Beyond Borders: Global biotechnology report 2010

addition, the Government committed to
enhancing the protection of intellectual
property rights and steps to ensure
the safe use of biological technologies
and products. Priority sectors include
biopharmaceuticals, agricultural biotech,
bioenergy, biomanufacturing and
bioenvironmental protection.
Accelerated process for new drug
approvals
In 2009, the State Food and Drug
Administration (SFDA) issued its special
procedure to accelerate the approval
of four categories of drugs: 1) active
pharmaceutical ingredients (APIs) new
to the Chinese market; 2) drugs, APIs
or biologic products that have not been
approved worldwide; 3) new treatment
for AIDS, cancer and other rare diseases
with significant efficacy over current
treatments; and 4) new drugs targeting
unmet medical needs. Under the fast-track
procedure, the SFDA’s Center for Drug
Evaluation (CDE) has five days to decide
whether to accept the application if the
drug is eligible under the first and second
categories. For drugs under the third and
forth categories, the CDE has 20 days to
respond to the application. The fast-track
procedure shortens the approval period
for investigational new drugs (INDs) from
90 days to 80 days and the New Drug
Application (NDA) timeline from 150 days
to 120 days.
Pre-IND meetings have also been
introduced to the fast-track approval
mechanism. Similar to the US FDA’s
pre-IND meetings, the mechanism
encourages discussion of specific drug
development issues in advance to expedite
approval and understand the SFDA’s
position. This procedure is particularly
effective when the sponsor’s questions are
not fully addressed by guidance or other
information provided by the agency.
These changes in the new drug approval
process seek to make China a preferred
country for simultaneous global drug
development programs and enable earlier
32 Beyond borders Global biotechnology report 2010
product launches to benefit patients
in China.
Intellectual property reform
The “third amendment” to China’s patent
law came into effect in October 2009 and
further strengthens intellectual property
protection for innovative discoveries by
bringing the rules closer to international
standards. Major changes include higher
damages for patent infringement and
the adoption of an “absolute novelty”
standard, meaning that the invention must
be novel globally, not just in China, to be
patentable. This will allow challenges to
the issuance of Chinese patents where
prior art is known to exist outside of China.
The rules also seek to encourage foreign
patent filings on Chinese inventions by
removing the requirement to file first in
China. However, prior to filing a patent in
a foreign jurisdiction, inventors must make
a confidential filing with the patent office
for a national security clearance. Similar
to US law, the new rules also permit
generic drug makers to utilize a patented
medicine for the purposes of regulatory
and administrative filings, which benefits
generic drug makers preparing to market a
product rapidly after patent expiration.
Finally, of particular relevance to the
biotech industry is a new requirement
that inventions that depend on “genetic
resources” disclose the direct source
of such resources or disclose why the
applicant is unable to do so. While the
term “genetic resources” is not precisely
defined, it is expected to be interpreted
broadly. In addition, the genetic material
must have been obtained in accordance
with applicable laws. Although the
protection of genetic diversity has been
discussed by and among many emerging
countries, China is the first to require