Mumbai: Swiss drug maker F Hoffmann La Roche Ltd —which trimmed prices of its valganciclovir hydrochloride drug used to treat HIV-related infections after India reduced import duty on it in April—is set to defend later this week its local patent for the drug against at least five post-grant oppositions at the Chennai patent office.
Patient groups and local drug makers claimed that the price cut will not help Roche in its defence of the 2007 patent.
Domestic drug makers Cipla Ltd, Ranbaxy Laboratories Ltd and Matrix Laboratories Ltd and patient groups Network for People Living with HIV-AIDS and Tamil Nadu Networking People with HIV-AIDS have filed the oppositions, questioning the patent’s validity on technical grounds.
Drug tussle: The Roche AG headquarters in Basel, Switzerland. A generic version of Roche’s valganciclovir hydrochloride, used to treat HIV-related infections, was launched by Cipla under the brand name Valcept. Adrian Moser / Bloomberg
Roche last week announced it had cut the retail price of its valganciclovir hydrochloride drug, sold under the brand name of Valcyte, by 35% in response to the central government’s budget recommendation to cut customs duty on it.
After the price reduction, Valcyte sells for Rs475 a tablet, down from Rs700, said Amitabh Dube, business unit director of Roche Scientific Co. (India) Pvt. Ltd, a wholly owned subsidiary of Roche in India.
Treatment with Valcyte is typically spread over four months and 264 tablets, which means the cost of the treatment is Rs1,25,400.
Valganciclovir hydrochloride is considered the most effective antiviral treatment for an eye infection known as cytomegalovirus retinitis among HIV-positive patients.
“The company offers the drug under its patient access programme in India and at least one fifth of the patients undergoing treatments with Roche’s speciality drugs in India have been enrolled in these access programmes,” Roche Scientific’s managing director Girish Telang told the media. The company would continue such support programmes irrespective of the status of its patent, he added.
A generic version of valganciclovir hydrochloride, launched by Cipla in 2008 under the brand name Valcept, costs about Rs245 a tablet, or Rs64,680 for the entire treatment, almost half the price of treatment with Valcyte.
Since Cipla’s product was launched in spite of Roche’s patent, the Swiss company filed cases against Cipla in the Bombay high court for patent and trademark infringements. The high court asked Cipla to change its brand name in the trademark case; the patent litigation is still pending.
In March, following an appeal by the two patient groups against the Chennai patent office’s decision to reject their pre-grant opposition, the Supreme Court in March directed the patent controller to hear and dispose all post-grant opposition in 12 weeks.
Cipla’s joint managing director Amar Lulla said: “We welcome Roche’s decision to immediately pass on the custom duty cut to patients as it will reduce the prices to the patients, but the only thing we don’t want is the exploitation of patients by creating monopoly through evergreening of patents.”
Evergreening refers to the extension of the life of a patent with a variation, often minor, of the original patent.
Leena Menghaney, Delhi-based campaign co-ordinator of the global healthcare non-profit Medecins Sans Frontieres’ Campaign for Access to Essential Medicines, said: “Originator discounts are not as effective as generic competition. In HIV/AIDS treatment worldwide, the discounted price of $10,439 (Rs4.95 lakh) for a year’s treatment per patient has come down to $61 per patient per year as a result of increased generic production.”
A patent lawyer for one of the Indian drug makers that have filed the post-grant opposition to Roche’s patent clarified that his client is objecting to the validity of the patent in terms of technology and innovation that deserves a monopoly under Indian patent law, and not just the pricing. The lawyer declined to be identified.
According to two of the opposing parties in the case who Mint spoke with, the technical grounds against the patent include special clauses in the law. These clauses don’t allow new forms of an old drug for a grant of patent, these people said on condition of anonymity.
Valganciclovir hydrochloride is a salt of a known drug ganciclovir. These people claimed that valganciclovir hydrochloride thus does not fulfil the criteria of novelty, as the anti-viral properties of ganciclovir and its salts have been known since 1982.
“If patents are granted for known medicines, which block generic competition in India, there is a definite need to revisit the validity of the patent,” Menghaney said, adding that her organisation believes this to be the case with valganciclovir hydrochloride.