Introduction
The topic has been studied in the specific context of patent laws. This article analyses the present Indian position as per the Patents (Amendment) Act 2002. The European position under the European Patent Convention, 1973 has also been studied. The Indian and the European patents systems have been compared, specifically in relation to three areas namely "diagnostic method", "capable of industrial application", and "unity of invention". An attempt has been made towards a better understanding of whether the domestic Patent laws promote or suppress the Indian intellectual property through a comparative study and also locating the areas wherein the Indian laws lag behind the European Patent Convention. Measures to rectify the present loopholes in the patent regime have also been suggested.
Patentability of Diagnostic Method
Section 3(i) of the Indian Patents Act, 1970 states that any process for the medicinal, surgical, curative, prophylactic or other treatment of human beings or any process for a similar treatment of animals or plants to render them free of disease or to increase their economic value are not patentable. Although with the advent of The Patents (Amendment) Act, 2002, any process for treatment of plants has now become patentable, the diagnostic or therapeutic process are still not considered to be patentable.1
The European Patent Convention contains a prohibition on the grant of patents for "methods of treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body". A 1987 Appeal Board decision, Non-invasive measurement/Bruker, held that the only diagnostic methods that are excluded from patent protection are those whose results immediately make it possible to decide a particular course of medical treatment. As a result of this, it had been held that methods, which produce only interim results, are not barred from patentability.
In Cygnus,Inc.2 it was held:
The Board is therefore convinced that the only diagnostic methods to be excluded from patent protection are those whose results immediately make it possible to decide on a particular course of medical treatment.
In Joos v. Commissioner of Patents,3 the vital issue of patentability in respect of methods of strict medical treatment was by-passed by Barwick C.J when he said at p. 63:
"…the only matter for consideration in this appeal is whether a process must be held not to be a proper subject for a grant simply because it is a process for ‘treatment’ of a part of the human body. For the purpose of deciding this question it may be granted that a process for the treatment of the human body as a means of curing or preventing a disease, correcting a malfunction or removing an incapacity is not a proper subject mater for grant of monopoly."
Therefore, instead of outright rejecting the diagnostic methods or therapeutic processes from patent protection, the Indian courts should apply the European approach in determining whether diagnostic methods are patentable and allow patentability of those diagnostic methods which produce only interim result without suggesting a particular course of medical treatment.
Capable of Industrial Application
Section 2(1)(j) of The Patents(Amendment) Act, 2002 defines invention as: -
"invention" means a new product or process involving an inventive step and capable of industrial application.
According to this definition irrespective of the fact that the subject matter is a method, machine, apparatus, or article, it would be considered an invention as long as it is new, useful and involves an aspect of manufacture.
The Patents Act 1970 (India), before the 2002 Amendment, did not have the requirement of ‘capable of industrial application’. However, one of the requirements of a patentable invention under the Act was that it should be useful.4 Thus the Act, previous to the 2002 Amendment required satisfaction of the criteria of utility, which was substituted by the words ‘capable of industrial application’ as a result of the Patents (Amendment) Act 2002.
A mere reading of the two terms leads to the conclusion that the amendment has made broad what was previously a narrow term. ‘Useful’ previously was qualified with the end-result of the invention. It required the process of manufacture should result in a vendible product. This ‘purpose’ or ‘result’ has been further broadened by the 2002 amendment by inserting the words ‘industrial application’. Now the situation is that even if the claim does not result in a vendible product, so long it is new and has industrial application (irrespective of the vendibility requirement), it can be patented. However, this ‘industrial application’ requirement is a very vague concept because no criteria has yet been evolved to determine what constitutes industrial application.
In the case of Indian Vaccum Brake Co. Ltd.,5 it was held by a single Judge of the Calcutta High Court that the term ‘utility’ used in the Act has been used in a special sense. Mere usefulness is not sufficient to support the patent. Patent for making in one piece articles which were formerly prepared in two or more pieces could not be called to be a valid patent.
