IP Enforcement in
Japan
Nae MATSUDA
Patent Attorney
NAKAMURA & PARTNERS
Tokyo, Japan
October 2013
1
Table of Contents
I.
II.
III.
IV.
V.
Current Situation of Patents and
Chemical Technology in Japan
IP Enforcement in Japan:
Overview and Characteristics
Risk of Invalidity
Interpretation of the Technical Scope
of a Patented Invention
Recent Court Cases
2
I. Current Situation of Patents and
Chemical Technology in Japan
3
Patent Applications in Japan
Data from JPO
4
Chemical technology is…

A tool for creating a novel material and for changing
the material into another.




The material is born from a finding in a laboratory.
The material itself is placed in a market.
The changing process is scaled up to be industrialized.
Used in wide area of industry
Impact on developments of other industries!
5
Chemical industry in Japan is….

2nd-largest industry behind automobile
industry!

Inseparably connected with various industries.
Economic Boost ?!
“Abenomics”
Tokyo Olympic in 2020
Chemical Patents will be more actively utilized.
6
II. IP Enforcement in Japan:
Overview and Characteristics
7
Solution for Solving Dispute

Judicial? Administrative? Others?
Warning letter
 Infringement Action

• Injunction
• Regular Action / Preliminary Action
• Damages
ADR
 Customs

8
Infringement Action

Injunction
 Regular Action or Preliminary Action
 Injunction order will be granted
if there is infringement.
 No equitable consideration

Damages
9
Organization & Exclusive Jurisdiction
Final Instance
2nd Instance
1st Instance
*
*
Supreme Court
Intellectual Property High Court
(4 Divisions)
OSAKA District Court
TOKYO District Court
(2 IP Divisions)
(4 IP Divisions)
* Non-technological cases such as design, trademark or copy rights can be handled by
other district courts and high courts.
10
Intellectual Property High Court





Established on 01 April 2005
Exclusive jurisdiction for appeals against
decisions issued by Tokyo and Osaka
District Courts for the IP civil cases.
4 Divisions, each has 4-5 judges who are
well-experienced in IP litigation
Normal panel consists of 3 judges.
Grand panel consists of 5 judges, including
4 presiding judges of each division.
 For unification of IP decisions
11
Intellectual Property High Court

Judicial Research Official
 Participates in proceedings of all cases
 Carries out research on necessary mattes for
examination.
 Has technical knowledge in general and is familiar
with the patent prosecution.
• Explanations may NOT be adapted as evidence.

Technical Advisor
 May participate in a dispute over highly specialized or
advanced technology.
 Provides easy-to-follow explanations on expert
knowledge to judges and parties.
 ca.200 including university professors, researchers at
public or private institutes, or patent attorneys.
• Explanations may NOT be adapted as evidence.
12
How long does it take at 1st Instance?
Filed
Concluded
(Number
of of
Cases)
Number
Ave. Time Interval
Month
Average in all IP cases
including Patents,
Design, Trademark,
Copyrights, etc.
Cases
2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Data from IP High Court.
13
How long does it take at 2nd Instance?
Filed
Concluded
Concluded
Number of
Cases
Ave. Time Interval
Month
Average in all IP cases
including Patents,
Design, Trademark,
Copyrights, etc.
2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Data from IP High Court.
14
Litigation Proceeding
Plaintiff
Complaint
Court
Arguments & Evidence
Hearing
Scheduled
Examination
of
Evidence
Discussion
over issues
and evidence
Decision
Arguments & Evidence
Written Reply
Defendant
Settlement
recommended
Settlement Reached
15
Model Timetable
Action
Filed
at Court
1st
Hearing
5th
Hearing
Decision
Reply
Dispute
arises
1 wk
1 to 1.5 M
1 to 2 M interval
• Infringement Issues
2M
Damage Issues
•Claim Construction by Court
•Literal Infringement
•Doctrine of Equivalents
• Invalidity Issues
16
After Consideration of
Infringement & Invalidity Issues



Court attempts to make parties settle the case.
 ca. 1/3 of all cases are settled.
If settlement fails or if no infringement exists,
court declares the hearing closed.
If infringement of a valid patent exists, damages are
determined.
 “Patentee’s profit per unit × number of infringing
products” (Art.102(1) of Patent Law)
 “Infringer’s profits” (Art.102(2) )
 “Reasonable royalty” (Art.102(3) )
• Not cumulative, in principle.
17
III. Risk of Invalidity
18
Risk of Invalidity
- Kilby Case dramatically changed the IP world!

Before Kilby
Not allowed to consider validity
 “Narrow Interpretation”, only when it is
very very clear that the patent is to be
invalidated, or
 wait for the decision of invalidation
trial to be made by JPO.

19
Kilby Case

Supreme Court Decision (11 April 2000)

Kilby Patent was issued in violation of the
requirements for divisional application.
• Highly probably to be invalidated by JPO.


Claim based on Kilby Patent is prohiibited as
“ABUSE of RIGHT”.
Court is allowed to consider if patent is valid
or not.
20
After Kilby

Art.104-3 newly introduced on April 2005
“In patent infringement litigation, the patentee shall not
exercise his/her patent right to the other person, where
the patent is considered to be invalidated in a patent
invalidation trial.”

