JAPAN Law and Practice Contributed by: Hirofumi Tada, Ohno & Partners
3.3 Acceptable Pre-Launch Preparations There are no differences between small molecules and biologics in terms of acceptable pre-launch prepara ‑ tions. Experimental use defence applies to biologics, and activities necessary for clinical trial do not consti ‑ tute infringement. On the other hand, the manufactur ‑ ing of drugs during the patent period for sale after the patent’s expiry constitutes infringement. 3.4 Publicly Available Drug and Patent Information There are no differences between small molecules and biologics in terms of publicly available drug and patent information. New drug applicants of biologics voluntarily report substance and use patents covering their new drugs to the government agency, MHLW, so MHLW has a non-public list of patents. MHLW does not grant marketing approval if a biosimilar drug is covered by substance or use patents of new drug applicants. 3.5 Reimbursement and Pricing/Linkage Markets Japan does not have an official patent linkage scheme. The approval process for biosimilars is unclear, just internally being handled by the government agency, MHLW. But MHLW reveals that the process is similar to the two-stage process of generic drugs. Unlike the Biologics Price Competition and Innovation Act (BPCIA) in the US, Japan does not have specific litigation procedures (ie, patent dance) for biosimilars. Thus, typically, a new drug applicant of biologics files litigation against biosimilars after launch.
notifications by the government agency, the MHLW. The process has two stages. In the first stage, the MHLW decides if a generic drug infringes (i) substance patent, (ii) effect/efficacy pat ‑ ent, or (iii) use/dosage patent of new drug applicants. In determining this, the MHLW relies on the non-pub ‑ lic list of patents voluntarily submitted by new drug applicants. If there is no patent infringement found, it proceeds to the second stage. In the second stage, the MHLW requests the generic drug applicant to negotiate and solve problems with other patents (such as dosage form or manufacturing method patents), if any, before the drug pricing. Even if the generic drug company fails to solve the problem, it usually does not matter to the price listing. Typically, even if there is a second medical use patent, a generic drug application can be approved but the patented use should be excluded from the indication. Sometimes it is difficult to exclude the patented use from the label, and the generic drug application will not be granted. Unlike ANDA in the US, Japan does not have specific litigation procedure for generic drugs. Thus, typically, a new drug applicant files litigation against generics after launch. The MHLW is setting up a new scheme in which it will seek an expert panel’s advisory opinion on pat ‑ ent infringement issues in order to decide whether to grant market authorisation.
3. Biosimilar Market Entry 3.1 Infringing Acts
4. Patent Term Extensions for Pharmaceutical Products
4.1 Supplementary Protection Certificates Japan has a patent term extension for a shorter peri ‑ od (i) from the start of clinical trials to the marketing approval grant, and (ii) from the patent registration to the marketing approval grant. The maximum exten ‑ sion period for a patent is five years even if it takes longer than that.
There are no differences between small molecules and biologics in terms of infringement acts, skinny label, and parallel importation. 3.2 Data and Regulatory Exclusivity The data exclusivity periods of biologics are basically the same as small molecules.
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