1. Knowledge Commons: The Case of the Biopharmaceutical Industry Arti K. Rai Duke Law School

2. 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

3. 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

4. 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)) Datamonitor

7. NMEBLA 2004315 2005182 2006 (up to 7/31) 103 (though 418 “in pipeline”)

8. 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)

9. 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)

10. 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?

11. 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

12. 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)

14. 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?

15. 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?