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YUASA AND HARALAW, PATENT, TRADEMARK & DESIGN and ACCOUNTING
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YUASA AND HARALAW, PATENT, TRADEMARK & DESIGN and ACCOUNTING
YUASA AND HARALAW, PATENT, TRADEMARK & DESIGN and ACCOUNTING
AIPLA 2009 Annual MeetingIP Practice in Japan Committee - Pre-meeting
October 14, 2009
Koji Hirayama
YUASA and HARA
Patent Term Extension:Case Law in Japan
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YUASA AND HARALAW, PATENT, TRADEMARK & DESIGN and ACCOUNTING
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Life Cycle Management of Drugs
Introductory Period Growth Period Maturation Period Declining Period
Perform sales
promotion
activity
Sales decrease
due to a drop in
market share
and price
Sales start
Hit the market
Sales expand
Acquire profits to
recoup research
and development
costs
time
sales
Profitability
point
Patent Term
Entry of
Generic Drugs
Sales
Authorization
by Government
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Life Cycle Management of Drugs (cont’d)
Introductory Period Growth Period Maturation Period Declining Period
“Gross Sales”Authorization
by Government
Entry of
Generic Drugs
• How to Maximize “Gross Sales” ?
• Accelerate the start of sales by expediting
authorization from government
• Delay the entry of generic drugs by “patent
term extension”
“Gross Sales”
Patent Term
Extension
Expediting
authorization
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Concept of Patent Term Extension
• If the patented invention could not be worked for the
necessity of obtaining a marketing approval provided
under legal regulations designed for ensuring product
safety
Ex. Drug, Pesticide (Japan)
• Benefit of exclusive rights cannot be enjoyed despite
the validity of patent rights.
• Such situations pose problems affecting the basis of
the patent system, and a measure of extending the
patent terms is necessary in order to resolve the
situation.
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Patent Term Extension System
registration
date
filing date clinical
trial
starting
date
approval by
government
20 years
from
filing date
whichever
is later
extension
period
0 < extension period ≦ 5 years
extension
period
Patent Term
working of the
patent right
prohibited
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US *1 JP *2
Products applicable for
patent term extension
drugs, medical equipment,
food additives, artificial
colors
drugs, pesticides
Term to be extendedup to 5 yrs
(within 14 yrs from approval)up to 5 yrs
Patent(s) extendible
based on one approval
only one patent
chosen by applicant
one or more patents
relating to approved
product
Number of times for one
patent to be extendedonly once no limitation
Effect of extended
patent right
Limited to approved product,
but including a later-approved
use
Limited to approved
product and use
*1 35 USC §§155-156 *2 Japanese patent law §67bis
Brief Comparison – US v. JP
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“Multiple patents” corresponding to one approval
chemical substance patent
medical use A patent
production process patent
filing
date
filing
date
filing
datetime
patent term expires
patent term expires
patent term expires
extension period
extension period
extension period
All the patents individually extendible as long as
there is a necessity to obtain an approval for the
working of each of the patented inventions
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US *1 JP *2
Products applicable for
patent term extension
drugs, medical equipment,
food additives, artificial
colors
drugs, pesticides
Term to be extendedup to 5 yrs
(within 14 yrs from approval)up to 5 yrs
Patent(s) extendible
based on one approval
only one patent
chosen by applicant
one or more patents
relating to approved
product
Number of times for one
patent to be extendedonly once no limitation
Effect of extended
patent right
Limited to approved product,
but including a later-approved
use
Limited to approved
product and use
*1 35 USC §§155-156 *2 Japanese patent law §67bis
Brief Comparison – US v. JP
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“Multiple approvals” corresponding to one patent
Chemical substance patent
patent term expires
filing
date
extension period
for medical use A
extension period for medical use B
extension period
5 years maximum
time
patent term
20 years
Extension may be granted
for each of the different
medical uses
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US *1 JP *2
Products applicable for
patent term extension
drugs, medical equipment,
food additives, artificial
colors
drugs, pesticides
Term to be extendedup to 5 yrs
(within 14 yrs from approval)up to 5 yrs
Patent(s) extendible
based on one approval
only one patent
chosen by applicant
one or more patents
relating to approved
product
Number of times for one
patent to be extendedonly once no limitation
Effect of extended
patent right
Limited to approved product,
but including a later-approved
use
Limited to approved
product and use
*1 35 USC §§155-156 *2 Japanese patent law §67bis
Brief Comparison – US v. JP
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Statutory Requirements
• [T]here is a period during which the patented invention
is unable to be worked because […] “[a] disposition
designated by Cabinet Order” […] is necessary to
obtain for the working of the patented invention…
Section 67(2)
• Marketing approval for drugs and pesticides
• What acts are covered by “the working of the
patented invention” ?
