Driving Business Advantage

1 patenting by BethE.Arnold and T in Legally A Patenting

G uidebook for echnologies P rotecting T hose P roducts I nvolved

Foley Hoag eBook Hoag Foley Contents

Preface...... 3

Chapter 1 What Is a ?...... 4

Chapter 2 What Is Potentially Patentable?...... 8

Chapter 3 What Is Not Patentable?...... 10

Chapter 4 How Is a Patent Obtained?...... 16

Chapter 5 What Should You Do Before Filing a ?...... 26

Chapter 6 What Shouldn’t You Do Before Filing a Patent Application?...... 31

Chapter 7 How Are Foreign Obtained?...... 32

Chapter 8 Who Is an on a Patent?...... 37

Chapter 9 Who Owns the Patent?...... 39

Chapter 10 How Long Is a Patent in Effect?...... 43

Patent Group...... 46

About Foley Hoag...... 46

Beth E. Arnold...... 47

Attorney advertising. Prior results do not guarantee a similar outcome. © 2009 Foley Hoag LLP. All rights reserved. Patenting A Guidebook for Those Involved in Legally Protecting Products and Technologies

by Beth E. Arnold “Intellectual properties, such as patented technology and world-class trademarks, are at the very core of corporate success. Preface These assets capture huge market shares, command premium prices and hold customer loyalty. They are also scarce in supply and expensive Patenting generally offers a superior means for legally protecting to create. Companies that possess such assets will grow and prosper. most , particularly since: Those without access to intellectual property will stagnate for awhile in low-commodity businesses and eventually fade out of existence.” • copyright, when available, does not provide a broad scope ­— G.V. Smith and R.L. Parr of protection; and Intellectual Property: Valuation, Exploitation and Infringement Damages, • the ability to effectively protect an as a trade secret (John Wiley & Sons, New York, 2005) Fourth Edition is in constant jeopardy, due to publication or oral disclosure.

Unfortunately, the patenting process can be complicated, time-intensive and costly. However, costs can often be minimized and opportunities for establishing value in products and technology maximized if scientists and business professionals with an understanding of the patenting process are actively involved throughout.

This publication was prepared to provide an overview of patenting, particularly as it pertains to innovative technologies such as biotechnology and information technology.

2 3 4 patenting and, dependingonwhat itcovers,canbeveryvaluable. assignment the rightscanbecontractedtoacommercial (viaan partner infringing avalidclaimofthepatent.Alternatively, allorsomeof can seekaninjunctionagainstand/ordamages from anyparty the patentowner’s marketshare. Forexample,thepatentowner patent owneragainstcompetitor The rightsconferred byapatentcanbeenforced bythe incourt 3)  2)  1)  for, dependingonthenature ofthesubjectmattertobeprotected: In theU.S.,anyofthree different kindsofpatentsmaybeapplied defined bythepatentclaims,fordurationofterm. with rightstoprevent competitorsfrom profiting from theinvention A patentisagovernment-issueddocumentthatprovides itsowner What IsaPatent? Chapter 1 Plant Variety Protection Actof1970 legal protection pursuanttothe uponcertification, (Sexually reproduced varietiesare alsoentitledtocertain distinctive asexuallyreproduced plantvarieties. ornamental design. products andprocesses, andisthefocusofthispublication. The The The mostpopular plant patent design or

patentprotects anynew, original,or license agreement isusefulonlyforprotecting newand patentprotects avarietyof infringers ). Apatentisanintangibleasset .) toprotect orincrease

it isadvisabletoconduct a Because evenapatented product mayinfringeanother’s patent, Blocking Patents distinction. important unless theowner’s permissionisobtained.This isasubtlebut it intotheUnitedStates, within theUnitedStatesorimporting tosell–theinvention making, using,orselling–evenoffering patent claims.Instead,itconferstherighttoprevent othersfrom righttomake,use,orselltheinventiondefinedby affirmative torealizeIt isimportant thatapatent doesnotgiveitsowneran What aPatentIsNot symbols are theprecursors oftoday’s trademarks. orproductsperformed madeby guild members.Those The earlyguildsalsousedsymbolsandpictures toidentifyservices public domain. a newandusefulitem,process, orcreative workintothe copyright –foralimitedperiodoftimetoanyonewhodisclosed inventions andideasbygrantingexclusiverights–apatentor governments passedlawstoencouragedisseminationof inresponsePartly totheclosedsocietiesarisingfrom theguilds, trade secrets. closely guarded techniquesandskillsare precursors oftoday’s each otherbutguard itfrom disclosure tooutsiders.Their Members ofmedievalguildswouldshare theirknowledgewith Intellectual property protection originatedinmedievalEurope. The OriginofPatentsandTrademarks

freedom tooperate search todetect

5 patenting 6 patenting • aserviceoffered byyourcompany;or • aprocess used byyourcompanytomakeaproduct; • aproduct made,used,orsoldbyyourcompany; appropriate, prepare awrittennon-infringementopinionif: You shouldretain apatent attorneytoreview thepatentand, if Do You Need aNon-InfringementOpinion? obtained whentheproduct orprocess isactuallybeingsold. the negotiationofmore favorablelicensingtermsthancouldbe Alternatively, earlyidentificationofablockingpatent mayfacilitate product orprocess thatisnotcovered bythepatentclaim). potential infringerto If ablockingpatentisidentifiedearly, itmaybe possible fora claim maybeinfringed. be retained toconstruethepatentclaimsanddetermineifany If apotentialblockingpatentisidentified,attorneyshould claim basicenablingtechnologiesare frequently granted. technology fieldsinwhichpioneeringpatentsofbroad scopethat Blocking patentsare prevalent particularly inburgeoning T searching thestacksofissuedpatentsin a product, shouldbesearched separately, eithermanually(by as theprocess usedtomakeaproduct andmethodsforusing a newservice.Eachcomponentofproduct orprocess, aswell market, implementinganewmanufacturingprocess, oroffering potential blockingpatentspriortoputtinganewproduct onthe rademark Office ) and/orinanappropriate computerdatabase. design around (i.e.,developanalternative U.S. Patentand

• • patent attorneytochallengethevalidityofaby: occasionally issue.Accordingly, apotentialinfringercanretain a the lawrecognizes thatimproperly examinedpatentsmay (USPTO orinthe challenged incourt available underunreasonable terms,thepatent’s validitymaybe If theblockingpatentisnotavailableforlicensingoronly Invalidity Challenges • or businessmethodisbeingused,offered forsale,orsold made, used, offered for sale, or sold; or where a process, service infringes a patent issued in a country in which the product is being a business method practiced by your company potentially federal districtcourt. instituting adeclaratoryjudgmentactioninanappropriate initiating areexamination proceeding inthe ) . AlthoughanissuedU.S.patentispresumed tobevalid,

