New sulphonylureas whose blood-sugar-lowering utility was the inventor's own discovery were inventive though made by known methods, so the tolbutamide process patent was upheld and its infringement restrained.
Summary
Vimadalal J described "a suit for infringement of patent under section 29 of the Indian Patents and Designs Act, 1911" brought by "the legal owners and proprietors" of "Indian patent No. 58,716 in respect of the manufacture of new sulphonylureas, salts of those compounds and of antidiabetic preparations containing such compounds" (p 56). According to the plaintiffs, the first defendants "have since May 1961 wrongfully and with full knowledge of the plaintiffs' said patent No. 58,716 infringed the said patent by manufacturing, preparing and selling UNI-TOLBID tablets or tolbutamide" (p 56). The defence was "that there is no infringement of the plaintiffs' said patent" because the defendants "have manufactured the compound tolbutamide in accordance with a different process described in the second defendants' patent No. 64,323", "by desulphurisation with hydrogen peroxide", and "that the plaintiffs' said patent No. 58,716 is invalid and is liable to be revoked on the grounds of insufficiency of description, lack of novelty, want of inventive step and lack of utility" (p 57). "Mr. Blanco White has conceded that, on the suit as framed, the infringement that has been complained of is infringement only of claims 1 and 11 of the plaintiffs' said patent No. 58,716." (p 60)
The Court held that "claim 11 is as a matter of plain language" ... "wide enough to include desulphurisation of thioureas by any chemical substance including hydrogen peroxide which the defendants claim to use" (p 63), and that "from the facts admitted in the pleadings, the conclusion that claim 11 has been infringed by the defendants must follow" (p 64). On validity it held that "The novelty in the plaintiffs' patent lies entirely in the R and the R1" (p 66); that "If the useful qualities of the new substances produced are the inventor's own discovery, that would be sufficient to repel the objection that there is no inventive step" (p 67); and, declining "to follow the decision of the Exchequer Court of Canada" (p 73), that "the objection on the ground of want of utility must fail" (p 74). "In the result, all the grounds on which the validity of the plaintiffs' patent was challenged stand rejected" (p 74). "I grant an injunction in terms of prayer (a) and pass an order in terms of prayer (d). I also order that the defendants do pay the plaintiffs' costs of the suit." "Under section 32 of the Indian Patents and Designs Act, I certify that the validity of the patent came in question in this suit." (p 74)
What the court decided
- Delay and acquiescence. "The position, therefore, is that mere delay is no bar to the granging of relief by way of perpetual injunction at the hearing of the suit, unless there is something more than mere delay which has caused prejudice to the defendants. There is no averment to the effect in the pleadings in the present suit, and certainly no evidence whatsoever to prove that the defendants were prejudiced in any manner by the alleged inaction of the plaintiffs over a considerable period of time." "Issues Nos. 4, 5 and 6 must, therefore, be answered in favour of the plaintiffs." (p 58)
- Infringement a mixed question. Citing Lallubhai Chakubhai Jariwala v Chimanlal Chunilal (1935): "As stated by B. J. Wadia, J. in Lallubhai Chakubhai v. Chimanlal Chunilal & Co. 37 Bom. L. R. 665, the question of infringement is a mixed question of law and fact." (p 58)
- The statutory scheme. "Section 2(8) of that Act defines 'invention' as meaning any manner of new manufacture and as including an improvement. Section 2(10) of the said Act defines the term 'manufacture' as including any art, process or means of producing, preparing or making an article, and also any article prepared or produced by manufacture." "Section 29(1) provides that a patentee can file a suit in the nature of an infringement action against any person who, during the continuance of the patent, makes, sells or uses the invention without his licence, or counterfeits it, or imitates it. Sub-section (2) of that section further provides that every ground on which a patent may be revoked under section 26 would be available by way of defence to a suit for infringement." (p 58–59)
- Presumption from the product. "It is true that, as stated by Halsbury, 3rd edn. vol. 29 p. 106 para. 218, the onus as to infringement lies on the plaintiff." Of section 41(2) of the Canadian Patent Act, under which "any substance of the same chemical composition and constitution shall, in the absence of proof to the contrary, be deemed to have been produced by the patented process", the Court held: "Though there is no corresponding provision in the Indian Patents and Design Act, I see no reason why a presumption to the same effect should not be drawn by me against the defendants in the present case under the general provisions contained in section 114 of the Indian Evidence Act, since it is admitted by the defendants that it is the very drug tolbutamide in respect of which the plaintiffs have obtained their patent No. 58,716 that they have prepared and sold." (p 59)
