The implementation of the new patent law has not been authorized to produce Tamiflu as possible - Duffy - pharmaceutical industries

The implementation of the new patent law has not been authorized to produce Tamiflu as possible - Duffy - pharmaceutical industries

The third revision of "The People's Republic of China Patent Law" (the "Patent Law") on October 1, 2009 into effect, for professional, highly technical and complex Medicine Intellectual property protection, the role will have can not be ignored.

Recently held in Shanghai forefront of the global pharmaceutical (China) Forum, around the "Patent Law" and its impact on R & D from government, business and the legal profession had a thorough discussion.

Increase the content of the compulsory licensing system

At the forum, the State Intellectual Property Office, Department of Medical Biological Review First Minister Zhang Qingkui sort of "Patent Law" The major changes. Protection of genetic resources to increase the content of the "mixed novelty" to "absolute novelty" and raise the authorized design standards, to increase related to public health, compulsory licensing system to increase the drugs and Medical Devices Experimental exceptions, etc, are the pharmaceutical industry is more significant changes to the Department.

Zhang Qingkui example, that in the past, foreign medicines and medical equipment as long as there is no open to the public in the form of publications, may still apply for patent protection in China, and the "Patent Law" in the relevant provisions of the revised as "absolute novelty standard" After this application will no longer be possible patent protection.

"This gives companies a higher level of R & D requirements." Sine on the Pharmaceutical Group, Dr. Zhang Jundong Drug Research Institute said that only "absolute novelty" products can be patented, which will enable enterprises to focus on the real innovation, in the long run help to improve the innovative R & D enterprise.

Newly revised "Patent Law" has also increased the compulsory licensing. Zhang Qingkui that this will help combat intellectual property and public health crisis and resolution. In fact, as early as 2005 Bird flu Outbreak, the Guangzhou Baiyun Mountain General Pharmaceutical Factory (hereinafter referred to as "White Cloud Mountain") has developed generic Tamiflu, but had no Roche Authorize the production, the "Patent Law" involving public health, an increase of compulsory licensing regime, will launch anti-Baiyun Mountain Influenza A H1N1 influenza Drugs provided a legal basis. Once a flow of large-scale outbreak of the epidemic, public health and patent protection through trade-offs between the mainland's first case of compulsory patent licensing is not without potential.

Finally, Zhang Qingkui also referred to the experimental exceptions?? "To provide the information necessary for administrative approval to manufacture, use, Import Patent medicines or medical equipment is not infringing. "This and Drug Registration in the relevant provisions of the echoes to help early generics market, bullish on generics.

A number of issues still doubtful

"Patent Law" amendment will promote pharmaceutical innovation, but there are several issues still unresolved.

First of all, the world's patent systems in many countries have established drugs to extend patent protection system, but not yet considered the amendment extended the patent issue. Zhang Qingkui this view, this situation will weaken patent protection, not conducive to encouraging innovation.

Jun-Dong Zhang proposed to extend drug patent protection, can make up for drugs listed in the application and approval process was time consuming, more conducive to stimulating business innovation and driving force, but companies can also use a variety of patent portfolio, all-round protection of patents and patent extension period.

"This requires the company has a strong patent awareness." Jun-Dong Zhang said.

Second, the Drug Registration Requirements "the applicant shall apply for registration of their prescription drugs or use, process, use, etc., to provide the applicant or others in China, state ownership of the patent and its description; others in China there is a patent, the applicant shall submit the patent to others, the statement did not constitute infringement. "

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