International and European Patent Law by vxj14228

VIEWS: 53 PAGES: 101

									European Patent Law
       Düsseldorf 2008
 Dr. Lior Zemer IDC Herzliya
What is a patent?
Granted for inventions provided they comply with
  the following conditions:
    Involve an inventive step
    Capable of industrial application
    Subject-matter not excluded
  That is:
    Patent is not an automatic right
    Patent requires registration (v. copyright)
  A monopoly right (complete control) for 20 years
  First-to-file (Europe) v First-to-invent (US)
Before we talk patent…
Seven deadly sins of the inventor
1. The invention is more complex than the problem merits.
2. The invention is not kept secret until the date of filing.
3. The invention isn't new
4. The inventor hasn't fully considered the problem.
5. No-one wants it.
6. An invention is safer if it's kept secret.
7. The inventor has an unrealistic idea of the value of his invention.
Evolution of Worldwide Patent Filing
the Protection of Industrial Property) to 2005.
Top 20 Offices of Filing
International Patent Law
  Standard of Protection:
    Paris Convention Articles 1-5
    Patent Law Treaty (PLT)

  Methods for Obtaining Protection
    The Patent Cooperation Treaty
    The Budapest Treaty

    Strasbourg Agreement Concerning the International
    Patent Classification
Paris Convention
Paris Convention Main Features
  Main: the framework for the        Art. 5: Compulsory Licenses:
  PCT, EPC and CPC. Art 19           right to enact measures. NOT
  Art. 2(1): National Treatment      applied before the expiry of
  (Berne 5, 3 TRIPs, 1703            four years from the date of
  NAFTA); NT = non-                  filing application or…
  discrimination; MFN (most
  favoured nation) = if country X    Art. 5bis: Minimum periods of
  to the Treaty benefits country Y   grace: for the payment of fees
  = accorded to all states           and for domestic legislation
  Art. 4: Priority Date = priority   (provide for restoration of
  in respect of other applications   patents which have lapsed due
  for the same invention within      to non-payment of fees)
  12 months in any other
  Contracting State = subsequent     Established an Assembly &
  filings in any other State NOT     Executive Committee
  rendered invalid by any public     Admin tasks by = WIPO
  disclosure for 12 months           responsibility (Specialised
                                     Agency of the UN whose task is
                                     to administer some 21 IP
TRIPs Agreement
TRIPs Agreement
  Between members of the WTO; a key
  multilateral instrument for IP
  Arts 27-34
  Art. 27:
    27(1): “Patents shall be available for any inventions,
    whether products or processes, in all fields of
    technology, provided they are new, involve an
    inventive step and are capable of industrial
    application” +
    27(1): “without discrimination as to the place of
    invention, the field of technology and whether
    products are imported or locally produced”
    27(1) = subject to (2) and (3)
    Developing countries Art 65(4) permits delay
Article 27

          27(1)                      27(1)
All fields of technology   All fields of technology
 Products or processes     Patents rights enjoyable
 Subject to (2) and (3)    Without discrimination
  the three conditions

                                   Article 27(3)
                             Diagnostic, therapeutic,
       Article 27(2)
                           surgical methods, treatment
  Ordre public exception
                            Plants & animals OTHER
        & morality
                             Than micro-organisms
   Protection of human,
                            And essentially biological
   animal or plant life,
                                Processes OTHER
  health the environment
                             than non-biological and
The TRIPs Agenda 1
 Art 28(1) = patent = exclusive rights
 Covers products & processes
 Products = making, using, offering for
 sale, selling or importing
 Processes = same
TRIPs Agenda 2
  28(2) right to assign the right
  Condition for the right: Art 29 = clear
  disclosure + enabled for the person skilled in
  the art
  Exception: Art 30 = fair dealing?
  Opportunity for judicial review for revocation:
  Art 32
  20 years protection from the filing date: Art
  33 = minimum (“shall not end before”)
TRIPs Agenda 3: Art 30
  The patent three-step test TRIPs Art 29

Do not Unreasonably
Conflict with a normal exploitation of the patent
Do not unreasonably prejudice the legitimate
  interests of the patent owner and third parties
Third parties = 4th Step?

