Le géant pharmaceutique Bayer perd en Inde face à un labo de médicaments
génériques contre le cancer
Le Vif
<http://www.levif.be/actualite/auteurs/le-vif-77.html>
13/12/2014 à 15:56 - Mis à jour à 16:05
Source: Belga
La justice indienne a rejeté la requête de l'entreprise allemande Bayer,
qui voulait faire arrêter la production d'une version générique de l'un de
ses médicaments contre le cancer.
La justice indienne a rejeté la requête de l'entreprise allemande Bayer,
qui voulait faire arrêter la production d'une version générique de l'un de
ses médicaments contre le cancer. Le Haute Cour de Bombay avait refusé en
juillet de retirer la licence accordée à l'indien Natco Pharma pour la
vente du Nexavar à 140 euros par mois. Bayer facture lui ce traitement à
4.410 euros mensuels.
L'entreprise allemande a fait appel mais a été déboutée vendredi, rapporte
The Economic Times. Le Nexavar est destiné aux patients souffrant de
cancer du foie et des reins. Quelque 29.000 cas de ces deux maladies sont
recensés chaque année en Inde. Bayer s'est dit "déçu" et envisage d'autres
actions. Médecins Sans Frontières salue la décision et souligne le rôle de
pionnier joué par l'Inde dans l'accès aux soins.
E-DRUG: Indian Supreme Court says no to Bayer, upholds compulsory license
on Nexavar
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[Cross-posted from IP Health with thanks]
December 12, 2014- In a momentous decision that would have wide-ranging
implication for access to medicines, the Supreme Court of India refused to
entertain Bayer's appeal to set aside the compulsory license (CL) on
Sorafenib (Nexavar). The Supreme Court's dismissal of Bayer's Special
Leave Petition against the Bombay High Court's decision upholding of the CL
concludes the legal proceedings on the first ever CL issued in India.
The grant of Compulsory license (CL) to NATCO for the anti-cancer drug -
sorafenib tosylate - and the litigation ensuing around it is the first of
its kind in India. Sorafenib tosylate is a crucial drug for patients
living with kidney and liver cancer. Bayer was selling the product under
the brand name Nexavar for Rs. 2,84,000 per patient per month which is
unaffordable to most patients in India. On 9 March 2012, the Patent
Controller granted a CL to Natco Pharma to market a more affordable
generic version of Nexavar at around Rs. 8, 800 per person per year.
Bayer unsuccessfully challenged the order before the Intellectual Property
Appellate Board (IPAB) and later at the Bombay High Court.
In the order granting the CL, the Patent Controller had noted that as
against the demand of 8842 patients in the year 2011, Bayer had supplied
the drug to less than 200 patients after more than three years of the
grant of the patent. Moreover, Nexavar was exorbitantly priced at Rs.
2,80,000 per month per patient. Bayer's Patient Access Programme which was
only initiated once the CL proceedings were initiated and still only met a
fraction of the demand. Lastly, despite having manufacturing facilities in
India, Bayer imported the drug from its facilities in other countries, not
fulfilling the working requirement under the law. The Patent Controller
granted a CL to Natco with royalty rate of 6%. In Appeal before the IPAB
the license was upheld, but the royalty rate was increased to 7%. Bayer
then approached the Bombay High Court by way of a writ petition alleging
that the decision of the IPAB was arbitrary. The Bombay High court
dismissed the writ petition
upholding the order of the Patent controller and the IPAB.
Appearing for Bayer before the Supreme Court, Mr. Sudhir Chandra, Senior
Advocate, submitted that the Bombay High Court in its judgment had made
unsustainable findings on several questions of law and fact. He contended
that, for instance, while considering whether the reasonable requirements
of the public had been met by the patentee under section 84, the Bombay
High Court should have taken into account CIPLA's infringing sales.
Refusing to concur with the submission, the bench comprising Justice
Ranjan Gogoi and Justice Rohintan Nariman asked Mr. Chandra to satisfy the
court about how the set of facts in the present case warranted
interference. The bench enquired as to how many patients in India
currently required the drug, responding to which Mr. Anand Grover, Senior
Advocate appearing on behalf of Natco answered that in fact more than
17000 patients currently need the drug.
On the challenge to the royalty rate determined, Justice Nariman pointedly
enquired why Bayer had not made available the unaudited accounts of the
research and development (R&D) expenses to develop the drug which would
have been the best evidence to arrive at a reasonable rate of royalty. Mr.
Chandra submitted that 98% costs accrue from failed drugs, making it
impossible to provide a precise account. Unimpressed, the Bench opined
that in absence of any evidence supplied by Bayer, Natco's affidavit
stating that all R&D costs have been recouped within the first year
itself, can be taken into account. The Bench also noted that the Bayer
failed to supply Nexavar to a significant number of cancer patients
require the drug despite its patient access programme.
Concluding that there was no reason to interfere with the order of the
Bombay High Court and that the question of law could be adjudicated in
future CL cases, the Bench dismissed Bayer's SLP.
The decision to dismiss the SLP has sent a wave of happiness and
celebration amongst patient groups. Mr. Y.K. Sapru, Chairman of Cancer
Patients Aid Association (CPAA) said, "We are extremely happy with this
decision. It ensures that the cancer patients will continue to get access
to this drug at an affordable price. MNC profits should not be allowed at
the cost of patient lives."
The decision is also being welcomed by treatment providers who procure
affordable Indian generic medicines to increase access to treatment for
their patients. Leena Menghaney, from Medecins Sans Frontieres Access
Campaign observed, "We were fully confident that the compulsory license
would be upheld by the Indian judiciary. This license is granted to
increase access to a more affordable generic version of a medicine and we
need many more such decisions in the future with new medicines being
patented in India. We will continue to push for use of public health
safeguards in the Indian patent law to promote an increased access for
patented medicines which are being priced out of reach of patients and
treatment providers."