The document discusses three patent term extension cases in Japan regarding later drug approvals. The Intellectual Property High Court ruled that the Japan Patent Office (JPO) could not refuse extension applications without proving the patented invention's prohibition of use was not dissolved by marketing approval or that approved acts did not constitute working the invention. The court also redefined key terms, allowing later dosage form approvals to extend patent terms. This impacts pharmaceutical profitability but could delay patent law reforms until the Supreme Court rules on JPO's appeal.

1. YUASA AND HARA LAW, PATENT, TRADEMARK & DESIGN and ACCOUNTING TRADEMARK & DESIGN DIVISION ACCOUNTING & AUDITING DIVISION LAW DIVISION PATENT DIVISION Patent Term Extension: Case Law in Japan YUASA AND HARA LAW, PATENT, TRADEMARK & DESIGN and ACCOUNTING AIPLA 2009 Annual Meeting IP Practice in Japan Committee － Pre-meetingOctober 14, 2009 TRADEMARK & DESIGN DIVISION ACCOUNTING & AUDITING DIVISION LAW DIVISION PATENT DIVISION Koji Hirayama YUASA and HARA hirayama-ch@yuasa-hara.co.jp 1

2. 2 Life Cycle Management of Drugs Introductory Period Growth Period Maturation Period Declining Period Perform sales promotion activity Sales decrease due to a drop in market share and price Sales start Hit the market Sales expand Acquire profits to recoup research and development costs Patent Term Entry of Generic Drugs sales Sales Authorization by Government Profitability point time

4. Accelerate the start of sales by expediting authorization from government

7. 6 Brief Comparison – US v. JP *1 35 USC §§155-156 *2 Japanese patent law §67bis

8. 7 “Multiple patents” corresponding to one approval patent term expires extension period chemical substance patent patent term expires extension period medical use A patent patent term expires extension period production process patent All the patents individually extendible as long as there is a necessity to obtain an approval for the working of each of the patented inventions filing date filing date filing date time

9. 8 Brief Comparison – US v. JP *1 35 USC §§155-156 *2 Japanese patent law §67bis 8

10. 9 “Multiple approvals” corresponding to one patent patent term expires extension period 5 years maximum patent term 20 years extension period for medical use A extension period for medical use B Chemical substance patent Extension may be granted for each of the different medical uses filing date time

11. 10 Brief Comparison – US v. JP *1 35 USC §§155-156 *2 Japanese patent law §67bis 10

13. Marketing approval for drugs and pesticides

15. [An extended] patent right shall not be effective against any act other than the working of the patented invention for “the product” which was the subject of the approval […] (where the specific use of the product is prescribed by the disposition, the product used for that “use”). Section 68-2.

16. JPO’s Interpretation:

17. “product” “an active ingredient”

19. [W]hen approvals are granted to pharmaceuticals with the same active ingredient (product)andthe same efficacy / effect (use) and differing only in […] dosage forms, etc., patent term extension shall be granted on basis of the earliest approval only. Examination Guidelines Part IV 3-1-1(1)

23. Same active ingredient

24. Same efficacy / effect

26. Should “the product” in Section 68-2 (defining the scope of a patent right to be extended) be interpreted as “an active ingredient” ?18

29. (i) that “the disposition designated by Cabinet Order” does not dissolve prohibition of working of the patented invention; or

30. (ii) that acts whose prohibition is dissolved by “the disposition designated by Cabinet Order” do not fall within acts of working of the patented invention.

31. “product” means a product specified by “ingredient,” “amount,” and “structure” of the drug which is the subject of the disposition.

34. IP High Court vacates its own precedents.

35. Possible effects on Patent Law Reform

37. Need to pay attention to the progress before the S. Ct.

38. Whether a writ of cert is granted

39. If granted, how the S. Ct. decides the casesOR Trick or Treat ! Supreme Court 23

40. YUASA AND HARA LAW, PATENT, TRADEMARK & DESIGN and ACCOUNTING TRADEMARK & DESIGN DIVISION ACCOUNTING & AUDITING DIVISION LAW DIVISION PATENT DIVISION Thank you for your attention ! YUASA AND HARA LAW, PATENT, TRADEMARK & DESIGN and ACCOUNTING TRADEMARK & DESIGN DIVISION ACCOUNTING & AUDITING DIVISION LAW DIVISION PATENT DIVISION Koji Hirayama YUASA and HARA hirayama-ch@yuasa-hara.co.jp 24