1. Linking Intellectual Property Rights to Drug Registration: Practices and Experiences Jose Maria A. Ochave, Esq. Philippine Judicial Academy Seminar on Data Exclusivity and Patent Linkage in FTA: Interpretation and Implications to Public Health, August 25, 2006, Rama Garden Hotel, Bangkok

2. Presentation Outline IPRs relevant to the Pharmaceutical Sector The Philippine Experience as a case Study in Anti Competitive Use of IPRs The Response of the Phillipine Bureau of Foods and Drugs Thai experiences requesting for patent linkage Concluding Remarks

3. IPRs Relevant to the Pharmaceutical Sector Patents  product patent (e.g., molecular, formulation, salt, enantiomer)  process (e.g., synthesis, purification)  Second use/new use, method of use Trademarks Copyright Undisclosed Information

4. The Philippine Experience as Case Study Market is 72% controlled by MNCs Recognition of importance of IPRS among local generic companies happened only about 5 years ago Easy to enforce IPRS in pharma. Sector IPRS have been used by some MNCs as tool to prevent competition Developing capacity of generic companies in patent infringement analysis and souring of non-infringing products  IP Code does not even contain TRIPS flexibilities

5. The Philippine Experience as Case Study Typical roadblocks against generic companies competition:  Threats of patent infringement suit  Interventions to prevent or delay product registration by alleging safety issue and “data exclusivity”  Marketing campaign to create doubts about safety of generic products and indirectly link them to fake medicines

6. Dragging BFAD into Debate The attempt to drag the Philippine drug regulatory authorities into IPR issues  Cefaclor case  Parallel importation by Philippine International Trading Corporation  Felodipine case  Sidenafil dispute  Amlodipine besylate incident

7. BFAD response DOH Administrative order No. 2005-0001, on Patent and trade secrets DOH Administrative Order No. 2005-0016, on Brand Name

8. Thai Experiences: Case I Patent relevant: New Finasteride Process Warning request from a law firm indicating that  it is possible that the Thai FDA may approve certain generic formulations incorrectly as the generic products are protected by a patent claimed  With respect to the FDA, it is recommend that the FDA withdraw the approved generic formulations

9. Thai Experiences: Case II Patent relevant: ezetimbe submitted information for registration of ezetimbe and fenofibrate combination therapy Action request  the FDA shall not approve any generic formulations containing ezetimbe as it is protected by a patent  the FDA shall not approve a third party marketing authorization for generic formulations containing eztimbe and fenofibrate combined therapy based on the information submitted by the original company before

10. Concluding Remarks. IPRs must be protected, but abuses of the system should be curtailed There is a huge economic incentive to prevent generic competition. Hence, the attempt to link IPRS and drug registration Drug regulatory authorities (DRA) are not in any position to protect IPRS on behalf of their owners. The principal mandate is safety, efficacy, and quality.

11. Concluding Remarks Transparency in drug registration process, while desirable, could be abused to prevent or delay generic competition. There are institutions outside the DRAs that can better address IPRs concerns In the Thai registration system, even no current legislation is allowed for patent linkage, requests from a law firm for providing its clients a patent linkage happened Both the industry and FDA must be well aware and should not be cheated by the law firm

12. Acknowledgment Mr. Jose M. Ochavem Esq. and colleagues for allowing to use the his slide presentation on patent linkage

13. Thank you