Stem Cells R&G 2010
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Stem Cells R&G 2010

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Stem Cells R&G 2010 Stem Cells R&G 2010 Presentation Transcript

  • Dr. Mark Einerhand European Patent Attorney Partner Vereenigde Stem Cells
  • Human embryonic stem cells
  • Totipotent stem cells
    • A stem cell that has the potential to form a whole organism
  • Pluripotent stem cells
    • A stem cell that has the potential to form all tissues but not extra-embryonic tissue
  • Regenerative medicine
      • Neurons
      • Hart muscle
      • Blood cells
      • Pancreatic cells
    • Article 53(a)
      • European patents shall not be granted in respect of inventions the publication or exploitation of which would be contrary to “ordre public” or morality
        • but not merely because prohibited by law or regulation in one or more states
      • EPC2000
      • “ publication and exploitation” replaced by
      • “ commercial exploitation”
    Are stem cells patentable?
  • Are stem cells patentable?
    • Rule 23d
      • European patents shall not be granted in respect of biotechnological inventions which concern:
      • (c) Uses of human embryos for industrial or commercial purposes
      • EPC2000
      • moved to rule 28 c)
  • The “Edinburgh patent”
    • EP 0695351 granted with claims that covered human embryonic stem cells
    • Appeal T1079/03
      • oral proceedings on substantive issues
    • Decision stayed awaiting Enlarged Board of Appeal
  • Wisconsin Alumni Research Foundation (WARF)
    • EP0770125 directed toward primate embryonic stem cells
    • Use of Human embryo source described as essential
    • Refused in examination
    • Board of Appeal (T1374/04) referred case to Enlarged Board of Appeal pending under G2/06
  • G2/06: Questions
    • Does Rule 23d(c) EPC forbid the patenting of claims directed toward products (here: human embryonic stem cells cultures) which – as described in the application – at the filing date could be prepared exclusively by a method which necessarily involved the destruction of the human embryo from the said are derived, if the said method is not part of the claims?
    • If the answer is no, does Article 53a forbid patenting of such claims?
  • Odontis’ claims
    • EP 1259593
    • Granted claim 1: “ Use of a cultured stem cell to produce a tooth progenitor cells, provided that the stem cell is not a human embryonic stem cell”
  • Crucell claims
    • EP 0833934
    • Amended in opposition
      • “ A packaging cell harbouring an adenovirus E1A gene, wherein said cell is a human embryonic retinoblast cell, human embryonic kidney cell, or a human embryonic lung cell.”
  • Consider national filing
    • Different states have different ethical criteria
      • UK will grant patents for human embryonic pluripotent stem cells but not for totipotent stem cells
    • Ethical criteria change with time
      • National registration patents
      • NL, FR, BE etc
  • Single cell isolation
  • From adult cells
    • Mesenchymal stem cells (human bone marrow)
    • Reprogramming adult cells
  • Personalized diagnostics/medicine
  • Methodology
    • Micro arrays
    • Mutation analysis
    • Single nucleotide
    • polymorphism
    • SNP)
    • RFLP and
    • variants
  • European Patent Office
    • There are no provisions in the EPC that would block such claims
    • Genetic predisposition tests are held allowable by the European Patent Office