Many of you may have already heard the breaking news today……..the Madras High Court ruled against Novartis, holding that section 3(d) is not unconstitutional. It also ruled that it is not competent to adjudicate upon whether or not section 3(d) is TRIPS compliant.
Not a very surprising result for SPICYIP, which had already predicted this outcome in an earlier post, noting as follows:
“Which way is the court/IPAB likely to go? Difficult to tell at this stage, but to the extent that one might reasonably predict outcomes, this is my take:
i) The Madras High Court is likely to avoid ruling on the TRIPS compatibility of section 3(d). Firstly, since India is a “dualist” nation, international treaties are not directly enforceable in India, but have to be separately legislated upon before they are enforceble. No doubt, the Vishaka case was an exception to this rule–but one will remember that the court was careful to qualify that international norms would be incorporated only if such norms did not conflict with domestic law.
The Novartis challenge is quite different. Secton 3(d) is already part of domestic law. Novartis seeks to invalidate existing domestic law (section 3(d)) as not complying with an international legislation i.e. TRIPS. Secondly, the right forum to moot such a challenge is the WTO dispute resolution panel and not a domestic court. Thirdly, given the sensitivity of the Novartis case and the international uproar, the Chennai High Court is more likely to duck the issue , on the ground that it lacks jurisdictional competence.
ii) If the Madras High Court were to however rule on this aspect, the decision is likely to go against Novartis i.e. the likely holding will be that section 3(d) is compatible with TRIPS, as it is an “obviousness” standard that member states are free to define in a manner consistent with their national policy. Section 3(d) does not “discriminate” against the pharmaceutical sector but only makes a “justified” differentiation, given the specificity of salt forms in the pharmaceutical sector i.e. other technology sectors such as mechanicals, electronics etc do not face “different salt form” kind of issues.
It bears noting that US patent law encompasses a heightened utility requirement in the context of gene patents—i.e. in order to be patentable, a gene sequence has to demonstrate “substantial”, “specific” and “credible” utility. This came out of a desire to put a stop on the multitude of frivolous gene patent applications that cited the obvious utility of being a “mere probe”. These steps that cater to the specificities of technology sectors are perfectly legitimate exercises of national discretion by member states. And India is no different. For similar reasons, section 3(d) is not likely to be struck down as an “arbitrary” standard under Art 14 of the Constitution of India.”
Anyhow, for those interested in more detail, there are plenty of news/blog items reporting on this important judgment–and as expected, both Novartis and civil society groups have begun putting their spins on the outcome. In particular, note the following statement from Novartis:
“Medical progress occurs through incremental innovation. If Indian patent law does not recognise these important advances, patients will be denied new and better medicines,’ said Paul Herrling, head of corporate research at Novartis.”
I’m not sure I agree with this. As discussed in an elaborate exchange with Prabir Purkayastha of the Delhi Science Forum, section 3(d) protects incremental advances, provided those advances are really “incremental” and not “frivolous”. Novartis seems to assume that section 3(d) will bar all kinds of incremental advances—and not just those that fail to demonstrate “increased efficacy”.
Now that we have this TRIPS/constitutional law issue out of the way, one can pay closer attention to the “tamasha” unfolding at the IPAB. What’s the likely outcome at the IPAB? Well, prudish as I am when it comes to gambling, I’m willing to bet on the following outcome:
1. The High Court will not permit Chandrasekharan to hear the appeal as a “technical” member of the IPAB. In all likelihood, he will be recused and another technical member appointed to take his stead (just for this case). Or perhaps the IPAB will decide the matter without him–but I’m not sure whether they could do this, given that their “patent” competence came only from the appointment of Chandrasekharan.
2. The IPAB will likely rule against Novartis, on grounds of both section 3(d), as well on general “non obviousness” grounds. Firstly, the Board is likely to hold that the 1992 patent application covering the Imatinib free base also anticipates the Imatinib Mesylate salt (perhaps in an “inherent anticipation” sort of way).
Therefore, under section 3(d), the “efficacy” comparison has to be between “Imatib Mesylate” and the “Beta Crystalline form of Imatinib Mesylate”. If this is the case, there is bound to be no sufficiently enhanced “efficacy”, as would enable Novartis to cross the section 3(d) threshold.
