Facts

1. Indirect Infringement of Patent for Combination of Drugs (part 2)Kaoru Kuroda, Attorney at Law Abe, Ikubo & Katayama 1

2. Facts 2

3. 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 Ain combination withdrug B. Drug A = an insulin sensitivity enhancer. Drug B = an alpha-glucosidase inhibitor or a biguanide. 3

4. 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 Defendantsis a complete drug and can be used for treatment of diabetes on its own. 4

5. Japanese Patent Act 101(2) – indirect infringement 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; 5

6. Japanese Patent Act 101(2) – indirect infringement 101(2) basically requires four elements: The material produced by the defendant as business is to be used for the producing of the patented product (“producing requirement”); The material is indispensable for the resolution of the problem by the invention (“indispensable requirement”); The material has not been widely distributed within Japan (“non-widely distributed requirement”); and The defendant knew that this invention is patented and the material is to be used for the working of the invention (“subjective requirement”). 6

7. Japanese Patent Act 101(2) – indirect infringement 7

8. 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). • (by pharmacists ) Combining drug A with drug B. • (by patients) Taking both drug A and drug B. • (by doctors) Preparing a prescription, which leads the above activities. 8

9. 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. 9

10. 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. 10

11. 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 11

12. 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. 12

13. 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. 13

14. 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). 14

15. 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. 15

16. Thank you ! ABE, IKUBO & KATAYAMA 16