- Facts especially within knowledge. "Moreover, though the general burden of establishing the case of infringement undoubtedly rests on the plaintiffs as laid down in the statement from Halsbury mentioned above, which is in accordance with section 101 of the Indian Evidence Act, the burden of proving a particular fact, viz., the process by which tolbutamide is being prepared by the defendants, would be on the defendants since that is a fact 'especially' within their knowledge within the terms of section 106 of the Indian Evidence Act. It is impossible for the plaintiffs to know by what precise process tolbutamide is being prepared by the defendants and it is precisely to that sort of a case that section 106 is intended to apply." (p 59)
- Claims define the monopoly. "As stated in Halsbury 3rd edn. vol. 29 p. 6 para. 8", "the specification ends with the claims delimiting the monopoly granted by the patent, and since they define the monopoly they must, in the event of legal proceedings, be scrutinised with as much care as any other document defining a legal right, and require to be as carefully drawn." (p 60)
- Construing the claims. "the specification is to be read as a whole, and that the body of the specification should be read first. The claims must, however, be read as ordinary English sentences without incorporating into them extracts from the body of the specification, or changing their meaning by reference to the language used in body of the specification, though the body of the specification should be referred to for the purpose of resolving difficulties of construction occasioned by the claims when read by themselves. It is, therefore, clear that in an infringement action the main function of the court is to contrue the claims which are alleged to have been infringed, without reference to the body of the specification, and to refer to the body of the specification only if there is any ambiguity or difficulty in the construction of the claims in question." (p 60)
- Obiter. Method and process. Of counsel's distinction between "method" and "process": "I am afraid no support is to be found for this distinction in any of the standard works or decided cases. The terms 'method' and 'process' have been used indiscriminately at various places in standard works and in decided cases to mean the same thing". (p 62)
- Claims 1 and 11 together. "In my opinion, that is the proper construction of claims 1 and 11, and the position, therefore, is as stated by Mr. Blanco White, that claims 1 and 11 must stand or fall together, and that if claim 11 is infringed, claim 1 must necessarily be infringed." (p 63) "As claim 11 is comprised in the wider claim contained in claim 1, it must follow that claim 1 has also been infringed by the defendants." (p 63–64)
- An unambiguous claim. "claim 11 is as a matter of plain language -- and that is how a claim should be construed as stated in the passage from Halsbury referred to earlier -- wide enough to include desulphurisation of thioureas by any chemical substance including hydrogen peroxide which the defendants claim to use. Since claim 11 is unambiguous in its terms, it would not, in my opinion, be right to seek to construe it by reference to anything stated in the body of the specification." (p 63)
- Admissions in the pleadings. "As stated in section 56 of the Indian Evidence Act, facts which are admitted need not be proved." (p 63) "In my opinion, there can be no doubt that these facts admitted on the pleadings are sufficient to show that claim 11 in the plaintiffs' specification is necessarily infringed by the defendants." "in view of those admissions it was unnecessary for the plaintiffs to lead any evidence to prove infringement on the part of the defendants." (p 63–64)
- The patentee's own method. "The fact that, as Dr. Aumuller has deposed, the plaintiffs in practice adopt the direct method in the production of tolbutamide for sale is immaterial. The question is, not as to the method actually followed by the plaintiffs, but is whether the method followed by the defendants whichis an indirect method, is covered by and of the claims in the plaintiffs' patent. Even a cursory look at claim 11 is sufficient to show thatit is wide enough to cover all methods of eliminating sulphur from thioureas". (p 64)
- Onus on validity. "It may be stated that the onus in regard to all objections to validity lies on the defendant, Halsbury, 3rd edn. vol. 29 p. 106 para. 218." (p 64)
- Sufficiency of description. Adopting Halsbury, the Court stated "that the claim need only be as clear as the subject admits, and that a patentee need not so simplify his claim as to make it easy for infringers to evade it", "that the patentee's duty is not to prevent all possible argument as to whether there is or is not infringement in particular cases, but to enable the court to formulate the questions of fact to be answered", and "that insufficiency of description has two branches, (1) the complete specification must describe 'an embodiment' of the invention claimed in each of the claims, and that the description must be sufficient to enable those in the industry concerned to carry it into effect 'without their making further inventions'; and (2) that the description must be fair i.e. it must not be unnecessarily difficult to follow." (p 64–65)
- The skilled addressee. "The specification and claims are addressed to those with a high degree of knowledge of the field of science to which they relate, particularly when they relate to chemistry and allied subjects. It is not necessary to describe processes in the claims to a specification when they are part of the common knowledge available to those skilled in the science who can, after reading them, refer to the technical literature on the subject for the purpose of carrying them into effect." "The ground of insufficiency of description alleged by the defendants must, therefore, fail." (p 65)