U.S. PatentandT USPT rademark Office rademark Office O ; or

7 patenting 8 patenting optimal protection. However, process claims–includingprocesses Therefore, generally speaking,issuedproduct claims provide regardless of howitwasmadeortheusethatis ofit. Product claims patentable subjectmatter. specified function,includingfinancialcalculations, maybe have heldthatsoftware andcomputerprograms a thatperform Likewise, intheinformationtechnologyarena, recent decisions the establishmentofanindustry. for patentingbiotechnologyintheU.S.andpavedway made byman.”Thisdecisionestablishedbroad parameters interpreted 35U.S.C.101to“covereverythingunderthesun subject matter. ofitsholding,theSupreme Insupport Court contains energy-generating plasmidswere heldtobepatentable Chakrabarty In thelandmark1980Supreme case, Court United StatesCode: matter intheU.S.isdefinedSection101ofTitle35 The definitionofwhatconstitutespotentiallypatentablesubject What IsPotentiallyPatentable? Chapter 2 and requirements ofthistitle.(35U.S.C.101) may obtainapatenttherefor, subjecttotheconditions of matter, oranynewandusefulimprovement thereof, process, machine,manufacture orcomposition Whoever inventsordiscoversanynewanduseful , claimstoageneticallyengineered bacteriumthat protect acomposition,manufacture, ormachine Diamond v.

“ owner willbesuccessful. infringer willbedeterred orthataninfringementsuitbythepatent product orprocess, thegreater thechancethatapotential The greater thenumberandtypesofpatentclaimsprotecting a new therapeuticusesforaknowncompound. Process ofusingclaims nonessential componentofanotherproduct. by asubsequentprocess ordoesnotbecomeatrivialand activity, aslongthatproduct hasnotbeenmateriallychanged patented intheU.S.(aprocess ofmakingclaim)aninfringing sale,oruseofaproductimportation, madeabroad byaprocess In addition,35U.S.C.Section271(g)makesunauthorized • • • also provide usefulprotection: resultfor makingorusingaproduct acertain –can oraffecting is potentiallyis patentable.” manufacture or composition of matter… [A]ny new and process, useful machine, claims are obtainable. as anextralayerofprotection, evenifbroad product if onlyproduct claimsofnarrow scopeare obtainable;or if claimsontheproduct cannotbeobtained; can be particularly usefulforprotecting canbeparticularly

9 patenting 10 patenting probe is not enough. To be patentable, the law requires that the motion machines. Use of a nucleic acid sequence as a nonspecific patent offices typically reject attempts to try to patent perpetual an inventionactuallywork.Thelackofutility isthereason why However, tiedinwiththeutilityrequirement istherequirement that met bymostinventions.Forexample,games are considered useful. T Hurdle #2:Utility composition ofmatter matter: i.e., that it is a process, machine, manufacture or correspond to one of the specified classes of patentable subject Section 101 of the patent statute requires that an invention Hurdle #1:PatentableSubjectMatter 4) Nonobvious? 3) New? 2) Useful? 1) Statutory(orappropriate) subjectmatter? Is yourinvention: The Hurdles Ahead of mostforeign countries,withslightvariations. basic hurdles (i.e.,patentabilityrequirements) existunderthelaws of the U.S. patent statute (35 U.S.C. 100 et seq.). These same does not overcome four hurdles defined in three separate sections Under U.S. law, a patent will not be granted on an invention if it What IsNotPatentable? Chapter 3 his second hurdle to , the utility requirement, is easily

(see Chapter2 ) .

“ an interference.” be…will awarded priority status in invention and actually reduce to practice Generally, the first to conceive of an in aninventionasofwhenitwascreated. TheU.S.,therefore, has The U.S. patent system is unique in the world in recognizing rights First toInvent statute’s terminology). U.S.C. 102isdevotedtodefiningwhatnotnewor I not considered tobenew. a method that is nothing more than a mathematical algorithm is unpatentable under 35 U.S.C. 101 for not being “new.” Similarly, hands, i.e., has not been isolated or purified) will be rejected as that occursinnature andissubstantiallyunaltered byhuman The inventionmustalsobenew. A Hurdle #3: of anucleicacidsequenceas“probe” willnotbeenough. is patent applicationprovide “a n addition to the requirements of section 101, much of 35 credible ” for all that is claimed. Throw away utilities like the use

specific product ofnature and substantial (something (something utility that novel

(in the

11 patenting 12 patenting • canprecludeexamples ofpriorart apatentfrom beingawarded: therefore willnotbeawarded patentprotection. Thefollowing Inventions thatare publiclyknownare nottrulynew(novel)and place theinventioninpublicdomain. application topredate theoccurrence eventsthatcould ofpriorart advisabletodiligentlyfileapatent invent, itisnevertheless Despite thefactthatinU.S.apatentisawarded tothefirst inaninterference. priority status(i.e.,isthe“SeniorParty”) filing apatentapplicationdisclosingtheinvention)willbeawar the process) or (that invention)to first to applicants may take steps to provide an interference. determine theactualfirstinventor. Alternatively, oneofthepatent matter, theUSPTOmayinitiatean application andanissuedpatent,claimthesameorsimilarsubject In theeventthattwopendingpatentapplications,ora first toinvent. application’s filingdate, regardless ofwhomayhavebeenthe first-to-file a first-to-invent anywhere inthe world(35U.S.C.102(a),102(b)); either bytheinventor(s) orsomeoneelseandappearing patent, orpubliclyavailable thesisorgrantapplication)author abstract,publishedpatent application,issued journal article, description oftheinventionina conceive patent system judge potential rights only as of a patent patentsystemjudgepotentialrightsonlyasofa

patent system. constructively reduce of(thinkof)aninventionand practice (bymakingtheproduct orperforming I n contrast, countries that have a printed publication interference theinventionto actually reduce proceeding to (includinga practice Generally, the

ded (by ed *This isthebasis ofinterference practice (inthestatute’s terminology). period forobtainingapatent onlyasix-monthgrace Japanese andAustraliansystemsoffer is nograceperiodforobtainingaEuropean patent,andthe foreignrights maybelostincertain countries.Forexample,there during whichaU.S.patentapplicationmay stillbefiled,patent events,(the102(b)events), the occurrence priorart ofcertain Although section102provides aone-yeargraceperiodfollowing • • • evidence thattheinvention: Inventors canalsolosetherighttoobtainapatentifthere is • • • concealed (35U.S.C.102(g)).* the priordevelopmenthasnotbeenabandoned,suppressed, or was firstmadebysomeoneelseanywhere intheworld,provided application (35U.S.C.102(f));or was inventedbysomeoneotherthanthosenamedonthepatent has been in theU.S.before theinventionbypatentapplicant(102(e)). published U.S.orinternationalpatentapplicationbyanotherfiled filing datepriortotheofinventionbyapplicantorina description patent applicationhasbeenfiled(35U.S.C.102(b));or or someoneelseintheU.S.more thanoneyearbefore the sale else intheU.S.(35U.S.C.102(a),102(b)); demonstration) oftheinventionbyinventor(s)orsomeone public knowledge of the invention or even an offer forsalebytheinventor(s) oftheinventionorevenanoffer abandoned oftheinventioninaU.S.patentbyanotherwith (e.g.,anoraldisclosure) oruse(e.g.,a (35U.S.C.102(c)); (see Chapter7formore details

) .

