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					                                                                                                   MODULE   2

                                          RED DE PROPIEDAD INTELLECTUAL E INDUSTRIAL
                                                      EN LATINOAMÉRICA

PILA-Network is a project co-funded by the European Union in the framework of the ALFA programme

PILA M2 Meeting, 26-27 October 2009   2
International sources of patent law

• Paris Convention
     • Right of Priority
     • Independence of patents
     • Compulsory licence
• Trade-Related Aspects of Intellectual Property
     • Substantive provisions
• Patent Cooperation Treaty
     • Procedures for „international” patent
• European Patent Convention
     • European patent regulation
General characterisitc


     Legal title

  Exclusive right to: make use of invention
     (prevent others from making use)

    Limited territory

      Limited time
Patents are granted for:
• Methods
   – Description of actions, operations; their parameters, raw
     materials used
• Devices (instruments, machnies, tools)
   – Description of structure (construction), mutual relations of
• Products (substances)
   – Description of components (quantitative and qualitative)
• Application (use)
   – subcategory of methods
         Patentable Inventions

          The legal definition of invention does
                not exist (in traditional sense)
Invention must meet the criteria of:
•   Technical nature                                                                        Art. 27 TRIPS
    –    An invention must have a technical character.

•   Novelty
    –    An invention can be patented only if it is new.

•   Inventive step
    –    An invention has an inventive step if it is not obvious (having regard to the state of the art)

•   Industrial capability
    –    An invention is industrially susceptible if it can be made or used in any kind of industry
Novelty                                                    Art. 27(1) TRIPS

                                                                Art. 54 EPC

               An invention shall be considered to be new if
               it does not form part of the state of the art.

          State of art comprises:
          everything made available to the public by
                    - written or oral description, use, or any
                      other way,
          before the date of filing (priority)
        Global, local or mixed novetly

                                   New medical use of already known substances

 The state of the art comprises the content of applications filed
 before the date of filing but not published until on or after that date

  • First filing with the NPO                             Art. 4 of Paris Convention

          – The day when NPO received the application (post, fax)
  • Conventional
          – duly filed an application for a patent (utility model) for
            any state party to the Paris Convention for the Protection
            of Industrial Property
          – the day of duly filed application               12 months

  • From exhibition
          – The day of exhibtion                             6 months

   Convention on international exhibitions signed at Paris on 22 November 1928

            Non-prejudical disclosures

  Disclosures occurred no earlier than six months before the
    date of filing
   as a consequence of an evident abuse in relation to
    the applicant („abuse grace period”)
                                                  6 months
   displaying at an official international exhibition falling
    within the terms on international exhibitions

  US grace period (1 year)
                                                                      Art. 27(1) TRIPS
Inventive step
                                                                             Art. 56 EPC

              An invention shall be considered as involving an
              inventive step if, having regard to the state of the
              art, it is not obvious to a person skilled in the art.

 •   State of art does not comprise prior applications not yet disclosed
     (difference to novelty)
 •   Not satisfied if the invention directly results from state of the art
 •   The examination under „problem and solution approach”
      – identifying the „closest prior art”
      – assessing the technical results (or effects) achieved
      – defining the technical problem to be solved
      – examining whether or not a skilled person would have suggested the claimed
          technical features for obtaining the results
 •   Who is considered as a „person skilled in the art”?
                                                                       US approach
Inventive step
                                     Art. 103 of Patent Act

        US approach

 Non-obviousness should assessed by
 • determining the scope of the content of the
   prior art
 • ascertaining the difference between prior art
   and applied invention
 • resolving the level of ordinary skill in the
   pertinent art
                                           TSM test
Industrial application                                    Art. 27(1) TRIPS

                                                               Art. 57 EPC

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

     • Non-controversial requirement
     • „Industry" in the field of industrial property is widely understood
       in its broadest sense
     • Liberal interpretation
     • Always satisfied when industrial exploitation (application) is

                             putting into practice is not necessary
Technical nature                                      Art. 27(1) TRIPS

                An invention must have a technical character.

