1. Patent Term extension in the Japan Patent system
10th International Seminar of MarkPatent.ORG on IP Rights
February.14-15, Ahmedabad INDIA
Patent Term extension in the Japan Patent system
Kazuaki TASAKA
The Tokyo-Marunouchi Law Offices/ Nagasawa Patent Firm

2. Outlines Global Trend of Patent Term Extension
Patent Term Extension of Japan
Patent Term Extension in World IP
Summary
Outlines

3. Global trend of patent term extension
Significance of Patent Term Extension
History of Patent Term Extension
Comparison between countries
Global trend of patent term extension

4. Significance of Patent Term Extension
Theory on Patent protection
Natural Right (Basic Right)
Property right
Beneficiary right
Industrial Policy
Compensation for disclosure (Japan)
Incentive for invention
Protection of excessive competition

5. Significance of Patent Term Extension (cont.)
Patent Term Extension (PTE)
Certain period for Exclusiveness
20 years from the filing
Unworkable period during Patent Term
Regulatory, etc.
Unfair between the patentees
Compensation of the unworkable period
Extension of the patent term

6. History of Patent Term Extension
“Hatch-Waxman amendments” in US
Drug Price Competition and Patent Term Restoration Act (1984)
Patent term extension for innovators
Bolar Provision, 35 U.S.C. §271 (e)
Non-infringement for generic manufacturers
Under “Safe Harbor provisions”
Balance between Innovators & GE
ANDA (Abbreviation New Drug Approval) System

7. History of Patent Term Extension (cont.)
PTE Introduction in Japan
Revision of Patent Act (1987)
Article 67, Paragraph 2
Maximum 5 years extension
Medicine & Agricultural chemicals
Bolar provisions
No revision in Patent Act
Supreme Court Decision (1999)
Working for filing an approval for a generic

8. History of Patent Term Extension (cont.)
Supreme Court Decision in 1999
Case No. Hei. 10 (JU) 153
Working of a patent Invention for the purpose of necessary experiments for the application of an approval of a generic drug under Article 14 of Pharmaceutical Affairs Law does correspond to the working under Article 69 of the Patent Act, so the working of the patent invention does not constitute an infringement of the patent.
24 court decisions during 1996 – 1999
Case No. Hei. 10 (JU) 153

9. Comparison between countries
USA
Drug Price Competition and Patent Term Restoration Act (1984), Part 2
Calculated Extended term
(Application for clinical test – Application for approval )×1/2 + (Application for approval – Approval )
Maximum 5 years
Restored period + remained term at the time of approval < 14 years
Only one time at the 1st approval, and one extension per one disposition

10. Comparison between countries (cont.)
United Kingdom (EU)
Regulation No.1768/92 on SPC (1993)
Calculated Extended term
Starts from Expiry of the basic patent, and during the period < (Period of Filing of the basic patent – Approval)
Maximum 5 years
Restored period + remained term at the time of approval < 15 years
1st approval for the “product”
ＥＵにおける医薬品及び診断薬のための追加保護証明（ＳＰＣ）に関する理事会規則No.1768/92

11. Comparison between countries (cont.)
Counties having the system
Japan, Korea
Singapore (Article 36A)
US, EU (UK, FR, GE, IT, IR, DN, BE, LU)
Countries not having the system
China
Malaysia, Philippines, Thailand, Indonesia, etc.
India
ＥＵにおける医薬品及び診断薬のための追加保護証明（ＳＰＣ）に関する理事会規則No.1768/92

12. patent term extension of japan
Japan Patent Act, Article 67
JPO Guidelines 1987
IPHC Decision in 2009
Supreme Court Decision in 2011
Revision of JPO Guidelines in 2012
IPHC Decision in 2014
patent term extension of japan

13. Japan Patent Act Article 67, Paragraph 1
The duration of a patent right shall expire after a period of 20 years from the filing date of the patent application.

