1. Enablement requirement in view of recent IP court decisions Toshihiko Aikawa Japan Patent Attorneys Association International Activities Center AIPLA Mid-Winter Institute January 26-27, 2016

2. Written Description Requirements Patent Act Article 36(4)(i) Statement shall be so clear and sufficient as to enable any person ordinarily skilled in the art to work the invention. (Enablement) Patent Act Article 36(6)(i) Claimed invention shall be disclosed in the specification. (Support) AIPLA Mid-Winter Institute 20162

3. IP High Court (2012.4.11) Cases: 2011 (Gyo-Ke) 10146, 10147 2007.6.22 Patent No. 3,973,280 2010.5.11 Invalidation Trial 2010-800088 2011.3.22 Decision –Claims 1-6 not 36 ④ i, or ⑥ i satisfy 29 ② –Claims 7-9 satisfy 36 ④ i, ⑥ i, and 29 ② Plaintiff: Sawai Defendent: Takeda AIPLA Mid-Winter Institute 20163

4. 2011 (Gyo-Ke) 10146, 10147 Patent No. 3,973,280 1. Preventive/therapeutic medicine for diabetic (complication): combination of pioglitazone & biguanide (phenformin, metformin, buformin). pioglitazone phenformin AIPLA Mid-Winter Institute 20164

5. 2011 (Gyo-Ke) 10146, 10147 7. Preventive/therapeutic medicine for diabetic (complication): combination of pioglitazone & glimepiride. pioglitazone glimepiride AIPLA Mid-Winter Institute 20165

6. 2011 (Gyo-Ke) 10146, 10147 Claim 1 Pioglitazone, biguanide, & glimepiride were manufacturable as of filing date. → Satisfy enablement requirement. –*JPO’s reason is more like “support requirement” AIPLA Mid-Winter Institute 20166

7. 2011 (Gyo-Ke) 10146, 10147 Claim 1 No experimental result of combination of pioglitazone & biguanide. But different mechanisms for them were known. No evidence for antagonistic to each other on combination. Ref: biguanide + Troglitazone (enhance insulin) AIPLA Mid-Winter Institute 20167

8. 2011 (Gyo-Ke) 10146, 10147 Claim 1 It was well-known that pioglitazone and Troglitazone enhance insulin sensitivity →It was conceivable that both agents might work in different mechanisms and might be effective for diabetic. →Satisfy support requirement AIPLA Mid-Winter Institute 20168

9. 2011 (Gyo-Ke) 10146, 10147 Claim 7 JPO’s decision: Ref. 3: either of pioglitazone or glimepiride is used by itself, not combination. AIPLA Mid-Winter Institute 20169

10. 2011 (Gyo-Ke) 10146, 10147 AIPLA Mid-Winter Institute 201610 Ref. 3 glimepiride Troglitazone pioglitazone

11. 2011 (Gyo-Ke) 10146, 10147 Ref: biguanide + Troglitazone (enhance insulin) →may not expect synergy effect, but may at least expect additive effect AIPLA Mid-Winter Institute 201611

12. 2011 (Gyo-Ke) 10146, 10147 Rescinded JPO decision Claims 1-6 not satisfy 36 ④ i, or ⑥ i –Enablement and Support Requirement Claims 7-9 satisfy 29 ② –Inventive step. Invalidation Trial 2010-800088 continued Decision: Claims 1-6 invalidated for lacking the inventive step. (2013.3.6) AIPLA Mid-Winter Institute 201612

13. IP High Court (2015.8.5) Case: 2014 (Gyo-Ke) 10238 JP Appl. 2006-536494 was finally rejected in JPO Trial No. 2011-20954 (2014.9.22). Filed complaint (2014.11.3). An active foam made of rubber and containing zirconium/germanium compound to contact human body upon drug administration AIPLA Mid-Winter Institute 201613

14. 2014 (Gyo-Ke) 10238 1 foam sheet (rubber/resin & zirconium and/or germanium compound) 2 cover sheet Lady in 50’s sat on the foam sheet to improve blood flow (experimental result). AIPLA Mid-Winter Institute 201614

15. 2014 (Gyo-Ke) 10238 JPO’s reason for rejection Not written so that any person ordinarily skilled in the art could understand and recognize the synergistic effects of the simultaneous use of a drug and the active foam of the Invention. AIPLA Mid-Winter Institute 201615

16. 2014 (Gyo-Ke) 10238 Upon drug administration: –merely specifies timing of using active foam. Claims not specify purpose/usage of Invention (increasing effect of drug or promoting cure of disease). Failing to disclose synergistic effects of simultaneous use may be OK. If any other technical significance in use. AIPLA Mid-Winter Institute 201616

17. 2014 (Gyo-Ke) 10238 Rescinded JPO decision Now, return to the Trial Examination at JPO. AIPLA Mid-Winter Institute 201617

18. IP High Court (2015.4.28) Case: 2014 (Gyo-Ke) 10229 2008.1.25 Patent No. 4,072,282 2012.3.6 Invalidation Trial 2012-800022 2012.9.18 Decision: invalidated claims 1-4 –2012 Filed IP Court & JPO Correction to return to the invalidation trial. 2013.5.27 Decision: invalidated claims 1-3 –2013 Filed IP Court & JPO Correction to return to the invalidation trial. AIPLA Mid-Winter Institute 201618

19. 2014 (Gyo-Ke) 10229 2014.9.5 Decision: invalidated claims 1-3 2014 Filed complaint to IP Court. Issue: only enablement requirement 2015.4.28. Holding: affirm invalidation. AIPLA Mid-Winter Institute 201619

20. 2014 (Gyo-Ke) 10229 Claim Position detection device comprising: contact member (5) and detection circuit (3, 4), portion of contact member (5) is made of non-magnetic material including WC and Ni(binder). AIPLA Mid-Winter Institute 201620

21. 2014 (Gyo-Ke) 10229 5 contact member 16 sphere body 17 bar (non-magnetic) 18 screw (non-magnetic) *16: non-magnetic but including WC and Ni(binder). AIPLA Mid-Winter Institute 201621

22. 2014 (Gyo-Ke) 10229 WC: non-magnetic Ni: ferromagnetic WC-Ni: non-magnetic (characteristic feature) → Ｎｉ :non-magnetic Melting Ni in mold and sinter composite in sphere and cooling sphere out of mold. (Possible way disclosed in extrinsic evidence.) However, the specification does not disclose. AIPLA Mid-Winter Institute 201622

23. Enablement Requirement Distinguished from Support Requirement in the law. But, often judged at the same time. Sometimes confusing. Technical aspect may be emphasized. Possibility may not be enough. For medicine: there are additional requirements. AIPLA Mid-Winter Institute 201623

24. Toshihiko Aikawa to.aikawa@nifty.com Orion International Patent Office Thank you for your attention AIPLA Mid-Winter Institute 201624