Cipla can sell erlotinib, generic version of Roche’s patented drug Tarceva, in India, says High Court

Indian High Court allows Cipla to sell generic version of Roche’s patented drug Tarceva (erlotinib).

Ball-and-stick model of the erlotinib molecule. Author Ben Mills

Cipla launched generic erlotinib in India despite Roche holding the patent.

Now, however, the Indian drug maker Cipla has been allowed to manufacture and sell Roche’s patented drug Tarceva (erlotinib) by the Delhi High Court.

Erlotinib or Tarceva is a lung cancer drug originally invented by Swiss pharma firm Hoffman La Roche Ltd.

Erlotinib was granted a patent for erlotinib in India in September 2007. Soon after, Roche started selling the drug for Rs 4,800 ($122) a tablet.

Despite this, Cipla Ltd of Mumbai launched a generic version of Tarceva – erlotinib – the active ingredient in the drug – last year.

While launching the drug, Cipla was quoted as saying that they intended to launch their own version of the drug at far lesser price – Rs1,600 ($41) a tablet.

Following this, Roche sued Cipla for patent infringement in the Delhi High Court and applied for a temporary injunction. During hearings, Cipla counterclaimed that the patent was invalid and should be revoked.

“If any company launches this product in India, it is an infringement of the patent and we will be forced to take necessary action immediately,” stated Roche India managing director Girish Telang.

Cipla claimed that erlotinib (Tarceva) is a derivative of an earlier substance called gefatinib, and therefore should not have been granted a patent, unless increased efficacy can be proved.

The litigation concerned Indian patent number 196774, which was issued against a mailbox application dated March 1996. In March 1999 the Indian government amended its patent law to allow companies to file mailbox pharmaceutical patent applications prior to the launch of India’s product patent regime. The law applied retrospectively from January 1 1995 and the Patent Office began to examine them in 2005, after the law was changed to allow product patents to be issued for pharmaceuticals.

However, a High Court bench vacated its interim order by which Cipla was restrained from exporting the drug to other countries in which La Roche has patent rights.

The Delhi High Court dismissed the plea of the Swiss company saying that the Indian company should be restrained from manufacturing and selling the generic drug till the issue of patent rights was decided through litigation.

The Swiss company had approached the Division Bench of the High Court after a single Bench had dismissed its plea to restrain Cipla.

The Court also imposed a cost of Rs five lakh (US $ 10,000) on Roche.

India’s patent law allows companies to oppose patents both before and after grant. Natco, another Indian drug maker, filed an unsuccessful pre-grant opposition against Roche’s application for erlotinib.

It has to remembered that Section 3(d) of India’s Patent Act, which was challenged by Novartis in the courts last year, was also the feature in the case. Section 3(d) restricts what can be patented. In particular, the section states that salts and other derivatives of known substances “shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy”.