- The discovery at the basis. "the secret or discovery essential to the validity of the plaintiffs' invention as claimed and forming the very basis of it is not the method, but is the previously undiscovered fact of a new class of chemical compounds having hitherto unknown blood sugar lowering properties, twenty-one methods of synthesis of sulphonylureas being already known at the material time". (p 65)
- The test of novelty. "The test of novelty as formulated by Halsbury, 3rd edn. vol. 29 p. 27 para. 58 is in the following terms": "To anticipate a patent, a prior publication or activity must contain the whole of the invention impugned; i.e., all the features by which the particular claim attacked is limited. In other words, the anticipation must be such as to describe, or be, an infringement of the claim attacked." (p 65)
- Novelty in the radicals. "That was the prior art and, in that state of knowledge, it was not possible for a skilled chemist to predict that the combining of the two starting materials mentioned in the plaintiffs' patent would produce compounds which would have hypoglycaemic properties. The idea which is new in the plaintiffs' patent is the discovery that a useful antidiabetic preparation could be obtained by constructing a molecule with a sulphonylurea in the middle and carefully planned lumps of radicals at either end. The novelty in the plaintiffs' patent lies entirely in the R and the R1." "I therefore hold that the objection to the validity of the plaintiffs' patent on the ground of want of novelty must stand rejected." (p 66)
- New substances by known methods. The Court held that "the principles to be applied by the court in regard to the same are to be found well-formulated by Jenkins, J. in the leading case of May & Baker & Ciba Ltd's. Patent", including that "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." (p 66) "The mere fact that the methods adopted are known methods cannot, therefore, lead to the conclusion that there is no inventive step." "If the useful qualities of the new substances produced are the inventor's own discovery, that would be sufficient to repel the objection that there is no inventive step." (p 66–67)
- Selection from a known series. The third of the principles adopted was that "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. in I.G. Farbenindustrie A.G.'s Patents (1930) 47 R.P.C. 289 as essential to the validity of a selection patent are satisfied, i.e. the patent must be based on some substantial advantage to be gained from the use of the selected members of the known series or family of substances, the whole, or substantially the whole, of the selected members must possess this advantage, and this advantage must be peculiar, or substantially peculiar, to the selected group." (p 67)
- Known methods and utility. "The objection on the ground which I am now discussing, therefore, ultimately resolves itself into a consideration of the utility of the plaintiffs' invention". (p 67) The objection "that the methods of manufacture comprised in the plaintiffs' patent are old" is "an objection which also rests in the ultimate analysis on the decision in regard to the question of utility." (p 67, 69)
- The skilled worker. "The test of 'obviousness' is laid down with characteristic lucidity in Halsbury 3rd edn. vol. 29 p. 42 para. 95 in the form of a question": "Was it for practical purposes obvious to a skilled worker, in the field concerned, in the state of knowledge existing at the date of the patent to be found in the literature then available to him, that he would or should make the invention that subject of the claim concerned?" (p 67)
- Three stages of invention. "It is further stated in Halsbury p. 43 para. 95 that 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 or overcoming the difficulty and (3) the choice of the particular means to be used. It is further stated in the said paragraph that 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." (p 67)
- Prior knowledge in India. "In order to support this objection it is necessary for the defendants to show in the present case that carbutamide was known in India. If the plaintiffs could show that it was not obvious to a man in the art like the director of the Haffkine Institute even after notionally putting in his hands standard works like Houben-Heyl and the article by Kurzer in the Chemical Review vol. 50 as well as other scientific material on the subject then available in India that he would or should make the invention which is the subject of the plaintiffs' patent, the defendants' objection now under consideration must fail." "there is no evidence which Mr. Mistree has been able to point out to the court to show that carbutamide was known in India at the material time. That by itself would be sufficient to dispose of the defendants' objection on that score." (p 67–68)
- The inventive step. "the only difference in the respective chemical compositions of carbutamide and tolbutamide is that the latter has the methyl group (CH3) in place of the amine group (NH2) which occurs in the former in the para position in the radical R, as Dr. Aumuller himself has admitted. That, however, is the crux of the plaintiffs' invention to which patent No. 56,716 relates. The substitution of CH3 in the para position for NH2 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." (p 68–69)
