The IPAB (Intellectual Property Appellate Board) just ruled that Novartis’s patent application covering Glivec (beta crystalline version of Imatinib Mesylate) is not patentable, since it fails to satisfy the requirements under section 3(d) of the Indian patents act. This section requires that in order to be patentable, a pharmaceutical derivative must demonstrate significantly enhanced “efficacy” over and above the prior known molecule.
The decision by a panel consisting of ZS Negi (sitting as Chairman) and Dr PC Chakraborti (sitting as technical member) dated 26th June, 2009 is almost 200 pages long! But here are the quick highlights from my quick reading of this decision:
1. The IPAB held that while the claim covering the beta crystalline (BC) version of IM (Imatinib Mesylate) is both novel and inventive, it fails the test under section 3(d), which requires a demonstration of “significantly enhanced efficacy”.
Comment: In an article, we’ve defended the TRIPS compatibility of section 3(d) on the grounds that it is nothing more than a refined non obviousness standard that applies to pharmaceutical inventions.
However, I’m not entirely sure if this explicit holding by the IPAB that section 3(d) presents a standard over and above “inventive step” now opens the doors to TRIPS violation claims? The IPAB of course notes at several parts that section 3(d) is a heightened inventive step standard. Nonetheless it fails to reconcile this finding with its finding that the BC version of IM is inventive, and yet fails under section 3(d).
In order to appreciate the above point, let me lay out again the various steps that underlie the alleged “Glivec” invention:
i) Synthesizing imatinib as its free base, a compound that was patented in the US, EU and several other countries in or around 1993. However, this could not be patented in India, owing to the fact that in 1993, India did not provide product patents for pharmaceutical substances.
ii) Converting the free base to a particular salt form, imatinib mesylate, by adding methanesulfonic acid.
iii) Crystallising the imatinib mesylate to obtain the beta crystalline form, which is allegedly the most stable polymorphic form of the salt. A patent application was filed for this in India in 1999 and it is this application that is the subject matter of dispute.
iv) Formulating the beta crystalline form of imatinib mesylate into a pharmaceutically useful drug, Glivec, which was granted regulatory approval in 2001.
2. The IPAB held that the only kind of efficacy that would satisfy section 3(d) is therapeutic efficacy. Novartis’s BC version may possess improved bioavailability, thermodynamic stability, improved flow properties and lower hygroscopicity, but this does not amount to an increase in “therapeutic efficacy”.
Comment: In previous articles, I’ve opined that “efficacy” under section 3(d) does not necessarily have to mean “therapeutic” efficacy. This interpretation is likely to stay till such time as a court of law overrules it. This restrictive interpretation also explains the apparent incongruence of the IPAB in finding in favour of “inventive step” but against compliance with section 3(d). Had section 3(d) been interpreted to mean any kind of advantage, then perhaps one might have found a better congruence between the “inventive step” standard and the section 3(d) standard. And this might have also bought the Indian section very close to the “unexpected properties” standard articulated in the US and EU.
3. Section 3(d) embodies a high level of scrutiny and owing to this, patents granted in other countries may not be granted to India. Therefore the fact that Glivec has been patented in 35 other countries is not a relevant factor when considering the patentability or otherwise of Glivec in India.
4. In perhaps what will turn out to be the most controversial part of its decision, the IPAB notes that any patent granted over Gleevec is likely to cause “public disorder”!
It elucidates by stating that since Gleevec costs Rs 120,000 per month per patient, it is far too high a price for the common man. Therefore any patent granted to support such a high monopoly price would be against public order and can be denied a patent under section 3(b). This section notes in pertinent part that patents cannot be granted to “an invention the primary or intended use or commercial exploitation of which could be contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment”.
Comment: This is plain ridiculous! There is nothing in the patents act to support such a reading. As we’ve been stressing on this blog, one ought to draw a distinction between the grant of a patent and the subsequent use/abuse of a patent.
The grant or otherwise of a patent ought to be dicated by strict “patentability” criteria alone: does the invention represent a good enough technical/scientific advance to merit a 20 year monopoly? The fact that the patentee charges or may charge a high price cannot be used to deny the grant of a patent.
Once the patent has been granted, the use or abuse of a patent can be regulated. And to this extent, one can reduce the scope of the patent monopoly through compulsory licensing, price control etc.
