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Emerging vaccine manufacturers and management of intellectual property
Trends based on studies in Brazil and India
Miloud KaddarJulie MilstienPatrick Gaulé
Emerging vaccine manufacturers and management of IPRs2 |
OutlineOutline
Introduction and context
Main problems faced by emerging manufacturers in the field of intellectual property
How they deal with this constraint
Potential role for DCVMN
Emerging vaccine manufacturers and management of IPRs3 |
ContextContext
Emerging manufacturers are moving from incrementalinnovation (e.g. development of known processes to scale up production) to development of new products
Stronger intellectual property laws have been adopted in developing countries in compliance with the TRIPS agreement
Patentability domain is growing and number of patents exploding
Emerging vaccine manufacturers and management of IPRs4 |
Patents for vaccinesPatents for vaccines
Expression system
Platform technologies
Purification process
Formulation
Immunogenicity, stability, reactogenicity
Delivery Devices
M. Friede, WHO/IVB/IVR
Emerging vaccine manufacturers and management of IPRs5 |
Patents and know-howPatents and know-how
Two types of intellectual property are relevant for vaccines:
Know-how: protected only against copying. know-how is protected only insofar as it can be kept secret
Patents: protects against copying but also against independent invention => much more powerful form of intellectual property; may cover parts of the production process (including testing) as well as the products themselves in some cases (usually only for well-characterized molecules)
Emerging vaccine manufacturers and management of IPRs6 |
WHO activities on IP and vaccinesWHO activities on IP and vaccines
Technical meeting (April 04)
(http://www.who.int/intellectualproperty/events/vaccines_meeting/en/)
Publications (WHO Bulletin, Health Affairs,..)
Inputs to the WHO Commission
Field studies in India (November 05) and Brazil (November 06)
Emerging vaccine manufacturers and management of IPRs7 |
WHO activities on IP and vaccines (2)WHO activities on IP and vaccines (2)
http://www.who.int/bulletin/volumes/84/5/360.pdf
Emerging vaccine manufacturers and management of IPRs8 |
WHO activities on IP and vaccines (3)WHO activities on IP and vaccines (3)
http://www.who.int/intellectualproperty/en/
Emerging vaccine manufacturers and management of IPRs9 |
Problems for emerging vaccine manufacturers (1)
Problems for emerging vaccine manufacturers (1)
Huge backlog of patent applications – a Damocles sword?
– In Brazil patent applications from 1997-98 are currently being examined. Here the pipeline is transparent- applications are published 18 months after the priority date (or application date if earlier) but there is uncertainty on whether the patents will be granted.
– In India, around 200 patent applications on vaccines in the mailbox, the documents were not publicly available in 2005 and general problems of access to information
Emerging vaccine manufacturers and management of IPRs10 |
The content of the Indian mailboxThe content of the Indian mailboxNumber of patent applications in the mailbox for vaccines
as of November 05, 2006 Process PatentsProduct PatentsDisease
310Tuberculosis
-9HIV
58Salmonellosis
-8Hepatitis A&B
-8Meningitis
-7Helicobacter pylori
-6Malaria
-5Cancer
-4Dengue
2-Cholera
2-Anthrax
1-Rubella
1-Polio
6-Miscellaneous
Source:
Indian patent office, 2005
Emerging vaccine manufacturers and management of IPRs11 |
Problems for emerging vaccine manufacturers (2)
Problems for emerging vaccine manufacturers (2)
Dealing with intellectual property requires specialized resources and expertise as well as experience. Lack thereof may result in:
– Patent infringement and liability for damages;– Undue cautiousness;– Failure to challenge dubious patents;– Delay in product line expansion, leading to potential
loss of markets and profits
Emerging vaccine manufacturers and management of IPRs12 |
Problems for emerging vaccine manufacturers (3)
Problems for emerging vaccine manufacturers (3)
Even if there is no patent:
Reverse engineering (taking a product apart to analyze its workings in details) is almost impossible due to the biological nature of the product
Acquiring independently the know-how necessary to produce a new product is difficult and very time consuming
Access to virus and bacterial seed strains and cell substrates may be blocked by preexisting exclusive agreements
Emerging vaccine manufacturers and management of IPRs13 |
How do emerging manufacturers constructively deal with the constraint of intellectual property?
How do emerging manufacturers constructively deal with the constraint of intellectual property?
