The Utility Model (UM) in China has always been a popular choice for patent filing due to its relatively low cost and speed of prosecution. The UM prosecution only includes a preliminary examination, which is essentially a mini (stripped down) version of an invention application’s substantive examination.[1] With the simplified examination process, UMs are typically granted without issue. Unfortunately, this may soon not be the case anymore. Heightened Inventiveness Standard + Formal Search The CNIPA[2] has recently published an official letter in response to a Proposal from a CPPCC member regarding problematic patents and malicious competition based thereon in the lithium battery industry.[3][4] The key messages stated in these letters…
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Compositions Limited by Use: A Cautionary Tale
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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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…
