A patent is an exclusive right granted to the original inventor for a novel product or a novel process that provides, a unique way of doing something, or which discloses a new technical solution to a problem. It provides monopoly right to the inventor to make, sell his invention or product. Hence it is very essential that patent is only awarded to those innovations which justify the exclusive right and comply with the patentability criteria. Opposition proceedings are structured to restrain wrongful obtaining of patents and claiming of the frivolous or petty inventions. Laws providing under Indian patent act for pre grant and post grant of patent are essential to obstruct the unlawful grant of patent. Under Indian Patent act, there are two provisions when opposition may be filed either via pre-grant opposition or post-grant opposition provision depending upon the stage of the patent. The recent heave in patent filings in India may be attributed to the revolution in the Indian Patent System on 1st January, 2005, when India signed the Trade Related Aspects Intellectual Property Rights (TRIPS) agreement, wherein Section 25 of the Act was amended in light of the TRIPS agreement to introduce an "integrated" system of both pre-grant and post-grant opposition in India.1
Pre Grant Opposition:
Section 25(1) of the Patent (Amendment) Act 2005 provides provisions for pre grant opposition of Patent. Under this provision any person or any third party or Government may challenge the application of grant of patent and inform to the controller of Patents for opposition, in writing against the grant of a patent after the application for a patent has been published but before the grant of a patent a patent. Pre-grant opposition acts as a defensive shield to confirm the validity of the patent applications before patents are granted to them. Furthermore pre grant opposition proceeds as a business approach, where opponents take it as a golden opportunity for opposing the unlawful protective rights.
Pre-grant opposition can be made on the grounds listed under section 25(1)(a) to (k) of the Patent Amendment Act, 2005:
- Wrongfully obtaining the invention
- anticipation by prior publication
- anticipation by prior date, Prior claiming in India
- Prior public knowledge or public use in India
- Obviousness and lack of inventive step
- non patentable subject matter
- insufficiency of description of the invention
- non-disclosure of information as per the requirement or providing materially false information by an applicant
- Patent application not filed within 12 months of filing the first application in a convention country
- nondisclosure/ wrong mention of source of biological material
- Invention anticipated with regard to traditional knowledge of any community, anywhere in the world.
Post Grant Opposition:
Post grant opposition may be filed at any time after the grant of patent but before the expiry of a period of one year from the date of publication of grant of the patent. Under this provision any person interested may give notice of opposition to the Controller in the prescribed manner on any of the grounds mentioned in section 25 of the Patent (Amendment) Act 2005. Section 2(1)(t) of Indian patent act defines "person interested" as including a person engaged in, or in promoting, research in the same filed as that to which the invention relates. In addition, interested person may also include any organization that has a manufacturing or trading/ financial interest in the goods related to the patented product.
Similar to the pre-grant opposition, a post-grant opposition may be filed on a number of grounds as specified under section 25(2) of the Act. It is notable that many of the grounds are similar to the grounds required for filing pre-grant opposition.
Procedural Differences Between Pre Grant And Post Grant Patent Opposition In India:
Pre and post –grant opposition both contain the almost identical grounds for proceeding the opposition and there is nothing which excludes a pre-grant opponent from subsequently filing a post grant opposition. However despite the similarities there are also several procedural differences between the two types of the opposition which are illustrated below:
- The most important difference between pre grant and post-grant opposition is that pre grant proceedings may be initiated by "any person", while only a "person interested" can introduce a post grant opposition.
- Next remarkable difference is with infringement proceedings. Infringement proceedings can not be started during pre grant opposition prosecution as the patent is still in the application stage, where as infringement proceedings may be introduced in post grant opposition.
- Section 25(1) of the Act does not openly allow the patent applicant an opportunity to be heard in a pre-grant opposition.
- Moreover, the Indian Patents Act does not explicitly allow the opponent to be heard in a pre-grant opposition. The opponent has to make a request for hearing and the rules do not detail how a hearing is to be conducted. The opponent's right to be heard solely depends upon the discretion of the Controller, who decides the same based upon the merit of the opposition. Additionally, the rules are also not clear whether the opponent will be heard in the presence of the applicant. In contrast, the opponent in a post-grant opposition can proceed with the case irrespective of the merit of the notice of opposition.2
- Further more, as per the stand taken by IPAB on numerous occasions; there is no remedy against an order of the controller in a pre-grant opposition except to file a writ petition under Indian constitution.
- The main drawback of the post-grant opposition process is that this remedy is available only through the courts, making redressal a lengthy process and, in the case of bad patents, allowing the patent holder to enjoy a wrongful monopoly. This is of particular concern in India, given the protracted nature of the judicial process.3
- Pre grant opposition on the other hand is more cost effective and result in faster disposal of cases on merits thereby reducing the costs incurred in contesting the post grant proceedings.