If a country does use the “price” yardstick to assess the patentability or otherwise of an invention, it will most likely fall foul of TRIPS as well. Further, TRIPS would seem to suggest that inventions can be excluded from public ordre or morality, only when products (drugs) embodying such inventions are banned from the country altogether. Thus, unless India bans the sale of Glivec, it cannot exclude a patent covering it on the grounds of public ordre or morality.
Of course, this bit of the IPAB decision may be simply treated as “obiter”, since the IPAB had anyway denied a patent on the grounds of section 3(d).
5. The IPAB held that Novartis cannot add material to support the patentability of its invention. Rather, it can only rely on material supplied as on the date of applying for the patent.
Comment: This appears unduly harsh, given the fact that a number of these applications were filed as “mailbox” applications prior to the introduction of section 3(d) in 2005. Consequently, applicants were not expected to know that in 2005, they would be faced with having to demonstrate “increased efficacy” as well. Under the IPAB’s own ruling here, the invention meets the “inventive step” criteria, but fails under section 3(d). Since applicants did not know of this standard at the date of filing, shouldn’t they be permitted to submit evidence documenting increased efficacy (if at all they can adduce such evidence)?
In fact, introducing an allegedly new standard (section 3(d)) at a later date and insisting that such standard be complied with retrospectively may thwart the very promise of protecting mailbox applications under TRIPS. This could in turn attract a potential WTO complaint. Again, this is but a tentative thought: so I welcome a discussion from readers on this aspect.
6. Since the BC version of IM is not patentable under section 3(d), any composition or formulation of this BC version is also not patentable under section 3(e). Any such combination is merely an addition of its individual components, sans any synergestic effect.
7. The IPAB noted that although the product claim covering the BC version of IM was not patentable, the process for manufacturing the BC version could be patentable. However, even if granted, such a process patent is likely to be weak and relatively easy to invent around by Indian generic manufacturers..
Conclusion
From the above, it would appear that the reasoning of the IPAB is flawed in some aspects. However, does this impact their final conclusion that Novartis ought not to get the patent? The answer is unclear. But here are a few thoughts for consideration:
The IPAB holds that the earlier known substance for the purpose of comparison under section 3(d) is “Imatinib Mesylate” and not the Imatinib free base, as Novartis claims. And to this extent, any “efficacy” comparison under section 3(d) has to be between the claimed BC version of IM and IM itself. I’ve taken a similar view in earlier posts.
If IM is indeed “known” from the ’93 patent application covering the Imatinib free base, the key question would be: would a skilled person have found it obvious to get from IM to the BC version of IM? Or would the skilled person have been likely to pursue another polymorphic form or derivative? The IPAB holds that the skilled person might not have been motivated to get to the BC version specifically. However, their reasoning on this account is not completely convincing. Particularly in the light of expert evidence submitted by IICT (on behalf of the opponents) that when preparing IM, one would inevitably get the BC cystals. The IPAB rightly concluded that the “inevitability” of always getting to the BC version was in doubt since there could be other processes by which one could make the BC version of IM (and not just the process used by IICT).
However, the fact that when some processes are used, one does get to the BC version should itself suggest that a skilled person may have been likely to get to the BC form when experimenting with IM. The court also suggests that Novartis may be entitled to a selection patent on this count. Here again, I’m not entirely convinced. But this post will have to wait for another day.
ps: I want to really thank Sandeep Rathod for bringing this decision to my attention. He has been a great friend of SpicyIP and has referred innumerable nuggets of valuable information to us.
sigh!
🙁
Thanks Shamnad for sharing both the news and your thoughts. On the issue of 3(d), I think, the confusion is persisting. If I could recall rightly then Justice Bhat in Tarceva case has construed it as a standalone requirement independent of inventive step. What is the actual state of affairs?
as i ve said earlier also, i am really saddened with the quality of orders passed in recent times in really crucial patent matters. except for the points 3, 6 & 7, i am really sad how the patent office has ‘reasoned’ before concluding. its a different matter that, just like madras high court’s decision in re novartis, the patent office, too, has arrived at the right conclusion, using faulty reasoning. pricing factor is an extraneous consideration, hence jurisdictional error. imperfect interpretation and use of section 3(d) is certainly exposing india to the claims of non-compliance with trips. how much i wish for the patent office / judiciary to learn the ropes faster n become mature!!!!!!!!!!!!!! just as i ve advocated all along that judiciary perhaps needs a trained cadre of specialist judges for IPR, i would similarly advocate a proposal to impart specialist legal training to the patent office functionaries (or at least have a legal member in the adjudicating panel).
