Friday, December 31, 2010

An Old Pharma Decision: Bombay High Court (1968) – III

Continuing our discussion from the last 2 posts, in this post the remaining grounds of invalidity have been discussed. 

B. Want of Novelty

As stated in the last post, the essential embodiment of the plaintiffs’ invention did not lie in a method of desulphurisation of sulphonylthioureas, it lay in selecting and combining certain base materials which upon reaction would throw up a product with hypoglycaemic results, sans the side effects in the prior art. 

In the prior art, amino-sulphonamides were used in anti-diabetic treatment, however the groups/radicals attached to either ends of amino-sulphonamides caused certain undesirable effects. The plaintiffs’ invention was devoid of these harmful effects owing to the limitation on the maximum number of carbon atoms which R and R1 could contain. In other words, identification and use of R and R1 constituted the inventive step in the plaintiffs’ invention, which was unknown to the state of art prior to the plaintiffs’ disclosure.

C. Lack of Inventive Step

This brings us to the question of non-obviousness; the Court’s observations on this issue are, for me, the most significant contribution of the judgment to Indian patent jurisprudence. The Court rightly recast the issue of non-obviousness in the case as one involving a question of “production of new substances by known methods from known materials, which can be supported from the point of view of subject-matter”. 

This was apt because the inventive step of the plaintiffs’ invention lay in selecting the right materials from available materials to produce compounds with desired characteristics. The Court recalled the test laid down in May & Baker Ltd. and Ciba Ltd., (1948) 65 RPC 255, which was as follows:

(i) An invention consisting of the production of new substance from known materials by known methods cannot be held to possess subject-matter, merely on the ground that the substances produced are new, for the substances produced may serve no useful purpose, in which case the inventor will have contributed nothing to the common stock of useful knowledge (the methods and materials employed being already known) or of useful materials (the substances produced being ex hypothesis, useless).

(ii) Such an invention may, however be held to possess subject-matter provided the substances produced are not only new but useful, though this is subject to the qualification that the substances produced must be truly new, as opposed to being merely additional members of a known series (such as the homologues) and that their useful qualities must be the inventor's own discovery as opposed to mere verification by him of previous predictions.

(iii) Even where an invention consists of the production of further members of a known series whose useful attributes have already been described or predicted, it may possess sufficient subject-matter to support a valid patent provided the somewhat stringent conditions prescribed by Maugham J., as he then was, in I. G. Farbenindustrie A. G.'s Patents, (1930) 47 RPC 289 as essential to the validity of a selection patent are satisfied, i. e. the patent must be based upon on some substantial advantage to be gained from the use of the selected members of the known series or family of substances, the whole) of the selected members must possess this advantage, and this advantage must be peculiar (or substantially peculiar) to the selected group

The Court again cited Halsbury, which postulates thus:

An invention usually involves three stages:
(1) the definition of the problem to be solved, or the difficulty to be overcome,
(2) the choice of the general principle to be applied in solving the problem overcoming the difficulty; and
(3) the choice of the particular means to be used. 

The merit in any one of these stages, or in the whole combined, may support the invention, and it is, therefore, probably more important to consider the advance in knowledge due to the inventor rather than to examine in detail the variations from the former product.

In this case, the inventive step was the replacement of radicals attached to amino-sulphonamides (such as carbutamide) by a methyl group, resulting in Tolbutamide. On the ingenuity of the inventive step, the Court’s views are of critical importance:

“The substitution of CH. 3 in the para position for NH. 2 was the inventive step. It was a novel idea and the plaintiffs' patent therefore embodies a new and useful composition of matter, or at any rate, a new and useful improvement in it. It was not a thing which just any person working in this field would try, but it required extensive research. As observed in the Irish judgment to which I will refer later on, Courts of law must guard against the common human failing of being wise after the event in regarding something that has been discovered by research as obvious.”

The so-called “hindsight bias” which the US Supremes had warned against in KSR v. Teleflex in 2007, the Bombay High Court had already cautioned against in 1968. Commenting further on the inventive step, the Court held:

“...though sulphonylureas were known prior to the invention in suit, it was not known that if they were activated by certain radicals they would have blood sugar reducing properties. The use of sulphonyl-ureas with radicals on either side with certain limitations in regard to Carbon atoms so as to obtain hypoglycaemic properties would itself be an addition to the “common stock of useful knowledge” within the May & Baker's case, (1948) 65 RPC 255”

On the basis of the above reasoning, the Court dismissed the ground of obviousness.

As for the ground of lack of utility/usefulness of the invention, I leave it for the readers to read for themselves some very insightful observations of the Court in holding the invention useful, despite the patent taking within its ambit an unknown number of unknown compounds which were identified/characterised on the basis of the base materials used and the properties exhibited.


More than anything, the judgment of the Bombay High Court is a case in point to show that independence of mind and “vertebracy” are two essential prerequisites if Indian Courts are to develop their own principles and doctrines.  I say this because, unlike this decision, the fear of the unknown is palpable in most Indian decisions on patents, which I think, is the reason that most decisions are mere recapitulations of case laws from either sides of the Atlantic. 

Case laws can help Indian Courts only to the extent of equipping them with certain tools of adjudication, but application of those tools to the facts of a case is something Indian Courts have to do by themselves. Surrogacy in application of the mind simply does not and cannot work, particularly in a field which is highly contextual. 

Let’s hope Indian Courts draw inspiration from Justice Vimadalal's attempts to shape an Indian view on patents.

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