[Ip-health] new work from the accessibsa project
aprabhala at gmail.com
Sat Apr 21 11:39:46 PDT 2018
Dear ip-health members,
I work on access to medicines in India, South Africa and Brazil on a
fellowship from the Shuttleworth Foundation, and along with a lot of
other people, manage a short-term project we've called accessibsa.
Our project website: http://accessibsa.org
Who we are: http://accessibsa.org/about/
Today, we have a new paper out that you might be interested in:
The full title is: "Pharmaceutical Patent Grants in India: How our
safeguards against evergreening have failed, and why the system must be
The paper is a comprehensive analysis of all pharmaceutical patent
applications filed in India between 2005 and 2016, and that could be
classified as 'secondary'.
There are a number of interesting findings, some of which I'll summarise
- Of all pharma patent applications granted in these 10 years, the
overwhelming majority or 72% related to secondary claims; only 28%
contained a primary compound claim
- Our analysis finds that all secondary patent applications granted in
India were granted in contravention of what the law (esp Sec 3 and
subsequent clarifications of it) allows, leading to the Indian Patent
Office operating with a 72% error rate on its pharmaceutical patent grants
- Indian patent law has absolute exceptions and conditional exclusions,
and patent applications have been granted in error under both
situations, ie when the application goes against an absolute exception,
as well as when a condition needs to be satisfied
- Importantly, we have not found a single case in which conditional
exclusions have been satisfied by the applicant, for instance, with
regards to increased therapeutic efficacy, once the Novartis case
standards have been applied
When read in conjunction with an earlier paper -
http://accessibsa.org/media/2017/12/Rejected-in-India.pdf - "Rejected in
India: What the Indian Patent Office got right on pharmaceuticals patent
applications (2009-2016)" where we analysed all 1723 rejections of
pharma patents in India in the same years, 2005-2016 - some interesting
things come up.
- Excluding biologics, and a small number of pharma patent applications
for which the IPO is missing data, the total number of pharma patent
applications in these 10 years is 4016, of which 1723 were rejected,
leading to an operating reject rate of 42%.
- Our analysis, however, suggests that if Indian patent law was applied
correctly, the number of rejected applications would be closer to 3377
applications, leading to an effective rejection rate of 84%.
We are working on ways to implement our recommendations, which stem from
our analysis, that patent examination guidelines in India must be
revised, and that the 2005 Indian patent law amendment needs further
refinement, in light of the experience of these last 13 years.
Additionally, we've released all our data in the public domain, for
re-use and further analysis. The data thus far pertains to India, and
we'll be adding data from South Africa and Brazil in the coming weeks
and months, as we finish and put out more work.
As any of you working with Indian patent data will know, even though
it's technically 'public' the Indian patent office websites resist
downloading and complex queries, and are further complicated by
competing databases and interfaces, which means that well-sorted and
useful data can be hard to come by. We spent considerable time and money
assembling this data, which comes with links to detailed
notes/correspondence/etc as available on each application, and we're
particularly keen that it is available to as many people who have
something they can do with it - so do pass this on to anyone you know in
the community of researchers and activists.
You can see all the data we have here: http://accessibsa.org/data/
There's also plenty of other work on the website from Brazil and South
Africa. Please look around, and do get in touch with us (through the
website, through me, or to the authors of different papers and arguments
directly) if there's anything you would like to know more about.
Thank you, and good wishes -
- Achal Prabhala
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