3. Even assuming Novartis’ invention does manage to pass the section 3(d) “efficacy” threshold, it would fail to pass muster under the normal “inventive step” or non obviousness” standard. In other words, understanding that the claimed invention is really a 2 step process (i.e getting from Imatinib to “Imatinib Mesylate” and finally to the “Beta crystalline form of Imatinib Mesylate”), it is likely that the court may hold that:
i) Imatinib Mesylate is obvious from Imatinib free base
ii) The “beta crystalline form of Imatinib Mesylate” is obvious from “Imatinib Mesylate”.
It’d be interesting to hear which way our readers expect the decision to go. Are we all betting on the same outcome?? Let’s watch the dice roll….
Hi Shamnad
Great post and as always, very helpful. I have written a blog post and a detailed article which will publish later today over at my website.
Here are some of the thoughts I expressed:
IPAB Appeal
Inherent anticipation – this is a courageous call. In many other jurisdictions the requirement for inherency is that the subject matter is inevitably present (every time) the earlier disclosure is followed. Is that that the case in India? If so – is that really the case here?
Obviousness – the two steps to get to obviousness of the mesylate of the beta crystalline form seem to be quite large. I’m not so sure that automatic invalidity on the obviousness question is on cards.
Section 3(d) – aren’t they arguing that the crystalline form itself provides increased bioavailability? I can imagine a (perhaps semantic) counter-argument that bioavailability itself is not ‘efficacy’ and so fails.
The challenge to s3(d).
I tend to agree with you about Novartis’ prospects in relation to the new form of a known substance part of s 3(d). However, what do you think of a separate attack on the ‘new use of a known substance’ restriction (which does not seem to depend on your obviousness line of argument for TRIPS compliance).
Regards
Duncan
duncanbucknell.com
Dear Duncan,
Thanks very much for your thoughtful comments. Let me take you’re point about section 3(d) first. You state: “aren’t they arguing that the crystalline form itself provides increased bioavailability?”
Yes, they are. But the key question here is: against what ought this comparison to be made? If made against the free base, then it will most certainly have increased bioavaviliability that may be 30% or more. But when compared as against Imatinib Mesylate (IM), the allegedly increased bioavailability may only be marginal.
This brings us to another aspect that implicates the analysis under section 3(d). The 1992 application comes very close to “anticipating” IM. The application claims all pharmaceutically acceptable salts and discloses ways of working towards salts by acid addition and discloses methanesulfonic acid as one of the potential acids. So it may be possible that the patent office does not even need to go as far as “inherent anticipation”.
As for obviousness, why do you think this is large–particularly given how the IM comes very close to being anticipated in the original 1992 document?
I didnt quite understand your point about 3(d) and new use. Are you suggesting that a provision that stipulates that new uses are not patentable violates TRIPS?
Great post Shamnad. Thank you.
Hi Shamnad
Thanks very much.
In relation to the s3(d) point and the appropriate comparison to be made. I understood the argument to be that the beta crystalline form creates the 30% increased bioavailability. This is in addition to any benefit conferred by having the mesylate salt. Hence, even if the comparison was with the mesylate salt, it would pass the 3(d) test as the beta crystalline form confers this advantage over it as well.
On the anticipation point – ok so in the absence of an inherency case, then I guess the question is then whether the disclosure is enabling of the mesylate salt. Time will tell, I guess.
(I’d still love your comments on the law of inherency in India, if you don’t mind.)
As to obviousness it seems likely that the skilled addressee would not have found it obvious to take the two steps to get from the base to (a) the mesylate salt and (b) the beta crystalline form. There have been so few Indian patent cases that I can’t confidently suggest which way it might go, but in other jurisdictions, it would be hard to prove obviousness on these facts alone. (There’s probably some other prior art out there which may change the arguments.)
In relation to the new use of a known substance argument – yes I am.
Perhaps it would be easier, if you have time, to have a quick look at the argument as I have set it out in my article which published today at – http://duncanbucknell.com/articles/109/
(Let me know if you don’t want to, and I’ll set it out here, too.)
Hi folks,
I think this 3(d) is nothing but inventive step disguised in another form. Regarding Mr.Chandrashekaran’s removal as technical member of IPAB,appointing another person in his place is not going to be swift considering the speed at which appointments are handled by the Government. So unless Novartis decides to appeal to the apex court,I do not expect any progress in this case.
