Press release |

DNP+ press release on valganciclovir pre-grant patent opposition

New Delhi, 27 June 2008 — The Delhi Network of Positive People (DNP+), an organization run by and representing the needs of people living with HIV/AIDS (PLHAs), filed a post-grant opposition against a patent for valganciclovir, a treatment for a common infection that can cause blindness or death to people living with HIV/AIDS.  Roche, a Swiss multinational pharmaceutical company was granted the patent last year by the Chennai Patent Office.

Valganciclovir is a treatment for cytomegalovirus (CMV), a virus that often attacks the retina of people with compromised immune systems, such as PLHAs.  Left untreated, CMV retinitis leads to irreversible blindness.  CMV infection can also attack other parts of the person's body, such as the gastro-intestinal system or brain. Such systemic CMV infection is serious, and without treatment, will progress and invariably result in death in a person whose immune system is weakened by HIV. 

CMV can be effectively treated with oral doses of valganciclovir.  However, Roche, which owns the patent on valganciclovir in India and other countries, charges as much as US$ 10,000 for a four-month supply of oral valganciclovir.  In India, the price for a full course of treatment is over Rs. 2,70,000.  Due to the patent that was granted in India, Indian companies are blocked from manufacturing generic versions of the drug. 

Due in part to the high costs, for most people in India and throughout the developing world, no treatment for CMV is available at all, or is substituted with invasive and extremely painful injections of other drugs directly into eye or through intravenous, twice-daily treatment requiring a long stay in the hospital.

"The exorbitant price that Roche is charging for valganciclovir shows how the patent system has failed in making treatments accessible for those most in need," said Loon Gangte, President of DNP+.  "Thousands of people are unnecessarily losing their vision and their livelihoods - or worse - as a result of what is otherwise a treatable condition, simply because the treatment is too expensive," he continued.

In December 2006, two other patient groups had filed a "pre-grant" opposition against the patent application for valganciclovir.  Despite this, the Chennai Patent Office granted the patent to Roche, even without giving the patients groups an opportunity to present their arguments to the Patent Controller. 

"Indian law requires that the Patent Controller provide the opponents an opportunity to be heard," said Anand Grover, Director of the Lawyers Collective HIV/AIDS Unit.  "We still have not received a clear explanation from the Chennai Patent Office as to how they proceeded to grant this patent without giving the opponents a fair hearing." 

The opposition filed by DNP+ argues that valganciclovir is a known compound, that it is insufficiently inventive, and that it is, at most, a "new form" of an already known substance that shows no improvement in efficacy.  Remarkably, the opposition also points out that many of the claims that the Chennai Patent Office granted were rejected by the United States Patent Office, which operates under laws that are generally considered to be far more liberal than the standards in India.