A Primer to European A Primer to European Patent LawPatent Law

Vinita RadhakrishnanVinita Radhakrishnan

RevisionRevision Patentability RequirementsPatentability Requirements US Patent lawUS Patent law Patent searching and DraftingPatent searching and Drafting

European Patent LawEuropean Patent Law IP and BiotechnologyIP and Biotechnology Patent Drafting specific to Biotech/pharma Patent Drafting specific to Biotech/pharma

inventionsinventions

About EuropeAbout Europe Europe: Bundle of statesEurope: Bundle of states European Union (EU): European Union (EU):

Economic and political union of 27 Economic and political union of 27 member statesmember states

Single Market Single Market free trade free trade free movement of people, goods, services free movement of people, goods, services

and Capitaland Capital What about IP?What about IP?

What about IP?What about IP? Each country has its own lawEach country has its own law Community TMCommunity TM Community DesignCommunity Design Community Patent????Community Patent???? EPCEPC

EPCEPC Convention on the Grant of European Convention on the Grant of European

Patents of 5 October 1973 (Revised in Patents of 5 October 1973 (Revised in 2000)2000)

Multilateral treaty Multilateral treaty Instituted the Instituted the European Patent European Patent

OrganizationOrganization Provides legal framework for granting of Provides legal framework for granting of

European patent European patent Single harmonized grant procedureSingle harmonized grant procedure Not a unitary rightNot a unitary right

Bundle of rightsBundle of rights Bundle of patents :Bundle of patents :

Essentially IndependentEssentially Independent Nationally enforceableNationally enforceable Nationally RevocableNationally Revocable

The grant procedure undertaken before The grant procedure undertaken before the the European Patent OfficeEuropean Patent Office

EPOrgEPOrg Public international organization Public international organization Created in 1977 to grant patent under EPCCreated in 1977 to grant patent under EPC Seat in MunichSeat in Munich Administrative and financial autonomyAdministrative and financial autonomy Not legally bound to EUNot legally bound to EU Has 2 organs:Has 2 organs:

Administrative councilAdministrative council EPOEPO

Administrative councilAdministrative council Supervisory body of the organizationSupervisory body of the organization Made up of members of the contracting Made up of members of the contracting

states states Responsible for overseeing the work of the Responsible for overseeing the work of the

European Patent OfficeEuropean Patent Office BudgetBudget Appoints presidentAppoints president Approve EPO presidents ActionsApprove EPO presidents Actions Amends the Rules and some particular Amends the Rules and some particular

provisions of the Articles of the EPC provisions of the Articles of the EPC

EPOEPO Executive body of the organizationExecutive body of the organization Does not have a legal entityDoes not have a legal entity Directed by presidentDirected by president

Main office: MunichMain office: Munich Branch offices: Hague, BerlinBranch offices: Hague, Berlin Official language: English, French Official language: English, French

and Germanand German

EPO (Departments)EPO (Departments) Receiving SectionReceiving Section Examination DivisionExamination Division Opposition DivisionOpposition Division Board of Appeal (final instance in Board of Appeal (final instance in

granting and opposition)granting and opposition) Enlarged board of Appeal (to ensure Enlarged board of Appeal (to ensure

uniform application of Law)uniform application of Law)

MembersMembers Contracting States: 36Contracting States: 36 Extension States: 5Extension States: 5

EPO Member statesEPO Member states

Contracting statesContracting states AustriaAustria BelgiumBelgium BulgariaBulgaria SwitzerlanSwitzerlan

dd CyprusCyprus Czech Czech

RepublicRepublic GermanyGermany DenmarkDenmark EstoniaEstonia

SpainSpain FinlandFinland FranceFrance United United

KingdomKingdom GreeceGreece CroatiaCroatia HungaryHungary IrelandIreland IcelandIceland ItalyItaly

LiechtensteiLiechtensteinn

LithuaniaLithuania LuxembourgLuxembourg LatviaLatvia MonacoMonaco Former Former

Yugoslav Yugoslav Republic of Republic of Macedonia Macedonia

MaltaMalta

NetherlandNetherlandss

NorwayNorway PolandPoland PortugalPortugal RomaniaRomania SwedenSweden SloveniaSlovenia SlovakiaSlovakia San MarinoSan Marino Turkey Turkey

