Novartis challenges Glivec patent decision in Indian Supreme Court

Novartis has now moved Indian Supreme Court for refusing patent protection for its anti-cancer drug Glivec (imatinib mesylate), following the footsteps of Roche.

The Swiss drug giant Novartis AG has filed a special leave petition with the Supreme Court of India against the of Intellectual Property Appellate Board (IPAB) decision to reject the company’s appeal for a patent for Glivec (imatinib mesylate) in India.

IPAB is the authorised body to look into disputes relating to intellectual proprties in India.

Novartis’ application for Glivec patent in India has been rejected by IPAB, in June. Refusing the patent, IPAB argued that Novartis’ application for patent rights for the beta-crystalline form of imatinib mesylate did not meet the requirement of increased therapeutic efficacy, as claimed.

Novartis alleged that IPAB has wrongly relied on the interpretation of section 3(d) by the Madras High Court, that a patent applicant has to show an increase in therapeutic efficacy.

“Novartis has filed a special leave petition (SLP) with the SC challenging the denial of Glivec patent. The denial was based on Sections 3(d) and 3(b) of the Indian Patent Law,“ the company said in a press release.

IPAB’s contention, citing Section 3(b), that the price of the drug is too unaffordable in refusing the patent, is irrelevant, Novartis said.

Several patient groups and NGOs working in the healthcare sector have challenged novartis’ move to get a patent for Glivec.

Novartis has been selling Glivec at Rs 120,000 (USD 2400) per month. While generic versions of imatinib mesylate were available in India at a cost of around Rs 8,000 (USD 160) to Rs 12,000 (USD 240) per month.

Novartis, however, vehemently disputed this point claiming that 99% of all Glivec patients in India (more than 11,000) receive their medicine free of cost through the company’s patient assistance program (GIPAP).

Novartis has started its legal battle for a patent for glivec way back in 2003. Chennai Patent Office’s rejected Novartis patent claim on Glivec in 2005. Novartis approached the Madras High Court challenging the decision of the patent office. Novartis, in its high profile petition challenged even the legal validity of section 3(d) of the Indian Patent Act.

In 2007, the Madras High Court rejected Novartis’ challenge to section 3(d) and held that it had no jurisdiction to determine the issue of TRIPS compatibility. 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”.

Last week, the Indian Supreme Court dismissed a 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.

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.

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.
(Full story:http://www.dancewithshadows.com/pillscribe/indian-supreme-court-dismisses-roches-patent-suit-against-ciplas-erlotinib-tarceva-generic/)