Hi Patent
I’d have to agree about the slow pace.
Amongst other things, s 3(d) states that the following is not patentable:
“…the mere discovery of any new property or new use for a known substance…”
I’m struggling to see how this fits inventive step, but always happy to be enlightened.
hi duncan
section 3(d)is complimentary to inventive step. “patent” is correct in his reasoning.
put in another way, what is “invetive” is non obvious
and what is “not inventive” is obvious.
Hi Medicherla Ravi
Thanks. Sorry – let me clarify.
I agree that the bulk of s 3(d) is couched in terms that are analogous to obviousness / lack of inventive step.
(I’m guessing that everyone is in heated agreement about this because the words of s 3(d) talk about ‘new’ substances etc – ie the section is saying, notwithstanding that the invention is novel, it is still not patentable. This makes sense, sure. In some other jurisdictions, it could be couched as a ‘lack of manner of manufacture’ argument as well – though this wouldn’t be as useful for India in arguing TRIPS compliance.)
And, of course, a new use for a known substance may well fail the test for inventive step – if it fits the normal test – that it would be obvious to a skilled addressee in light of the prior art.
No problem, of course.
The point here is that lack of inventive step requires an assessment of obviousness to the skilled addressee. There must be some extra property which takes the invention beyond what would have been obvious.
Section 3(d) has three parts, here are the words, broken down into the three parts which are disallowed from patentability:
(i) 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;
(ii) or the mere discovery of any new property or new use for a known substance
(iii) 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.
So here’s the problem – Parts (i) and (iii) each describe an extra property in a proviso which creates the inventive step analogy – unless you have some enhanced new result or product (or reactant), it will not be patentable – analagous to obvious.
But part (ii) has no such proviso. It automatically bans any (a) discovery of a new property (fine – its long been held that they are not patentable by themselves), or (b) new use for a known substance. There is nothing which tells us how to cure this. If it is a new use of a known substance, its all over. This is not the same as stating that unless you come up with an enhanced result it is not patentable.
Let me know what you think.
(I’ll co-post this comment on the equivalent post on my site so that readers over there can track it.)
Cheers
Duncan
duncanbucknell.com
Dear Duncan, Ravi, Patent
Section 3 [not merely Section 3(d)] is that Section 3 covers situations which are inventions but are exceptions as “inventions not patentable”. I know it is not correct to interpret a section based upon the title of the Section, but in this case Chapter II is purely dedicated to “INVENTIONS NOT PATENTABLE” or in other words, that the Act has demarcated that there are certain inventions cannot be granted patents. Hence simply put these are exceptions to “patentable inventions” and creation of statute based upon the prevailing socio-politio-economic conditions of a country.
In fact this is quite obvious to decipher from Novartis case where the constitutional validity of Section 3(d) has been challenged since according to Novartis Section 3(d) raises the patentatibility bar. There are exceptions such as business methods and computer programme per se which are allowed in several countries (which means that they are regarded a inventions in these countries) but are not allowed in India. I hope I am clear on this point.
Duncan you are correct in India new use of a known substance is not patentable nor is the mere discovery of new form of a known substance unless there is increased efficacy. This is unique for India. Therefore, Novartis ran into this first road block. To clear this road block constitutionality was challenged. This is history.
Unfortunately, for Novartis, Ranbaxy and Natco were able to prove that the increased efficacy is not present since Novartis themselves have stated that free base form and the salt form compared with β-crystal form of imatinib mesylate and the difference in bioavailability is only 30 per cent and also the difference in bioavailability may be due to the difference in their solubility in water.
Unfortunately again for Novartis they were not able to show any improvement in the efficacy of the β-crystal form over the known substances rather was proved that the base can be used equally in the treatment of diseases or in the preparation of pharmacological agents wherever the β-crystal is used.
The second and more significant problem that Novartis has run into is that of the imantib mesylate (IM) itself. The opponents (Ranbaxy and Natco) have successfully been able to prove that imatinib mesylate salt inherently existed in the β-crystelline form which is the most stable form of the salt. Even the affidavit of Novartis in the opposition proceedings states that the β-form is thermodynamically more stable. Ranbaxy and Natco were able to show through prior publications and studies done by two reputed government institutions Indian Institute of Chemical Technology, Hyderabad and Indian Institute of Technology, Delhi that the salt exists in the β-crystalline form. These experiments were performed not once but at least ten times and at all times the crystals were found to exist in the β-form. Hence the invention has been compromised/ anticipated before even the application by Novartis was filed.