E.g. experiments, research BUT much more limited
  than copyright
TRIPs Agenda 4: Art 31
  If a MS provides “other use without
  authorisation” – compulsory licenses – then:
    Case to case basis
    Adequate remuneration
    Request for a license was exhausted
    Limited in scope and duration
    Used predominantly for the supply of the domestic market
    authorising such use
    If request to a second patent in order to exploit P1 MUST
    show P2 important technical advance + considerable
    economic significance for P1

    Art 33: protection will last for 20 years from the filing date
The TRIPs Agreement Enforcement
 Enforcement             Substantive
 provisions considered   provisions: went
 the remarkable          beyond existing IP
 achievement             conventions by
 The method: state       delineating standards
 compliance with the     to which procedures
 enforcement             for private
 mechanisms = a          enforcement of
 matter subject to the   domestic IPRs would
 WTO DS procedures       be measured in Part
                         III of TRIPs.
The Patent Cooperation Treaty (PCT) 1
 139 Members; US since 1978
 Iran signed but did not ratify
 Reason for PCT: rationalising patent application for MS
 Complements the Paris Convention (latter concerned with
 rationalising substantive patent laws)
 Aim: centralises and simplifies applications for series of countries
 Essence: procedural treaty DOES NOT grant patents
 Signed 1970, entered into force 1978
 Result: a system of:
     Coordinated international search
     Possibility of a preliminary and advisory examination
     A single international application designating to the PCT
     Countries selected by the applicant
Permits an applicant to file an “International Application” at
  his local national office/”Receiving Office” (RO) for countries
  in which protection is sough/”Designating Countries
  RO confirms compliance with formalities             remit
  copies to WIPO          also copies to the International
  Research Authority (ISA)             search of the prior art
  issues International Research Report (ISR)
  application enters the national phase             the
  international phase under PCT ends
International phase          national phase         explains
   that the decision to grant patents remains solely within the
   jurisdiction of national offices

Result: applicant will have a sense of patentability and the
  countries that will recognise the right
  PCT leads to a bundle of patents which may differ in scope

Do not forget: the PCT is merely a filing procedure and does
  not create an international patent
 PLT: Patent Law Treaty: coordinated by
 WIPO Standing Committee on Patents.
 Adopted by a Diplomatic Conference on
 June 1, 2000. In May 2001, the SCP
 started discussions on substantive patent
 law harmonization treaty (SPLT)
 18 members
 Last to join: Hungary 2008
 The aim of the Patent Law Treaty (PLT) is to:
   harmonize and streamline formal procedures in respect
   of national and regional patent applications and patents,
   and thus
   to make such procedures more user-friendly.
   With the significant exception of the filing date
   requirements, the PLT provides maximum sets of
   requirements, which the Office of a Contracting Party
   may apply
      This means that a Contracting Party is free to provide for
      requirements that are more generous from the viewpoint of
      applicants and owners, but are mandatory as to the
      maximum that an Office can require from applicants or
Strasbourg Agreement 1971
 Strasbourg Agreement Concerning the
 International Patent Classification (IPC)
 57 members; US since 1975
 Establishes the International Patent
 Classification which (in its 8th edition)
   Divides technology into eight sections
   Approximately 70,000 subdivisions
   Each subdivision has a symbol consisting of
   Arabic numerals and letters of the Latin
Budapest Treaty 1977
 Budapest Treaty on the International Recognition
 of the Deposit of Micro-organisms for the
 Purposes of Patent Procedure
   68 members
   Main issue: since disclosure of the invention is a
   requirement for the grant of patents, an invention is
   disclosed by means of a written description. However,
   where an invention involves a microorganism or the use
   of a microorganism is needed
   Art 3(1) International Depository
A Note on Regional Patent Arrangements
  Regional Convention:
    Eurasian Patent Convention (1996, can be
    designated under the PCT. Members, mainly
    former USSR states);
    African Intellectual Property Organisation
    (OAPI) and the African Regional Industrial
    Property Organisation (ARIPO).
