James’ paper poses an effective counter to the piece commissioned by the US India Business Council (USIBC) that effectively advocated the deletion of section 3(d) and I would urge you to read it.
The point of this post is to reflect on the supposed frivolous grant of patents and find ways of curbing the dirty habit of “evergreening”. As many of you know, while “evergreening” has a healthy overtone in an “environmental” context, it connotes a rather sick practice in the “pharmaceutical” context, referring as it does to the practice of extending patent monopolies by effectuating mere modifications of existing drugs, where such modifications do not deliver any significant health benefits to the public.
I remember reading about these allegedly wrongful grants several months back and the first question that struck me was: Why on earth weren’t these patent applications opposed? Surely, once granted, our already burdened patent office can’t be expected to review them of their own accord (for they would then would have to do this each time anyone made similar allegations in relation to any patent grant). Rather, competitors are meant to be vigilant and challenge applications that impact them (through an opposition mechanism that is one of the most potent in the world) or petition for their revocation, if granted.
After all, the potential challengers to these 81 applications are our own Indian pharma majors, many of whom are aggressive para IV patent challengers in the US and have extensive experience with knocking down bad patents. Surely, if they can knock down patents in the US at such exorbitant costs, they can do so in India as well. It was therefore quite heartening to see a recent news item, where DG Shah of the Indian Pharma Alliance (IPA: a body comprising of leading Indian pharma majors) has now vowed to go after bad patents through the opposition mechanism.
Indeed at a broader level, all stakeholders in the Indian patent system including civil society institutions must leverage the opposition mechanism as best as they can. Funnily enough, the big bad MNCs are finding that if there is one practice that they cannot possibly monopolise, it is that of “evergreening”. For our Indian majors have begun to take to this culture with great gusto.
Indeed, in the context of the famed Novartis patent case, it came to light that Natco, an Indian company that opposed Novartis’ application covering Gleevec, a polymorphic form of Imatinib Mesylate, had itself filed several applications covering various other polymorphic forms of Gleevec. Further, in a recent patent litigation, an Indian company, Cadilla was caught on the wrong side of section 3(d).
Therefore, unless we have a vigilant civil society, we’ll let our own companies get away with murder!
In this context, readers may recollect an earlier post, where I bemoaned the pitiable number of oppositions filed, noting that:
“It is not immediately clear as to what accounts for the rather paltry number of oppositions filed…a mere .3% of the total number of pharma applications were opposed! Particularly since India has a vibrant generic sector and a very active NGO community that opposes frivolous pharma patents.”
The number of oppositions have of course increased since we did our last study and we are in the process of updating it.
In the meantime, we must appreciate that all of us have a collective stake in the Indian patent system and must actively leverage the opposition system to help the patent office in weeding out bad patents. Indeed, any of us can file a pre-grant opposition: all it takes is a couple of hours and at no cost!
If you don’t believe me, ask Manoj Tongra, a drug control officer from Rajasthan who drafted and filed a post grant opposition recently (in his personal capacity) against what would appear to be a frivolous pharma patent by Venus Remedies, an Indian company. The patent (236996) which claims a combination of ceftrioxane sodium, sulbactum sodium and EDTA is being challenged for flouting section 3(d) and section 3(e). Of course, we’re going to have interesting issues of “locus” cropping up here (since a post grant can only be filed by an “interested person”)..but I really hope courts interpret the term “interested person” widely to include members of the public who have a stake in ensuring that undeserved patents that cause high drug prices are not granted.
For its part, the government must find ways of incentivising a greater triggering of the opposition mechanism and a more efficient and quicker decision making process. Only then can we hope for a “never-green” patent system to take root in India.
while it is true that they(ipa members) are filing para iv filings becoz of 180 day exclusivity, what is the equivalent carrot here .probably none.may be they are justified in their cries by which may be the concerned will be more carefull in future!
Reg “As many of you know, … “evergreening” … connotes a rather sick practice in the “pharmaceutical” context, referring as it does to the practice of extending patent monopolies by effectuating mere modifications of existing drugs, where such modifications do not deliver any significant health benefits to the public.”
I thought all national laws were consistent in the following, contrary to the above statement.
Assume someone filed for a patent in 2000 for basic drug B, and then filed for a modification B-mod in 2005. Any patent granted for drug B would be effective only upto 2020, while any patent granted for drug B-mod would be effective upto 2025.
