# \[e-med\] La cour suprême de l'Inde a rejeté la requête de Bayer qui voulait protéger son brevet sur le Nexavar°

**URL:** <https://talk.edrugplus.org/t/e-med-la-cour-supreme-de-linde-a-rejete-la-requete-de-bayer-qui-voulait-proteger-son-brevet-sur-le-nexavar/41261>\
**Category:** e-med\
**Created:** [December 15, 2014, 9:12am UTC](https://talk.edrugplus.org/t/e-med-la-cour-supreme-de-linde-a-rejete-la-requete-de-bayer-qui-voulait-proteger-son-brevet-sur-le-nexavar/41261 "2014-12-15T09:12:36Z")\
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**Author:** ![c.bruneton](https://avatars.discourse-cdn.com/v4/letter/c/3ec8ea/32.png) [@c.bruneton](https://talk.edrugplus.org/u/c.bruneton)\
**Post date:** [December 15, 2014, 9:12am UTC](https://talk.edrugplus.org/t/e-med-la-cour-supreme-de-linde-a-rejete-la-requete-de-bayer-qui-voulait-proteger-son-brevet-sur-le-nexavar/41261/1 "2014-12-15T09:12:36Z")

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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&gt](http://www.levif.be/actualite/auteurs/le-vif-77.html&gt);  
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]

&nbsp;&nbsp;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."