1 PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD

by BethE.Arnold Post-America InventsActWorld A GuidebookForPatentingina PATENTING: Foley Hoag eBook Hoag Foley Contents

Preface...... 1

Chapter 1 What Is a ?...... 2

Chapter 2 What Is Potentially Patentable?...... 5

Chapter 3 What Is Not Patentable?...... 7

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

Chapter 5 What Should You Do Before Filing a ?...... 25

Chapter 6 What Shouldn’t You Do Before Filing a Patent Application?...... 28

Chapter 7 How Are Foreign Obtained?...... 29

Chapter 8 Who Is an on a Patent?...... 33

Chapter 9 Who Owns the Patent?...... 35

Chapter 10 How Long Is a Patent in Effect?...... 39

About Foley Hoag...... 42

About the Author: Beth E. Arnold...... 43

Attorney advertising. Prior results do not guarantee a similar outcome. © 2015 Beth E. Arnold. All rights reserved. Patenting

by Beth E. Arnold

Patenting generally offers a superior means for legally protecting most , particularly since:

• copyright, when available, does not provide a broad scope of protection; and • the ability to effectively protect an as a trade secret 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 to establish value in products and technology maximized if professionals with an understanding of the patenting process are actively involved throughout. This book is intended to provide that understanding.

1 2 PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD and, dependingonwhat itcovers,maybeveryvaluable. assignment orlicenseagreement). Apatentis anintangibleasset the rightscanbecontractedtoacommercial (viaan partner infringing avalidclaimofthepatent.Alternatively, allorsomeof can seekaninjunctionagainstand/ordamages from anyparty the patentowner’s marketshare. Forexample,thepatent owner patent owneragainstcompetitorinfringers toprotect orincrease The rightsconferred byapatentcanbeenforced bythe incourt 3)  2)  1)  depending onthenature ofthesubjectmattertobeprotected: the U.S.,anyofthree different kindsofpatentsmaybeappliedfor, defined bythepatentclaims,fordurationofterm.In with rightstoprevent competitorsfrom profiting from theinvention A patentisagovernment-issueddocumentthatprovides itsowner Chapter 1 What IsaPatent? Act of1970.) pursuanttothePlant upon certification, Variety Protection reproduced varietiesare legalprotection alsoentitledtocertain distinctive asexuallyreproduced plantvarieties.(Sexually The plantpatentisusefulonlyforprotecting newand ornamental design. The designpatentprotects anynew, original,or products andprocesses, andisthefocusofthispublication. The mostpopularutilitypatentprotects avarietyof

PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD 3 The Origin of Patents and of Patents The Origin Europe. in medieval originated protection property Intellectual with each their knowledge share guilds would of medieval Members Their closely guarded to outsiders. disclosure it from but guard other, trade secrets. today’s of precursors skills are techniques and the guilds, closed societies arising from to the Partly in response dissemination of inventions passed laws to encourage governments patent or copyright – for a exclusive rights – a and ideas by granting a new and useful of time to anyone who disclosed limited period work into the public domain. or creative item, process, to identify services symbols and pictures The early guilds also used guild made by guild members. Those performed or products trademarks. of today’s the precursors symbols are What a Patent Is Not its owner an affirmativeA U.S. patent does not give right to make, by the patent claims. Instead, it use, or sell the invention defined making, using, or selling from others confers the right to prevent – or even offering invention within the United States or to sell – the permission is importing it into the United States, unless the owner’s importantobtained. This is a subtle but distinction. Blocking Patents patent, it may infringe another’s Because even a patented product to detect to operate search is advisable to conduct a freedom but potential blocking patents, as early as possible in development, the market, on at any rate, prior to putting a new product offering or a new implementing a new manufacturing process, as the as well or process, service. Each component of a product 4 PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD available whentheproduct orprocess isactuallysold. negotiate amore favorablelicensethanwouldotherwisebe product orprocess thatisnotcovered bythepatentclaim)or potential infringertodesignaround (i.e.,developanalternative If ablockingpatentisidentifiedearly, itmaybepossiblefora claims shouldbeheldinvalidand/orunenforceable. the DoctrineofEquivalentsand/orwhetherrelevant patent determine ifanyclaimisactuallyinfringed,eitherliterallyorunder should construetheclaimsofpotentialblockingpatentsto Because claimconstructionisamatteroflaw, apatentattorney in appropriate computerdatabases. of issuedpatentsintheU.S.PatentandTrademark and/or Office) should besearched separately, manually(bysearching thestacks process usedtomakeaproduct andmethodsforusingaproduct, PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD 5

Association for Molecular Pathology v. Myriad Genetics Inc. Association for Molecular Pathology v. Whoever invents or discovers any new and useful or discovers any new and Whoever invents or composition of machine, manufacture process, thereof, improvement or any new and useful matter, subject to the conditions may obtain a patent therefor, of this title. (35 U.S.C. 101) and requirements Mayo Collaborative Services v. Prometheus Laboratories, Prometheus (2013) and Mayo Collaborative Services v. Office has In addition, the U.S. Patent and (2012). Inc. view of the Office’s issued Eligibility Guidances intended to provide Eligible Subject Matter Court engineered held that a genetically In 1980, the Supreme matter and in so doing, broadly bacterium is patentable subject under the sun made 35 U.S.C. 101 to cover “everything interpreted In 1981, the S. Ct. 1980) Chakrabarty, by man.” (Diamond v. Court held that section 101 contains an importantSupreme implicit natural phenomena and exception, “[L]aws of nature, , S.Ct. 1981) Diehr not patentable. (Diamond v. ideas” are cases dealing Court has ruled on three the Supreme recently, More CLS Bank Int’l. Ltd. v. with subject matter eligibility: Alice Corp. Pty. (2014); The definition of what constitutes potentially patentable subject of what constitutes potentially The definition 101 of Title 35 of the United U.S. is defined in Section matter in the States Code: Chapter 2 Chapter Patentable? Is Potentially What 6 PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD importation, sale, oruseofaproductimportation, madeabroad byaprocess In addition,35U.S.C. Section271(g)makesunauthorized • • • protection (whenavailableaspatentablesubjectmatter): resulta product acertain –canalso provide oraffecting useful However, process claims–includingprocesses formakingor using optimal patentprotection. claims thatare directed toandcoveranactualproduct provide than thatdescribedinthepatent.Therefore, generallyspeaking, the product ismadedifferently orisusedforadifferent purpose composition ofmatter”)coveranitemandmaybeinfringedevenif Product claims(i.e.toa“machine,manufacture or (35 U.S.C.287(c)). matter, medicalpractitionersare exemptedfrom infringement procedure onahumanbodymaybepatenteligiblesubject Further, a medicalorsurgical althoughmethodsofperforming directed toorencompassingahumanorganism ortaxstrategy. The AmericaInventsActspecificallybarsthepatentingofanyclaim patent subjectmattereligibilityjurisprudenceandpublicfeedback.” continuing withperiodicsupplementsbasedondevelopmentsin acknowledge thatimplementation“willbeaniterativeprocess subject mattereligibilitybasedonthecaselaw. TheGuidances are obtainable. as anextralayerofprotection, evenifbroad product claims if onlyproduct claimsofnarrow scopeare obtainable;or if claimsontheproduct cannotbeobtained;

PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD 7 Chapter 3 What Is Not Patentable? to patentable subject matter In addition to being directed invention must also be useful and(discussed in Chapter 2), an (35 U.S.C. 101). patentable to be considered actually work, in order of In addition to the requirements new. The invention must also be 102 is devoted to defining what is section 101, much of 35 U.S.C. not novel. 35 U.S.C. 102 (a)-(d) of the America Invents Act, substantially being changed the U.S. law for determining novelty and is now applied for all patent applications having a first effective filing date 16, 2013. on or after March patented in the U.S. (a process of making claim) an infringing claim) of making (a process in the U.S. patented changed been materially has not product long as that as activity, trivial and become a or does not process by a subsequent of another product. nonessential component and types of patent the number the greater Generally speaking, the chance the greater or process, a product claims protecting infringing or from infringer will be deterred that a potential held liable for . ultimately be 8 PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD assignment to the same person as of the effective filingdateofthe assignment tothesame personasoftheeffective were ownedby the samepersonorsubjecttoanobligation of In addition,iftheclaimed inventionandthe102(a)(2)disclosure resulting from suchdisclosure isalso excluded. inventor (102(b)(1)).Inaddition,anysubsequent publicdisclosure an inventororapersonwhoderivedthe disclosure from the year graceperiodisprovided withrespect todisclosures madeby respect102(a)(1) and102(a)(2).With to102(a)(1),alimited one Section 102(b)provides ofsection exceptionstotheprior art under 35U.S.C.119or120)(Seesection102(d)). priority date,ifisclaimedfrom apriorapplication (e.g. filingdateofa102(a)(2) The effective reference istheearliest U.S.filing date. date ofinventionearlierthanitsearliesteffective an applicantcannotantedatea102(a)(2)reference byshowinga filingdate.However,of itseffective unlikepriorsection102(e)(1), as patent orpublishedapplicationinventedbyanotherispriorart Section 102(a)(2),likepriorsection102(e)(1),provides thata and oralpresentations). filingdateofaclaimedinvention(e.g.experimentaluses effective disclosure thatwasotherwiseavailabletothepublicbefore the underthenewlawalsoencompassesanyotherformof public useandsaleare expressly However, definedaspriorart. the filingdateofapplication.Printedpublications,patents, encompass anyinformationthatisavailabletothepublicprior fromscope ofpriorart thatspecifiedbythepriorlawto considered Section102(a)(1)significantlybroadens priorart. the available tothepublicpriorapplicationfilingdatewillbe Section 102(a)provides abarunderwhichanyinformation PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD 9 A patent may not be obtained though the invention is not identicallyA patent may not be obtained though the invention is not between the subjectdisclosed or described…if the difference such that thematter sought to be patented and the prior art are time thesubject matter as a whole would have been obvious at the skill in the art toinvention was made to a person having ordinary which the subject matter pertains…(35 U.S.C. 103(a)). claimed invention, the disclosed subject matter is excluded from from is excluded matter disclosed subject invention, the claimed art as prior being applied under 102(a)(2). research include joint ownership to common 102(c) defines Section in effect date of a claimed as of the filing that are agreements patent must clearly the patent application or invention. However, agreement of the partiesidentify the names to the joint research under the joint of activities must be a result and the invention agreement. research of prior artby a research to avoid the creation Accordingly, must be in writing and in effect agreements research collaborator, agreements begins. In addition, research the research before so that resulting describe the scope of work, should broadly collaborators should Also, research clearly covered. inventions are but also of the research, not only of maintain good written records, The names of to collaborators. public and confidential disclosures should be documented,all parties involved in the research that potential prior so agreement, in the actual research preferably when may be identified. Finally, a collaborator from art resulting should be patents or patent applications resulting appropriate, of all partiesamended to disclose the names involved with the collaborative research. Non-obviousness 10 PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD defeats anobviousness challenge. thelabel“hindsight” doesnotjustifyarigidapproachaffixing that not bedefinedbasedontheuseofhindsight bias,butsimply testimony. pointedoutthattheproblem further should TheCourt publicationorthesubjectofexpert can befoundinapriorart known problem, evenwhenneitherthatproblem nor its solution used toprovide motivationtocombinereferences todealwitha basic technologies),commonsenseand ordinary creativity canbe alsosaidthatwhenappropriateIn KSR,theCourt (e.g.formore claimed combination. endeavor atthetimeofinvention”canprovide amotivation forthe solve. KSRheldthat“anyneedorproblem knowninthefield of combine references, totheproblem theinventorwastryingto limitation ofthe“problem” thatcouldgiverisetothemotivation elements. Inparticular, rejected theCourt theFederalCircuit’s obviousness challengestopatentsclaimingcombinationsofknown Teleflex Inc.,rejected theFederalCircuit’s “rigidapproach” to The U.S.Supreme Court’s 2007decisioninKSRInternationalv. commercial success,failure ofothers,andunexpectedresults. 4) Evidenceofsecondaryconsiderations,suchasalong-feltneed, towhichtheinventionpertains 3) Levelofskillintheart andtheclaimedinvention 2) Differences betweenthepriorart atthetimeofinvention 1) Scopeandcontentofthepriorart four factualinquiries: Determination thataninventionisnon-obvioustypicallybasedon The inventionmustbeanunobviousadvanceoverthepriorart. PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD 11 1. The claimed invention is made by or on behalf of parties invention is made by or 1. The claimed to the that was in effect or before on agreement a joint research was made; date the claimed invention of activities undertaken the result 2. The claimed invention is and agreement; research within the scope of the joint on the claimed invention 3. The application for patent disclose the names of the partiesdiscloses or is amended to USC §103(c)) (35 agreement. to the joint research Enablement patent application itself to determineThe examiner also studies the adequately described and enabledwhether the invention has been of the patent application (the(35 U.S.C. 112). The body invention andspecification), must contain a written description of the of of making and using it…to enable one of the manner and process skill in the art to which it pertains…toordinary make and use the same (35 U.S.C. 112), without undue experimentation. of all patent systems. In is at the root The enablement requirement theexchange for teaching the public how to practice an invention, Since 2004, U.S. law has excluded from consideration for consideration from has excluded U.S. law Since 2004, prior art purposes, obviousness by a non-inventor made at the art if the prior were, invention and the claimed collaborator, owned or subject invention was made, commonly time the claimed A claimed entity. of assignment to the same to an obligation which by a collaborator, subject matter developed invention and by the same entity deemed to be owned artqualifies as prior are if: to the same entity, an obligation of assignment or subject to 12 PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD Written Description claims mustbebroadly enabled. commensurate withthebreadth oftheclaims.Inotherwords, broad that inventionforalimitedterm.Thescopeofenablementmustbe inventor isprovided exclusiverightstoprevent othersfrom exploiting canceling ormaking a claimunenforceable, evenifitislatershown disclose theirbestmode isnolongerabasisforinvalidating, infringement ofapatent. Inotherwords, thefailure of aninventorto longer beusedasadefenseinanyaction involvingthevalidityor the AmericaInventsAct,bestmodeisstill required, butcanno retaining criticalelementsoftheinventionastradesecrets. Under application wasfiled.This requirement prevents inventorsfrom inventor(s) forcarryingouttheinventionat thetimepatent patent specificationmustdisclosethebest modeknownbythe In additiontoappropriately describingandenablinganinvention,the Best Mode sequences mustalsobesubmittedtotheUSPTOoncomputerdisk. nucleotides. Inadditiontoappearinginthewrittenpatentapplication, amino acids,andanydisclosednucleicacidoftenormore (not merely claimed)protein (orpeptide)consistingoffourormore The specificationmustincludeasequencelistingforanydisclosed “possession” oftheclaimedinvention,asfilingdate. terms. Thewrittendescriptionmustbedetailedenoughtoconvey invention, preferably inveryspecificaswellmore general should describeallpossibleparametersandcomponentsofan the patentspecificationmaybeclaimed.Thespecification,therefore, relevant identifyingcharacteristics(asopposedtojustfunctionally)in and Only thatwhichhasbeenspecificallydescribedbysufficient

PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD 13

that the inventor knew of a best mode and did not disclose it in its disclose it and did not of a best mode inventor knew that the application. patent Claims Definite that the patent specification 112 also requires 35 U.S.C. Section out and claims specifically pointing one or more conclude with §112, para. 2). For years the invention (35 U.S.C. distinctly claiming is indefinite when it is not held that a claim the Federal Circuit ambiguous.” In Nautilusconstruction” or it is “insolubly “amenable to Court that the held 2014, the Supreme Biosig Instruments, S.Ct. v. satisfy the definiteness does not standard Federal Circuit’s some ambiguous of Section 112, because it “tolerates requirement Court then held that “a patent Supreme claims, but not others.” The read in light of the if its claims, is invalid for indefiniteness fail to history, patent and prosecution specification delineating the in the art those skilled about the certainty, inform, with reasonable scope of the invention.” the most important partThe claims are of an issued patent: They the Clearly, patent provides. that the define the extent of protection to the claims deal of thought a great patent applicant should devote an application. when drafting and prosecuting not generally known or used in the claims that are and terms Words relation to the meaning in that may have a specific or different patent: they define the extent of protection.” of extent the define they patent: The claims are the most important part of a part important most the are claims The “ 14 PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD patent termfrom 17yearsafterissuanceto20 the filing dateforpriority purposes.TheGATT-implemented changein onlybythenewdisclosuresupported willonlybeentitledtotheCIP’s application willbeentitledtotheparent’s filingdate,whileclaims disclosures, bytheparent anyclaiminaCIPthatissupported patent application. Indeterminingpatentabilityin lightofpriorart application, whichaddsnewdisclosure totheoriginal,parent (CIP)patent claims maybefiledintheU.S.viaaContinuation-In-Part patent applicationwasfiledthatbroadens thescopeoforiginal On theotherhand,additionalinformationordatadevelopedaftera patent applicationduringprosecution. matter” (i.e.additionstothespecification)maybeintroduced tothe arguments, tosupport (such asdeclarationsoraffidavits) no“new or specification.Althoughapatentapplicantmayintroduce evidence out errors intheexaminer’s reasoning and/oramendingtheclaims more grounds. Thepatentapplicantcanthenrespond bypointing rejecting theclaimsand/orobjectingtospecificationononeor examination. Almostinevitably, action theexaminerissues anoffice Claims inapatentapplicationare nottypicallyalloweduponinitial reasonably bedevelopedbasedontheinventor’s actualwork. describe whattheinventordiscloses,buteverythingthatcould processes tobemarketed).Thepatentapplicationshouldnotonly claiming commercial embodiments(theultimateproducts or inbiotechnology,Another challenge,particularly isindisclosingand is specific,butofabroad enoughscopetoprovide usefulprotection. challenges ofdraftingapatentapplicationistoprovide languagethat invention mustbedefinedinthepatentspecification.Oneof PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD 15 One of the challenges of drafting a patent patent a drafting of challenges the of One is that language provide is to application to scope enough broad of a but specific, provide meaningful protection.” original patent application filing date (see Chapter 10) places 10) places (see Chapter filing date patent application original a the outset, at patent applications well-considered on filing premium on filing CIPs. relying rather than “ 16 PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD How IsaPatentObtained? Chapter 4 Chapter 3). determining thenovelty and/ornon-obviousnessoftheinvention (see date ofthecompleteapplicationwillnotbe considered for priorart after thefilingdateofprovisional application,butbefore thefiling result, thepublication,publicuse,orsaleofinventionoccurring application’sa filingdateusedtocalculatethepatent term.As the prioritydatefordeterminingpatentability, withtheutilitypatent the dateonwhichprovisional applicationwasfiledservesas within oneyearaftertheprovisional patentapplication’s filingdate, a comparable,completepatentapplication(includingclaims)isfiled disclosure oftheinvention,butnotnecessarilyclaims).Aslongas provisional patentapplications(patentcontaininga Agreement onTariffs andTrade (GATT) -theUSPTOhasaccepted Since June8,1995-thedayU.S.implementedGeneral Provisional PatentApplication a memberofstatebar). engineer whoisregistered topracticebefore theUSPTO, butisnot ofatleastonestate)orapatentagent(ascientist the courts practice before theU.S.PatentandTrademark (USPTO)and Office by apatentattorney(ascientistorengineerwhoisregistered to technical requirements, apatentapplicationisgenerallybestdrafted Patent andTrademark Becauseofthemanylegaland Office. application mustbeprepared, filed,andprosecuted intheU.S. To begrantedapatentonaninventionintheU.S.,

PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD 17

Utility Patent Application Utility application is patent to a provisional) utility (as opposed When a sure it to make the application review PTO officialfiled, a briefly will application the and direct if so, grant a filing date is complete and, Depending examining group. in an appropriate to an examiner anywhere it may take of applications in the group, on the backlog to actually be years for an application a few months to a few from examined. Examination Accelerated for prioritized examination of The USPTO now accepts requests One prioritized patent the Track patent applications through or plant one allows applicants of utility Track examination program. September 26, 2011 to have theirpatent applications filed after 12 months, if they file an appropriate applications examined within all drawings and a complete application including request (or $2,400 if the applicant and pay a fee of $4,800 electronically The application must also contain noqualifies as a small entity). independent. than four are than thirty claims of which no more more they fully describe what is ultimately claimed.” is ultimately what describe fully they for securing an early filing date, but only if only but date, filing early an securing for “Provisional patent applications may be useful be may applications patent “Provisional 18 PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD Examiner Patent Applicant Patent U.S. PatentApplicationTimeline restriction requirement. and distinctinventions,inwhichcasetheexaminermayissuea The patentexaminermayconsidereachofthesetobeindependent 8) diagnosticuseoftheantisensenucleicacids. 7) diagnosticusesoftheantibodies;and 6) therapeuticusesoftheprotein; 5) processes formakingtheprotein; 4) nucleicacidsequencesantisensetothecodingsequence; 3) nucleicacidsequencesencodingtheprotein; 2) antibodiestotheprotein; 1) theprotein itself; include claimstoanyorallofthefollowing: For example,apatentapplicationfornewrecombinant protein may they are directed totwoormore independentanddistinctinventions. A patentexaminerinitiallylooksattheclaimstodeterminewhether Restriction Requirement (optional) application patent provisional File ≤ 1year

application patent File utility Six months to Six monthsto a fewyears

* • • •

to, but if the Office Actionis madefinal,thePatentApplicantmusteither: to, butiftheOffice Actions,whichthePatentApplicantmust The ExaminercancontinuetoissueOffice respond abandontheapplication. fileacontinuationapplication; or appealtotheBoard of Patent AppealandInterferences;

or First or FirstOffice a RestrictionRequirement Examiner issues 1 month

3 months Requirement Restriction Respond to

First Action Respond to or allowsclaim* Action Office Examiner issues

months a few

PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD 19

appropriately enables, describes and claims the invention appropriately is novel (35 U.S.C. 101 and 102); and was not obvious at the time it was made (35 U.S.C. 103); is directed to appropriate subject matter (35 U.S.C. 101); to appropriate is directed has at least one utility (35 U.S.C. 101); • • • A patent applicant is typically given one month in which to elect one which to elect one month in typically given applicant is A patent for further of claims) examination the groupings (i.e., one of invention stands, restriction If the the restriction. merits or to dispute on the and may be pursued pending will remain nonelected claims the any time before filing a divisional patent application separately by change in issue as a patent. The GATT-implemented elected claims after the after issuance to 20 years 17 years from patent term – Chapter 10) – provides application filing date (see original patent importanton commercially divisional applications incentive for filing rather than later. claims sooner in inevitably results of a patent application Although restriction effortincreased for obtaining the issuance of various and expense that each group is a USPTO acknowledgment claims, the restriction A subsequent ruling of invalidityof claims is separately patentable. would not necessarily to one invention, therefore, on claims directed to another invention. claims directed invalidate restricted the patent is required, or if no restriction Following restriction, of the prior art substantively and examiner conducts a search to determine whether the“examines” the patent application invention: • • 20 PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD obvious over the prior art citedduringprosecution.obvious overtheprior art prosecution, since thepatentispresumed tobenovel andnon- case, apatentisstronger ifallrelevant was citedduring priorart permanently unenforceable basedoninequitableconduct.Inany defenseto accused infringerasanaffirmative render thepatent A violationofthedutycandorandgood faithcanberaisedbyan Supplemental IDS. a known atthetimeaninitialIDSisfiledcan besuppliedlaterin not Statement (IDS)listingrelevant Relevantpriorart priorart. obligation isfulfilledwiththefilingofanInformationDisclosure application isfiledorthatbecomesknownduringprosecution. This ofaninventionthatisknownbefore thepatent patenting are relevant obligedtodiscloseallpriorart tothe words, patentattorneys/agents,inventorsandothersinvolvedinthe application hasadutytoactwithcandorandgoodfaith.Inother Each individualassociatedwithfilingandprosecuting apatent Information Disclosure Statement to anyapplicationsthenpending. provision onSeptember16,2012andwillbeapplicable tookeffect publications, 122(e)requires anexplanationoftherelevance. This previously prohibited from any explanationofthepatentor offering intervening noticeofallowability).Also,whereas third were parties no action,whicheverislater(assuming window orfirstoffice been published(asprovided by37C.F.R. 1.99)toasixmonth totheUSPTOfrom could submitpriorart whenanapplicationhas This provision expandsthetwomonthwindowinwhichathird party The AmericaInventsActaddsasubsection“e”to35U.S.C.122. Pre-Grant Submission PriorArt

PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD 21

If all the above requirements of the patent application are met and are the patent application of above requirements If all the and a be allowed claims will surpassed, hurdles the patentability on the application. will be issued patent filing application’s or utility patent provisional be eligible for the To patent purposes, divisional or continuation date for priority claims, or claims different for pursuing nonelected applications (e.g., but supported the allowed claims, must be by the application), from is therefore issue as a patent. It the allowed claims filed before pending to idea to keep a patent application generally a good claims. the option of pursuing additional preserve Ex Parte for laws to provide amended the patent In 1981, Congress the patentee or a third of patents. Anyone including reexamination but it could only be used to ex parteparty reexam, could request on prior art the validity of claims based patents or printedreconsider publications. by the favors the patentee. If initiated Ex parte reexamination participatepatentee, the public can not actual proceedings. in the to this procedure. The AIA made minor changes

be a novel and nonobvious over cited prior art.” prior cited over nonobvious and a novel be during prosecution, since the patent is presumed to to is presumed patent the since prosecution, during A patent is stronger if all relevant prior art was cited cited art was prior relevant all if is stronger A patent “ 22 PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD $14,000 ofwhichis refunded ifthepetitionisnotgranted. The feeforfilingan IPR petitionofupto20claimsis$23,000, opinion). (e.g. depositionsofthosewhosubmitafactual orexpert the request. InadditionIPRproceedings includelimiteddiscovery will prevail withrespect toatleastoneoftheclaimschallenged in IPRs are initiatedifthere isareasonable likelihoodthattherequester Rather thanthesignificantnewquestion of patentabilitystandard, There are alsoalotofdifferences from reexam. theoldinterpartes toamendtheclaims. patentee hasonlyoneopportunity arguments patentsorprintedpublications.The basedonpriorart an estoppel.Also,therequestor canonlyraisenoveltyandobviousness For example,thereal ofinterest party mustbeidentifiedandthere isstill examremaininter partes intheIPR. panel ofthree administrativepatentjudges.Manyoftherulesfor by Reexaminationwasreplaced On September16,2012InterPartes as adefenseinsubsequentpatentinfringementsuitfederalcourt. Reexamination,couldnotberaisedagain raised intheInterPartes provision, sothatanythingachallengerraisesorcouldhave intheproceedings. participate Theselawsincludeanestoppel Congress in1999toprovide third withlimitedrightsto parties Reexaminationwere Laws establishingInterPartes enactedby Review Inter Partes fairly easystandard tomeet. new questionofpatentability”hasbeenraised,whichisconsidered a reexamination A petitionforexparte willbegrantedifa“significant Review.Inter Partes TheIPRproceeding isconductedbefore a

PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD 23

A patent must have been in existence for at least 9 months for an 9 months for for at least in existence must have been A patent a final most circumstances, Under to be granted. IPR challenge the Parties before settle anytime can a year. is issued within opinion is no estoppel is a settlement, there is issued. If there written opinion confidential. will remain of the proceeding and the substance Post-Grant Review For patents having a priority date on or after March 16, 2013, the 16, 2013, March a priority date on or after For patents having allows Opposition Proceedings, Act, like European America Invents cancellation of one or patent owner to petition for anyone but the The petition must be filed of invalidity. claims on any ground more The reissuance. or broadened within 9 months of patent issuance if with a post-grant review and proceed USPTO will grant the petition least one challenged claim likely than not at it determines that more is unpatentable. The office also grant a petition if it raises “a can novel or unsettled legal question.” and Board and Appeal Trial is conducted by the Patent The review may be a 6 months, although there must be completed within 12 The decision can be appealed tomonth extension for good cause. Once the petition is filed, a patentee may file a the Federal Circuit. The the USPTO considers the petition. before response preliminary of up to 20 claims is $30,000, $18,000fee for filing a PGR petition if the petition is not granted. Like IPR, PGR of which is refunded motion practice and the right to an oral includes limited discovery, if a final written decision is issued. Also, as with IPR a hearing before will be terminated PGR is settled prior to a decision, the proceeding without any finding and no estoppel will attach. Review Business Method Covered for a special post-grant review The America Invents Act also provides certain business method patents (those that claim a method or 24 PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD and provide anexplanationoftheissuesraised byeachitem. examination isnotneeded. Thepetitioncanidentifyupto10 items The feeis$16,500(large entity)withthemajorityrefunded ifthe ofthepetition. may bemadeduringtheexamination,but notaspart presents asignificantnewquestionofpatentability. Amendments Any issuemayberevised andanexaminationwilloccurifthepetition validity ofoneormore claimsofthepatent. to prevent aninequitableconductclaim,inactionchallengingthe correct informationbelievedtoberelevant tothepatent,”presumably supplemental examinationofapatentto“consider, reconsider or Under theAIA,asofSeptember12,2012,apatenteemayrequest Supplemental Examination Supplemental Examination which isrefunded ifthepetitionisnotgranted. Like PGR,thefilingfeeforupto20claimsis$30,000,$18,000of suchaspublicuseorsale. art, believed toberelevant tothepatent,includingnon-publicationprior reexamination patent ownertoinitiateexparte foranyinformation that raisesasubstantialquestionofpatentability. Thisallowsa A patentownercanalsorequest examinationonanygrounds further to stayacivilaction,canberetroactively appliedto existingpatents. after theAct’s enactment(9/16/12).Thisreview, whichcanbeused and thefilingmustoccurwithin8yearwindowbeginningone review suedorcharged canonlybefiledbyaparty withinfringement inventions,” asdefinedbytheUSPTO).Apetitionforthistypeof financial product orservice,exceptpatentsfor“technological operations usedinthepractice,administration,ormanagementofa corresponding dataprocessing apparatusforperforming orother

PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD 25 Before filing a patent application, you should document the invention you should document filing a patent application, Before invention. to the with collaborators relating and communications Proceedings the Invention and Derivation Documenting Act does away with interferenceAlthough the American Invents multiple applicants was the for determining who among proceedings documenting the records notebook first to invent, appropriate a still important, for example, to provide conception of an invention are seeks to determine whether which defense in a derivation proceeding, filed application “derived” the claimeda named inventor in an earlier filed patent application. an inventor of a later A subject matter from by filing a petition within party initiate a derivation proceeding may third of a claim to an invention that is theone year after the first publication as a claim filed in an earlier filed patentsame or substantially the same for patent applications is only available application. Such a proceeding 16, 2013. March having a priority claim after of prior artIn view of the expanded definition under the America good written collaborators should keep Invents Act, research but also public and not only of laboratory research, records and by collaborators for use as to, from confidential disclosures evidence, if prior art generated by a collaborator ever becomes an issue. Chapter 5 Chapter Filing Do Before You Should What Application? a Patent 26 PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD computer program asatradesecret. software companiesoftenguard a thebasicalgorithmsupporting protected manufacturingtechnologiesastradesecrets. Similarly, term. Forexample,pharmaceuticalcompanies havetraditionally sincetradesecretspatent particularly are notlimitedtoaparticular sense toprotect inventionsastrade secrets certain ratherthan merchandising, production, inventionorimprovement. Itmaymake represents, evidencesorrecords asecret scientific,technical, intangible orelectronically keptorstored, whichconstitutes, A “tradesecret” isdefinedbymoststatesasanythingtangibleor Trade Secret Protection • • • • • • outset, factorstoconsiderinclude: Although thecommercial toassessatthe potentialmaybedifficult involved. commercial potentialtomeritthecostsandeffort A patentshouldonlybepursuediftheinventionhassufficient patent lawconsiderations. sense. Thisdeterminationofteninvolvesbusiness,scientific,and decision shouldbemadeastowhetherpursuingapatentmakes If aninventionispotentiallypatentable(SeeChapters2and3)a Determining WhetherPatentingIsAppropriate whether tradesecret protection ispreferable expected usefullifeoftheproduct whether there isarecognized needfortheinvention ease andcostofproduction anduse whether noninfringingalternativesare available size ofthepotentialmarket PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD 27 This strategy can be effective when the invention itself provides no effective can be This strategy itself provides the invention when particularly actually made, invention was of how the indication since to claims process broad be difficultit may sufficiently to obtain around. against a design effectively guard pursued, appropriate is to be protection if trade secret However, in fact be so that the invention will must be in place, safeguards court. the issue ever arises in a if To a trade secret considered or access to laboratory trade secret, consideration as a ensure limited should be secrets facilities containing trade manufacturing Also, the few employees knowing to “authorized personnel only.” obliged to keep the should be contractually the trade secret information or materials confidential. 28 PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD Filing aPatentApplication? What Shouldn’tYou DoBefore Chapter 6 • • • • • invention, theinventor(s)shouldnot: For example,before apatentapplicationhasbeenfiledonan an inventor. has beenfiled.Inotherwords, shouldnotbecreated priorart by should notoccurbefore apatentapplication(provisional orutility) Any actionbyaninventorthatcouldprevent issuanceofapatent sell theinvention. or theinventionforsale(advertise); offer demonstrate theinvention; talk abouttheinventiontoothers; or fundingapproval; submit adocumentdisclosingtheinventionforpublication PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD 29 Chapter 7 Chapter Obtained? Patents Foreign Are How for and granted on a country-by- generally applied Patents are filing decisions need foreign however, Fortunately, country basis. the Paris Convention, which the outset. Pursuant to not be made at a foreign by virtuallyhas been signed country, every industrialized may be filed to a U.S. application corresponding patent application application filing date one year after the U.S. patent any time within date for priority purposes. filing the U.S. application’s and still retain as if it will be treated patent application This means that a foreign application for purposes of filed on the same day as the U.S. were or sale so that any publication, public use, determining patentability, the filing of the U.S. application is notof the invention occurring after patent application. to the foreign prior art with respect considered application the U.S. patent occurring before Any public disclosure patent prior art in the foreign is considered filing date, however, the patent laws in certain countries provide application. However, a one-year grace Canada provides grace periods. For example, of application after the occurrence period in which to file a patent certain a six-month prior art events. Japan and Australia provide grace period. It is generally advisable to wait until close to the one-year foreign anniversary of the U.S. filing date to file a corresponding application is as that the foreign patent application to ensure complete as possible. This is particularly important for inventions which continue to be developed over the course of a year. 30 Months PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD *IfPCTisafirst filing, theISAwillestablishISRand WOoftheISAbefore theexpiration of 9months from theprioritydate(Rule 42.1) 0 patent can be made effective inwhicheverofthedesignated patent canbemadeeffective relevant needbeinvolved.Upongrant,the patentoffice) regional associate (apatentattorneyregistered topracticebefore the application (inEnglish,foranEPOapplication)andoneforeign The majoradvantageofpursuingaregional patentisthatonlyone former SovietUnion. Regional systemprovides protection countriesofthe incertain Africanregionsin certain (OAPIandARIPO);theEurasian European countries);tworegional filingsystemsprovide protection European PatentConvention(EPC)membercounties(i.e.,most issued from theEuropean (EPO)canbeenforced PatentOffice in is enforceable inanymembercountry. Forexample,apatent is desired, severalregional filingsystemsissueasinglepatentthat ofthecountryinwhichprotectionapplication withthepatentoffice Although mostforeign patentsare obtainedbyfilingapatent Direct NationalorRegionalForeign Filings (for internationalapplicationsfiledonorafterJanuary1,2004) PCT Timeline:ChapterII U.S. filing

PCT filing 12 written opinion written opinion International publication (WO) ofISA* International International 2 monthsfrom ISR:

