Pre-Grant Opposition is not a new concept in India. It was introduced for the first time in the 1911 Act and is applicable even today. Section 25(1) of the Patents Act, 1970, and Rule 55 of the Patent Rules, 2003, deal with the pre-grant opposition procedure in India. Pre-grant opposition can be filed after the publication of the patent application and before the grant of the patent. It can be filed by any person i.e. any third party can file pre-grant opposition before the Controller. Pre-grant opposition is filed on Form 7A, as per First Schedule and no fee is applicable on filing the pre-grant opposition.
The grounds on which a pre-grant opposition can be filed are given under section 25 clause (1) sub clause (a) to (k) as discussed above.
Procedure for Pre-grant Opposition
The procedure for pre-grant opposition provided under Rule 55 of Patent Rules, 2003, provides that the representation (including a statement and evidence and a request for hearing) for pre-grant opposition shall be filed in form 7(A) at the appropriate office within six months of the publication of the patent application. Such representation will be considered by the controller only if a request for examination of the application has been filed. After considering the representation if the controller is of the opinion that the application for patent shall be refused or amended, he gives notice to the applicant along with such representation. After receiving the notice, the applicant shall file his statement and evidence within three months from the date of the notice. After considering the statement and evidence filed by the applicant the controller may either refuse grant of the patent or require the complete specification to be amended. After considering the representation made during the hearing the controller proceeds further and either rejects the representation and grants the patent or accepts the representation and refuses to grant the patent.
Figure 1- Pre-Grant opposition Procedure
In Novartis AG v. Natco Pharma Ltd.1, an application for patent was filed for an invention titled "Crystal Modification of A.N.-Phenyt-2-Pyrimidineamine derivative and process for its manufacture" by Novartis AG. After publication of Novartis's patent application, pre-grant patent opposition was filed by Natco Pharma on the grounds of prior publication, lack of inventive step and non-patentability. After the examination of the opposition the controller was of the view that the application did not fulfill the criteria given under section 25 and was in contravention of the patentability requirements mentioned under the said section and accordingly he accepted the opposition and refused to grant patent to Novartis.
In Hindustan Lever Ltd. v. Godrej Soaps2, two patent applications were filed by Hindustan Lever Ltd. in respect of an invention relating to detergent bars suitable for personal bathing or fabric washing and for the improved process for preparing detergent bars. Both applications were published, after which Godrej Soaps filed opposition to the patent on the grounds of prior publication, prior public use & prior public knowledge, obviousness & lack of inventive step, non-patentability and insufficiency and clarity of description. After the hearing, the controller ordered for amendment of the specifications. The applicant amended their specifications and the opposition was dismissed as the opponents were unable to establish opposition to the satisfaction of the controller.
The Madras High Court, in Indian Network for People Living with HIV/AIDS v. Union of India3, dealt with the issue 'can patent be granted without giving the opportunity of hearing to opponent under section 25(1) of the Patents Act, 1970 and Rule 55 of the Patent rules, 2003'. In this case the petitioner was a society which provides help to persons suffering from HIV/AIDS. It opposed a patent granted to F. Hoffman-La Roche Company for a drug used to treat CMC retinis and wanted hearing under section 25(1) and Rule 55. The controller sent a notice of opposition to the applicant and granted patent without hearing the opponent. The Division Bench of Madras High Court discussed section 25(1) and Rule 55 and held that under sub rule (6) of Rule 55, it is provided that after considering the representation and submission made during hearing, if so requested, the controller shall proceed further simultaneously either rejecting the representation and granting the patent or accepting the representation and refusing the grant to the patent. Accordingly, the patent granted was rejected and it was held that the petitioner have a right of hearing under the Patent Act and Rules.
