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Indirect Infringement of Patent for
Combination of Drugs
Kaoru Kuroda, Attorney at Law
Abe, Ikubo & Katayama
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ABE, IKUBO & KATAYAMA
Facts
• Case
Osaka District Court, Sep. 27, 2012
Hei 23 (wa) no. 7576, 7578
• Plaintiff
Takeda Pharmaceutical
• Defendants
Sawai Pharmaceutical, et al
ABE, IKUBO & KATAYAMA
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Facts: Patents at issue
Expired patent
Pharmaceutical composition for treatment of
diabetes which comprises drug A.
Patents at issue
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’ acts
•Defendants are going to produce
pharmaceutical composition for treatment
of diabetes comprising drug A, which is
within the scope of the expired patent.
• Drug A is a complete and independent
pharmaceutical composition. It is not
supposed to be elaborated further.
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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;
ABE, IKUBO & KATAYAMA
Japanese Patent Act 101(2)
– indirect infringement
Plaintiff asserted that Defendants’ acts constitute
indirect infringement because . . .
1. Defendants produce drug A as a business;
2. Drug A is used for the producing of the
patented product (pharmaceutical composition
comprising drug A in combination with drug B);
3. Drug A is indispensable for the resolution of the
problem; and
4. Defendants know that the invention is a patented
invention and drug A is used for the working of the
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invention.
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What is the meaning of “comprising drug A
in combination with drug B” in the claim?
Plaintiff’s assertion
It means simple mixing of drug A and drug B.
The patented product is not limited to a compound
drug.
Defendants’ assertion
It means a compound drug which comprises a
preformulated amount of drug A and drug B in
order to prevent the difficult selection of drugs in
the clinical settings.
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ABE, IKUBO & KATAYAMA
What is the meaning of “producing”
the patented product in 101(2)?
Plaintiff’s assertion
Simple mixing of different drugs, which were
formulated independently, should be “producing”.
Defendants’ assertion
It 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.
An act of using such material for the originally
intended purposes thereof should not be “producing”.
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Therefore . . .
Plaintiff’s conclusion
Following acts should constitute “producing” the
patented product.
1) Doctor’s formulation of drug A and drug B
2) Pharmacist’s formulation of drug A and drug B
3) Patient’s self-administration of drug A and drug B
Defendants’ conclusion
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Those acts are simply mixing different drugs
formulated independently, which is not “producing”
the patented product.
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Court’s holdings
Court agreed with Defendants.
1) Doctor’s formulation of drug A and drug B
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• Drug A is a complete and independent
pharmaceutical composition. It is not supposed
to be elaborated further. Thus it cannot to be
used to “produce” the patented product.
• Because simple “mixing” is one way to “use” the
product, if the Plaintiff’s view is correct, the
patented invention will cover an unpatentable
medical treatment.
ABE, IKUBO & KATAYAMA
Court’s holdings
2) Pharmacist’s formulation of drug A and
drug B.
• “Pharmaceutical composition comprising drug A
in combination with drug B” means a new drug
created by combining drug A and drug B.
• Simple mixing of several drugs does not create a
new drug.
• Simple mixing of drugs does not change the
property of each drug.
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ABE, IKUBO & KATAYAMA
Court’s holdings
3) Patient’s self-administration of drug A and
drug B
• Administering a combination of drug A and drug
B does not create a new drug in the patient’s
body.
• “Producing” the patented product in 101(2) does
not include an act of using such material for the
originally intended purposes thereof.
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Prior case (Tokyo District Court, May
15, 2002): Facts
Defendant’s product
Patent
≠
A blade with a
ceramic coating of
up to 0.25mm thick.
The coating becomes abraded
over time through ordinary use.
＝
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A blade with a ceramic
coating of 0.313 to
0.525mm thick.
A blade with a ceramic
coating of up to 0.25mm
thick.
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Prior case (Tokyo District Court, May
15, 2002): Court’s holding
Court rejected Plaintiff’s assertion:
“Producing the product” in 101(2) means
newly creating a product which contains all
the elements in the claim, using something
which does not contain all the elements in
the claim as a material.
It does not include an act of using such
material for the originally intended purposes.
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Thank you !
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