Transcript Claimed limitation related to dosage/administration

Recent Developments in
Pharma Patent Case Laws in Japan
at GPIP
2015.09.28
Takanori ABE
Attorney at Law (JP&NY)
Guest Professor, Osaka University
Graduate School of Medicine
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Recent Developments in
Pharma Patent Case Laws in Japan
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MHLW’s promotion of the use of Generic Drugs- “80% generic” era IP Courts in Japan
New Criteria on Inventive Step
Product by Process Claim
Patent Term Extension
Combination Drug Patents
DOE of Process patent
Late pharmacological test results and disclosure
Later submitted experimental data and inventive step
Inventive step on dosage/administration
New Patent Opposition System
PITAVA trade mark infringement denied
Who assist Judges to understand technology?
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MHLW’s promotion
of the use of Generic Drugs
- “80% generic” era -
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Copyright 2010 Takanori ABE
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Copyright 2010 Takanori ABE
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Copyright 2010 Takanori ABE
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Copyright 2010 Takanori ABE
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Copyright 2010 Takanori ABE
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IP Courts in Japan
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Source：Court website
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IP High Court
• From April 2005
• Demand for Uniformity of Decision
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ＣＡＦＣ
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Pharma Patent Case Laws
in Japan
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New Criteria on Inventive Step
IP High Court 2009.01.28
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New Criteria on Inventive Step
IP High Court 2009.01.28
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Criticism by Judge Iimura
• Hindsight
• JPO can deny inventive step
with logics other than TSM test
and the EPO problem-solution
approach
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New Criteria on Inventive Step
• (i) in determining inventive step objectively, it
is necessary to understand the characteristic
point of the said invention, ie the problem to
be resolved by the said invention accurately.
• → similarity with the EPO’s problem-solution
approach
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New Criteria on Inventive Step
• (ii) it is insufficient that it can be presumed that
such person would have made an attempt by
which he/she could reach the characteristics of
the invention,
• but it is necessary that there is an implication or
the like suggesting that he/she must have made
such an attempt with the intention of reaching
the characteristics of the invention.
• →the suggestion; similarity with the TSM test
• →“must have made”; similarity with the EPO’s
could-would approach
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Practical Tips
• The patent invalidation rate BOTH in JPO and
courts
• Enforceability
• Accused infringers
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Winning rate in Tokyo district court
Source：Judge Shimizu’s article
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Product by Process Claim
Supreme Court 2015.06.05
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Medicinal Drug at Issue
• Pravastatin sodium salt
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Drugs for the treatment of hypercholesterolemia
Brand-name drug: Mevalotin
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Patent in Suit
• Teva owns a patent with a PBP claim
• “Pravastatin sodium substantially free of
pravastatin lactone and epi-pravastatin, and
compositions containing the same”.
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Product Identity Theory v.
Manufacturing Process Limitation Theory
• Adopted product identity theory
• Both in
 the gist of the invention of PBP claims
 the technical scope of the invention
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Clarity Requirement
• PBP claims are unclear
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whether the determination of the technical scope of
the invention and the gist of the invention would be
interpreted as being limited to the products
manufactured through the manufacturing process
• PBP claims are inappropriate as
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readers of the claims cannot understand the contents
of the invention clearly
it makes it harder to foresee the scope of the
patentee’s monopoly right
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Clarity Requirement
• clarity requirement might be satisfied
• only when “it was impossible or entirely
impractical” to directly specify the product by
means of the structure or feature of the
product
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Practical Tips
JPO
• JPO started to revise examination guideline
• New practice from October
• New practice will apply to future examination
and current one
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Practical Tips
Infringement v. Validity
• Product Identity Theory
• For patentee with PBP claims
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Strong infringement argument
Weak invalidity argument
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Practical Tips
Uniqueness
• Product identity theory both in
 the gist of the invention of PBP claims
 the technical scope of the invention
• To achieve uniformity
• Japanese practice differs from US one
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Practical Tips
Exceptionally Allowed
• PBP claims will be exceptionally allowed when
“impossible” or “entirely impractical”
• “impossible” =impossible for a person skilled in
the art primarily from the technical point of view
to directly specify the product
• “entirely impractical” = entirely impractical for a
person skilled in the art to directly identify the
product not because of the technical difficulty
but because of the waste of time and money
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Practical Tips
Prosecution
• Justice Yamamoto: most of the patents with PBP
claims may be rejected due to violation of the
clarity requirement
• Justice Chiba: applicants should also file an
application as to the invention of a process for
producing a product
• Death sentence to PBP claims
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Practical Tips
Invalidity arguments
• An invalidation action or defense against patents with
PBP claims may occur
• Justice Chiba: applicants should utilise correction of the
claims
• Justice Yamamoto: as applicants could not recognise
the “impossible” or “entirely impractical” criterion at
the time the patent was granted, such circumstance
should be carefully considered in the relevant lawsuits
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Patent Term Extension
IP High Court 2009.05.29/2014.05.30
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Former Practice of JPO and Precedents
• Patent term extension should not be allowed
• If the drug has the same active ingredient and
efficacies/effects as an earlier drug
• even though other characteristics of the drug
such as dosage form differ from the earlier
drug.