13 patenting 14 patenting Day Day Inventor 2wins. to Inventor2’s reduction topracticecanbeshown–otherwise, Inventor 1willwinaslongdiligenceinreduction topracticeprior Interference B: practice, wins. Inventor 1,thefirsttoconceiveofinventionand reduce itto Interference A: theInterference? Win Who Will 1 1 the invention I the invention I nventor 1 conceives nventor 1 conceives I 2 2 nventor 2 conceives 3 3 the invention 4 4 5 5

6 6 the invention I nventor 2 conceives 7 7 8 8 I nventor 1 reduces the invention topractice 9 9

10 10 invention topractice I nventor 2 reduces the 11 11 12 12 13 13 I I nventor 1 reduces the nventor 2 reduces the 14 14 invention topractice invention topractice 15 15 16 16 17 17 18 18 19 19 4)  3) 2) 1) four factualinquiries: Determination thataninventionisnotobvioustypicallybasedon The inventionmustbeanunobviousadvanceoverthe The finalhurdle topatentabilityisthenonobviousness requirement: Hurdle #4:Nonobviousness commercial success,failure ofothers,andunexpectedresults. Level ofskill Differences Scope Evidence of the subject matter pertains…(35 U.S.C.103(a)). the subjectmatterpertains…(35 made to a person having ordinary to which skill in the art would have been obvious at the time the invention was the prior art are such that the subject matter as a whole between thesubjectmattersoughttobepatentedand identically disclosedordescribed…ifthedifference A patentmaynotbeobtainedthoughtheinventionis andcontentofthe betweenthe in the art towhichtheinventionpertains intheart secondary considerations prior prior

art andtheclaimedinvention art art atthetimeofinvention art , suchasalong-feltneed, prior art .

15 patenting 16 patenting “ disclosure oftheinvention,butnotnecessarilyclaims).Aslongas provisional patentapplications Agreement onTariffs andTrade (GATT) ­ Since June8,1995–thedayU.S.implementedGeneral Provisional PatentApplication of astatebar). is registered topracticebefore the least onestate)ora U.S. PatentandT (a scientistorengineerwhoisregistered topracticebefore the a patentapplicationisgenerallybestdraftedby Offic be prepared, filed,andprosecuted inthe T How IsaPatentObtained? Chapter 4 priority date.” may for be useful securing an early Provisional patent applications o begrantedapatentonaninvention,applicationmust e . Becauseofthemanylegalandtechnicalrequirements, rademark Office rademark Office patent agent (patentapplicationscontaininga

(ascientistorengineerwho (USPTO USPT – the U.S. PatentandT O ) and the courts ofat andthecourts butisnotamember USPT patentattorney O hasaccepted rademark

Examiner P Applicant P to afewyears foranapplication tobeexaminedafter itisfiled. applications inthegroup, itmaytakeanywhere from afewmonths the appropriate examining group. Dependingonthe backlogof if acceptable,grants afilingdateanddirects theapplication to filed inthe When autility(asopposedtoprovisional) patentapplicationis Utility PatentApplication U.S. PatentApplicationTimeline invention fordeterminingthenoveltyand/ornonobviousnessof art filing dateofthecompleteapplicationwillnotbeconsidered prior after thefilingdateofprovisional applicationbutbefore the a result, the publication, public use, or sale of the invention occurring patent applicationfilingdateusedtocalculatetheterm.As as the date, thedateonwhichprovisional applicationwasfiledserves filed withinoneyearaftertheprovisional patentapplication’s filing a comparable,completepatentapplication(includingclaims)is atent atent priority date (optional) application patent provisional File (see Chapter3 ≤ 1year USPT O , a PTO official briefly, aPTOofficial reviewsit for contentand, application patent File utility fordeterminingpatentability, withtheofficial Six months to a fewyears ) .

* • • • respond Actionismadefinal,thePatentpplicantmusteither: to,butiftheOffice The Examiner can continue to issue Office Actions, which the Patent Applicant must abandontheapplication. fileacontinuationapplication;or appealtotheBoard ofPatentAppealandInterferences;

First Office Action First Office Requirement or a Restriction E 1 month xaminer issues 3 months

First Action Respond to or allowsclaim* Action Office E

xaminer issues

17 patenting 18 patenting may issuea be independentand distinct inventions,inwhichcasetheexaminer The patentexaminer may considereachoftheseeightelements to 8) diagnosticuseoftheantisensenucleic acids. 7) diagnosticusesoftheantibodies;and 6) therapeuticusesoftheprotein; 5) processes formakingtheprotein; 4) nucleicacidsequencesantisenseto the codingsequence; 3) nucleicacidsequencesencodingthe protein; 2) antibodiestotheprotein; 1) theprotein itself; may includeclaimstoanyorallofthefollowing: For example,apatentapplicationfornewrecombinant protein they are directed to two or more independent and distinct inventions. A patentexaminerinitiallylooksattheclaimstodeterminewhether Restriction Requirement interpretation andincludingnon-patentliterature. on allclaimedelements,giventheirbroadest reasonable make astatementthatpre-examination search wasconducted must bedirected toasingleinvention.Theapplicantmustalso than 20totalclaimsandthree orfewerindependentclaims,which Document. Inaddition,theapplicationmustcontainnomore appropriate petition,fee,andAcceleratedExaminationSupport applicants mustelectronically fileacompleteapplicationwithan within 12monthsafterfilingthepatentapplication. To qualify, provide patent applicants with a final decision regarding patentability On August25,2006,the Accelerated Examination restriction requirement

USPT

O introduced aprogram thatwill

.

