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Indian Supreme Court dismisses Roche’s patent suit against Cipla’s erlotinib (Tarceva) generic

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Friday, August 28, 2009, 14:29 This news item was posted in Featured, Patents category and has 0 Comments so far.

Supreme Court bench ordered that the ongoing trial at the Delhi High Court be expedited.

The Indian Supreme Court dismissed the special leave petition filed by Roche on a generic version of its erlotinib (Tarceva) from Cipla, challenging the order passed by a the division bench of the Delhi High Court in April 2009. Related stories: Cipla Erlotinib sale in India allowed

The key reason for dismissing Roche’s special leave petition appears to be that the final trial in generic erlotinib case is also underway. Retired judge SM Chopra is appointed as a court commissioner to hear evidence in the patent infringement dispute. Supreme Court’s intervention in this dispute at this point of time could only further delay the final trial, experts said.

While dismissing Roche’s appeal, the two-judge — Justice Dalvir Bhandari and Justice MK Sharma — Supreme Court bench ordered that the ongoing trial at the Delhi High Court be expedited. They also stated that nothing in the Delhi Division bench order would bind the trial court judge, who is expected to decide the case on final merits.

Erlotinib or Tarceva, a lung cancer drug originally invented by Swiss pharma firm Hoffman La Roche Ltd, was granted a patent in India in September 2007.

Despite this, Cipla Ltd of Mumbai launched a generic version of erlotinib branded Erlocip last year.

While launching the drug, Cipla was quoted as saying that they intended to launch their own version of the drug at a lesser price – Rs 1,600 ($41) a tablet. Roche’ selling price was Rs 4,800 ($122) per a Tarceva tablet.

Following this, Roche sued Cipla for patent infringement in the Delhi High Court and applied for a temporary injunction. During hearings, Cipla maintained that the patent was invalid and should be revoked. 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 trial judge refused to grant an interim injunction on the ground that since Cipla was selling the drug at 1/3rd of the price of Roche, an injunction would mean impeding affordable access for a large number of cancer patients in India. Therefore, “public interest” demanded that no injunction (restraining order) be granted.

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.

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.

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.

Another Swiss drug maker Novartis AG also challenged the contentious Section 3(d) of India’s Patent Act, last year, 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”.

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