Mak, Toby --- "BIOTECHNOLOGICAL, CHEMICAL AND PHARMACEUTICAL INVENTIONS II: SUPPORT AND EXPERIMENTAL DATA" [2014] ELECD 667; in Luginbuehl, Stefan; Ganea, Peter (eds), "Patent Law in Greater China" (Edward Elgar Publishing, 2014) 87

Book Title: Patent Law in Greater China

Editor(s): Luginbuehl, Stefan; Ganea, Peter

Publisher: Edward Elgar Publishing

ISBN (hard cover): 9781781954836

Section: Chapter 5

Section Title: BIOTECHNOLOGICAL, CHEMICAL AND PHARMACEUTICAL INVENTIONS II: SUPPORT AND EXPERIMENTAL DATA

Author(s): Mak, Toby

Number of pages: 7

Abstract/Description:

The basic principles of patentability in China are similar to the rest of the world. However, support requirements in China have undergone significant changes in the last ten years, resulting in a relatively low predictability of prosecution of patent applications, in particular of applications in the areas of chemistry, pharmaceutics and biotechnology. This chapter will discuss the specific requirements for protection in these areas and how to rid oneself of obstacles to patent grant. Before 2004, support requirements in China were in line with those in the majority of patent regimes. Specifically, sufficient description and experimental data were required to allow a person skilled in the art to practice the invention. Back then, the requirements were not as stringent as today, which will be explained below. In fact, before 2004, experimental data for one single compound covered by a Markush-type claimwas sufficient to support such claim. The now obsolete Examination Guidelines of 2001 did not allow further addition of unpublished data to the specification after the application date, but the applicant could use such data to convince the examiner to accept novelty, inventiveness, and/or utility of the invention when responding to an office action. All this changed drastically in 2004 when Pfizer’s Chinese Viagra patent CN ZL94192386.X (hereinafter ‘386’) was declared invalid by the Patent Re-examination Board of SIPO. The validity of this Chinese patent had been challenged by eight Chinese companies. Specifically, ‘386’ had only one single claim directed to a single compound, as Pfizer chose this compound during prosecution of the