      Under ARIPO patentee files a single application and
      designates any MS of the Contracting parties. There
      is a patent office. It is in addition to national IP laws;
    The Americas: NAFTA (patent provisions
    parallel TRIPs)
The Question
Do we have a world patent?
European Patent Law
(i) The EPC System
(ii) The EC System
International IP in Europe?
Attitudes towards international
patent law in Europe 1
 “Not all members of the European Patent Convention are
 members of the EU, and the EPO is not an organ of the EU.
 Nor is the EPO a signatory to TRIPs. To meet their
 obligations under the EU or TRIPs it would be sufficient for
 Contracting States to modify their national patent laws. The
 Board does not see the possibility of giving the EPC any
 interpretation different from that it had on signing, merely
 because of the existence of TRIPs or EU Directives” The
    Technical Board of Appeal in 1996: T-1054/96
Attitudes towards IP 2: The Spirit
of Cooperation
 B & R Relay’s Application [1985] RPC 1,
 “It is of the greatest importance that in this
 jurisdiction we should take note of the
 decisions of the EPO and that, so far as may
 be possible in all those countries which are
 now bound by the common interest created by
 the Convention, an attempt should be made to
 give the same meaning to relevant provisions,
 whichever the jurisdiction which is being
The Options
  An applicant for             File a European patent
  patent protection in         under the EPC: centralised
                               application, search and
  Europe has many              examination process = a
  options:                     basket of national European
     Series of parallel        patents is granted
     national filing in        In the future: Community
     European countries        patent IF CPC
     within 12 months of the   approved/Regulation
     first filing of the       Alternative: number of
     invention                 hybrid paths. Example:
     Use of PCT: single        Euro-PCT route =
     international             international application is
     application and search    made under the PCT but at
     for countries which are   a subsequent stage, the
     members of the PCT.       EPO takes over the
     BUT leaves substantial    prosecution and grant the
     examination to            application in relation to
     countries in which        MSs of the Community.
     protection is sought
  Regional arrangement by European states
  Not the European Union (EU)
  Centralised system of granting patents in
  Headquarters in Munich: application under the
  EPC to the EPO
  The Result: a bundle of national patents in
  the designated countries
  Operation: once granted, the issue of validity
  and infringement post-grant are matters for
  the national courts who theoretically will
  uniformly apply the substantive law of the EPC
Basic Features 1
 Art 52:
    Involve an inventive step and
    Susceptible of industrial application
 Art 63: 20 years
 Apart of the EPC as the guiding Treaty; the EPC provides:
    Secondary legislation: Implementing Regulations
    EPO Official Journal
    EPO Guidelines for the Examination in the EPO (assistance for
    applicants); and
    Information on How to Get a European Patent
Basic Features 2
 EPC =
   A regional convention for patents only in Europe
   A special agreement within the Paris Convention and
   A regional treaty within the the PCT
   European patents can be granted also on the basis of an
   international application under the Euro-PCT Route
   (initial procedure governed by the PCT designating the
 Novartis (above)
 TBA =
  TRIPs binding on its Contracting States; EPO not a
  member of the WTO or signatory to TRIPs;
  Important to take account of the principles of the TRIPs
  “…the only source of substantive patent law for
  examining European patent applications at this moment
  is the European Patent Convention”
Substantive Requirements
EPC & Novelty 1
  Art 52(1)
  Art 54
  New = not part of the SoA = comprise of everything
  made available to the public
  “Available to the public” = all characteristics
  combined in the claim; public = skilled person (T-
  877/90 HOOPER/T-Cell Growth Factor [1993])
  Oral disclosure at an international conference which
  included an advance abstract, a subsequent paper, a
  poster presentation and workshop discussions = prior
  art (T-455/91 GENENTECH/Expression in Yeast
  Also: Prior art = not permissible to combine items of
  prior art together (“mosaicing”); NO prior art if
  disclosure is made to persons under duty of
EPC & Novelty 2: Examples
 Chemical compounds: person skilled in the art MUST know how
 to make the compound NOT merely to know the formula; need to
 know the ability to manufacture the patent + “without undue
 burden” (T-93/89 HOECHST [1992])
 Selection patents:
    The basic feature = motivation of the person skilled in the art
    to investigate the full rage of products to find an inventive
    sub-range IS relevant
    Novelty does NOT reside in the sub-range of the products per
    se, but the discovery of a surprising technical effect relating to
    that sub-range product.
