Written by Haoyu ZHOU
CNIPA and the NMPA jointly published <Methods for Early Resolution of Drug
Patent Dispute (Pilot
Program)> on July 4, 2021, which has immediately come into effect on the
same day (hereinafter referred to as the “Methods”).
means that any pharmaceutical patent disputes between the branded and generic
companies can now resort to the Methods (or commonly known as pharmaceutical
patent linkage system) for early resolution in China.
of the key objectives and contents of the Methods are highlighted below in this
I. It specified the types of patents that can be put on the Patent
Listing Platform for Authorized Drugs in China (Hereinafter referred to as the “Platform”)
(i) patents in relation to pharmaceutical active ingredient; (ii) patents in
relation to pharmaceutical composition comprising active ingredient; or (iii)
medical use patents;
preparations: (i) patents in relation to active ingredients of sequence
structures; or (ii) medical use patents;
Chinese Medicines (TCMs): (i) TCM composition patents; (ii) TCM extract
patents; or (iii) medical use patents.
Methods clarified that patents in relation to intermediate products,
metabolites, crystal forms, methods of preparation and/or methods of measuring/testing
can’t be listed on the Platform.
II. It clarified how to make Statement (I, II, III and IV) and challenge
generic drug applicant must file the marketing authorization application by submitting
one of the four Statements.
Type I Statement: There were
no patents listed on the Platform in relation to the drug;
Type II Statement: The
patents listed on the Platform were either terminated or invalidated, or have
been licensed to the generic drug applicant;
Type III Statement: The
generic drug applicant promises to delay the marketing of the drug until the
patents listed on the Platform are expired; or
Type IV Statement: The patent
listed on the Platform shall be declared invalid, or the generic drug did not
fall within the scope of the patent.
generic drug applicant must be responsible for the accuracy of the Statement. The
NMPA will lay open of the Statement to the public and the generic drug
applicant must send a Notice to the Marketing
Authorization Holder (MAH) about
Statement and the grounds of such Statement, within 10 working days from the date when the drug authorization application is received by
the NMPA. According
to the Methods, said Notice must be at least sent to email addresses of the MAH
displayed on the Platform.
particular, the Methods also clarified that, if Type IV statement is made on the ground in which “the drug does not
fall within the scope of the patent(s)”, then the Statement must include the
technical solution of the generic drug, a comparison analysis chart between the
claim(s) and the generic drug, together with relevant technical evidence.
III. It specified the method
of triggering the 9-month stay period
patentee or the party of interest in relation to chemical
drug patent could file an opposition against
Type IV Statement (not applicable to Type I, II and III Statement),
within 45 days from the date when the generic
drug applicant files the marketing authorization application. The opposition
must be filed to either the CNIPA or the Court. When the CNIPA or the Court
receives the opposition as filed, they will send a Notice to both of the NMPA and
the generic drug applicant. Then the NMPA will set a 9-month
stay period, calculated from the date when the CNIPA or the Court
receives the case.
during the stay period, the NMPA will not
stop the technical examination for the drug, but will only stop the marketing
authorization and hold off issuing a license for drug authorization.
according to the Methods, generics of biologics and TCMs are excluded from the
9-month stay period. In other words, if patents of biologics or TCMs are
challenged under Type IV Statement and if the patentee files an opposition against
said Type IV Statement, the NMPA will not
set a stay period for such cases.
this perspective, there seems to be no good incentives for MAHs of biologics
(or TCMs) to list their patents on the Platform.
IV. It clarified the events
where the NMPA shall resume the activity of marketing authorization
any of the three events below occurs, then the 9-month stay period will be
terminated and the NMPA will resume its normal activity of marketing
(i) The CNIPA or the Court decides that the chemical
generic drug does not fall within the claimed
scope of the patent, or the parties reach a settlement;
(ii) The CNIPA or the Court decides that the
patent right be declared invalid; OR
(iii) The NMPA fails to receive any decision from
the CNIPA or fails to receive any judgement or mediation agreement from the
Court within the stay period.
the NMPA, during the marketing authorization, receives a judgement from the
Court or a decision from the CNIPA indicating that the chemical generic drug
falls within the scope of the patent, then the NMPA will postpone the marketing
authorization until close to the expiry of the patent term.
our opinion and according to our experience, 9 months are relatively short for
the CNIPA or the Court to make a timely decision or judgement, especially for
complicated cases such as pharmaceutical patent disputes. So, we are concerned
that a large number of “early resolution” cases may end up with item (iii)
above, where the CNIPA or the Court failed to make timely decision within the
9-month stay period.
V. It clarified the
applicability of market exclusivity for the first generic
the first chemical generic that successfully challenged the patent under Type IV Statement, the NMPA will grant it a 12-month market exclusivity. This means that the NMPA
will not approve any other
generics of the same kind within 12 months from the date of obtaining the
a successful patent challenge herein means a successful challenge under Type IV
Statement and the patent must have been declared invalid during the opposition
the question is, would it be considered a successful challenge if the patent is
“partially invalidated” such that the generic drug no longer falls within the
scope of the patent? We will wait for the NMPA and the CNIPA to answer that.
you have any questions on this topic, please feel free to contact Elliot ZHOU