The term discovery is used in Section 3 (c) and Section 3 (d) of the Patents Act 1970, but it is not defined under the act and the Patent Rules 2003. In the absence of any definition, the term ‘discovery’ in general is a name that can be given to everything that is newly found in the arts and the sciences. Invariably, this term finds its application when what one claims to have discovered is not only new, but also curious, useful, and difficult to find. Additionally, this finding should have a certain degree of importance. Chance discovery of the compass or discovery of electric shock was a discovery made by chance, and which did not require great effort. They fall into the category of mere discovery in terms of the patent law exceptions. However, patent claims that require the participation of human efforts fit easily into the patent eligibility spectrum under the patent law. This is possible when such an invention is a new product or process with inventive having an industrial application.
Meaning of ‘New product’
The term “new product” is not defined in the Act, but it takes the meaning as interpreted by the Supreme Court in para 169 in Novartis AG v. U.O.I. (2013) 6 SCC 1 case.
“169. Section 2(1)(j) defines “invention” to mean, “a new product or …”, but the new product in chemicals and especially pharmaceuticals may not necessarily mean something altogether new or completely unfamiliar or strange or not existing before. It may mean something “different from a recent previous” or “one regarded as better than what went before” or “in addition to another or others of the same kind” [The New Oxford Dictionary of English, Edn. 1998.] .”
(Emphasis supplied)
With this interpretation of the new product in place patent office is expected to give expensive meaning to section 2(1) (J). In Diamond Star Global SDN BHD v Joint Controller of Patents (2023/DHC/2316) IP division of Delhi High Court categorically reminded the controller that “the authority, and the Court, is required to bear in mind the existing statutory patent regime in force – in India, in the form of the Patents Act, 1970.” and stated that:
“31. In this context, the following exordium, from Novartis AG v. U.O.I. (2013) 6 SCC 1 which, though rendered in a challenge which involved the application of Section 3(d) of the Patents Act, is clearly of universal application as a statement of the law, cannot be afforded to be forgotten….”
This clearly indicates that this exordium in the Novartis case is of special relevance in examining the patent applications and the court found this quite relevant when it observed that:
“36. Within the ambit of the expression “new product or process” in Section 2(1)(j), as per the law declared by the Supreme Court in Novartis AG (2013) 6 SCC 1 would be included not merely “something altogether new or completely unfamiliar or strange or not existing before” but also “something “different from a recent previous” or “one regarded as better than what went before” or “in addition to another or others of the same kind” ”. The Supreme Court, therefore, advocates according, to the expression “new product or process” in Section 2(1)(j), an expansive, rather than a restrictive, interpretation, and Article 141 of the Constitution of India makes that interpretation binding on every authority lower in the judicial hierarchy, including this Court.
[emphasis added]
In view of the considered interpretation of the meaning of the term new product in the Novartis case, the court went on to rule that:
“I do not see how the claims of the appellant, of which it sought a patent, which identified the Rhizophora apiculata tree as the appropriate source of the wood vinegar to be used, the process to which the wood vinegar would have to be subject, and the appropriate strength in which the wood vinegar, so processed, would have to be added, with other additives, while preparing the skin care formulation, can be regarded as lacking in any inventive step. The claims of the appellant are interdependent, not independent, and have to be seen as such.” [Emphasis added]#
Without mincing the words, the court also directed all to follow this precedence as it is binding on every lower authority lower in the hierarchy including the court and reminded that “Article 141 of the Constitution of India makes that interpretation binding on every authority lower in the judicial hierarchy, including this Court “
Section 3(c) Redefined
The commercial division of Delhi High Court further examines the scope and reach of the exception to patentability under Section 3(c) in Diamond Star Global SDN BHD v Joint Controller of Patents (2023/DHC/2316) where the Joint controller refused the patent application for claim for a “method of preparing a personal care product, which involved obtaining wood vinegar from Rhizophora apiculata and adding 18-22% w/w of the wood vinegar to a personal care product.” The court examined the conspicuous absence of the word ‘mere’ from the second limb of section 3(c ) “or discovery of any living thing or non-living substances occurring in nature“, specifically in the context of an invention involving naturally occurring substances and ruled that:-
“34.1 …….. Section 3(c). The provision has, in my considered opinion, to be interpreted as it stands. The word “mere”, as used in the opening part of the said Clause would apply, in my opinion, both to the first part, i.e. “discovery of a scientific principle or the formulation of an abstract theory” as well as to the second part, i.e. “discovery of any living thing or non-living substances occurring in nature”. [Emphasis Added ]
The court went on further to clarify that:-
“It is only mere discovery of a living thing, or non-living substance occurring in nature which, therefore, according to me, would fall within the second part of Section 3(c).”
In order to prove this, point the court also illustrated it with an example that if someone were to seek a patent for guaiacol it would be possible to reject the application on the ground that guaiacol is a substance occurring in nature. The court observed that:
“35. To analogize the issue to the facts of the present case, for example, if someone were to seek a patent for guaiacol, it would be possible to reject the application on the ground that guaiacol is a substance occurring in nature and, therefore, even if it had not been earlier discovered, the mere discovery of guaiacol was not patentable as an invention, in view of the proscription contained in Section 3(c).” [emphasis added]
Universally accepted exception to patentability
There are many universally accepted exceptions to patentable subject matter like the laws of nature, physical phenomena, and abstract ideas. The mere discovery of a scientific principle the formulation of an abstract theory, or the discovery of any living thing or non-living substance occurring in nature, the mere discovery of a new form of a known substance and the mere discovery of any new property are also considered non-patentable in India under Section 3…
(c) the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non-living substance occurring in nature;
(d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.
However, there still exist grey areas relating to the extent to which the scope of mere discovery can be held as non-patentable. For example, patenting of genes or patenting the metabolic products of in vivo conversion. Though the patent offices in different jurisdictions have not issued clear guidelines in this matter, inventions that include a human being as part of their structure or operation are generally considered non-patentable.
Non-Patentability of discovery: Position in US
In Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948) the court held that
“Discovery of the fact that certain strains of each species of these bacteria can be mixed without harmful effect to the properties of either is a discovery of their qualities of noninhibition. It is no more than the discovery of some of the handiwork of nature and hence is not patentable.”
Claim 1 in this case was for “An inoculant for leguminous plants comprising a plurality of selected mutually non-inhibitive strains of different species of bacteria of the genus Rhizobium, said strains being unaffected by each other in respect to their ability to fix nitrogen in the leguminous plant for which they are specific.”
If we take a relook at the famous Diamond v. Chakrabarty case we will find that original claim 1 for “A stable energy-generating plasmid, which provides a hydrocarbon degradative pathway.” was denied by the court for the reason that there is no indication that the claimed plasmid has any characteristics (structural, functional, or otherwise) that are different from naturally occurring energy-generating plasmids. Because there is no difference between the claimed and naturally occurring plasmid, the claimed plasmid does not have markedly different characteristics, and thus is a “product of nature” exception.
Similarly, in the Myriad case [133 S. Ct. at 2117] the Supreme Court looked back to this claim as an example of ineligible subject matter, stating that “the composition was not patent eligible because the patent holder did not alter the bacteria in any way.”
It may be noted that the bacterium of claim 2 in Diamond v. Chakrabarty [447 U.S. 303 (1980)] was held to be patent-eligible subject matter since it has markedly different characteristics than naturally occurring bacteria. The court found that the Chakrabarty bacterium was new with markedly different characteristics from any found in nature due to the additional plasmids and resultant capacity for degrading oil. The Court held that the modified bacterium was patentable. It explained that the patent claim was not to a hitherto unknown natural phenomenon but to a non-naturally occurring manufacture or composition of matter a product of human ingenuity having a distinctive name, character, and use.
All these cases point towards the fact that when a new product is considered as a mere discovery of something that exists in nature, they are not patentable in the USA as well. However, If the new product is altogether new or different it may qualify for a grant of a patent.
