15 October 2012
Anju Ghangurde, Scrip Intelligence
An Indian court has dismissed an appeal by Cipla in a case concerning the potential launch of its generic version of Pfizer’s anticancer, Sutent (sunitinib malate). Activists have red-flagged the development given that the patent on Sutent was recently revoked in India and cut-price generic versions were expected to be available shortly.
Cipla is said to have moved a division bench of the Delhi High Court, after a single judge bench had, in response to a plea by Sugen Inc, disallowed Cipla from taking any steps towards launching its generic version of Sutent till 15 October. The case before the single judge has now been adjourned till 6 December, implying that the stay on Cipla’s generic holds till then.
Activists say that the court’s stance is of concern given that India had recently revoked the patent on Sutent and a stay on the cut-price generic in the absence of a patent is a ‘big concern’ in terms of legal precedence. “We are not sure of the details of the ruling but it undermines the legal flexibility of post grant oppositions in India,” said an official with an international humanitarian body.
The official also said that courts perhaps need to be ‘more cautious’ in their approach for granting injunctions especially in the pharmaceutical industry, given that lives of patients are at stake. Cipla’s proposed generic version is expected to about 75% cheaper than Sutent, which currently carries a maximum retail price tag of Rs255,149 ($4,931) for a pack of 28 capsules, though it is said to be available to patients at about Rs196,000.
While details of the division bench’s reasoning were not immediately available, the indications are that Sugen/Pfizer had apparently claimed that natural justice had been denied to them in the case. The multinational is believed to have claimed that it did not receive a copy on the recommendations of a three-member ‘opposition board’ [which is constituted by the patent controller and examines the notice of opposition etc] in the case, though this could not be officially confirmed. Pfizer told Scrip that it does not wish to make ‘any comment’ on the Sutent patent in India as the matter is currently sub judice.
Dr Nilanjana Mukherjee, assistant controller of patents and designs at the Delhi patent office, had in a ruling dated 24 September, held that the invention claimed in the [Sutent] patent did not involve an inventive step and was obvious to the person skilled in the art. Cipla had in 2008 filed an opposition against Sugen Inc and Pfizer’s 2007 patent for Sutent in India. Pfizer has said that it will appeal to India’s Intellectual Property Appellate Board (IPAB) against the revocation order
Significantly, industry experts also told Scrip that while Cipla may have sit out of the market for now, other Indian players can technically launch their products, though it’s unclear how many firms would do so. Moreover, it’s also unclear if Pfizer would perhaps consider similar legal action against potential entrants.