14. Japan Patent Act (cont.)
Article 67, Paragraph 2
Where there is a period during which the patented invention is unable to be worked because approvals prescribed by relevant Acts that are intended to ensure the safety, etc. or any other disposition designated by Cabinet Order as requiring considerable time for the proper execution of the disposition in light of the purpose, procedures, etc., of such a disposition is necessary to obtain for the working of the patented invention, the duration of the patent right may be extended, upon the filing of a request for the registration of extension of the duration, by a period not exceeding 5 years.

15. Japan Patent Act (cont.)
3 Patterns of patent term extension
depending on the Date of Clinical Trial Start, Patent Registration, and Approval ① ↑ ↑ ↑ ↑ ↑ ⇑ ⇑
3 years
Application for NDA
Patent
Application
Patent
Registration
Starting
Clinical
Approval
for NDA
Patent Term
Extension ← →
3 years ② ↑ ↑ ↑ ↑ ↑ ⇑ ⇑
5 years
Patent
Registration
Application for NDA
Patent
Application
Starting
Clinical
Approval
for NDA
Patent Term
Extension ← →
6 years ③ ↑ ↑ ↑ ↑ ↑ ⇑ ⇑
3 years
Patent
Application
Starting
Clinical
Application for NDA
Patent
Registration
Approval
for NDA ← →
Patent Term
Extension
3 years

16. Japan Patent Act (cont.)
Article 67-3, Paragraph 1
Where an application for the registration of extension of the duration of a patent right falls under any of the following items, the examiner shall render the examiner's decision to the effect that the application is to be refused:
(i) where the disposition designated by Cabinet Order under Article 67(2) is not deemed to have been necessary to obtain for the working of the patented invention;
(iii) where the period for which the extension is requested exceeds the period during which the patented invention was unable to be worked;

17. Japan Patent Act (cont.)
Article 68-2
(Effect of patent right in the case of duration extension) :
Where the duration of a patent right is extended (including the case where the duration is deemed to have been extended under Article 67-2(5)), such 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 disposition designated by Cabinet Order under Article 67(2) which constituted the reason for the registration of extension (where the specific usage of the product is prescribed by the disposition, the product used for that usage).

18. Old JPO Guidelines 1987
Necessary for the Working of the Patented Invention
Important factor among the matters specified
product (or product and its use)
Earlier disposition
PTE based on a later disposition with active ingredient and efficacy/effect both identical as in earlier disposition shall be refused
Differing only in dosage form, manufacturing process,
Plural extensions may exist per one disposition or patent

19. IPHC decision 2009 IPHC Hei.20 (GyoKe) 10460, in May 2009
“Morphine Hydrochloride Capsule Case”
Broader scope of PTE
Not only concerning active ingredient or efficacy/effect but also concerning changes of formulations, etc., patent term extension can be granted.
“Interpretation of Article 68-2 by JPO is wrong”
Not “active ingredient” or “efficacy/effect”
“ingredient,” “dosage,” or “structure” of the medicine
Later PTE for Slow-releasing formulation having the same “ingredient” and “efficacy/effect of precedent PTE.
IPHC revocated the appeal decision of JPO.
JPO appealed to the Supreme Court.

20. Supreme Court decision 2011
Supreme Court Small Panel Hei. 21 (GyoHi) 326, in April 2011
“Morphine Hydrochloride Capsule Case”
Dismissed the appeal of JPO
In case antecedent to the present approval (disposition) a precedent approval (disposition) exists for the medicine with the active ingredient and efficacy/effect same as the present approval,
precedent medicine is not covered by any claim of the concerning patent
the patent extension of the concerning patent can be granted.
Hei. 21 (Gyo Hi) 324 – 326
patent relates to a release-controlling compositions
In case precedent drug is not covered by any claim of the concerning patent even if the drugs are the same in both active ingredient and efficacy/effect, the patent extension of the concerning patent can be granted.

