1. 2011/6/31 Legal Protection for Pharmaceutical Patents & Generic Drugs in Taiwan Sung-Mei Hsiung Judge, Intellectual Property Court, Taiwan J.S.D., U.C. Berkeley School of Law, U.S.

2. 2011/6/32 Outline ／ Topics The Role of Pharmaceutical Industries in Human Health The Role of Patents in Pharmaceutical Technology The Challenges of Pharmaceutical Patents in Taiwan The Role of Generic Drugs in Human Health A Tug of War between Pharmaceutical Patents and Generic Drugs

3. 2011/6/33 Outline ／ Topics The Competition of Pharmaceutical Patents and Generic Drugs in Taiwan The Protection of Pharmaceutical Patents in Taiwan The Measures of Facilitating Generic Drugs’ Entry in Taiwan The Judicial Role in Protecting Pharmaceutical Patents and Generic Drugs in Taiwan Case Study

4. 2011/6/34 The Role of Pharmaceutical Industries in Human Health The pharmaceutical industries drive innovation of new drugs, including the contraceptive pills, penicillin, vaccines and other antibiotics that have saved millions of lives over years. Health Care Policy ： Prevention v.s. Prescription

5. 2011/6/35 The Role of Pharmaceutical Industries in Human Health The pharmaceutical industries produce both patents drugs and generic drugs which are equivalent to pioneer drugs (patent drugs) containing same active ingredient as the patent drugs. Independent Inventor v.s. Research Fund

6. 2011/6/36 The Role of Patents in Pharmaceutical Technology Incentive for drug research: moneymaking product The importance of patent system in pharmaceutical technology field 30 yrs after the Chakrabarty Case (June 16, 1980, US Sup. Ct.) Prof. Ananda M. Charkrabarty U. Illinois at Chicago College of Medicine

7. 2011/6/37 The challenges of Pharmaceutical Patents in Taiwan Generally, pharmaceutical patents are protected based on the same rules as other kinds of patents. The challenges of patentable requirements: definiteness, enablement and non- obviousness ATORVASTATIN (LIPITOR)

8. 2011/6/38 The challenges of Pharmaceutical Patents in Taiwan The standard to decide the patentable requirements: A person having ordinary skilled in the art (PHOSITA): a hypothetical person

9. 2011/6/39 The challenges of Pharmaceutical Patents in Taiwan Factors that may be considered in determining level of ordinary skill in the art include: (1) the educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) educational level of active workers in the field.

10. 2011/6/310 The challenges of Pharmaceutical Patents in Taiwan “A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” “In many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” (KSR v. Teleflex, 550 U.S. 398, 2007)

11. 2011/6/311 The challenges of Pharmaceutical Patents in Taiwan Example: A patent related to the creation of a compound to treat ear infections without damaging a patient's hearing The PHOSITA shall be a pediatrician or an otologist ? v.s.

12. 2011/6/312 The challenges of Pharmaceutical Patents in Taiwan Types of Pharmaceutical Patents  Substance patent  Use patent  Process patent  Formulation patent  Crystal form patent  Salt hydrate patent  Medical Procedures?

13. 2011/6/313 The Role of Generic Drugs in Human Health The patent term that covered the pioneer drug’s active ingredient has expired. Market competition leads to substantially lower prices. public interest v.s. industries interest

14. 2011/6/314 A Tug of War Between Pharmaceutical Patents & Generic Drugs want to extend patent protection as long as possible want to enter the market as early as possible Pioneer drugs Generic drugs

15. 2011/6/315 The Competition of Pharmaceutical Patents and Generic Drugs in Taiwan Principle: Making a balance between patent protection & encouraging generic entry The Hatch-Maxman Act (1984, U.S.) Extending the patent term of pharmaceutical patents Facilitating generic drugs to enter the market

16. 2011/6/316 The Protection of Pharmaceutical Patents in Taiwan Ⅲ, Sec. 51, Patent Law (2010/8/25,Taiwan) The term of an invention patent right shall ends with 20 years from the filing date of the patent application. Ⅰ, Sec. 52, Patent Law(2010/8/25,Taiwan) Patents concerning pharmaceuticals, agrichemicals and their processes A patentee may apply for an extension of the patent term for 2 to 5 years (effected on 2002. 1.1)

17. 2011/6/317 The Measures to Facilitate Generic Drugs’ Entry in Taiwan Basically, application procedure for generic drugs is much simpler than for new drugs. Only three tests related to (1) standards and test methods, (2) stability, and (3) biological equivalence are required.

18. 2011/6/318 Experimental Use Exception Sec. Ⅰ, Art. 57, Patent Law (effected on2002/1/1) The effect of an invention patent right shall not extend to any of the following matters: 1. Where the invention is put into practice for research, educational or experimental purposes only, with no profit-seeking acts involved therein. Of course, generic drugs company is not non-profit… However, if the act is only for speeding up the generic drug to enter the market… The Measures to Facilitate Generic Drugs’ Entry in Taiwan

19. 2011/6/319 The Measures to Facilitate Generic Drugs’ Entry in Taiwan Experimental Use Exception Sec. Ⅴ, Art. 40-2 Pharmaceutical Affairs Law (effected on 2006/5/30) The protection offered by this Article does not apply to data (of a new patent drug to apply for the approval to enter the market) collected by non- patent holders for educational and clinical research purposes.

