Transcript Designing Strategies for Neglected Disease

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