so, he can make it up during
prosecution, for example, upon
request of the examiner. The direct
source must be provided, although
the original source can be
exempted if it is not known to the
applicant. However, the applicant
has to give explanations as to the
reason why he has no knowledge
of the original source.
For a PCT entry case, the
applicant may disclose the source
of genetic resource at the
time of Chinese national entry
or during prosecution in the
When a patent application involves a new biological
material that is not available to the public, the applicant
shall make deposit of the material in a recognized
depositary by the priority date of the application. As
China is a party to Budapest Treaty, deposit at a
depositary that is recognized internationally under the
Treaty will suffice. In addition, the applicant has to
furnish a copy of the deposit receipt and the viability
report issued by the depositary within 4 months from
the filing date or from the date of national entry.
Property in Beijing
WHEN A PATENT APPLICATION INVOLVES NUCLEOTIDE OR
AMINO ACID SEQUENCES, ARE SEPARATE SEQUENCE
LISTINGS REQUIRED TO BE SUBMITTED?
Yes. When an application involves a nucleotide
sequence of 10 or more nucleotides, or an amino acid
sequence of 4 or more amino acids, both a hard copy
and a computer-readable form of the sequence listings
shall be furnished together with the application. If there
are any discrepancies between the two versions, the
hard copy prevails.
IS BIOLOGICAL TEST DATA REQUIRED IN CHEMICAL AND
BIOTECH PATENT APPLICATIONS? IF SO, IS IT REQUIRED IN
THE INITIAL APPLICATION? IS LATER SUPPLEMENT OF
DATA POSSIBLE? IS CLINICAL DATA REQUIRED FOR
When a person skilled in the art would not have been
able to predict the alleged effect of the invention based
on literal description of the patent application in light of
the prior art, test data has to be filed so as to prove that
the claimed invention can solve the targeted technical
problem or achieve the intended technical effect. This is
very often the case with chemical and biotech patent
applications. This data is required for the purpose of
sufficient disclosure and/or claims being supported
from the description and must be provided in the initial
application. Any data submitted later for such purposes
will not be considered.
In some cases, data is also required to demonstrate
inventiveness. Supplement of data for such purpose is
possible but only on the condition that the effect shown
by the data has been sufficiently disclosed in the
When presenting data, the compounds or materials
that were tested must be specified.
There are no strict rules on whether in vitro test or
clinical data should be provided as long as the data is
convincing to a person skilled in the art that the claimed
invention can solve the targeted technical problem or
achieve the intended technical effect.
IS IT POSSIBLE TO GET EXTENSION OF PHARMACEUTICAL
PATENT, FOR EXAMPLE TO COVER DELAYS IN REGULATORY
No. It is not possible to get any extension of patent term
even though there is a delay in the regulatory process.
IS “BOLAR EXEMPTION” APPLICABLE TO
PHARMACEUTICAL PATENTS AVAILABLE IN CHINA?
Yes. It was introduced in the Third Amendment of the
Patent Law in 2008. According to the current law,
manufacture, use and import of a patented drug or
patented medical device for the purpose of providing
information necessary for regulatory approval is
exempted from patent infringement.
GIVEN BOLAR EXEMPTION PROVISION IN THE LAW, WHEN
CAN GENERIC VERSIONS OF A DRUG BE ENTERED?
According to Chinese Food and Drug (FDA)’s
regulations, an application for generic entry may be
filed with the Chinese FDA within two years of the
expiry of relevant patent(s). However, the license by the
FDA will be granted only upon termination of the
IS DATA EXCLUSIVITY AVAILABLE UNDER CHINESE LAW?
Yes. According to Chinese FDA’s regulations, data
exclusivity is given to a company who produces or sells
a drug containing a new chemical entity for six years
from granting a license to it. ■
Peksung Intellectual Property Ltd.
908 Shining Tower, 35 Xueyuan Road,
Haidian District, Beijing 100191
Tel: +86-10-8231 1199
Fax: +86-10-8231 1780; +86-10-8231 1782
Managing Partner, Patent Attorney
Peksung Intellectual Property Ltd