Extension States: Extension States: Albania, Bosnia and Herzegovina, Montenegro, SerbiaAlbania, Bosnia and Herzegovina, Montenegro, Serbia

Legal BasisLegal Basis European Patent Convention EPCEuropean Patent Convention EPC

Articles & RulesArticles & Rules Guidelines for ExaminationGuidelines for Examination Case law Case law

Board of Appeals (BOA's) decisions Board of Appeals (BOA's) decisions Enlarged BOA decisionsEnlarged BOA decisions

Patentability RequirementsPatentability RequirementsRequirements for Patentability: Requirements for Patentability:

Art. 52 (1) EPCArt. 52 (1) EPC European patents shall be granted European patents shall be granted

for any for any inventionsinventions which are susceptible of which are susceptible of industrial industrial

application application which are which are new new andand which involve an which involve an inventive stepinventive step

Art 52(2)Art 52(2)The following in particular shall not be regarded The following in particular shall not be regarded as inventions within the meaning of as inventions within the meaning of paragraph 1paragraph 1::

(a) (a) discoveriesdiscoveries, , scientific theoriesscientific theories andand mathematical methodsmathematical methods;;

(b) (b) aestheticaesthetic creations; creations;

(c) (c) schemesschemes, , rulesrules and methods for and methods for performing mental actsperforming mental acts, , playing gamesplaying games or or doing doing businessbusiness, and , and programs for programs for computerscomputers;;

(d) (d) presentations of informationpresentations of information..

Art 52(4)Art 52(4)Not inventions:Not inventions: Methods for treatmentMethods for treatment of the human or of the human or

animal body by surgery or therapy animal body by surgery or therapy Diagnostic methodsDiagnostic methods practised on the practised on the

human or animal body human or animal body

This provision shall This provision shall not applynot apply to to productsproducts, , in particular substances or in particular substances or compositionscompositions, , forfor useuse in any of these methods. in any of these methods.

Art 53 (Exceptions to Art 53 (Exceptions to patentability )patentability )

European patents European patents shall notshall not be granted in be granted in respect of:respect of:

(a) inventions the publication or exploitation of (a) inventions the publication or exploitation of which would be contrary towhich would be contrary to "ordre public" "ordre public" or or moralitymorality, provided that the exploitation , provided that the exploitation shall not shall not be deemed to be so contrary merely because it is be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of prohibited by law or regulation in some or all of the Contracting Statesthe Contracting States;;

(b) (b) plant or animal varietiesplant or animal varieties or or essentially biological essentially biological processesprocesses for the production of plants or animalsfor the production of plants or animals; ; this provision does not apply to this provision does not apply to microbiological microbiological processesprocesses or or the products thereofthe products thereof..

Patentability RequirementPatentability RequirementArticle 52 (1) EPC RequirementsArticle 52 (1) EPC Requirements• • industrial applicabilityindustrial applicability::– – Art. 52(4)Art. 52(4)• • novelty:novelty:– – Article 54Article 54• • inventive step:inventive step:– – Article 56Article 56• • Invention:Invention:– – no positive definition; definition by exclusion (Art. no positive definition; definition by exclusion (Art.

52(2))52(2))– – implicit requirement: technical characterimplicit requirement: technical character

NoveltyNovelty Self-evident requirement of IP lawSelf-evident requirement of IP law

““You cannot take from the public what is You cannot take from the public what is already theirs”already theirs”

Also in copyright and trademark law Also in copyright and trademark law Historically undisputed, unlike inventive step!Historically undisputed, unlike inventive step!

An absolute requirementAn absolute requirement No such thing as ‘a little bit novel...’No such thing as ‘a little bit novel...’ a straightforward requirementa straightforward requirement

Normally easily established ... and easily Normally easily established ... and easily overcome!overcome!

Article 54Article 54((1) An invention shall be considered to be new 1) An invention shall be considered to be new if it does not form part if it does not form part

of the state of the art.of the state of the art.

(2) The state of the art shall be held to comprise (2) The state of the art shall be held to comprise everything made everything made available to the publicavailable to the public by means of a written or oral description, by by means of a written or oral description, by use, or in any other way, before the date of filing of the European use, or in any other way, before the date of filing of the European patent application.patent application.

