This material shows the recent changes on the scope of protection of extended patent rights in Japan in the pharmaceutical field, based on an IP High Court Decision.

1. Hiroshi Higuchi
Allegro IP Law Firm
New Ruling on Scope of Protection
of Extended Patent Rights in JAPAN

2. 2
Disclaimer
The materials prepared and presented here reflect the personal
views of the author and do not necessarily represent any other
individuals or entities. Allegro IP Law Firm does not assume any
responsibility for the materials.
It is understood that each case is fact specific and the materials
are not intended to be a source of legal advice. These materials
may or may not be relevant to any particular situation.
The author, Allegro IP Law cannot be bound to the statements
given in these materials. Although every attempt was made to
ensure that these materials are accurate, errors or omissions
may be contained therein and any liability is disclaimed.

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Contents
• Patent Term Extension in Japan
• Main Issues
• Scope of Protection of Extended Patent Right
• Key Takeaways
• Related Topics

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Patent Term Extension in Japan
1. Overview
 Objective:
 To restore the period during which a patented invention was unable to be worked
because it was necessary to obtain an “disposition” ((i) Registration related to
agricultural chemicals; and (ii) Regulatory Approval related to pharmaceuticals)
 Basic Limitations:
 5 years at the maximum
 Pharmaceuticals, in-vitro diagnostic reagents, regenerative medicine products and
agrochemicals are eligible (not applied to intermediates, catalysts and
manufacturing apparatus)
[Patent Law Art. 67] (Duration of patent rights)
(i) The duration of a patent right shall expire … 20 years from the filing date … ; and
(ii) Where there is a period during which the patented invention is unable to
be worked because an approval or other disposition … is necessary to be obtained
for the working of the patented invention, the duration … may be extended … not
exceeding 5 years.

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Patent Term Extension in Japan
2. New Drug Development Process
Basic
Study
Non-
clinical
Study
Clinical Trial
Phase I, II, III
Examination
for Approval
Examination Non-enforceable
Protection
of Product
Patent Term
Extension
Patent
Application
Patent Right
Sales
9 years
20 years up to 5 years
IND Filing Regulatory Approval
Patent
Granted

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Patent Term Extension in Japan
3. Basic Requirements
 Applicant
Patent Holder
 Timing
 Before the original patent term expires
 Within 3 months of regulatory approval
 Disposition
 Disposition was necessary to be obtained for the working of the patented invention
 Patentee or Licensee obtained the disposition
 Patent Term to be Extended
 Start: when clinical trial is started or when patent is registered, whichever is later
 End: when applicant receives regulatory approval
 Official Fees
 JPY 74,000

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Comparison between JP and US Practices
JP US
Legal Basis Patent Act Hatch-Waxman Act
Maximum Extension 5 years 5 years
Extendable Patent(s) per
Product
Plural patents Only one patent
Number of Extension
Time(s) per Patent
Plural times Only once
Eligible Pharmaceuticals,
diagnostic reagents,
regenerative medicines,
agrochemicals
Drugs, food or color
additives, medical devices

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Main Issues regarding Patent Term Extension
1. Whether it was “necessary to obtain a disposition”
 Pacif Supreme Court Judgment (April 28, 2011):
If the earlier pharmaceutical, for which the earlier disposition was already obtained, is
not included in the technical scope of the patented invention, the Patent Term
Extension based on the later disposition is not denied.
Examination Guidelines revised in 2011
 Bevacizumab Supreme Court Judgment (November 17, 2015):
If the implementation of the pharmaceutical covered by the earlier disposition
includes that of the pharmaceutical covered by the later disposition, it was “not
necessary to obtain a disposition”.
Even if active ingredient and application of the prior and present pharmaceuticals are
identical, the necessity of the later disposition should not be denied so long as dosage
and administration are different.
Examination Guidelines revised in 2016 (current version)
2. Scope of protection of extended patent right
 Oxaliplatinum IP High Court Judgment: Debiopharm v. Towa Pharmaceutical
(January 20, 2017)

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Scope of Protection of Extended Patent Right
Overview of Oxaliplatinum Case
 Main Issues in this case:
I. Does Towa’s product fall within the scope of Debio’s patent (literally or
under DoE)?
II. Is Debio’s extended patent right effective against Towa’s products?
 Tokyo District Court said:
 Debio’s extended patent right is not effective against Towa’s products (Issue II)
(no decision on Issue I)
 IP High Court said:
 Debio’s extended patent right is not effective against Towa’s products (Issue II)
 Towa’s products do not fall within the scope of Debio’s patent (Issue I)

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Scope of Protection of Extended Patent Right
Overview of the patent at issue
 Japanese Patent No.: 3547755 (‘755 Patent)
 Patent Holder: Debiopharm (Swiss)
 International Filing Date: August 7, 1995
 Original Patent Term: August 7, 2015
 Extended Patent Term: January 29, 2020
 Claim 1:
A pharmaceutically stable preparation of oxaliplatinum for the administration by the
parenteral route, consisting of a solution of oxaliplatinum in water at a concentration of 1 to 5
mg/ml and having a pH of 4.5 to 6, the oxaliplatinum content in the preparation being at least
95% of the initial content and the solution remaining clear, colorless and free of precipitate after storage for a
pharmaceutically acceptable duration of time.
 Summary of History:
 1st Office Action Argument without amending claims Allowance
 3 Invalidation Trials
 7 Extensions

