[Ip-health] new work from the accessibsa project

Achal Prabhala 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/

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Today, we have a new paper out that you might be interested in: 
http://accessibsa.org/media/2018/04/Pharmaceutical-Patent-Grants-in-India.pdf

The full title is: "Pharmaceutical Patent Grants in India: How our 
safeguards against evergreening have failed, and why the system must be 
reformed"

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 
here:

- 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%.

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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.

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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/

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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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