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JAPAN: An Introduction to Intellectual Property: Domestic

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Abe Ikubo & Katayama

Intellectual Property in Japan 

1. Pro-patent trends may be still found in recent court decisions in Japan:

In May 2021, the IP High Court upheld validity of a patent claims finding inventive step in a functional feature therein (MSD v. Wyeth, case No. 2020 (gyo-ke) 10015). The subject patent covers Prevenar 13®, the most widely used pneumoniacoccal conjugate vaccine in the world. MSD contended that the functional feature of the claims was intrinsic in the precedent product Prevenar, which had been solved before the priority date. However, closely examining documented evidence submitted by both parties, the IP High Court found that the problem to be solved, which was the premise of the functional feature, was not recognisable by a POSA as of the priority date and held that the functional feature was not obvious and thus the claims had the inventive step.

2. The IP High Court clarified that Japanese Bolar exemption covers clinical testing for not only “generic” but also “innovator” drugs (X (individual) v. Amgen; Case No.: 2020 (Ne) 10051).

In this case, Amgen was sued by patentee X (an individual) who asserted that Amgen’s “bridging study” in Japan for an innovator drug infringed X’s patent, but in February 2021, the IP High Court rendered a decision favourable for the plaintiff.

The main issue in this case was whether or not clinical testing for “innovator” drugs were covered by the research exemption under Article 69(1) of the Japanese patent law. In relation to this, the Supreme Court had rendered a decision on April 16, 1999 in Ono Pharmaceuticals v. Kyoto Pharmaceutical Industries, that, under the Article 69(1), clinical testing for “generic” drugs during the patent term does not constitute patent infringement. The reasoning was that if clinical testing of generic drugs was not allowed during the patent term, third parties, i.e., generic drug companies, would not be able to freely practice the patent (including commercial sale of generic drugs) for a considerable period of time even after the expiry of the patent, which goes against the spirit of the patent law system. The IP High Court ruled in this case that such Supreme Court’s reasoning applies not only to “generic” drugs, but also to “innovator” drugs.

3. Japanese Intellectual Property Law revisions have been enacted this year.

Revisions to the IP laws reflect the recent changes in people’s lifestyles and economic activities caused by the spread of the COVID-19 virus - including the shift to “social distancing,” rapid growth of e-commerce, and expansion of patent licensing in the field of telecommunication.

Key points of the revisions are highlighted below (the IP to which the revisions apply are indicated as [P]=Patent, [U]=Utility model, [D]=Industrial design, [T]=Trademark).

(i) Web conference systems for JPO oral hearings ([P][U][D][T]) - in force as of October 1, 2021

Web conference systems are now an option to use for oral hearings at the JPO by the decision of the Chief Examiner. Before the revision, the parties need to physically appear before the JPO panel of appeal examiners in order to attend the oral hearing, but the revision allows parties to attend the oral hearing through monitor screens.

(ii) Third-party opinion (Japanese version of amicus brief) system in infringement cases at court ([P][U]) - in force as of April 1, 2022

In a patent or utility model infringement case, a district court or the IP High Court will be able to invite the public to submit opinions regarding application of law and other issues related to the case (Japanese version amicus brief). This will help the court make decisions based on a wide range of opinions, especially in cases that have large social impact.

(iii) Licensee’s consent not required for correction/waiver of rights ([P][U][D]) - in force as of April 1, 2022

The current requirement of obtaining consent of all licensees prior to correction/waiver of a patent/utility model claim (under which licences are granted) will be abolished. The requirements have been criticised as unrealistic especially in the case of patents for which numerous licensees exist. This revision will increase the right holder’s ability to correct their claims as a countermeasure against invalidation actions. The licensee’s consent will become unnecessary for waiver of industrial design rights too, but will continue to be necessary for waiver of trademark rights (except for international trademark registrations to which the consent requirement does not apply).

(iv) Stronger restriction against counterfeit goods from abroad ([D][T]) - in force as of April 1, 2022

With respect to industrial design and trademark rights, the act of “having someone bring into Japan” (by mail or otherwise) counterfeit goods from abroad will newly become an act of infringement. By this revision, even sellers abroad who sell counterfeit goods to individuals in Japan by e-commerce (and thus do nothing themselves within Japan) could be accused of infringement.

(v) JPO’s grant decision in electronic form for international design/trademark applications ([D][T]) - in force as of April 1, 2022

The JPO’s grant decision for international design/trademark applications will be sent to the applicant electronically via WIPO. Currently, the grant decision is sent in hard copy by mail but there are risks of interruptions/delays in postal service, especially under the current COVID-19 pandemic.

(vi) Other revisions ([P][U][D][T]) - in force as of April 1, 2022

a. Ease of requirements for recovery of rights extinguished due to failure of taking necessary procedures within the prescribed time period.
b. Surcharge exemption for late payment of registration fees (and renewal fees for trademark registrations) for a certain period of time, if the late payment was due to reasons such as the spread of infectious diseases and natural disaster.
c. Review (and possible increase) of official fees to be paid to the JPO upon taking certain procedures.