                                                          Art. 52(1) EPC
• Requirement now expressly formulated
   • inventions, in all fields of technology…(EPC 2000)

• description should contain specification of the
technical field to which the invention relates
• the claims shall define the matter for which protection
is sought in terms of the technical features of the
• technical character test is prior to examination of other
CASE LAW - an invention has a technical character if it
provides a technical contribution to the art in a field not
excluded from patentability
Non-inventions (as such)
                                                            Art. 52(2) EPC

  • discoveries, scientific theories and mathematical methods;
      – Lack of technical effect
      – Revealing what already exists                         DNA gene?
      – Pure intellectual methods
  • aesthetic creations;
      – Non-technical solutions
  • schemes, rules and methods for performing mental acts, playing
    games or doing business,
      – Non-technical solutions
  • programs for computers;
      – Specific interpretation of tehcnical contribution
  • presentations of information
      – Non-technical solutions
Non-patentable inventions
                                                                Art. 27(2-3) TRIPS

                                                                     Art. 53 EPC
Inventions excluded from patentability:
• inventions the publication or exploitation of which would be contrary to
  "ordre public" or morality,
    – certain types of ammunition, bombs
    – certain biotechnological inventions
• plant or animal varieties or essentially biological processes for the
  production of plants or animals;
    – this provision does not apply to microbiological processes or the products
    – there exists other form of protection
• methods for treatment of the human or animal body by surgery or
  therapy and diagnostic methods
    – except substances
Term of protection

• 20 yrs from the filing date

• Problem:
  – the term of protection in case of priority: 20 yrs from the
    priority date or from the filing date?

• Supplementary Protection Certificate SPC
     - Pharmaceuticals
     - Plant protection products
Suplementary Protection Certificate SPC
         Council Regulation (EEC) No. 1768/92 concerning the creation of a
 supplementary protection certificate for medicinal products (and 1610/96 for
                         plant protection products)

   –    Within the scope of primary patent
   –    15 years from the day of the authorization
   –    Additional protection is granted when
        •   the product is protected by a basic patent in force;
        •   a valid authorization to place the product on the market as a medicinal product has
            been granted in accordance with Directive 65/65/EEC or Directive 81/851/EEC
        •   the product has not already been the subject of a certificate;
        Extension of the term of the protection
   –    up to 5 years (maxiumum)
   –    depends on the time period between the day of application and the day
Suplementary Protection Certificate

How to count?

                         Date of first
 Patent application                          Date of the patent   Date of the SPC
                      marketing approval
     date (A)                                   expiry (C)          expiry (D)

                          (A – B) – 5 years = the SPC period

                               C + the SPC period = D
Suplementary Protection Certificate - 3

 Effective time of protection: 15 yrs (or less)
 Example 1: period between application to authorization: 6 yrs.
                         6 yrs – 5 yrs = 1 year
                         20 yrs – 6 yrs = 14 yrs
                         14 + 1 = 15 yrs
 Example 2: the said period: 9 yrs. 9 – 5 = 4 yrs
                         20 – 9 = 11
                         11 + 4 = 15 yrs
 When period is less than 5 yrs (no place for SPC)
 When period is more than 10 yrs: 11 – 5 = 6 (but SPC cannot exceed 5
                20 – 11 = 9
                9 + 5 = 14 yrs
Territory of protection – ways of obtaining patent

                                    EUROPEAN PATENT
                                     a single application before the EPO
                                     unitary substantive law
  single country application
                                     a bundle of national patents valid on
  valid on its territory
                                    the territory of designated states
  law of the country is relevant
                                     grants the same rights as national


  only unitary procedure            unitary patent
  no unitary substantive law        valid on the territory of UE
  patents granted by national       a single application
 offices                             still at proposal stage
        Scope of protection - 1
Negative sphere
• Right to prevent third parties from
   – making, using, offering for sale, selling, or importing
   – patented product or product obtained from patented
• Monopoly or blocking effect?
Positive sphere
• Right to assign, or transfer by succession
• Right to conclude licensing contracts.
     Scope of protection - 2
     Patent claims

                                                  - equivalents
                              - partial protection of invention
    Art. 69 EPC
The extent of the protection shall be determined by the terms of the
claims. Nevertheless, the description and drawings shall be used to
interpret the claims.
Scope of protection – 3
The equivalence

Theory of equivalence requires that the other subject-
  matter must be:
   – objectively equivalent to the technical mean
   – obvious to this skilled in art person

                     Protocol on the Interpretation of Article 69 EPC
Example: The Epilady case

     EPILADY PATENT                            REMINGTON PATENT

Hair remover for use on ladies' legs   Hair remover for use on ladies' legs
with the rotating helical (spring)     with rotating rubber bar with slits in it.

