Patent

Industry Funding and Bias (I): Some Personal Reflections in the Aftermath of the Mashelkar Massacre


settled-science

Reddy vs Ragavan

Industry funding into academic spaces has always been a bone of deep contention. Little wonder then that we’ve had sharply divergent views on this blog in the recent past. While Prof Srividya Ragavan cautioned against industry funding into the academic space on account of the potential for bias/industry capture, Prashant Reddy thinks it’s perfectly kosher; in fact, he goes on to endorse a greater infusion of industry funding into this space.

The Mashelkar Massacre:

While I’m no expert in this area, let me recount my own personal experience to offer a more contextual flavour to this debate. I was literally massacred during the Mashelkar committee fiasco for having accepted industry funding to do a report, that went on to be extensively relied upon by the committee.

That the committee relied on my report is no fault of mine. I took it as a compliment then, as I do now; my only wish however was that they would have expressly credited the borrowing rather than consigning it to the fag end of their report.

Unfortunately, a number of activists keen on trashing the report saw me as collateral damage. And attacked the fact that my report commissioned by IPI was funded by Interpat (an association of global pharma companies) and therefore ought to be junked and rubbished. I protested vociferously then and I continue to do so, that the circumstances/terms of the industry funding have to be reviewed in order to establish whether an allegedly independent academic report is swayed by the tone of its funder or not.

At least in my mind, I was clear that I had taken an independent stand on the issue and written exactly what I would have written, even outside of the funding/commissioning.

The “Daya”-less Emails

Some years after the fiasco, Daya Shankar, an academic I have immense respect for and who is now unfortunately no more, wrote two nasty emails on ip-health, a globally reputed public listserv (run by KEI), mounting a vicious ad-hominem attack against me.

I let the first one go, but responded to him on this second email thus:

Dear Daya:

This is your second diatribe against me. I let the first one go, as I was not interested in dignifying your rant with a response…Your harsh tone in this second round of personal attacks force me to respond in this manner.

If you claim to be an academic interested in “facts”, then you must go out and seek them before jumping to conclusions and letting your misplaced emotions get the better of you. Firstly, the Novartis case was in the Madras High Court and not the Karnataka High Court, as you state in your post below. This small mistake does not really impact the outcome of our debate, but I’ve noticed a series of such mistakes in all your earlier posts on the Mashelkar controversy, where your rhetorical sermons include inaccuracies such as the fact that I was based at Rutgers University, that Dr Menon hails from Bhopal etc.

All this causes one to think that you are just shoddy and do not bother investigating and getting your facts right.

Secondly, and more importantly, contrary to what you suggest in your tryingly long winded posts, Mashelkar’s mandate was not to examine the TRIPS compatibility of section 3(d). Rather, it was to examine the TRIPS compatibility of a provision advocated by the Left Parties (who, as you know, are part of the ruling coalition in India) that would have completely excluded patentability for all pharmaceutical derivatives. The difference between section 3(d) and the proposed amendment that the Left Parties wanted to bring in is this:

Under section 3(d), a derivative of an existing pharmaceutical substance would merit a patent, if it demonstrated a significant enhancement in efficacy over and above the earlier known pharmaceutical substance. Under the proposed amendment, no derivate would gain patent protection, whether or not it demonstrated increased efficacy.

I argued in the report (commissioned by the Intellectual Property Institute, UK [IPI] and funded by Interpat) that the proposed amendment is not in compliance with TRIPS. And I still continue to believe this to be the case, and have not seen any literature to suggest otherwise. However, I have always consistently maintained that section 3(d) is compatible with TRIPS. I did so in 2005, much before the Mashelkar Committee was even constituted. If you’re interested in this “fact”, then see this article of mine published in the first issue of the IJLT.

…Thirdly, if you had the patience to dig deeper, you might have taken a more nuanced view on this controversy. For one, “bias” has to be judged with respect to several factors, and not just the funding source. I have maintained this TRIPS conclusion even outside of this specific report. And I sincerely believe this to be the correct conclusion even today, as I haven’t seen any convincing analysis to the contrary. More importantly, I was commissioned to do a second report for the IPI (funded by Interpat again) and this went against the interests of big pharma, as it completely rubbished the argument that Article 39.3 mandated data exclusivity. If you’re interested, I have detailed all of these factors that militate against the notion of “bias” in this specific blog entry here.

Most of my works (outside of this report) have attempted to present a balanced and issue-based perspective on pharma patent issues. And my blog postings are reflective of this too. Some of my conclusions end up favouring big pharma and some favour public health activists. And I sincerely believe that that’s a great place for an academic to be in-i.e. not to be seen taking sides. But perhaps I’m naïve and wrong. In a deeply polarised world, people love to see things only in black or white. Reflective perhaps of George Bush’s “either you’re with us or against us” attitude. And taking the middle ground on some of these issues effectively means that you’re constantly attacked by both camps for not having chosen the “right” side.

Of course, this is not to say that industry sponsored research does not come with its share of problems. Since this controversy, which affected me quite deeply, I’ve gone through most of the literature on sponsorship bias. I have to come to appreciate, that even if funding does not influence one’s conclusions, there is a strong prima facie presumption that it does. Particularly when it relates in some way to pharmaceuticals.

