Concept & Editing by: Dr. Niti Dewan
Setting a precedent the Hon’ble Madras High Court, on the 2 nd of December ordered the Patent office to re-examine the patent granted to Swiss drug maker F Hoffman-La Roche's Indian Unit for the drug valgancyclovir, marketed under the brand name Valcyte in India. The review petition was filed by the Indian Network of Positive People and the Tamil Nadu Network of People with HIV/AIDS against the Chennai Patent Office's decision to grant patent for Valgancyclovir without hearing their pre-grant opposition.
In India there is a very rigorous process for grant of paten involving substantative examination. During the examination process before the grant of the patent any person can file a pre grant opposition by way of representation at the Patent Office. There is no automatic right of hearing. It is at the absolute discretion of the Patent Office to hear the opposer. Once a patent is granted the rules also allow an opponent to file a formal opposition within one year of the grant of the patent (post grant opposition). After one year an interested person can apply for revocation of the patent on several grounds. This revocation application has to be filed at the Intellectual Property Appellate Board. However, recently in the case between Roche and the abovementioned groups the Hon’ble High Court of Madras has “invented” another mechanism for posing a hurdle to patents. It appears that this will now compel the Patent Office to hear every pre-grant opposition. Since pre-grant oppositions are free, virtually every patent application can be blocked indefinitely by multiple pre-grant oppositions filed sequentially.
The Patent Office granted a patent to Roche for the drug in June 2007. The abovementioned groups allege that the drug lacks novelty and hence is not patentable. According to the groups, since the drug was first patented in the US in 1994 and as product patent regime is applicable in Indian Patent law for patent applications filed after 1January 1995, the drug cannot be considered patentable.
The Madras High Court’s decision may affect another case being heard by the Bombay High Court between Roche and Indian drug maker Cipla on the same drug.
Roche had filed two petitions against Cipla-the first petition claiming that Cipla infringed Roche’s patent by launching a generic version of Valcyte and the second petition alleging that Cipla infringed the Swiss drug maker’s trademark by launching the product with a similar sounding name, "Valcept".