Independent Intellectual Property: Gunning For (or Against) Glivec?

On this momentous occassion of India's 67th independence anniversary, I thought it fit to reflect on the space for "independent" intellectual property thinking. Sadly, tis' a space that is fast shrinking. And the root cause is one that I've highlighted time and again on this blog. A polarisation of our IP debates, and a Bush like "either you're with us or against us" kind of approach. 

Anyone with a half decent view on IP is immediately forced to align with one of the opposing camps: either those that indiscriminately swear by patents OR those that swear at patents! Folks that resist this alignment are hunted down and silenced. This sentiment is wonderfully captured in the context of the "copyright wars" by leading IP scholar, Jessica Litman:

"Like conventional wars, the copyright war has been intensely polarizing. The conflict has been protracted and venomous. The middle ground seems to have disappeared. Anyone who works or writes in the copyright field is either “one of us” or “one of them.” It seems to me that this us-versus-them mentality had some unfortunate effects on the sort of scholarship we all write. "

The Middle Path in IP:

I could not agree more with Prof Litman, particularly since the "middle path" is a favourite theme of mine, finding itself repeated ad nauseam on this blog, including this piece to commemorate the World IP day, where I'd recounted the story of Buddha's salvation and its connection to IP:

"'If you make the string too tight, it will break. If you make the string too loose, it will not play'. These pearls of wisdom, communicated by a music teacher to his pupil in order to explain to him the optimal tautness of the string of a musical instrument, helped catapult the Buddha to nirvana. It led this saint to articulate the “Middle Path” — a position that urges one to avoid taking “extreme” positions. What’s the connection with intellectual property (IP), you may ask? Well, just as we have religious extremism, we’re now witnessing an increasing extremism in IP debates as well."

Also, for those interested, here is another piece of mine advocating for a middle path solution to the drug patent linkage conundrum.

(Un)Seating Glivec:

Unfortunately, this polarisation continues unabated and I witnessed a most vicious version of it in the recent Glivec patent saga.  During one of the hearings, a public health activist walked upto my counsel Gopal Sankarnarayan who had just spotted a vacant seat behind Novartis' counsels and taken it (usual practice in courts to occupy vacant seats wherever one finds them) and exclaimed: I see you've already taken a side in this dispute! Gopal immediately retorted: "Why don't you use your time more productively and read our written submissions. You'll know where we stand without basing it on where we sit. After all, your legal qualification must stand for something, and, at the very least, the ability to read and comprehend legal briefs."

Later, during the hearings, my arguments before the court were thoroughly mis-characterised by Jayant Mehta, the counsel for the IPA (Indian Pharmaceutical Alliance), an organisation that represents the interests of a number of generic manufacturers. He effectively argued before the judges that my interpretation of efficacy and section 3(d) favoured Novartis and the multinational lobby. Given that he came in rather late into the show as an intervenor and did not make any other significant submission other than this blatant mistruth, I was left wondering as to why he did what he did. For my written submissions as an intervenor before the court clearly articulated that Novartis was not entitled to a patent. 

For those interested, the links to my submission are available in this Bar and Bench story and in this SpicyIP post by Prashant. My conclusion (available right in the first page of the summary note to the court) states: "Therefore, under the present set of facts and the evidence filed, the new form (as claimed by Novartis in its patent application) does not cross the section 3(d) hurdle."

I would assume that even a six year old was capable of reading and understand these simple lines. But perhaps Mr Mehta understands the English language in a distinctly different way. For those interested, I've elaborated on why I think the Novartis decision went the way it did in my article in the India Business Law Journal titled "Much ado about Nothing". The full text of this piece is now available on Livelaw.

After the Novartis hearings had concluded, we were deliberating on pharmaceutical patent law and compulsory licensing at a workshop organised by the Delhi based Center for WTO Studies (IIFT). Here, another leading public health activist (for whom I had great respect and regard....well up until that point at least) expressed her outrage at my intervention before the court, which according to her brazenly supported Novartis. Here again, I implored her to do her homework and read my submissions to the court, which had been made public by then and clearly opined that Novartis was not entitled to a patent.