I’ve therefore decided to never accept industry funding again, as I can ill afford to waste all this valuable time in rebutting this strong presumption by calling upon folks to dig deeper into the facts.

A friend of mine states that, at worst, he would accuse me of naivete. And I think he is right. When asked by the Intellectual Property Institute (IPI), a leading IP think tank in the UK if I was interested in investigating this TRIPS issue, my enthusiasm got the better of me and blinded me to the fact that industry sponsorship would mar the sanctity of the findings.

After all, I was just beginning to set my foot in the world of academia and this was only my second commissioned report (unfortunately, the first report, dealing with the compulsory licensing regime in India and commissioned by the JPO was never made public. I have finally got their consent to make this available…).

Being a senior academic and claiming to be a fellow Indian, there were far more constructive ways in which you could have handled this. Yet to chose to mount deeply vicious attacks against me. Almost suggesting that I should never again be invited to any conference dealing with patent issues!

In fact, from your previous participation on this list, I notice that you’ve become something of an expert on personal ad-hominem attacks. You’ve taken shots at very respectable IP scholars, including Fred Abbot and Jerome Reichman.

I appreciate that some of my comments to you border on the personal too. However, I hope that list readers.. will forgive me for stooping to your level to give you a bit of your own “medicine” back–perhaps appropriate, given that the controversy we discuss relates to pharmaceuticals.

You bemoan the fact that “life” can be quite “tough”. Unfortunately, mounting personal vitriolic attacks against everyone in sight is not going to make it better for you..Interestingly, you will also find that your name “daya” means compassion/kindness-a very far cry from what your emails make you out to be. Let’s hope that you begin to correct that impression in the days to come.

Take Home Message?

At least for me, the take home message is this: whether we like it or not, industry funding does raise a prima facie presumption of bias. This can of course be dislodged through a careful review of the conclusions, methodology and the terms of funding. But this is really hard work; and given our woefully short attention spans and the limited time at our disposal, we’re more likely to simply go with the perception of bias, than a careful evaluation of the context and a more nuanced take.

In my limited understanding, cases in which industry sponsorship leaves the researcher with a complete free hand, sans any agenda, are relatively rare. At some point, the agenda will rear its ugly head. This was made more than amply evident to me during the commissioning of a second report by Interpat, which I mention in my email to Daya. This report was meant to investigate whether or not Article 39.3 mandated data exclusivity. I concluded that it did not mandate data exclusivity but that it could be taken to mean a compensatory liability regime of sorts. This was not a conclusion that Interpat was happy with; and I was requested several times to revisit my conclusion. But I stuck to it. Naturally enough, no other commissioned work came my way!`

Am sure there are countless other examples. In fact, at one of the industry sponsored conferences that Prashant mentions in his post, I took a position diametrically opposite to that which the particular industry player wanted to hear. Surprise surprise! I was not invited to their next conference (hosted by the same educational establishment). Of course, its’ quite possible that they were just sick and tired of my views and wanted fresher and more engaging perspectives.

But bottom-line is this: while it is theoretically possible for industries to fund truly “independent” research or pursue an agenda that is not linked to their immediate bottom-lines, this is more often the exception than the rule. And sooner or later, when the dividends don’t show up, the funding will dry up.

So I’m inclined to lean on the side of Srividya that industry funding must cause us to be more cautious about the research outcome. And force us to interrogate the methodology deployed and the terms of the sponsored research with greater rigour. Though I have to say that wishing away industry funding altogether is a tall order! Indeed, can there ever be a truly objective funding body or institution or individual? Even within supposedly kosher funding spaces, donors often pursue their pet agendas through the institutions /researchers that they fund. But on this, let me save my reflections for a future post.

In the meantime, a happy Deepavali to all of you! May this festival of lights pave the way for more light (and less heat) in our IP discourse!

ps: Image from here.

Shamnad Basheer

Shamnad Basheer

Prof. (Dr.) Shamnad Basheer founded SpicyIP in 2005. He's also the Founder of IDIA, a project to train underprivileged students for admissions to the leading law schools. He served for two years as an expert on the IP global advisory council (GAC) of the World Economic Forum (WEF). In 2015, he received the Infosys Prize in Humanities in 2015 for his work on legal education and on democratising the discourse around intellectual property law and policy. The jury was headed by Nobel laureate, Prof. Amartya Sen. Professional History: After graduating from the NLS, Bangalore Prof. Basheer joined Anand and Anand, one of India’s leading IP firms. He went on to head their telecommunication and technology practice and was rated by the IFLR as a leading technology lawyer. He left for the University of Oxford to pursue post-graduate studies, completing the BCL, MPhil and DPhil as a Wellcome Trust scholar. His first academic appointment was at the George Washington University Law School, where he served as the Frank H Marks Visiting Associate Professor of IP Law. He then relocated to India in 2008 to take up the MHRD Chaired Professorship in IP Law at WB NUJS, a leading Indian law school. Later, he was the Honorary Research Chair of IP Law at Nirma University and also a visiting professor of law at the National Law School (NLS), Bangalore. Prof. Basheer has published widely and his articles have won awards, including those instituted by ATRIP, the Stanford Technology Law Review and CREATe. He was consulted widely by the government, industry, international organisations and civil society on a variety of IP issues. He also served on several government committees.

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