Enhancement of Known Efficacy
The anti-evergreening provision states that drug molecules cannot be patented in India if they result from "the mere discovery
of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance."4 The phrase enhancement of the known efficacy is vague. Its meaning is really for the IPO to decide in each case.
Lack of Recourse
To protest the IPO's decision, Novartis brought two cases in the Chennai High Court. The first, which protested the IPO's
decision, was referred back to the IPO's appeal board.7 The second, against the 2005 Act itself, claimed that its anti-evergreening clause had violated TRIPS. The Chennai High
Court dismissed this second case simply because it lacked the jurisdiction to determine whether Indian laws comply with international
trade agreements. Provided that the IPO complies with Indian law, foreign companies in Novartis's situation have no legal
recourse on their own, other than an appeal to India's Intellectual Property Appellate Board. Only a state has the standing
to take up a TRIPS-compliance case before the WTO, and in Novartis's case, Switzerland was not going to do so.7
Public Pressure Against Patent Protection for Expensive Drugs
Novartis's case inspired opposition from nongovernmental organizations (NGOs) and other groups, ranging from India's Cancer
Patients Aid Association and the All-Action Drug Network to the Swiss-based Doctors Without Borders, who wanted access to
less expensive drugs. The result was negative publicity for the company and pressure on the Indian government to rationalize
a rejection of Novartis's claims. The NGOs' point was that a Novartis victory would have cut off access to existing Gleevec
generics costing less than a tenth of what Novartis charged.8 It was even alleged that despite Novartis's free supply of the drug to some needy Indian patients, a number of other patients
died or became bankrupt after the company was granted exclusive marketing rights to Gleevec in 2003 and most competing generics
makers were barred from the market.7
OPPOSITION PROVISIONS & DELAYS
Another anti-Western provision of the 2005 Patent Act is the wide scope it gives to interested parties to oppose the granting
of patents, including grounds such as:4
- "that the complete specification does not disclose or wrongly mentions the source and geographical origin of biological material
used for the invention,"
- "that the invention so far as claimed in any claim of the complete specification was publicly known or publicly used in India
before the priority date of that claim," or
- "that the invention so far as claimed in any claim of the complete specification was anticipated having regard to the knowledge,
oral or otherwise, available within any local or indigenous community in India or elsewhere."
Indian generics makers have made use of these provisions by filing pregrant oppositions to patents for Western-developed drugs.
The targets of these tactics have included Novartis's Gleevec, Astra Zeneca's Rosuvastatin, Lilly's Tadalafil, Pfizer's Voriconazole,
and many others.9–11
Taking their cue from the Novartis case, India's generics manufacturers have frequently argued that a drug is not really new.
If nothing else, these opposition filings have succeeded in delaying the granting of patents to Western pharmaceutical companies.10
A DIFFICULT SITUATION
Some IPR proponents in the West view the recent changes to India's Patents Act as cosmetic, and the overall IPR situation
remains hazardous. Greg Kalbaugh, director and intellectual property counsel for the US-India Business Council, based in Washington,
DC, has been quoted saying that "Indian patent laws make it difficult for outside companies to get their product patented
in India, while at the same time making it easier for Indian companies to violate their intellectual property."12