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Criticism on
Former Practice of JPO and Precedents
• Drug delivery systems (DDS)
• Unreasonable to reject the extension of the
duration of the patent right for such drugs.
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IP High Court, May 29, 2009
Pacif Case
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IP High Court, May 29, 2009/
Supreme Court, April 28, 2011
Pacif Case
• Patent term extension should be allowed
• because the earlier drug was not included in the
technical scope of the present invention
same active ingredient and efficacies / effects
patent
the earlier disposition
the later disposition
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Remaining Issue
• The Court’s opinion is unclear
• when the earlier drug is included in the
technical scope of the patented invention of
the present patent.
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IP High Court, May 30, 2014
Avastin Case
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IP High Court, May 30, 2014
• Patent term extension should be allowed
• where an applicant obtains a disposition
which differs in dosage or administration from
a prior disposition
• even if its effectiveness and efficacy are the
same as that of a prior disposition.
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Patent Term Extension
IP High Court 2009.11.19
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JPO
• JPO rejected patent term extension for 4 years
10 months 4 days
• JPO only allowed 1 month 24 days
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IP High Court
• IP High Court allowed 4 years 10 months 4
days
• Novartis could not practise the patented
invention during the period.
• Novartis followed MHLW’s instruction.
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Combination Drug Patents
Osaka District Court 2012.09.27/Tokyo District Court 2013.02.28
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Copyright 2015 ABE & PARTNERS
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Osaka District Court 2012.09.27/
Tokyo District Court 2013.02.28
• Denied indirect infringement.
• Defendants’ drugs did not fall under “any product
to be used for the producing of the said product”
• New criteria: regarding an invention of multiple
product combination, an existing component
would not fall under “indispensable for the
resolution of the problem by the said invention”
unless there are “special circumstances” such as
the existing component is produced or sold for
the invention.
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Practical Tips
• First case regarding indirect infringement of
combination drug patents.
• LCM strategy
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DOE of process patent
IP High Court 2016.12.24
Copyright 2014 Takanori ABE
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Medicinal Drug at Issue
• Maxacalcitol
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Drugs for Keratosis treatment
Brand-name drug: Oxarol
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Patent at Issue
• Maxacalcitol is manufactured through the following
two-step reactions starting from cis-type starting
material
First step reaction
base
Second step reaction
to open the epoxy ring
opening the ring of an
epoxy compound
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Accused process
cis isomer
Claimed process
trans isomer
Accused process
• No literal infringement due to the difference in
starting material
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Tokyo District Court
• Infringement under DOE
• Claimed invention and accused process have
the common measure to solve the problems
• accused process exploits the first step and
second step reactions
• whether starting material is cis-type or transtype is not significant from the view point of
the measure to solve the problem
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Practical Tips
• First DOE case for process patent
• Court does not determine the essential part of
the invention element-by-element basis
• Courts tend to broaden the scope of
equivalence by determining the essential part
of the invention at the level of the technical
concept
• LCM strategy using process patents
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Late pharmacological test results and disclosure
IP High Court 2010.01.28
Copyright 2014 Takanori ABE
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Late pharmacological test results
and JPO Examination Guidelines
• “Pharmacological test result or a statement
that should be deemed to be equivalent
thereto” is usually required for
• enable requirement and support requirement
of medical inventions
• Later submitted pharmacological test result
cannot overcome rejection
Copyright 2014 Takanori ABE
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JPO
• Boehringer Ingelheim
“use of Flibanserin for the treatment of a
sexual disorder”
• JPO examiner rejected
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Support requirement not satisfied
nothing to prove the usefulness of
Flibanserin in the detailed explanation of
the invention
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IP High Court
• “pharmacological data or a statement that
should be deemed to be equivalent thereto”
• Not necessary for support requirement
• support requirement and enablement
requirement are independent
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IP High Court
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obiter dictum
enablement requirement
even if there is no specific description,
the court should consider all the
circumstances
• decide whether a person skilled in the art can
understand the technical meanings and can
practice the invention
Copyright 2014 Takanori ABE
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Practical Tips
• Avoid the risk that pioneering inventions
would not be patented
• Put the brakes on JPO toward stricter
judgment standards
• However, JPO does not follow, but apply both
support requirement and enablement
requirement
Copyright 2014 Takanori ABE
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Practical Tips
• Foreign pharmaceuticals criticized JP practice
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not being in line with western practice
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difficult to pursue global IP strategy
• Obiter dictum imply late pharmacological test
result could be accepted
• even if there is no specific description in the
specification
Copyright 2014 Takanori ABE
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Later submitted experimental data and inventive step
IP High Court 2010.07.15
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Later Submitted Experimental Data
• P&G submitted the experimental data 1
during JPO appeal procedure.
