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

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

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

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

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

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

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

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

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

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

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

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

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.

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.

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

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;

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).

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

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.

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.

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

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.

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.

IPHC Decision 2014 IPHC Hei.25 (GyoKe) 10198, in May 2014 “Anti-VEGF “ Case on JP Patent No. 3957765 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)

IPHC Decision 2014 (cont.) IPHC Hei.25 (GyoKe) 10198, in May 2014 “Anti-VEGF “ Case on JP Patent No. 3957765 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.

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

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

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

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

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.

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

Summary

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

Thank you for your attention! Kazuaki TASAKA K-tasaka@tmlo.jp The Tokyo-Marunouchi Law Offices/ Nagasawa Patent Firm Thank you for your attention!