whether theinvention hasbeenadequatelydescribedandenabled The examinerstudies thepatentapplicationitselftodetermine Appropriately Enables, Describes,andClaimstheInvention Examination ofaPatentApplication toDetermineWhetherIt • • • • “examines” thepatentapplicationtodeterminewhetherinvention: examiner conducts a search of the prior art and substantively Following restriction, orifnorestriction isrequired, thepatent invalidate restricted claimsdirected toanotherinvention. on claims directed to one invention, therefore, would not necessarily of claims is separately patentable. claims, therestriction isa andexpenseforobtainingtheissuanceofvarious increased effort Although restriction ofapatentapplicationinevitablyresults in commercially claimssoonerratherthanlater. important Chapter 10 to 20yearsaftertheoriginalpatentapplicationfilingdate implemented changeinpatentterm–from 17yearsafterissuance time before theelectedclaimsissueasapatent.TheGATT be pursuedseparatelybyfilinga restriction stands,nonelectedclaimswillremain pendingandmay examination onthemeritsortodisputerestriction. Ifthe one invention(i.e.,ofthegroupings ofclaims)forfurther The patentapplicantistypicallygivenonemonthinwhichtoelect was notobviousatthetimeitmade (35U.S.C.103). is novel(35U.S.C.101and102); has atleastoneutility(35U.S.C.101); is directed toappropriate subject matter(35U.S.C.101); ) –provides incentiveforfilingdivisionalapplicationson USPT O acknowledgmentthateachgroup divisional patent A subsequent ruling of invalidity

applicationany (see -

19 patenting 20 patenting European ( EPO PatentOffice adequately enables). Manyforeign including the patentoffices, materialwasobtained written descriptionofhowaparticular whethera made) andunnecessarydeposits(when it isuncertain resulting indelayedpatentfilings(untilafteradepositcanbe made priortotheforeign patentapplicationfilingdate,potentially In contrast,mostforeign patentoffices require thatdepositsbe the materialare otherwiseindicatedasallowablebythe purposes, a deposit need not be made until patent claims involving Collection (ATCC a recognized culture depository, suchasthe the material can not be provided, that material must be deposited in where characterizationof containing celllines,particularly further biological materialssuchasrare isolates,hybridomas,orgene- Biotechnology Claims In otherwords, broad claimsmustbebroadly enabled. enablement mustbecommensuratewiththebreadth oftheclaims. exploiting thesameinventionforalimitedterm.Thescopeof the inventorisprovided exclusiverightstoprevent othersfrom In exchangeforteachingthepublichowtopracticeaninvention, The enablementrequirement isattheroot ofallpatentsystems. Enablement use thesame makeand one ofordinary towhichitpertains…to skillintheart and ofthemannerprocess ofmakingandusingit…toenable specification), must (35 U.S.C.112).Thebodyofthepatentapplication(the

(35U.S.C.112). ) located in Manassas, Virginia. For U.S. patent contain awrittendescriptionoftheinvention : T o enable an invention involving certain ) , alsorequire thatorganisms A merican T USPT ype Culture O .

“ the scope of protection.” part of an issued patent: they define The claims are the most important program ­ describing howtheprogram works.Amuchmore complicated appropriately enabled by providing a flow chart and functionally various pieces of software and to hardware components could be For example,asimpleprogram involvingroutine functioncallsto required thusdependsonthelevelofcomplexitysoftware. the program withoutundueexperimentation.Thelevelofdetail be disclosedsothataprogrammer withordinary skillcouldcreate computer software, theoverallfunctionalityofsoftware must Information Technology Claims provide apotentialcompetitorwithready source ofthematerial. appropriate scopedonotultimatelyissueasapatent.Itcouldalso the abilitytoprotect thematerialasatradesecret, ifclaimsof applicant selectsthe (i.e., 18monthsfrom thepriorityfilingdate).Unlesspatent request toanypersonasofthepatentapplicationpublicationdate apatentapplicationbemadeavailableupon deposited tosupport – forexample,acomputeroperatingsystem­ expert option expert : T o enableaninventioninvolving , thisrequirement canjeopardize – mayrequire

21 patenting 22 patenting claims specifically pointing out and distinctly claiming the invention. claims specificallypointing outanddistinctlyclaimingtheinvention. 112 requires that the patent specification conclude with one or more define the scope of protection on the disclosed invention. 35 U.S.C. ofanissuedpatent:They The claimsare part themostimportant Claims retaining criticalelementsoftheinventionastradesecrets. application wasfiled.This requirement prevents inventorsfrom inventor(s) forcarryingouttheinvention atthetimepatent the patentspecificationmustdisclose bestmodeknownbythe In additiontoappropriately describingandenablingtheinvention, Best Mode the written patentapplication,sequencesmustalsobesubmittedto acid oftenormore nucleotides.Inadditiontoappearinginthe consisting offourormore aminoacids,andanydisclosednucleic listing foranydisclosed(notmerely claimed)protein (orpeptide) adequately described,thespecificationmustincludeasequence For aninventiondisclosinganucleicacidorprotein tobe more generalterms. components ofaninvention,preferably inveryspecificaswell therefore, shoulddescribeallpossibleparametersand in thepatentspecificationmaybeclaimed.Thespecification, relevant identifyingcharacteristics(asopposedtojustfunctionally) and Only thatwhichhasbeenspecificallydescribedbysufficient Written Description requiring thesource codeitselftobeappendedtheapplication. a considerableamountofdetailtobedisclosed,perhapseven USPT

O oncomputerdisk.

“ to provide protection.” useful both specific and of a broad enoughscope application to is provide language that is One of the challenges of drafting a patent matter maybeaddedtothepatentapplication duringprosecution. arguments, tosupport (such asdeclarationsoraffidavits) nonew or specification. out errors in the examiner’s reasoning and/or amending the claims more grounds. rejecting the claims and/or objecting to the specification on one or examination. Almostinevitably, theexaminerissuesan Claims in a patent application are not typically allowed upon initial into thefuture anddescribeseverythingthatmaybedeveloped. not onlydescribeswhattheinventordiscloses,butlookstenyears products orprocesses tobemarketed).Agoodpatentattorney disclosing andclaimingcommercial embodiments(theultimate protection. inbiotechnology, Anotherchallenge,particularly isin that isbothspecificandofabroad enoughscopetoprovide useful challenges ofdraftingapatentapplicationistoprovide language invention mustbedefinedinthepatentspecification.Oneof or thatmayhaveaspecificdifferent meaningin relation tothe Words andtermsusedintheclaimsthatare notgenerallyknown the claimswhendraftingandprosecuting anapplication. Clearly, thepatentapplicantshoulddevoteagreat dealofthoughtto T he patent applicant can then respond by pointing A lthough a patent applicant may introduce evidence office action office

23 patenting 24 patenting “ nonobvious over cited prior art.” the patent presumed is to be novel and was cited during prosecution, since A patent stronger is if all relevant prior art disclose all prior art relevantdisclose allpriorart tothe patentabilityofaninventionthat words, patentattorneys/agentsandinventorsare obligedto application hasadutytoactwith Each individualassociatedwithfilingandprosecuting apatent Information Disclosure Statement relying onCIPpractice. well-considered patentapplicationsattheoutset,ratherthan application filingdate from 17yearsafterissuanceto20theoriginalpatent priority purposes.TheGATT the newdisclosure willonlybeentitledtotheCIP’s filingdatefor entitled totheparent’s onlyby filingdate,whileclaims supported bytheparentin aCIPthatissupported patentapplicationwillbe disclosures,determining patentabilityinlightofpriorart anyclaim application claims maybefiledintheU.S.viaa patent applicationwasfiledthatbroadens thescopeoforiginal On theotherhand,additionalinformationordatadevelopedaftera , whichisbasedontheoriginal,parent application.In (see Chapter10 -implemented changeinpatentterm candor andgoodfaith Continuation-In-Part (CIP) Continuation-In-Part

