Drug-maker Pfizer has approached the Delhi High Court for a stay on Cipla, to prevent it from selling a generically-similar version of sunitinib, a liver and kidney cancer drug, in the local market.
The development comes even as Pfizer got a stay against Natco, on the same drug, earlier this week.
The hearing on the stay against Cipla, scheduled to come up today, will now come up early next week, sources familiar with the development told
Pfizer sells sunitinib under the brandname Sutent. But the patent on this drug was revoked by the Patent Controller in October, following Cipla’s post-grant opposition.
Cipla does not have its product in the market, but Natco reportedly sold its product briefly in the interim period when the patent on Sutent had been revoked, an industry representative said.
Patent-packed week
In the last two months or so, Sutent has witnessed several legal twists and turns. Following the patent rejection, Pfizer approached the Supreme Court. The Supreme Court reinstated the patent and returned the case to the Patent Controller for a fresh hearing on Cipla’s post-grant opposition, Pfizer said.
With the apex court sending the issue back, Pfizer approached the Delhi High Court, asking it to stay Cipla from selling the drug, “on the grounds that Pfizer’s patent was now reinstated”, Pfizer said.
Next week is packed with patent hearings. Besides the stay-related hearing against Cipla, it will also see the Supreme Court-directed hearing on Sutent at the Patent Controller’s office.
The Sutent case is part of a string of patent-related cases being fought in different courts within the framework of the amended Indian Patent Law. The law, amended in 2005, protects product patents — that allow innovators a 20-year marketing monopoly.
Price concerns
Public health circles fear that a patent-holder could keep the price high on an innovation, triggering a deeper concern when the innovation involves medicines. Generic drug-makers, spending less money on research (compared to an innovator) are able to price their versions of the original medicine lower.
The price of Sutent is reportedly about Rs 2 lakh for a 45-day course. But Pfizer says: “We know that access to affordable cancer treatment can be a challenge. To ensure we make our innovative cancer medicine available to patients who need it, Pfizer has developed the Sutent Patient Assistance Program (SPAP).”
SPAP is designed to provide eligible patients a partial or completely subsidised treatment option determined by medical and socio-economic criteria, the company said.