(ISR) and (ISR) and amendments 16 file claims file claims 18

19 18 18 22 IPRP (ChapterII) established 28

30 to EOs IPRP (ChapterII) IB communicates phase entry national Chapter II PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD 31 countries protection is still desired by meeting national formal meeting national by is still desired protection countries fees. processing paying national and requirements than obviously simpler application is regional filing a single Although patent country’s applications with each individual filing separate since only one risky, be more can also office, this approach all member countries. rule on the patentability for examiner will filing national patent be minimized, at a price, by This risk can application is filed. the same time the regional applications at (PCT) Filings Patent Cooperation Treaty and research substantial Since many inventions require file a popular option is to development prior to commercialization, (PCT) rather Cooperation Treaty an application under the Patent patent application. national or regional than a direct a patentability search is a convenient way to obtain The PCT route examination on a single, or in the U.S.) and an initial (in Europe By filing a PCT application, international patent application. (including potentially country or region examination costs for each translations) can be filing appropriate high costs for obtaining and Chapter I is selected) or 18 months (if delayed for eight months (if to the advantage of deferred Chapter II is selected). In addition and the passage of time of the examination expenses, the results or can enable a better assessment of the patentability – marketability – of the invention. 32 PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD 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 cost ofpatentingsincethecostsinitialexaminationare in a singlesearch, foreign filingviathePCTcanincrease theoverall Although itdelaysthepaymentofmajorexpensesandprovides for or diagnosticproduct. against thecompanysupplyingpractitioner withthetherapeutic will notbeenforced against themedicalpractitioner, butrather medical useisalready known).Firstorsecondmedicaluseclaims different formatsknownasthefirst orsecondmedicaluse(ifafirst may oftenstillbeobtainedinEurope simplybydraftingclaimsin However, patentprotection fortherapeuticor diagnosticmethods surgery, therapy, ordiagnosticmethodscannotbepatentedinEurope. addition, methodsforthetreatment ofahumanoranimalbodyby biotechnology-related inventionssuchastransgenicanimals.In countries willnotallowpatentsforsoftware orforcertain when filingapatentapplicationoutsideoftheU.S.Forexample,some similar tothoseintheU.S.,somedifferences shouldbeconsidered Although patentabilityrequirements inmostforeign countriesare Patentability Requirements ofForeign Countries PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD 33 Inventorship is a legal question that can be complex and is therefore complex and is therefore a legal question that can be Inventorship is not all Unlike authorship, by a . best determined only necessarily inventors. The team are research members of a a material those who made as inventors are members qualifying and operative the conception of the complete contribution to As long as the conception in the patent claims. invention as defined to practice is ultimate reduction is of a workable invention, the to an inventorship determination. irrelevant or if skill, however, extraordinary to practice requires If the reduction conceived composition of matter isno way of making or using a practice may be inventive to reduction known, contributions to the sciences, U.S. courtscontributions. In certain have unpredictable can only occur when the inventionheld that a complete conception to practice. has been successfully reduced of inventorship must be made by a A good faith determination is filed. Although inventorship an application patent attorney before or patent, procedures on a pending application can be corrected In inventorship can be time consuming and costly. for correcting made to or omissions were addition, if material misrepresentations inventorship, the patent could be held regarding the if the inventorship invalid. A patent may also be held unenforceable intent.” and was made with “deceptive determination is erroneous Chapter 8 Chapter on a Patent? Is an Inventor Who 34 PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD of contribution(35U.S.C.116). together oratthesametime[or]…maketypeamount matter. However, eachjointinventorneednotphysicallywork inventor musthavemadesomecontributiontothesamesubject application. Forthere tobejointorco-inventorsofaclaim,each Inventorship mustbedeterminedforeachclaimofthepatent PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD 35

In the absence of any agreement to the contrary, each to the contrary, of any agreement In the absence may make, use, offerof the joint owners of a patent to within the Unitedsell or sell the patented invention States, or import the patented invention into the United of and without accounting toStates without the consent 262).the other owners (35 U.S.C.

Chapter 9 Chapter the Patent? Owns Who the startingfor determining point provides In the U.S., inventorship the inventors own the The general rule is that who owns a patent. to apply for and obtain a including the rights rights in the invention, U.S. patent law inventor, than one is more there patent. When that: provides the patent rights in his or her inventionThe rule that an inventor owns to two general exceptions. An inventor may not subject is, however, or impliedly rights have been expressly own the patent rights if the obligated to another. The only members [of a research team] qualifying qualifying team] research a [of members only The a material made who those are as inventors contribution to the conception of the complete and invention…” operative “ 36 PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD • • • restriction is: weighed indeterminingreasonableness includewhetherthe it isreasonable, basedonthetotalityofcircumstances. Factors employee leftthecompany, isgenerallyonlyenforced if byacourt the employerrightstoinventionsthatwere conceivedonly afterthe A “holdoveragreement,” whichrequires anemployeetoassign Holdover Agreement example whiletheemployeeisworkingforanotheremployer. of employment,evenifreduced topracticesometimelater–for employer ofinventionsconceivedbytheemployeeduringcourse enforce employmentagreements thatobligateassignmenttothe inthemajority–butnotallstateswillalso employment. Courts practice bytheemployeeduringandinconnectionwithhisorher employer ofallrightstoinventionsconceivedandreduced to enforce anemploymentagreement thatrequires assignmenttothe to assigntherightsininventionanemployer. will Mostcourts A signedemploymentagreement canexpressly obligateaninventor 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 PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD 37

