“I took the Indian patent office exam today at New Delhi. I think it was a most welcome break from the pattern of previous years exams. A friend of mine expected to answer the objective type question by simply regurgitating the sections, fees/form number etc., but found that he had to now analyse the provisions and think through the nuances of each question.
As regards Paper II, the mechanical question was a bit difficult, but the chemical question balanced the difficulty in the mechanical question.”
We’re very lucky that an accomplished patent expert such as Rajiv has begun taking an active interest in Indian patent issues. Clearly, with more such commentators, we’re likely to have more informed and insightful discussions, as will enable us to devise a more optimal patent regime for India.
In so far as the Valcyte patent decision is concerned, Rajiv takes issue with the section 3(d) analysis. Readers may recall that in an earlier post, I had stated that while the “inventive step” reasoning was logically coherent, the section 3(d) analysis was a bit fuzzy.
Rajiv recommends a numerical quantifier to make for a more determinate interpretation of section 3(d). I’m not entirely sure if we can have precise mathematical formula here–but to the extent that he recommends clarity on section 3(d) through guidelines of some sort, I think he is spot on. In fact, in a rather long and dull piece, Prashant Reddy and I make some very specific suggestions for clarifying the scope and ambit of section 3(d). For those interested, please see page 258 of the paper which proposes a very detailed amendment to section 3(d) to make it clearer and more coherent (the paper can be downloaded for free on SSRN).
Should there be a numerical quantifier for Section 3(d)?
By Rajiv Choudhry
Claim 1 of patent 207232 provides: The compound 2-(2-amino-l,6-dihydro-6-oxo-purin-9-yl) methoxy-3-hydroxy-l-propanyl-L-valinate or a pharmaceutically acceptable salt thereof, in the form of its (R)- or (S)-diastereomers, or in the form of mixtures of the two diastereomers.
The reasoning for §3(d) is based upon an obviousness analysis (§§ 2(1)(j), 2(1)(ja) inventive step). But the decision cannot substitute an obviousness analysis for the analysis required under § 3(d), because § 3(d) sets a higher bar than the inventive step analysis.
In this case, the mono ester was demonstrated to have more bio-availability compared to that of bis ester of ganciclovir. But the patent office did not consider it to be efficacy. The decision stressed that efficacy and bio-availability are two different concepts and are not the same. The decision discussed the definition of efficacy as therapeutic effect being independent of property (i.e. bio-availability) but did not provide any further detail. The decision then concluded that Claim 4 ( A compound according to Claim 1 in crystalline form) is not particularly described and in the absence of any improved effect the crystalline form considered as another form of known substance u/s 3(d) of the Act.
The decision refers to §3(d) under heading 6, ‘Not an invention’ and states that an “[e]ster of the known substance prima facie will get a patent only if it shows significant enhancement of efficacy.” The Chennai High Court in the case of Novartis A.G. v Union of Indiahad stated that “efficacy means therapeutic efficacy.”
In the judgment, the High Court had observed that the patent applicant is expected to be aware of the difference between the therapeutic effect of the patented drug and the drug in respect of which patent is asked for.
The High Court also made a requirement for providing comparative details showing that the discovery of a new form of a known substance had resulted in the enhancement of the known efficacy of the original substance and the derivatives so derived will not be the same substance, since the properties of the derivatives differ significantly with regard to efficacy. (Novartis AG v. Union of India W.P. 24760/2006).
The High Court decision does not contain a quantification/minimis requirement for efficacy. All it states is that there should a comparison between the new substance and the original substance. The draft Manual of Patent Practice and Procedure, 2008 (MPPP) does provide a specific statement regarding quantification of efficacy. The MPPP states that the efficacy need not be quantified in terms of numerical value to determine whether the product is efficacious because it is not possible to have a standard numerical value for efficacy for all products including pharmaceutical products.
There are two problems with this statement. First the law regarding the ‘quantification of efficacy’ is vague because it is not reasonably possible to comply with the requirements. Second it leaves great scope for discretion of the Patent Office while considering applicability of §3(d).
There is a heavy burden imposed upon the applicant to disclose a comparison between the new form of a substance and an existing form. Once the Applicant has provided the necessary details in the form of a comparison, the Patent Office cannot post-facto object to the comparison and substitute its own judgment of what kind of comparison is required (as has been done in this case). Hence the term ‘therapeutic efficacy’ requires that it be quantified in terms of a numerical value as there is unfettered discretion with the Patent Office.
The application and the declarations discussed in the decision clearly state the beneficial effects of the claimed invention are because of increased bio-availability, side-effect profile, and drug-interactions.
