LAW, PATENT, TRADEMARK & DESIGN and · PDF fileLAW, PATENT, TRADEMARK & DESIGN and ACCOUNTING...

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YUASA AND HARALAW, PATENT, TRADEMARK & DESIGN and ACCOUNTING


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AIPLA 2009 Annual MeetingIP Practice in Japan Committee － Pre-meeting

October 14, 2009

Koji Hirayama

YUASA and HARA

[email protected]

Patent Term Extension:Case Law in Japan



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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





colors

drugs, pesticides





only one patent

chosen by applicant

one or more patents


product



Effect of extended

patent right



use

Limited to approved

product and use



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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



1010

US *1 JP *2





colors

drugs, pesticides





only one patent

chosen by applicant

one or more patents


product



Effect of extended

patent right



use

Limited to approved

product and use



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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


patent term expires

filing

date

extension period

for medical use A


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


patent term expires

extension period

for medical use A


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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Thank you for your attention !

Koji Hirayama

YUASA and HARA

[email protected]

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