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‘Non’-Pharmaceutical Substance and Efficacy under Sec 3(d)

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Can Section 3(d) be applied to a non pharmaceutical invention? The MHC in Novozymes v. Asst. Controller of Patents and Designs made some interesting observations on this issue. Discussing the court’s decision and highlighting what can be ‘efficacy’ for such a non-pharmaceutical subject matter, we are pleased to bring to you this guest post by Amit Tailor. Amit is a Postgraduate in Pharmaceutical Sciences from National Institute of Pharmaceutical Education and Research (NIPER), S.A.S. Nagar (Mohali) and LL.B. from Faculty of Law, Maharaja Sayajirao University of Baroda (MSU), Vadodara. He has also completed his graduation in Pharmacy from MSU, Vadodara. Amit is a registered Patent Agent and is currently part of IP litigation team at Sun Pharmaceuticals. Amit also writes poetry at amittailor.kavi (Instagram), અમિત ટેલર (Facebook) and at AmitTailor.com. Views expressed are those of the author’s alone.

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‘Non’-Pharmaceutical Substance and Efficacy under Sec 3(d)

By Amit Tailor

Medicines & non-patentable subject matter u/s 3(d) – is a routinely discussed & debated issue amongst the patent practitioners in India, and also amongst the foreign practitioners prosecuting or willing to prosecute patents in India for their overseas clients. However, complexity builds up and curiosity arises when Sec 3(d) is applied to the so-called ‘non-pharmaceutical’ substances, i.e. those substances, which do not purport to be a product for a medicinal, surgical, curative, prophylactic diagnostic, therapeutic or other treatment of human being and/or animal.

This apparently complicated and very rarely encountered question was discussed before the IPD of Madras High Court in Novozymes vs The Controller. The matter was originally an appeal from rejection of an application before the IPAB, which was in turn transferred to the Madras HC. The subject matter in question was an enzyme that acted as a catalyst for digestion and which was aimed to be used (most probably as an additive) in cattle feed. Claims for such enzyme were rejected u/s 3(d) for being a ‘new form’ of a known enzyme (of the same kind/type/class) not resulting in enhancement of the efficacy thereof. Upon appeal the applicant primarily argued that the claimed enzyme is not a ‘drug’, i.e. it is not a pharmaceutical substance, and therefore Sec 3(d) is not applicable. Thus, the issue, amongst others, before the Court was whether the application of Sec 3(d) is limited to pharmaceutical substances only? and, if the answer is no, what kind and amount of data is required to establish enhancement of known efficacy.

Sec 3(d) Specifically ‘Targets’ Pharmaceutical Sector?

The Court initiated the inquiry by referring to the relevant clause of Sec 3(d), which reads as “new form of known substance” and not “new form of known ‘pharmaceutical’ substance”, therefore it would not be apt to assert that Sec 3(d) only applies to pharmaceutical substances. One of the additional contentions from the applicant/appellant was that the subject matter is a ‘biological’ material and not a ‘synthesized’ chemical, for that reason also Sec 3(d) is not applicable. To which also, the Court held that, there is nothing in the statute that would indicate that the provision is limited to ‘synthesized’ chemical(s) only.

The Court supported their position by referring to the discussion on (i) the language of the Clause (d), that existed before 2005, and that amended by the Patent (Amendment) Act, 2005; and (ii) ‘efficacy’, by the SC in Novartis vs UOI. The Sec 3(d), after being amended in 2005, reads as follows –

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.

Explanation.—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.” [emphasis in original]

Novartis categorically stated that the said amendment (in bold), made to the language of Sec 3(d), including the ‘Explanation’, was focused on medicines and drugs only. In addition to that, nearly 80% of the parliamentary debate on the concerned amendment to Sec 3(d) was also focused on medicines and drugs, and the remaining 20% was focused on agricultural chemicals. Accordingly, in summary, it can be said that the entire debate in the parliament on the issue of said amendment was limited to drugs or medicines and agrochemicals only [para 94-98].

