The Patents Amendment Act, 2005 provided for an integrated opposition system in India which allows both Pre and Post-grant opposition of a patent so as to ensure the quality and validity of granted patents.
Though the grounds for both pre and post-grant opposition are same, there are various differences regarding proceedings between the two systems. While ‘any person’ can represent in writing for pre-grant opposition, only the ‘interested person’ explaining specific interest can file a post-grant opposition. Another important difference being that in case of pre-grant opposition the act does not unequivocally provides the patent applicant the opportunity to be heard. Additionally, in pre-grant opposition there is no remedy provided by the act against the decision of the controller.
The grounds for opposition listed in the act primarily includes: (a) Wrongful obtaining of the invention (b) lack of novelty (c) prior public knowledge or public use (d) Invention is not patentable (e) Invention is anticipation having regard to the knowledge, oral or otherwise, available within any local or indigenous community in India or elsewhere etc.
The pre-grant opposition is made by way of ‘representation’ to the Controller of Patents any time after the publication of the application but before grant supported by a statement and evidence, if any, along with a request for hearing if so desired. However, the Controller shall consider such representation only when a request for examination of the application has been filed. On consideration, if the Controller is of the opinion that the application for patent should be refused or requires amendment, he gives a notice to the applicant to which applicant has to reply within three months time from the date of the notice. After considering the representation, submission and hearing the parties (if requested), the controller simultaneously either rejects the representation and grant the patent or accept the representation and refuse the grant of patent ordinarily within one month from the date of completion of the proceedings.
Post Grant opposition
The post grant opposition is made by ‘notice of opposition’ by the opponent within one year from the date of publication of grant in prescribed form to the Controller along with a written statement setting out the nature of his/her interest, the facts on which he/she bases his/her case, the relief that he/she seeks and evidence (if any) and providing a copy thereof to the patentee also. Upon receiving the notice, the Controller constitutes an ‘Opposition Board’ consisting of three members and one of the members nominated as Chairman. The examiner who has dealt with the patent application at the time of the grant is disqualified from being a member. The Opposition Board examines the notice of opposition and forward a report within a period of three months from the date on which the documents were forwarded to it.
If the patentee desires to contest the notice of opposition, he/she leaves the reply statement setting out fully the grounds upon which the opposition is contested and evidence within a period of two months from the date of receipt of the opponent’s written statement and notice and also delivers to the opponent a copy thereof. The opponent may within a period of one month of the receipt of the patentee’s reply statement and evidence leave evidence at patent office strictly in reply confined to matters in the patentee’s evidence with a copy thereof to patentee as well. After this no further evidence can be delivered by either party except with the leave of the Controller. On completion of presentation of evidence and after receiving the recommendations of Opposition Board, the Controller shall fix a date for hearing and give the parties a notice of not less than 10 days of such hearing. If either of the party desires to be heard, it gives a notice along with the prescribed fee to the Controller and after hearing both the parties, controller notifies his decision with reasons therefor.
The new integrated opposition system in India has suitably addressed the post TRIPS concerns of the generic pharmaceutical industry regarding the increase in the number of grant of many false patents. However, the patent applicants are now at the risk of multiple pre-grant oppositions filed by the competitors as a part of their business strategy resulting in constant and repeated opposition proceedings and thus causing a delay in the grant of the patent. Furthermore, a pre-grant opponent may subsequently file a post-grant opposition after the patent grant thus complicating the scenario for the patent applicant. On the other hand, Post grant opposition has been well acknowledged as its proceeding serves the interests of both patent applicant and opponent.