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  • David Vance

Revised Chinese Patent Examination Guidelines

Some excellent patent news came out of China last month. A new set of

patent examination guidelines came into effect on 15 January 2021. These

guidelines should be a great help to those of you pursuing pharmaceutical

patents in China.

Taking a step back, one of the most difficult decisions in the patent world

is deciding when to file a patent application. If you have an upcoming

disclosure (e.g., paper publishing), then you are usually forced to file

before that disclosure. But, if you do not have such a critical date, then

when you file can depend on factors including whether there is a competitor

in the field, if investors need a patent issuance (or allowance) to further

invest, and when you will have the necessary funding to afford a patent


One of the differences between US patent law and China is the need for

data. In the US, one does not necessarily need data (e.g., physical data

proving a compound is made or activity data showing a compound works as

described). However, China requires such data and before 15 January 2021,

it needed to be present in the application as filed. So if you file your

application prior to data generation, then you might not be able to patent

your compounds in China. Even worse, if your claimed compounds are

considered obvious, you can file comparative data in the US to overcome

such a rejection. But, before 15 January 2021, you could not submit this

data in China to overcome the rejection. Luckily, it appears that data

submission rules have changed in China. If post-filing data is "derivable"

from the application, the CNIPA can now consider it. This is great news.

Let's look at a few examples.


Let's consider a claim to a compound where its method of

making and using has been described along with a description of how to

test the compound for activity. If a US examiner were to request activity

data, it could be provided. However, before 15 Jan 2021, a Chinese

examiner could reject the compound for a lack of activity data. There was

no way around this rejection. Now, the activity data can be submitted

(assuming the new "derivable" standard is met). This will allow US

applicants to file their applications prior to actual utility data is


Inventive Step:

Sometimes it's necessary to show that your invention

is superior to the prior art via comparative data. This is typically a

showing that the activity of your invention (e.g., anti-tumor activity) is

unexpectedly better than that of the prior art. If your application as

filed only showed a range of activity for a tested compound, you would not,

before 15 Jan 2021, be able to supplement that data with a specific value

in order to compare against the prior art. Now, such activity data can be

submitted in order to establish an inventive step (what we call

non-obviousness in the US).

A few other beneficial changes also have been made to the patent rules in

China. I would suggest you consult with a Chinese patent law firm for all

of the details.

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