Relying on such observations, Novozymes determined that Novartis held that the amendment made to Sec 3(d) by the Patents (Amendment) Act, 2005, was primarily and especially intended to deal with the pharmaceutical and agrochemical substances. However, this does not imply that Sec 3(d) as a whole is restricted to pharmaceutical and agrochemical substances only. There already existed a Sec 3(d) before 2005, and the amended clause, as a whole, is more than the ‘clause’ and the ‘explanation’ added thereto by the amendment. Therefore, it would not be appropriate to limit the Sec 3(d) only to the amendment. The Court then insightfully bifurcated the principle clause of Sec 3(d) in three limbs, as follows –

(i) The NEW FORM OF KNOWN SUBSTANCE (apparently inserted by the 2005 Amendment)

(ii) The (a) NEW PROPERTY, or (b) NEW USE, OF A KNOWN SUBSTANCE (two sub-limbs (a) and (b))

(iii) The MERE USE OF KNOWN PROCESS OR APPARATUS

– and, the three (or four) limbs are separated by the disjunctive “or” [para 12]

The Court stated that, at least, the limb (iii) of the clause is not applicable to ‘known substance’, as it is directed to ‘known process’, or ‘known machine’ or ‘known apparatus’.

Thereby, relying on the ‘combined effect’ of the history of enactment of Sec 3(d), the overall three (rather four) limb structure of the clause, and the guidance by Novartis on ‘efficacy’ (discussed later) Novozymes held that Sec 3(d), as a whole, cannot be said to be limited to pharmaceutical or agrochemical substances only.

‘Explanation’ Restricts Sec 3(d) to Synthesized Chemicals Only?

The immediate follow-on contention of the appellant/applicant was that the ‘Explanation’ enumerates several derivatives that can be subjected to Sec 3(d) and they are – salts, esters, ethers, polymorphs, metabolites, and ‘the like’; all of which are derivatives of synthesized chemicals only. Therefore, according to the principle of ejusdem generis, the ‘derivatives’ should be limited to derivatives of synthesized chemicals only. The Court agreed therewith and decided that the explanation restricts the derivatives enumerated in Sec 3(d) to derivatives of synthesized chemicals only (para 16).

The above argument and conclusion vis-a-vis the principle of ejusdem generis by Novozymes appears not tenable on the face of it. The relevant language of ‘Explanation’ is not limited to salts, esters, ethers, polymorphs and metabolites only, as relied upon by the Court, but in addition to them, it also reads on other ‘derivatives’ viz. – pure form, particle size, isomers, mixtures of isomers, complexes, and combinations. Here, ‘pure form’ and ‘particle size’ cannot be said to be limited to synthesized chemicals only; e.g. ‘purity’ and size of solid ‘particle’ can be associated with any kind of substance obtained by isolation from natural environment or by a biological process followed by purification and isolation, or a synthetic compound isolated from the reaction mixture or isolation, purification, crystallization, or recrystallization from solvent; or it being subjected to a milling operation etc. Likewise, ‘isomerism’ or ‘isomer’ cannot be limited to the chemical domain only, but can be associated with biological domain, as well. (e.g. see while biological systems have evolved to develop a great functional diversity,…functional diversity or specificity is achieved using isomers … Stereochemically, an absolute configuration is often preferred given to the stereospecific nature of the enzymatic active site.) Similarly, ‘complex’ and ‘combination’ can also not be said to be limited to small molecules, or synthesized chemicals, e.g. an ‘enzyme substrate complex’: a complex formed between an enzyme (a biological substance) and its substrate (can be a ‘small’ molecule or a macro-molecule) etc. Therefore, it would not be appropriate to conclude that the ‘explanation’ is limited to derivatives of synthesized chemicals only, by selectively picking a few initial generic terms therefrom. This would need additional research and argumentation as suggested herein, which can open up the avenue for further discussion.

Though the Court in Novozymes determined that the explanation of Sec 3(d) is limited to synthesized chemicals only, as discussed above, interestingly they did not alter their earlier position and maintained that Sec 3(d), as a whole, is not limited to pharmaceutical or agrochemical substance and not to the derivatives of synthesized chemicals, as well.