    T-366/90 UNILEVER/Interesterification Process [1993]
EPC & Inventive Step 1
  52(1); Art 56
  The rule: if having regards to the SoA, it is NOT
  OBVIOUS to a person skilled in the art
  Guideline C-IV 9.3: obvious = “that which does not
  go beyond the normal progress of technology but
  merely follows plainly or logically from the prior art, i.e.,
  something which does not involve the exercise of any
  skill or ability beyond that to be expected of the person
  skilled in the art”
  The Objective Approach: as in the case of novelty ,
  inventive step is an objective concept: the history of the
  invention is irrelevant = the objective status of the SoA
  = one must consider the problem which the invention
  deals with and what the skilled person without
  knowledge of the patent application would have done.
EPC & Inventive Step 2: Problem
and Solution Approach
 The risk in this approach = lead to an artificial
 approach to the issue of inventiveness + over
 generalisation of the problem
 TBA in T-465/92 ALCAN/Aluminium Alloys
   Applying this approach may lead to a multi-step
   reasoning where the facts are clear for or against
   If an invention breaks entirely new ground, it may
   suffice to say that there is no close prior art, rather than
   constructing a problem based on what is tenuously
   regarded as the closest prior art
EPC & Inventive Step 3: Man
Skilled in the Art
 Normally an ordinary practitioner      aware of what was
 common general knowledge in the art at the relevant date
 presumed to have had access to everything in the SoA
 BUT it may not be obvious to the person skilled in the art to
 use such a knowledge        A man skilled in a particular art
 will be deemed to be conversant with neighbouring fields of
 technology BUT not more remote fields           the skilled
 person does NOT have to be the same person for all
 aspects of obviousness
EPC & Inventive Step 4
 Unexpected side effects where solution is obvious = patent not
 saved, especially when the claim does not disclose such an effect.
 The question to apply: whether the effect is a mere side effect
 OR the actual solution to an important aspect of the complex
 T-1027/93 L’AIR LIQUIDE/Gas Separation [1996]:
    Separation of gas mixtures
    Opposition Division EPO: rejected the patent as there was a
    better way of achieving the same effect
    TBA: rejected Opposition Division: the fact that there might
    be a better way X to reach result Y in invention Z = NOT
    renders the claim unpatentable
    In TBA’s words: “In fact, in view of this futility, it could be
    said to be completely non-obvious”
 Ok, I am not sure I am
 supposed to do this…
Condition III: Industrial Application
EPC & Industrial Application 1
  Art 52(1) (mentioned as     TBA: “In the case of the
  the first condition); Art   prostitute, the appellant
  57                          referred to the 'oldest
  Patentable = if can be      industry in the world'.
  used in any kind of         Since 'industry' in the field
  industry (industry =        of industrial property is
  independent and for         widely understood in its
  financial gain)             broadest sense (Article
  Example 1: use of           2(3) of the Paris
  product X in a beauty       Convention), such a liberal
  parlour = capable of        interpretation may also
  industrial application      apply to Article 57 EPC…
  Example 2: T-74/93
  BTG [1995]: a rather
  amusing discussion on
  whether contraception as
  practised by a prostitute
  or a nurse is capable of
  industrial application?
