[Ip-health] China: Patent conditions amended for drugs

[Joan-Hu-Yuanqiong]

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[ Picked text/plain from multipart/alternative ]
>From Hu Yuanqiong

Legal Consultant

China Access to Medicines Research Group

Email: joan_hu_msf@yahoo.com



Chinadaily:
http://www.chinadaily.com.cn/china/2010-02/05/content_9431261.htm
Patent conditions amended for drugsBy Wang Yan (China Daily)The country has amended a patent regulation
to give a clear definition of "patented pharmaceuticals" that are
subject to compulsory licensing, amid a system that allows parties to
exploit patented inventions without the permission of the patent's
owner.

he existing Patent Law granting a
compulsory license for patented pharmaceuticals in China for the
purpose of public health. It applies to manufactured products in China
as well as exports to qualified countries under international treaties
to which China is a member.
But the law fails to give a clear definition of "patented pharmaceuticals" that are subject to such practice.

The latest move, which was released on Jan
9 and took effect on Monday, makes it clear that "patented
pharmaceuticals" are "any patented products or products directly
obtained according to patented processes in the medical and
pharmaceutical field to address public health issues, including
patented active ingredients needed in the production of the product and
diagnostic supplies necessary for the application of the product".

"The purpose is to make the compulsory
licensing system compatible with the need to cope with public health
crises," Yin Xintian, director of legal affairs department of the State
Intellectual Property Office, said at a press conference on Wednesday.
China's amendment to the compulsory
licensing is based on a World Trade Organization (WTO) protocol agreed
in December 2005 that allows WTO members to issue compulsory licenses
for the production and export of pharmaceuticals to an eligible
importing member. China accepted the protocol in December 2007.

When patented foreign drugs are deemed too
expensive for domestic consumers, compulsory licensing is usually
adopted to help provide relatively cheaper generic counterparts.

China's newly amended law clears the way in
legal issues for the use of generic versions of patented drugs
domestically, but whether a mature compulsory license system is able to
develop in the country relies on the specific operations of the law,
said Jia Ping, founder and CEO of the China Global Fund Watch
Initiative and a leading researcher on HIV/AIDS, law and human rights
in China.

"Demand for HIV/AIDS, cancer, hepatitis and
cardiovascular diseases drugs are currently high in China, but patents
of most major drugs are held by a number of international
manufacturers, which push domestic ones downstream in the industrial
chain," Jia said.

He said a number of big Western companies adopt an "evergreen" method to prolong their patent periods.

"The standard patent protection period is
20 years. When the deadline approaches, the companies patent an
improvement on the drug - sometimes just a small step - which grants
another 20 years," Jia said.
So far, compulsory licenses have never been issued in China, leading to a lack of generic versions of these drugs, Jia said.

"Take HIV/AIDS as an example. China is
highly dependent on government procurements and internationally donated
drugs. Two years ago, there was an outcry demanding more lamivudine
around the country. To fulfill domestic needs, local production of such
drugs under compulsory licensing is necessary," Jia said.
But Jia said the government needs to do more to motivate local pharmaceutical factories.

"You have to ensure the factories that the
law will be fully carried out to protect their rights when it comes to
legal disputes. The compulsory licensing has been in the law for long,
but some insiders complained that the regulations were not detailed
enough. Now that they have further amended the law, the question will
be how other government bodies will make use of it," he said.
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