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JPO’s Interpretation of Statutory Law
• In judging requirements for registration for extension,
JPO considers “the scope of a patent right to be
extended.”
• JPO’s Interpretation:
• “product” “an active ingredient”
• “use” “efficacy / effect”
• [An extended] 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 approval […] (where the specific use of
the product is prescribed by the disposition, the
product used for that “use”). Section 68-2.
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JPO’s Practice and Court’s Precedents
• JPO’s Practice:
• [W]hen approvals are granted to pharmaceuticals
with the same active ingredient (product) and the
same efficacy / effect (use) and differing only in
[…] dosage forms, etc., patent term extension shall
be granted on basis of the earliest approval only.
Examination Guidelines Part IV 3-1-1(1)
• Court’s precedents upheld JPO’s practice.
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Extension Inapplicable to Later Approval
Chemical substance patent
patent term expires
filing
date
extension period
for medical use A
extension period for medical use B
extension period
5 years maximum
later approval of dosage
form of medical use B
time
patent term
20 years
same active ingredient
same efficacy / effect
different dosage formExtension is inapplicable to a later approval for
dosage form if there is a preceding approval in
which active ingredient and efficacy / effect are
the same
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IP High Court Cases
• Three cases are brought before IP High Court,
challenging appropriateness of JPO’s interpretation
of law and Court’s precedents.
IP High Court (Tokyo High Court)
No. 2008-10458, -10459, -10460
(May 29, 2009)
(decided on the same day
by Judge Iimura’s panel)
These cases are related to
different patents.
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Preceding Approval
active ingredient A
efficacy / effect B
dosage form C
Later Approval
active ingredient A
efficacy / effect B
dosage form D
Patent Term Extension
• Takeda obtained two marketing approvals under the
Pharmaceutical Affairs Law.
Facts in common among 3 cases
Takeda files an application for
patent term extension.
JPO examiner rejects the application
due to an existence of the preceding
approval .
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Case Preceding Approval Later Approval
2008-10458 Liquid / 5mg, 10mg Capsule / 30mg
2008-10459Injection solution
One-month sustained release
Injection solution
Three-month sustained release
2008-10460 Liquid / 5mg, 10mg Capsule / 30mg
Facts – Details of Approvals
• Between preceding and later approvals,
• Same active ingredient
• Same efficacy / effect
• Different dosage form
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• Should “the scope of a patent right to be
extended” be considered in judging requirements for
registration for extension ?
Issues of the Cases
• Should “the product” in Section 68-2 (defining the
scope of a patent right to be extended) be interpreted
as “an active ingredient” ?
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• Should “the scope of a patent right to be
extended” be considered in judging requirements for
registration for extension ?
Holding of the Cases
NO.
• Should “the product” in Section 68-2 (defining the
scope of a patent right to be extended) be interpreted
as “an active ingredient” ? NO.
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Holding of the Cases (cont’d)
• “product” means a product specified by “ingredient,”
“amount,” and “structure” of the drug which is the
subject of the disposition.
• “use” refers to a case of a use invention.
• To refuse an application for patent term extension, an
examiner shall prove:
• (i) that “the disposition designated by Cabinet Order”
does not dissolve prohibition of working of the
patented invention; or
• (ii) that acts whose prohibition is dissolved by “the
disposition designated by Cabinet Order” do not fall
within acts of working of the patented invention.
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• Patent term extension may be applicable to a later
approval of dosage form.
• Pharmaceutical company can recoup more investment.
Effect of the Cases
Chemical substance patent
patent term expires
extension period
for medical use A
extension period for medical use B
extension period
5 years maximum
patent term
20 years
later approval of dosage
form of medical use B
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• IP High Court denies JPO’s interpretation of the
statutory law.
• IP High Court vacates its own precedents.
• Possible effects on Patent Law Reform
• Ministry of Economy, Trade and Industry (METI)
has been studied on possibility of reforming
patent term extension system, but now stops
proceeding of the study until the decisions of
these three cases become conclusive and final.
Short Summary
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What comes the next ?
• JPO appeals to the Supreme Court
• Need to pay attention to the progress before the S. Ct.
• Whether a writ of cert is granted
• If granted, how the S. Ct. decides the cases
Trick or
Treat !
Supreme Court
OR
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YUASA AND HARALAW, PATENT, TRADEMARK & DESIGN and ACCOUNTING
Thank you for your attention !
Koji Hirayama
YUASA and HARA