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Scope of Protection of Extended Patent Right
Towa’s Products:
Towa Product 1 Towa Product 2 Towa Product 3
Content/Vial 10 mL 20 mL 40 mL
Active Ingredient oxaliplatin
50 mg
oxaliplatin
100 mg
oxaliplatin
200 mg
Additive conc. glycerin
50 mg
conc. glycerin
100 mg
conc. glycerin
200 mg
Nature colorless and clear liquid
pH 4.0 – 7.0
Efficacy | Effects identical with Debio’s
Dosage | Administration identical with Debio’s

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Scope of Protection of Extended Patent Right
[Patent Law Art. 68bis] (Effect of patent right in the case of duration extension)
Where the duration of a patent right is extended …, 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 … (where the specific usage of the product is prescribed
by the disposition, the product used for that usage).
Fundamental Policy
The extended patent right is effective against the "working of the patented invention" for the
"product" specified by the "ingredients, quantity, dosage, administration, efficacy, and effects"
specified by a specific disposition.
Enlargement of Scope of Extended Patent Right
Extended patent right is effective … also against products which are substantially identical with
said "product" as a medicine.

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Scope of Protection of Extended Patent Right
• Substantially Identical?
Even if there is a part that differs from the subject product …, if said
part is merely a slight difference or formal difference as a whole, it is
reasonable to understand that the subject product is included in the
products which are substantially identical with the product … as a
medicine and falls within the scope of the extended patent right.
*Note: The IP High Court said that it is impossible to apply or analogically
apply the five requirements of the doctrine of equivalents in determining the
scope of being substantially identical.

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Scope of Protection of Extended Patent Right
4 types
IP High Court ruled where the products are recognized as being substantially
identical :
i. where … a different ingredient (not the active ingredient) is partially added,
converted, etc. based on well-known or commonly used art … in relation to a
patented invention which is characterized only by the active ingredient of a
medicine …;
ii. where … a different ingredient is partially added, converted, etc. based on well-
known or commonly used art … in relation to a patented invention pertaining to
stability or dosage form, etc. of a medicine with a publicly known active
ingredient, and the products are recognized as being identical with each other
in the technical features and function/effect in light of the content of the
patented invention;
iii. … only a quantitatively meaningless difference … in terms of the "quantity" or
"dosage and administration"; and
iv. … differ in the "quantity" … but are recognized as being identical with each
other in consideration of "dosage and administration".

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Scope of Protection of Extended Patent Right
• Comparison of Debio and Towa products
Towa
Product 1
Towa
Product 2
Towa
Product 3
Content 10 mL 20 mL 40 mL
Active
Ingredient
oxaliplatin
50 mg
oxaliplatin
100 mg
oxaliplatin
200 mg
Additive conc.
glycerin
50 mg
conc.
glycerin
100 mg
conc.
glycerin
200 mg
Debio
Product 1
Debio
Product 2
Debio
Product 3
Content 10 mL 20 mL 40 mL
Active
Ingredient
oxaliplatin
50 mg
oxaliplatin
100 mg
oxaliplatin
200 mg
"ingredients" include only
oxaliplatin and injectable
water and do not include any
other ingredients
"ingredients" include
concentrated
glycerin as an additive (stabilizer),
in addition to oxaliplatin and
injectable water
literally different
* “ingredients” are not limited to active ingredients

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Scope of Protection of Extended Patent Right
• Substantially Identical?
Specification of ‘755 patent recites:
the purpose of the invention can be attained by using an "aqueous solution of
oxaliplatinum that is free of any acidic or alkaline agent, buffer or other additive" and
"this preparation is free of any other ingredients and should, in principle, not contain
more than about 2% of impurities".
One of the technical features of the patented invention lies in the aqueous solution of
oxaliplatinum free of any additive
The difference in "ingredients" between the Debio products and the Towa products
cannot be considered as a slight difference or formal difference as a whole
Towa products cannot be considered to be included in those that are
substantially identical with the Debio products.

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Key Takeaways
 Extended Patent Right is effective against “substantially
identical” product
 IP High Court ruled 4 types where the products are recognized
as being “substantially identical”
 Patent Term Extension practice in Japan
Plural patents extendable based on one disposition
Plural extensions available per patent

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Related Topics
• Possible Revisions regarding Patent Term Extension under the TPP
The TPP requires member nations to allow patent applicants to request
adjustment of the patent term due to unreasonable or unnecessary delays
by the Patent Office.
Under the revised law, patent applicants may request adjustment (extension)
of patent term if:
(1) a patent takes more than five years to issue from the filing date;
or
(2) patent examination continues beyond three years from the date
of filing the request for examination;
whichever is longer.

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Hiroshi Higuchi
higuchi@allegropat.com
Allegro IP Law Firm
Thank you for your kind attention.