By entering technology transfer and partnership agreements
By strengthening in-house intellectual property resources
By inventing around patents (sometimes)
By challenging dubious patents (one known case where an emerging manufacturer was involved in patent opposition)
Emerging vaccine manufacturers and management of IPRs14 |
Stages in the evolution of corporate IP policiesStages in the evolution of corporate IP policies
Source: Granstrand, O (1999) The Economics and Management of Intellectual Property: Towards IntellectualCapitalism. Edward Elgard Publishing Ltd, London
Stages Characteristics of IP policies
1 IP ignored2 Rewards for patents
IP issues left to legal department3 Selective patenting based on the evaluation of pros and cons of disclosure
Licensing in if needed and licensing out if requestedTrade secrets defended in courtReview of patent positions
4 Intellectual property opportunities are part of business strategy, project selection and project management to maintain focus, speed, internal point of comparison and learning opportunitiesTechnical staff rotate through intellectual property departmentLicensing based on business and technical assessmentsComprehensive trade secrets policies
Emerging vaccine manufacturers and management of IPRs15 |
Emerging vaccine manufacturers and stages in IP policies
Emerging vaccine manufacturers and stages in IP policies
– Emerging manufacturers are strengthening their capacity to deal with intellectual property
– There remains substantial heterogeneity between emerging manufacturers; some are better prepared …
– Freedom to operate studies are routinely performed, with one exception
– Being part of a larger institutional structure helps
Emerging manufacturers
visited
Stage
1: IP ignored
XBetween 1 and 2
X2: IP issues left to legal department
XXXXBetween 2 and 3
X3: Selective patenting and licensing; review
of patent positions4: IP at the heart of corporate strategy
Emerging vaccine manufacturers and management of IPRs16 |
Technology transfer agreementsTechnology transfer agreements
Commonly used, but conditions may vary
Often there are no underlying patent rights - agreements for the transfer of know-how only
Different types of partners: academic institutions, MNCs, biotechs, other emerging manufacturers
Typically involve exchange of material and various forms of technical assistance
Agreements may cover distribution territories
May be the fastest route to develop a product, even a jointly produced one
Emerging vaccine manufacturers and management of IPRs17 |
Technology transfer agreementsTechnology transfer agreements
Source: Boston Consulting Group. Global Vaccine Supply (2005): the Changing Role of Suppliers. Slides available on GAVI web site.
Emerging vaccine manufacturers and management of IPRs18 |
Technology transfer agreements: mostly know-how, the example of Brazil
Technology transfer agreements: mostly know-how, the example of Brazil
Licensor Licensee Object of the contract Year Know-how
Patent
GSK Fiocruz Production of Hib vaccine in Brazil
1998 X
Pasteur Mérieux
Butantan Production of Influenza vaccine in Brazil
1999 X
Biken Fiocruz Production of measles and rubella vaccine in Brazil
2000 X
GSK Fiocruz Production of MMR vaccine in Brazil
2003 X
NIH Butantan Exploratory license for a rotavirus vaccine
2005 X X
Source: INPI [Brazilian patent office], Publicly available information
Emerging vaccine manufacturers and management of IPRs19 |
What emerging manufacturers bring to the tableWhat emerging manufacturers bring to the table
In partnerships with other producers:
Market access-location in an important market is a big advantage
Manufacturing capacity
Alternative regulatory pathway for the developing market
In partnerships with academics and biotech:
Facilities and experience in production
Emerging vaccine manufacturers and management of IPRs20 |
Limitations of the technology transfer modelLimitations of the technology transfer model
Full transfer of technology?
Question of continuing access to seeds and strains
Emerging manufacturers may have to accept restrictions, for instance export restrictions
Need to find a willing partner! The less technology owners there are the more difficult it is to find a partner and to negotiate good conditions.
Emerging vaccine manufacturers and management of IPRs21 |
Conclusions and directions to consider ?Conclusions and directions to consider ?Emerging suppliers need to understand the national and international patent situation around new products
It is important to have a clear strategy to deal with IP issues
DCVMN members may want to collectively develop IP capacity– Common training activities– IP expert group (patent mapping, database,…) – Share resources and tools (web site,…)– Document IP concerns, obstacles, issues – Alarm system on patent status of needed vaccines, technologies– Challenge dubious and "immoral" patents– Support contacts (PIIPA, MIHR,..) – Encourage innovative ways to deal with IP and public health issues
(e.g. strain bank,…)– Contribute to national and international debate (WHO working
group, new treaty on R&D, update of national laws,..)
THANKS for your attention
Miloud Kaddar
FHC-IVB-EPI
kaddarm@who.int
41 22791 1436
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