This also answers your question that a comparison of beta-crystalline form with mesylate salt will not be able to overcome the 3(d) bar.
The two steps defined by Novartis that (i) the imatinib free base has been chemically changed into a salt form (ii) a particular crystal form of the salt has been made through human intervention and that this was non-obvious for a person skilled in art nor was it anticipated in the prior US patent of 1993 (1993 Patent) and was in fact obvious to a skilled person
Once again the opponents were able to show that “1993 patent discloses methanesulphonic acid as one of the salt forming groups and also the 1993 patent specification states that the required acid additions salts are obtained in a customary manner. Further, claims 6 to 23 of the 1993 patent claim a pharmaceutically acceptable salt of the base compound. The patent term extension certificate for the 1993 patent issued by the US Patent Office specifically mentions imatinib mesylate (GleevecR) as the product. All these points clearly prove that imatinib mesylate is already known from the prior art publications and the Opponent has satisfactorily proved that the salt normally exists in the β-form which is the most thermodynamically stable product. Hence I conclude that the Opponent has succeeded in proving that this invention is anticipated by prior publication.”
There while your points are most definitely arguable the hitch is that Novartis faces an uphill task to prove the following “and” conditions:
1. That the invention is not barred by Section 3(d); and
2. That the compound is novel; and
3. That it is non-obvious; and
4. That Novartis did not disclose that the application was based upon a non-convention country nor did it make any efforts to change this position. This has been viewed as a misleading tactics. Though probably this is the weakest of the four, but still will be required to be proved
I have tried to address this based upon Indian law and practice. I am sure that the above points may not be sufficient in some other country and Novartis would have a fighting chance. However, in India these changes are not going to happen in a hurry plus the Indian Patent Office is quite a stickler of the written words in the Act and not really interpreting them harmoniously at the moment. Therefore, the question of “new uses are patentable” would be required to be decided by the WTO Dispute Resolution and not the Courts of India which scenario Shamnad had predicted long ago and now has been followed by High Court as well!
I hope I have been able through some light on this issue.
Hi Vaibhav
Thanks very much for this and your email – this is great.
As promised, I’ll pick up the conversation over at my blog, IP ThinkTank rather than take up everyone’s time over here.
best regards
Duncan
duncanbucknell.com
Dear Duncan,
Let me address your point about the TRIPS compatibility of a provision that bans the patenting of any new use of a known substance. As you know, TRIPS only mandates that all “inventions” that are “new”, “non obvious” and “useful” have to be granted patent protection–but it does not define any of these terms. A member state could therefore argue that a “mere new use” of an existing substance does not amount to an “invention”. Some member states have this patent eligibility criterion in their patent legislation. Given these two factors, I think it unlikely that a WTO panel will hold that such a provision violates TRIPS.
Regards,
Shamnad
Dear Duncan,
Let me respond to some of your comments:
DB: “I understood the argument to be that the beta crystalline form creates the 30% increased bioavailability.”
SB: As I mentioned earlier, what “substance” is this increase in bio-availability judged against? Novartis’ proof of increased bioavailability related to a comparison b/w the Imatinib free base and the beta crystalline form of IM–which as I’ve stressed earlier, ought not to be appropriate comparison. Rather, the comparison ought to be b/w IM and the beta crystalline form of IM.
DB: “This is in addition to any benefit conferred by having the mesylate salt. Hence, even if the comparison was with the mesylate salt, it would pass the 3(d) test as the beta crystalline form confers this advantage over it as well.”
SB: Where are you getting this from? I don’t think any of the evidence submitted points this way.
DB: “As to obviousness it seems likely that the skilled addressee would not have found it obvious to take the two steps to get from the base to (a) the mesylate salt and (b) the beta crystalline form. There have been so few Indian patent cases that I can’t confidently suggest which way it might go, but in other jurisdictions, it would be hard to prove obviousness on these facts alone. (There’s probably some other prior art out there which may change the arguments.)”