Arguments on Patent Invalidity as Defense

Courts have been very active in finding that patents
shall be invalid in patent infringement litigations.
 No presumption of validity.
21
Invalidation Trial at JPO


Patent can be totally invalidated only in an
Invalidation Trial at JPO.
Even when a court considers that the patent
is to be invalidated during patent
infringement litigation, the patent is still
alive. The effect of court decision applies
only to the parties.
Invalidation Trial
at JPO
invalid
retroactively
extinguished
valid
alive
Consideration of
validity at Court
valid
alive
invalid
alive
22
Unfavorable to Patentee?
Filed
Concluded
(Number
Cases)
Numberofof
Cases
Ave. Time Interval
Month
Average in all IP cases
including Patents,
Design, Trademark,
Copyrights, etc.
Art.104-3
IP High Court
2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Data from IP High Court.
23
From Negative to Positive to Patentee
Invalidation Trial at JPO
Year
Filed
Concluded
Valid
Invalid
2007
2008
2009
284
292
257
224
274
246
82
92
123
142
182
123
Valid/
Concluded
(%)
37
34
50
2010
2011
2012
237
269
217
231
231
217
129
140
144
102
91
73
56
61
66
Appeal against Trial Decisions made by JPO
Data from JPO
Filed
Concluded
137
182
174
153
158
165
108
99
107
93
101
105
Decisions
Maintained
79
72
78
68
75
74
(73%)
(73%)
(73%)
(73%)
(74%)
(70%)
Decisions
Canceled
29
27
29
25
26
31
(27%)
(27%)
(27%)
(27%)
(26%)
(30%)
24
IV. Interpretation of the
Technical Scope of a Patented
Invention
25
Interpretation of Technical Scope of
Patent

Literal Interpretation





Based on statements in the scope of claims (Art.70(1))
In view of the description of a specification (Art.70(2))
Prosecution history may be considered.
Standard of Technology at the filing date also to be
considered.
Doctrine of Equivalents
Supreme Court in “Ball Spline case” dated 24 Feb 1998
<<Five Conditions for equivalents>>





1. Non-Essential element
2. Capability of Replacement
3. Obviousness of Replacement
4. “The defense of the free state of art”
5. Prosecution History Estoppels, etc.
26
V. Recent Court Decisions
27
Product-by-Process Claim
Teva v. Kyowa Hakko Kirin
IP High Court, Grand Panel, H22 (NE) 10043, 27 Jan 2012

Claim 1 of JP 3737801 B:
Pravastatin sodium with less than 0.5% (w/w)
contamination by pravastatin lactone and less than
0.2% (w/w) contamination by epiprava, prepared by a
process comprising the steps of:
a) forming a concentrated organic solution of
pravastatin;
b) obtaining pravastatin as a pravastatin
ammonium salt;
c) purifying the pravastatin salt by
recrystallization;
d) transposing the cation of the pravastatin
ammonium salt to pravastatin sodium; and,
e) isolating pravastatin sodium.
28
Product-by-Process Claim
Teva v. Kyowa Hakko Kirin
IP High Court, Grand Panel, H22 (NE) 10043, 27 Jan 2012



Technical scope of patent shall be determined dependent
on the process by which it has been obtained, unless
there were any bars which made it impossible or difficult
to directly define the product by its structure or property at
the filing date.
No infringement exists
Patent is invalid
*Current JPO Practice
Patentability of “product by process” claims are
considered, independent of the process by which it has
been obtained.
29
Combination of Medicines
Takeda v. Sawai et. al.
Osaka District Court, H23(WA)7576, 7578
Tokyo District Court, H23(WA)19435,19436
Patent 1:
“Medicine comprising A in combination with B.”
 Patent 2:
“Medicine comprising A in combination with C.”


Accused product:
Medicine comprising A.

Indirect infringement – not exist
30
Patent Term Extension of Pharmaceutical Patent
Takeda v. JPO
Supreme Court, H21(Gyo-Hi)326, 28 April 2011

Before Takeda


When earlier market approval and later market
approval are the same in terms of active
ingredient & effect/efficacy, Patent Term
Extension based on the later market approval
is NOT granted.
Later market approval is required, if, e.g., a
dosage form is different from that of the
earlier approval, even when the active
ingredient & effect/efficacy are the same.
31
Patent Term Extension of Pharmaceutical Patent
Takeda v. JPO
Supreme Court, H21(Gyo-Hi)326, 28 April 2011

Supreme Court Decision
“…in the case where the earlier medicine
does not fall within the scope of the
patent, it shall not be said that the later
market approval is recognized as being
unnecessary to be obtained in order to
work the patent due to the earlier market
approval.”
32
Patent Term Extension of Pharmaceutical Patent
Takeda v. JPO
Supreme Court, H21(Gyo-Hi)326, 28 April 2011

JPO practice After Takeda


Examination Guideline was revised in 28 Dec
2012.
Patent Term Extension may be allowed, when
a partial change of market approval is made.
• favorable to originator companies

Patent Term Extension may not be allowed, in
case of a product-by-process claim, when the
process for preparing a claimed medicine (or
active ingredient) differs from the process of
market approval.
• favorable to generic companies
33
Thank you for
your attention!