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Washington D.C., USA, 22-27 July 2012www.aids2012.org
Methodology to Determine the Patent Status of Key ARVs and Other Essential Medicines:
A Strategy to Reduce Cost of Treatment
Mandeep Dhaliwal, Tenu Avafia, Boyan Konstantinov & Jeffrey O’Malley
UNDP BDP, HIV/AIDS Practice
The methodology is co-authored by
Barbara Milani and Cecilia Oh
Washington D.C., USA, 22-27 July 2012www.aids2012.org
The need for patent transparency
• Lack of transparency can hinder innovation or affordable access to health technologies
• Consequences include:
(i) inappropriate claims of patent infringement;
(ii) money wasted on unnecessary work arounds;
(iii) Undeserved licensing revenues;
(iv) Blocked generic entry e.g. (combivir in Ghana)
(v) Increased spending on procuring more expensive medicines, when cheaper options are available
• Transparency requirements should be key components of patent laws and systems
• In practice this is not the case
Washington D.C., USA, 22-27 July 2012www.aids2012.org
How to improve transparency
Databases:
• National patent authorities
• Medicines Patent Pool Database
Washington D.C., USA, 22-27 July 2012www.aids2012.org
UNDP focuses on
• Developing a Methodology that empowers relevant local officials to conduct patent searches
• Training local officials and procurement agencies to assess the validity of IP claims
• Preventing the granting of patents to undeserving applications by encouraging the refinement of patentability criteria
Washington D.C., USA, 22-27 July 2012www.aids2012.org
What does the Methodology rely on?
• Publicly available sources of patent information on finished pharmaceutical products
• Publicly accessible information on priority patent data and patent families
• Use of the “priority data” concept to retrieve and analyze patent data
• Capacity of national or regional patent office to verify the patent data provided (i.e., priority data and/or patent family data), and to determine the patent status/validity in the country
Washington D.C., USA, 22-27 July 2012www.aids2012.org
Public sources of information
The Methodology relies on the US FDA Orange Book, the Health Canada Patent Register, and INAPDOC
Why the Orange Book
All patents submitted/listed by innovator companies, which are likely to seek the highest and longest patent protection in the US market
Why the Health Canada Patent Register
“Relevant” patents are listed after the revision carried by Health Canada, on the list of patents submitted by the innovator companies
Why INPADOCInternational patent collection, contains patent families
Washington D.C., USA, 22-27 July 2012www.aids2012.org
Advantages and limitations
• Relies on open sources available free of charge, transparent
• Transfers research skills to and empowers local actors• Has a multiplying effect…………………………………………………………………….
• Does not cover medicines not in the Orange book and Health Canada (e.g. vaccines and biomedicines)
• For such medicines, a patent search would be necessary• Is more complex than database use, requires training
Washington D.C., USA, 22-27 July 2012www.aids2012.org
The four steps
Washington D.C., USA, 22-27 July 2012www.aids2012.org
Process and desired outcomes• UNDP intends to use of the patent search tool in low and
middle income countries • Bring together stakeholders
– Pilot training workshops on the methodology and tool for health,
– Procurement agencies and principal recipients– Patent landscaping exercises using the Methodology
• Desired outcomes:– Contribution to procurement cost-effectiveness– Legal certainty for current and future procurement– Cost savings from reduced IP assistance needs– Consistence with the TRIPS Agreement and its public
health flexibilities