Remedy Where Pre-Grant Opposition is Rejected
If a pre-grant opposition is rejected, and as long the person who filed the opposition application is 'person interested', he can apply for a post-grant opposition under section 25(2) and also file an application before the Intellectual Property Appellate Board (IPAB) under section 64 of the Patents Act, 1970 for revocation of the patent. So, as long as the person is the 'person interested', he is not without a remedy after his pre-grant opposition is rejected. Even after the rejection of his post-grant opposition, he can file an appeal before IPAB under section 117- A and against the decision of IPAB he will have the remedy of judicial review by filing a petition in High Court.4
The Supreme Court, in J. Mitra and Co. Pvt. Ltd. v. Assistant Controller of Patents and Designs,5dealt with the issue 'whether appeal against the decision of the controller pertaining to pre-grant opposition had to be preferred to Appellate Board or to the High Court in view of the promulgation of the Patents Amendment Act, 2005'. In this case a dispute occurred between Span Diagnostics Ltd., a public limited company involved in indigenous development and manufacture of a comprehensive range of ready-made diagnostic reagents made by clinical pathology laboratories, and J. Mitra and co. which manufactured medical equipments. On June 14, 2000, J. Mitra and Co. filed an application for grant of patent (notified on November 20, 2004) which was opposed by Span Diagnostics by way of pre-grant opposition under section 25(1) on March 21, 2005. The opposition was rejected by the controller, against which the opponent applied for appeal but it was also rejected as the amended Act of 2005 did not come into force. The court held that since the amended Act had not come into force, the appeal would be heard and disposed-off by the high court under Section 116 of the 1970 Act as it stood on 19.10.2006.
In M/s UCB Farchim Sa v. M/S Cipla Ltd.6, Intellectual Property Appellate Board (IPAB) rejected a pre-grant opposition by holding that there did not lie an appeal before it from an order of rejection of a patent application in a pre-grant opposition proceeding. Against this order of IPAB a writ petition was filed before the high court wherein the court held that the refusal of pre-grant opposition by controller is not appealable to IPAB. However, an order of refusal of patent application is appealable to IPAB and therefore, the rejection of a patent application by the controller in pre-grant opposition is appealable to IPAB.
Remedy where Pre-Grant Opposition is Allowed
Where the pre-grant opposition is allowed, the applicant (patentee) can appeal against the order of the controller to the IPAB. In Yahoo! Inc. v. IPAB case7 the application was for a method of operating a computer network search apparatus and it was rejected by the controller on the ground that the invention did not pass the novelty and the patentability test. Against this order of the controller the appeal was preferred to the IPAB but IPAB refused to entertain the appeal on the ground that in as much as no appeal would lie against an order under Section 25(1), Indian Patents Act as provided under Section 117-A of the Act, the same cannot be entertained. Against this order of the IPAB, the petitioner went to the High Court of Madras and the court found that an appeal would lie against the refusal of the patent under section 25(1), since the same is relatable to an order passed under Section 15 of the Act which in effect is one appealable under Section 117-A of the Act.
In Novartis v. Cipla8, Novartis filed a patent application in 2005, for their invention 'Dispersible tablets comprising Defracirox'. Cipla filed a preg-rant opposition against the application of Novartis as per Section 25(1) of the Patents Act, 1970, which was allowed by the controller. Novartis filed the reply statement with evidence and during the hearing it was found that the invention was hit by section 25(1)(b) and (e). Accordingly, the opposition was allowed and the patent was refused.
The opposition procedure at pre-grant stage is without any fee and a smooth process involving few formalities, which can be filed by any person (any third party). The said procedure has been useful in helping many people and various companies to oppose patents on similar grounds on which a post-grant opposition is filed. Opposition as a means of invalidating a patent finds favor particularly owing to lesser expenses and quick resolution as compared to revocation and litigation proceedings, which are expensive and time-consuming. A large number of patent oppositions are filed mainly by pharmaceutical industry in India but lately other industries have also started applying for the opposition proceedings because of the advantages it provides.
1. Novartis AG v. Natco Pharma Ltd.,2006.
2. Hindustan Lever Ltd. v. Godrej Soaps, 1996
3. Indian Network for People Living with HIV/AIDS v. Union of India, 2008
4. J. Mitra and Co. (P) Ltd. v. Asst. Controller of Patents & Designs, AIR 2009.
5. J.Mitra and Co. v. Asstistant Controller of Patents and Designs, Air 2009.
6. M/S UCB Farchim Sa v. M/S Cipla Ltd., 2010
7. Yahoo! Inc. v. IPAB (2010)
8. Novartis v. Cipla, 2011
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