October 14, 2014

Novartis logo vs CIPLA logo

Cipla, the fifth largest drug making company of India has filed a petition with Department of Industrial Policy & Promotion (DIPP), New Delhi on October 21, 2014 to revoke five patents on respiratory drug Onbrez held by Novartis.

Patent Number Title
IN222346 Beta 2 Adrenoceptor Agonists
IN230049 A process for the preparation of 5 (haloacetyl) 8 (substituted oxy) (1h) quinolin 2 ones
IN210047 Process for preparing 2 Aminoindan Derivatives
IN230312 A process for preparing 5 [(r) 2 (5,6 diethyl indan 2 ylamino) 1 hydroxy ethyl] 8 hydroxy (1h) quinolin 2 one salts
IN214320 A Pharmaceutical Composition for the Treatment Of
Inflammatory And Obstructive Airways Diseases

The revocation request has been made under Section 66 (i.e. Revocation of Patent in public interest) and Section 92 (i.e. Special Provision for Compulsory license on notification by Central government) of the Indian Patents Act, 1970.

Cipla in its petition alleged that:

The said drug is one of the preferred medications for a widely prevalent respiratory disease known as Chronic Obstructive Pulmonary Disease (COPD). Even though other alternative treatment options are available but they are not adequate to deal with and respond to the growing scale of the advance of COPD. Moreover, the alternative treatments also have their disadvantages in terms of dosage, efficacy etc.

In spite of holding the patents for six years, Novartis is not making the medicine locally or importing it in the quantity required. Only very insignificant amounts of the drug are being imported in India by Novartis through its licensee Lupin Limited, due to which the Fundamental right of the citizens of India under Article 21 (right to a better healthcare and adequate access to medicines and treatments) is jeopardized.

Cipla alleged that Novartis has misused the exclusive rights inter alia, in the following manner:

  • By not manufacturing the drug in India since the grant of the patent i.e., since 2008, either by itself or through any other Indian company;
  • By not transferring the technology for manufacture to any Indian company;
  • By only importing limited quantities of the drug through an Indian company by way of an alleged license which appears to be a complete “eyewash”; and
  • By not making available to the public, adequate quantities of the drug at reasonable prices for the patients in India for a disease which is prevalent in epidemic proportions.

They also mentioned in their petition that the lack of availability of the said drug is because of the following reasons:

  • A very limited amount of drug is imported by Novartis through Lupin Limited.
  • Neither Novartis nor Lupin Limited manufactures the drug in India.
  • Lupin Limited sells the drug mostly to Government Institutions and the drug is not available across all chemists.
  • Lupin is not even fully selling what it is being imported by Novartis.
  • The price of the drug is very high and the MRP of Novartis for Onbrez is approximately Rs.2000/ per month per patient.

Cipla spokesperson said that Novartis is importing only about 54,000 units which are not even sufficient for 4,500 patients. Holding monopoly over the patents is depriving 99.97% of the 15 million people in India for whom the drug is an urgent requirement.

On the other hand, Cipla has launched the generic version of Onbrez (Indacaterol) under the mark UNIBREZ. The price at which the product is being sold by Cipla is Rs.130/ in the comparison to Rs.677/ MRP per 10 capsules of Novartis.

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