Post on 14-Jan-2016
PATENT POOL & its CONCERNS
Manmohan A Amonkar20 July 2010
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”
WORKING
PatentPool
Patent Owner Generics
R o y a l t y
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.
Benefits for Patent Owner
Receipt of Royalties from Generic Companies
Access to new markets
Boost to reputation
Benefits for generic companies
Easier access to IP by Generic Companies
Reduction of licensing transaction costs
Elimination of difficulties due to blocking patents
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
Cryptic Dangers
VOLUNTARY LICENSES (Hidden Devils)
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
Restrict Innovation
“One Stop Shop” for purchasing technology
Dependency on innovator companies
Stifle generic companies from developing their own technology
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
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
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
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