- Wise after the event. "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." (p 69)
- Addition to useful knowledge. "The use of sulphonylureas 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". (p 69)
- An expert's word "obvious". Of Dr. Bander's answer that the "blood sugar reducing effect of tolbutamide is obvious", the Court held that "Mr. Mistree has not elicited from Dr. Bander the point of time at which the blood sugar reducing effect of tolbutamide became obvious to him", that "There is no evidence to show that it was known that the blood sugar lowering property of carbutamide lay in its sulphonylureas", and that "the statement of Dr. Bander that the blood sugar reducing property of tolbutamide 'is obvious' cannot really help the defendants to sustain the objection based on obviousness on the ground of alleged knowledge of carbutamide and the same must be rejected." (p 69)
- The quantum of utility. "The first question that arises in regard to the subject of the utility of the plaintiffs' patent is, what is the quantum of utility required to support of patent?" Adopting the statement "that in the absence of any promise in the specification that a definite degree of advantage would result from the use of the invention, the amount of utility required to support a patent is very small", and that "the test is whether the new method 'gives the public a useful choice.'" (p 69), the Court held: "Judged by these tests, the position is that the plaintiffs' patent in the present case cannot be attacked on the ground of want of utility, since it certainly gives a 'useful choice' in the matter of compounds with a blood sugar lowering property which was not known till then, unless by the specification a higher degree of utility was promised by the plaintiffs." The defendants showed only "that some of those compounds were weaker than others, a point which is of no relevance for the purpose of the present case." (p 69–70)
- The promise of the specification. "A careful scrutiny of the specification shows that all that is promised therein is, (1) that all the compounds falling within the plaintiffs' patent would lower the blood sugar and (2) that they are not sulphonamides and avoid the difficulty of the administration of sulphonamides". "I am afraid, however, the statements in the specification on which Mr. Mistree has relied cannot be torn from their context." "I, therefore, hold that there is no claim in the specification in regard to utility of the compounds falling within the patent which has been disproved by the evidence led in this case." (p 70–71)
- Foreign decisions. "In my opinion, therefore, the decision in the Canadian case cannot be distinguished on facts from the present case. Even so, I must proceed to consider whether I should follow the same, as decisions of Canadian courts do not bind me." (p 71)
- Prediction after research. "In my opinion, when a process patent is obtained after prolonged and thorough research work, it may be possible to predict that the substances produced by that process would have a particular property, though it is usually impossible for anybody to test all the possible substances that could be produced by that process." (p 72) "it is wrong to suppose that 'there is no prevision in chemistry.' I accept the evidence of Dr. Bander that when several pharmacological compounds having the same characteristic structure exhibit the same pharmacological behaviour, it can be predicted that other such compounds would have the same behaviour, provided the necessary limitations in regard to radicals are observed, particularly when compounds without those limitations have also been tested and found not to have the property in question." (p 72–73)
- Claims to untested compounds. "I am afraid I am unable to agree with the decision of the Exchequer Court of Canada in the above case that merely because a process patent may embrace a very largenumber of compounds all of which or even a substantial number of which, cannot be individually tested, the patent must be held to be invalid. To take that view would, in my opinion, invalidate a large number of process patents. I, therefore, decline to follow the decision of the Exchequer Court of Canada in the above case. If the Supreme Court of Canada intended to lay down a different test, viz. the test as to whether the new substances produced by that process can after proper research, be predicated as possessing 'unexpected utility' in the form of hypoglycaemic effect, I agree with that view. That test is satisfied in the present case, as held by me above." (p 73)
- Claims to processes that will work. Of Kenny, J. in the Irish action: "In my opinion, the writer of the claims in a process patent is entitled to include claims for processes which he is certain will work because of the results of other processes." "I am in full agreement with that view of Kenny, J." (p 73)
- Obiter. Chemical patents. "There is, therefore, no warrant for chemical patents being treated in this country in a way different from other patents in regard to which the Patent Office in this country does grant patents for substances per se. In the absence of express statutory provisions, as stated in Terrell on the Law of Patents 11th edn. pp. 127-128 para. 315, the belief that the law applicable to chemical cases is peculiar is erroneous, and the principles applicable in the case of patents for chemical processes are 'precisely similar' to those applicable in the case of other patents." (p 73)