EPC & Industrial Application 2
 …But the decisive question is not whether a prostitute's
 profession is an industry, but whether the application by a
 prostitute of a contraceptive composition is part of an
 industry…The application of a contraceptive composition as
 claimed…is not part of the business relationship between a
 prostitute and her client, and the contract between them
 does not cover the question of which means of
 contraception she may apply to herself. She has the
 freedom and responsibility to decide which one to choose,
 taking into consideration factors such as tolerance or
 reliability. This holds true at least as long as the client is
 not affected; if the prostitute applied contraceptive means
 to her client, their use might become part of the business
    I should leave this for you (EPOR 279)
Unpatentable Inventions
 From computers to
 biotechnological inventions and
 public morality
 The EPC does not define “invention” BUT Art
 52(2) defines what is not patentable
   (a) discoveries, scientific theories and mathematical
   (b) aesthetic creations;
   (c) schemes, rules and methods for performing mental
   acts; playing games or doing business and programs for
   (d) presentations of information
Computer-related Inventions 1
 “As such”
 EPO Guideline C-IV 2.2: “If a computer program
 is capable of brining about, when running on a
 computer, a further technical effect going beyond
 these normal physical effects, it is not excluded
 from patentability, irrespective of whether it is
 claimed by itself or as a record carrier. This
 further technical effect may be known as the
 prior art”
Computer-related Inventions 2
 T-935/97 IBM/Computer Programs [1999]: patent for a
 program which displayed information from a first window in
 another part of that window when obscured by a second
 Appellant: EPO should interpret EPC in line with TRIPs Art
 27(1) “all fields of technology”.
 TBA = TRIPs inapplicable
 TBA held: programs cannot have technical effect as they
 are programs for computers = physical modification of the
 hardware driving from execution of the instructions given
 by programs for computers could NOT per se constitute
 technical character, AS these were common to all computer
 TBA held: “…a technical effect of that kind is achieved by
 the internal functioning of the computer itself under the
 influence of the said program”
Computer-related Inventions 3
 T-208/84 VICOM/Computer-related
 Invention [1987]: a claim to a method of
 digitally processing images in the form of
 two-dimensional data array = patentable
 = produced direct technical result as
 invention related to a technical process
 carried out under the control of a program
 rather than to a computer program as
Biotechnological Inventions 1
 The industry’s claim: once the function of a
 part of a gene is discovered, biotech co’s can try
 to isolate the sequence, and if such has a
 beneficial effect, it can be inserted into other
 organisms to produce “transgenic organism” =
 claim the discovered technical effect of part of a
 gene sequence patentable
   Harvard Oncomouse
 Example: a particular plant may have an anti-
 fungal effect. Biotech Co’s will invest in isolating
 the relevant sequence in the DNA of that plant
 which carries this effect; NEXT they will claim use
 of that sequence in producing an anti-fungal
Biotechnological Inventions 2: The Hurdle
 Art 53: no inventions that are contrary to
 “ordre public” and for plant or animal
 varieties or essentially biological processes
 for the production of plants or animals
Patent V. Public Morality
 Art 53(a)
 Purpose: exclude from protection inventions
 likely to induce riot or public disorder or to lead
 to criminal or other generally offensive behaviour
 Invoked only in rare case (bomb)
EPC: Appeals
 Three appellate bodies
  Technical Board of Appeal (TBA): from
  the Opposition Division
  The Legal Board of Appeal (LBA):
  appeals purely on legal grounds NOT
  The Enlarged Board of Appeal (EBA):
  highest appellate body in the EPO. Only
  the Board of Appeal or the President of
  the EPO can refer any question or point
  of law to the EBA
The EU/EC System
Community Patent Measures
EPC Patent V. EC Patent
  EPC Three main weaknesses               Austria: rejected the
    Burdensome language regime            claim of infringement
    Owner must principally                More arbitrary decisions:
    enforce its European patent,          Italy, Belgium, France,
    which consists of a bundle of         Holland and Switzerland
    national patents individually in
    each MSs
    Scope of protection varies              EC Patent
    from MS to MS, especially in
    respect to the concept of          CPC cannot be implemented
    “equivalence” = inconsistency      Regulation can be
    = impediments to competition       implemented on time
    & consumer
    Example: the Epilady v.            BUT = unitary system =
    ‘Smooth & Silky” Saga.             avoid EPC’s inconsistencies +
        Germany: ‘Smooth &             legal certainty
        Silky’ = infringement             Similar to the CTM
        (obvious to an average
        expert)                        A Patent Court
        English Patent Court: no
        infringement (no obvious
        to the expert)
 The Luxembourg Convention Establishing the
 Community Patent Convention CPC (1975) (like
 TM) (EPC entered into force 1977)
 CPC required ratification; Denmark and Ireland
 did not ratify. The beginning of problems…
 Attempt to establish the Patent Court
 Unlikely that the CPC will ever enter into force
Draft EC Patent Regulation
 Towards an EC patent regime?