Honestly, I did not know what to make of this. Was this a concerted deliberate attempt to malign and discredit someone who did not fully align with the camps and had a slightly different take on the issue? For I had effectively recommended a standard for defining efficacy which I saw as a middle ground between a highly restrictive definition (which would have effectively granted patents only to new chemical entities) and a highly liberal one that would have granted patents to all ever-greened varieties that demonstrated next to no improvement over an existing drug. Unfortunately the judges refused to wade into this terrain. Or was this just a case of sheer sloppiness of alleged experts who had simply not bothered to read a legal document despite possessing law degrees? Only time will tell.

Glivec and Common Sense:

As for my take on the judgment itself, I think Justices Alam and Desai did a terrific job of infusing a fair amount of common sense back into patent law, a theme which I dwell on extensively in my comments to Darren's incisive post where he castigates the Supreme Court for their allegedly flawed analysis. I extract a key part of my response to his post below:

"You go on to admonish the Supreme Courts' reasoning as sloppy and confused. I think they were pretty clear at least on this count. The apex court held the way it did owing to Novartis's admission in the patent document that the salts specifically outlined in the patent (including the methane sulfonic salt) could be prepared by "known processes". If Novartis knew that the salts specifically disclosed (including Imatinib Mesylate) could not be prepared by "known processes", why did it state so in the patent application? One might be tempted to answer "standard practice". Well, the court is well within its right to disregard a standard practice that is so obviously wrong under a grammatical and dare I say "logical" construct of the English language.

To me, the court did something commendable here: it helped infuse basic common-sensical evidentiary wisdom into patent law. A field that certainly deserves more of such infusion and less of the hyper technical esoteric wisdom that we (patent specialists) often clothe it with. "

Glivec and Attribution:

However, my little quibble with the judges is that they did not credit a critical part of the interpretative framework that they used to me, despite it being very clearly a part of my submission (and not expressed by any of the other myriad counsels who appeared in this case). I had interpreted efficacy to mean "therapeutic efficacy" relying on the very structure of section 3(d), and noted in my written submission as below:

"Illustratively, the Explanation to section 3(d) clearly states that all pharmaceutical derivatives would be considered the same “substance”, unless “they differ significantly in properties with regard to efficacy.”

The above clause refers to only those “properties” that have some bearing on “efficacy” and not all properties. If "all properties" were to qualify, it would effectively render the term "efficacy" redundant. Had Parliament intended “any property” to qualify under section 3(d), the Explanation would simply have stated "unless they differ significantly in properties". Therefore, not all advantageous properties of a new form (such as improved processability or flow characteristics, storage potential etc) ought to qualify under section 3(d), but only those properties that have some bearing on efficacy."

The court effectively borrows directly from this line of reasoning and notes in its judgment that the structure of section 3(d) (what they term as an "internal aid to interpretation") makes clear that efficacy is to be interpreted restrictively (para 157):

“Our inference that the test of enhanced efficacy in case of chemical substances, especially medicine, should receive a narrow and strict interpretation is based not only on external factors but there is sufficient internal evidence that leads to the same view.It may be noted that the text added to Section 3(d) by the 2005 Amendment lays down the condition of “enhancement of the known efficacy”. Further, the Explanation requires the derivative to “differ significantly in properties with regard to efficacy”. What is evident, therefore, is that not all advantageous or beneficial properties are relevant, but only such properties that directly relate to efficacy, which in case of medicine, as seen above, is its therapeutic efficacy."

Independent IP:

Anyway, let me hark back to the independence day theme that I began with. On this historic day, let us work towards freeing our IP debates from the clutches of these caustic camps...at least for the sake of our younger generations that are now joining the IP fray and bringing their own zeal, vigour and creativity into the debate. To burden them with our coloured views and force them to take sides without thinking for themselves would be the greatest disservice.

With the fervent hope that the coming years will see a fresh infusion of vibrant and independent views on IP, let me wish all of you a wonderful Independence Day (at least whatever is left of it now).

ps: image from here.