Update! The finalized Implementation Measures are now out. You can read the details here: Breaking: China Released New Implementation Measures for the New Patent Linkage System Last month September 11, 2020, China’s National Medical Products Administration (NMPA) and the China National Intellectual Property Administration (CNIPA) jointly issued a draft set of measures for public opinion about early dispute resolution mechanisms for drug patents, what is referred to as a patent linkage system. Below is a summary highlighting key provisions. Creation of an “Orange Book” List The NMPA will create a public registration platform that will list patent information for all drugs marketed or seeking marketing authority in China (similar to…
-
-
Polymorph Patents in China: What is the Standard for Inventiveness for New Crystal Forms?
This case is focused on polymorphs, namely what are the standards for novelty and inventiveness when it comes to new crystal forms of a known drug? A recent Supreme People’s Court decision in China is illustrative of the way Chinese courts are thinking about polymorph patents in China. Grünenthal is a German pharmaceutical company and inventor of the opioid painkiller Pentadol[1]. Grünenthal has a Chinese patent (ZL 200580021661.1) with claims directed towards a new crystalline form of particular phenol hydrochloride (“tapentastat hydrochloride” and “Form A” in claim 1), processes for preparing tapentastat hydrochloride (claim 3), and processes for preparing Form A (claims 16 and 23). Form A is made by…
-
The Latest on Post-Filing Data in China’s Patent Law
Post-filing data can sometimes be the crucial difference between a patent allowance and a final rejection. The reasons are endless why important data may not have been included in the original patent application as filed. Time and budget may have been insufficient to generate data over the full scope of the claims at the time of filing. The priority of a company’s business may have changed, meaning now more resources are available to generate data in this new area. Whatever the reason, patent practitioners often rely on data generated after the filing of the original application in order to overcome rejections from the patent office. Traditionally, China has been known…
