We sincerely appreciate the steps taken by the Government of India in providing product patent protection for pharmaceuticals in India. There continues to be some areas of concern for us as an industry. You are aware that the provision for pre-grant opposition was one of the most contentious issues while passing of the Patents Third Amendment Act, 2005. Our concern was that the pre-grant opposition proceedings can be used by competitors to substantially prolong patent issuance. This note is intended to bring to your notice our experience in the working of the system and that our worst fears are coming out true. A regime structured to invite unlimited delay does not provide adequate and effective protection of intellectual property rights.

There are about 200 pre-grant oppositions filed in the four patent offices. The Indian Patent system allows any person to delay the grant of patent rights, sometimes indefinitely through sequential and cyclic “pre-grant” opposition proceedings.

In accordance with Section 25 (1) of the current Patents Act, pre-grant opposition by way of  representation can be instituted any time after publication and anytime before the grant of Patent.

During the last two years, It has been observed that multiple pre-grant oppositions alleging identical issues  are being filed sequentially by  competitors for the same patent application leading to a substantial delay in issuing a decision thereby delaying the grant of a patent. Frequent and extended delays under this system of pre-grant opposition demonstrate that India does not comply with the requirement of Article 62.2 and 62.4 of TRIPS. Please note that the pre-grant opposition system is operating to deprive patent owners of a substantial portion of their patent term, which is inconsistent with obligations under TRIPS. It may be worthwhile to mention here that the patent term starts from the date of application.

The legislative intent of the Government to simplify and shorten the prosecution time for a patent and ensure expeditious grant of patents is being paralyzed given the open ended timeline. This will lead to abuse of the prosecution process and delay the grant of a patent and erode much of the term of any patent . This eventuality would also be against the principle of equity as a rightful patentee cannot make good of the loss of time from the life of his patent caused due to frivolous opposition in the absence of any provision for patent term restoration.

In the light of the above, it becomes imperative that the provision of  pre-grant opposition is streamlined to the effect that it is not unjustifiably prejudicial towards the patent applicant. We understand that an attempt to shorten the period for filing pre-grant opposition would necessitate amendment to Section 25 (1) of the Patents Act by the Parliament. However, till the time such amendment is done , we would like to extend the following suggestions to be included in the Rules in order to minimize the drawbacks inherent in such system:

1. No pre-grant opposition should be allowed to be filed after the date on which the patent application is put in order for grant under Section 21 of the Patents Act and Rule 24 B(4)(1).
2. All pre-grant oppositions filed against one application alleging similar grounds must be tagged together and disposed off  in a single office action.
3. Once a particular ground taken in a pre-grant opposition fails against the merits of an application, later opposition filed on the grounds must be summarily rejected. 
4. There must be a provision which ensures that opposition proceedings are concluded within a specified timeline from their commencement, and that the term of a patent which is issued after an opposition proceeding (i.e., the third party opposer loses) be extended by the period of time beyond such specified period.
5. Patent applicant should be provided with the right to terminate the opposition on the grounds that the challenger has not established sufficient grounds to challenge the patent.
6. Patent applicant should be permitted to make amendments to the claims during the procedure.
7. Opposition decisions may be appealed by either party, but if the Patent Applicant is initially successful during the opposition proceedings, then the patent will be granted, with all the legal rights associated with a granted patent.
8. Patent applicant should be given rights under the Patent Act against the opposer as from the date of publication or the date of the filing of an opposition, so that if the patent owner “wins” the proceeding, it is able to collect damages as from the date of the opposition.