Patent Term Extensions and Supplementary Protection Certificates (SPCs) Latest developments in Japan

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1 AIPPI Congress Toronto (2014) Workshop Pharma 3 (Patent Term Extension) Patent Term Extensions and Supplementary Protection Certificates (SPCs) Latest developments in Japan Tsuyoshi Sueyoshi, Ph.D., attorney-at-law YUASA and HARA 1

Protection Certificates (SPCs) Latest developments in

2 Contents Judgment of IP High Court Grand Panel (substantially en banc) on May 30, 2014 in the Genentech v JPO case - IP H. Ct. denied the JPO s guideline. - IP H. Ct. shows its own constructions. (Yuasa and Hara* represented Genentech in this case. (*Kozo Yabe, Tsuyoshi Sueyoshi, Takumi Terachi and Akiko Nakahama) Provisions of the Japanese Patent Act. Development in construction - History and changes in practice 2

(Yuasa and Hara* represented Genentech in this case.

3 Background A patent can be extended in multiple times. Patent Scope (Compound A For anticancer) registration Approval (colon) Approval (lung) Expiration Separately extended in each scope. Extension Requirements of multiple extension has not been clear. (Wording of the Patent Act is unclear.) An approval causes extensions in multiple patents. An approval (Active Ingredient: Compound A Indication: Hiperlipemia) Extension in patent of Compound A Extension In patent of use invention (HL) 3

each scope. Extension Requirements of multiple extension has not been clear. (Wording of the Patent Act is unclear.

4 Disputes in construction of provisions of the Patent Act Q1 How should we define the scope of rejection derived from prior approval? Approval: Specific product (point) Patent Scope Approval I Approval II Scope of Rejection Certain range Scope of Rejection registration Expiration Extension Allowance or rejection of extension by Approval II depends on scope of rejection of Approval I. Q2 How should we define the scope of extended patent? Should scope of rejection be the same as scope of extended patent? Patent Scope Approval Scope of Rejection Extended Scope of patent 4

Expiration Extension Allowance or rejection of extension by Approval II depends on scope of rejection of Approval I.

5 IP H. Ct. (Grand Panel), May 30, 2014 Facts(1) Two approvals are rendered for different dosages of Avastin (bevacizumab) in colon cancer. (Active ingredient and indication are in common.) Both of the products of the 1 st approval and 2 nd approval fall under the scope of patent. 5

6 IP H. Ct. (Grand Panel), May 30, 2014 Facts(2) FOLFOX + Avastin; 2 weeks/cycle (1 st approval) Avastin:5mg/kg i LV, L-OHP (Day 1) 5-FU (IV; 46hrs) (Day 1&2) No dosage (Day 3 to 14) XELOX + Avastin; 3 weeks/cycle (2 nd approval) Avastin:7.5 mg/kg i LV, L-OHP (Day 1) Capecitabine (oral administration) (Day 1 to 15) No dosage (Day 16 to 21) 6

7 IP H. Ct. (Grand Panel), May 30, 2014 Answers in Q1 and Q2 A1 Scope of rejection derived from the 1st approval (Allowance of patent term extension on the basis of the 2 nd approval) Patentee can obtain patent term extension if at least one of ingredients (active or non-active), an amount (of an ingredient), dosage-administration and indications is different from those of the 1 st approval. A2 Scope of extended patent Defined by ingredients (active and non-active), dosageadministration and indications + equivalents and substantially identical products. 7

the basis of the 2 nd approval) Patentee can obtain patent term extension if at least one of ingredients (active or non-active), an amount

8 IP H. Ct. (Grand Panel), May 30, 2014 Tentative practice under the judgment Patentee can obtain multiple patent term extensions in a stepwise manner for a patent (ex. each dosage-administration). Scope of extended patent for each extension is segmented. Future court cases are necessary for clarifying the scope of equivalents and substantially identical in infringement of extended patent (Does equivalents mean bioequivalence of generics?). It is desirable to file patent term extension application for each pharmaceutical approval. We are waiting the judgment of the Supreme (the JPO filed a request of acceptance of final appeal; the judgment has not become final or binding.). 8

Future court cases are necessary for clarifying the scope of equivalents and substantially identical in infringement of extended patent (Does equivalents mean

9 Problems in construction of provisions Relationship between three factors Approval Pharmaceutical Affairs Act Article 14-1, 2, 9 Reason for Rejection (for subsequent approval) Article 67-3, paragraph 1 Scope of Extended Patent Article 68-2 No Explicit Relationship among (i) product of prior approval, (ii) reason for rejection and (iii) scope of extended patent. Wording is not clear. 9

Article 67-3, paragraph 1 Scope of Extended Patent Article 68-2 No Explicit Relationship among

10 Provisions of the Patent Act (1) Overview The provisions were introduced in (substantially) No amendment after Article 67, paragraph 2 [Basic provision; Period, Disposition by Authority] Extended Period: 5 years at maximum. When a patentee or licensee has a period in which he/she cannot perform patented invention because he/she needs to obtain approval or any other disposition designated by Cabinet Order ( Disposition Designated by Cabinet Order ) (ex. pharmaceutical approval), the patent term can be extend for such period. 10

When a patentee or licensee has a period in which he/she cannot perform patented invention because he/she needs to obtain approval or

11 Provisions of the Patent Act (2) Reason for Rejection (1) Article 67-3, paragraph 1, (i) to (v) (i) where the Disposition Designated by Cabinet Order (ex. pharmaceutical approval) is not found to have been necessary to obtain for the working of the patented invention; The wording of not necessary has no clear definition. Relationship between Disposition Designated by Cabinet Order and patented invention is not clear. The term active ingredient or indication is NOT used. 11

pharmaceutical approval) is not found to have been necessary to obtain for the working of the patented invention; The