‘Efficacy’ of ‘Non’-Pharmaceutical Substance

Now as the Court has concluded that Sec 3(d) is not limited to pharmaceutical or agrochemical substance, it raises another question as to what would be ‘efficacy’ or what would be the relevant test of efficacy, for the purpose of Sec 3(d), for a substance which is not a ‘medicine’. As on date, the answer to this may best be found from Novartis itself, which states that –

“180. … Efficacy means “the ability to produce a desired or intended result”. … the test of efficacy in the context of section 3(d) would be different, depending upon the result the product under consideration is desired or intended to produce. In other words, …  the function, utility or the purpose of the product …” [Emphasis added]

Determination of ‘efficacy’ of ‘substance’ would depend upon the function, utility, or the purpose thereof, or the result desired or intended to be produced by the substance – being a broad and general definition of efficacy, and the way it is applied by the SC in the context of Sec 3(d), it opens up the scope much wider to bring many kinds of substances under the ambit of the Clause. And the kind and amount of scientific or technical data required to support the enhancement of efficacy, shall also be required to be determined accordingly.

In addition to this, Novartis also noted that –

“…the text added to section 3(d) by the 2005 amendment lays down the condition of “enhancement of the known efficacy”. … What is evident, therefore, is that not all advantageous or beneficial properties are relevant, but only such properties that directly relate to efficacy,…

181. … it must also be kept in mind that each of the different forms mentioned in the explanation have some properties inherent to that form e.g., solubility to a salt and hygroscopicity to a polymorph. … Hence, the mere change of form with properties inherent to that form would not qualify as “enhancement of efficacy” of a known substance. ”

[emphasis added]

– which clearly indicates that not all (otherwise) advantageous properties, but only those (advantageous) properties that are directly related to the efficacy, i.e. the properties that are directly related to the function, utility, or the purpose of the substance, or the result desired or intended to be produced by the substance, would be relevant for the purpose of Sec 3(d). So, taking a hypothetical example of a chair (though it may not be called a ‘substance’) what can be considered as function, utility, or the purpose of a chair – providing comfort, better posture, and/or relevant position in space (i.e. appropriate height of a sitting position) etc.? In that case, can a chair with a better cushion, an ergonomic back support or height adjustability etc. be considered as relevant to efficacy? or can a property imparted to a chair by an invention that deter rusting be considered relevant for its efficacy? or if not, can it be considered as directly related to its ‘efficacy’? or, provision of a bottle holder on the arm-rest of the chain which may ‘improve’ user comfort is ‘mere change of form’ with comfort inherent to such change? Finding answers to such questions for a ‘substance’ in question can help to determine what would be the ‘efficacy’ of the substance and what would be or would not be relevant to determination of ‘enhancement of efficacy’.

Another interesting and important observation from the SC is –

“180… test of enhanced efficacy in case of chemical substances, especially medicine, should receive a narrow and strict interpretation … 182. … the test of enhanced therapeutic efficacy must be applied strictly, but the question needs to be considered with greater precision….” [emphasis added]

– so does that mean that there may exist (a1) a ‘narrow and strict’ test for chemical substances, especially medicine; and (b1) a ‘broad and loose’ test for other than chemical substances; and that with either (a2) a ‘greater precision’; or (b2) a ‘lesser precision’ standard; while determining ‘efficacy’ u/s 3(d)?

Scope and Bounds of Sec 3(d) and Non-Pharmaceutical Substance: Summary

The Madras High Court has determined that though the ‘Explanation’ to Sec 3(d) is limited to synthesized chemicals (which does not appear tenable), the Sec 3(d) as a whole is not limited to synthesized chemicals or pharmaceutical substances only, and provided a nice and easy to understand 3(or 4) limb structure of Sec 3(d). With that the Court has laid open the field of discussion for determination of ‘efficacy’ for ‘substance’ which are not ‘medicine’. Surely, Novartis can provide some guidance as to what is efficacy, and how to apply the test of enhancement of efficacy, in general; but at the same time, as discussed above, it has left some of the questions like – what would be the ‘narrow and strict’ or ‘not-so-narrow and not-so-strict’ test; and what would be a ‘greater precision’ or ‘no-so-great precision’ standard; for determining efficacy in non-pharmaceutical domain. More clarity can and would come, if and when the jurisprudence on this issue evolves over the time. Let’s hope that a second ‘Novartis’ would reach the SC, and this time for a ‘non-pharmaceutical’ substance to provide us more clarity on efficacy u/s 3(d) for non-pharmaceutical substances.

(Disclaimer: This work is purely an academic exercise to compile and summarize, in general, the discussion on the issues by the Courts. This does not represent final or binding views of the author on any of the issues discussed herein; and this cannot be attributed, in any way, to the past, present or future employers of the author, as well.)

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