HC allows Cipla to sell Roche drug

New Delhi: Justice Ravinder Bhat of the Delhi High Court on Wednesday allowed Cipla Ltd to continue selling its lung cancer drug which is a copy of Tarceva, the branded, patented version owned by Swiss drug giant Roche AG.

Roche had sought an interim injunction against the sale of the drug (known as erlotinib, in its generic form).
Cipla, on the other hand, had filed a counter-claim seeking revocation of the patent held by Roche.
Roche is now supposed to file a reply to Cipla’s counterclaim asking for a revocation. Also, Roche can file a complaint against Delhi High Court’s today’s order before a separate divisional bench.
“Cipla had challenged the validity of the patent (held by Roche over the drug). The court feels it is an arguable case and that the patent can be invalid,” said Pratibha Singh, a senior advocate representing Cipla in the court.
If the injunction was granted and the patent found to be invalid later, many patients suffering from cancer would be deprived of a cheaper medication, she added.
“The court has, hence, ruled in the favour of public interest,” Singh said.
Roche officials were not available for comment.
Roche was granted a patent for Tarceva in India in February 2007. It sells the drug for Rs 4,800 per tablet, while Cipla sells the generic version, called Erlocip, at Rs 1,600 per tablet.
Sources said the price differential was a key factor behind Wednesday’s ruling.
Cipla has been asked to keep a record of Erlocip sales so that if the court upholds Roche’s patent later, the company can be compensated for damages accordingly, the person said.
Patent experts, however, said this may not serve the purpose, as the damages to Roche following the ruling will be far more than what Cipla earns by selling the drug.
“Cipla is selling the drug at one-third Roche’s tab. Now when Cipla is allowed to sell it, Roche will be compelled to reduce match Cipla’s price if it has to keep selling Tarceva,” said a patents lawyer who wishes to remain unnamed due to conflict of interest issues.
“The court assumes that in case it later turns out that Roche’s patent is valid, the damages (paid by Cipla) will be adequate remedy (to compensate) Roche,” said the expert.
“The injunction can normally be granted in cases where the court accepts that the damages are not an adequate remedy.”
There is also very little chance of the case getting disposed of before five-six years from now, by which time, Roche would have suffered huge damages, he said.
In India, public interest is not considered, while ruling on patent cases, unlike the United States.
“If the court has taken into account public interest as well, it may set a new precedent altogether regarding patent disputes,” he said.
Cipla’s lawyer Pratibha Singh, however, said, “Indian courts are mature enough to handle patent-related cases. In a recent case, injunction was granted where the patent was found to be invalid. But in a case where the patent is under question, granting of an injunction is uncalled for.”
Shaleen Agrawal/ DNA MONEY Thursday, 20 March , 2008, 07:54
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