PATENT POOL & its CONCERNS

1. PATENT POOL & its CONCERNS ManmohanA Amonkar 20 July 2010

2. Patent Pool • “An Agreement between 2 or more patent owners to license 1 or more of their patents to one another or to third parties” • Way to centralise licensing processes • Stop & Shop Facility • Overcome the “Tragedy of Anti-commons”

3. WORKING Patent Owner Generics Patent Pool R o y a l t y

4. Timeline of Medicines Patent Pool Foundation (MPPF) • 2006: Proposal to UNITAID to establish a patent pool on medicines • July 2008: UNITAID Executive Board (EB) agreed, in principle, to establish a Voluntary Medicines Patent Pool • June 2010: UNITAID EB decided to establish the Medicines Patent Pool Foundation (MPPF) as a separate not-for-profit entity constituted under the laws of Switzerland.

5. Benefits for Patent Owner • Receipt of Royalties from Generic Companies • Access to new markets • Boost to reputation

6. Benefits for generic companies • Easier access to IP by Generic Companies • Reduction of licensing transaction costs • Elimination of difficulties due to blocking patents

7. Benefits to patients: MPPF Goals • Expedited availability of low cost medicines without having to wait for patent term to expire. • In context of need for second-line and newer lines of treatment, • Fixed Dose Combinations • Pediatric Formulations • Heat stable formulations • Increased access to affordable medicines in developing countries • Price Reduction

8. Cryptic Dangers • VOLUNTARY LICENSES (Hidden Devils)

9. Voluntary Licenses Contd.. • Control Generic Competition • 2006: Gilead offered voluntary licenses to 11 generic companies (Indian and others) on certain terms and conditions: • Licensees should purchase active pharmaceutical ingredients only from certain authorised sources • Licensees should not export finished products to markets not approved by Gilead (eg Brazil) • withdraw patent oppositions on TENOFOVIR • Brazil: Tenofovir costs US$1,387 pppy while, in India, generic versions cost approximately US$ 99 pppy

10. Restrict Innovation • “One Stop Shop” for purchasing technology • Dependency on innovator companies • Stifle generic companies from developing their own technology

11. EVERGREENING • “Evergreening” of patents on medicines due to patents on • Fixed dosed combinations • Pediatric formulations • Heat-stable formulations • These new forms are likely to be patented in several countries. • MPPF provides incentives to such evergreening practices

12. Compulsory Licensing • Compulsory licensing is a recognised flexibility available under the Agreement on Trade Related Aspects of Intellectual Property Rights • Negotiations with MPPF may enable patent holder to delay issuance of compulsory licences or government use

13. Market Segmentation • MPPF is purely VOLUNTARY in nature • Balance of power titled in favour of patent holders • Insistence on exclusion of countries • Tiered pricing / royalty

14. Conclusion • We must learn from the previous experience of Gilead voluntary licences • We must ensure that use of TRIPS flexibilities and other mechanisms such as anti-competition laws are not compromised • We must demand greater transparency • We must remember that this is one PROPOSED solution, and continue to work to push for strong public health safeguards in patent laws and oppose the present patenting practices