NEW DELHI - The Delhi High Court ordered Indian drugmaker Cipla to refrain from exporting a generic version of Roche's locally patented lung cancer drug Tarceva (erlontinib) to nations where the Swiss company has patent registration for the product, a court official said.

The court ruling follows a decision by a separate bench of the Delhi High Court on March 19 that said Mumbai-based Cipla cannot be halted from manufacturing and selling a generic version of Tarceva in India. The earlier ruling was termed by Cipla as a "landmark" case on the country's patent regime and its impact on drug prices (Also see "Indian Court Allows Cipla to Continue Sales of Generic Roche Lung Cancer Drug Tarceva" - Scrip, 20 March, 2008.).

In March, the court ordered Cipla to maintain records of erlontinib sales to compensate for possible damages in the eventuality of a favorable ruling for Roche in the future. The case heard April 22 pushed the issue ahead by asking Cipla to respond in detail within two weeks on Roche's move to block a generic version.

"[Cipla] in the meantime shall, while complying with the order of [the] single bench, not export the drug in the question where [Roche] has patent registration," a two-judge bench said, noting that other companies that may want to make generic Tarceva should not use the earlier ruling as a "precedent for the purpose of manufacturing the drug."

A lawyer for Roche, Abhishek Manu Singhvi, said the earlier order contradicted India's 2005 patent law, which brought the country in line with World Trade Organization guidelines on intellectual property rights.

"The single bench order [March 19] was said to be in the public interest on the ground that there was a huge price differentiation in the product of the two firms, however there was no correlation between patent law and public interest as patent grants a company statutory monopoly," Singhvi told the court.

Cipla declined to comment.

Roche's local arm, Roche Scientific Company, was granted a patent for Tarceva in India in 2007. The drug is also the focus of a case before the Indian patent office by Hyderabad, India-based Natco Pharma seeking a compulsory license to sell the drug in Nepal (Also see "India Patent Office to Make Key Decision on Export of Roche, Pfizer Cancer Drugs" - Scrip, 27 February, 2008.).

Natco had previously sold a generic version of Tarceva in India, but stopped after Roche won the patent in 2007. Cipla however started making a generic version a few months ago prompting a legal case by Roche seeking an injunction on manufacture and sales.

A key point in the case is the affordability of the drug as some analysts contend the patent law conflicts with India's aim to make life-saving drugs affordable by manufacturing generic versions of licensed products locally.

The price issue was addressed by Singhvi who said Tarceva sold in India for 3,200 rupees ($80) per tablet, which included 32 percent in import duties that if waived would bring the drug price within range of Cipla's generic version.

"If we reduce this amount [the customs duty] there was not much difference in Cipla's drug price, which was selling within the range of 1,600 [$40] to 1,800 [$45]" rupees, he said.

- Ed Lane (pharmasia@elsevier.com)

Indian Court Restrains Cipla From Exporting Generic Tarceva

More from Archive

More from Scrip