Transcript Kuroda Indirect Infringement

Indirect Infringement of Patent for
Combination of Drugs (part 2)
Kaoru Kuroda, Attorney at Law
Abe, Ikubo & Katayama
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Facts
Osaka Case
Tokyo Case
Court
Osaka District Court
Tokyo District Court
Date
Sep. 27, 2012
Feb. 28, 2013
Case Number
Hei 23 (wa) no. 7576, 7578
Hei 23 (wa) no. 19435,
19436
Plaintiff
Takeda Pharmaceutical
Takeda Pharmaceutical
Defendants
Sawai Pharmaceutical, et al
(8 companies)
Nissin Pharmaceutical, et al
(10 companies)
Patents at issue JP3148973, 3973280
JP3148973, 3973280
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Facts: Patents at issue
Expired patent (JP1853588)
Pharmaceutical composition for treatment of
diabetes which comprises drug A.
Patents at issue (JP3148973, 3973280)
Pharmaceutical composition for prophylaxis or
treatment of diabetes which comprises drug A
in combination with drug B.
Drug A = an insulin sensitivity enhancer.
Drug B = an alpha-glucosidase inhibitor or a biguanide.
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Facts: Defendants’ activities
• Defendants produce pharmaceutical
composition for treatment of diabetes
comprising drug A, which is within the scope of
the expired patent.
• Drug A produced by Defendants is a complete
drug and can be used for treatment of
diabetes on its own.
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Japanese Patent Act 101(2)
– indirect infringement
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The following acts shall be deemed to constitute
infringement of a patent right . . .
(2) where a patent has been granted for an
invention of a product, acts of producing . . . any
product (excluding those widely distributed within
Japan) to be used for the producing of the said
product and indispensable for the resolution of the
problem by the said invention as a business,
knowing that the said invention is a patented
invention and the said product is used for the
working of the invention;
Japanese Patent Act 101(2)
– indirect infringement
101(2) basically requires four elements:
I.
The material produced by the defendant as business is
to be used for the producing of the patented product
(“producing requirement”);
II. The material is indispensable for the resolution of the
problem by the invention (“indispensable requirement”);
III. The material has not been widely distributed within
Japan (“non-widely distributed requirement”); and
IV. The defendant knew that this invention is patented and
the material is to be used for the working of the
invention (“subjective requirement”).
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Japanese Patent Act 101(2)
– indirect infringement
Osaka Case
Court dismissed
Plaintiff’s claim based
on Requirement I
(Producing
requirement).
Tokyo Case
Court dismissed
Plaintiff’s claim based
on Requirement II
(Indispensable
requirement).
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Requirement I: (Osaka Case)
What does “producing” in 101(2) mean?
Plaintiff’s assertion
• Simple combination of different drugs should
constitute “producing”, even if these drugs had
already been formulated separately.
• Thus, the following acts should constitute
“producing” of the patented product in 101(2).
1)(by pharmacists ) Combining drug A with drug B.
2)(by patients) Taking both drug A and drug B.
3)(by doctors) Preparing a prescription, which leads
the above activities.
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Requirement I: (Osaka Case)
What does “producing” in 101(2) mean?
Defendants’ assertion
• “Producing” means newly creating a subject matter
of the patented invention by processing or
assembling materials.
• An act of using material for the originally intended
purposes thereof should not constitute “producing”.
• Because (1) Drug A can be used for treatment of
diabetes on its own and (2) simple combining of Drug
A with Drug B does not create new product, all
activities Plaintiff mentioned do not constitute
“producing” of the patented invention.
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Requirement II: (Tokyo Case)
Is the material “indispensable”?
IP High Court, Sep. 30, 2005.
• If “the problem to be solved by the invention” cannot be solved
without the element, this element should be “indispensable for the
resolution of the problem by the invention”.
Plaintiff argued based on this definition.
Tokyo District Court, Apr. 23, 2004.
• Element “indispensable for the resolution of the problem by the
invention” is different from the constituent element of the patented
claim. It means something that directly forms “a characteristic
technical means of the invention” which was newly disclosed by the
invention and not seen in prior arts.
Defendants argued based on this definition.
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Requirement II: (Tokyo Case)
Is the material “indispensable”?
Plaintiff’s assertion
• “The problem to be solved by the invention” is to develop
combination drug having synergistic effect compared with
administration of either active component alone. Because
this problem will be solve only by using Drug A, Drug A
should be indispensable for the resolution of the problem.
Defendants’ assertion
• In this invention, “a characteristic technical means” is
combination of Drug A and Drug B. Thus, Drug A itself is
unrelated to the resolution of the problem by the invention
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Osaka Case: Decision
-Requirement I (Producing requirement)
• “Producing” means newly creating a product containing
all the elements in the claim, by using a material which
does not contain all the elements in the claim, and
“producing” does not include “using” of the material for
the originally intended purposes.
• Since Drug A is a complete drug and is not supposed to
be changed or converted, Drug A will never be utilized to
“produce” any product.
• All activities that Plaintiff listed as embodiments of
“producing” of the patented invention are merely “using”
of Drug A and Drug B.
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Tokyo Case: Decision
-Requirement II (Indispensable requirement)
• Court adopted the second definition.
• In this invention, “a characteristic technical means of the
invention” is a certain combination of Drug A and Drug B.
Thus, Drug A itself is unrelated to the resolution of the
problem by the invention.
• In patents relating to combination of known elements,
the known element itself should not be regarded as
“indispensable for the resolution of the problem”, except
for a special circumstances such as the known element
is manufactured and sold for the purpose of being used
for the invention.
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Discussion
Osaka Case
“Since Drug A is a complete drug and is not supposed
to be changed or converted, Drug A will never be
utilized to ‘produce’ any product.”
“Combining Drug A with Drug B is merely ‘using’ of
these drugs.”
• As long as one of the combination of drugs is a
complete drug, it seems almost impossible for the
patent holder to claim indirect infringement based on
101(2).
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Discussion
Tokyo Case
“In patents relating to combination of elements, the
known element should not be regarded as
‘indispensable for the resolution of the problem’,
except for a special circumstances such as the known
element is manufactured and sold for the purpose of
being used for the invention.”
• Outcome of the application of “indispensable
requirement” could vary from case to case.
• The court permits exceptions.
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Thank you !
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ABE, IKUBO & KATAYAMA