 Green Paper 1999: based on Art 235 ECT
   Unitary nature throughout the Community
     Article 2: “The Community patent shall have a
     unitary character”
   EPO manage filing
The Regulation’s 5 Core Elements
(1) Article 1: Application of the EPC      (2) Clear substantive
(“Munich Convention”) 1973                 rule on patentability
    Meaning 1: Community law on            (3) Cost effective
    patents                                processes for
    Meaning 2: community patent law        obtaining a patent
    applies to all patents designating
    the Community granted by the EPO       (4) Resolution of
    under the provisions of the EPC        disputes: a
    Meaning 3: “For purposes of this       community court
    Regulation, such patents shall be      (principle of
    considered to be Community             supremacy applies
    patents and the term “application      (e.g., Article 54))
    for a Community patent” shall          (5) Due regard to
    mean an application for a European
    patent designating the Community”      other public policy
                                           interests (e.g.
    Commission explains: “The
    expertise offered by the EPO should    environment,
    therefore be used in the granting of   competition)
    the Community Patent”
Communication April 2007
 Commission’s Communication
 Highlights that Europe's current patent system is considerably
 more expensive than the US and Japanese systems
 A Community patent would be far more attractive than models
 under the present system which is a bundle of national patents
 A European patent designating 13 countries is 11 times more
 expensive than a US patent and 13 times more expensive then a
 Japanese patent
 The existing system of patent litigation in the EU, with the risk of
 multiple patent litigation in several countries on the same patent
 issue, leads to unnecessary costs for all the parties involved and
 causes lack of legal certainty
 Three other items the Commission raises:
    Political will: Lack of political will by different interest groups
    Jurisdictional arrangements: The need to establish a Community
    Patent Court to work according to the draft European Patent Litigation
    Agreement (EPLA)
    Costs of translations: Article 24a: “When the patent is granted, the
    applicant shall file a translation of all the claims into ALL the official
    languages of the Community”
So what do we have now?
Biotech Directive 1
 Directive 98/44 came into force 1998
 MSs had until July 30 2000 to implement
Biotech Directive 2
  Biotech inventions are not defined in the
  It is generally recognised as involving the
  creation of a new life-form by the tampering
  with the genetic code of an existing life-form
  Also used to apply to inventions relating to the
  discovery of part of a genetic sequence of a
  life-form which causes a particular effect; e.g.,
  a rare medical disease
  A major aim: to clarify applicability of
  exception to patentability amongst MSs
Biotech Directive 3
 Art 3(1) requires a biotech invention to meet all three criteria
 Patentable = even if concern a product consisting of or containing
 biological material
 Art 2(1) = “biological material” = any material containing genetic
 information and capable of reproducing itself or being reproduced
 in a biological system
 Art 3(2) = biological material isolated from its natural
 environment = patentable = if produced by means of technical
 process, even if previously occurred in nature = CLARIFIES the
 distinction between a mere discovery of biological material
 and its industrial applicability.