      Non-consistent judgements of European courts
Scope of protection – 4.
Partial protection of invention

      No standards - practice differs

Example 1:
        process consists of 10 elements. The competitor
omits 1 element. Does he violate the patent?
Example 2:
        the patent protects the construction of a pill. There
are 3 ”balls” (spheres) which seem to be necessary (the
first holds pharmaceutical, the second: protect this first, the
third: taste (eg. orange). The competitor managed to
eliminate the second sphere. Does he violate the patent?
Scope of protection – 5
Indirect protection of invention
1. The subject matter of a patent is a process for obtaining
   a product.
2. The defendant is to prove that the process to obtain an
   identical product is different:
   – If the product obtained by the patented process is new
   – If there is a substantial likelihood that
       • the identical product has been made by patented process
       • the owner of the patent has been unable through
         reasonable efforts to determine the process actually used
   Problem of protection of business secrets of defendant
  Scope of protection – 6
  Indirect protection of invention.
  The example
In country „A” has been patented a process for
   production of crystalline form of chemical compound
In country „B” (where there is no patent protection of
   the process) the chemical compound „X” is
   produced, but not in crystalline but in amorphous
   (i.e. non-crystalline) form.
The company New Age has been imported „X” to the
   country „A.
Does the company violate a patent?
Limitations of patent exclusivity
   • Transport purposes
      – patents to means of transport
   • Important purposes of the state
      – in particular, safety and public order
      – must be proportional
   • Research or scientific purposes
   • Compulsory licences:
      – because of dependence of patents
      – because of patent abuse

      Conditions for non-authorized use          Art. 31 TRIPS
     Specific subject-matters
• Pharmaceuticals

• Biotech inventions

• Computer-related inventions

• Diagnosis, therapeutic, and surgical methods for the
  treatment of humans and animals shall not be
• Pharmaceuticals are patented
   – Problem with patenting the 1st and the 2nd medical use of
     a known product
   – Bolar exemption (exploitation of an invention for a
     purpose to obtain registration necessary to put the
     product on the market)
   – Preparation of a medicine in a pharmacy
  Biotechnological inventions - 1
                                                             part of EPC

    Directive 98/44/UE on the legal protection of biotechnological inventions

     consisting of a product or containing biological
     material or a process by means of which biological
     material is produced, processed or used

             BIOLOGICAL MATERIAL means any material containing
             genetic information and capable of reproducing itself or
             being reproduced in a biological system.

• Biological material isolated from its natural environment
• Element isolated from the human body, including sequence of
  a gen
Biotechnological inventions – 2
Exclusion from patentability

   • Any biological material as found in

   • Natural biological process, as
     existing in nature
 Biotechnological inventions – 3
 Exclusion from patentability for ethical

• 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 processes.
Biotechnological inventions - 4
Specific issues

• Novelty/discoveries problems

• Industrial application problem

• Disclosure problems

• Scope of patent problems
Computer implemented inventions
                     Computer programs are not patentable (as such)

    Requirement of technical contribution
    Met when:
    •   the technical effects are obtained by solving the problem underlying in the
    •   the problem underlying in the invention is of a technical nature
    •   the details of the solutions in the invention require technical consideration
        that imply a technical problem

Computer implemented business-methods

                                                                  US approach
How to exploit patented invention?

• Transfer of rights
   – Patent
   – Right to obtaining patent
   – Written form
• Licensing agreements
   – Exclusive and non-exclusive
       • Sole licence
       • Recorded in the patent registry
   – Full or limited
       • Depending on the scope of the use
   – Sublicense
       • Prohibited on default
End of protection

  • Lapse of the patent
     – End of protection period
     – Forfeiture
     – Lack of renewal fee

  • Revocation of the patent
     – in specific procedure
     – as a whole or in due part
                                                   RED DE PROPIEDAD INTELLECTUAL E INDUSTRIAL
                                                               EN LATINOAMÉRICA

                                       Thank you for your attention

PILA Kick-off Meeting, 19-20 January 2009 is a project co-funded by the European Union in the framework of the ALFA programme