Section 4.2.3, Part II Chapter 10 of the CNIPA’s Examination Guidelines (“Guidelines”) stipulates that if the specification only discloses one property or use of a composition, the composition claim shall be drafted as a “composition limited by the function or the use”. Furthermore, it specifically states that “most pharmaceutical claims shall be drafted as claims limited by use” (emphasis added). Note: this rule only applies to compositions claims, not composition of matter claims directed towards a single active ingredient. Compositions are defined as any combination/mixture of two or more components, such as pharmaceutical formulations (active ingredient + excipients) or mixtures of various ingredients. How does the Examiner determine whether there…
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How the Chinese Patent Office Rejected a Plate-Making Method Based on Food Safety Law
Previously we published an article about CNIPA rejecting a patent application claiming a food that could also be used to treat or prevent diseases based on the food’s alleged non-compliance with Food Safety Law. China’s Food Safety Law includes a provision which states any use of a composition as a food must be strictly separated from any medicinal use. Recently, we have noticed a worrying trend of such “food safety” type rejections impacting a broader class of inventions, even for inventions that are not directed towards the food itself. Here is one such case. Manufacturing Methods for Making a Plate The patent application[1] at issue is directed towards a method…
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China’s Supreme People’s Court (SPC) Hands Down First Patent Linkage Appeal Decision
China has been implementing a plethora of new laws and measures that are particularly favorable to drug companies, such as patent term extension and patent linkage. Details of the new implementation measures for patent linkage (technically “early dispute resolution mechanisms for drug patents”) came into effect on July 4, 2021. At around the same time, China’s public registration system for innovator companies to list patent associated with marketed drugs (China’s version of the US FDA’s “Orange Book”) began accepting registrations. It has been close to one year since these mechanisms were put in place. The first legal decisions from these patent challenges are now coming out, and the first appeal…
