Korean Patent Practice - Pharmaceutical field -

1. Korean Patent Practice- Pharmaceutical field - Jonghyeok ParkMS., Ph.D.course Partner Pharmacist Patent Attorney Y. S. CHANG & ASSOCIATES May 2009

2. Presenter Mr. Jong-Hyeok Park Partner, Pharmacist, Patent Attorney • B.S., Pharmacy • M.S., Pharmacy • Ph.D. Course, Pharmacy

3. Ⅰ Basic Information ⅰ Patentable Subject Matters ⅱ Claim Description ⅲ Support requirement (Pharmacological data) Ⅱ PTE application ⅰ Outline of the PTE system ⅱ Extension period ⅲ Problems Ⅲ Issues regarding FTA ⅰ Patent-approval linkage ⅱ Data exclusivity ⅲ Patent Term Extension ⅳ Bolar exception ⅣLitigation - Case studies ⅰ PLAVIX® (clopidogrel bisulfate) ⅱ NORVASC® (amlodipine besylate) ⅲ Lipitor ®(atorvastatin) ⅳ ULTRACET® (tramadol/AAP) Contents

4. Patentable Subject Matters • Surgical and diagnostic methods practiced on the human are not allowed • A method of surgery • Treating method of a human beings including DNA therapy • Method of diagnosis for human beings • Exception • Medical treatment is allowed if a human beings is expressly excluded • Diagnosis method may be patentable if claim • does not contain the clinical decision step(i.e., deductive decision phase). • does not contain the surgical step which is practiced on human in order to collect data New System (From 2008)

5. Claim Description • “Use of compound for the use of treating ~” claim is not allowed • Instead, “Pharmaceutical composition comprising the compound for treating ~” should be used. • Medical use of a pharmaceutical composition must be recited in claims when claiming a pharmaceutical composition • Medical use should be specified by the specific diseases, e.g., treating pulmonary cancer, etc. • No functional expression, no reach through claim can be used in claims when specifying the medical use. • Contrary to the KIPO’s guideline, “angiogenesis inhibitor” has been exceptionally allowed by Supreme Court, but not normal practice.

6. Support Requirement(Data Requirement) • Specific pharmacological data are strictly required • Actual data such as IC50 values of individual compounds should be contained in originally filed specification • Simple description on pharmacological activity is not sufficient • Reasonable correlation between the pharmacological activity and the claimed medical use should be substantiated by data described in specification • Later submission of data is not allowed • Before 2000, supreme court allowed the applicant to submit such data during prosecution

7. Type of Inventions eligible for PTE only permitted for inventions pertaining to pharmaceutical products and agricultural chemicals Cosmetics, food additives, pigments, and medical instruments may not be entitled to PTE Deadline for filing PTE Within 3 months from the approval date except for the last six months from the expiry date of the original patent term Number of times of PTE One(1) extension is allowed per one patent A divisional application should be preferably filed during examination stage if two or more approval can be obtained If three patents for one approval, each of the patents is entitled to PTE Maximum amount of time that the patent can be extended 5 years Outline of the PTE system

8. Restoration Period • Calculated from the sum of “Period required to conduct clinical trial” and “period required to conduct regulatory review” • Can be reduced when the applicant fails to act with due diligence

9. Period required to conduct clinical trial in foreign country is not added to the restoration period. Restoration periods which global pharmaceutical companies has actually obtained are not that long, a few months. US-Bahrain FTA 15.9(6) Problems

10. Patent Linkage • US requests Korean government to introduce patent linkage, but in progress • Generic companies have to inform HIRA on when they will begin to sell the generic drugs, in case there is patent right covering the drug. • If an innovator company raises a legal measure against generic companies, 12 months stay will be obtained • Points at issue • Whether of not a confirmation trial should be included in the legal measure • Whether of not 12 months stay should be appropriate, too short?, too long?

11. Data exclusivity • There is no explicit provision regarding data exclusivity in Korean pharmaceutical affair act • However, as a practical matter, the KFDA has a reexamination system based on data exclusivity by which a pharmaceutical company that first obtains regulatory approval, can block a second company from obtaining a second, subsequent approval, for a certain product for a given period • 6 years for new drugs • 4 years for drugs having new medical use

12. Patent Term Extension • No issue • Korea has already PTE system which can meet US’s request • Clinical Trial conducted in Foreign countries • Maybe not easy

13. Bolar Exception • Article 96 (Limitations on Patent Right) • (1) The effects of the patent right shall not extend to the following: • Working of the patented invention for the purpose of research or experiment; • Vessels, aircraft or vehicles merely passing through the Republic of Korea or machinery, instruments, equipment or other accessories used therein; or • Articles existing in the Republic of Korea at the time the patent application was filed. • Therefore, generics manufacturers are allowed to manufacture the patented drug for the purpose of obtaining marketing approval before the patent protection expires. • Storage after obtaining approval does not constitute patent infringement(Patent Court, now pending before supreme court)

14. Blood Clot inhibitor Patent has been invalidated due to lack of an inventive step by PatentCourt Enatiomer : selection invention No unexpected effect is achieved by adapting one enantiomer from racemate Point at issue Of opinion that it does have an unexpected effect by adapting the salt of “bisulfate” Now, pending before supreme court PLAVIX® (clopidogrel bisulfate) Sanofi-Aventis vs. 17 Korean generic manufacturers

15. LEVOTENSION (S-amlodipine besylate dihyrate) Falls within the scope of the patent right relating NORVASC® (amlodipine besylate) because S-amlodipine besylate dihyrate is only one specific embodiments of amlodipine besylate. Patent right relating a compound can cover both anhydride and hydrate thereof But, later, this patent has been invalidated, same as United States NORVASC® (amlodipine besylate) Pfizer Inc. vs. Ahn-Gook Pharm. Co.,Ltd.

16. Patent covering Ultracet duly exists. A generic manufacture has filed an invalidation trial against the patent. More than 100 generic companies have applied for marketing approval for generic version of Ultracet® and obtained marketing approval. Now many kinds of generic version of Ultracet® are being sold. Waiting for the 1st instance decision If they are not successful in the invalidation trial, then? ULTRACET® (tramadol/AAP) Ortho-McNeil-Janssen Pharmaceuticals vs. 15 Korean generic manufacturers

17. Any Questions? Thank you very much