Cipla scores a generic win over Roche

Cipla wins over Roche
NEW DELHI: In what could be a shot in the arm for Indian generic drug makers, the Delhi High Court on Wednesday rejected an injunction plea by Swiss drug major Roche to prevent Cipla from manufacturing and selling generic versions of its patented anti-cancer drug Tarceva (Erlotinib) in India.

The Indian drug maker's generic version of Tarceva is priced at one-third the price of Tarceva and the HC rejected Roche appeal in public interest given the huge cost difference between the two drugs.

However, this is only an interim order and HC will deliver its final judgement at the completion of the hearing. The court has also directed Cipla to keep a separate record of the sale of its generic anti-cancer drug as it will have to compensate 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 which allows Cipla to market the generic copy of Tarceva. However, Cipla has been asked to keep the sales record of Tarceva separately, as Cipla would have to pay profit and damages cost to Roche if the Swiss company gets a favourable verdict after the complete hearing," an executive of an Indian drug maker who attended the hearing told ET.

Cipla's share closed at Rs 206 on BSE, up 0.76% from Tuesday's close of Rs 204.45. Roche received patent for Tarceva in India last year, but has been subsequently facing post-grant patent opposition from Cipla and NGOs. Two months ago Cipla decided to market copy cat 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 battle ground 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.

In addition, there are concerns in the government that once drugs are patented, the cost of medical treatment could become unaffordable and will prevent many patients from getting treatment of 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 that 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 drug maker, Hyderabad-based Natco has also sought compulsory licensing (CL) from the government for two cancer drugs Tarceva and Pfizer's Sunitnib (Sutent). However, the decision on Cipla's case is not expected to have any bearing on Natco's plea for a CL.