PRODUCT PROTECTION IN CHINA by ProQuest

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Another challenge, however, is that while China's criminal code has provisions for dealing with "fake" drugs, it does not follow the wider WHO definition. Only drugs with no active ingrethent and which have caused "harm" will meet the criteria for a "fake" drug. Otherwise, counterfeit pharmaceutical cases are usually pursued under criminal provisions for trademark counterfeiting, which imposes a higher threshold for criminal liability.

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PRODuCT
PROTECTION
IN CHINA
China’s healthcare market receives a great deal of attention because of its demographic make-up. But, the
health of China’s IPR regime is often a cause for concern in an industry that relies on strong patent protection
and enforcement. Chris Bailey, IPR lawyer and China IPR SME Helpdesk expert, addresses practical steps for
SMEs to better protect their IPR in two key areas: during R&D and in tackling counterfeit products.

                   hile China’s Patent Law          companies that have managed to obtain such        IP regime. When engaging in R&D, there are
                   has recognized patents for       concessions in other countries. Considering       certain specific aspects of the Chinese system
                   pharmaceutical compounds         that one of China’s major weaknesses is the       that all companies should be aware of.
                   and processes since 1992,        long approval process, practical shortening of
the country has enacted its third amendment         the patent term is a real issue.                  First Filing
to the legislation, which comes into effect                                                           Companies engaged in R&D in China should
on 1 October 2009. This has a number of             Compulsory Licensing                              be aware of the requirements under the new
important implications for patent registration      So far, China’s SIPO has never granted a          law to file patents first in China, when the
and protection in China, although many              compulsory license. The new Patent Law            invention was “completed” in the country, or
of the details are yet to be clarified in the       contains more specific wording for the criteria   obtain permission from SIPO to file elsewhere.
Implementing Regulations, which are still           under which a compulsory license is issued,       Patent applications for inventions that appear
under draft.                                        but also applies a broader standard for issuing   to have been invented in China, but which were
   Patent attorneys in China agree that             compulsory licenses for pharmaceuticals.          first filed overseas without obtaining permission
pharmaceutical patents in China are harder          This potentially raises the possibility of        from SIPO are at risk of being refused
to obtain than for other inventions, and the        compulsory licenses being issued for public       registration in China. The criteria that determine
scope of allowed claims is narrower. While          health purposes in the future. In addition,       whether an invention was created in China —
China’s SIPO (State Intellectual Property Office)   China’s recently enacted Anti-Monopoly            and the details of the process for obtaining a
has made efforts to recruit examiners, the          Law also contains provisions for compulsory       permit — are to be covered in the Implementing
examination period (approximately 3 years) is       licensing where “abuse of IPR” is determined.     Regulations. Pharmaceutical companies with
also a major consideration in time-to-market.       As yet, the full effect of these laws on a        R&D in China are advised to be cautious and,
   In terms of drug registration, the new           patentee’s monopoly rights has not been           if in doubt, be prepared to draft patents in
patent law provides for the so-called               tested. Companies should keep abreast of          Chinese for first filing in China.
“Bolar” exemption, which clarifies that using       developments in the application of these laws
a patented formula for the purposes of              and seek legal advice on whether they are at      Co-Invention and
obtaining regulatory approval does not count        risk from having compulsory licenses imposed.     Inventor Remuneration
as infringement of the patent. This allows                                                            There are a number of IP issues to consider
generic drug companies to start the approval        Developing Your                                   when companies contract with a research
process before the patent for the original          Product in China                                  laboratory to jointly develop or commercialize
drug has expired, giving them quicker time to       For those engaged in drug discovery, the fact     an invention. When, as is often the case, the
market. The law does not, however, provide          that GSK, AstraZeneca, Aventis and other          research partner is a university or a related
for patent term restoration or extension, which     major firms have set up R&D centres in China      research institute, the authority for entering
has proved disappointing to pharmaceutical          indicates the growing confidence in China’s       the agreement m
								
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