LS&HC Horizons 2022 - Flipbook - Page 50
Hogan Lovells | 2022 Life Sciences and Health Care Horizons
50
Patents, Litigation, and Beyond
An update on patent term extension and patent linkage systems in China
With the amended Chinese Patent Law coming into effect on 1 June
2021 and the subsequent implementation regulations issued in early
July, a number of patent linkage actions have now been filed with the
Beijing Intellectual Property Court and the China National Intellectual
Property Administration (CNIPA). These are the two venues with
exclusive jurisdiction to deal with such cases and determine whether
a generic drug covered by a marketing approval application falls
under an eligible patent that has been registered with the Patent
Registration Platform of Listed Drugs. The CNIPA proceedings
are provided as an alternative to court proceedings, and provide
administrative adjudication of patent linkage disputes. The early
numbers of cases filed and some industry comments suggest the new
administrative dispute resolution mechanism provided by the CNIPA
may be preferred over the court, possibly because of an expectation
of higher efficiency and obtaining a quicker decision. We are so far
unaware of a decided patent linkage case or a generic drug marketing
authorization being suspended in a patent linkage case. A number of
cases are likely to be decided in 2022 and can be used as references for
pharmaceutical companies when deciding on best strategies to protect
their markets for their patented drugs.
Julia Peng
Counsel, Hong Kong
On the equally important topic of patent term extension (PTE) in
China, there are so far still no official implementation regulations
on PTE, another new system brought in by the amended Chinese
Patent Law. Key issues remain open, such as whether patent owners
of originator drugs will need to ensure their new drug is “absolutely
new”, in the sense that the same drug has not been approved for
marketing authorization anywhere else in the world, in order to
apply for Chinese PTE. The amended Patent Law used the wording
“new drug” instead of “innovative drug”, leaving some room for
interpretation by the implementation regulations. In its proposed
clarification on PTE, CNIPA’s August 2021, Draft Revised Patent
Examination Guidelines, requires an eligible chemical “new drug” to
contain a novel active substance, or cover a new indication of a known
active substance, or cover a substantively improved ester or salt form
of a known chemical active ingredient, all of which need to have not
been approved for marketing authorization anywhere in the world.
While the draft regulations for implementation of PTE have not yet
been finalized and may be subject to changes, international life science
originators should bear in mind a potential dilemma they may face for
some of their drugs if the current rules are enacted as suggested in the
draft examination guidelines, of having to choose between an earlier
global launch and possible loss of PTE in China, or a later global
launch with the possibility of obtaining PTE in China.
Andrew Cobden
Counsel, Hong Kong
