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
filing.
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.
Enablement:
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
generated.
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.
