JAPAN Trends and Developments Contributed by: Naoko Nakatsukasa, Katsuya Hongyo, Tatsunori Enomoto and Ronald Kaloostian, Chuo Sogo LPC
original drugs in the procedures for the approval of generics. The purpose of patent linkage is to ensure a stable supply of generics by consider- ing the patent rights related to the original drugs. The implementation of the system and its con- tents differ from country to country. In Japan, the patent linkage system has no clear legal basis, and it is handled as an administra- tive practice under the guidance of the Ministry of Health, Labour and Welfare (MHLW) based on two administrative notifications (both are notifications by a section chief and are thus col- lectively referred to as the “Two Section Chief Notifications”). The details of the practice are as follows. • If a patent exists on the active ingredient of the original drug and the manufacturing of that active ingredient is not possible, the generic will not be approved. • If a patent exists for part of the indications, dosage and administration (“indications, effects, etc”) of the original drug, and if it is possible to manufacture a drug adopting other indications, effects, etc, the generic drug will be approved. However, the indica- tions, effects, etc, for which a patent exists are not approved. • The existence or non-existence of a pat- ent shall be determined on the scheduled approval date of the generic. In the procedure of the National Health Insur- ance (NHI) price listing of generic drugs, the Two Section Chief Notifications require that mat- ters with patent-related concerns be adjusted between the parties in advance and that listing procedures be taken only for items considered capable of stable supply. However, this prelimi- nary adjustment between the parties is to be made during the NHI price listing after obtain-
ing approval for the generic, and the actual practice is that, even if discussions or adjust- ments between the parties are unsuccessful, the MHLW permits the NHI price listing of the generic if there is an application from a generic drug manufacturer. Also, as mentioned above, although the MHLW is responsible for determin- ing whether the generic drug infringes the pat- ents of the original drug, there is no mechanism in place for the MHLW to rely on any judicial judgment. Rulings Bayer Yakuhin Co., Ltd., a Japanese subsidi- ary of the defendant, manufactured and sold an anti-VEGF agent using the recombinant fusion protein Aflibercept (the “Defendant’s Original Drug”) for indications such as age-related macu- lar degeneration (AMD). After the launch of the Defendant’s Original Drug, the defendant obtained a patent for a specific use aimed at treating a particular sub- group of wet age-related macular degeneration (AMD) patients who meet certain inclusion and exclusion criteria (the “Defendant Patent”). The Defendant Patent is characterisedcharacterised as a use invention, based on the discovery of a previously unknown property of Aflibercept—a known substance—showing superior therapeu- tic effects in patients meeting specific criteria, and creating a novel use with remarkable effec- tiveness. Through its manufacturing and sales subsidiary in Japan, the plaintiff submitted an application to the MHLW for marketing approval of the plain- tiff’s product (the “Plaintiff’s Biosimilar Drug”), as a biosimilar to the Defendant’s Original Drug. The Plaintiff’s Biosimilar Drug included wAMD as an indication and adopted the same descrip-
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