Big Pharma ‘evergreening’ nixed

Introducing highly expensive patented drugs that show little or no improvement over existing ones — or attempts to evergreen patents — is getting tougher for multinationals.
A slew of patent applications by Pfizer Inc of the US, GlaxoSmithKline of the UK, Novartis AG of Switzerland and Gilead Sciences of US, have been rejected by the Delhi Patent Office in the last few weeks on the grounds of them being mere modifications or extensions of known salts.

These include Gilead’s bird flu medicine Tamiflu, the alpha crystalline form of Novartis’ Glivec (chronic myeloid leukemia), Pfizer’s Caduet (for high cholesterol and high blood pressure) and GSK’s rosiglitazone salt (diabetes).

The rejection of the patent application for Caduet, based on a pre-grant opposition filed by Ahmedabad-based Torrent Pharmaceuticals, was on the grounds that the drug is a combination of Pfizer’s Norvasc and Lipitor.

On Gilead’s Tamiflu, the patent office noted that the description of innovation provided by the company was ambiguous and insufficient, and the invention fell under Section 3 (d) of the Indian Patent Act of 1970.

The said Section holds that mere discovery of a new form of a known substance, which does not result in the enhancement of the known efficacy of that substance, shall not be treated as an invention within the meaning of the Act.

Applications for the other two drugs, namely GSK’s ethane sulphonate salt for its diabetes drug rosiglitazone, and the alpha crystalline form of Novartis’ cancer drug Glivec, were also rejected for falling under Section 3 (d) of the Patent Act.

Going by patent experts and industry observers, these rejections amount to a victory for generic companies and make it tougher for MNCs to get patents.

According to Shamnad Basheer, who is the ministry of human resources’ chair in intellectual property law at the National University of Judicial Sciences, the patent rejections indicate that “our Act has the right provisions.”

“These are all cases of ‘evergreening’, which is a technique used to extend market monopoly and prevent the entry of generic competitors,” he says.

YK Sapru, founder chairman and CEO of Cancer Patients Aid Association (CPAA),
the Mumbai-based NGO which had locked horns with Novartis over the patent for the beta form of Glivec, points out how after the patent for the beta form of Glivec was rejected, the company tried to get the alpha form patented. “MNCs want to keep prices high by patenting mere modifications as inventions. Several patients can’t afford even the Rs 8,000 for generic versions of some drugs.”

According to an official from a Mumbai-based pharma company, which had filed a pre-grant opposition against the patent application of one of the abovementioned MNCs, big pharma should resist from making patent applications for mere modifications.

The patent office is taking a strict view of Section 3 (d) of the Patent Act, says Anuradha Salhotra, partner at New Delhi-based intellectual property law firm Lall, Lahiri & Salhotra.

“But the patent office rejection is not the final verdict as the MNCs can approach the Intellectual Property Appellate Board and then the courts for putting forth their views,” says Salhotra.

In a statement, Ranjit Shahani, vice-chairman and managing director of Novartis India said the company has 90 days to review the merits of the decision and evaluate the options.

According to Chennai-based patent expert Feroz Ali, following the rejection of patent applications, generic companies like Cipla, Sun Pharma and Torrent Pharma can for the time being sell their low-cost versions in the market, which cost a fraction of what the patented drugs cost. Novartis’ Glivec costs more than Rs 1.2 lakh per month per patient, while generic versions of the same from companies such as Natco Pharma come for Rs 8,000-10,000 a month.