Eli Lilly Nederland B.V. v. China State Pharmaceutical Administration

In June 1998, the Higher People's Court of Beijing Municipality, upon hearing the administrative case of appeal, Eli Lilly Nederland B.V. v. China State Administration for Supervision of Pharmaceutics, made its final ruling to reject the appeal and to maintain the original judgment. The court has established a principle: the analogy process patent of medicinal mixture can not serve as a base for application for administrative protection of pharmaceutics.

In November 1994, Eli Lilly Nederland B.V. applied to the China State Pharmaceutical Administration (the former State Administration for Supervision of Pharmaceutics (thereinafter referred to as the Administration for pharmaceutical administrative protection for its capsular agent of PROZAC and its active ingredient Fluoxetine Hydrochloride. It is based on No.181654 patent of Netherlands, a patent also known as the analogy process patent for a medicinal mixture.

In July 1995, the Administration made its Conclusion of Examination (as in Yaoxinbaojiezi (95) No.1 Document)not to grant its pharmaceutical administrative protection for the aforementioned pharmaceutical product. The Reexamination Board of Pharmaceutical Administrative Protection of the Administration reexamined the Conclusion and, in December 1995, rejected the requester's reexamination request. Dissatisfied, Eli Lilly Nederland B.V. instituted administrative proceedings in No.1 Intermediate People's Court of Beijing Municipality. The Court, after hearing the case, rendered the judgment of first instance, maintaining Yaoxinbaojiezi (95) No.1 Conclusion of Examination made by the Administration. Dissatisfied with the judgment of the first instance, the plaintiff appealed to the Higher People's Court of Beijing Municipality.

Based on its hearing, the Higher People's Court of Beijing Municipality held that pursuant to the bilateral treaty or agreement, when a foreign exclusive right holder applies to a competent administrative authority for administrative protection for a pharmaceutical product, the pharmaceutical product for which application for such protection is filed, subject to the related law and regulations, should meet the following conditions: (1) its exclusive right was not protected according to the provisions of the Chinese Patent Law before 1 January 1993; (2) the exclusive right was acquired from 1 January1986 to 1 January 1993, prohibiting any others from manufacture, use or sale in the country of the applicant; and (3) it was not sold in China prior to the date of application for the administrative protection. The appellant's No. 181654 Patent of Netherlands is not a pharmaceutical patent, but a process patent, for which an application for patent protection can be filed according to the Chinese Patent Law before 1 January 1993. Besides, as for the scope of protection for the Netherlandish patents, the scope is confined to patented processes and extended to the substances manufactured according to the processes. But, it cannot prohibit others from making the medicine, using or selling the medicine for the similar kind according to other processes. That is, in legal sense, the patent is not completely exclusive in respect of the pharmaceutical product Fluoxetine Hydrochloride. Therefore, the Higher People's Court of Beijing Municipality finally ruled to reject the appeal and to maintain the original judgment.

So far, a conclusion has been made with the closing of the case regarding the issue which has aroused controversy relating to whether a analogy process of a medicinal mixture can be granted its patent right according to the Chinese Patent Law as of 1984. That is, patent right can be granted, according to the Chinese Patent Law as of 1984, to analogy processes of medicinal mixtures, such as the process for preparing medicinal mixture by blending active compounds with medicinal carriers.

Wu Yuhe