In the first instance of its kind, the Chennai patent office has granted a patent to an anti-HIV drug, valganciclovir, to F Hoffman-La Roche Ltd, a Swiss drug maker, without hearing groups opposed to the monopoly protection given to the medicine.
The patent will prevent makers of off-patent, or generic drugs, in India from copying the drug. Indian drug maker Cipla Ltd is currently developing a generic version of valganciclovir but it could not be immediately ascertained by when it would be available.
There are no other generic copies of the drug, an important medicine used by HIV patients to ward off infection.
Lawyers Collective, a Mumbai-based non-governmental organization that works for AIDS patients’ access to medicine in India as also civil and women’s rights, plans to file a case against the patent controller of India and the Chennai patent office for giving the patent despite a pre-grant opposition having been filed.
“We are planning to move the Madras high court against the patent office’s discriminatory decision,” Lawyers Collective project director Anand Grover said.
This is likely to be the second controversy in as many years involving the Chennai Patent Office. It was at the centre of a controversy since early 2006 when it declined a patent to Novartis AG’s anti-cancer drug Glivec. The Swiss drug maker is fighting the patent rejection in court.
Valganciclovir, sold by Roche as Valcyte internationally, was granted the India patent early this month.
Lawyers Collective had filed a pre-grant opposition to the valganciclovir patent application of Roche in 2006 on the ground that the drug was a pre-1995 molecule.
Drugs patented 10 years before the Indian Patents Act, 2005, are not eligible for such protection in India.
Valganciclovir, which was invented by Roche in 1994, was patented first in Switzerland the same year, said Chan Park, a senior advocate at Lawyers Collective in New Delhi, who filed the pre-grant opposition. “It is an important drug for HIV patients the world over and Roche has priced this exorbitantly.
“Once it is patented in the country, it will prevent entry of cheap generic versions and deny access of this key medicine to poor patients in India,” he said.
V. Rangaswamy, assistant controller, patents and designs at the Chennai patent office, said his office had acted strictly in accordance with law.
“We have granted patent to Roche looking at the merits in the application and we are not bound to hear pre-grant opposition,” he said in a phone interview.
But legal experts differ.
“There is no precedent in India so far where a patent is granted without hearing a pre-grant opposition, even though the law specifies that a hearing is mandatory only if the opponent asks for a hearing,” said Gopakumar Nair, a senior patents lawyer and consultant in Mumbai.
Park of Lawyers Collective said his petition had specifically asked for a hearing, saying. “There is a clear case of either discriminatory decision or a mistake on the part of the patent office,” he said.
Girish Telang, managing director, Roche Scientific Co. (India) Pvt. Ltd, the wholly owned subsidiary of Roche in India, declined comment.
A pre-grant opposition on patent application is allowed as per Section 25 of the newly amended Indian patent law as it offers opportunity for an individual or an organization to raise opposition to the claims of patent applicant on reasonable grounds.
“Normally, the pre-grant opposition, if it is accepted by the patent office, is followed by at least one personal hearing of the opponent and a clarification from the applicant. A decision on the application is taken by the patent office only after hearing both views,” said Nair, the Mumbai lawyer.
Valganciclovir is an important drug used for the treatment of so-called opportunistic infection such as that caused by cytomegalovirus that seriously affects the eye-sight in HIV patients.
The drug is also used for prevention of such infections in kidney, heart, and pancreas transplant patients.
Roche charges about $9,900 (nearly Rs3.96 lakh) for a three-month treatment for valganciclovir and has reduced the price to $1,800 for NGOs and customers in Sub-Saharan African and least developed countries.
The product is yet to be officially launched in India by the company.
Valcyte is the fifth Roche drug that has been granted patents in India since 2006.
The Swiss drug maker received India’s first product patent for its hepatitis treatment drug Pegasys last year and now in the last few weeks, it has been granted four more product patents.
It has obtained patents for its latest drug Mircera, which is an advanced form of organ transplant drug erythropoetin.
Roche has also been granted product patents for Tarceva, the drug it launched last year for treatment of lung cancer, and also its breast cancer drug Herceptin in India.