• P&G alleged inventive step
Copyright 2014 Takanori ABE
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JPO
• JPO did not take into account the
experimental data
• In the specification
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only qualitative description regarding effects of
the claimed invention
No numerical data
Copyright 2014 Takanori ABE
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IP High Court
• The court can take into account later
submitted experimental data
• when a person skilled in the art is able to
recognise or presume the effects of the
invention from the description of the original
application
• as long as the effects do not exceed the
description
Copyright 2014 Takanori ABE
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Practical Tips
• Opened the door for the new evidence to be
accepted
• Promotes international harmonisation
• Problem that a patent granted in Western
countries would be rejected in Japan is solved
to a certain degree
Copyright 2014 Takanori ABE
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Inventive step on
dosage/administration
IP High Court 2016.12.24
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Medicinal Drug at Issue
• Zoledronic acid hydrate
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Drugs for the treatment of hypercalcemia
Brand-name drug: Zometa
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Patent application at Issue
1.2-(imidazol-1yl)-1-hydroxyethane-1,1-diphosphonic acid or
pharmaceutically acceptable salts thereof for use in the
treatment of bone metabolism disease, wherein 4 mg of 2(imidazol-1yl)-1-hydroxyethane-1,1-diphosphonic acid is to
be administered intravenously over a period of 15 minutes
to a patient in need of said treatment.
Red：Claimed limitation related to
dosage/administration
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JPO
• problem of the invention to be solved is reduction of an
adverse effect against kidney
• according to the examination guideline
• the invention is likely to be rejected due to lack of inventive
step
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IP High Court
• According to references 1 and 2 (results of
clinical trials phase 1 and 2) ,
• adverse effect by administering 4 mg
zoledronic acid at the duration of 5 minutes
was not confirmed.
• no motivation for ordinary skills in the art to
expand the duration of 5 minutes further
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Practical Tips
• Examination guideline was revised in 2009
• but dosage/administration claim is still
difficult to overcome rejections due to lack of
inventive step
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Practical Tips
• In line with recent judgement which requires
the problems to be solved need to be set
easily by ordinary skills in the art to reject due
to lack of inventive step
• Applicants should consider to allege the
problem of the invention to be solved is not
“well-known” in the guideline
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New Patent Opposition System
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PITAVA trade mark infringement denied
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Medicinal Drug at Issue
• Pitavastatin calcium salt
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Drugs for the treatment of hypercholesterolemia
Brand-name drug: Livalo
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Trade mark and accused mark
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Tokyo District Courts/IP High Courts
• 7 Tokyo district courts’ judgments
• 5 IP High courts’ judgments
• All denied trade mark infringement
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Tokyo District Courts/IP High Courts
• No “use” of the trade mark
• The portion of defendant’s product name is
attached to show the nature of the generic drug
• according to the notice of MHLW and Japan
Generic Medicines Association
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MHLW/Japan Generic Medicines Association
• MHLW
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generic drug’s name shall be generic name
to prevent medical accident caused by drug mix-up
• Japan Generic Medicines Association
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change from brand name to generic name for the generic
drug already approved before the MHLW’s notice
Strong demand from medical practitioners
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Practical Tips
• Judges viewed public interest to avoid medical
accident important
• IP ＜medical safety
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Practical Tips
• LCM strategy using trade mark right against
generic name
• Judge Shimasue
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Primary method should be patents
• Design or trade mark regarding PTP packaging
or packaging design
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Judicial Research Officials
• Research on technical matters
• Assist Judges to understand technology
Source：IP High Court website
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Technical Advisors
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Source：IP High Court website
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