Pharma and Biotech Patent Litigation

The Chinese Supreme People’s Court expressly opines how to construe a close-ended claim, By Dr. Stephen ZOU*

In the [2012] Civil Retrial No. 10, the Chinese Supreme People’s Court (hereinafter “SPC”) delivers its opinion regarding how to construe a close-ended claim. The patent at issue claims a freeze-dried powder injection, consisting of ATP and magnesium chloride with the ratio of 100 mg to 32 mg. The alleged infringer sold a drug containing ATP and magnesium chloride and other excipients. The amount of ATP and that of magnesium chloride, and the ratio of ATP to magnesium chloride in the accused infringing product are the same as those defined in the claim. The court of first instance held that the non-infringement defense of existing excipients was untenable and infringement was established. The court determined that the accused infringing product includes all the three essential technical features: a freeze-dried powder injection, a freeze-dried powder injection of ATP and magnesium chloride, and the ratio of ATP to magnesium chloride. The excipients in the accused infringing product do not affect the ratio between ATP to magnesium chloride. The judgment was maintained by a higher level court. The accused infringer dissatisfied with the judgment and filed a request for retrial. After retrying, the SPC reversed the judgment made by the lower level courts. The reasoning of the SPC lies in that the Guidelines for Patent Examination expressly stipulates that a claim drafted in open-ended mode and the one drafted in close-ended mode have different scope and different examination criteria apply to the two kinds of claims. When a claim is drafted by the applicant in close-ended mode, it indicates that other components not defined in the claims are excluded from the scope of the claim. After being granted, the claim in close-ended mode should be construed under the same standard. Therefore, a close-ended claim should be construed as not including the structure component(s) or step(s) which are not defined; and for a composition claim drafted in close-ended mode, it should be construed as that the claimed composition only contains the components limited, but a common amount of impurity might be included; and the excipients are not impurities. * Dr. Stephen ZOU is a partner and patent attorney at Lung Tin International Intellectual Property Agent Ltd.. His email address is [email protected].  

ZOU, Zongliang (Stephen)ZOU, Zongliang (Stephen), Ph.D, LL.M Patent attorney

  Experience: Dr. Zou is a partner and a patent attorney at Lung Lin, where he focuses on patent matters, primarily on patent application preparation and prosecution in the fields of pharmacy, chemistry, and biotechnologies, as well as on patent reexamination, invalidation and litigation. In particular, Dr. Zou has rich experience in providing clients with patent infringement analysis. Dr. Zou joined Lung Tin in 2012.   Since Dr. Zou started his professional as a patent attorney from March 2003, he has been entrusted by several multinational pharmaceutical giants to handle their patent matters in China, helped them obtain regulatory approval, and helped them solve IP matters in drug pricing & drug bidding activity.   Prior to joining Lung Tin, Dr. Zou had served in a well-known IP firm as a patent attorney and a partner for over nine years.   Before his legal profession, he had been an assistant professor at China Academy of Military Medical Science from 2000 to 2002.   Education: Dr. Zou obtained his Ph.D. in pharmaceutical chemistry at China Academy of Military Medical Science in China (2000), and Master of Laws in Intellectual Property Law from John Marshall Law School in US (2010). Dr. Zou’s working languages are English and Chinese.   Contact Information: Email: [email protected] Cell Phone: 86-139 1012 6372 Telephone: 8610-84891188 ext. 602  

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Pharma & Biotech Patent Litigation