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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 From making, using, selling, importing the invention Must first show that the invention is • novel • non-obvious (inventive step) • useful (capable of industrial application) 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? What can be patented (relevant to medical research?) • new compounds (“AZT”) • a new use of 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) Ritonavir + Lopinavir Number Relevant Claim 5,648,497 RTV molecule 5,674,882 use of RTV with a PI for inhibiting HIV Use 5,635,523 use of RTV with an RTI for inhibiting HIV Use 5,541,206 use of RTV for inhibiting HIV Use 5,846,987 combination of RTV and an RTI Product Combination 5,886,036 combination of RTV and a PI Product Combination 1991 Product New Chemical Entity 1993 * 1996 6,037,157 use of RTV to boost a PI Use 6,703,403 use of RTV to inhibit cytochrome P450 monoxygenase Use 1996 5,914,332 LPV molecule Product New Chemical Entity 6,284,767 use of LPV with RTIs or PIs 6,232,333 soft-gel formulation of RTV Product Formulation 6,458,818 soft-gel formulation of RTV & LPV Product Formulation 6,521,651 soft-gel formulation of LPV Product Formulation Use 1997 U.S. Patents on Ritonovir * U.S.A., Botswana, India 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) U.S.A., Botswana, India “Access In” Research tools Compounds etc. 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/. 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/. From Anatole Krattiger, MIHR IP Handbook, Chap. 14.1, at http://www.iphandbook.org/handbook/ch14/p01/ From Anatole Krattiger, MIHR IP Handbook, Chap. 14.1, at http://www.iphandbook.org/handbook/ch14/p01/ Other solutions for “access in” • Move research to jurisdiction w/ FTO • Open source (with funders prompting?) • “Patent Pools” “Access Out” • Open access • At cost pricing The Effects of Generic Competition From Médecins Sans Frontières, Untangling the Web of ARV Price Reductions (July 2008). 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 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