(3) Additionally, the content of European patent applications as filed, of (3) Additionally, the content of European patent applications as filed, of which the which the dates of filing are prior to the datedates of filing are prior to the date referred to in referred to in paragraph 2paragraph 2 and which were and which were publishedpublished under under Article 93Article 93 on or on or after that after that datedate, shall be considered as comprised in the state of the art., shall be considered as comprised in the state of the art.

(4) (4) Paragraph 3Paragraph 3 shall be applied only in so far as a Contracting State designated shall be applied only in so far as a Contracting State designated in respect of the later application, was also designated in respect of the in respect of the later application, was also designated in respect of the earlier application as published.earlier application as published.

(5) The provisions of (5) The provisions of paragraphs 1paragraphs 1 to to 44 shall not exclude the patentability of shall not exclude the patentability of any substance or composition, comprised in the state of the art, for use in a any substance or composition, comprised in the state of the art, for use in a method referred to in method referred to in Article 52, paragraph 4Article 52, paragraph 4, provided that its use for any , provided that its use for any method referred to in that paragraph is not comprised in the state of the art.method referred to in that paragraph is not comprised in the state of the art.

Novelty: Article 54 EPCNovelty: Article 54 EPC Art. 54 (1) defines what is considered Art. 54 (1) defines what is considered

to be "new“to be "new“ .... something which does not form part .... something which does not form part

of the state of the artof the state of the art

What is the State of the Art?What is the State of the Art? defined by Art. 54 (2)defined by Art. 54 (2) also Art. 54(3) & (4) for EP applicationsalso Art. 54(3) & (4) for EP applications

What is state of the art?What is state of the art? Everything made available to public Everything made available to public

by means of :by means of :

State of Art

…before the filing date of application

What is the "State of the What is the "State of the Art"?Art"?

Conflicting applications Conflicting applications

Art. 54 (3) EPC ... European patent applications Art. 54 (3) EPC ... European patent applications [filed] prior to the date referred to in paragraph 2 [filed] prior to the date referred to in paragraph 2 [filing/priority date application] and ... [filing/priority date application] and ... published ... on or after that date, shall be published ... on or after that date, shall be considered as comprised in the state of the art.considered as comprised in the state of the art.

Art. 54 (4) EPC [Paragraph (3) only for Art. 54 (4) EPC [Paragraph (3) only for overlapping states]overlapping states]

Against double patentingAgainst double patenting Also for PCT applicationsAlso for PCT applications For novelty only. Not for inventive step!For novelty only. Not for inventive step! Must be pendingMust be pending

Filing and PriorityFiling and Priority

First Filing “priority “State A State B State C State D

12 Months

Entitled to use the “priority date“ as the first filing dateNOT entitled to use the “priority date as the first filing

Art 56Art 56 An invention shall be considered as An invention shall be considered as

involving an inventive step if, having involving an inventive step if, having regard to the state of the art, it is not regard to the state of the art, it is not obvious to a person skilled in the art. obvious to a person skilled in the art.

If the state of the art also includes If the state of the art also includes documents within the meaning of documents within the meaning of Article 54, paragraph 3Article 54, paragraph 3, these documents , these documents are not to be considered in deciding are not to be considered in deciding whether there has been an inventive step. whether there has been an inventive step.

Article 56 EPCArticle 56 EPC An invention shall be considered as An invention shall be considered as

involving an inventive step if, having involving an inventive step if, having regard to the regard to the state of the artstate of the art, it is , it is not not obviousobvious to a person to a person skilled in the art.skilled in the art.

PHOSITAPHOSITA Compare to imaginary "man in the Compare to imaginary "man in the

street", "man on the street", "man on the Clapham Clapham omnibusomnibus", "man on the ", "man on the Underground" from, especially, Underground" from, especially, British law.British law.

Person skilled in the art is peculiar to Person skilled in the art is peculiar to patent law.patent law.

PHOSITAPHOSITA An ordinary practitionerAn ordinary practitioner Aware of what is common general Aware of what is common general

knowledge in a particular technical field knowledge in a particular technical field (the art in question) at the relevant date.(the art in question) at the relevant date.

Has access to everything in the state of Has access to everything in the state of the art.the art.

Has normal capacity for routine work, but Has normal capacity for routine work, but has no inventive skills.has no inventive skills.

