Wednesday, July 19, 2006

Patent for nimesulide preparation refused on Panacea's pre-grant objection

This article was published in Pharmabiz on Wednesday, July 19, 2006.

Stoplik Services India Pvt Ltd filed an application for Patent No. 183458 (454/BOM/1998 dated 14.07.1998) for "A process for the preparation of a therapeutic anti-inflammatory and analgesic composition containing nimesulide for use transdermally". The said application was opposed by Panacea Biotec Ltd which filed a notice of opposition on Feb 1, 2000 against the grant of patent.

The case involves opposition proceeding under the Patents Act, 1970 before the recent amendments which introduced a two-stage opposition, i.e., pre-grant opposition and post-grant opposition. The reference to section 25 in the proceeding is to the provisions of the section as it was before the Patents (Amendment) Act, 2002.

The invention is defined in the claim of the specification as follows:

1. A process for the preparation of a therapeutic anti-inflammatory and analgesic composition for tropical use which comprises the following steps:
(a) forming a mixture of 0.5% w/w to 30% w/w of a percutaneous enhancer and 2.5% w/w to 30% w/w of one or more vehicle/base as herein described;
(b) adding to the said mixture of step (a) 0.1% w/w to 10%w/w of nimesulide following by stirring the mixture until completely dissolved;
(c) forming homogenous mixture of 0.5% w/w to 12% of a surfactant, 0.2% w/w to 50% w/w of a Gelling agent/thickening agent of the kind herein described and 2.5% w/w to 30% w/w of one or more the said vehicle/base in a homogeniser to obtain a homogenized mixture;
(d) adding the said mixture obtained in step (b) to the said homogenized mixture obtained in step (c) under stirring to obtain the desired composition for analgesic use and wherein up to 2.0% w/w of a neutralising agent/pH adjusting agent as herein described is added to the composition to neutralize or adjust the pH of the mixture.

The application was opposed on the following grounds

Wrongfully obtained: Section 25(1)(a)

The opponent produced proof to show that the business of the applicant dealt with compression packing, yarn packing and zero compression packing and that the applicant was not a pharmaceutical company. The opponent alleged that the patent was wrongfully obtained from different specifications and documents. The present patent was also identical with Patent Application No. 1389/Del/1995 filed on July 25, 1995. The opponent pointed out that all the figures, the way of presentation and even the grammatical mistakes were common to both the applications. The applicant denied that above allegations. The Controller observed that the Application No. 1389/Del/1995 was not published or accepted before the date of filing of the Application No. 454/BOM/1998. Hence the earlier application was not in the public domain at the time of filing of the alleged invention. The Controller held that no clear case of wrongful obtainment was made as there was no sufficient evidence to prove this ground.

Reference cited by the opponent that the applicant was involved in a different trade (not in pharmaceutical business) will not in itself be a ground to conclude that the invention was wrongfully obtained. The order of the Controller did not throw any light on this issue.

Prior Publication: Section 25(1)(b)

The opponent had also pleaded that the invention as described in the specification and claims of the Patent Application No. 183458 has been defined and described in several patents granted and published - a detailed list of which was given by the opponent. It was alleged that these patents anticipate the subject matter of the present application.

Despite citing many patents, the stress of the opponent case was based on the Patent Application filed in Sri Lanka having Patent No. 11012, granted on September 20, 1996. The opponent compared the said document with the present application. In defence, the applicants stated that all the cited applications were not open to public on the date on April 4, 1997, the filing date of the parent application to which the present application is antedated. The applicant prayed for the dismissal of this ground as being baseless and vague. Moreover, they pointed out that the opponents have not furnished English translated copy of many patent of foreign countries on which they had relied upon and hence the same could not be taken on record as evidence. The applicant also distinguished the US Patent No.5688829 as being one for product where as the present application was for a process.

With regard to anticipation, the Controller relied on Canadian General Electric Company v Fada Radio AIR 1950 PC 1 to show that to amount to anticipation, the latter invention must be described in the earlier publication that is held to anticipate it. It is not sufficient to show that the earlier invention described in an early specification could have been used to produce a particular result. It must be shown that the specifications contain clear and unmistakable directions on how to use it. It must be shown that the public have been so presented with the invention that it is out of the power of any subsequent person to claim the invention as his own.

The test of anticipation is that the antecedent statement must be such that a person of ordinary knowledge of the subject would at once perceive and understand and be able to practically apply the discovery without the necessity of making further experiments. Only such disclosure can invalidate a subsequent patent. To establish anticipation, the publication relied upon should satisfy the following conditions.

1. it must have been effected before the priority date of the claim which is the subject of attack by the opponent, and
2. such publication may include any specification filed in pursuance of an application for a patent made in Indian on or after Jan 1, 1912 or any other document published anywhere, and
3. the claim attacked must be contained in any of the said publication.

The Controller held that non-production of translated copies of the document containing prior disclosure would be detrimental to the case of the opponent. However, the Sri Lankan and Nigerian Patent application relied upon by the opponent were granted on 20/09/1996 and 03/03/1997 respectively. The Controller after making a comparative table on the impugned patent and the Sri Lankan and Nigerian patents concluded that two questions should be answered in determining whether an invention is novel.
1. Does a particular document or action disclose the invention in such a way as to make it part of the state of the art?
2. Does the document or action make available the necessary information to destroy the novelty of the invention?

While compared to the Sri Lankan and Nigerian patents, the Controller held that the impugned application did not pass the test of novelty. A comparison of claim 1 of the impugned application and claims 20, 21 and 22 of the Sri Lankan or Nigerian Patents show that the principal claim lacks novelty. Claims 2 and 3 of the impugned application also lacks novelty in view of the claims 5 and 7 of the above said foreign patents.

Prior public knowledge or prior public use in India: Section 25(1)(d)

In the light of the several patents relied upon by the opponent, it was canvassed that the invention was publicly known and used in India. It was brought to the notice of the Controller that the product relating to Nimesulide gel/tropical and transdermal composition was present in the Indian market in July 1996. The Controller held that the opponent would succeed on this ground too for the reasons given for the earlier ground of prior publication.

Obviousness and lack of inventive step: Section 25(1)(e)

The opponent had alleged that the impugned application was substantially identical as the invention disclosed and claimed in prior published and granted in Sri Lanka and Nigeria. For the reasons stated by the Controller under the ground of prior publication, it was held that it is very obvious that a man in the art could have done the same thing as claimed by the applicants. The above ground was also granted in favour of the opponents.

Novelty: Section 25(1)(f)

The Controller held that the opponents would succeed even on this ground for the reasons given above.

The Controller ordered that the grant of the Patent on the application for Patent No. 183458 shall be refused and ordered cost of Rs 17,100 to be paid by the applicants.

The above case amply illustrates the effectiveness of opposition procedure. Unlike the examination conducted by the Patent Office which could be plagued with information-scarcity, the opponents have a distinct advantage with regard to knowledge of the invention. Being active participants in the pharmaceutical trade, the competitors can provide for vital information with regard to prior publication and prior user.

Order on costs

Under section 77(1)(e), the Controller has the power to award costs in an opposition proceeding. The matters in respect of which cost can be awarded and the limit of such costs are detailed in the Fourth Schedule. As per section 77(2), the order for costs awarded by the Controller shall be executable as a decree of a civil court.

No comments: