New Delhi: People living with HIV may soon be able to buy cheaper versions of antiviral drug Valcyte, the oral dosage form of intravenously administered ganciclovir, which is used to treat HIV-related infections.
On Wednesday, the Indian Patent Office annulled the patent on Valcyte, granted to Swiss drug maker F. Hoffmann-La Roche Ltd, following opposition by domestic drug makers and patient groups.
Photo: Peter Frommenwiler/Bloomberg
Cipla Ltd, Ranbaxy Laboratories Ltd, Matrix Laboratories Ltd and Bakul Pharma Ltd, along with patient groups Indian Network for People Living with HIV/AIDS and Tamil Nadu Networking People with HIV/AIDS, had challenged the Valcyte patent on technical grounds.
“Since the object of the invention is to provide a prodrug of ganciclovir with improved oral bioavailability, the comparison provided in the specification to show such an improvement is not scientific,” said S.P. Subramaniyan, patent controller.
A prodrug is biologically inactive itself, but gets converted into an active drug inside the body. Bioavailability is the amount of a drug that reaches the systemic circulation in its original form after administration.
Amar Lulla, chief executive of Cipla, said the patent office’s decision was fair.
“We are exploring the legal options,” said a spokesperson for Roche.
In August, Roche reduced the price of Valcyte by nearly one-third after the government slashed import duty on it. The medicine became available for Rs475 per tablet, down from Rs700. But the generic version of Valcyte, launched by Cipla in 2008 under the brand name Valcept, costs Rs245 a tablet, or Rs64,680 for the entire treatment—almost half the cost of treatment with Valcyte.
Roche filed patent and trademark infringement lawsuits in the Bombay high court as Cipla’s version defied its patent. But with Roche’s patent now annulled, the lawsuits may also be dismissed. Cipla can continue selling its generic version, while other manufacturers can launch their own versions.
“If there is no patent, they (Roche) cannot fight anything,” said Anand Grover, director of the Lawyers Collective on HIV/AIDS in India, who was a counsel for the two patient groups opposing the patent.
However, Roche has the option of filing an appeal against the patent office’s decision at the Intellectual Property Appellate Board (IPAB).
“Since this appears a well- reasoned and logically coherent decision, the chances of it being overruled by IPAB are slim,” said Shamnad Basheer, professor in intellectual property law at National University of Juridical Sciences.
“This decision sends a strong signal to the world that India will not permit very obvious tweaking of existing molecules, but will permit only meritorious pharmaceutical inventions to pass the patentability filter,” he added.