Supreme Court of India directs Patent Controller to decide valganciclovir case on merits
Valganciclovir update: Supreme Court of India directs Patent Controller to decide valganciclovir case on merits
New Delhi, 2 March 2009
The Supreme Court of India today directed the Patent Controller to hear and dispose off all post-grant oppositions against a patent application for valganciclovir by F. Hoffmann-La Roche AG (Roche) within 12 weeks. Valganciclovir is a drug used to treat CMV retinitis, a viral infection that especially affects people with suppressed immune systems including persons living with HIV.
A Division Bench of the Supreme Court, comprising Justice S.H. Kapadia and Justice Aftab Alam, issued the order while hearing a case filed by Indian Network for People Living with HIV/AIDS (INP+) and Tamilnadu Networking People with HIV/AIDS (TNNP+) challenging the Patent Office’s decision rejecting its pre-grant opposition.
As you may recall, in June 2007, the Patent Office had granted a patent (Patent No. 207232) to Roche’s patent application (patent application No. 959/MAS/1995) for valganciclovir without hearing the pre-grant opposition filed by INP+ and TNNP+. Some generic pharmaceutical companies and civil society groups filed post-grant oppositions against this grant.
In the meanwhile, INP+ and TNNP+ challenged the grant of the patent before the Madras High Court on the ground that the patent office had granted the patent without hearing the opposition filed by them. INP+ and TNNP+ had filed a pre-grant opposition arguing that a patent should not be granted because it was already in the public domain and that Roche had not submitted information about filings in other countries to the Controller. On 2 December 2008, the Madras High Court set aside the grant of the patent and directed the Patent Controller to hear the pre-grant opposition filed by INP+ and TNNP+. Roche appealed to the Supreme Court of India against the order of the Madras High Court. The Supreme Court modified the order of the High Court and directed the Assistant Patent Controller to dispose off Roche’s patent application by 31 January 2009, and to consider the pre-grant opposition and hear the parties while doing so.
In January 2009, the Assistant Patent Controller held a hearing of the pre-grant opposition. On 30 January 2009, the Assistant Patent Controller passed an order rejecting the pre-grant opposition. The Assistant Patent Controller refused to take on record the rejoinder filed by INP+ and TNNP+, which pointed out why valganciclovir should not be granted a patent. Further, though the Patent Office was to decide the patent application and the pre-grant opposition, it did not pass any order on the patent application while rejecting the pre-grant opposition. INP+ and TNNP+ challenged the Patent Controller’s order before the Supreme Court on these and other issues.
At the hearing today, Cipla, which is marketing generic versions of valganciclovir and had earlier filed a post-grant opposition, intervened and addressed the court. In a bid to resolve the issues, the Supreme Court directed that INP+ and TNNP+ could intervene in the pending post-grant oppositions and raise all grounds to oppose the grant of the patent. The Bench directed that it would be considered as if a patent had been granted. In the meantime, an infringement suit filed by Roche against Cipla before the Bombay High Court is to remain pending. Roche has also given an undertaking not to press for an order restraining others from selling generic versions of the drug. The Controller is to dispose off all post-grant oppositions within 12 weeks. The Supreme Court clarified that this case was being treated as a special case and its order in this case would not be considered as a precedent for other cases. Once the Controller decides all the oppositions, the matters will be listed before the Supreme Court.
We will post further updates on the developments in this case.