Ronil Emmavi J.Remoquillo Long-Term Research Fellowship April 1- September 30, 2009

1. Implications of the patentability requirements and other policy considerations on the pharmaceutical industry: the Japanese and Philippine experience Ronil Emmavi J.Remoquillo Long-Term Research Fellowship April 1- September 30, 2009

2. Outline of the Presentation • Introduction • Objectives • Patents and the Pharmaceutical Industry • Japanese and Philippine Experience • Impacts on the Pharmaceutical Industry • Conclusion and Recommendation

3. This study will look into the effects of patentability requirements and other policies in the pharmaceutical industry specifically the amended Intellectual Property Code to the pharmaceutical industry in the Philippines. introduction Patient with diabetes before and after insulin Statement of the Problem

4. Objectives

5. The Global Pharmaceutical Industry * sales, profits and assets are in billions * Source: Special Report: The Global 2000. Forbes Magazine http://www.forbes.com/lists/2008/18/biz_2000global08_The-Global-2000_IndName_9.html

6. Drug Discovery and development process Source: innovation.org

7. Reasons for patenting in the pharmaceutical industry

8. Patent Concept TRIPSAgreement

9. Patents and the Pharmaceutical Industry

10. The Japanese pharmaceutical industry case study

11. Top Pharmaceutical Companies in Japan • Takeda • Pfizer • Daiichi Sankyo • Eisai • Roche( Chugai) • Taisho • Dainippon Sumitomo • Novartis • Mitsubishi Pharma • Astellas Source: Japanese Pharmaceutical Market, 2006-2011

12. No. of Drug Patents in Japan Source: JPMA Data Book 2009

13. The philippine pharmaceutical industry case study

14. Top 20 Pharmaceutical Companies in the Philippines in Terms of Market Data

15. No. of Drug Patents in the Philippines 1

16. No. of Drug Patent Applications in the Philippines

17. Patents are like safety-nets for the pharmaceutical industry specifically among companies that develop their own drugs to suppress competition and ensure their profits.

18. Philippine Situation Prices of medicines in the Philippines is very expensive compared to other Asian counterparts making them inaccessible to the public.

19. Universally Accessible Quality and Cheaper Medicine Act of 2008 • A move by the Philippine government to combat the high prices of medicines in the country • Address the public health concerns by creating a competitive environment through government policies • Promote local pharmaceutical companies that generally manufactures generics medicines • More generics means cheaper medicines for the public

20. Role of the IP Amendment to Philippine Healthcare

21. Amendments in the Intellectual Property Code of the Philippines • Limiting patentable invention (2nd medical use, mere discovery) • Bolar Provision and • Parallel importation • Compulsory Licensing

22. Japanese Experiences

23. Impacts of the Patentability Requirements and Other Policies on the japanese pharmaceutical industry

24. Impacts of the Patentability Requirements and Other Policies on the philippine pharmaceutical industry

25. Summary • The IP Code amendment is one of the solutions that the Philippine government introduced to make medicines in the country cheaper and accessible to the public. • For the government, patents give many companies the chance to monopolize the market and affect prices of medicines. • The amendment uses the flexibilities of the TRIPS Agreement to address its national interests. • The amendments can pave the way for generics and beneficial for many Philippine local pharmaceutical companies. • Japan’s pharmaceutical industry is the perfect example on how patent system can help the local pharmaceutical industry to be competitive and stable.

26. Conclusion IP amendments and policies have significant effects on the pharmaceutical industry of different countries depending on the level of their technological development. • In Philippine context, changes in patentability requirements and policies can help build-up domestic capacity in manufacturing and R&D operations of the local industry. • Bolar provision and limiting of patentable invention can help promote development of R&D of local industry. • Compulsory licensing and parallel importation can open the doors for the transfer of technology to local industry • Patent activity of the local industry will not be significantly affected in the short-term perspective, however, a significant impact will be felt in the society and the over-all healthcare of the Filipinos. Good patent laws and policies will help in the development of the local industry, but this is not the only factor. Other factors to consider are the environment, human resources, development of technology and others.

27. Recommendations • Philippine pharmaceutical industry must learn from the Japanese experience on how its patent system played a major role in improving its local pharmaceutical industry. • Pharmaceutical companies must utilize the new policies to have their share of competition in the market. • Government agencies must safeguard the welfare of the public against those who might take advantage of the new policies like counterfeit drugs. • Government should support the local industry to encourage local investment.

28. Maramingsalamatpo! Arigato gozaimas!