In some fields the skilled person can be In some fields the skilled person can be equated with a team, rather than with a equated with a team, rather than with a single person.single person.

How do we decide onHow do we decide onobviousness?obviousness?

Various tests in different national Various tests in different national systems.systems.

One of the tests used by the German One of the tests used by the German office was that every invention is a office was that every invention is a solution to a technical problem.solution to a technical problem.

In the very first case heard by the Board In the very first case heard by the Board of Appeal the problem and solution of Appeal the problem and solution approach was used to determine the approach was used to determine the question of inventiveness.question of inventiveness.

The problem and solutionThe problem and solutionapproach (PSA)approach (PSA)

1. Determine the 1. Determine the closest prior artclosest prior art2. Based on this, 2. Based on this, establish the objective establish the objective

technical problemtechnical problem to be solved to be solved3. Consider whether the claimed 3. Consider whether the claimed

invention, starting from the closest invention, starting from the closest prior art and the objective technical prior art and the objective technical problem, problem, would have been obvious to would have been obvious to a skilled persona skilled person..

Stage 1Stage 1Identify the Closest Prior Art Identify the Closest Prior Art

(CPA)(CPA) The item of prior art (normally a The item of prior art (normally a

written disclosure) disclosing written disclosure) disclosing technical effects, purpose or technical effects, purpose or intended use most similar to the intended use most similar to the invention.invention.

Often it has the greatest number of Often it has the greatest number of features in common with the features in common with the invention.invention.

Stage 2Stage 2Establish theEstablish the

objective technical problemobjective technical problemHow to modify or adapt the closest How to modify or adapt the closest

priorpriorart to achieve the technical effect(s) art to achieve the technical effect(s)

whichwhichthe invention provides over the closestthe invention provides over the closestprior art.prior art.

Stage 3Stage 3Decide on obviousnessDecide on obviousness

Is there an indication in the prior art Is there an indication in the prior art thatthat

would prompt the skilled person to would prompt the skilled person to solvesolve

the objective technical problem by the objective technical problem by modifying or adapting the closest prior modifying or adapting the closest prior

artartto arrive at the claimed invention?to arrive at the claimed invention?

The problem and solution The problem and solution approachapproach

(PSA) - five questions (1)(PSA) - five questions (1)1. (Stage 1) What is the 1. (Stage 1) What is the closest prior artclosest prior art??2. (Stage 2) What is the difference, in 2. (Stage 2) What is the difference, in

terms of the claimed technical features, terms of the claimed technical features, between the claimed invention on the between the claimed invention on the one hand and the cpa on the other?one hand and the cpa on the other?

3.What technical effect is caused by this3.What technical effect is caused by thisdifference?difference?

The problem and solution The problem and solution approachapproach

(PSA) - five questions (2)(PSA) - five questions (2)4.What, therefore, is the objective 4.What, therefore, is the objective

technical problem underlying the technical problem underlying the claimed invention?claimed invention?

5.(Stage 3) Would the skilled person 5.(Stage 3) Would the skilled person solve this problem in the manner solve this problem in the manner indicated on the basis of the totality of indicated on the basis of the totality of the prior art, without at any stage the prior art, without at any stage employing any inventive skill?employing any inventive skill?

Article 57Article 57Industrial application Industrial application

An invention shall be considered as An invention shall be considered as susceptible of industrial application if it susceptible of industrial application if it can be can be made made or or usedused in in any kind of any kind of industryindustry, including agriculture., including agriculture.

Mere fact that a substance can be made in Mere fact that a substance can be made in some way does not necessarily mean that some way does not necessarily mean that the Patentability requirements are fulfilled, the Patentability requirements are fulfilled, unless there is also some unless there is also some "profitable use""profitable use" for which the substance can be employed.for which the substance can be employed.

Grant ProcedureGrant Procedure Request for GrantRequest for Grant

DescriptionDescription Claim Claim DrawingDrawing AbstractAbstract

Formality ExaminationFormality Examination Search Report PreparationSearch Report Preparation Substantive Examination (On request)Substantive Examination (On request) OppositionOpposition Appeal ProceedingsAppeal Proceedings GrantGrant National PhaseNational Phase TranslationsTranslations

Enforcement and Enforcement and maintenancemaintenance

Infringement ProceedingInfringement Proceeding Defenses Defenses RemediesRemedies

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