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[e-med] L'Inde attribue une licence obligatoire en faveur de Natco pour le sorafenide de Bayer

Chers E-mediens, il y a peu (le 27 février 2012), vous avez pu lire un
message indiquant que Bayer était appelé à fournir les éléments justifiant
le prix du sorafenib, en Inde. En leur absence, le gouvernement s'apprêtait
à demander une licence obligatoire afin de permettre l'accès des plus
démunis au traitement;
La suite vient de sortir ci-dessous. En essence, les éléments fournis par
Bayer n'ont pas convaincu le tribunal qui a ordonné une licence obligatoire
en faveur de Natco.
D'un côté, on peut y voir un succès puisque Natco pourra mettre le produit
sur le marché à un prix qui serait 3% de celui de Bayer actuellement (69.000
$US/an). Par contre seul Natco bénéficierait de la licence obligatoire, lui
conférant ainsi un monopole au risque que les capacités de fabrication de
Natco ne lui permettent pas de satisfaire toute la demande en Inde. Natco ne
pourra non plus importer le produit pour satisfaire la demande. De
plus,cette licence n'ouvrirait pas la porte aux exportations. D'autres labos
qui auraient pu bénéficier de cette licence sont dans l'expectative, dont
CIPLA qui est sous le coup d'un procès pour infraction au brevet.
Tout ce qui précéde est à prendre avec circonspection car on s'attend à une
demande d'appel de Bayer.
(NDLR : que le prix de Natco soit au conditionnel montre aussi la limite de
cette action, car le monopole dont jouira Natco pourrait le conduire à
demander beaucoup plus, personne ne lui ayant demandé de s'engager sur ce
Charles Rambert

        ----- Original Message ----- 

        Statement of James Love, Knowledge Ecology International 

        Today India granted a compulsory license on patents held by Bayer on
the cancer drug sorafenib. The Bayer price of INR 3,411,898 per year (69
thousand USD) is more than 41 times the projected average per capita income
for India in 2012, shattering any measure of affordability. Bayer tried to
justify its high price by making claims of high R&D Costs, but refused to
provide any details of its actual outlays on the research for sorafenib, a
cancer drug that was partly subsidized by the US Orphan Drug tax credit, and
jointly developed with Onyx Pharmaceuticals. Onyx told the SEC that the cost
of R&D, pre-Orphan Drug tax credit, was $275 million through the 2005 FDA
approval of sorafenib, including outlays on other compounds, indications
that were not approved for marketing, and for expanded access trials in the
United States that had limited value as scientific experiments. Bayer has
made billions from sorafenib, and made little effort to sell the product in
India, where its price is far beyond the means of all but a few persons. 

        The Controller rightly rejected the several Bayer's defenses, and
granted the compulsory license, in an early test of the India requirement
that patent monopolies will be limited when products are not "reasonably
affordable." Because the facts in the Bayer case were extreme, the
Controller was faced with a stark choice, and had the compulsory license
been denied, the India statute on "reasonably affordable" pricing would have
seemed like an empty protection for the public. 

        The decision granting the license was limited in important ways.
Only NATCO can manufacture under the compulsory license. CIPLA still faces
infringement charges, and would have to seek a separate license. NATCO
cannot import the drug to satisfy the Indian market -- a restriction that is
not that important in India, but which would be very difficult if imposed
outside of India, where the capacity to manufacture with efficient economies
of scale and scope are limited. We were disappointed that the Controller did
not make explicit reference to the 2001 Doha Declaration on TRIPS and Public
Health, that obligates WTO members to take measures to promote access to
medicine for all. It would have been nice for the decision to acknowledge
the several compulsory licenses on drugs and medical devices that were
issued in Italy and the United States in recent years. [For the US, see:
http://keionline.org/node/862, http://keionline.org/node/1219. For the four
Italian CL cases on drugs, see: http://keionline.org/content/view/41/1]

        We were pleased that the Controller cited the plain evidence of
inadequate access as a test of the affordability of the product.

        Bayer is expected to appeal the decision, and the case may reach the
India Supreme Court. Today the India government took a first step toward
protecting its public from high prices on patented drugs. We hope this will
lead to more standardized policies for the grant of compulsory licenses when
products are so expensive that access is limited to only the most wealthy


        De : Carinne Bruneton [mailto:remed@remed.org] 
        Envoyé : lundi 12 mars 2012 17:26
        À : 'Charles Rambert'
        Objet : suite de notre article sur Bayer
        bonjour Charles
        merci de traduire pour e-med
        Compulsory License granted in India



        Content-Type: text/plain; charset=windows-1252

        India has just granted a CL to a generic company. See decision at:


        Background: In July 2011, NATCO, an Indian pharmaceutical company,
applied for a compulsory licence (CL) in the Mumbai patent office to
manufacture an affordable generic version of sorafenib tosylate ? the
anti-cancer drug for which Bayer has obtained a patent IN215758 in India in
2008. The patent expires in 2020.



        In its CL application NATCO is proposing to market the same drug at

        8,800 per patient per month if the patent office grants it a
compulsory license. The price is likely to come down to 3% of what Bayer is

        Bayer currently markets the drug at a high price of approximately

        2,80,000 per patient per month. This case is also important as it
will test Section 84 of the Indian Patent Act, under which the CL mechanism
kicks in when generic competitors request a CL.



        Several hearing have been held by the Indian Patent Controller in
the last nine months. Bayer aggressively opposed and tried to delay the
grant of the CL. Now a decision granting a CL has been published today by
the Patent Office in India.



        Under the WTO's TRIPS Agreement, CLs are a legally recognised means
to overcome barriers in accessing affordable medicines.



        The CL documents and information regarding the hearings are
available at:



        Leena Menghaney

        Tel: 46573730/1, 9811365412


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