Emerging vaccine manufacturers and management of ...€¦ · Emerging vaccine manufacturers and...

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


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


Patents for vaccinesPatents for vaccines

Expression system

Platform technologies

Purification process

Formulation

Immunogenicity, stability, reactogenicity

Delivery Devices

M. Friede, WHO/IVB/IVR


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)


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)

http://www.who.int/intellectualproperty/events/vaccines_meeting/en/





WHO activities on IP and vaccines (2)WHO activities on IP and vaccines (2)

http://www.who.int/bulletin/volumes/84/5/360.pdf


WHO activities on IP and vaccines (3)WHO activities on IP and vaccines (3)

http://www.who.int/intellectualproperty/en/


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


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




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




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


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)


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 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


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


Technology transfer agreementsTechnology transfer agreements

Source: Boston Consulting Group. Global Vaccine Supply (2005): the Changing Role of Suppliers. Slides available on GAVI web site.


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


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


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.


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

[email protected]

41 22791 1436

mailto:[email protected]

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