Implied Contract Implied been signed, has not agreement employment a written Even when a court contract, or an implied may nevertheless recognize rights to his or her the employee to assign patent obligation on was specifically hired when the employee For example, employer. implied contract to an a particularto invent or solve problem, may be held to exist. the employee and employer assign between of trust with the the employee holds a position In addition, where as a corporate officer),company (such an implied read a court may to the According patent rights to that company. contract to assign uses a nontrivial amount of the shop right doctrine, if an employee an invention, the to create time and/or resources employer’s employer a nonexclusive, employee must grant to the the invention for the license to use nontransferable, royalty-free term of the patent. Roche v. Bayh-Dole and Stanford allows universities and research The Bayh-Dole Act of 1980 rights in technology developed from institutions to obtain exclusive most universities have patent Although government-funded research. their rights in an invention to that inventors assign policies requiring An inventor owns the rights to his or her her or his to rights the owns inventor An been have rights those unless invention, another.” to obligated implied or expressly “ 38 PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD may beaccomplishedthrough alicenseagreement. (for example,a50%interest). Transfer oflesserrightsinapatent provided byapatent,oranundividedfractionofalltherights An assignmenttypicallytransfersallpersonalproperty rights • • recordation ofapatentintheUSPTOeffectively: of apatentapplication.Althoughnotrequirement, proper Patent andTrademark (USPTO)inconjunctionwiththefiling Office agreement andfilethesignedagreement withtheUnitedStates institutes shouldhaveinventorsexecuteanappropriate assignment To ensure ownership,companies,universitiesandresearch Assignment Agreement employer istoobtainthoserights.”(Stanford v. Roche,S.Ct.2011) must expressly granthisrightsinaninventiontoemployerifthe or herrightstoacompany. “Inmostcircumstances, aninventor these policiesdonotprevent aninventorfrom actuallyassigninghis the universityorresearch institute,theSupreme hasheldthat Court same patenttoanewentity–forexample,employer. assignees shouldtheinventorlaterattempttoreassign the protects theowneragainstchallengesbysuccessivepurported lists thepatentassigneeoncoverpageofissuedpatent;and PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD 39 .

Patent Term issue date or 20 years 17 years from the earliest effective filing date, whichever from is longer (transitional status) the earliest effective 20 years from filing date

filed before June 8, 1995 filed before a patent application Patent issued from filed on or after June 8, 1995 Patent Right June 8, 1995 or patent Patent issued before a patent application issued from The patent term may be further extended based on certain exclusivities regulatory What is the Patent Term? Historically, U.S. utility and plant patents were granted for a period granted patents were U.S. utility and plant Historically, on the the patent issue date (indicated from of 17 years, measured on the other hand, the patent). Design patents, cover page of the date of issuance. of 14 years from granted for a period were (GATT), and Trade on Tariffs General Agreement Pursuant to the became effective which in the U.S. on June 8, 1995, the however, on an application filed after June 7, term of a U.S. patent issued effective the earliest U.S. filing date.* 1995, is 20 years from on June 8, 1995 force status was granted to patents in Transitional applications filed prior to June 8, and to patents that issue from the issue date either 17 years from a term of 1995, by providing effective the earliest U.S. filing date (the longer of or 20 years from and patent was unaffectedthe two).The term of a design by GATT the date of issuance. continues to be 14 years from Chapter 10 Chapter in Effect?Is a Patent Long How 40 PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD product hasbeenapproved by the agency. a Applications mustbefiledwiththeUSPTO within60daysafter marketing alsoisdelayedforreasons ofFDAprocedures. subsequently approved drugcovered bythesamepatentwhose restoration periodcannotbeobtainedforagencyreview ofa government approval. Onlyonerestoration maybesought.A patentee isunabletosellormarketaproduct whileawaiting legislation restores ofthepatenttermduringwhicha aportion section, whichimplementsprovisions ofthe1984Hatch-Waxman medical devices)before itscommercial marketingoruse.This have beensubjecttoaregulatory review period(e.g.drugsor 156 provides forextensionofthepatenttermproducts that In additiontoanyadjustmentsunder35USCSection154, after receiving actionorsubmittinganincomplete anoffice reply. of anapplication,forexample,byfailingtoreply withinthree months toconcludeprocessingengage inreasonable orexamination efforts failures maybelostifthePTOdeterminesthatapplicantfailedto reduced, anyextensionwhichmaybewarrantedinviewofPTO patent withinthree years.Whilethepatenttermitselfcannotbe failure totakeactionwithinprescribed limitsorotherwiseissuethe may beadjusted(daysaddedtothe20yearterm)forPTO’s with anypatenttermadjustment(PTA). Forexample,thepatentterm term extends20yearsfrom filingdatetogether thefirsteffective For patentapplicationsfiledonorafterMay29,2000,the Adjustments (PTAs) Patent Term Extensions(PTEs)andPatentTerm *  patent applicationclaimspriority. ordivisional) which acontinuation(e.g.,file wrappercontinuation,continuation-in-part, to i.e., Thefilingdateofthepatent applicationortheearliestfilingdateofapriorU.S. PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD 41 Fees Maintenance paid at are fees unless maintenance patents will expire Issued If post issuance). and 11.5 years (3.5, 7.5 time periods designated of the expiration that within two years can prove the patent owner a however, was “unavoidable” or “unintentional,” the nonpayment reinstated. patent may be 42 PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD For more informationvisitwww.foleyhoag.com. common emphasisonclientservice. regional,combines powerful nationalandinternationalpracticesthatshare a legal advicethatistailored toeachofourclients’uniquegoals.FoleyHoag From inBoston, ouroffices Washington, D.C.andParisweprovide strategic responsibility services. leading internationallitigationandarbitrationcorporatesocial management, andprofessional services.We ourclientsmarket- alsooffer life sciencesandhealthcare, technology, energy andrenewables, investment disputes andtransactionsworldwide.Weinindustriessuchas haveexpertise Foley Hoagisadynamiclawfirmthat represents clientsinawiderangeof About FoleyHoagLLP PATENTING: A GUIDEBOOK FOR PATENTING IN A POST-AMERICA INVENTS ACT WORLD 43 Beth E. Arnold About the Author About For over 25 patent group. Arnold is a partnerBeth E. in Foley Hoag’s on biomedical patent protection on obtaining worldwide has focused years she companies and for some of the most innovative and technologies products performs due patent also routinely institutions in the world. She research clearance, renders with public or private financings; diligence in connection and drafts a variety and invalidity opinions; and negotiates non-infringement, Ms. Arnold was agreements. development and commercialization of research, Corporation, as well as a patent counsel at Genzyme formerly an in-house the University a B.S. in biology from She received researcher. pharmaceutical and a J.D. University, Boston a M.S. in molecular biology from of Rhode island, Northeastern University. from biography. Click the image below for a full www.foleyhoag.com

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