Patentability of discovery: Position in India
In Diamond Star Delhi High Court examined the patentability of discovery in the context of the claim for (i) identifying the wood vinegar obtained from the Rhizophora apiculata as being free of guaiacol and, therefore, suitable for addition of skin care cosmetics and (ii) working out the composition of 18 to 22% as the appropriate strength in which, on addition of the said wood vinegar to the skin care preparations, optimum antimicrobial properties, which would do away with harmful bacteria even while preserving beneficial lactic acid bacteria. The court observed that:
“35. To analogize the issue to the facts of the present case, for example, if someone were to seek a patent for guaiacol, it would be possible to reject the application on the ground that guaiacol is a substance occurring in nature and, therefore, even if it had not been earlier discovered, the mere discovery of guaiacol was not patentable as an invention, in view of the proscription contained in Section 3(c).” This, in fact, appears to me to be one of the major grounds on which the Controller has erred in the impugned order.
A running thread, through the impugned order as well as in the FER which preceded it, is the observation of the Controller that the applicant was merely seeking to take advantage of the property of a naturally occurring substance, i.e. wood vinegar from the Rhizophora apiculata tree, being the absence of guaiacol. To the extent that the appellant was, in fact, stressing the absence of guaiacol in the wood vinegar obtained from the Rhizophora apiculata tree, the observations of the Controller do not brook any cavil. “
Additionally, the court looked into where the controller erred when the court observed:
“…….the Controller has erred in failing to observe that the appellant was not seeking to merely patent wood vinegar obtained from the Rhizophora apiculata tree. The claim of the appellant was that, as an antimicrobial additive to skin care preparations, which would be free of any pungent constituents as well as capable of eradicating harmful bacteria even while preserving beneficial lactic acid bacteria, the wood vinegar obtained from the Rhizophora apiculata tree, added to the skin care preparations at a strength of 18 to 22%, would provide optimum results.
It is in this background that the appellant sought to patent the process by which the wood vinegar obtained from the Rhizophora apiculata tree was added to the skin care preparations at a concentration of 18 to 22%, and the product which was so added, in Claims 1 to 14 and Claim 15, respectively, in the appellant’s application.”
Consequentially, the Controller’s, impugned order dated 2nd June 2022, was quashed, and set aside. The court ruled that there is no other objection to the patenting of the appellant’s invention and the invention was entitled to grant of a patent in this case.
Looking forward
Does the conspicuous absence of the word ‘mere’ in the second limb of section 3(c) leave a window for the patentability of an invention relating to substances occurring in nature which are not merely discovered? Or does the occurrence of these substances in nature where they are structured similarly to in vivo form creates a patentability hurdle of being not new as compared to naturally existing one? Or does the usefulness in terms of efficacy in an in vivo form, can make it cross the patentability line? All these questions are difficult to answer today as there are still grey areas relating to the extent to which the scope of mere discovery can be held non-patentable.
Mind you, there exists no inherent bias on the patentability of materials derived or obtained from nature. There exists a clear distinction between finding new substances in nature and making transformed substances in the body like metabolites available in a usable form. For example, patenting of genes or patenting the metabolic products of in vivo conversion. Though the patent offices in different jurisdictions have not issued clear guidelines in this matter, inventions that include a human being as part of their structure or operation are generally considered non-patentable. Does the imputed presence of the word ‘mere’ in the second limb of section 3(c) in view of the Diamond Star case leave a window open for patentability of the invention relating to substances occurring in nature which are not merely discovered? Does the occurrence of these substances in nature where they are structure similar to in vivo form creates a patentability hurdle of being not new as compared to naturally existing one? Its usefulness in terms of efficacy in an in vivo form, however, can make it cross the patentability line. This clearly means that the mere discovery of a living thing, or non-living substance occurring in nature is not patentable. However, if pursued properly, the inventions relating to discovery can in certain situations like in the Diamond Star case qualify for the grant of a patent. It will take some time for IPO to crystalise the extent to which the scope of mere discovery under section 3(c) can be extended to be held as non-patentable. This interpretation by the court is a welcome one as it dispersed the mist surrounding the applicability of section 3(c). Expert advice can be helpful to resolve the prosecution hitches in the patentability of discovery of any living thing or non-living substances occurring in nature.