Paragraph 57 of the order states that improved bio-availability may increase the clinical efficacy in turn it may influence the therapeutic efficacy for which there is no support provided in the specification. It concludes that the claimed compound does not fulfill the requirement under the provision of the Act because it is obvious that the pro-drug of compound exhibit improved solubility, low resistance, no mutations, system exposure and avoidance of the drawbacks of the intravenous treatment which are inherent and expected properties of the prodrug.
The patentee tried to show a causal connection between increased bio-availability, and therapeutic efficacy but the Order took an extremely narrow view of the term therapeutic efficacy by concluding that increased bio-availability cannot be equated with therapeutic efficacy.
This decision of the Controller highlights the reason why the Courts need to provide more clarity in interpreting §3d as regards the term efficacy and provide a numerical quantifier to it.
Can anybody provide the specification for IN 207232?
shamnad,
since u guys r talking of some sort of ‘quantification’ vis-a-vis section 3(d), i was wondering whether instead of a singular quantum, there should be a matrix, having lots of parameters, each parameter having been assigned a particular weightage (may b on the basis of some historical data / experience of the patent office) n only then some qualifying threshold (your ‘quantification’), say 50% (this is just my suggestion; let patent office decide on the actual bar), by fixed. only those candidate drugs (claiming ‘significantly enhanced efficacies’) who cumulatively score more than this minimum threshold, should be deemed to have cleared the test u/s 3(d). i ve already proposed this in a research paper.
i know, developing a matrix of parameters, each with some pre-assigned weightage, is a mighty task, but if the patent office wants, i ll b more than glad to extend my assistance (n i am sure, so wud u, too).
on some other aspects: at one place, u ve relied upon mppp, 2008. if i remember correctly, it has been withdrawn. pls correct me if it has been re-instated.
also, if i aint wrong, thn u are referring to your paper ‘ironing out the creases in section 3(d)….’. u must ve noticed that in my paper published in sept., 2009, issue of jipr, i had largely endorsed (though i have minor differences with u on smaller sub-sub-points thereof) your proposed amendments to section 3(d). in my paper, i had summarised (point-wise) the controversial/undecided issues relating to section 3(d), as it came to be interpreted in re novartis and in your said paper. due to sever space-crunch imposed by the publisher of jipr, i couldnt elaborate on those undecided points. but in the context of the present blog-post, i feel that the points enumerated by me therein can provide a very reasonable list of parameters that can be considered while developing a matrix of parameters (towards the quantification of section 3(d) criteria, esp. vis-a-vis ‘significantly enhanced efficacy’).
i wud luv to have yr views on this.
-aditya kant
Aditya,
If you can work out a matrix for this, it would be terrific. I can refer you to some excellent journals that can publish this, if you work it out. Perhaps you and Rajeev can get together and work out this formula, that will provide broad guidance but will also be flexible enough to cater appropriately to the specificities of individual cases.
shamnad,
in my hypothesis, i propose to assign (‘identifying’ the parameters is not so difficult as ‘assigning’ weightage to them) weightage on the basis of some sort of historical empirical data and experience of the patent office. so, in general, i anticipate that it wud by highly imperative that the patent office itself be involved for this kind of an exercise. but who knows, when two scholarly minds (i mean u n rajiv, not me, lol) meet, one can figure out novel ways of data-mining, n b able to establish parameters/weightages on the basis of existing publicly available patent data itself?
but here again (just as in the case of my earlier proposed study plan regarding examination of feasibility of transformation of indian pharma ind from its current myopic generics-centric approach to long-term innovation-centric vision), i feel the need for personal meetings/brainstorming sessions (at least 1-2 at the conceptualization stage n 1-2 at the conclusive stage) amongst the collaborators. reason is simple: i dont want my studies to be superficial; instead i want them to be seminal, having great pursuasive value. this was the reason why i agreed with u to postpone my earlier proposed study till mid-next year, when u cud join. similarly, in the present case, too, if u r serious in your liking for my idea of developing a matrix of parameters, then let this issue be the second area of colaboration between u n me. i dunno mr. rajiv choudhry, but if he is your trustworthy, then he, too, is welcome aboard. lemme know.
-aditya kant
hey shamnad,
after a long time i am here. actually, I am in the final stages of finishing my thesis on this very issue (dev. of a quantifiable matrix of parameters). once my degree is granted, i ll send u the paper for publication in some gud research journal. since i dont belong to the regular scholar circle, hopefully u wud be able to recommend some scholarly journals (of course, only if there is merit in it, hehe). lemme know.
tho its an old post, but i am still writing here coz its bang on the topic.
-aditya kant