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The intellectual property landscape of the human genome

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The intellectual property landscape of the human genome

  1. 1. The intellectual property landscape of the human genome Kyle Jensen PhD Candidate MIT Chemical Engineering Fiona Murray Assistant Professor Management of Technology Innovation & Entrepreneurship MIT Sloan School of Management
  2. 2. The “tragedy of the anti-commons” describes resource under-usage when many agents have rights to exclude M. A. Heller, R. S. Eisenberg, Science 280 , 698 (1998). Tragedy of the commons Tragedy of the anti-commons
  3. 3. There is some evidence for an anti-commons effect in the broader field of biotechnology Use forward citations as a measure of scientific progress All publications from Nature Biotech 97-99 Patent Grant Date Patent Patent FC jt FC jt FC jt FC jt FC jt FC jt FC jt Publication Publication Publication Publication FC jt FC jt FC jt FC jt FC jt F. Murray, S. Stern, NBER Working Paper 11465 , 2005.
  4. 4. Many suggest a genomic anti-commons effect exists; however, supporting evidence is limited and anecdotal <ul><li>Genomic anti-commons in a nutshell: </li></ul><ul><ul><li>IP rights, paired with exclusive licensing will increase transaction costs and </li></ul></ul><ul><ul><ul><li>Slow development of new medicines </li></ul></ul></ul><ul><ul><ul><li>Stifle academic R&D </li></ul></ul></ul><ul><ul><ul><li>Discourage downstream investment </li></ul></ul></ul><ul><li>But, classic rationale for patent system is to promote investment, R&D </li></ul><ul><ul><li>Evidence for genomic anti-commons is ancedotal </li></ul></ul>Nuffield Council on Bioethics, The ethics ..., Tech. rep. , London, UK (2002). T. Caulfield, E. Gold, M. Cho, Nat Rev Genet 1 , 227 (2000) L. Andrews, Nat Rev Genet 3 , 803 (2002) S. M. Thomas, M. M. Hopkins, M. Brady, Nat Biotechnol 20 , 1185 (2002). M. Stott, J. Valentine, Nat Rev Drug Discov 3 , 364 (2004).
  5. 5. The growth in sequence-oriented IPR prompts many of the same questions for the human geome 1:50 scale How much of the human genome is covered by IPR? By whom? D. L. Wheeler, et al. , Nucleic Acids Res 33 Database Issue , 39 (2005). No. sequences in Genbank No. sequences disclosed in issued US patents
  6. 6. To map patents to human genes we assembled a database of nucleotide sequences from issued US patents <ul><ul><ul><li>686,864 sequences from Genbank </li></ul></ul></ul><ul><ul><ul><li>+109,766 parsed from patent full-texts </li></ul></ul></ul><ul><ul><ul><li>Only from patents with a valid sequence listing </li></ul></ul></ul>D. L. Wheeler, et al. , Nucleic Acids Res 33 Database Issue , 39 (2005). User Services, National Center for Biotechnology Information (2004). Personal communication. O. of Public Affairs, U.S. Patent and Trademark Office (2005). Personal communication USPTO, Patent FullText and FullPage Image Databases, http://www.uspto.gov/patft/index.html (2005).
  7. 7. From this database, we extracted only sequences that are explicitly mentioned in the patent claims <ul><ul><ul><li>Natural language modeling using simple regular expressions </li></ul></ul></ul><ul><ul><ul><li>Applicable only to claims using SEQ ID nomenclature </li></ul></ul></ul>
  8. 8. An all-by-all homology search was used to determine which patented sequences correspond to human genes USPTO Patent Sequences 796,630 sequences (82,395 claimed) from 30,048 patents NCBI RefSeq 495,772 sequences from 2,969 species Blastn Eval = 0.0 >= 150 bp Conflicts resolved by highest bit-score X Patent 1 sequences Patent 2 sequences Patent N sequences Gene 1 transcripts Gene M transcripts NCBI, The RefSeq Database, http://www.ncbi.nlm.nih.gov/RefSeq/ (2005). K. D. Pruitt, T. Tatusova, D. R. Maglott, Nucleic Acids Res 33 Database Issue , 501 (2005).
  9. 9. Our analysis show that 4,382 of the 23,688 genes in the human genome are claimed in granted U.S. patents NCBI Map Viewer. Build 35.1 http://www.ncbi.nlm.nih.gov/mapview/ (2005). D. Maglott, J. Ostell, K. D. Pruitt, T. Tatusova, Nucleic Acids Res 33 Database Issue , 54 (2005).
  10. 10. Most genes are claimed in only a single patent; a few genes are covered by extensive IPR
  11. 11. The most IP-protected genes tend to be involved in cancer and cellular processes such as signal transduction, cellular differentiation, and cell proliferation NCBI Map Viewer. Build 35.1 http://www.ncbi.nlm.nih.gov/mapview/ (2005). D. Maglott, J. Ostell, K. D. Pruitt, T. Tatusova, Nucleic Acids Res 33 Database Issue , 54 (2005).
  12. 12. The institutions with the most gene-oriented patents tend to be biotech or research institutes rather than larger pharmaceutical companies * * Variations in assignee names across patents strongly effects this result. For example HGS is occasionally “ Human Genome Sciences” instead of “Human Genome Sciences, Inc.” Also, this does not account for mergers and acquisitions or subsidiary relationships. Assignee name standardization by EPO. European Patent Office, INPADOC, http://www.european-patent-office.org/inpadoc/ (2005).
  13. 13. Private US-based firms tend to own the most human gene IP
  14. 14. Most genes have a single rights-holder; however a handful of genes have highly fragmented IPR ownership
  15. 15. Our results suggest that disease-associated genes have heavier IP coverage than others <ul><li>Of 291 known cancer genes, 131 appear “patented” </li></ul><ul><ul><li>45% vs. 18% background rate </li></ul></ul><ul><ul><ul><li>Significant with p-value<0.01 based on binomial distribution </li></ul></ul></ul><ul><ul><li>Those that are patented, are more heavily patented than expected by chance </li></ul></ul><ul><ul><ul><li>Significant with p-value<0.01 based on chi-squared test </li></ul></ul></ul><ul><li>Of 1,456 genes in Online Mendelian Inheritance in Man TM database 517 are “patented” </li></ul><ul><ul><li>35% vs. 18% background rate </li></ul></ul><ul><ul><ul><li>Significant with p-value<0.01 based on binomial distribution </li></ul></ul></ul>
  16. 16. A patent density view of disease pathways reveals the IP barrier of various targets Huntington's disease pathway
  17. 17. Questions?

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