21. Revised JPO Guidelines 2012
Judgment of Article 67-3 (1) (i)
Judgment whether “obtaining a disposition designated by the Cabinet Order was necessary”
the phrase “to work the patented invention”
should not be interpreted as an act of manufacturing and marketing or otherwise handling the DRUG PRODUCT per se that was the subject of the disposition

22. Revised JPO Guidelines 2012 (cont.)
the phrase “to work the patented invention”
should be interpreted as an act of manufacturing and marketing or otherwise handling such DRUG PRODUCT or as an act of manufacturing, importing, or otherwise handling such agricultural chemical that is defined by the "matters falling under the matters to define the invention" of the DRUG PRODUCT or the agricultural chemical that was the subject of the disposition.

23. Revised JPO Guidelines 2012 (cont.)
"matters falling under the matters to define the invention"
The "matters falling under the matters to define the invention" means all matters specified in the approval certificate or the registration card, etc. falling under the matters to define the patented invention.

24. IPHC Decision 2014 IPHC Hei.25 (GyoKe) 10198, in May 2014
“Anti-VEGF “ Case on JP Patent No
Precedent disposition
Active ingredient: Bevacizumab (recombinant)
Efficacy/Effect: Metastatic colorectal cancer…
Usage & Dosage: 5mg/kg or 10mg/kg iv, 2 weeks of dose interval
Present disposition
Additional Usage & Dosage
7.5mg/kg iv, 3 weeks of dose interval
Rejection under Article 67-3 (1) (i)

25. IPHC Decision 2014 (cont.) IPHC Hei.25 (GyoKe) 10198, in May 2014
“Anti-VEGF “ Case on JP Patent No
Revocation of the JPO Appeal Decision
JPO: Scope specified by “matters falling under the matters to define the invention” is workable by the precedent disposition
IPHC: Regarding the interpretation of Article 67-3 (1)(i), “to work the patented invention” of the revised JPO Guidelines (2011) is wrong
IPHC: “To work the patented invention” is the working acts of the medicine specified by the matters of Article 14 (1) or (9) of Pharmaceutical Affairs Law (ingredient, amount, usage, dosage, efficacy and effect)
JPO appealed to the Supreme Court and maintained the Examination Guidelines on PTE.

26. patent term extension in Global IP
North-South Divide under WIPO
WTO/TRIPs
TRIPs Flexibility
Two Streams in Global IP
Trend of FTA/EPA
By the way, where is the PTE positioned in the Global IP matters?
patent term extension in Global IP

27. North-South Divide under WIPO
IP protection
Progressed countries assert the strengthening
Progressing countries opposes
Access to medicines by nation
Development of the industries in those countries
Dispute between North & South in WIPO

28. WTO/TRIPs IP system in WTO TRIPs Agreement in 1995
IP protection is mandatory in each country
Grace period for Progressing countries
Article 65 & 66
e.g., Substance patent in India

29. TRIPs Flexibility Problem on the Access to medicines
Sub-Saharan countries
Anti-HIV, Anti-tuberculosis, Anti-tropical diseases drugs
Doha Ministerial Declaration
Assertion of TRIPs Flexibility
Compulsory License
Substance Patent in India

30. Two Streams of Global IP
After Breakdown of Negotiation in Doha Development Agenda
FTA and EPA
Between the countries and Territories
“TRIPs plus Approach” asserted by USA
Two streams in Global IP
TRIPs Flexibility
TRIPs plus Approach by FTA, EPA,etc.

31. Trend in TRIPs plus Approach
Bolar Provision
Protection of Data of Drug Approval
Patent linkage
Patent Term Extension

32. Summary

33. Summary Global Trend of Patent Term Extension
Patent Term Extension of Japan
Patent Term Extension in Global IP
Future of Patent Term Extension of Japan
Future IP of India

34. Thank you for your attention!
Kazuaki TASAKA
The Tokyo-Marunouchi Law Offices/ Nagasawa Patent Firm
Thank you for your attention!