Industrial application may be an issue where a range of substances is claimed and it is argued that some do not do what is claimed. In Chiron Corp v. Murex Diagnostics Ltd,6 a range of polypeptides encoded by a genome of Hepatitis C virus was claimed. The defendant in an infringement action challenged the validity of the patent on the basis, inter alia, that the invention was not capable of industrial application because the claim included polypeptides unconnected with Hepatitis C virus. The polypeptides had no conceivable use at first instance. Aldous J. held that the patent was capable of industrial application. He said:
"Although the range of polypeptides falling within the claims…may be large, there is no evidence to suggest that once the sequence is known they could not be made by the industry."7
The defendant appealed, claiming that Aldous J was wrong to substitute the word ‘by’ for ‘in’, arguing that the correct question was whether the invention could be made or used in industry and not by industry. The defendant submitted that there is no industry in making the useless. The plaintiff argued that whilst what was claimed must have some practical use, a claim in respect of practical things is not invalidated by the inclusion at the edge of the claim of something for which there is no present or foreseeable use. The Court of Appeal was unimpressed by that argument and Morritt LJ. said:
"We accept that the polypeptides claimed…can be made…[but it is required] that the invention can be made or used ‘in any kind of industry’ so as to be ‘capable’ or ‘susceptible of industrial application’."
This approach by the European Patent Office is commendable. The EPO has interpreted ‘capable of industrial application’ in relation to its use in the industry, that is its feasibility to be used in the industry on the day when patent is claimed. The EPO has clearly denied any patent on mere assumption of utility by the industry in future. This objective criteria for determining industrial application should be incorporated by the Indian courts.
Unity Of Invention
"Single Inventive Concept" has been incorporated in Section 10(5) of the Patents Act by The Patents (Amendment) Act, 2001. As per the current provision, claims of a patent specification can relate to a group of inventions linked so as to form a single inventive concept. The claims in a specification should relate to a single invention or a group of invention linked so as to form a single inventive concept. Now, by this amendment it may be possible to claim more than one process in a single application if these processes fall under one group and are closely linked.
The requirement for unity of invention is set forth in Article 82 of the European Patent Convention (EPC) 1973:
"The European patent application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept."
Single inventive concept is defined in Rule 30(1) of the EPC as:
Where a group of inventions is claimed in one and the same European patent application, the requirement of unity of invention referred to in Article 82 shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression "special technical features" shall mean those features which define a contribution which each of the claimed inventions considered as a whole makes over the prior art.
A single inventive concept may also be recognised between independent claims of same category. This is however limited to specific cases, such as :
1.Several uses of a same product, such as a pharmaceutical use and a non-therapeutic use,8 or a first medical use and a second medical use.9
2.Intermediate product(s) and final product deriving therefrom, provided they share a same essential structural element.10
In Canadian General Electric Co. Ltd. v. Fada Radio Ltd.,11 it was held that:
"Sometimes it is the combination that is the invention; if the invention requires independent thought, ingenuity and skill, producing in a distinctive form a more efficient result, and uniting them all into apparatus which, taken as a whole is novel, there is a subject matter. A new combination of well known devices, and the application thereof to a new and useful purpose, may require invention to produce it and may be good subject matter for a patent."
Although the Indian Patents Act provides for combined application of independent product or processes (which are separately patentable), such a concept is yet to be in practice. This is so because it goes against the ossified notion in the Indian Patent Offices that there must be a single patent application for one single invention.12 Therefore when two separate processes are involved, a single application for their patentability is rejected outright. This deliberate indifference in giving effect to the legal provisions should be corrected.
Conclusion
In conclusion, the Indian Patent system is lagging behind the European Patent Convention, due to its constricted approach towards patentability of various processes as well as the narrow interpretation given to various technical terms in the Patents Act. However, if the recommendation given in this paper are implemented, then the Indian Patent system will be at par with the international standards, thereby removing the disharmony presently existing and the suppression of the ‘ambit of patents’ resulting therefrom.
Footnotes
1. See http://www.patentoffice.nic.in/ipr/patent/salient_f.htm
2. Case No. T 964/99 of the EPO
3. [1973] R.P.C 59
4. See section 2(1)(j): "invention means any new and useful –
(i) art, process, method or manner of manufacture;
(ii) machine, apparatus or other article;
(iii) substance produced by manufacture,
and includes any new and useful improvement of any of them, and an alleged invention.
5. AIR 1926 Cal 152
6. [1996] RPC 535.
7. Id. at 575.
8. Case No. T 200/86 of the EPO
9. Cases No.W 5/91, W 28/91
10. Cases No. T /82, T 110/82, T 35/87, T 470/91.
11. AIR 1930 PC 1
12. See Section 7(1), The Patents Act, 1970 (India).
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