Transcript Problems in Flow of Scientific Knowledge, Data, Materials:

Knowledge Commons:
The Case of the
Biopharmaceutical Industry
Arti K. Rai
Duke Law School
Definition of Knowledge Commons
(for purposes of panel)
• Information shared on standard terms
outside boundaries of single firm
• Can range from “club good” to public
domain
• Most interesting cases may involve
competitors
Issue 1: “Anti-Commons”
• Pharma response: support efforts to put
“upstream” information in public domain
– Fully public projects e.g. GenBank, HapMap
– Public-private e.g. Genome Wide Association
Studies, SNP
– Stronger utility and written description
standards
– Not great for small bioinformatics firms
Issue 2: Declining Productivity
“Companies must fundamentally review R&D
business models and exploit new strategies for
re-establishing core drug discovery expertise”
(From: Addressing Pharma's R&D Productivity
Crisis: Technological and Strategic Initiatives
to Improve Core Drug Discovery Capabilities
Datamonitor (2004))
SOURCE: FDA, INNOVATION OR STAGNATION (2004)
SOURCE: FDA, INNOVATION OR STAGNATION (2004)
NME
BLA
2004
31
5
2005
18
2
2006
10
(up to 7/31)
3 (though
418 “in
pipeline”)
The anti-intellectual effects of intellectual property
Opinion
Christopher A Lipinski
Current Opinion in Chemical Biology 2006, 10:380-383
Over eight year period, 3 drugs for novel targets discovered
per year (vs. 3000-4200 druggable targets from genome)
Problems
• Lots of drug failures for lack of efficacy,
toxicity (in clinical trials and even once on
market) (FDA Report)
• Difficulty in validating new targets
(Lipinski, 2006)
The Current State of Play
• Lots of vertical bio-pharma alliances (1
bio, 1 pharma) over last 10 years
• Only limited success with small molecules
• Could we have other types of
collaboration?
Horizontal Public-Private
Partnerships for Toxicity, Efficacy
• Need new “biomarkers” for toxicity, efficacy
• Biomarkers “beyond the capacity of any single
sector . . .much less single institution” (Charles
Sanders M.D); i.e. need to pool information
– TCC (toxicity only) (March 2006)
– Oct. 2006 Biomarkers Consortium with NIH
Foundation as “trusted intermediary” (toxicity and
efficacy)
– Trusted intermediary manages flow of confidential
information and is assigned patent rights
New Targets? (Molecular Libraries
Screening Center Network)
•
•
•
•
NIH generating small molecule libraries
Nine screening centers
Academics submit assays
Collected information (though not
necessarily assays, targets) goes into
public domain (PubChem)
Source: Christopher Austin et al., NIH Molecular Libraries
Initiative, 306 SCIENCE 1138 (2004).
Benefits, Problems
• Pooled information on molecular pathways
important
• But will lead (at best) to partially
validated target
• Pharma does not like patents on
assays, targets (allowed under MLSCN)
• Other ways of fostering collaboration?
In Sum . . .
• In biopharm, most alliances thus far have
been vertical (also limited to one bio, one
pharma)
• Horizontal pooling of information may help
• Nascent formation of horizontal PPPs
(mediated by trusted intermediary)
• Large-scale university collaboration with
pharma?