LSHC Horizons Brochure 2024 - Flipbook - Page 61
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | APAC
61
A spotlight on life sciences in Japan
With COVID-19 restrictions having been finally
lifted in H1 2023, Japan and Japan’s biopharma
industry continue to generate renewed interest.
From the perspective of Japanese Life Sciences
companies, many appear re-energized and
are now seeking cross-border opportunities,
especially in the form of licensing transactions
(especially in cell and gene therapy, regenerative
medicine, oncology, and related fields) and
other forms of collaboration.
We anticipate that international companies
will still prioritize and invest in 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. Advocacy has
continued for the maintenance of suitable
pricing (price maintenance premium system)
for innovative drugs, refinement of the system
of repeated price cuts to patented medicines,
and improvement of the Health Technology
Assessment (HTA) processes; if successful,
this may lead to improved commercial
predictability and transparency, and thus
some restoration of the Japanese market’s
attractiveness. There is continued desire to
eliminate “drug lag,” encourage simultaneous
global development of drugs (with the relevant
regulator seemingly recognizing the benefits
of harmonizing Japanese rules and regulations
more closely with those of other countries),
and provide practical support for
developing bioventures.
Dr. Frederick Ch'en
Office Managing Partner
Tokyo
We expect continued focus on data privacy/
protection, cybersecurity, digitization and
digital health (especially wearable tech and
personalized data-driven care), automation
and artificial intelligence; there may also be
a measured approach to addressing issues
relating to access to medicines as well as
unmet medical needs.
Originator versus generics patent cases are
expected to endure. The “patent linkage”
system has been under recent scrutiny
following at least two on-going cases in which
the relevant regulator apparently changed
its policy and unexpectedly approved generic
versions of originator products even though
certain patent claims arguably covered the
originator product. This has created some
uncertainty for both originator companies
(which may now query the precise scope of
protection conferred by certain patent claims
and potentially also the strategic investment in
Japan more broadly) and generic companies
(which may be forced to launch “at risk” and
face heightened costs of patent litigation).
We expect that the Japanese courts will
help resolve this issue in the coming 12-24
months. In addition, 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. As in previous years,
we recommend analyzing and assessing
the practical impact of Japan-specific
developments in due course.
Band One for Life
Sciences in Japan and
Asia-Pacific in Chambers
Asia-Pacific, 2024
