[Ip-health] Matrix of Export Possibilities under Gilead HCV Licence

Tahir Amin tahir at i-mak.org
Thu Oct 2 12:57:46 PDT 2014


Jamie,

Thanks for sharing earlier versions of the matrix with me on which I shared
some of my comments with you, but was not able to for this latest version.
I just want to make a few points again for the broader readership here:

1. For 10.3(c) to even see the light of day, please provide a scenario
where Gilead will not have a pending patent in India (that is not
considered to  have a reasonable possibility of being granted) bearing in
mind how patent practice works. Simply reading clause 10.3(c) in the
abstract without regard to practice is fruitless for the purpose of
creating such scenarios. This matrix may make the language in the license
seem better than it is, but the actual impact of this license is clear as
day: under section 10.3(c), export is simply not possible to excluded
countries.

To be clear, if India has pending patents on sofosbuvir, and excluded
country X has no patents or pending patents on sofosbuvir, Indian licensees
can still ***not* supply Country X. There are five sofosbuvir applications
currently pending in India, and we certainly expect more.

In our ten years of monitoring Gilead's patenting behaviour on multiple
drug products in India, we can tell you without a doubt that Gilead always
files multiple patent applications (including divisionals) on a single drug
product. This behavior is par for the course for most patent applicants and
the pending applications can span the course of over a decade. This is
considered 'reasonable' in the world of patenting. This is why we fight
secondary and divisional patents. We wish this was different, but this is
the practical reality.

2. How grey is your grey area for issuing a CL on a pending patent if the
oppositions in India are successful, or if examination alone results in a
rejection? And how soon do you think that would happen given that s92A of
India's Act clearly states that such CLs are to be issued on *patented*
pharmaceutical products?

By the time these scenarios have been navigated, Gilead will have achieved
its objectives of creating an illusion of giving hope when there was never
any practical reality of these licensees supplying to excluded territories.
Seven Indian generic companies will be blocked from supplying excluded
territories where there are no patents, or where there are pending patents
or appeals in these countries - countries which could easily reject the
applications given how their laws are framed.

Once again our best hope for people needing the drug is to identify
multiple suppliers who won't enter into a license, and hope that advocacy
efforts to persuade these suppliers into Gilead's license are unsuccessful
- unless and until we have at least 2-3 suppliers who won't get into bed
with Gilead, we have very little hope for the millions living with HCV in
the excluded countries.

Such a matrix is good for theorising, but what we need is a realistic look
at how things work in practice. Sadly your matrix focuses on so-called grey
areas that are not really grey at all in the current state of practice, and
gives Gilead and this license much more credit than they deserve.

Tahir

On 2 October 2014 06:19, Jamie Love <james.love at keionline.org> wrote:

> Source URL: http://keionline.org/node/2104
>
> KEI was asked to make a presentation on Hepatitis C, on September 30, 2014,
> at a lunch seminar at UNITAID. I am attaching a PDF of the slides I used
> [2], as well as an eight page memo that takes a look at the recent Gilead
> license. The memo on the license was last edited on September 30, 2014, and
> is presented as a draft that may be revised in the future.
>
> See: Matrix of Export Possibilities under Gilead HCV Licence [3].
>
> The memo on the license presents a matrix that describes the freedom or
> restrictions that exist for making and supplying generic APIs for
> sofosbuvir (SOF) and ledipasvir (LDV), under the Gilead voluntary license
> (VL), to and from countries outside the 91 countries in the licensed
> territory. The matrix only addresses patent related issues, and does not
> extend to other barriers, such the requirements to register products with
> drug regulators.
>
> For an importing country outside of the licensed territory, we considered
> cases where the country has granted patents, where patents have been not
> been granted and are not expected to be granted, and where the patents have
> been filed, but have an uncertain status. For countries seeking to supply
> the countries outside of the territory, we consider each of the same
> scenarios. Collectively, this involves (3+3) x 3 = 18 different scenarios.
>
> We have shared earlier drafts of this memo with a diverse groups of experts
> following this issue, and with Gilead.
>
>
> Links:
> [2]
> http://keionline.org/sites/default/files/Hepatitis_UNITAID_30Sep2014_0.pdf
> [3]
>
> http://keionline.org/sites/default/files/Draft_4_MatrixofExportPossibilitiesGileadHCVLicence.pdf
>
>
> --
> James Love.  Knowledge Ecology International
> http://www.keionline.org/donate.html
> KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
> +41.76.413.6584, twitter.com/jamie_love
> _______________________________________________
> Ip-health mailing list
> Ip-health at lists.keionline.org
> http://lists.keionline.org/mailman/listinfo/ip-health_lists.keionline.org
>



-- 
Tahir Amin
Co-Founder and Director of Intellectual Property
Initiative for Medicines, Access & Knowledge (I-MAK)
*Website:* www.i-mak.org
*Email:* tahir at i-mak.org
*Skype: *tahirmamin
*Tel:* +1 917 455 6601/+1 646 884 7418/+44 771 853 9472



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