) placesapremium onfiling

. Inother include claimsthatare laterdeterminedtobedesirable. patent applicationpendingincasetheissued patentdoesnot claims issueasapatent.Itisgenerallygoodideatokeep broader thantheallowedclaims),mustbefiledbefore theallowed applications (e.g.,forpursuingnonelectedclaims,orclaims date forprioritypurposes,divisionalorcontinuationpatent T allowed claims. and the patentability hurdles surpassed, a patent will issue on I citedduringprosecution.nonobvious overthepriorart prosecution, sincethepatentispresumed tobenoveland case, apatentisstronger ifallrelevant wascitedduring priorart permanently unenforceable basedon defenseto an accusedinfringerasaffirmative render thepatent A violationofthedutycandorandgoodfaithcanberaisedby can besuppliedlaterina notknownatthetimeaninitialIDSisfiled Relevantpriorart art. of an known duringprosecution. Thisobligationisfulfilledwiththefiling is knownbefore thepatentapplicationisfiledorthatbecomes f all the above requirements of the patent application are met o beeligiblefortheprovisional patentapplication’s orofficial filing Information Disclosure Statement(IDS) Supplemental IDS inequitable conduct . listingrelevant prior . Inany

25 patenting 26 patenting “ to merit the costs and effort involved.” invention has sufficient commercial potential A patent should only be pursued if the written records ofconception(mental realization) ofinventions notebook. Forpatentpurposes,thenotebook shouldalsocontain Scientists typicallyrecord experimental protocols andresults ina occurred aftertheinventionwasmade. thatpredatesprior art thepatent application’s filingdate,butwhich obtaining apatentby for documenting theconceptionofaninventioncanbeimportant patent rights.Inaddition,appropriate notebookrecords interference and bywhomaninventionismadecanbecomecriticalin first tofileapatentapplication.As result,evidenceofwhen,how providing patentrightstothefirsttrueinventor, ratherthantothe As discussedin Documenting theInvention the inventionispatentable. determine whetherpatentingisappropriate, anddeterminewhether Before filing a patent application, you should document the invention, a PatentApplication? What ShouldYou DoBefore Filing Chapter 5 proceeding fordeterminingwhoisentitledtoU.S. Chapter swearing behind 3 , theU.S.patentsystemisuniquein

–andthereby removing –

• • • • • • outset, factorstoconsiderinclude: Although thecommercial toassess atthe potentialmaybedifficult involved. commercial potentialtomeritthecostsandeffort A patentshouldonlybepursuediftheinventionhassufficient often involvesbusiness,scientific,andpatentlawconsiderations. to whetherpatentprotection shouldbepursued.Thisdetermination A Determining WhetherPatentingIsAppropriate • • • – andpreferably two–credible peoplewho: page corroborated onthatdatebytheinventorandatleastone of aninventionshouldbedocumentedbytheinventorandeach T constructive reduction topractice (or provisional application,ifoneisinitiallyfiled)constitutesa solely onconception,inwhichcasethefilingofapatentapplication of theinvention).Patentapplicationsmay, however, bebased and, if possible, o serveasadequateevidence,detailsrelated totheconception fter an invention has been documented, a decision can be made as whether tradesecret protection ispreferable expected usefullife of theproduct whether there is arecognized needfortheinvention ease andcostofproduction anduse whether noninfringingalternativesare available size ofthepotentialmarket have beenobligatedinwritingtokeeptheinventionconfidential have “witnessedandunderstood”theinvention; are notinventors; actual reduction to practice

.

(successful completion

27 patenting 28 patenting copyright registration). within thefirstorlast25pagesofcode (whichare filedwiththe The trickistomakesure thattheessenceofprogram isnot confidential whilestill registering thecodeforcopyrightprotection. ofacomputer softwarekeep asignificantportion program code are deposited.Unlikeacomputeralgorithm,itispossibleto program issatisfiedifthefirstandlast25pagesofsource Although, thedepositrequirement foracomputersoftware as atradesecret, itshouldnotberegistered forcopyright. confidential. For example, if a computer algorithm is to be protected should be contractually obliged to keep the information or materials personnel only,” and the few employees knowing the trade secret facilities containing trade secrets should be limited to “authorized ensure tradesecret status,accesstolaboratoryormanufacturing invention will in fact be classified as a trade secret by a court. To pursued, appropriate safeguards must be in place so that the However, if trade secret (as opposed to patent) protection is to be acomputerprogram.basic algorithmsupporting Similarly, software companiesoftenguarded asatradesecret the a competitorfrom designingaround canbedifficult. broadobtaining sufficiently process prevent claimsthateffectively themselves provided noindicationofhowtheywere made,and becausetheantibiotics by patent.Thisstrategywaseffective technologies forproducing antibioticsastradesecrets ratherthan Pharmaceutical companiestraditionallyprotected fermentation Trade Secret Protection

the inventorsmaynot beaware. patentability search given atalkonsubject matterrelated totheinvention.Inaddition,a Inventors generallyknowiftheyoracolleague hadpublishedor • • • •  patent applicationwasfiled,theinventionwas: it wascreated bytheinventor(s)ormore thanoneyearbefore a Novelty isacriticalissue.Aninventionnotnovelifeitherbefore • • • • As discussedin an invention should be assessed before a patent application is filed. In additiontoassessingcommercial potential,thepatentability of Determining WhetherTheInventionIsPatentable by publishingorotherwisepubliclydisclosingtheinvention. however,same invention.Theeffect, canbeaccomplished prevents subsequentinventorsfrom obtainingapatentonthe enforced againstaninfringer, creates which itineffect priorart, Registration (SIR)from theUSPTO.AlthoughanSIRcannotbe Another (defensive)optionistoobtainaStatutoryInvention Statutory InventionRegistration described inaprintedpublicationtheU.S. oraforeign country; described inaU.S.-filedpatentapplication thatissuedasapatent. on saleorevenoffered forsalein the U.S.;or publicly knownorusedbyothersinthe U.S.; was notobviouswhenitmade. is novel;and has atleastoneutility; is directed toappropriate subjectmatter;

Chapter can be carried out to identify prior art ofwhich canbecarriedoutto identifypriorart 3

, aninventionispatentableifit:

29 patenting 30 patenting rebutted byevidenceofcommercial success,orlong-feltneed. befiled,sinceanobviousness may nevertheless rejection canbe references, secondaryconsiderationssuchasapatentapplication commercial potentialisarguably obviousinviewofprior art obviousness oftheclaimedinvention.Evenifaninventionwithhigh in apatentapplication,thereference maystillbearonthe If areference ofaninvention,asdescribed describesonlypart the patentapplicationfilingdate). publication (or, ifthepublicationisanissuedU.S. patent,priorto conceived of the invention before the publication date of the printed the inventor(s)mustswear(andpreferably prove) thatheorshe If thepublicationisauthored bysomeoneotherthantheinventor(s), or before theone-yearanniversarydateofprintedpublication. the inventionmaystillbepatentedifapatentapplicationisfiledon unpatentable inmostforeign countries.IntheU.S.,however, complete inventionasdescribedinaclaim,thatwillbe drafted. Ifthereference provides anenablingdescriptionofthe should beobtainedandreviewed before apatentapplicationis A ny publication appearing to disclose a complete or partial invention

* Note, however, thatthebarringeventispublication orpublicdisclosure, notsubmission. • • • • • invention, theinventor(s) shouldnot: Specifically, beforean apatentapplicationhasbeenfiledon an inventor. has beenfiled.Inotherwords, shouldnotbecreated priorart by should notoccurbefore apatentapplication(provisional ororiginal) Any actionbyaninventorthatcouldprevent issuanceofapatent Filing aPatentApplication? What Shouldn’tYou DoBefore Chapter 6 sell theinvention. or theinventionforsale(advertise); offer demonstrate theinvention; talk abouttheinventiontoothers; or fundingapproval (e.g.,agrantproposal);* submit adocumentdisclosingtheinventionforpublication

31 patenting 32 patenting application toensure thattheforeign applicationisas completeas of theU.S.filingdate tofileacorresponding foreign patent It is generally advisable to wait until close to the one-year anniversary after theoccurrence ofapublicdisclosure. do notprovide foragraceperiodfilingpatentapplication to recognize thatEuropean countries require absolutenoveltyand foreign countriesprovide asix-month graceperiod.Itisimportant events prior art in whichtofileapatentapplicationaftertheoccurrence ofcertain application. LiketheU.S.,Canadaprovides aone-yeargraceperiod filing date,however, isconsidered intheforeign priorart patent Any publicdisclosure occurring considered of theinventionoccurring determining patentability, so that any publication, public use, or sale were filed on the same day as the U.S. application for purposes of This means that a foreign patent application will be treated as if it and stillretain theU.S.application’s filingdateforprioritypurposes. any timewithinoneyearaftertheU.S.patentapplicationfilingdate patent application corresponding to a U.S. application may be filed has been signed by virtually every industrialized country, a foreign not bemadeattheoutset.Pursuantto country basis.Fortunately, however, foreign filingdecisionsneed Patents are generallyappliedforandgrantedonacountry-by- How Are Foreign PatentsObtained? Chapter 7 prior art

(see Chapter3 withrespect totheforeign patentapplication. after the filing of the U.S. application is not thefilingofU.S.applicationisnot ) . Japan,Australia,andmanyother before theU.S.patentapplication Paris Conventio n , which , which “ occurrence of apublic disclosure.” for filing a patent application after the and do not provide for agrace period European countries require absolute novelty relevant needbeinvolved.Upongrant,the patentoffice) regional associate (apatentattorneyregistered topracticebefore the application (inEnglish,foranEPOapplication)andoneforeign The majoradvantageofpursuingaregional patentisthatonlyone countriesoftheformerSovietUnion. in certain and ARIPO);theEurasianRegionalsystemprovides protection filing systemsprovide protection Africanregions incertain (OAPI member counties(i.e.,mostEuropean countries);tworegional Germany, canbeenforced in patent issuedfrom the patent thatisenforceable inanymembercountry. Forexample,a protection isdesired, severalregional filingsystemsissueasingle ofeachcountryinwhich application withthepatentoffice Although mostforeign patentsare obtainedbyfilingapatent Direct NationalorRegionalForeign Filings substantial developmentscanoccurwithinthecourseofayear. forinventionsinwhich important possible. Thisisparticularly European (EPO PatentOffice European PatentConvention(EPC

) inMunich,

)

33 patenting 34 patenting cost ofpatentingsince thecostsofinitialexaminationare in a singlesearch, foreign filingviathe PCTcanincrease the overall Although itdelaysthepaymentofmajorexpenses andprovides for assessment ofthepatentability–ormarketability –oftheinvention. examination and the passage of time can enable a better addition to the advantage of deferred expenses, the results of the (if Chapter I is selected) or 18 months (if Chapter II is selected). In and filing appropriate translations) can be delayed for eight months examination costsforeachcountryorregion (includingobtaining international patentapplication.ByfilingaPCTapplication, (in Europe or in the U.S.) and an initial examination on a single, The PCT route is a convenient way to obtain a patentability search than adirect nationalorregional patentapplication. an applicationunderthePatentCooperationTreaty (PCT)rather development priortocommercialization, apopularoptionis tofile Since manyinventionsrequire substantialresearch and Patent CooperationTreaty (PCT) Foreign Filings applications atthesametimeregional applicationisfiled. This riskcanbeminimized,ataprice,byfilingnationalpatent examiner willruleonthepatentabilityforallmembercountries. thisapproachoffice, canalsobemore risky, sinceonlyone filing separateapplicationswitheachindividualcountry’s patent Although filing a single regional application is obviously simpler than requirements andpayingnationalprocessing fees. countries protection isstilldesired bymeetingnationalformal inwhicheverofthedesignated patent canbemadeeffective

Months similar tothoseinthe U.S.,somedifferences shouldbe considered Although patentability requirements inmostforeign countriesare Patentability Requirements ofForeign Countries *** ** *IfPCTisafirstfiling,theISAwillestablishISRandWOofbefore theexpirationof9monthsfrom theprioritydate(Rule42.1) (for internationalapplicationsfiledonorafterJanuary1,2004) PCT Timeline:ChapterII should bepursued. made, used,orsoldinaforeign country, direct nationalfilings Therefore, ifacompetingproduct orprocess isalready being of aforeign patentand,therefore, therightstoexcludeothers. Filing internationallyviathePCTalsoultimatelydelaysgranting country orregion. addition to–notinlieuofthepatentcostseachdesignated and WOoftheISA,or22monthsfrom theprioritydate,whichevertimelimitexpires later(Rule54 A demand for international preliminary examination may be filed at any time prior to the expiration of 3 months from the date of transmittal of the ISR filed before theexpirationof19monthsfrom theprioritydate(foranupdatedlistofStatesconcerned,seePCT’s Internetsite) In respect of a few States, the time limit of 30 months to enter national phase will, however, only apply if those States have been elected in a demand 0 (priority date) PCT filing/ National/Regional/

