In a ruling that can have far-reaching implications on the way medicine patents are granted in the country, the Madras high court on Tuesday called for re-examination of a patent granted to Swiss drug maker F Hoffman-La Roche's valgancyclovir, marketed under the brand name Valcyte in India.
This is the first time an Indian court is reviewing the decision of the patent office. Valgancyclovir is a critical drug needed for patients suffering with life threatening illnesses such as AIDS to prevent them from infections.
"As per my information, the court wants the patent granted on Valgancyclovir to be re-examined before January 31, 2009. We will abide by the rules of the country," Girish Telang, managing director of Roche Scientific India, the Indian unit of F Hoffman-La Roche said.
The court's decision is in response to a petition filed by the Indian Network of Positive People and the Tamil Nadu Network of People with HIV/AIDS against the Chennai patent office' decision to grant patent for Valgancyclovir without hearing their pre-grant opposition.
Indian laws permit pre-grant opposition against a patent application. It also allows post-grant opposition within one year of patent grant. There are multiple post-grant oppositions pending before the patent office on the particular drug, sources said.
Lawyer's Collective, the Mumbai-based non-governmental organisation that represented the case on behalf of the patient groups, said they are yet to get details of the judgment.
The patent was granted for Roche in June 2007, without hearing the opposition filed by the groups alleging that the drug lacks novelty and hence non-patentable.
The patient groups has maintained that the drug was first patented in the US in 1994 and as Indian laws provide product patent protection only to those drugs that are patented after 1995, and hence, cannot be considered patentable.
"Valgancyclovir is an important drug for HIV/AIDS patients and a product patent allows monopolistic situation in India, where the drug is sold at very high price. We are happy about the court decision," said Loon Gangte, president of Delhi Network of Positive People.
Earlier, Girish Telang had told Business Standard that Roche was selling many of its essential HIV/AIDS and cancer drugs in India at much subsidised prices to help the Indian patients access the drugs.
Meanwhile, industry observers said the Madras High Court decision could impact another case being heard by the Bombay high court between Roche and Indian generic drug maker Cipla on the same drug.
Roche had filed patent infringement case against Cipla seeking an order to stop the generic drug maker from selling its version of Valcyte, which was launched in January, this year.
Meanwhile, industry observers said the Madras HC decision could impact another case being heard by the Bombay HC between Roche and India's Cipla on the same drug.
Roche had filed patent infringement case against Cipla seeking an order to stop the generic drug maker from selling its version of Valcyte, which was launched in January, this year.
