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The Potency of Pre-Grant Opposition of a Patent

Changes have been made in the Patents Act, 1970 by Patents (Amendment) Act, 2005 to meet the requirements of Trade Related Aspects of Intellectual Property Rights (TRIPS) and the Patent Cooperation Treaty (PCT). One of the most important changes of the recent amendments is the introduction of the two-stage opposition, i.e., pre-grant opposition and post-grant opposition. The procedure of the grant of patents has been completely refurbished by the substitution of Sections 25 and 26 in the amended Act.  Now, there can be substantive opposition even before the grant of a patent.

Opposition before Grant of Patent – The Controller will publish the patent application and any person can file the application of opposition of the grant of patent under section 25 (1). The notice of Opposition must be filed within three months of the date of publication or before the grant of patent, whichever is later.

Opposition after Grant of Patent – Under Section 25(2), any person can file an opposition after the grant of patent but before the expiry of a period of one year from the date of publication of grant of patent.

The two-stage opposition of patents has stirred multiple apprehensions in the pharmaceutical industry. But it is only an inevitable change which India, as a founding member of the WTO, had agreed to ten years ago. India has international obligations and the industry stands to gain little by seeking changes in the amendments. Section 25 (1) allows a person to oppose a patent application before the grant of patent on grounds, which are identical to the grounds of a post-grant opposition. The pre-grant opposition has aroused dissatisfaction in the pharmaceutical industry. Once the first pre-grant filings made by a competitor has been ended with, another opposition, by another competitor or even the same competitor, who initiated the first opposition proceedings, may be filed. The post-grant opposition also does not prevent a person, who has made a failing pre-grant opposition, from raising an opposition to a patent after its grant. This sequential opposition leads to continuous and repeated opposition proceedings against the same patent application. Such delays are of course, a big cause of worry, for the patent applicant, as the patent terms starts running from the date of filing of the application.

Under the Indian patent law, one of the grounds for opposition of grant of a patent, as per Section 25 (1) (e) and Section 25 (2) (e), is no involvement of any inventive / innovative step. If an invention, in so far as claimed in any claim of the complete specification in the application for a patent, is obvious and clearly does not involve any inventive step, it may be opposed and may be found to be non-patentable. Under the new regime of patents, pharmaceutical companies have gone into a frenzy of pre-grant oppositions. According to a recent news report in the daily Economic Times of New Delhi, domestic pharmaceutical companies have filed 148 pre-grant oppositions to patent applications. Another source has placed about 40 pre-grant oppositions in Delhi alone. This flurry of oppositions has the beneficial edge of minimizing a patient’s burden of high-cost drugs. It is unreasonable on all counts, to make a patient pay the peak cost of drugs that are not authentically inventive.

Panacea Biotec Ltd successfully made a pre-grant opposition for a patent for a nimesulide preparation. Stoplik Services India Pvt Ltd filed an application for “a process for the preparation of a therapeutic anti-inflammatory and analgesic composition containing nimesulide for use transdermally”. This application was opposed by Panacea Biotec Ltd which filed a notice of opposition on February 01, 2000 against the grant of patent.

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The grounds on which the Controller of Patents allowed the opposition are – prior publication [section 25 (1)(b)]; prior public knowledge or prior public use in India [section 25(1)(d)]; obviousness and Lack of inventive step [section 25 (1)(e)]. The opponent stressed on the Patent Application filed in Sri Lanka having Patent No. 11012 granted on September 20, 1996. The opponent compared the document procured from Sri Lanka and the patent application. The Controller of Patents took the test of anticipation, which is that the antecedent statement must be of such nature that a person of ordinary knowledge of the subject would be able to perceive and understand at once and be able to practically apply the discovery without further experiments. The Controller made a comparative table of the impugned application and the Sri Lankan patent and held that the impugned application did not pass the test of novelty. The Controller was also brought to notice the presence, in the Indian market since July 1996, of the product relating to Nimesulide gel/ tropical and transdermal composition, also held that the impugned invention was publicly known and used in India. For the reasons of prior publication, the Controller also held that it was very obvious and there was no inventive step.

The case illustrates the effectiveness of the new regime of patent opposition. The issue of patentability is significant in importance as it limits the scope of inventions for which patents can be claimed. The earlier procedure of examination conducted by the Patent Office could be beset with scarcity of information. It brings to the knowledge of the Controller even rare information pertaining to traditional medicinal knowledge. It limits the scope of patentability of an invention, which is anticipated, in so far as claimed in the complete specification, as there might be knowledge, oral or otherwise, available within any local or indigenous community in India or elsewhere [section 25 (1) (k)]. The opposition of patents at the pre-grant stage helps in accretion of information, which otherwise, the patent examiner would not have been aware of. The competitors, acting as active participants in the pharmaceutical industry, can provide crucial information with regard to prior publication, prior user and inventiveness.