Fry Committee (1901)

Apart from the extensive examination conducted by the Patent Office, opposition provisions act as the most important check in the procedure for grant of patent. Patent laws in different national jurisdictions vary with respect to such checks in the grant procedure. For instance, the US Patents Law does not provide for opposition, instead anyone can request for re-examination upon issuance of a patent, on grounds of patentability in view of a relevant new prior art citation. Australia also follows the US system of re-examination. In Chinese patent law, the mechanism of pre-grant opposition was substituted with procedures for post-grant opposition or revocation by the amendment in 1992. UK Patents law provides for representation on grounds of patentability in case of published pending applications, wherein any person may make observations in writing to the comptroller, stating reasons for the observations.

In light of the product patent regime for pharmaceuticals, opposition has become a very important tool for not only thwarting frivolous claims from getting accepted but also for obtaining commercial benefits. The Patent Office has begun the publication and examination of WTO/Mail Box applications and efforts are being made to study the scope and content of inventions claimed in the Mail Box applications. Many provisions of the Patents Act provide flexibility to read limitations into as well as to expand the scope of these provisions. The possible interpretation of these provisions by expanding the meaning thereof will be the line of argument that the knowledge-based companies would like to resort to. On the contrary, Indian generic pharmaceutical companies would prefer to read as much limitations in the provisions as possible. One such contentious provision would be Section 3 (d) of the Patents Act. It provides that salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of the known substances are to be considered the same unless they differ significantly in properties with regard to efficacy. Whereas the pioneer drug companies will claim significant difference in efficacy, the generic companies would try to prove otherwise. All this makes Patent Opposition very tricky but important affair in India today.

There are two stages in which opposition to the grant of patent can be launched. They are: ‘pre-grant opposition’ and ‘post-grant opposition’. This two-tier opposition system has added on to the above complexities. The third amendment to the Indian Patents Act, 1970 brought about significant changes in law, both substantial and procedural. One of the procedural changes was- introduction of post-grant opposition and amendment of the earlier provision of ‘opposition after acceptance of application’ to ‘representation by way of opposition’.

Unlike the earlier pre-grant opposition, any person can file ‘representation’, after the publication of patent application but before the grant of patent. Now, if we look at the procedure of pre-grant opposition, we can see an imbalance in the rights conferred on an opponent vis-à-vis an applicant. A person filing the representation has to support his/her observation with a statement and evidence, if any, and he/she can also request for a hearing, if so desired. The Examiner shall consider any such representation, only when a request for examination has been filed for the patent application. Based on the representation, the Examiner shall consider the application and shall intimate the applicant in case the application for patent needs to be amended or the patent is to be refused. The applicant has one chance to reply to the Controller’s notice in a month’s period, but he/she cannot request for a hearing. As such the applicant’s chance to counter the representation is limited to written reply. However, the Patent Draft Rules, 2005 propose an amendment to rule 55(4), giving a chance to the applicant to be heard, so as to make the procedure more fair and just for the applicant.

The grounds for filing the representation that were introduced by the (Amendment) Act, 2002, are retained as such. The similar grounds are available for post-grant opposition also. The difference in the two oppositions is of the person eligible to file the opposition, i.e. only ‘interested person’ can file post-grant opposition whereas ‘any person’ can file pre-grant opposition. Whereas the former has to demonstrate specific interest in making an opposition the latter need not. The Patents (Amendment) Ordinance, 2004, however, had grounds based only on the patentability of the invention for filing representation, which was expanded to include the current grounds in the 2005 (Amendment) Act.

The similar grounds for opposition, in both pre-grant and post-grant opposition, in principle provide two oppositions for a case. Unlike the representation at UK Patent Office or the re-examination at USPTO, the representation at Indian Patent Office (IPO) is not limited to patentability of the invention. As such, the present provisions practically leave negligible difference between the pre-grant and post-grant opposition. Further, the law provides opportunity to be heard during the pre-grant opposition as well. These provisions bring the pre-grant proceedings closer to the post-grant proceedings, thus extending the opposition period from the publication of application under Section 11A till the expiry of 12 months period from the publication of patent under Section 43(2).

Now let us analyze the post-grant opposition proceedings in order to appreciate the differences between the two stages of opposition. Upon receiving a notice of opposition, the Controller shall notify the patentee and shall constitute an Opposition Board, which shall conduct the examination. The Opposition Board shall consist of three members, one of the members being nominated as the Chairman of the Board. In the post-grant opposition proceedings, the opponent has an opportunity to submit reply evidence against the patentee’s evidence. The function of the Opposition Board is to examine the notice of opposition, statements and evidences, and submit a reasoned report on each ground of opposition contained in the notice of opposition along with its recommendation, within a period of three months.

The Examiner who has examined the application is disqualified from being a member of the Opposition Board. On one hand, this provision precludes the apprehension of bias from the mind of the opponent, on the other hand the examiner who has initially examined the application, and therefore understands the case and can provide better advise, is no more a part of the opposition proceedings. The shift of opposition from pre-grant to post-grant would avoid unnecessary delay in the grant of a patent.

It was expected that there would be an upsurge in the opposition proceedings after the introduction of product patent regime. However, there have not been much opposition filings (as published in the Patent Office Journal, till October 7, 2005). Out of those that have been filed, very few oppositions are related to the field of pharmaceuticals. About more than 500 Mail Box applications have been published for pre-grant opposition. However, till now, very few representations have been filed against these Mail Box applications. Hence the speculation of an upsurge in opposition in post-product patent regime has not come true.

Under section 83 of the Indian Trademarks Act, 1999, Intellectual Property Appellate Board (IPAB) was established to hear patent cases, as it would be technically equipped to handle such cases. However, till date the IPAB is not notified to hear patent cases. The low number of oppositions in the pharmaceutical field is probably due to the ambiguities in the Patent law and the inability of the IPAB to hear disputes relating to the patent oppositions. Since both the generic and knowledge based companies can take advantage of the nebulous provisions, the companies fear the uncertainties in the outcome of the disputes.

As such, the existence of a robust generic pharmaceutical industry and the presence of more than 7000 applications in the Mail Box, can lead to a deluge of patent oppositions. The absence of a specialized adjudicatory body and ambiguities in the Patents law has diffused this explosive situation to a great extent. In times to come, when these ambiguities are removed, and loopholes plugged, opposition system under the Indian Patent Law would become most efficacious among all the patent opposition systems across the world.