Intellectual Property Management to support SECOPI-AGRO’s Agricultural Innovation Process

1. Strengthen TeamWork between IP Managers and Scientist: GALVmed, Commercialization of Vaccines in the Developing World Monica Alandete-Saez, University California Davis, PIPRA Intellectual Property Management to support SECOPI-AGRO’s Agricultural Innovation Process Bogota, August 11-12th 2010

2. Invention Investment Capital Tech Transfer Office Regulatory steps IP Management Manufacture, etc. Technology Transfer Public Research Private Sector Public-Private Partnership (PPPs) Commercialization of a lucrative product (Agricultural or Health) Interest in Profitable Market

3. Vaccine Commercialization R&D Phase II Phase I Phase III Vaccine Discovery Commercialization Registration 4.5 Years 3 Years 4 Years $160 M $8 M $4 M $$ Attract Private Sector Regulatory Process has increased the cost of the vaccine development to very high IP Management IP rights are essential for mobilizing the funds necessary to meet the regulatory requirements

4. Global Pharmaceutical Market and Neglected Diseases Chagas disease, malaria, tuberculosis, leishmaniasis, African sleeping sickness, schistosomiasis,… Chapter 17.19. IP handbook of best practices Availability: Vaccine needed predominantly by the poor do not receive high priority for R&D by the private sector Cost: New vaccines are sold at prices beyond what the poor or their representatives can afford to pay

5. $$ FOUNDATIONS Public Research Product Development Partnerships: PDPs Private Sector Public Benefit

6. Program for Appropriate Technology in Health Drugs for Neglected Disease initiative International non-for-profit organizations help provide appropriate health technology to the poorest countries by collaborating with public and private partners Objectives to meet with potential partners: 1-Availability:Guarantee supply for the developing world 2-Accessibility:Right channels to actually reach the target 3- Affordability:Negotiate upfront prices for different markets

7. Product Development Partnerships

8. Global Access Strategies to introduce vaccine into developing countries Discovery Research Development Registration Commer- cialisation Sustained Delivery Inconsistent supply Counterfeit products. Lack of patent protection. Poor quality and efficacy. • Lack of funding for development studies - high risk, • high cost. • Poorly designed, poorly controlled field trials. • Unclear and varied regulatory requirements. • Multiple regulatory authorities. • R&D programs • IP Management and licensing • Safety regulations • Manufacture standards

9. GALVmed- The Global Alliance for Livestock Veterinary Medicines A Global Not for Profit Organization established under UK law based in Scotland in 2005 GOAL: To develop, register and launch 4 to 6 vaccine, pharmaceutical, or diagnostic product by 2015 that meets the needs of the world’s poorest livestock keepers

10. East Coast Fever • Newcastle Disease • Rift Valley Fever • Porcine Cysticercosis

11. GALVmed Industry Academy PIPRA PIPRA: Freedom to Operate Reports Negotiations & Contracts with third parties

12. Public Sector Animal vaccines • Pro Poor • Small dose package • Low price • Registered vaccine • Good Practice Manufacture • Sustainable Production

13. GALVmed PIPRA Introduction of ALL PARTIES involved in the project in a conference call Very Important for successof the project to clarify humanitarian mission from the beginning

14. Phase II Phase I Phase III 4.5 Years 3 Years 4 Years $8 M $4 M $160 M FTO Analysis or IP Report Vaccine Discovery Commercialization Registration DE-CONSTRUCTION of Vaccine Development and Future Manufacture Process IP Manager needs ALL details of invention, including location of MTAs. Long and could be a Frustrating process

15. FTO Analysis or IP Report will have three possible outcomes: 1 - Continue project after negotiating LICENSES 2 - Continue project after CHANGING commercialization STRATEGY 3 - FINALIZE project FTO Analysis is TERRITORIAL based in the commercialization strategy

16. Global Access Strategies. Benefits of Site R&D and Commercialization Discovery Research Development Registration Commer- cialisation Sustained Delivery • Lower IP constraints • Retain local talent and expertise • Raise awareness in the community • Support and enhance local research capacity • Infrastructure remains in the community

17. Types of Vaccines Live attenuated organisms which have been passed repeatedly in tissue culture or chick embryos so that they have lost their capacity to cause disease, but retained an ability to induce antibody response. Potential reversion. Inactivated or killed organisms which have been killed by heat or chemicals but retain and ability to induce antibody response. They are generally safe but less efficacious than live vaccines and require multiple doses. Recombinant vaccines DNA sequences are inserted by molecular engineering techniques into a virus grown in cell culture. Antigen Molecule recognized by the immune system capable to trigger an immune response.

18. Case Study I. Recombinant Vaccine: DNA sequence cloned into an inactivated virus University created a recombinant vaccine that immunize animals and wanted to donate it to GALVmed, but did NOT PATENT it Recently another University obtained a patent for use of such DNA sequence to develop vaccines in the territories chosen. Case Study II. Diagnostic method University is developing an immunoassay that detects the presence of an antigen that correlates with a disease. R&D and Manufacture process used a cell expression system and a purification method covered by TPRs and IPRs

19. Case Study III. East Coast Fever Vaccine in Tanzania in 2010 Experimental vaccine against ECF was developed 30 years ago with major funding of UK’s Government Department of International Development (DFID) and Bill & Melinda Gate Foundation Aim is to REGESITER a vaccine to secure sustainable supply through commercialization GALVmed is leading the registration, commercial distribution and delivery of the vaccine ($28M donated by DFID and Bill & Melinda Gate Foundation) The new ECF vaccine is an “infection-and treatment method”

20. Plant-Made Vaccines or Therapeutics Three plant systems: 1- Oral delivery. Vaccine ingestion (stable plant transformation) 2- Transient or stable plant expression (vaccine is purified) 3- Bioreactorusing plant cells Definition: Protein products with clinical or veterinary applications produced in recombinant plant systems Major advantage of plant expression systems over the traditional vaccine production: • Reduced manufacturing Cost • Eliminates cross-contamination with animal diseases

21. Plant-Made Vaccines

22. Plant-Made Vaccines in Southern Africa Partnership to produce cost-effective animal and human VACCINES

23. Vaccine Commercialization in Developing Countries requires a Global Access Strategy IP Management is an important Tool for reinforcing vaccine development and marketing strategy Public & Private sector should use Best IP Practices to directly address Global Public Interest Royalty-free Humanitarian Licenses for pharmaceutical products for Developing Countries

24. THANK YOU Monica Alandete-Saez, University California Davis, PIPRA Intellectual Property Management to support SECOPI-AGRO’s Agricultural Innovation Process Bogota, August 11-12th 2010