SB: Again, what is your basis for stating that this finding of “obviousness” is not “likely”. We are engaged in predicting a likely legal outcome–and as you are well aware, the law cannot be divorced from its attendant socio-economic and political circumstances. We need to travel back in time to see that this is one case that made it almost every day to mainstream media headlines as hurting the poor in India. Not that I agree with these emotional outcries on the impact of Gleevec on access–as Novartis gives this drug away for free to most that need it. Secondly, even if a patent issues, generics can easily come up with an alternative polymorphic form (and if I am not mistaken, Hetero has come up with the H form), and continue selling. Lastly, even in the face of a patent, generics can continue to sell the same copy of the drug, provided they pay a “reasonable” royalty.
Having said this, to a not so nuanced audience, such a patent would have adverse consequences and may set in the wrong kind of precedent on patentability–and I am willing to wager that our patent office/courts will succumb to this sympathy. I’d written a paper in the IPQ sometime back on what I call the “policy style” reasoning at the Indian patent office, where historically, the office has always applied more stringent criteria in judging patentability when compared with its Western counterparts, owing to a prevailing notion that more patents are bad for the country/economy. I list the abstract below:
“With the introduction of pharmaceutical product patents for the first time (via the 2005 amendments to India’s patents act), it is feared that there would be a steep rise in drug prices and a consequential adverse impact on access to important drugs. Civil society proponents argue that the TRIPS flexibilities available were not exploited appropriately and that adequate safeguards were not built in to ensure an affordable supply of medicines. While this concern by civil society has some merit, what it misses is the flexibility that already inheres in the Patent Office to tailor patent protection to suit policy needs. This article argues that the Indian Patent Office has had an interesting history of taking itself to be a policy guardian of sorts and demonstrating a rather conservative approach to the issue of patentability. This policy-style reasoning can be traced back to the Ayyangar Committee report, a document that formed the very basis for the current Indian patent regime. Underlying this report was the clear message that fewer patents resulted in a stronger indigenous industry, particularly in the area of pharmaceuticals and chemicals. This article demonstrates the influence of this policy document on the decisions of the Patent Office even today and posits that, rooted in a system that stressed the virtues of a weak patent system, it is likely that the Patent Office would continue with a conservative approach to the issue of patentability, even with regard to pharmaceutical inventions (that are patentable under the 2005 Act).”
If you wish to download this paper, please see http://papers.ssrn.com/sol3/papers.cfm?abstract_id=829464.
You have to view to “wagering” on the legal outcome in the light of this context. For the same reason, although we haven’t had any cases on “inherent anticipation” (you will appreciate that the country hasn’t seen that many patent cases till date), there is good reason to suspect that the patent office/courts will adopt this, should the occasion so demand.
I hope this clarifies where I’m coming from.
Hi Shamnad
Thanks very much for taking the time to clarify. I’m really interested in the discussion, so please forgive me if my zeal makes appear me impolite or abrupt (it’s not intended).
I’d be delighted if you or other readers could provide examples of member states which disallow patentability for new uses of known substances.
30% increase in bioavailability (etc) – I get it now, thanks and thanks also to the earlier comment from Vaibhav.
Probability of an obviousness finding for the two steps. From your and Vaibhab’s comments, I now have a better picture of the prior art, and can see that the case is pretty good.
Having said that, if I understand it correctly, then I might have to respectfully disagree with your approach to obviousness here. The question of obviousness has nothing to do with the economic plight of the citizens of India – there’s nothing in the legal test that allows the judge to take into consideration. However, the economic plight of the poor in India is a very real and extremely important factor (but can’t be used to determine a legal test such as obviousness). Instead, the Indian government can fight this case (and probably win), and even if it doesn’t it can take the policy route of ordering a Compulsory License (as I mentioned on my blog). As you say, the generic companies have a raft of avenues open to them, not least of which include following the prior art.
Policy style reasoning at the Indian patent office – thanks for the abstract and the link – this is really interesting.
The restrictions on pharmaceutical patents have been great for the Indian economy and I think India has been very clever about this from a policy perspective. I wonder though, whether the increasing prevalence of NCE development by India’s major pharmaceutical companies will put pressure on the government to go the other way (and thus water down provisions such as 3(d)).
Thanks again
Duncan
dear duncans
u are broadly right in saying sorry…3 d
doesnot cover all aspects .but again as u can see it is more specific abt chemistry..thats way
i used the word complimentary..
Hi Ravi
Thanks very much.
best regards
Duncan
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