Q&A

MOEGI PATENT ATTORNEYS

What regulations govern the marketing authorization of generic pharmaceutical products in Japan?

In Japan, the marketing authorization of generic products is nominally governed by "Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices" as well as by the implementing regulation for the Act. In practice, however, almost all of the important issues are governed by numerous notifications from officials at the Ministry of Health, Labour and Welfare. These notifications are directed to other governmental officials, and therefore, have no legal effect on pharmaceutical companies. This means that it is not possible to take legal action against these notifications. The approval process for pharmaceuticals is conducted by the Pharmaceuticals and Medical Devices Agency (PMDA).

Is there a patent linkage system in Japan?

There is a pseudo patent linkage system in Japan.

On 5 June 2009, the Director of the Economic Affairs Division of the Medical Affairs Bureau and the Director of the Review and Management Division of the Pharmaceutical and Food Safety Bureau of the Ministry of Health, Labour and Welfare issued a joint notification to the directors of health departments in each prefecture, stating the following.

  1. The following procedures shall be followed in the approval review of generic drugs under the Pharmaceutical Affairs Act. The existence of patents shall be determined based on the scheduled approval date.
    (1) If the active ingredient of the original drug is covered by a patent, and as a result, the active ingredient itself cannot be manufactured, the generic drug shall not be approved.
    (2) If a patent exists for some of the indications, effects, dosage, and administration (hereinafter referred to as ‘indications, effects, etc.’) of the original drug, but it is possible to manufacture a drug that claims other indications, effects, etc., the generic drug may be approved. In such cases, the policy is not to approve the indications and effects covered by the patent. Therefore, applicants for generic drugs should confirm this in advance.
    (3) In addition, for drugs with indications and effects that are clearly different from those of drugs already approved for manufacture and sale due to the development of new indications and effects, a four-year re-examination period is generally required, so please note this.
  2. Regarding the inclusion of generic drugs in the drug price standards, for items where there are concerns regarding patents, it has been requested that prior adjustments be made between the parties and that procedures for inclusion in the drug price standards be taken only for items where stable supply is deemed possible (see ‘Regarding the Inclusion of Generic Drugs in the Drug Price Standards, etc. (Medical Policy and Economics Notice No. 0115001 dated 15 January 2009)’). Therefore, regardless of the above point 1, please continue to handle this matter without omission.
  3. Other
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In this regard, it is important for the original drug manufacturer to inform the PMDA about the patents covering its products.

Generic applicants are not required to notify the patent owner and/or the marketing authorization (MA) holder upon submitting an MA application. In fact, it is not easy for the generic applicants to identify patents covering the original drugs with marketing authorization. When a generic drug manufacturer applies for MA, PMDA will ask the manufacturer about the patent, based on the information provided by the original drug manufacturer. Marketing of generic products is not approved unless non-infringement is evident to the PMDA examiner.

PMDA does not disclose or notify the submission of a generic MA application.