Seems the patent office is learning a lot these days from vote bank politics. I wonder who are they trying to please by putting the cost factor argument in rejecting the grant of application?
Going by this argument, i dont see a need for having provisions relating to compulsory licensing in the patent act any more. every product that is highly priced, its patent can be revoked on grounds of not being patentable under section 3b now!
Going by their logic…probably the next argument that you can expect would be…the concept of 20 years of monopoly itself is against public morality, hence all patent should be rejected!
Dear Shamnad,
If the data is relevant and within the scope of the invention then it should be taken on record irrespective of when it is produced more specifically in section 3 (d) matters given that the applicants were simply not aware of any future introduction of section 3(d). Moreover, the efficacy data relates to the same drug that was filed for protection, its efficacy is not going to change over a period of time. The efficacy data would be the same if it is provided at the time of filing of the application or after filing of the application. It would be interesting to look at the reasonings by IPAB for not allowing the addition of material. I cannot agree that the efficacy data cannot be provided at a later date of filing of the application. I fail to understand why is the Patent Office so adamant in not allowing matters to be added. If the matter is out of the scope of the invention its fine on their part to not allow the addition (it’s sometimes really tough to convince given that scope of the invention differs from examiner to examiner—recently we have been asked to provide the efficacy data in the course of prosecution).
As many applicants at the time of filing didn’t have any idea of Section 3 (d), at least they should be refunded the money they had paid in the process given their unawareness and the patent application not fulfilling the requirement of ‘enhanced efficacy’ (I doubt if the Patent Office ever refunds).
The prices are of course very high. Where most of the people cannot afford it but then some can. What about public morality or disorder then? To tackle problems of over pricing, provisions are provided. Its difficult to digest this as a reason for rejecting the application.
Thanks for all your comments,
I’m sure this will be appealed and at least the “pricing” and public interest bit will be struck down by a sensible court. As for limiting section 3(d) to just therapeutic efficacy, I’m not entirely sure which way courts are likely to go. Also, on the evidentiary aspect, I think its grossly unfair to have a blanket ban on introduction of any evidence at the stage of prosecution, given that section 3.d was introduced much later in time. Again on this one, a reasonable court would prevail in favour of the patentee. A court ought to grab votes (as one of you rightly pointed out) would decide otherwise.
And as many of you stressed, Indian courts and tribunals have a long way to go before they start doling out some sensible patent jurisprudence. I was at a conference recently where my main theme was the increasing politicization of patents and its impact on govt functionaries in India. The Novartis decision has once again endorsed that thesis. Hopefully this trend of ignoring the rule of law in favour of sentimental rhetoric will soon be overturned.
You’re right Aziz,
Section 3.d is coming to be increasingly construed as a standalone requirement–and perhaps a bare reading of the statute would suggest that this might be the correct way of approaching section 3.d. However, it also subjects it to a more fatal TRIPS scrunity than would have been the case had the section been simply treated as a species of the “inventive step” test as applicable to chemicals.
Dear Shamnad,
Thanks for your comments, however, there are some unusual factors in this decision-
IPAB held that while the claim covering the beta crystalline form of Imatinib mesylate is both novel and inventive, it fails the test under section 3(d), which requires a demonstration of “significantly enhanced efficacy”.
The very fact that section 3 (d) talks about what is patentable and what is not, while Imatinib mesylate was already acknowledged to possess both novel and inventive and certainly utility is in treatment of cancer. Further, Imatinib base can not be formulated in tablet, how and why the question comes for comparing any efficacy. Is there any tablet in the market known with Imatinib base or any other salt, which need to be compared? Rationale of using section 3(d) apparently doesn’t look OK. Further, more pathetic condition, where IPAB has considered one of the ground as cost of Rs. 1,20,000/- per month for one patient. It appears ridiculus, since IPAB is a penal of Intellectuals and not the politicians/economists/NGO/Welfare organisation. Why IPAB has not acknowledged that-amount of revenue spent , time and wages of Scientists worked in R&D/ Development cost / Clinical cost of the molecule? This decision apparently may pose question on several legal aspects in the coming time while deciding cases pertaining to Innovator companies patents. Please correct me if my understanding is wrong. Dr Akshaya
Dear Shamnad,
Thanks for your comments, however, there are some unusual factors in this decision-
IPAB held that while the claim covering the beta crystalline form of Imatinib mesylate is both novel and inventive, it fails the test under section 3(d), which requires a demonstration of “significantly enhanced efficacy”.
