2021 LS&HC Horizons - Flipbook - Page 54
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Hogan Lovells
Important patent law changes in China
On 1 June, 2021, some important amendments
to the Patent Law of China will take effect. The
key changes for the life sciences industry are
the adoption of a patent linkage system and
a right to apply for a patent term extension
for pharmaceutical patents. Life sciences
companies doing business in China or that
have Chinese patents should be preparing for
these changes.
Patent linkage
New article 76 of the Patent Law provides a
framework for China’s long-awaited patent
linkage system. Under this new system, the
issuing of marketing authorizations for generic
drugs is, to a certain extent, made dependent
on the absence of infringement claims by
patentees. The amendments provide that
during the marketing authorization procedure
for a generic drug, a patentee (or stakeholder)
can bring an infringement proceeding before a
court or the CNIPA, which, if successful, would
lead to a suspension in issuing a marketing
authorization. The patent owner will need
to act quickly and start infringement
proceedings within 45 days of the publication
of the generic company’s application for a
marketing authorization.
Patent term extension for
pharmaceutical patents
Similar to the legal regimes existing in the
European Union, the U.S., and elsewhere,
the amended Patent Law allows patentees
of innovative pharmaceuticals to apply for a
patent term extension of up to five years, with
a cap so that the effective term of the patent
after obtaining marketing approval would
not be more than 14 years. The right to such
extension is not granted automatically, and
must be applied for by the patentee within
three months of obtaining marketing approval.
As is the case for the patent linkage regime,
the details regarding patent term extension
are left to implementing regulations. A draft
version proposes that applications for patent
term extensions can be made for certain patents
covering chemical, biological, and Chinese
herbal drugs.
Final versions of the regulations will be released
closer to June 2021. Please visit Hogan Lovells
Engage for our updates on patent linkage and
patent term extensions in China and more
information about what life sciences companies
should consider.
Andrew Cobden
Counsel, Hong Kong
andrew.cobden@hoganlovells.com
