INDIA BUSINESS WORLD - March 16th - March 31st - 2008
DELHI HC REJECTS SWISS DRUG MAJOR ROCHE’S PLEA TO STOP CIPLA FROM MANUFACTURING AND SELLING GENERIC VERSION OF ITS CANCER DRUG
In what could be a shot in the arm for Indian generic drugmakers, the Delhi High Court has rejected an injunction plea by Swiss drug major Roche to prevent Cipla from manufacturing and selling generic versions of its patented anticancer drug Tarceva (Erlotinib) in India. The Indian drugmaker’s generic version is priced at one-third that of Tarceva and the court rejected Roche’s appeal in public interest.
However, this is an interim order and the court will deliver its final judgement after the hearing ends. The court has also directed Cipla to keep a record of sales of its generic anti-cancer drug, giving rise to the possibility of a compensation payout by the Indian drugmaker to Roche if the final verdict goes in favour of the Swiss company.
“Roche has applied for a stay (on the sale of the generic version of Tarceva). This is an interim order for not granting the stay,” said Cipla joint MD Amar Lulla.
“The court has given an interim order that allows Cipla to market the generic copy of Tarceva. However, Cipla has been asked to keep sales record of Tarceva separately as the former would have to pay profit and damages cost to Roche if the Swiss company gets a favourable verdict after the hearing ends,” an executive of an Indian drugmaker, who attended the hearing said.
ROCHEreceived patent for Tarceva in India last year but has been facing post-grant patent opposition from Cipla and NGOs. Two months ago, Cipla decided to market copycat versions of the drug in India at Rs 1,600 per tablet—one-third the cost of the patented drug.
India, with a strong generic drug industry, is fast becoming a battleground between domestic drug makers and big pharma MNCs. With the Indian pharma industry set to grow annually at 13%, drug discovery companies are keen to establish a strong presence in India and protect their patents here. Domestic drug makers, on the other hand, want a liberal interpretation of the Indian patent laws and any favourable verdict strengthens their case. Watching closely from the sidelines are consumers who stand to gain if generic versions are introduced at lower costs.
There are concerns in the government that once drugs are patented, the cost of medical treatment could become unaffordable, which will prevent many patients from receiving treatment for diseases such as HIV and cancer. Several Indian companies and NGOs have filed both pre-patent and post-patent oppositions to prevent global companies from getting patent protection. In the much-publicised Glivec case, Novartis had unsuccessfully challenged Section 3(d) of the Indian patent law, which states an innovation to a drug can only be granted patent if the new drug provides significant therapeutic advantages. This decision had made Indian patent laws one of the most effective in the world. Another Indian company, Hyderabad-based Natco, has sought compulsory licensing from the government for two cancer drugs—Tarceva and Pfizer’s Sunitnib (Sutent). However, the Delhi High Court’s decision in the Cipla case is not expected to have any bearing on Natco’s plea for compulsory licensing
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