Wang, Mei-hua Director General Intellectual Property Office MOEA, Taiwan June 2011

1. Pharmaceutical Issues in Patent Act Amendment in Taiwan Wang, Mei-hua Director General Intellectual Property Office MOEA, Taiwan June 2011

2. Outline

3. Number of Patent Applications for Medical Industry(2008~2010) *IPC classification related medical industry:A61B、A61C、A61F、A61G、A61H、A61J、 A61K、 A61L、A61M、A61N、A61P、A61Q

4. Patent Applications for Medical Industry by Nationality (2008-2010) *IPC classification related medical industry:A61B、A61C、A61F、A61G、A61H、A61J、 A61K、 A61L、A61M、A61N、A61P、A61Q

5. Basis for the Draft Amendment Making Amendments

6. Comprehensive Amendment

7. Amendment Timeline

8. Exceptions to Patent Rights Conferred Article 30 of TRIPS Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions : • do not unreasonably conflict with a normal exploitation of the patent • do not unreasonably prejudice the legitimate interests of the patent owner • taking account of the legitimate interests of third parties

9. Research and Experimental Exemptions

10. Explanation of Amendment Reference to §11(2) of German Patent Act and §60 (5)(b) of UK Patent Act, the limit on “with no profit-seeking acts ” is to be deleted. In consideration of the ambiguity of definition of “education” and for keeping fine balance between public interest and private interest, “educational” is to be deleted. The scope of the “[a]ctivities necessary for research or experimental purposes” shall not be broadened to beyond the purposes of research and experiment, avoiding impacting the patentees’ economic interest.

11. Pharmaceutical—Research and Trial Exemptions Patentee Patent term expiration Patent granted Generic drugs maker Exemption for trial Market approval issued Clinical trial The effects of patent right shall not extend to research, trial, and necessary acts thereof, which are conducted for the purpose of obtaining Pharmaceutical inspection and registration approval under the Pharmaceutical Act or obtaining market approval of pharmaceuticals from a foreign country. • To encourage the develop of generic drugs • To promote the develop of clinical trial industries

12. Explanation of Amendment Pharmaceuticals include medicines and medical devices. The trial exemption applies to both new drugs and generics. Covering pre-clinical trials and clinical trials for obtaining regulatory approval. All trial acts and the direct relevant acts thereof before or after applying for the regulatory approval for the purpose of obtaining regulatory approval are exempt from liabilities. However, acts irrelevant to obtaining regulatory approval are not covered, such as test in hospitals for procurement purpose.

13. Preparation of prescribed medicines

14. Explanation of Amendment Clarify that the original meaning of “prescriptions made by physicians” is “acts of preparing medicines in accordance with prescriptions made by physicians” Reference to §13(3) of German Patent Act, §69(3) of Japan Patent Act and §96(2) of Korea Patent Act.

15. Situations for Patent Compulsory Licensing—Current Law

16. No longer required to wait for a final and irrevocable decision by court or by the Fair Trade Commission Based on the presidential order or the authority’s decision Situations for Patent Compulsory Licensing—To be Amended In the event of national emergencies or other circumstances of extreme urgency Non-commercial use of a patent for enhancement of public welfare 《prerequisite》 In the event of an applicant's failure to reach a licensing agreement with the patentee concerned under reasonable commercial terms and conditions within a considerable period of time For practicing a plant variety For practicing a re-invention patent Act of restricting competition or unfair competition confirmed by court or a decision by the Fair Trade Commission

17. Issues Concerning Public Health Patentee A Countries lacking pharmaceutical production ability or with inefficient pharmaceutical production Taiwan generic drugs company export pharmaceutical(s)

18. Issues Concerning Public Health According to TRIPS §31bis： • Scope for applying for compulsory license • Qualification of the importing countries • Negotiating with the patentee concerned under reasonable commercial terms and conditions in advanceis required • Conditions to be observed by compulsory licensee while exporting • Amount of compensation • Exemption from liability against test data exclusivity

19. Relaxing the threshold for Patent Term Extension (Current law) A patentee can only apply for a two-to-five year extension of the patent term. (To be amended) Deleting the minimum two-year threshold Applications filed for patent term extension prior to the enactment of the amendment whose decisions have not been issued and whose patents are still in force at the time the amended act takes effect, the amended act shall govern.

20. Effect of Filing Extension Request Maximum 5 years The patent term shall be deemed having been extended if the Patent Authority has not issued a decision before the original patent expiration date. However, where the Patent Authority rejects such extension request, the patent shall expire at the original expiration date. deemed having been extended Original patent term： 20 years Filing date Expiration date Granted date Extension request is approved Request for extension

21. Conditions for Patent Term Extension Regulatory approval approval1 approval2 approval3

22. Scope to be Extended • The scope of a patent right, of which the patent term extension has been granted, is confined to the active ingredients and its relevant indication(s) stated in the regulatory approval concerned. 20 years from the filing date Extension period Scope of patent right : a method for preparing aspirin A method for preparing aspirin that treats hypertension Active ingredient: aspirin Indication: hypertension An application for patent term extension is filed and granted

23. Thank you