 That is: mere DNA sequence without indication of a function des
 not contain any technical information and is therefore not a
 patentable invention (Recital 23)
Biotech Directive 4
  Particular reference to genetic material derived from the
  human body
  Art 5(1) = the human body at the various stages of its
  formation and development, and the simple discovery of
  one of its elements, including the sequence or partial
  sequence of a gene, CANNOT constitute a patentable
  invention UNLESS produced by means of a technical
  process (Art 5(2)
  The Rule: one cannot patent a mere discovery of a
  genetic sequence, ONLY its industrial applicability
  Clear from the Directive: it does NOT permit the
  patenting of human life form per se
Biotech Directive 5
  Art 6: ordre public and public morality + the
  following is unpatentable:
    Processes for cloning human beings
    Processes for modifying the germ line genetic
    identity of human beings
    Uses of human embryos for industrial or commercial
    Processes for modifying the genetic identity of
    animals which are likely to cause them suffering
    without any substantial medical benefit to man or
    animal, and also animals resulting from such
Plant Variety
 Patent for plant variety prohibited under TRIPs 27(3) and
 EPC 53(b) = the method of protection = sui generis
 Concerns expressed following the Rio Convention on
 Biological Diversity 1992, Arts 1-3 (using natural resources;
 developing countries, environment, etc). To date, not much
 influence on plant variety
 The UPOV Convention of the International Union for the
 Protection of New Varieties of Plants 1961 (1991 Act) =
 provides sui generis protection for plant varieties
 UPOV defines variety, the scope of protection, limitation
 1994 Regulation on Community Plant Variety Rights
 (CPVR); establishes a CPV Office (CPVO)
 Mirrors the 1991 UPOV Act
Supplementary Protection for
Pharmaceutical (SPC) 1
 Supplementary protection for patented pharmaceutical
    The SPC Regulation was challenged by Canada in the WTO. See DS
    153. In this dispute Canada claim that the EC Regulation discriminates
    on the basis of field of technology and thereby inconsistent with Article
    27.1 of the TRIPs, because the Regulation applies to pharmaceuticals
    (and another Regulation (Regulation 1610/96 applies only to
    agricultural products). Status: No panel established nor settlement
 Testing of pharmaceutical is governed by two directive
    Directive 65/65: Medicinal products for human use
    Directive 81/851: for veterinary products
 Testing = sometimes substantial delays = in 1988 survey =
 effective patent life of pharmaceuticals = 8 years
 US, Japan, Italy and France were the first to enact an SPC
 Europe followed: Regulation 1768/92 created a
 supplementary protection certificate for medicinal products
SPCs 2
 Regulation does not extend the life of the patent as such.
 Merely grants a sui generis supplementary protection certificate
 which is deemed to have the same effect as that of the patent
 Only available for patents relating to the active ingredients of
 medicinal or veterinary products used in human or animal healthcare
 Scope of Protection: Certificate confers the same rights and
 limitations as the patent. BUT protection will be more narrow than
 that of the patent as it is restricted to
     “…product covered by the authorisation to place the
     corresponding medicinal product on the market and for any use
     of the product as a medicinal product that has been authorised
     before the expiry of the certificate”, Art 4.
     Certificate takes effect at the end of the lawful term of the basic
     Duration of the certificate may not exceed five years from the
     date on which it takes effect;
     Art 63 EPC was amended so as to permit MSs to extend the term
     of a European patent
Enforcement Directive
 Do not forget this “invention” which
 transformed the European IP system
 Applicable to industrial property as well.
 Commission’s statement, 2005
 Harmonises issues such as evidence, the
 right for informational and infringement
 proceedings, corrective measures,
 damages etc
Computer-Implemented Inventions
 A CII is usually defined as an invention that works by using
 a computer, a computer network or other programmable
 apparatus. To qualify, the invention also needs to have one
 or more features which are realised wholly or partly by
 means of a computer program
 The proposed Directive intended to harmonise the way in
 which national patent laws deal with computer-implemented
 Such inventions can already be patented by applying to
 either the European Patent Office (EPO) or the national
 patent offices of the Member States
 However enforcement of patents is dealt with by national
 courts and, as the law may differ between Member States,
 the level of protection may, in practice, vary. This can
 represent a significant barrier to trade in patented products
 within the Internal Market.
 July 2005: EP rejects proposal; legislative process is closed
Still Proposals
Utility Models 1
 1995 Green Paper, 1997 Proposal, 2001 and 2002
 ‘Petty patents’?
 ‘Second-tier patents’?
 Definition: Utility models are registered industrial property
 rights which confer on proprietors exclusive protection of their
 technical inventions, particularly those with a limited degree
 of inventiveness or a relatively short period of
 exploitation. They offer more flexible and less burdensome
 protection than that offered by patents. Utility models are
 therefore an effective tool well-suited to enterprises -
 particularly SMEs (small and medium enterprises) - which are
 active in certain fields of innovation.