PCT filing 12

written opinion search report file claimsamendments (WO) ofISA* International publication nternational International 2 monthsfrom ISR: (ISR) and (ISR) and 16 rticle 34 amendments 34amendments Article and/or arguments*** 18

Filing of demand and 19 demand** E arly filing of 18 bis 18 .1(a)). 22 IPRP (ChapterII)

established 28

30 to EOs IPRP (Chapter II) I phase entry national Chapter B communicates II

35 patenting 36 patenting or diagnosticproduct. against thecompanysupplyingpractitionerwiththerapeutic will notbeenforced againstthemedicalpractitioner, butrather medical useisalready known).Firstorsecondmedicaluseclaims known asthe be obtainedinEurope simplybydraftingclaimsindifferent formats Patent protection fortherapeuticordiagnosticmethodscanoften animal body surgery, therapy, ordiagnosticmethodspracticedonthehuman addition, biotechnology-related inventionssuchastransgenicanimals.In some countrieswillnotallowpatentsforsoftware orforcertain when filingapatentapplicationoutsideoftheU.S.Forexample, methods forthetreatment ofhumanoranimalbodyby cannotbepatentedinEurope. first medicaluseorsecond (ifafirst “ has beensuccessfullyreduced topractice. held thatacompleteconceptioncanonlyoccurwhentheinvention unpredictable have contributions. Incertain sciences, U.S.courts known, contributionstothereduction topracticemaybeinventive if nowayofmakingorusingaconceivedcompositionmatteris If thereduction topracticerequires extraordinary skill,however, or irrelevant toaninventorshipdetermination. is ofaworkableinvention,theultimate invention as defined in the patent claims. contribution tothe members qualifyingasinventorsare thosewhomadeamaterial members of a research team are necessarily inventors. best determined by a patent attorney. Unlike authorship, not all I Who Isan Chapter 8 the complete and operative invention…” a material contribution to the conception of qualifying asinventors are those who made The only members [of a research team] nventorship is a legal question that can be complex and is therefore

conception Inventor of the complete and operative onaPatent? reduction topractice A s long as the conception T he only is is

37 patenting 38 patenting determination iserroneous andwasmadewith“deceptiveintent.” A patentmaybeheldunenforceable iftheinventorship …make thesametypeoramountofcontribution inventor neednot matter. According tothepatentstatute,however, eachjoint inventor musthavemadesomecontributiontothesamesubject application. Forthere tobe Inventorship mustbedeterminedforeachclaimofthepatent can notbecorrected andthepatentwillbeheldinvalid. were madetothePatentOffice regarding inventorship,inventorship costly. Inaddition,ifmaterialmisrepresentations oromissions for correcting inventorshipare timeconsumingand,therefore, can becorrected onapendingapplicationorpatent,procedures patent attorneybefore anapplicationisfiled.Althoughinventorship A goodfaithdeterminationofinventorshipmustbemadebya physically worktogetheroratthesametime[or] joint orco-inventors of aclaim,each (35U.S.C.116).

“ expressly or impliedly obligated to another.” invention, unless those rights have been An inventor ownsthe rights to his or her will enforce anemployment agreement thatrequires assignment to assigntherightsininventionan employer. Most courts A obligated toanother. her invention,unlessthoserightshavebeenexpressly orimpliedly impliedly obligatedtoanother. Aninventorownstherightsinhisor not ownthepatentrightsifhavebeenexpressly or is, however, subjecttotwogeneralexceptions. An inventormay The rule that an inventor owns the patent rights in his or her invention When there ismore thanoneinventor, U.S. patentlawprovides that: the invention,includingrightstoapplyforandobtainapatent. the patent. The general rule is that the inventors own the rights in Inventorship provides pointfordeterminingwhoowns thestarting Who OwnsthePatent? Chapter 9 signed employment agreement can expressly obligate an inventor accounting to the other owners (35 U.S.C. 262). accounting totheotherowners(35U.S.C.262). the UnitedStateswithoutconsentofand thepatentedinventioninto United States,orimport offer to sell or sell the patented invention within the each of the joint owners of a patent may make, use, In the absence of any agreement to the contrary,

39 patenting 40 patenting obligation ontheemployee toassignpatentrightshisor her recognize maynevertheless an a court Even whenawrittenemploymentagreement hasnotbeensigned, Implied Contract • • • restriction is: weighed indeterminingreasonableness includewhetherthe it is reasonable, based on the totality of the circumstances. Factors employee leftthecompany, isgenerallyonlyenforced if byacourt employer rightstoinventionsthatwere conceivedonlyafterthe A Holdover Agreement – forexamplewhiletheemployeeisworkinganotheremployer course ofemployment,evenifreduced topracticesometimelater the employerofinventionsconceivedbyemployeeduring also enforce employmentagreements thatobligateassignmentto inthemajority–butnotallstateswill her employment.Courts practice bytheemployeeduringandinconnectionwithhisor to theemployerofallrightsinventionsconceivedandreduced to holdover agreement creativity, andinvention. not injurioustothepublic’s interest inpromoting competition, and opportunities; not undulyrestrictive ontheemployee’s employment originally conceivedduringemployment); information, oriftheinventionisanimprovement toaninvention example, theemployer’s tradesecrets orconfidential necessary toprotect alegitimateinterest oftheemployer(for

, whichrequires anemployeetoassignthe

implied contract, or

. “ to anemployer, titleintheinventionwillremain withtheemployee Although ownershiprightsmaybeexpressly orimpliedlyobligated Assignment Agreement license tousetheinventionfortermofpatent. grant totheemployeranonexclusive,nontransferable,royalty-free time and/orresources tocreate aninvention,theemployeemust doctrine, ifanemployeeusesanontrivialamountoftheemployer’s recognize a patent rightstotheemployer, circumstances may incertain courts Although there maybenoexpress orimpliedobligationtoassign Shop Right contract toassignpatentrightsthatcompany. may a court company (such as a readcorporate anofficer), implied In addition,where theemployeeholdsapositionoftrustwith assign betweentheemployeeandemployermaybeheldtoexist. problem,to inventorsolveaparticular animpliedcontractto employer. Forexample,whentheemployeewasspecificallyhired the complete and operative invention…” a material contribution to the conception of qualifying asinventors are those who made The only members [of a research team]

shop right intheemployer. According totheshopright

41 patenting 42 patenting be accomplishedthrough alicenseagreement. (that is,a50%interest). Transfer oflesserrights inapatentmay provided byapatent,oranundividedfractionofalltherights An assignmenttypicallytransfersallpersonalproperty rights obtained from the Assignment informationrecorded afterapatenthasissuedmaybe • • proper recordation ofapatent inthe with thefilingofapatentapplication.Althoughnot requirement, United StatesPatentandT assignment agreements andfilethosesigneddocumentswiththe is intheemployer’s bestinterest tohaveemployee/inventors sign with thepatenttitleholderasoftimeinfringementoccurs,it can changejobsandtherighttosueforinfringementrests only in thepresence oftwocredible witnesses).Becauseemployees employee (preferably inthepresence ofanotary, butataminimum until an

