Protecting Biotechnological Processes

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ProtectingBiotechnological Processes

• Similarities and differences in the
  interpretation of the patent before the European
  Patent Office, US Patent Office and Japanese
  Patent Office

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Diversity of what is patentable

• In Europe (art.52.1 EPC) and Japan (Art. 29) an
  invention must be new, inventive and have
  industrial applicability
• In the USA whoever invents or discovers any new
  and useful process, machine, manufacture, or
  composition of matter may obtain a patent
  therefor (35U.S.C 101)

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Diversity of patentability criteria

• Novelty
• In Europe absolute novelty (Art. 54 EPC)
• In USA relative novelty (35 U.S.C. 102)
• In Japan relative novelty (Artt. 29.1 and 30 of
  the patent law)
• Novelty of proteins in US and EP

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Diversity of patentability criteria

• Inventive step and non-obviousness
• there is a similar approach in Europe (Art.56
  EPC), in the United States (35 U.S.C. 103) and in
  Japan (Art. 29.2 of the Japanese law) assessment
  made by the skilled person
• Inventive step of proteins in US (ex parte Gray)
  and EP (Amgen case T0412/93)

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Unity of inventionnew Biotechnological
Process/new Biotechnological product

• Japan Current section 37 and 25.8 of Patent Law
• (applicable to the applications filed after 1
  Jan 2004)
• Where there are two or more inventions, they may
  be filed in a single patent application provided
  that these inventions has a technical
  relationship defined by an ordinance of the
  competent Ministry, according to which two or
  more inventions must be linked so as to form a
  single inventive concept by having the same or
  corresponding technical features among them
• Europe Art. 82 EPC
• The European patent application shall relate to
  one invention only or a group of inventions so
  linked as to form a single general inventive
  concept
• USA restriction Practice
• 35 U.S.C. 121 If two or more independent and
  distinct inventions are claimed in one
  application, the Director may require the
  application to be restricted to one of the
  inventions and 37 CFR 1.141

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Interpretation of the scope of the process claim

• Europe if the subject- matter is a process, the
  protection conferred by the patent shall extend
  to the products directly obtained by such process
  (Art. 64.2 EPC)
• USA Process Patent Protection Act
• It is an act of infringement to make, use, sell,
  offer to sell or import a product made using a
  process patent in the United States, if such
  manufacture, use, sale or importation occurs
  during the term of the US patent.
• Japan Art. 68 a Patentee shall have an
  exclusive right to commercially work the
  patented invention, where Art. 2(3)(iii) defines
  as working acts of using, assigning, leasing,
  importing or offering etc. the product
  manufactured by the patented process

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product-by-process

• European Patent Office these claims confer
  protection upon the product regardless of the
  process by which it is prepared and defined
  (Amorphous TPM/Enichem T0020/94 Guidelines for
  Examinations, part C, Chapter III, 4.7.b).
• United States Office these claims are admitted
  and issued if the product is new regardless of
  the definition of the steps of the process.
• In spite of this

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product-by-process

• United States Office the US courts tend to
  interpret and limit the claim product-by-process
  to the sole process.
• Atlantic Thermoplastic vs Fatex
• Scripps Clinic vs Genetech
• Japan Identical Product Theory

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Sufficiency of disclosure

• European Patent Office
• The European patent application must disclose
  the invention in a manner sufficiently clear and
  complete to be carried out by a person skilled in
  the art Art. 83 EPC
• United States Patent Office
• The requirement of enabling the invention 35
  U.S.C. 112
• Japanese Patent Office
• Revised Guidelines (applicable to application
  examined after October 2003) a sustantial
  interrelation between the description and claims
  and not phraseological correspondence

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Thank You for your attention...

• Elisabetta CATTANEO
• Perani Mezzanotte Partners
• ecattaneo_at_perani.com