20. 2011/6/320 The Measures to Facilitate Generic Drugs’ Entry in Taiwan Experimental Use Exception The scope for experimental use is only for generic drugs entering the market sooner after the patent term expired. Not permitted if the purpose is to manufacture or sell generics before the expiration of the patent term Not permitted if the purpose is to manufacture stocks for selling generics after the expiration of the patent term

21. 2011/6/321 The Measures to Facilitate Generic Drugs’ Entry in Taiwan Data Exclusivity Protection for Pharmaceutical Drugs Exception Sec Ⅰ, Art. 40-1, Pharmaceutical Affairs Law (effected on 2006/5/30) For the purpose of protecting public interest, the central health competent authority may, where necessary, disclose the relevant information of a drug’s ingredients, instructions etc….

22. 2011/6/322 The Measures to Facilitate Generic Drugs’ Entry in Taiwan The Same Instruction Requirement Art. 20, Guideline for Registration of Medicines (effected on 2005/1/7) The instructions of the generic drugs shall be the same as the pharmaceutical patents Article 26, Pharmaceutical Affairs Law The term "instructions" as used in this Act shall refer to the instruction sheets accompanied with pharmaceuticals or medical devices.

23. 2011/6/323 Civil actions of the 1st & 2nd instance related to Patent Act Trademark Act Copyright Act Optical Disk Act Trade Secrets Act Fair Trade Act Others ‧ Criminal actions of the second instance related to IPR ‧ Excluding Juvenile criminal cases Administrative actions of the first instance related to IPR disputes Administrative Action Civil Action Criminal Action IP Court Jurisdiction The Judicial Role in Protecting Pharmaceutical Patents and Generic Drugs in Taiwan 智慧財產法院

24. 2011/6/324 Supreme Court (Civil & Criminal) The Judicial Role in Protecting Pharmaceutical Patents and Generic Drugs in Taiwan 2nd Instance Civil Action 2nd Instance Criminal Action 1st Instance Civil Action SupremeAdministrativeCourt 1st Instance Administrative Action Intellectual Property Office Intellectual Property Court Administrative Appeal 1st Instance Criminal Action District Court

25. 2011/6/325 The Judicial Role in Protecting Pharmaceutical Patents and Generic Drugs in Taiwan (statistics: July 1, 2008 to April 30, 2011) ) Type of IP Case Civil Action Administrative Action Criminal Action Number Patent1,114 472 01,566 Trademark 219 717232 1,168 Copyright 453 3488 944 Trade Secret 36 0 0 Others 517 47272 836 Total2,3191,2399924,550 Intellectual Property Court

26. 2011/6/326 The Judicial Role in Protecting Pharmaceutical Patents and Generic Drugs in Taiwan (statistics: July 1, 2008 to April 30, 2011) Technical FieldsNumber Electronic / Electrical Engineering 308 Computer Science 87 Mechanical Engineering 575 Civil engineering / Architecture 59 Chemistry / Chemical Engineering 113 Biotechnology Medicine 35 Industry Design 58 Total1,235

27. 2011/6/327 Case Study Case related to definiteness Case related to enablement Case related to non-obviousness Case related to crystal form patent Case related to experimental use exception Case related to extension of the patent term

28. 2011/6/328 Case Study Patent applicant ： U.S. Agouron Pharmaceuticals Inc. & Japan Tabacco Inc. Invention ： HIV protease inhibitors Independent Claim 1 ：

29. 2011/6/329 Case Study TIPO ： lack of definiteness & enablement requirements TIPC ： only one example could not describe enough how “R” or “R’ ” works; undue experiment are needed Not patentable (decided on 2010/7/1, no appeal)

30. 2011/6/330 Case Study Patent applicant ： U.S. Shering Corporation Invention ： Hydroxy-Substituted Azetidinone Compounds Useful As Hypocholesterlemic Agents US 2002/0019409 A1 ： Treating Allergic and Inflammatory Conditions In Taiwan, medical procedure is not patentable, so the applicant change the invention as a use patent and no priority right can be advanced in this case.

31. 2011/6/331 Case Study TIPO ： lack of non-obviousness requirement TIPC ： The use of the compound has known to PHOSITA = obvious Not patentable (decided on 2010/6/17, affirmed by the Supreme Administrative Court)

32. 2011/6/332 Case Study Patentee ： French Sanofi Aventis Opposing Party ： TW PharmaStar Invention ： Polymorphic Form of Clopidogrel Hydrogen Sulfate

33. 2011/6/333 Case Study The patentee is successful in defending Polymorphic Form 2 different from Form 1, and its effect at easier and more stable to make tablet is non- obviousness. TIPO ： Patent is valid. TIPC ： Patent is valid. (decided on 2011/3/10, appeal withdrawn on 2011/5/27)

34. 2011/6/334 Conclusion A balance between patent and competition policy will lead pharmaceutical patents and generic drugs become good friends in the market.

35. 2011/6/335 Vielen Dank Für Ihre Aufmerksamkeit! Sung-Mei Hsiung Judge, Intellectual Property Court, Taiwan J.S.D., UC Berkeley School of Law, U.S.