The very fact that section 3 (d) talks about what is patentable and what is not, while Imatinib mesylate was already acknowledged to possess both novel and inventive and certainly utility is in treatment of cancer. Further, Imatinib base can not be formulated in tablet, how and why the question comes for comparing any efficacy. Is there any tablet in the market known with Imatinib base or any other salt, which need to be compared? Rationale of using section 3(d) apparently doesn’t look OK. Further, more pathetic condition, where IPAB has considered one of the ground as cost of Rs. 1,20,000/- per month for one patient. It appears ridiculus, since IPAB is a penal of Intellectuals and not the politicians/economists/NGO/Welfare organisation. Why IPAB has not acknowledged that-amount of revenue spent , time and wages of Scientists worked in R&D/ Development cost / Clinical cost of the molecule? This decision apparently may pose question on several legal aspects in the coming time while deciding cases pertaining to Innovator companies patents. Please correct me if my understanding is wrong. Dr Akshaya
Dear Shamnad,
I feel the IPAB has exceeded its brief. Pricing of a patended product and its easy availability is a subject matter of Compulsory Licencing which is for the Government to consider. _ A V GOPALAKRISHNAN
Any chance you could post the decision or a link thereto..
Thanks.
The Myth that Patents are a Monopoly
A patent gives the holder the right to exclude others from making, using or selling their invention. 35 USC 154. It does not give the holder the right to make, use or sell their invention. A monopoly is an exclusive right to a market, such as an electric utility company. An electric utility company has the exclusive right to sell electricity in a certain territory. Since a patent does not even given the holder the right to sell their invention, let alone an exclusive right to a market, it is clearly not a monopoly.
When a person describes a patent as a monopoly to be consistent they should also state that they have a monopoly over their car or over their house. In fact, they have more rights in their car and house than a patent gives the inventor over their invention, since you have a right to use and sell your car or house. A patent does not give these rights to an inventor over his invention. All invention are built upon existing elements (conservation of matter) and if the elements that the invention uses are patented, then the inventor will not have the right to sell their invention without a license.
Some economists argue that a patent is designed to give the holder monopoly power. Those economists who are consistent also state that all property rights give some monopoly power. The property rights are monopolies thesis shows how confused economic thought is on this subject. The only logically consistent definition of a monopoly is an exclusive right to a market.
People who suggest a patent is a monopoly are not being intellectually honest and perpetuating a myth to advance a political agenda.
For more information on patents and innovation see http://www.hallingblog.com.
I know Shamnad, you have written about Section 3(d) and have had your own possible edits. I am however, still unconvinced about the need for the section; it adds confusion and there really is nothing that it achieves, that couldnt have been done with a stringent novelty and obviousness type analysis. I have seen cases where formulations improving drug solubility, decreasing toxicity, are nonobvious and novel and will still not pass the Section 3(d) muster and that would be a shame.
Secondly, the USPTO allows inventors to demonstrate unexpected results by inventor declarations, which may be based on data acquired after filing. I am curious, does the Indian Patent Office allow this. Is it possible to show efficacy based on postfiling data?
Hi Preeta,
Sadly, this is seldomely allowed at the Indian patent office. Unless the efficacy data is incorporated in your specification, there is little possibility of passing section 3(d) test.
But I think this kind of a setup is possible since Section 10(3) allows the Controller to consider an application based on further supplementation of model or sample illustrating the invention.
Respected Sir,
Before i coment on ur post further i must express my deepest gratitude to this post because am having ipr xam tomorow and this post helped me a lot. thanks a lot.
intention of section 3(d) is to prevent evergreening of patent. in order to prevent this u need a strict interpretation. if one construe efficacy in that sense IPAB did a good job i gus. but money shouldn’t be a criteria to reject patent. there are other ways to control the price for example drug price control order or compulsory licensing.
i know this is a bit late but i only came to know about this lately. 🙂