12 Pharmaceutical approval Name Ingredients (active or non-active) Amount Dosage and administration Indications Side effects and other quality matters Efficacy Safety stipulated under the Pharmaceutical Affairs Act (Article 14(2)(iii), 14(1) and (9)) Provisions of the Patent Act (3) Reason for Rejection (2) Patented Invention Constituent Features specified by each Different patentee Concept! 12

Pharmaceutical Affairs Act (Article 14(2)(iii), 14(1) and (9)) Provisions of the Patent Act (3)

13 Provisions of the Patent Act (4) Scope of Extended Patent Article 68-2 Scope of extended patent is defined by the product used for the usage of the Disposition Designated by Cabinet Order Product and Usage has no clear definition. Product: Usage: Approved product? Active ingredient? Indication? Dosage-Administration? 13

Designated by Cabinet Order Product and Usage has no clear definition.

14 History and development of practice 1987 Introduction of PTE system JPO s 1 st guideline,which was affirmed by high court in a long period Reason for Rejection = Scope of Extended Patent Product = Active Ingredient, Usage = Indications Judgment of IP H. Ct., May 29, 2009 Judgment of S. Ct., Apri.28, st guideline was denied. JPO s 2 nd guideline 2014 Here! Judgment of IP H. Ct. (Grand Panel), May 30, nd guideline was denied. JPO filed petition of writ of certiorari with S. Ct. 14

Judgment of IP H. Ct., May 29, 2009 Judgment of S. Ct., Apri.28, 2011 1 st guideline was denied. JPO s 2 nd guideline 2014 Here!

15 1 ST guideline of JPO(1) Overview Practice was governed by the 1 st guideline for a long period. A2: Scope of rejection = Scope of extended patent. Patent Scope Approval Scope of Rejection & Scope of extended patent A1 Scope of rejection(=scope of extended patent) is defined by (i) active ingredient and (ii) indications. Product in Article 68-2 Use in Article 68-2 = active ingredient = indications 15

Patent Scope Approval Scope of Rejection & Scope of extended patent A1 Scope of rejection(=scope of

16 1 ST guideline of JPO(2) Problem When the product of prior approval is outside the scope of the patented invention: Patent Scope (DDS; Applicable to various active ingredients) Approval I (non-dds) Rejected! Approval II (DDS) Scope of Rejection by Approval I (Defined by Active Ingredient & Indication) (* Approval 1 & 2 have active ingredient and indication in common.) No patent term extension is available for DDS technology, even if DDS improves QOL. 16

Approval II (DDS) Scope of Rejection by Approval I (Defined by Active Ingredient & Indication) (* Approval 1 & 2

17 IP H. Ct., May 29, 2009 & its final appeal (S. Ct., April 28, 2011) When the product of prior approval does NOT fall within the scope of any claim of the patent, patent term extension of subsequent approval should NOT be rejected on the basis of the prior approval. (Judgment of S. Ct., April 28, 2011) S. Ct. denied the 1 st guideline at least under the situation above. JPO released the 2 nd guideline on December 28,

18 2 nd guideline of JPO(1) Basic Concept Picking-Up of examination-approval items under the Pharmaceutical Affairs Act through features of patented claim (claim works as filter). (* Exception: Indications should be always picked up regardless of features of claim) Examination-Approval Ingredients Amount Dosage and administration Indications Side effects and other quality matters Efficacy Safety Claim (as filter) Compound A (novel compound) (No feature) (No feature) Blocked! No pick-up Exception Blocked! No pick-up Scope of rejection & extended patent Compound A Approved indications 18

(* Exception: Indications should be always picked up regardless of features of claim) Examination-Approval Ingredients Amount Dosage and

19 2 nd guideline of JPO(2) Problem(1) Features of claim are at the discretion of patentee. Picking up process can depend on claim-drafting. Examination-Approval Ingredients Amount Dosage and administration Indications Side effects and other quality matters Efficacy Safety Claim (as filter) Compound A (novel compound) 1pg to 10g/kg day (No feature) Blocked! No pick-up Scope of rejection & extended patent Compound A Approved dosage Approved indications Narrowly segmented 19

Examination-Approval Ingredients Amount Dosage and administration Indications Side effects and other quality matters

20 2 nd guideline of JPO(3) Problem(2) Scope of rejection & extended patent can depend on claim-drafting. Patent Scope Approval I Approval II Patent Scope Approval I Approval II Wide scope defined by Active ingredient, Indications Narrow scope defined by Active ingredient, Indications, Dosage IP H. Ct. dismissed the 2 nd guideline of JPO. 20

Patent Scope Approval I Approval II Patent Scope Approval I Approval II Wide scope

21 IP H. Ct. (Grand Panel), May 30, 2014 Answers in Q1 and Q2 A1 Scope of rejection derived from the 1st approval (Allowance of patent term extension on the basis of the 2 nd approval) Patentee can obtain patent term extension if at least one of ingredients (active or non-active), an amount (of an ingredient), dosage-administration and indications is different from those of the 1 st approval. A2 Scope of extended patent Defined by ingredients (active and non-active), dosageadministration and indications + equivalents and substantially identical products. 21

22 Thank you! Tsuyoshi Sueyoshi, Ph.D., attorney-at-law Section 206, New-Ohtemachi Building, 2-1, Ohtemachi 2-chome, Chiyoda-ku, Tokyo , Japan Main Telephone: Main Facsimile:

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