Emerging vaccine manufacturers and management of intellectual property

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1 Emerging vaccine manufacturers and management of intellectual property Trends based on studies in Brazil and India Miloud Kaddar Julie Milstien Patrick Gaulé

2 Outline 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 2

3 Context Emerging manufacturers are moving from incremental innovation (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 3

4 Patents for vaccines Expression system Platform technologies Purification process Formulation Immunogenicity, stability, reactogenicity Delivery Devices M. Friede, WHO/IVB/IVR 4

5 Patents and knowhow Two types of intellectual property are relevant for vaccines: Knowhow: protected only against copying. knowhow 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 wellcharacterized molecules) 5

WHO activities on IP and vaccines Technical meeting (April 04) (http://www.who.

6 WHO activities on IP and vaccines Technical meeting (April 04) ( perty/events/vaccines_meeting/e n/) Publications (WHO Bulletin, Health Affairs,..) Inputs to the WHO Commission Field studies in India (November 05) and Brazil (November 06) 6

7 WHO activities on IP and vaccines (2) 7

8 WHO activities on IP and vaccines (3) 8

9 Problems for emerging vaccine manufacturers (1) Huge backlog of patent applications a Damocles sword? In Brazil patent applications from 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 9

10 The content of the Indian mailbox Number of patent applications in the mailbox for vaccines as of November 05, 2006 Disease Tuberculosis HIV Salmonellosis Hepatitis A&B Meningitis Helicobacter pylori Product Patents Process Patents 3 5 Malaria 6 Cancer 5 Dengue 4 Cholera 2 Anthrax Rubella Polio Miscellaneous Source: Indian patent office,

11 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 11

12 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 knowhow 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 12

13 How do emerging manufacturers constructively deal with the constraint of intellectual property? By entering technology transfer and partnership agreements By strengthening inhouse intellectual property resources By inventing around patents (sometimes) By challenging dubious patents (one known case where an emerging manufacturer was involved in patent opposition) 13

14 Stages in the evolution of corporate IP policies Stages 1 IP ignored 2 Rewards for patents IP issues left to legal department Characteristics of IP policies 3 Selective patenting based on the evaluation of pros and cons of disclosure Licensing in if needed and licensing out if requested Trade secrets defended in court Review 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 opportunities Technical staff rotate through intellectual property department Licensing based on business and technical assessments Comprehensive trade secrets policies Source: Granstrand, O (1999) The Economics and Management of Intellectual Property: Towards Intellectual Capitalism. Edward Elgard Publishing Ltd, London 14

15 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 Stage 1: IP ignored Between 1 and 2 2: IP issues left to legal department Between 2 and 3 3: Selective patenting and licensing; review of patent positions 4: IP at the heart of corporate strategy Emerging manufacturers visited X X XXXX X 15

16 Technology transfer agreements Commonly used, but conditions may vary Often there are no underlying patent rights agreements for the transfer of knowhow 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 16

17 Technology transfer agreements Source: Boston Consulting Group. Global Vaccine Supply (2005): the Changing Role of Suppliers. Slides available on GAVI web site. 17

18 Technology transfer agreements: mostly knowhow, the example of Brazil Licensor Licensee Object of the contract Year Knowhow Patent GSK Fiocruz Production of Hib vaccine in Brazil Pasteur Mérieux Butantan Production of Influenza vaccine in Brazil Biken Fiocruz Production of measles and rubella vaccine in Brazil GSK Fiocruz Production of MMR vaccine in Brazil NIH Butantan Exploratory license for a rotavirus vaccine 1998 X 1999 X 2000 X 2003 X 2005 X X Source: INPI [Brazilian patent office], Publicly available information 18

19 What emerging manufacturers bring to the table In partnerships with other producers: Market accesslocation 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 19

20 Limitations 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. 20

21 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,..) 21

22 THANKS for your attention Miloud Kaddar FHCIVBEPI

Access to Medicines, Patent Information and Freedom to Operate

TECHNICAL SYMPOSIUM DATE: JANUARY 20, 2011 Access to Medicines, Patent Information and Freedom to Operate World Health Organization (WHO) Geneva, February 18, 2011 (preceded by a Workshop on Patent Searches