and and lists the patent assignee on the cover page of the issued patent; patent toanewentity–forexample,employer. assignees shouldtheinventorlaterattempttoreassign thesame protects theowneragainstchallengesbysuccessivepurported assignment agreement USPT O byfilinga request andpayingafee. rademark Office (USPTO rademark Office has beensignedbytheinventor/ USPT O effectively: effectively: ) inconjunction * patent application claimspriority. which a continuation (e.g., file wrapper continuation, continuation, continuation-in-part, or divisional) i.e., The filing date of the patent application or the earliest filing date of a prior U.S. application to issuance ofasecrecy order. or ifprosecution wassuspendedatsomepointduetogovernment patent applicationwasinvolvedinaninterference orwasappealed, patent. Forexample,extensionsinterm wouldbeavailableifthe delayswerethe 20-yearterm,ifcertain involvedwithobtainingthe The GATT legislationprovides foramaximalfive-yearextensionof Extensions andPatentTerm Adjustments(PTAs) continues tobe14yearsfrom thedateofissuance. byGATTthe two).Thetermofadesignpatentwasunaffected and or 20yearsfrom U.S.filingdate(thelongerof theearliesteffective 1995, byproviding atermofeither17yearsfrom theissuedate and topatentsthatissuefrom applicationsfiledpriortoJune8, Transitional statuswasgrantedtopatentsinforce onJune8,1995 1995, is20yearsfrom U.S.filingdate.* theearliesteffective term ofaU.S.patentissuedonanapplicationfiledafterJune7, however, intheU.S.onJune8,1995, whichbecameeffective Pursuant totheGeneralAgreement onTariffs andTrade (GATT), granted foraperiodof14yearsfrom thedateofissuance. cover pageofthepatent).Designpatents,onotherhand,wer of 17years,measured from thepatentissuedate(indicatedon Historically, U.S.utilityandplantpatentswere grantedforaperiod How LongIsaPatentinEffect? Chapter 10

e

43 patenting 44 patenting “unintentional,” however, apatent maybereinstated. years oftheexpiration thatthenonpaymentwas“unavoidable” or designated timeperiods. Ifthepatentownercanprove within two Issued patentswillexpire unlessmaintenancefeesare paidat Maintenance Fees a regulatory (FDAorEPA) approval process. of fiveyearstocompensatefordelaysin commercialization dueto Restoration I What isthePatentTerm? action,oranapplicantsubmittingincomplete office reply etc. applicant failingtoreply withinthree monthsafterreceiving an of anapplication.Examplesresulting insuchafindingincludean engage in reasonable efforts to conclude processing or examination failures may be lost if the reduced, anyextensionwhichmaybewarrantedinviewofPTO patent withinthree years.Whilethepatenttermitselfcannotbe failure totakeactionwithinprescribed limitsorotherwiseissuethe rules. Forexample,thepatenttermmaybeextendedforPTO’s patent termadjustment(PTA) thatmaybeafforded underthenew extends 20yearsfrom filingdatetogetherwithany theeffective For applicationsfiledonorafterMay29,2000,thepatentterm n addition, pursuant to the Drug filed onorafterJune8,1995 P filed before June8,1995 issued from a patent application P Patent Right atent issued from a patent application atent issued before June 8, 1995 or patent A ct of 1984, patent life may be extended a maximum

PT

O determines that the applicant failed to P rice Competition and filing date 20 yearsfrom theearliesteffective is longer(transitionalstatus) from the earliest effective filing date, whichever 17 yearsfrom issuedateor20years Patent Term P atent

T erm

For more informationvisit to high-quality legal advice regardless of how far their businesses take them. network of independent law firms, we ensure that our clients have access and white collar and business crimes. As a member of Lex Mundi, the global use; government strategies; intellectual property; tax, trusts and estates; and restructuring and workouts; corporate finance, mergers and acquisitions, creative solutions and results-oriented advice in the areas of bankruptcy, and ourEmerging EnterpriseCenterinWaltham, Massachusetts,weprovide and technology. 250 lawyersWith located in Boston and Washington, D.C. including biopharma, energy and utilities, financial services, manufacturing, United Statesandaround theworld.We serveawiderangeofindustries, Foley Hoag provides comprehensive legal services to clients throughout the About FoleyHoa or defendagainsttheenforcement ofpatentandtradesecret rights. financings, negotiateanddraftcommercialization agreements, andenforce validity, patent due diligenceperform in connection with public or private In addition, our patent lawyers provide opinions on and materials technologies,Internetapplications,andbusinessmethods. and control systems, optic, M software, electronics (network devices), telecommunications, aerospace diagnostics, agricultural biotechnologies, computer hardware, computer chiral chemistries), medical devices, drug delivery technologies, medical technologies (bioinformatics, proteomics, genomics, and combinatorial and technologies andproducts, includingpharmaceuticals,drugdiscovery and diversity, Foley Hoag is uniquely able to patent protect a variety of professors, engineers, and patent examiners. many ofwhomare formerdoctors,postdoctoralfellows,tenure-track Our group includes more than 50 patent practitioners of diverse backgrounds, Patent Grou IP Os; labor and employment; litigation; environmental issues and land p

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45 patenting 46 patenting Beth E.Arnold Click theimagebelowforafullbiography. University, andaJ.D.from University. Northeastern the UniversityofRhodeIsland,aM.S.inmolecularbiologyfrom Boston and writesonavarietyofpatentissues.Shereceived aB.S.inbiologyfrom Law, BusinessandRegulation(AspenLaw&Business),frequently speaks a pharmaceuticalresearcher. Sheisco-authorofthetreatise Biotechnology: was formerlyanin-housepatentcounselatGenzymeCorporation,aswell of research, developmentandcommercialization agreements. Ms.Arnold non-infringement, andinvalidityopinions;negotiatesdraftsavariety diligence inconnectionwithpublicorprivatefinancings; renders clearance, research institutionsintheworld.Shealsoroutinely patentdue performs products andtechnologiesforsomeofthemostinnovativecompanies years shehasfocusedonobtainingworldwidepatentprotection onbiomedical inFoleyHoag’sBeth E.ArnoldisaPartner PatentGroup. Forcloseto20 About theAuthor industry-specific alerts andupdatesfromindustry-specific alerts Sample otherfree titlesfrom theFoleyHoageBooklibrary, sign-upfor Foley HoageBookLibrary EMAIL ADDRSS LAST NAME FIRST NAME Visit our Visit

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