 Conditions: protection available for new inventions that
 involve an inventive step and are susceptible for industrial
Utility Models 2
    Exceptions very similar to patents
    Inventive step = if “it exhibits an advantage and having
    regard to the state of the art, it is NOT very obvious to the
    person skilled in the art”. Advantage must be “practical or
    technical advantage”.
    Duration: six years. Renewable for 2 more years. Maximum
    10 years.
    Examination: no need to examine the three conditions,
    merely that the formal requirements are met.
    X can apply for both utility model protection and patent
    protection. Utility = ineffective is patent is available
    Status in 2007: still a proposal
So, what system do we have?
          EPC v EC
Routes for Obtaining Patents in Europe 1
 National routes
 National patents-EPC Route
 Euro-PCT Route (Chapter I and II PCT)
Routes for Obtaining Patents in Europe 2
 Recommended Route: Euro-PCT II =
 patent protection internationally and in
 several (or all) European countries
 signatories to the PCT = reality
 How? = filing an international application
 under the PCT; using EPO as ISA and IPEA
 (search and examination); designated the
 EPO as an Elected Office for the EPC
Two Recent Developments
EU law to allow export of patented
medicine to countries in need 1
 Regulation 816/2006 April 2006
 On 6 December 2005, the WTO Members agreed to amend
 the Agreement on Trade-Related Aspects of Intellectual
 Property Rights (TRIPS Agreement). This amendment would
 make permanent a provisional decision on compulsory
 licensing originally adopted on 30 August 2003. The WTO
 General Council has submitted the proposed amendment to
 the WTO Members for acceptance. Once accepted and in
 force, this amendment will complete a process that began
 in 2001 with the Doha Declaration on the TRIPS Agreement
 and Public Health. The EU strongly supported these
 changes at every stage.
EU law to allow export of patented
medicine to countries in need 2
 The European Commission today welcomes the adoption by
 the European Council of a regulation allowing companies to
 produce copies of patented medicines under license for
 export to “countries in need” without sufficient capacity to
 produce them. The regulation implements within the EU the
 necessary conditions to meet a WTO Agreement of
 December 2005, under which national authorities can grant
 compulsory licenses for such production if certain conditions
 are fulfilled. Yesterday, the European Commission formally
 recommended that Member States approve EU ratification
 of the historic changes to WTO law. Today’s move is a clear
 signal of their intention to do so. The compulsory licensing
 regulation represents a crucial measure for some of the
 poorest countries in the world, which will gain improved
 access to affordable medicines which are safe and effective.
  The Future of Euro-US
       Patent Law
May 2008: European Commission-US
Roadmap to support and facilitate
international patent law harmonization
The next thing in IP
 Culture and the limits of
   intellectual property
A Question: Is the Bungee
   Jump patentable?
Declaration on the Rights of Indigenous
Peoples (2006)
 20 years of attempts
 Ambition: protecting the rights of indigenous communities
 UN vote:
    143 in favour
    4 against: Canada, Australia, NZ, US
Declaration on the Rights of Indigenous
Peoples (2006)
 Indigenous peoples have the right to the full and effective
 enjoyment of all human rights and fundamental freedoms
 recognized in the Charter of the United Nations, the Universal
 Declaration of Human Rights and international human rights
 law .
 Indigenous peoples have the right to practise and revitalize
 their cultural traditions and customs. This includes the right to
 maintain, protect and develop the past, present and future
 manifestations of their cultures, such as archaeological and
 historical sites, artifacts, designs, ceremonies, technologies and
 visual and performing arts and literature, as well as the right to
 the restitution of cultural, intellectual, religious and spiritual
 property taken without their free and informed consent or
 in violation of their laws, traditions and customs .
     Bunjee: think of the following
Bungee Jump 1
 Origin: Vanuatu
 Nagol or Land Dive = TCE = Traditional Cultural
Bungee Jump 2
 Mr AJ Hackett, NZ, was inspired by the Nagol
 Mr AJ Hackett registered a patent: the Bungee jump
 United States Patent 6352494

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