- The meaning of want of utility. "As stated by Halsbury 3rd edn. vol. 29 p. 59 para. 123, 'not useful' in patent law means that the invention will not work either in the sense that it will not operate at all or more broadly, that it will not do what the specification promises that it will do. It the invention will give the result promised at all, the objection on the ground of want of utility must fail. It is further stated in the said passage that the practical usefulness or commercial utility of the invention does not matter, nor does it matter whether the invention is of any real benefit to the public, or particularly suitable for the purposes suggested, and that it is only failure to produce the results promised that will invalidate the patent, not misstatements as to the purposes to which such results might be applied." (p 74)
- The promise of results. "the well-known rule is that the utility of an invention depends upon whether, by following the directions of the patentee, the result which the patentee professed to produce can in fact be produced", and "the protection is purchased by the promise of results, and that it does not, and ought not to, survive 'the proved failure' of the promise to produce the results." "The position, therefore, is that not only is there no 'proved failure' to produce the results promised by the plaintiffs patent specification, but there is a 'proved failure' on the part of the defendants to show that compounds falling within the patent do not have the blood sugar lowering properties promised by that. I, therefore, hold that the objection on the ground of want of utility must fail, and with it also the objection that the methods of manufacture are old and known methods and, therefore, there is no inventive step as far as the plaintiffs' patent No. 58,716 is concerned." (p 74)
- Procedure. Weighing the expert witnesses. "I am, however, constrained to say that Dr. Krishnamurthi Ganapathi's evidence did not impress me at all. The record of his evidence on paper, does not perhaps convey the halting and shaky manner in which he gave that evidence. In contrast with the evidence of Dr. Krishnamurthi Ganapathi, it may be stated that I was considerably impressed by the cogent and confident as well as frank manner in which Dr. Aumuller and Dr. Bander gave evidence on behalf of the plaintiffs". (p 57)
- Procedure. Relief. "the plaintiffs will be entitled to the normal reliefs available in an infringement action, namely an injunction, as well as an order for the delivering up or for destruction of all articles in the defendants' possession made in infringement of the plaintiffs' patent No. 58,716." The claim for damages "or the alternative claim for an account of the profits" was one "which must, therefore, be treated as not pressed by the plaintiffs." "Under section 32 of the Indian Patents and Designs Act, I certify that the validity of the patent came in question in this suit." (p 74)
What the court did not decide
On the plaint: "It is not necessary for me to decide on a construction of the said paragraph of the plaint whether the latter averment should be read as restricting the general averment with which the said paragraph opens" (p 60). On the claims in suit: "I am concerned in this case only with claims 1 and 11 which are in respect of what may be called 'process patents,' but I have thought it appropriate to refer incidentally to claim 22 also" (p 63). On method and process: "It is not necessary for me to arrive at a definite conclusion on this point" (p 62). On the Irish decision: "The question which arose for decision in the Canadian case and is raised by Mr. Mistree in the present case, however, did not arise before the court in Ireland and it is, therefore, not necessary for me to deal any further with the same." (p 73)
Subsequent treatment
- Followed — In Bishwanath Prasad Radhey Shyam v Hindustan Metal Industries (1978) the Supreme Court set out as a test of inventive step "Was it for practical purposes obvious to a skilled worker, in the field concerned, in the state of knowledge existing at the date of the patent to be found in the literature then available to him, that he would or should make the invention the subject of the claim concerned ?", as "referred to by Vimadalal, J. of Bombay High Court in" this case (para 25).
- Followed — In Cipla v F Hoffmann-La Roche (2015) the Delhi High Court Division Bench recorded that in this case "the main function of a Court is to construe the claims without reference to the specification; a reference to the specification being as an exception if there was an ambiguity in the claim" (para 66), reproduced its statement of what "not useful" means (para 93), and recorded that the Bombay High Court "guarded the Courts of law against the common human failing of being wise after the event in regarding something that has been discovered by research as obvious" (para 150).
- Followed — In Raj Parkash v Mangat Ram Chowdhry (1977) the Delhi High Court Division Bench set out Vimadalal J's holdings on the construction of claims, the onus as to invalidity and sufficiency of description, and recorded its respectful agreement with them (para 16).