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Fordham IP Conference Life Science Panel April 5-6, 2018 Eiji Katayama Abe, Ikubo & Katayama

Damages Relating To Lowered National Health Insurance Price “Can an innovator demand to the generics the damages caused by the lowered National Health Insurance price which had been reduced due to the appearance of the infringing generics? . Fordham IP Conference Life Science Panel

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Fordham IP Conference Life Science Panel April 5-6, 2018 Eiji Katayama Abe, Ikubo & Katayama

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  1. Damages Relating To Lowered National Health Insurance Price “Can an innovator demand to the generics the damages caused by the lowered National Health Insurance price which had been reduced due to the appearance of the infringing generics?  Fordham IP Conference Life Science Panel April5-6, 2018 Eiji Katayama Abe, Ikubo & Katayama

  2. Facts 【Innovator】 【Generics】 Columbia Univ. CHUGAI（X) 【Patent】 • Process Patent ’301 • Co-owned by Columbia and CHUGAI; CHUGAI is an exclusive licensee of Columbia’s share. • Found infringed based upon DOE by separate suit. Y１ Y2 Y3

  3. Damages Claimed • Lost Profit due to share loss(§102 para 1, Jap. Pat. Code) 【Y’s sales units】 ×【X’s profit per unit】-【Units X could not have sold】 • Damagecaused by the price down due to lowered National Health Insurance Price (General Tort provision §709 of Civil Code) 【Y’s original price】 -【Y’s reduced price due to lowered NHI price】

  4. Issues Share Loss • Competing other products not covered by Patent in the market (Whether X could not have sold all? If not, how much?) Other Products Ct’s Conclusion 42% ⇒ reduce by 10% Patented NotPatented 42% Infringing products

  5. Price Down • Japanese National Health Insurance Pricing; - When generic’s listed, innovator’s price is reduced. • Court held the difference is a legitimate legal interest to be protected.

  6. Other Issues • Whether presumption clause of negligence (§103) applied to DOE case? (Y argued that Y obtained expert’s opinions of non-infringement from EU patent attorney and Japanese Benrishi, and this wouldbreak presumption.) ⇒Court held “no”. The presumption of negligence still work on DOE case. • Whether reduction clause when no gross negligence (§102, para 4) be applied? ⇒ Court held “no.”

  7. Thank you! Eiji Katayama Abe, Ikubo & Katayama katayama@aiklaw.co.jp

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