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Lecture 5A Access in ND Research

Lecture 5A Access in ND Research. Designing Strategies for Neglected Disease Research Prof. Amy Kapczynski Feb. 10th. Today’s Program. Patent Basics (national and international law) Access to Inputs Access to Outputs. Patent Basics. 20 year right to exclude others.

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Lecture 5A Access in ND Research

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  1. Lecture 5AAccess in ND Research Designing Strategies for Neglected Disease Research Prof. Amy Kapczynski Feb. 10th

  2. Today’s Program • Patent Basics (national and international law) • Access to Inputs • Access to Outputs

  3. Patent Basics 20 year right to exclude others From making, using, selling, importing the invention • Must first show that the invention is • novel • non-obvious (inventive step) • useful (capable of industrial application)

  4. What can’t be patented? (in the US) 35 U.S.C. 101: “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor” can’t patent abstract ideas, formulas, “phenomena of nature” what if a scientist discovers that an elevated level of a protein corresponds to a vitamin deficiency? (Metabolite) or a surgeon comes up with a new surgery?

  5. What can be patented (relevant to medical research?) • new compounds (“AZT”) • a new useof a known compound (“AZT against HIV”) • a salt of a known compound (“the besylate salt of known compound X”) • an ester, isomer, enantiomer, prodrug of known compound • a combination of known compounds (“AZT + 3TC”) • a process for making a drug (esp. imp. in biotech) • genetically engineered organisms (“OncoMouse™”) • “isolated” nucleic acid sequences  (BRCA1)

  6. + Ritonavir Lopinavir

  7. * * U.S. Patents on Ritonovir

  8. U.S.A., Botswana, India

  9. TRIPS Agreement • 153 members of WTO • Must provide patents “without discrimination as to the place of invention, the field of technology, and whether products are imported or locally produced” (Art. 27.1) • May exclude “diagnostic, therapeutic, and surgical methods” as well as “plants and animals other than microorganisms” (Art. 27.3) • Patents must last at least 20 years • Limited exceptions: • Article 30 (“Bolar” exception, research exception?) • Article 31 (government use and compulsory licensing)

  10. U.S.A., Botswana, India

  11. “Access In” Research tools   Compounds etc.

  12. FTO for a Malaria Vaccine (top ten antigens in existing vaccine projects) 10 antigens 167 patent families (75 different organizations) 39 moderate or high priority (21 different organizations) From Sandra Shotwell, Patent Consolidation and Equitable Access: PATH’s Malaria Vaccines, MIHR IP Handbook of Best Practices, at http://www.iphandbook.org/handbook/ch17/p21/.

  13. From Sandra Shotwell, Patent Consolidation and Equitable Access: PATH’s Malaria Vaccines, MIHR IP Handbook of Best Practices, at http://www.iphandbook.org/handbook/ch17/p21/.

  14. From Anatole Krattiger, MIHR IP Handbook, Chap. 14.1, at http://www.iphandbook.org/handbook/ch14/p01/

  15. From Anatole Krattiger, MIHR IP Handbook, Chap. 14.1, at http://www.iphandbook.org/handbook/ch14/p01/

  16. Other solutions for “access in” • Move research to jurisdiction w/ FTO • Open source (with funders prompting?) • “Patent Pools”

  17. “Access Out” • Open access • At cost pricing

  18. The Effects of Generic Competition • From Médecins Sans Frontières, Untangling the Web of ARV Price Reductions (July 2008).

  19. Pros of open access • harnesses power of competitive dynamics • less oversight / don’t need to define “at cost” • innovation benefits? Pros of at cost pricing • may be more acceptable to licensee • in some areas competition (generics) may be less likely

  20. Issues for “Access Out” Licenses / Agreements • territories (LMI? HDI? Burden of disease? Sectors?) • fields of use • definitions • of end product and IP for OA (background tech?) • of “at cost” for ACP (and audits?) • drug registration and adequate supply (for ACP) • in-licensed technologies… • Technical assistance, regulatory data

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