Origiin IP Solutions sees that the opposition and revocation of a patent is of great significance for the pharma industry. This is because a revoked patent may be an excellent opportunity for generic drug manufacturers to produce a similar product in the market without risking a patent lawsuit.
Opposition of a patent application or a granted patent is an interesting provision of patent law where any person can file pre-grant opposition. Here the opposing party files an application for opposition at any stage of the patent process from the date of publication to the date of grant or person interested can oppose granted patent, Deepa ES, Senior Patent Analyst, Origiin IP Solutions LLP told Pharmabiz.
Subsequent to filing a patent application, it is published after expiry of 18 months from the date of priority. This waiting period is given deliberately in case the applicant wishes to make amendments to the application. After publication, the patent application can be opposed by any person on certain specified grounds. This opposition is called as pre-grant opposition. After grant of the patent, within 12 months from the date of grant, there is a window of opportunity in which the patent may be opposed, and is called as post-grant opposition, she added.
The company which is commenting on the Patent Opposition and its impact on the pharmaceutical industry said there are specific grounds listed in the patent act that may be used to oppose or revoke a patent.
According to Udit Sharma, intern, Origiin IP Solutions LLP, in case of a granted patent, an opposition proceeding could result in revocation of the patent. While in case of pre-grant opposition, the opposition proceeding may hinder the granting of the patent. However, if the patent is revoked in this process, the holder loses all legal rights for the patent, as a result of which third parties can use his patent without his permission.
There may be various reasons for patent opposition. If we take the example of basmati, neem, turmeric patents, it was seen that they were opposed on the grounds that they were based on traditional Indian knowledge. Similarly, an opposition of patents -is also filed by companies as a defence to infringement suits. For this, opposition is the way to invalidate or revoke a patent, said Deepa.
Another example where Intellectual Property Appellate Board (IPAB) revoked a patent, was India’s first product patent granted to Roche. This was for Pegasys and was revoked on the grounds of lack of efficacy, as compared to non-pegylated version of the drug. It was opposed by Sankalp Rehabilitation Trust, a community-based patient organisation that provides care and treatment for injection dependent drug users, who are vulnerable to infection with the hepatitis C virus.
Section 3 (d) of Indian Patents act is one of the most controversial provisions, which declares that a new form of the known substance is not patentable until and unless efficacy is proved. If the new chemical composition fails to prove its improvement, then it may be rejected. Opposition of patent have both pros and cons and plays an important role in pharma industry as it is a defence for the companies during infringement suits and beneficial to the generic companies, stated Deepa.