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Stem Cells R&G 2010


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Stem Cells R&G 2010

  1. 1. Dr. Mark Einerhand European Patent Attorney Partner Vereenigde Stem Cells
  2. 2. Human embryonic stem cells
  3. 3. Totipotent stem cells <ul><li>A stem cell that has the potential to form a whole organism </li></ul>
  4. 4. Pluripotent stem cells <ul><li>A stem cell that has the potential to form all tissues but not extra-embryonic tissue </li></ul>
  5. 5. Regenerative medicine <ul><ul><li>Neurons </li></ul></ul><ul><ul><li>Hart muscle </li></ul></ul><ul><ul><li>Blood cells </li></ul></ul><ul><ul><li>Pancreatic cells </li></ul></ul>
  6. 6. <ul><li>Article 53(a) </li></ul><ul><ul><li>European patents shall not be granted in respect of inventions the publication or exploitation of which would be contrary to “ordre public” or morality </li></ul></ul><ul><ul><ul><li>but not merely because prohibited by law or regulation in one or more states </li></ul></ul></ul><ul><ul><li>EPC2000 </li></ul></ul><ul><ul><li>“ publication and exploitation” replaced by </li></ul></ul><ul><ul><li>“ commercial exploitation” </li></ul></ul>Are stem cells patentable?
  7. 7. Are stem cells patentable? <ul><li>Rule 23d </li></ul><ul><ul><li>European patents shall not be granted in respect of biotechnological inventions which concern: </li></ul></ul><ul><ul><li>(c) Uses of human embryos for industrial or commercial purposes </li></ul></ul><ul><ul><li>EPC2000 </li></ul></ul><ul><ul><li>moved to rule 28 c) </li></ul></ul>
  8. 8. The “Edinburgh patent” <ul><li>EP 0695351 granted with claims that covered human embryonic stem cells </li></ul><ul><li>Appeal T1079/03 </li></ul><ul><ul><li>oral proceedings on substantive issues </li></ul></ul><ul><li>Decision stayed awaiting Enlarged Board of Appeal </li></ul>
  9. 9. Wisconsin Alumni Research Foundation (WARF) <ul><li>EP0770125 directed toward primate embryonic stem cells </li></ul><ul><li>Use of Human embryo source described as essential </li></ul><ul><li>Refused in examination </li></ul><ul><li>Board of Appeal (T1374/04) referred case to Enlarged Board of Appeal pending under G2/06 </li></ul>
  10. 10. G2/06: Questions <ul><li>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? </li></ul><ul><li>If the answer is no, does Article 53a forbid patenting of such claims? </li></ul>
  11. 11. Odontis’ claims <ul><li>EP 1259593 </li></ul><ul><li>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” </li></ul>
  12. 12. Crucell claims <ul><li>EP 0833934 </li></ul><ul><li>Amended in opposition </li></ul><ul><ul><li>“ 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.” </li></ul></ul>
  13. 13. Consider national filing <ul><li>Different states have different ethical criteria </li></ul><ul><ul><li>UK will grant patents for human embryonic pluripotent stem cells but not for totipotent stem cells </li></ul></ul><ul><li>Ethical criteria change with time </li></ul><ul><ul><li>National registration patents </li></ul></ul><ul><ul><li>NL, FR, BE etc </li></ul></ul>
  14. 14. Single cell isolation
  15. 15. From adult cells <ul><li>Mesenchymal stem cells (human bone marrow) </li></ul><ul><li>Reprogramming adult cells </li></ul>
  16. 16. Personalized diagnostics/medicine
  17. 17. Methodology <ul><li>Micro arrays </li></ul><ul><li>Mutation analysis </li></ul><ul><li>Single nucleotide </li></ul><ul><li>polymorphism </li></ul><ul><li>SNP) </li></ul><ul><li>RFLP and </li></ul><ul><li>variants </li></ul>
  18. 18. European Patent Office <ul><li>There are no provisions in the EPC that would block such claims </li></ul><ul><li>Genetic predisposition tests are held allowable by the European Patent Office </li></ul>