d ., 300 F.3d 1367 (Fed. Cir. 2002)1367 (Fed. Cir. 2002)

ANDA specification defines the accused product for ANDA specification defines the accused product for purposes of determining infringement purposes of determining infringement

If ANDA description of a If ANDA description of a compound meets the claim compound meets the claim limitation, then there is no fact limitation, then there is no fact question about infringement of question about infringement of that limitation.that limitation.Why? Generic mfr. is bound Why? Generic mfr. is bound to sell a drug conforming to the to sell a drug conforming to the ANDA filing ANDA filing


McNeil-PPC, Inc. v. L. Perrigo Co.,McNeil-PPC, Inc. v. L. Perrigo Co., 207 F. 207 F. Supp.2d 356 (E.D. Pa. 2002)Supp.2d 356 (E.D. Pa. 2002)

Patents for particular formulation of Immodium A-D Patents for particular formulation of Immodium A-D (antidiarrheal drug) held to be obvious(antidiarrheal drug) held to be obvious

Generic drug maker awarded attorneys’ Generic drug maker awarded attorneys’ fees. Exceptional case.fees. Exceptional case.McNeil’s prosecution misconduct and McNeil’s prosecution misconduct and persistence in prosecuting “exceedingly persistence in prosecuting “exceedingly obvious” inventions criticized.obvious” inventions criticized.Patents part of a “scheme” for protecting Patents part of a “scheme” for protecting drug about to go off patentdrug about to go off patent

IP YEAR IN REVIEWIP YEAR IN REVIEWPATENT LAW PATENT LAW ANDAND

LITIGATIONLITIGATION

The EndThe End

boston bar association 2002 year in review patent law and litigation robert m. asher erik paul belt...

Documents

prosecution estoppel

time of amendment

prior artaffirms absolute

stainless steel

boston bar association2002year

litigation robert

absolute barpatentee

copperaluminum laminates