With or without a patent for B-mod, no national patent law permits extension of monopolistic rights for basic drug B beyond 2020. In other words, either the patentee of B or any others, would NOT have a patent monopoly right on drug B after 2020, including in the duration 2020-2025.
If a company/anyone somehow tries to cover drug B using the patent for B-mod, the patent covering B-mod would be plain invalid.
To the extent B-mod is useless, no harm is there to anyone since it is a restriction on useless stuff that would not be used any way.
A publication of the entire application with claims and not just the cover page/abstract may help. The current format for publication of applications is too short on the details. The patent office must make the entire application including the file wrapper avialable electronically. Ensuring transparency in prosecution would reduce red tapism to a great extent.
Dear Naren:
You’re right in a way, since evergreening is coming to be used (wrongly) to refer to the entire gamut of undeserved pharma patents.
However, in its narrow and perhaps proper avatar, it rings technically true in certain contexts. Consider the prilosec vs nexium example and you’ll understand why. Although the patent expired, Astra’s marketing might had ensured that the later undeserved patented version (nexium) came to be prescribed by most doctors. So the cheaper generic off patent Prilosec version was not effectively available to the consumer.
Dear Anon,
More transparency will certainly help! and this is going to be the key aspect of a post that i will soon put up. However, the IPO website does give you entire details of a published patent application including the specification and claims. Of course prosecution history is still not available, but we made this request in our open letter to Mr Kurian a year back. And do hope that this will also be available in due course.
Dear Anon,
Do they really need a carrot for India? Costs are really low for oppositions in India (which is why I cited the example of Tongra’s oppn). And given the escalating challenges to some of the patents (by Cipla et al), it is clear that they will anyway take on MNC patents even in court without additional carrots.
More importantly, why should the consumer be denied open competition (that comes about from knocking a bad patent) and be hit with a duopoloy engendered for 6 months by a hatch waxman type regime?
Anon,
Secondly this crying to the media business and an effective trial by media situation shoudl be discouraged. Have you seen the 81 grants? Are you certain that all of them were frivolous? Unless we have the complaining parties challenge these patents in court (or revocation petition via IPAB) or through oppns (had they woken up earlier), we can never ascertain the veracity of their claims. Besides, teh patent office cannot suo moto review these matters and knock down patents. They tried doing so in the Abbott Humira case and look what happened–a court immediately restrained them!
While its true that these opposition methods would help, they seem to be more reacting to the problem of evergreening, rather than looking to solve the cause.
As impossible as the task may seem right now, wouldn’t a concentration on ‘educating’ and an enlargement of the numbers of patent examiners be a more effective solution?
Anon:
you’re right:
we need a slew of different types of measures to solve it, without relying on any one off them to do the job. And my second post will focus on things like reforms at the IPO, more transparency etc.
However, assuming that just internally reforming the IPO will result in all good patents is wishful. No matter how much we improve, the office will always continue making mistakes. If the better administered and more efficient USPTO and EPO make routine mistaken grants, can we ever assume that the IPO would reach a mistake free status?
Therefore, along with internal reforms, we need to maintain an outside vigilante society and competitors etc should help the office through oppns.
two quick comments, dear shamnad:
1. i love the ‘re-examination’ process of uspto. in my view, its a great tool towards obviating costly (n avoidable) litigations. indian patent regime, too, should ve a similar mechanism.
2. long time ago, while dealing with valcyte case, v had discussed the ‘any person’ vs. ‘any interested person’ in detail n i am of the view that there should not be much difference between these two terms (at least not in the matters of public whose interest/accessibility is going to be affected, especially in matters of life-saving / basic / essential drugs). this is my view, but i know that its a matter of individual’s interpretation (n sometimes, ideology, too). lemme inform u that despite this aspect having been raised, it had not been adjudicated upon by the apex court.
-aditya kant
It all boils down to the truth that there cannot be a tenable intellectual property unless it is preceded intellectual integrity..
A simple approch seems to be treat these modifications applications as patent of addition, so that their term expires along with parent patent application. Even otherwise, if these modification coming under ambit of Section 3D, are assumed to be so obvious, I am not sure whether the Court will allow infringment action by Patentee against those dealing with those obvious modifications.