- It mechanism is faster as compared to post grant opposition where trials and extension of hearings occurs in a conventional manner which it happens in the Courts. Unlike post-grant opposition, there is no fee stipulated for filing a pre-grant opposition.4
Landmark Cases Of Opposition In India
1. Novartis AG vs. Natco Pharma Ltd5
An application for patent was filed in India on 17th July, 1998 by Novartis AG, Switzerland, claiming Switzerland priority date of 18th July, 1997. Upon publication, the grant of patent was opposed by Natco Pharma Ltd., India on 26th May, 2005. The grounds for opposition were:
- Anticipation by prior publication
- Lack of inventive step
- Non-patentability under section 3(d)
- Wrongfully claiming the priority
The title compound was already known in a US patent (filed in 1993).The US patent claimed a pharmaceutically acceptable salt of the base compound. Another Document, "Nature Medicine" (5th May, 1996) also described the title compound. Also, the claimed salt inherently existed in the most stable form of the salt. Hence, the claims of the application for the product and process in respect of the title compound stood anticipated by prior publications. Additionally, based on section 3(d) the product claim amounted to a mere discovery of the new form of the known substance. Further, the application had claimed Swiss priority, but Switzerland was not a convention country on the date of filing in Switzerland. Hence, no priority of Swiss application could be claimed in respect of the Indian application.
In view of the above findings and arguments the Controller ruled that the above patent application cannot proceed for grant of patent.
2. Hindustan Lever Ltd. Vs. Godrej Soaps6
In another landmark case a patent filed by Hindustan Lever Ltd. on 14th Oct., 1992 in India was opposed by Godrej Soaps Ltd. The patent had two priorities of UK dated 14th Oct, 1991 and 14th July, 1992 and was granted on 18th May, 1996 in India. The grounds of opposition were:
- Prior publication
- Prior public use and prior public knowledge
- Obviousness and lack of inventive step
- Non-patentability
- Insufficiency and clarity of description
The applicant has failed to disclose to the Controller the information required by section 8 or has furnished the information which in any material particular was false to his knowledge After the hearing it was concluded that the teachings of the cited exhibits were insufficient to prove the grounds of opposition mentioned above. The applicant amended the claims and specifications to make their point clear and to overcome the opponent's allegations. After considering notice of opposition, statements and evidences from both of the parties and hearing, the opposition was dismissed.
3. Neon Laboratories Pvt.Ltd. vs 4) Assistant Controller Of ... on 26 November, 20107
In a recent decision in a writ petition, the Bombay High Court interpreted Section 25(1) of the Patents Act to categorically hold that when a pre-grant opponent requests for a hearing, it is mandatory on the part of the Controller to grant the pre-grant opponent such a hearing. The decision was delivered in a writ petition filed by Neon Labs against the order of the Patent Controller granting a patent to Troika Pharma pursuant to Rule 55(6) of the Patent Rules, 2003 in a pre-grant opposition.
Conclusion
Patent opposition process has principally affected the pharma industry because the patent applicants are now exposed to multiple pre-grant oppositions filed by the competitors, or even by a single competitor. Moreover there is nothing to stop a party which has filed a pre grant opposition from subsequently filing an opposition once the patent has been granted. Opposition proceedings are also putting the surfeit of patent prosecution at Indian patent office. Two-stage patent opposition process has stimulated fears among innovator companies, particularly in the pharmaceutical industry. It would be a challenge for India which is an emerging global economy to meet the commercial as well as legal challenges faced by the patent system of the country and become an attractive commercial destination for the foreign companies without violating any of its international obligations under the TRIPS Agreement.
Footnotes
2. http://techcorplegal.com/Indian_Law_Firm/patent_opposition_in_india_pregrant_patent_opposition_post_grant_opposition/ retrieved on 11/11/2013
4. Shikha, Neeti, Comparative Study of Pre Grant and Post Grant Patent Opposition in India (January 10, 2009). Available at SSRN: http://ssrn.com/abstract=1503188 retrieved on 11/11/2013
5. Novartis Ag vs Natco Pharma Ltd. on 25 January, 2006, http://www.indiankanoon.org/doc/1352538/ retrieved on 11/11/2013
6. Hindusthan Lever Limited vs Godrej Soaps Limited And Others on 11 April, 1996 , AIR 1996 Cal 367 retrieved on 13/11/2013
7. Neon Laboratories Pvt.Ltd. vs 4) Assistant Controller Of... on 26 November, 2010 http://indiankanoon.org/doc/651514/
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