LS&HC Horizons 2022 - Flipbook - Page 55
Hogan Lovells | 2022 Life Sciences and Health Care Horizons
55
Asia-Pacific
Life sciences in Japan
We expect the on-going Covid-19 pandemic in Japan to continue to
heighten public interest and awareness of the biopharma industry. The
initial delays in the vaccine rollout may now lead to greater alignment of
Japan with international standards for clinical trials, with the relevant
regulator potentially accepting the benefits of harmonizing the Japanese
rules and regulations more closely with those of other countries.
We expect sustained efforts to educate citizens and to enhance access
to new and innovative vaccines and drugs (including those for Covid-19
now being developed by Japanese pharma companies). Advocacy for
the maintenance of suitable pricing for innovative drugs may increase;
if successful, this may lead to improved commercial predictability and
thus some restoration of the Japanese market’s attractiveness.
We anticipate that companies will still prioritize Japan, while
monitoring closely how the world’s third-largest market refines the
regulatory process to strike an appropriate balance between encouraging
innovation and managing associated costs.
Originator versus generics patent cases are expected to endure.
The “patent linkage” system may evolve such that the extent to which
the regulator typically refrains from granting a marketing authorization
for a generic product falling within the scope of relevant patents may
become less clear. A number of biologics and biosimilar patent cases
remain the focus of dispute resolution in Japan, somewhat mirroring
cases elsewhere, and we expect these to increase. We recommend
analyzing and assessing the practical impact of Japan-specific
developments in due course.
Dr Frederick Ch'en
Office Managing Partner, Tokyo
Band One for Life Sciences
in Japan and Asia-Pacific in
Chambers Asia-Pacific, 2022
