11 Indirect Infringement of Patent for Combination of Drugs Kaoru Kuroda, Attorney at Law Abe, Ikubo & Katayama ABE, IKUBO & KATAYAMA

2 Case Osaka District Court, Sep. 27, 2012 Hei 23 (wa) no. 7576, 7578 Plaintiff Takeda Pharmaceutical Defendants Sawai Pharmaceutical, et al Facts

ABE, IKUBO & KATAYAMA 3 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. Facts: Patents at issue

ABE, IKUBO & KATAYAMA 4 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. Facts: Defendants’ acts

ABE, IKUBO & KATAYAMA 5 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

ABE, IKUBO & KATAYAMA 6 Japanese Patent Act 101(2) – indirect infringement 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 invention. Plaintiff asserted that Defendants’ acts constitute indirect infringement because...

ABE, IKUBO & KATAYAMA 7 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.

ABE, IKUBO & KATAYAMA 8 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”.

ABE, IKUBO & KATAYAMA 9 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 Those acts are simply mixing different drugs formulated independently, which is not “producing” the patented product.

ABE, IKUBO & KATAYAMA 10 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. Court agreed with Defendants. Court’s holdings 1)Doctor’s formulation of drug A and drug B

ABE, IKUBO & KATAYAMA 11 “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. 2) Pharmacist’s formulation of drug A and drug B. Court’s holdings

ABE, IKUBO & KATAYAMA 12 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. 3) Patient’s self-administration of drug A and drug B Court’s holdings

ABE, IKUBO & KATAYAMA 13 Prior case (Tokyo District Court, May 15, 2002): Facts A blade with a ceramic coating of up to 0.25mm thick. A blade with a ceramic coating of to 0.525mm thick. Patent Defendant’s product A blade with a ceramic coating of up to 0.25mm thick. ≠ ＝ The coating becomes abraded over time through ordinary use.

ABE, IKUBO & KATAYAMA 14 “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. Court rejected Plaintiff’s assertion: Prior case (Tokyo District Court, May 15, 2002): Court’s holding

15 Thank you ! ABE, IKUBO & KATAYAMA