JP Supreme Court (Nov. 17, 2015)
Patent Term Extension based on a
Second Marketing Approval
Pre-Meeting AIPLA MWI
La Quinta, CA: Jan.26, 2016
Hirokazu Honda, Attorney-at-Law
Abe, Ikubo & Katayama
Patent Term Extension
Research
PreClinical
Trial
Application
Clinical Trial
Registration
Examin
ation
Sale!!
20 yrs
Patent
Extension
“Cannot practice the patent”
Encroachment on Patent term
5 yrs Max.
2
Patent Law Art. 67
“2. Where there is a period during which the patented invention is
unable to be practiced because approvals prescribed by relevant Acts
that are intended to ensure the safely, etc. or any other disposition
designated by Cabinet Order as requiring considerable time for the
proper execution of the disposition in light of the purpose, procedures,
etc., of such a disposition is necessary to obtain for the practice of the
patented invention, the duration of the patent right may be extended,
upon the filing of a request for the registration of extension of the
duration, by a period not exceeding 5 years.”
In sum …

The patent term can be extended where a patentee could not practice
the patented invention because it was necessary to obtain a marketing
approval under the Pharmaceutical Affairs Law for such practice.

An application for registration of extension is required.
3
Case Plural Drug Approvals
Drug A
Can be
extended
Patent
For Drug A’
Can be
extended
Drug A’
Drug A
Drug A’
Drug A
For Drug A
Already practiced with
approval for Drug A’
⇒ Cannot be extended
4
Factors to be Considered?
Compare first drug (X) and second drug (Y) in various factors:
Similar drug has been sold (=practiced), the period of waiting
for approval as to the second drug cannot be considered as
parent term extension.
For a long time …
“Active Ingredient” and “Indication” had been factors to be considered
because those factors are important.
Drug X
Drug Y
Active Ingredient
AAA
AAA
Indication
BBB
BBB
Preparation
CCC
DDD
Form
EEE
FFF
Dosage & Administration
GGG
HHH
5
Amendment of Standard on Extension
[Problems]

Patents with technology on preparation, etc. without any character
on active ingredient or indication
ex. Patents on Drug Delivery System

Refusal of extension is unreasonable only because the second drug (DDS)
has the same active ingredient and indication as that of the first drug
(not DDS).

The first drug is out of the scope of such DDS patent: also Unreasonable
(IP High Court Decision on May 29, 2009; Sup. Court Decision on Apr 28, 2011)
Amendment of Standard by JPO
 Whether or not the marketing approval was necessary for practicing
the patented invention should be determined by all matters that fall
in the technical special features of patented invention
6
Supreme Court Case
[Patented Invention]
 a composition for treating cancer comprising effective amount
of vascular endothelial growth factor antagonist
[Drug]
 Brand name: Avastin drip infusion
 General name: bevacizumab (genetic recombination)
Drug X
Drug Y
Active Ingredient
bevacizumab
bevacizumab
Indication
incurable unresectable
advanced or recurrent
colorectal cancer
incurable unresectable
advanced or recurrent
colorectal cancer
Dosage &
Administration
5 or 10mg/kg body wt
Interval should be 2w
7.5mg/kg body wt
Interval should be 3w
7
Decision of JPO
Matters falling in the technical special features of patented invention

Active ingredient and Indication

Dosage and Administration is not feature of patented invention
Rejected an application b/c “features” are the same.
JPO
Dismissed the patentee’s trial for cancellation of the rejection
Appeal by Patentee
IP High Court
(May 30, 2014)
Supreme Court
(Nov 17, 2015)
Vacated the JPO’s decision
Appeal by JPO
Affirmed High Court Decision
8
Supreme Court Decision

“… when there are a prior disposition and a subject disposition, upon
comparing them, if the manufacture and sales of drug covered by the
prior disposition encompasses manufacture and sales of drug covered
by the subject disposition, the subject disposition is not found
necessary for practicing the patented invention”
Prior Drug (X): already practiced the patented
invention
Subject Drug (Y): approval for Y was not necessary
for practicing the patented
invention

“In this way, whether or not the subject disposition was necessary for
practicing the patented invention should be determined by comparing
the prior deposition and the subject disposition; it should not be
determined by all matters that fall in the technical special features of
the patented invention.”
9
Standard on “Encompassed by Prior Drug”

Comparison of both marketing approvals with regard to matters for
examination directly relevant to the substantial identity as drug in
light of types and subject matters of the subject patent

As a result of such comparison, where it is found that the manufacture
and sales of drug covered by the prior disposition encompasses
manufacture and sales of the subject drug, it is reasonable to find that
the subject disposition was not necessary for practicing the patented
invention

That holding means that not every matter for examination is
considered in comparison of both marketing approvals.

Patent term extension should not be granted by comparing matters
for examination which would never interfere practice of the
patented invention
10
Matters for Examination in This Case
[Invention directed to an ingredient of a drug]
Matters for examination of both approvals which are directly
relevant to the substantial identity as drug are:

Ingredients; Amount; Dosage; Administration; Indication
This Case
 The dosage and administration of both drugs are different.
 The prior approval did not allow manufacture and sales of the drug
for combination therapy of bevacizumab therapy and XELOX therapy,
and it was allowed by the subject approval for the first time.
The manufacture and sales of drug covered by the prior approval is
not found to encompass manufacture and sales of the subject drug
covered by the subject approval.
11
Effect of Patent Term Extension
Patent Law Art. 68-2
“Where the duration of a patent right is extended …, such patent
right shall not be effective against any act other than the practice
of the patented invention for the product which was the subject of
the disposition designated by Cabinet Order under Article 67(2)
which constituted the reason for the registration of extension
(where the specific usage of the product is prescribed by the
disposition, the product used for that usage).”

What is “the product (the product used for that usage)” which was
the subject of the approval?

Long time ago: Product specified by active ingredient and
indication
(Same as the standard of comparison of both marketing
approvals)
12
Effect of Patent Term Extension
[IP High Court (May 30, 2014)]
(Not an infringement action: stated as obiter dictum)

In light of the purpose of patent term extension and of a patent
infringement action,

in the case of a patented invention for an ingredient of a drug,

effective for the practice of the patented invention identified by:

Ingredients (not limited to active ingredient)
- as an invention pertaining to a product

Indication and dosage and administration
- as an invention pertaining to usage
[Supreme Court]
No decision.
13
Requisite and Effect
[Easy to be Rejected]
[Wider Range of Effect]
Prior Drug
Prior Drug
Subject
Drug
Subject
Drug
Compared by Less Matters
[Easy to be Granted]
[Narrower Range of Effect??]
?
Prior Drug
Subject Drug
Sup. Court Decision
?
14
Thank You!!
Hirokazu Honda, Attorney-at-Law
Abe, Ikubo & Katayama
E-mail: hirokazu.honda@aiklaw.co.jp
URL: http://www.aiklaw.co.jp
Phone: +81-3-3273-2600 Fax: +81-3-3273-2033